INTELLECTUAL PROPERTY LICENSE, COLLABORATION AND SUPPLY AGREEMENT
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Exhibit
10.4
INTELLECTUAL PROPERTY LICENSE, COLLABORATION AND SUPPLY
AGREEMENT
AGREEMENT
THIS INTELLECTUAL PROPERTY LICENSE, COLLABORATION AND SUPPLY AGREEMENT (“Agreement”),
effective as of November 9, 2007 (the “Effective Date”) is made and entered into by and between
APPLERA CORPORATION, a Delaware corporation, by and through its Applied Biosystems Group, having a
principal place of business at 000 Xxxxxxx Xxxxxx Xxxxx, Xxxxxx Xxxx, XX 00000 (“AB”), and
BIOTROVE, INC., having a place of business at 00 Xxxx Xxxxxx, Xxxxxx, XX 00000 (“BT”).
RECITALS
A. AB is engaged, among other things, in the business of making and selling instruments for
genetic analysis and reagents including, without limitation, AB TaqMan® genotyping assays and AB
TaqMan® gene expression assays.
B. BT is engaged in the business of making and selling BT Open Arrays™ and instruments for
genetic analysis.
C. The Parties desire to collaborate with respect to the development and commercialization of
arrays for genotyping and gene expression pursuant to the terms and conditions of this Agreement.
D. This Agreement sets forth, among other things, licenses granted to AB under BT intellectual
property.
NOW THEREFORE, in consideration of the mutual covenants and promises contained in this
Agreement, the Parties agree as follows:
ARTICLE I. DEFINITIONS
Terms, when used herein with initial capital letters, will have the meanings set forth herein.
Section 1.01 “AB Intellectual Property” means Intellectual Property that is Controlled by AB,
but excluding any Intellectual Property in or to Joint IP.
Section 1.02 “AB Technology” means all inventions and know-how, conceived solely by one or
more employees or consultants of AB during the term of this Agreement, arising out of work
performed pursuant to or in connection with this Agreement.
Section 1.03 “Affiliate” means a business entity directly or indirectly controlled by,
controlling or under common control with a Party to this Agreement. For purposes of this Section
1.03, the word and root “control” means, in the case of a corporation, either: (a) the direct or
beneficial ownership of more than fifty percent (50%) of the shares of stock entitled to vote for
Directors to the Board of Directors of such corporation, or, (b) where the laws of a
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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particular jurisdiction limit the percentage ownership of domestic corporations by foreign
corporations to less than fifty percent (50%) of the shares of stock entitled to vote for Directors
to the Board of Directors, the maximum percentage ownership permitted by such jurisdiction, and
provided that the Party nevertheless has the ability to direct the activities of such entity
related to this Agreement. For purposes of this Section 1.03, the word and root “control” means,
in the case of a non-corporate entity, either: (a) the right to receive more than fifty percent
(50%) of the net proceeds of such entity, or, (b) where the laws of a particular jurisdiction limit
the percentage ownership of domestic corporations by foreign corporations to less than fifty
percent (50%), the right to receive, the maximum percentage of the net proceeds of such entity
permitted by such jurisdiction, and provided that (in the case of both (a) and (b)) the Party
nevertheless has the ability to direct the activities of such entity related to this Agreement.
Section 1.04 “Arrays” means BT Open Arrays™ (with array sleeves or covers) loaded
with (a) AB TaqMan® SNP genotyping assays (such Arrays, “Genotyping Arrays”), (b) AB
TaqMan® gene expression assays; (c) SYBR Assays (such Arrays, described in (b) and (c)
above, “Gene Expression Arrays”); or (d) such other assays that the Parties jointly
agree to load onto BT Open Arrays™ for Commercialization hereunder.
Section 1.05 “Assays” means AB TaqMan® SNP genotyping assays (such Assays,
“Genotyping Assays”), (b) AB TaqMan® gene expression assays; (c) SYBR Assays (such
Assays, described in (b) and (c) above, “Gene Expression Assays”); or (d) such other
assays as the Parties may jointly agree to load onto BT Open Arrays™ for
commercialization hereunder.
Section 1.06 “BT Intellectual Property” means Intellectual Property (including,
without limitation, any Intellectual Property set forth on Exhibit G) that is Controlled
by BT, but excluding any Intellectual Property in or to Joint IP.
Section 1.07 “BT Open Arrays™” means those array products being commercialized by
BT as of the Effective Date under the “BT Open Array” xxxx in the Field, together with
any modifications and/ or improvements thereto.
Section 1.08 “BT Technology” means all inventions and know-how, conceived solely by
one or more employees or consultants of BT during the term of this Agreement, arising
out of work performed pursuant to or in connection with this Agreement.
Section 1.09 “Collaboration Product” means one or more System Components developed
or Commercialized under the Collaboration Program, including applicable System
Components individually as well as in combination.
Section 1.10 “Collaboration Program” means the collaborative activities (including,
without limitation, collaborative research, development and Commercialization of System
Components) of the Parties pursuant to the terms of this Agreement.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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Section 1.11 “Commercialize” and cognates thereof mean the sale, lease, transfer,
marketing or promotion of a product or service for commercial purposes. For example, a
Collaboration Product will be Commercialized when such Collaboration Product or its use
is provided to any Third Party for cash or other consideration.
Section 1.12 “Confidential Information” means data, information, and technology
(and all tangible and intangible embodiments thereof), which is owned or Controlled by a
Party, is disclosed by such Party (“Disclosing Party”) to the other Party (“Receiving
Party”) pursuant to this Agreement, and is either designated as Confidential Information
by the Disclosing Party at the time of disclosure or, if not designated as such, is of a
type or nature that the Receiving Party reasonably should have known to be or contain
confidential information of the Disclosing Party. Confidential Information will not
include information which, and only to the extent, a Receiving Party can establish by
written documentation: (a) is part of the public domain prior to disclosure of such
information by the Disclosing Party to the Receiving Party or becomes part of the public
domain, without the fault of the Receiving Party, subsequent to disclosure of such
information by the Disclosing Party to the Receiving Party; (b) has been received by the
Receiving Party at any time from a source, other than the Disclosing Party, rightfully
having possession of and the right to disclose such information free of confidentiality
obligations; (c) has been otherwise known by the Receiving Party free of confidentiality
obligations prior to disclosure of such information by the Disclosing Party to the
Receiving Party; (d) has been independently developed by employees or others on behalf
of the Receiving Party without access to or use of such information disclosed by the
Disclosing Party to the Receiving Party. Specific aspects or details of Confidential
Information will not be deemed to be within the public knowledge or in the prior
possession of the Receiving Party merely because the aspects or details of the
Confidential Information are embraced by general disclosures in the public domain. In
addition, any combination of Confidential Information will not be considered in the
public knowledge or in the prior possession of the Receiving Party merely because
individual elements thereof are in the public domain or in the prior possession of the
Receiving Party unless the combination and its principles are in the public knowledge or
in the prior possession of the Receiving Party. Further, for avoidance of doubt,
Confidential Information will include Confidential Information received by the
Disclosing Party from a Third Party. Prior to disclosure of such Third Party
Confidential Information to the Receiving Party, the Disclosing Party will determine
that it has the right to make such disclosure, advise the Receiving Party that the
disclosure includes Third Party Confidential Information and provide the Receiving Party
with the terms and conditions of any confidentiality agreement or confidentiality
provisions of an agreement between the Third Party and the Disclosing Party respecting
such Third Party Confidential Information.
Section 1.13 “Control” and cognates thereof means, with respect to Intellectual
Property that a Party either owns or has a license under such Intellectual
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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Property in each case if and to the extent such Party has the right to grant
licenses (or sublicenses as the case may be) to the other Party hereunder without
obtaining permission from any Third Party.
Section 1.14 “Early Access Period” means the period that commences on the Effective
Date and ends upon the last day of the later to end of the Genotyping Early Access
Period and the Gene Expression Early Access Period, as defined in Sections 3.01 and 3.02
respectively.
Section 1.15 “Field” means Genotyping and Gene Expression but excluding Human In
Vitro Diagnostics. As used herein “Human In Vitro Diagnostics” means the in vitro
measurement, observation or determination of attributes, characteristics, diseases,
traits or other conditions of a human being for the medical management of that human
being.
Section 1.16 “Gene Expression” means all analysis of ribonucleic acid (RNA), other
products of transcription of deoxyribonucleic acid (DNA) or any part or portion of RNA
or such transcription products, or modifications or derivatives thereof.
Section 1.17 “Genotyping” means all analysis of genomic deoxyribonucleic acid
(DNA), modifications or derivatives thereof.
Section 1.18 “Gene Expression Commercialization Phase” means the period commencing
upon the end of the Gene Expression Early Access Period, as defined in Section 3.02, and
continuing for the remainder of the term of this Agreement.
Section 1.19 Genotyping Commercialization Phase” means the period commencing upon
the end of the Genotyping Early Access Period and continuing for the remainder of the
term of this Agreement (and collectively with the Gene Expression Commercialization
Phase, the “Commercialization Phases”).
Section 1.20 “Instrument” means any and all of the following: (a) a Reader, (b)
sample loaders (whether manual or automated) for use with Arrays, (c) a real time PCR
thermal cycler (including Reader capable of real-time PCR analysis) specifically adapted
for use with Arrays and (d) an Array sealing device, as such are more fully described in
Exhibit A hereto. The term “Instrument” excludes the Reformatter. The term Instrument
excludes such instruments sold as of the Effective Date by AB and future modifications
thereof Commercialized by AB and any other instruments developed by AB outside of the
Collaboration Program.
Section 1.21 “Intellectual Property,” means Patents, patent applications,
copyrights, trademarks, inventions, know-how, trade secrets, and any other form of
intellectual property.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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Section 1.22 “Joint Development Committee” or “JDC” means the committee established
pursuant to Section 2.05(b) hereof to manage the Collaboration Program.
Section 1.23 “Joint IP” means inventions and know-how conceived jointly by one or
more employees or consultants of BT and one or more employees or consultants of AB,
during the term of this Agreement, arising out of work performed pursuant to or in
connection with this Agreement.
Section 1.24 “License Agreement” means that certain Patent License Agreement
entered into between the Parties of even date herewith.
Section 1.25 “Net Sales” shall mean the gross invoiced amounts received by AB for
the transfer, lease or sale of Collaboration Products by AB less the following
deductions: transportation costs, packing and crating charges, insurance, customs and
duties, rebates, discounts, rejections and returns actually allowed, allowances in lieu
of such actual returned or rejected Collaboration Products, other reasonable and
customary allowances, and sales, use, excise, value added and turnover taxes. With
respect to services rendered on a fee-for-service basis by AB for Third Parties, such
services shall be treated as a Net Sales of the Arrays that are consumed by AB in
rendering such services, at the average Net Sales amount per unit of the corresponding
(same type and model) Array that was realized by AB over the two calendar quarter period
that includes the calendar quarter in which such services were rendered and the
preceding calendar quarter. In the event System Components are transferred or sold in
combination with other System Components that do not bear revenue share, transfer
payment or royalty obligations hereunder or other apparatus or products that are not
System Components (any of such other System Components, apparatus or products being
“Other Components” and such combination being a “Combination Product”), the Net Sales of
such System Components sold as part of a Combination Product) for purposes of this
Agreement shall be the average (calculated over the six (6) month period that includes
the calendar quarter in which such transfer or sale occurred and the calendar quarter
preceding the date of such transfer or sale of such System Components) Net Sales price
of the same type and model of each System Component multiplied by the number of units of
such transfer price/revenue share/royalty bearing System Component(s) transferred or
sold as part of such Combination Product. If the foregoing average Net Sales price
cannot be calculated, the Net Sales Price of such System Components sold as part of a
Combination Product shall be the Net Sales price for the Combination Product multiplied
by the fraction A/(A+B), where “A” shall equal AB’s U.S. published list price of the
transfer price/revenue share/royalty bearing System Component(s) when sold alone and “B”
shall equal the sum of AB’s U.S. published list prices of all Other Components included
in the Combination Product. If no such published list price or prices are available,
then “A” shall equal AB’s fully burdened cost of goods of the transfer price/revenue
share/royalty bearing System Components(s) and “B” shall equal the sum of AB’s fully
burdened cost of
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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goods of all Other Components included in the Combination Product. Such fully
burdened cost of goods shall be calculated in accordance with AB’s standard and
documented accounting practices and in any event in accordance with United States
Generally Accepted Accounting Principles (“GAAP”).
Section 1.26 “Patents” means United States and foreign patents and patent
applications and all divisionals, substitutions, continuations, continued prosecution
applications, continuations-in-part applications, reissues, renewals, re-examinations,
extensions and supplementary protection certificates with respect to any of the
foregoing, patents issuing from any of the foregoing and all foreign counterparts of any
of the foregoing. “BT Patents” means Patents that are Controlled by BT.
Section 1.27 “Project Plan” means Exhibit A attached hereto that shall describe,
among other things, the Parties’ plan for research, development and Commercialization of
Collaboration Products and BT’s responsibilities, deliverables and time lines for
fulfilling the same.
Section 1.28 “Reader” means an optical imaging instrument for end-point PCR
analysis and illumination components, that is coupled to a computer (but that does not
include any device or components for thermal cycling) that is adapted for use with BT
Open Arrays.
Section 1.29 “Reformatter” means a device that aliquots Assays and loads such
aliquots into reaction holes of the BT Open Arrays™.
Section 1.30 “System Components” means one or more of the following components: (i)
BT Open Arrays™ loaded, or to be used as loaded, with an Assay (ii) any of the Assays as
loaded, or to be used as loaded, in the BT Open Arrays™, (iii) Instruments, (iv) data
collection and analysis software for use with the Arrays, and (v) such other accessory
components or consumables, if any, to be used in connection with the foregoing as may be
determined under the Collaboration Program, including, without limitation, components
supplied by a Third Party to a Party for distribution with other System Components
hereunder.
Section 1.31 “SYBR Assays” means SYBR Green genotyping and gene expression assays
and associated reagents and consumables, all of which are purchased from a licensed
supplier.
Section 1.32 “TaqMan Assays” means AB’s TaqMan® SNP genotyping assays and AB
TaqMan® gene expression assays and associated reagents and consumables.
Section 1.33 “TCSA” shall mean that certain “Thermal Cycler Supplier Agreement”
entered into between the Parties effective as of December 22, 2004.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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Section 1.34 “Third Party” means any entity or person except for AB, BT and their
Affiliates.
Section 1.35 “Territory” means worldwide.
Section 1.36 “Trademarks” means the trademarks used from time to time with respect
to the Collaboration Products, whether already owned or Controlled by BT or AB or
generated by one or both Parties under the Collaboration Program.
Section 1.37 “Valid Claim” shall mean a claim of an issued and unexpired patent
that has not been held invalid or unenforceable by a decision of a court, patent office,
or administrative tribunal from which no appeal is available or a [***].
ARTICLE II. COLLABORATION PROGRAM
Section 2.01 Scope of Collaboration. AB and BT will work together during
the term of this Agreement in accordance with the Project Plan to develop, manufacture
and Commercialize Arrays and associated System Components for use in the Field subject
to the licenses granted to AB under the BT Intellectual Property. During the term of
this Agreement, BT covenants that, except as expressly permitted under this Agreement,
BT shall not: (i) collaborate with or provide assistance to any Third Party in the Field
(other than an end user or distributor of a Collaboration Product to the extent
permitted under this agreement); nor (ii) grant licenses or other intellectual property
rights in the Field to any Third Party under Intellectual Property Controlled by BT. BT
shall retain all of BT’s rights to all applications to BT Intellectual Property outside
the Field. Notwithstanding anything herein to the contrary, and without limiting the
foregoing, BT shall not supply (or have supplied) System Components that are or contain
BT Open Arrays™ to any Third Party for use in the Field. Notwithstanding the foregoing,
BT may provide Custom Application Services as set forth in Section 6.04.
Notwithstanding anything herein to the contrary, BT may after the Effective Date enter
into agreements with Third Parties solely during the Gene Expression Early Access Period
solely to develop Gene Expression Arrays using assay and reagents developed by such
Third Parties for sale to end users, provided that (i) such Third Party agreements are
subject to BT’s obligations and AB’s rights hereunder and such agreements with Third
Parties do not conflict with AB’s rights and BT’s obligations hereunder; (ii) BT
provides AB with a copy of such agreement at least thirty (30) days prior to its
execution in order to allow AB to raise any objections with respect to provisions of
such agreement that conflict with BT’s obligations or AB’s rights hereunder (where AB
raises such objections BT shall use its best efforts prior to execution of such
agreement to eliminate such conflicting provisions or to amend the same to eliminate
such conflict; (iii) any Third Party agreements shall provide BT with the right to
terminate for any reason upon sixty (60) days notice and (iv) upon AB exercising its
right, pursuant to Section 5.01, to initiate the Gene Expression Commercialization
Phase, BT shall terminate such
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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agreements with such Third Parties at BT’s expense. The foregoing shall not be
construed as conveying to BT or to any such Third Party any right, license or immunity
from suit under any Intellectual Property Controlled by AB.
Section 2.02 Existing Commitments. AB acknowledges that BT has certain
existing contractual commitments to Third Parties in the Field that it has disclosed to
AB to the extent set forth on Exhibit F. BT represents, warrants and covenants that
such existing contractual commitments shall not in any way, except as expressly set
forth on Exhibit F, limit or affect BT’s obligations and performance under this
Agreement. BT agrees that by December 31, 2008, unless otherwise mutually agreed by the Parties
hereto, it will terminate all of such Third Party agreements or permit them to expire by
such date at BT’s expense. To the extent BT is unable to terminate such agreements with
such Third Parties and AB has commenced Commercialization (whether in the Genotyping
field or in the Gene Expression field) of Arrays, BT shall pay AB [***] of BT’s revenue
arising after December 31, 2008 that resulting from such sales or other activities under such
agreements Third Parties. If AB wishes BT to attempt to terminate any such commitments
sooner, BT will cooperate with AB in such efforts as determined by the JDC.
Section 2.03 AB further agrees that, during the term of this Agreement, except as
provided under this Agreement, AB does not have any right under applicable BT
Intellectual Property, to make, use or sell Arrays.
Section 2.04 Collaboration Program Phases. The Collaboration Program will
be divided into two consecutive phases: first, the Early Access Period and second, the
Commercialization Phase, as each are described in Articles III and IV, respectively.
Section 2.05 Collaboration Program Management and Governance. The
Collaboration Program will be managed as follows:
(a) Working Collaboration Team(s). The Parties will establish working teams and
subteams (collectively, “Working Collaboration Team”) to coordinate and oversee day-to-day
operations and development activities and such other aspects of the Collaboration Program as the
Parties agree. The Parties will have equal representation on the Working Collaboration Team. All
decisions of the Working Collaboration Team shall be by unanimous consent of both Parties. In the
event that any Working Collaboration Team is unable to resolve any disputes that arise, such
dispute will be referred to the Joint Development Committee.
(b) Joint Development Committee. The Parties will establish a joint development
committee (“Joint Development Committee” or “JDC”) to provide a means to facilitate communications,
coordinate development and Commercialization activities, discuss and address issues, make strategic
decisions and provide necessary approvals and resolve disputes with respect to the Collaboration
Program. Without limiting the foregoing, the Joint Development Committee will explore and approve
any future markets and applications within the Field for existing and next generation Collaboration
Products. The JDC will be composed of four
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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executives (two representatives of each Party). All decisions of the JDC shall be by
unanimous consent of both Parties. Unless otherwise agreed by the Parties, the JDC will meet at
least quarterly either in person or via telephone conference. The Parties shall alternate having
their respective representative chair the meetings, which chair shall be responsible for preparing
the agenda and minutes for such meetings and for obtaining mutual written approval of such minutes
from both Parties. Such minutes as approved by the Parties shall constitute the official record of
the actions of the JDC.
ARTICLE III. EARLY ACCESS
Section 3.01 Genotyping Early Access. The Early Access Period for the Genotyping
Arrays (the “Genotyping Early Access Period”) shall commence on the Effective Date and end upon
AB’s decision, made in its sole discretion, that it is ready to commence direct or indirect
distribution or sales of Genotyping Arrays. During the Genotyping Early Access Period:
(a) AB will offer AB customers the option of requesting that Genotyping Assays that
such customers purchase from AB be loaded onto BT Open Arrays. Customers requesting this
service will be invoiced for the Genotyping Assays by AB and such Genoypting Assays will by
sold by AB to such customers. AB will ship the customer’s Genotyping Assays to BT at such
customer’s sole expense. Subject to subsection (b) below, BT will use such AB customers’
Genotyping Assays during the Early Access Period solely to load such Genotyping Assays onto
BT Open Arrays for such customers. AB shall have the right to charge BT for the purchase
price invoiced to such customers by AB for any Assay provided by AB to BT for such purposes
that is lost, destroyed (or not fabricated into Arrays in accordance with such customers
request) by BT in excess of [***] of the units of Assay provided by AB (losses less than or equal to [***] representing ordinary yield loss). Such Genotyping Arrays and associated product literature will, as AB
may in its discretion instruct BT in writing, be labeled with AB’s trademarks and may also
be branded or co-branded (as the case may be) with BT’s trademarks (subject to AB’ prior
review and approval and to AB’s requirements with respect to AB trademarks, branding and
associated quality control standards); provided, however, that in any event such BT branding
or co-branding by BT shall be done in a manner that makes it clear to the customer that the
reagents and assays supplied or manufactured by AB are not a BT product and that BT’s
contribution and branding pertains solely to the BT Open Arrays and not to the Assays. In
no event will BT apply its trademark to any reagents or assays or associated product
literature manufactured or supplied by AB. BT may invoice the customer for the BT Open
Arrays, BT’s loading services, and shipping/handling, but will not charge the customers for
the Genotyping Assays themselves.
(b) AB will provide to BT a reasonable supply (at a price to be mutually agreed upon by the parties through the JDC) with a quantity, as set forth in
the Project Plan or as agreed upon by the JDC, of Genotyping Assays to be used by BT solely
to load BT Open Arrays for BT’s performance of BT’s internal research and development
responsibilities for the Collaboration Program under this Agreement as set forth in the
Project Plan and as otherwise determined by the JDC.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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(c) BT will have the right, solely as and to the extent provided in the License
Agreement, to manufacture, sell and service thermal cyclers with real-time capability in
connection with the sale of Genotyping Arrays hereunder during the Genotyping Early Access
Period. In addition, BT will have the right to promote for use by end-users of Genotyping
Arrays, thermal cyclers manufactured and sold by manufacturers licensed by AB (provided that
such use is consistent with the license entered into between AB and such manufacturer). BT
will also have the right to manufacture and sell basic (non-real time PCR) thermal cyclers,
solely as and to the extent provided in BT’s existing TCSA agreement with AB for use by
end-users of Genotyping Arrays.
(d) AB and BT will scale up to prepare for launch of Collaboration Products containing
Genotyping Arrays in accordance with the Project Plan (defined below).
(e) AB shall have the right, at AB’s sole discretion, upon thirty (30) days prior
written notice to BT, to designate particular (prospective) sales of Collaboration Products
on an individual customer account basis or on an individual order basis to be treated as if
with respect to such sales of Collaboration Products, the Genotyping Commercialization Phase
had commenced, thereby making such designated sales subject to the provisions of Article IV
(including applicable licenses from BT to AB), to Article VII and to other provisions of
this Agreement that would otherwise be applicable to such designated products only after the
Genotyping Commercialization Phase commenced. However, neither such designation by AB nor
AB’s Commercialization of such Collaboration Products shall be deemed to trigger the end of
the Genotyping Early Access Period or the commencement of the Genotyping Commercialization
Phase for any other Collaboration Products or for any other sales or accounts (and, except
for the revenues sharing provisions of Section 5.03 herein applicable to AB’s
Commercialization of such designated Collaboration Products, the financial obligations
(including, without limitation, those set forth in Section 4.01(b) and Section 5.01 herein)
of AB that would otherwise be applicable during the Genotyping Commercialization Phase shall
not be triggered as a result of AB’s designation or Commercialization of such sales of
Collaboration Products, accounts or orders pursuant to this Section 3.01(e)). Upon
receiving such notice, BT shall commence supplying AB with the corresponding Genotyping
Arrays or other Collaboration Product pursuant to Article VII and provide AB with reasonable
assistance as may be requested by AB to enable AB to fulfill such designated sales.
Section 3.02 Gene Expression Early Access. An Early Access Period for the Gene
Expression Arrays (the “Gene Expression Early Access Period”) shall commence on the Effective Date
and end upon AB’s decision, made in its sole discretion, that it is ready to commence direct or
indirect distribution or sales of Gene Expression Arrays. If AB and BT have agreed that AB will no
longer pursue (or has no interest in pursuing) Commercialization of Gene Expression Arrays or if
the Parties fail to reach an agreement on the financial terms of the option set forth in Section
5.01 (b) herein, then the Field of this Agreement shall be deemed to exclude the field of Gene
Expression and the contractual obligations of this Agreement shall not pertain with respect to Gene
Expression. During the Gene Expression Early Access Period, BT will
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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manufacture and distribute Gene Expression Arrays, and real-time PCR thermal cyclers (in
particular the thermal cyclers defined in the License Agreement as Licensed Real-Time Thermal
Cyclers) in accordance with the xxxxx and conditions of the License Agreement.
ARTICLE IV. COMMERCIALIZATION PHASE
Section 4.01 Genotyping Commercialization Phase. During the Genotyping
Commercialization Phase:
(a) BT will manufacture and supply, exclusively to AB, BT Open Arrays™ and other System
Components as may be requested by AB for use with Genotyping Arrays. Acting as a contract
manufacturer for AB, BT will load BT Open Arrays™ with Genotyping Assays as instructed by
AB. Subject to Section 5.03, such Genotyping Assays will be provided at no charge to BT, to
be used by BT solely in order to create Genotyping Arrays for AB. All System Components
manufactured or supplied by BT to AB (or on behalf of AB) would be exclusively distributed
(directly or indirectly) and otherwise Commercialized by AB pursuant to this Agreement as AB
products under AB’s trademarks. System Components that are not subject to the License
Agreement and that are not otherwise covered by Patents Controlled by AB would be co-branded
with BT’s trademark or otherwise have an attribution to BT. Arrays and other System
Components manufactured by BT hereunder and covered by the License Agreement or Patents
Controlled by AB would not be trademarked or co-branded as a BT product, but may be labeled
in a manner that indicates that such product is made by BT as a contract manufacturer for
Applied Biosystems (e.g., “made for Applied Biosystems by BioTrove, Inc.” or “Open
Arrays™”). Notwithstanding the foregoing, the Assays, or other assays or reagents supplied
by AB, and associated product literature, shall not bear BT’s trademark or any other
branding or statement implying that BT is the manufacturer or supplier of such Assay, other
assays or reagents. The labeling and branding of Arrays and other System Components shall
be done in such a manner that makes it clear that reagents, Assays and other assays
manufactured by AB are not a BT product.
(b) During each two calendar quarter period of the Genotyping Commercialization Phase,
AB shall purchase a minimum quantity of Arrays equal to at least [***] of AB’s forecast (submitted as per Section 7.03) for units of Arrays for such two-quarter periods. Such minimum unit
quantity would be determined as follows: beginning within thirty (30) days following June 30
and December 31 of the first year (each a Semi-Annual Period) within which the Genotyping
Commercialization Phase has commenced, and semi-annually thereafter, AB will compute the
number of units of Arrays equal to [***] of the forecast number for each Semi-Annual Period (the number of units so calculated for each
Semi-Annual Period, the “Minimum Purchase Requirement”). If AB fails to purchase at least
the corresponding Minimum Purchase Requirement for a given Semi-Annual Period, AB will
pay BT the payment amount computed as follows (the “[***]”): (i) first [***] made by [***]
from the [***] (the resulting number, the “[***]”); (ii) multiply the [***] by the average [***] for the corresponding [***] during
the relevant [***]; (iii) multiply the value computed in (ii) above by the applicable [***] set forth in [***] will, at AB’s request, [***] the number of [***] represented by [***] for which AB has
paid the [***] (and for which no [***] under [***] shall be due). The [***] for any partial period during the
Commercialization Phase, will be adjusted pro-rata, [***].
(c) Effective upon the commencement of the Genotyping Commercialization Phase, AB shall
have (i) the exclusive right (subject to the revenue sharing provisions of
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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Section 5.03) to market and distribute Genotyping Arrays directly and through its
distributors worldwide in the Field; and (ii) the nonexclusive, royalty-free right to use
Genotyping Arrays for research and development purposes in the Field. AB shall not use or
sell any Genotyping Arrays outside the Field. AB shall also have an exclusive
royalty-bearing (as set forth in Section 5.03) (provided however that if BT is making such
Instruments for AB, then such royalty shall be satisfied through the transfer price set
forth in Section 5.04) license under BT Intellectual Property to make, have made, use, sell,
offer for sale and import Instruments directly and through AB’s distributors in the
Genotyping field, throughout the Territory. BT shall not supply to Third Parties (or have
supplied) Instruments for use in Genotyping (i.e., that contain or are for use with
Genotyping Arrays) throughout the Territory during the Genotyping Commercialization Phase,
whether or not such Instruments can also be used for Gene Expression. BT shall transfer to
AB all such know-how and provide reasonable assistance to AB as necessary for AB to enjoy
the full benefit of such licenses.
Section 4.02 Gene Expression Commercialization Phase. During the Gene Expression
Commercialization Phase:
(a) BT will manufacture and supply, exclusively to AB, BT Open Arrays™ and other System
Components as may be requested by AB for use with Gene Expression Arrays. Acting as a
contract manufacturer for AB, BT will load BT Open Arrays™ with Gene Expression Assays as
instructed by AB. Subject to Section 5.03, such Gene Expression Assays will be provided at
no charge to BT, to be used by BT solely in order to create Gene Expression Arrays for AB.
All System Components manufactured or supplied by BT to AB (or on behalf of AB) will be
exclusively distributed (directly or indirectly) and otherwise Commercialized by AB as AB
products under AB’s trademarks. System Components that are not subject to the License
Agreement and that are not otherwise covered by Patents Controlled by AB will be co-branded
with BT’s trademark or otherwise have an attribution to BT (e.g., “made for Applied
Biosystems by BioTrove, Inc.”). Arrays and other System Components manufactured by BT
hereunder and covered by the License Agreement or Patents Controlled by AB would not be
trademarked or co-branded as a BT product, but may be labeled in a manner that indicates
that such product is made by BT as a contract manufacturer for Applied Biosystems (e.g.,
“made for Applied Biosystems by BioTrove, Inc.” or “Open Arrays™”). Notwithstanding the
foregoing, the Assays, or other assays or reagents supplied by AB, and associated product
literature, shall not bear BT’s trademark or any other branding or statement implying that
BT is the manufacturer or supplier of such Assay, other assays or reagents. The labeling
and branding of Arrays and other System Components shall be done in such a manner that makes
it clear that reagents, Assays and other assays manufactured by AB are not BT products.
(b) Effective upon the commencement of the Gene Expression Commercialization Phase, AB
shall have (i) the exclusive right (subject to the revenue sharing provisions of Section
5.03) to market and distribute Gene Expression Arrays directly and through its distributors
worldwide in the Field; and (ii) the nonexclusive
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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royalty-free right to use Gene Expression Arrays for research and development purposes
in the Field. AB shall not use or sell any Gene Expression Arrays outside the Field. AB
shall also have an exclusive royalty-bearing (as set forth in Section 5.03) (provided
however that if BT is making such Instruments for AB, then such royalty shall be satisfied
through the transfer price set forth in Section 5.04) license under BT Intellectual Property
to make, have made, use, sell, offer for sale and import Instruments directly and through
AB’s distributors in the Gene Expression Field, throughout the Territory. BT shall not
supply to Third Parties (or have supplied) Instruments for use in Gene Expression (i.e.,
that contain or are for use with Gene Expression Arrays) throughout the Territory during the
Gene Expression Commercialization Phase, whether or not such Instruments can also be used
for Genotyping. BT shall transfer to AB all such know-how and provide reasonable assistance
to AB as necessary for AB to enjoy the full benefit of such licenses.
Section 4.03 Marketing, Pricing. AB shall have the sole right, at AB’s sole
discretion, to set pricing and implement marketing strategies for Arrays, Instruments and other
products distributed hereunder by AB.
ARTICLE V. FINANCIAL TERMS
Section 5.01 License and Exclusivity Access Payments. AB will pay to BT the following
payments:
(a) License and Exclusivity Access Payments. In consideration of the rights
granted by BT hereunder to AB, including, without limitation, the exclusive rights granted
to AB pursuant to Article IV herein, BT’s exclusivity obligations under Article II and BT’s
performance of its other obligations hereunder, AB shall make the following payments to BT:
(i) [***] shall become due within thirty (30) days of the Effective Date of this Agreement,
and (ii) upon AB’s sole determination as indicated in writing to BT that it is prepared to
initiate the Genotyping Commercialization Phase, AB will, upon the date of commencement of
such Genotyping Commercialization Phase, pay to BT an additional [***].
(b) Gene Expression Commercialization Option. AB shall have the right at any
time during the term of this Agreement to initiate the Gene Expression Commercialization
Phase subject to the Parties, as set forth below, agreeing upon the financial terms of a
milestone payment that would be triggered by commencement of the Gene Expression
Commercialization Phase and the revenue share to be paid by AB to BT as the transfer price
for Gene Expression Arrays as per Section 5.03. AB’s right shall, until the second year
anniversary of the Effective Date, be in the form of an exclusive right of first negotiation
with the financial terms to be negotiated in good faith based on the fair market value of
the business opportunity represented by Commercialization of Gene Expression Arrays. In the
event that AB elects, before the second anniversary of the Effective Date, to exercise such
right of first negotiation it shall do so by written notice to BT and subject to the
procedure below. After such two year period, if AB shall
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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not have provided such written notice, BT shall have the right to Commercialize such
Gene Expression Assays in collaboration with a Third Party subject to BT first providing AB
with written notice of BT’s intention to Commercialize such Assays with a Third Party and
subject to the following conditions set forth in this Section 5.01(b). Within thirty (30)
days of receipt of such notice from BT, AB, at its sole discretion, may elect to exercise
the same initial exclusive negotiation procedure with BT as set forth in this Section 5.01
(b) as would apply were AB to exercise its right of first negotiation within such two year
period. Regardless of the circumstances under which AB exercises its right of first
negotiation hereunder (or when such right is exercised), the Parties shall commence such
negotiations within [***] after BT’s receipt of such notice or AB’s receipt (after such two
year period) of BT’s notice as the case may be. Such exclusive negotiation period shall,
unless AB elects to earlier terminate such discussions, extend for [***] beyond the
commencement date of such negotiation. If at the end of such period, BT and AB are unable
to agree on such financial terms for the Commercialization of Gene Expression Arrays, then,
unless the Parties agree to extend the negotiation period, AB shall promptly deliver to BT a
final proposal detailing AB’s proposed financial terms (the “Final Proposal”). BT shall
have [***] from receipt of the Final Proposal to notify AB of its willingness to enter into
an arrangement on such terms or not. If BT rejects such terms, then BT shall no longer be
restricted by the terms of this Agreement from entering into discussions with Third Parties
directed at a collaboration with respect to the Commercialization of Arrays for Gene
Expression and entering into such collaboration with such Third Party; provided, however,
that BT agrees that, with respect to any discussions with a Third Party involving
Commercialization of Gene Expression Arrays, it will not accept from such Third Party or
offer such Third Party financial terms that are more favorable to the Third Party than those
terms offered to or proposed to be entered into with AB. Prior to entering into any such
arrangement with a Third Party directed at the Commercialization of Arrays for Gene
Expression, BT shall provide AB with a true and accurate copy of the proposed financial
terms of such arrangement with such Third Party and AB shall have [***] from receipt of such
notice to elect to commence the Gene Expression Commercialization Phase on financially
equivalent terms (e.g., with a financially comparable milestone fee and revenue share). In
the event that, subject to BT’s compliance with the terms of this Section 5.01(b), BT enters
a definitive agreement with a Third Party, then on the date of execution of that agreement,
the Field shall be deemed to exclude Gene Expression and the terms and conditions of this
Agreement shall cease to apply with respect to Gene Expression products.
Section 5.02 Transfer Price. After commencement of the Genotyping Commercialization
Phase, the Transfer Price for BT Instruments supplied by BT to AB hereunder will be as specified
below:
INSTRUMENT | TRANSFER PRICE | |
NT Imaging System (Reader) and Case Sealing
Station (Array sealing device) (part number
|
$[***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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INSTRUMENT | TRANSFER PRICE | |
20262-100 and 20253) |
||
NT Cycling System ([real-time PCR thermal cycler
comprising imager and thermal cycling block])
part no. 20262-200 and Case Sealing Station part
no. 20253
|
$[***] | |
BT Open Array Automated Loader (sample loader) part no. 20353
|
$[***] |
The Transfer Price includes all charges for boxing, packing, crating, drayage, storage,
freight, insurance, and all federal, state and local taxes, and duties, with the sole exception of
taxes due on AB’s net income. Payments shall be made within thirty (30) days of receipt by AB.
Section 5.03 Array Revenue Sharing. The transfer price for Arrays (including cases
thereon) supplied hereunder by BT to AB shall be in the form of a revenue sharing based upon AB’s
Net Sales of such Arrays to Third Parties. Such revenue sharing shall also be in consideration of
the work to be undertaken by BT and BT’s other obligations set forth herein. The revenue sharing is
as set forth below (such revenue sharing payments, the “Revenue Sharing Payments”):
PERIOD | REVENUE SHARING PAYMENTS | |
Genotyping Commercialization Phase |
AB pays BT the following percentages of its Net Sales of Genotyping Arrays during each year of this Agreement, commencing upon the Genotyping Commercialization Phase: [***] during the first year following commencement of the Genotyping Commercialization Phase; [***] during the second and third year thererafter; and [***] during each subsequent year of the Collaboration Agreement. | |
Gene Expression Commercialization Phase |
To be determined in accordance with Section 5.01(b). |
All Revenue Sharing Payments under this Section 5.03 shall be made no later than [***] after
the end of the first and all subsequent calendar quarters following the commencement of the
applicable period or phase set forth above. During the Commercialization Phase, Revenue Sharing
Payments to be paid by AB to BT shall be adjusted downwards if BT fails to fulfill, but only so
long as it fails to fulfill, its supply obligations as set forth in Article VII. In addition, AB
shall have the right to credit against such Revenue Sharing Payments to BT the catalog price of
such quantity of Assay provided by AB to BT that is lost, destroyed (or not fabricated into
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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Arrays in accordance with AB’s instructions that conform to the requirements of this
Agreement) by BT in excess of [***] (losses less than or equal to [***] representing ordinary yield
loss).
Section 5.04 Instrument Royalty. During the Commercialization Phases only, AB shall
during the initial term of this Agreement, and any agreed upon renewals thereof, pay BT a royalty
on AB’s Net Sales of the following Instruments solely to the extent covered by Valid Claims of BT
Patents at the time, and in the country, of sale or to the extent incorporating know-how that is
Confidential Information of BT disclosed to AB hereunder:
INSTRUMENT | ROYALTY | |
AB manufactured Reader designed by BT
|
[***], if covered by Valid Claim of BT Patent; or | |
[***], if not covered by an issued patent that is a Valid Claim of a BT Patent but that is covered by a pending application that is a Valid Claim of a BT Patent and/or incorporates know-how that is Confidential Information of BT; provided however that where such Reader only incorporates such know-how but is not covered by a Valid Claim of the BT Patents, such royalty obligation shall continue for no more than [***] by AB of such Reader. | ||
AB manufactured Reader
where the design is an
AB modification of BT’s
design
|
[***], if covered by an issued patent that is a Valid Claim of a BT Patent; or | |
[***], if not covered by a Valid Claim but is covered by a pending application of a Valid Claim of a BT Patent and/or incorporates know-how that is Confidential Information of BT; provided however that where such Reader only incorporates such know-how but is not covered by a Valid Claim of the BT Patents, such royalty obligation shall continue for no more than [***] by AB of such Reader. |
All royalty payments under this Section 5.04 shall be made no later than [***] after the end
of the calendar quarter in which such Net Sales are realized by AB.
Section 5.05 Record Keeping; Reporting. AB shall keep complete and accurate records
of all information necessary for the computation of payments due to BT under Section 5.03 and
Section 5.04, and commencing upon the first calendar quarter in which such respective sales are
made by AB, AB shall, within [***] after the end of each calendar quarter, provide royalty reports
to BT of Net Sales of Arrays and Instruments during such calendar quarter. Such reports shall
indicate Net Sales on a country-by-country basis, and the calculation of the revenue share
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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due to BT, and any payments to be made hereunder. When AB delivers such reports, it shall
also deliver all payments due under this Agreement to BT for such calendar quarter. Both such
reports and the corresponding payment shall be delivered to BT at the address indicated in Section
14.03 (Notices).
Section 5.06 Audit Right. For the sole purpose of verifying payments due hereunder to
BT, BT shall have the right at its own expense, [***], to retain an independent certified public
accounting firm reasonably acceptable to AB, to conduct an audit in the location(s) where such
records are maintained upon [***] prior written notice (provided however that, at AB’s request, the
timing of such audit shall not be such as to coincide with AB’s end of fiscal quarter or end of
year accounting activities directed at 10Q and 10K preparation) and during regular business hours,
with all information disclosed being deemed and maintained by such auditors as Confidential
Information of AB. Records subject to such audit shall be limited to the [***]. The auditors
shall report the financial findings (together with such financial data reasonably necessary to
demonstrate the basis for such findings) to BT in writing with a copy to AB, but the auditors shall
not disclose to BT nor shall BT have the right to review AB’s records nor any other information
obtained by such auditors. Such audit shall be completed within [***], subject to reasonable
extension (not to exceed a further [***]) by the auditor if the auditor reasonably determines in
good faith that data or information it requires is not available and identifies the data or
information required. If the audit reflects an underpayment of amounts due, AB shall promptly
remit the amount of such underpayment to BT and if the audit reflects an overpayment, BT shall
promptly reimburse the overpayment to AB. The cost of such audits shall be paid by BT unless the
results of an audit reflect an underpayment of amounts due to BT by [***], in which case AB shall
reimburse BT for the costs of the audit.
Section 5.07 Currency Conversion. The Revenue Sharing Payments and royalty payments
due and payable under Section 5.03 and Section 5.04, respectively, shall be computed for each
calendar quarter in the currency in which the sale was made, but shall be definitely discharged by
payment in U.S. dollars converted from such currency using the closing spot exchange rate between
the two currencies quoted in the Wall Street Journal (or, if not available, such other mutually
agreeable financial publication of international circulation) in effect on the last business day of
the calendar quarter to which the payment relates.
ARTICLE VI. PRODUCT DEVELOPMENT
Section 6.01 The Project Plan. The preliminary specifications of Collaboration
Products to be Commercialized during the Commercialization Phase are set forth in Exhibit B, and
the activities to be undertaken by the Parties directed at the development and Commercialization
thereof shall be described in a mutually agreed Project Plan, the initial description of which is
set forth in Exhibit A. The Parties shall diligently and in good faith work to amend and finalize
a detailed Project Plan and Specifications within [***] of the Effective Date and append the same
to Exhibits A and B, respectively. Both Parties will use commercially reasonable efforts to achieve
first commercial release of the Genotyping Arrays within one year from the Effective Date. The
minimum commitments of resources and personnel for development of such Collaboration Products will
be specified in the Project Plan. The Project
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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Plan and Specifications may be modified from time to time in accordance with the mutual
agreement of the Parties, with such modified Project Plan and Specifications to be appended to
Exhibits A and B, respectively. The Parties shall use reasonable efforts and shall advise and
consult with each other to ensure that the Specifications of Collaboration Products reflect not
only desirable design attributes, form, fit and function but also, where reasonably possible,
design around valid Third Party patent rights that may otherwise cover such Collaboration Products.
Section 6.02 Product Development Responsibilities. Under the Project Plan,
(a) AB will be responsible for development of TaqMan Assays, data collection and
analysis software in accordance with the Project Plan.
(b) BT will be responsible for development of the sample loaders (both manual and
automated), the Array sealing device, the Reformatter and the BT Open Array component of the
Arrays in accordance with the specifications for the Collaboration Products to be
Commercialized during the Commercialization Phases. Such specifications will be set forth in
the Project Plan attached hereto as may be amended by mutual agreement of the Parties
through the JDC.
(c) The Parties will discuss and agree upon allocation of responsibility for
development of the following Collaboration Product components: thermal cyclers, Reader and
instrument accessories thereto.
(d) Each Party will bear its own costs and expenses associated with the performance of
its obligations under the Collaboration Program, including in performance of the Project
Plan (except to the extent expressly provided otherwise herein).
Section 6.03 Additional Support.
(a) In addition to what is set forth in the Project Plan, BT will provide, subject to
AB’s payment of the fees described below, additional services for the development and
Commercialization of Collaboration Products, including. without limitation, and as mutually
agreed between the Parties, services consisting of: (i) the development of improvements to,
and re-engineering and re-design work on, Collaboration Products other than as specified in
the Project Plan, (ii) additional training, marketing and sales work with respect to
Collaboration Products (all such additional services beyond what is already contemplated in
the Project Plan, “BT Services”). BT’s fees for such BT Services, and AB’s payment
obligations with respect thereto, shall be agreed upon by the JDC prior to the commencement
of any such BT Services not to exceed the lesser of: (i) BT’s fully burdened wage cost for
the employees allocated (in a reasonable number and with reasonable qualifications and
expertise) to perform such BT Services or; (ii) [***] (in a reasonable number and with
reasonable qualifications and expertise) to perform such BT Services. AB shall also [***].
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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(b) In addition to supplying to AB the quantities of BT Open Arrays forecasted for AB’s
commercial sales, BT will provide an [***], as directed by AB, with assays or dyes selected
by AB, [***], and [***] to AB for internal research and development purposes related to this
Collaboration Program in accordance with the delivery schedule requested by AB, [***] ([***]
as per Exhibit H for such products [***] as per Section 3.1(a)(ii) of the License
Agreement). BT will provide additional BT Open Arrays and Instruments as AB may reasonably
request during the term of this Agreement [***] in accordance with the fee schedule set
forth in Exhibit H to this Agreement.
(c) AB will provide to BT mutually agreed reasonable quantities and types of its
reagents (probes, enzymes), thermal cyclers and real time thermal cyclers as set forth in
the Project Plan for BT’s internal research and development use at a cost to BT to be agreed by the JDC.
Section 6.04 Custom Applications. Subject to the JDC’s prior written approval, BT
shall have the right to provide and collect fees for customer-requested custom assay layout or
custom sample layout configurations for Arrays as well as assay testing and validation services
(collectively, “Custom Application Service”). Notwithstanding the foregoing, the Arrays that are
the product of such Custom Application Services may only be Commercialized under the terms and
conditions mutually approved by the Parties under the JDC and, in any event, only subject to the
following conditions:
(a) The making, using or selling of such Custom Applications by BT shall not infringe
Third Party Intellectual Property rights; and
(b) BT Open Arrays™ for use with Custom Applications shall be sold exclusively by AB
through a restricted part number not in AB’s catalogue, subject to revenue sharing under
Section 5.03 and 5.04 hereunder.
ARTICLE VII. MANUFACTURING AND OEM SUPPLY
Section 7.01 Supply of System Components. For the Commercialization Phases, BT will
manufacture and provide BT Open Arrays and other System Components required or agreed to be
provided hereunder according to specifications set forth in Exhibit B (“Specifications”), as
modified from time to time by the Parties, with such modified Specifications to be appended to
Exhibit B of this Agreement (or the mutually agreed upon written document containing such
Specifications shall be referenced on Exhibit B and thereby incorporated by reference). The Parties
shall use commercially reasonable efforts to timely agree upon applicable Specifications for System
Components to be supplied hereunder. BT will supply a sufficient quantity of such System
Components to meet AB’s forecasted needs BT will maintain a safety-stock of such System Components
(including repair kits, preventative maintenance kits and spare parts) in the quantities and in
accordance with the procedures to be set forth on Exhibit C, as reasonably and mutually agreed from
time to time (collectively, “Safety-Stock”).
Section 7.02 Supply Failure. Without limiting AB’s other remedies, if BT fails to
fulfill its manufacturing and supply obligations with respect to Arrays or BT Open Arrays (defined
as the failure of BT to supply at least [***] (but only to the extent [***]) to be supplied to AB
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
19
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hereunder over any given [***], and failure to make up such shortfall within [***] after
written notice from AB thereof), the escrowed information and materials under Section 8.09 shall be
released and AB shall automatically be released from its obligation to purchase Arrays or BT Open
Arrays hereunder and AB may exclusively make or have made all Arrays and BT Open Arrays for the
Collaboration Products. Furthermore, the Revenue Sharing Payments under Article V shall be reduced
to [***] of Arrays in lieu of the Revenue Sharing Payments described in Section 5.03 (with [***]
thereof contingent upon the existence of Valid Claims of BT Patents that cover such Arrays, and
[***] reflective of BT know-how incorporated into such Arrays). BT will resume supplying if BT
demonstrates to AB’s satisfaction that BT has implemented corrective action and will be able to
consistently manufacture Arrays to applicable Specifications and timeframes or to exceed the AB or
third party manufacturer’s ability to do so (in which case, on a prospective basis, the
aforementioned purchase commitment and full revenue share shall be reinstated).
Section 7.03 Forecasts and Orders.
(a) Within [***] following the first commercial release of an Array as a Collaboration
Product, and within [***] from the beginning of each calendar quarter thereafter during the
term of this Agreement, AB shall furnish to BT a [***] (except as set forth in Section 4.01)
rolling forecast of Arrays covering the next [***], broken down into [***] increments (and
by type of Array if more than one involved). If orders are placed with BT that exceed such
rolling forecast, BT shall [***] but (unless BT nonetheless accepts such order) BT [***].
Orders [***] of the current quarter forecast shall not trigger the failure to supply
provision in Section 7.02. However, BT shall use reasonable efforts to fulfill such orders
or reach an accommodation acceptable to AB for orders in [***] of the forecast. AB or its
Affiliates will order Arrays by issuing to BT a purchase order (“Order”) therefor, which (a)
will specify the type and quantity of such Arrays ordered, place(s) of delivery, and
delivery date(s), (b) may also contain instructions as to carrier and method of shipment,
packaging and labeling, and (c) such other information as the parties mutually agree to be
included. BT hereby accepts all such Orders placed in compliance with the requirements of
this Agreement.
(b) Within [***] following the first anniversary of the Effective Date, or the first
purchase of an Instrument and within the [***] of each calendar quarter thereafter during
the term of this Agreement, AB shall furnish to BT a rolling forecast of the Instruments set
forth in Exhibit A (the “BT Manufactured Instruments”) covering the [***], broken down into
[***] increments (and by type of BT Manufactured Instrument if more than one involved).
Only [***] of each forecast shall be binding on AB while the [***] shall not be binding
commitments by AB. AB or its Affiliates will order Instruments by issuing an Order
therefor, which (a) will specify the type and quantity of such Instruments ordered, place(s)
of delivery, and delivery date(s), (b) may also contain instructions as to carrier and
method of shipment, packaging and labeling, and (c) such other information as the parties
mutually agree to be included. BT hereby accepts all Orders placed in compliance with the
requirements of this Agreement.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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(c) Any other System Components to be supplied by BT to AB hereunder shall be
forecasted and ordered in a manner similar to that provided for in (a) and (b) above.
Section 7.04 Delivery and Shipment. BT will ship each System Component, ordered by AB
pursuant to Section 7.03, so that it is delivered to AB’s dock on the delivery date set forth on
the Order, or on subsequent change orders as such may from time to time be issued by AB within AB’s
reasonable discretion (each such date a “Delivery Date”), provided, however, that no Delivery Date
for Arrays shall be [***] after the date the assays required to fill such Array are received by BT
(provided such Order is in accordance with the parameters set forth in Section 7.02 or 7.03). BT
shall immediately notify AB if a problem exists with respect to the Delivery Date. AB shall have
the right to cancel without BT recourse any Order for which BT cannot meet the Delivery Date,
notwithstanding any action taken by BT under the applicable Order. If BT should notify AB of a
problem with or fail to deliver on AB’s initially stated Delivery Date, AB may also, without
limiting its other remedies, direct expedited delivery and any increased costs due to expedited
delivery shall be paid by BT. Unless otherwise specified herein or as AB may otherwise agree in
writing, no deliveries shall be made in advance of AB’s delivery schedule. Overshipments shall be
held at BT’s risk and expense for a reasonable time awaiting shipping instructions. AB will be
credited for original shipping charges for returns. BT shall ship all System Components to AB’s
designated location, F.O.B. BT’s facility with risk of loss and title transferring to AB upon
delivery to the carrier selected by AB. BT shall insure the System Components against loss and
damage incurred prior to acceptance by AB at the designated place of delivery which shall be BT’s
factory. BT shall be solely responsible for, and the System Component payments, if any, specified
in Article V shall be deemed to be inclusive of, all costs and expenses arising in connection
therewith. BT will use a carrier account number as provided to BT by AB for freight charges.
Section 7.05 Packaging. Shipping cartons for System Components must be clearly
identified and marked with the System Component part number, Order number and quantity. BT
warrants that all System Component containers and packaging complies with all applicable U.S.
federal, state and local transportation laws and regulations, including, without limitation,
compliance with hazardous materials regulations promulgated by the U.S. Department of
Transportation (DOT) and published at 49 C.F.R. Section 107 et seq.
Section 7.06 Inspection by BT. BT shall inspect, test, or otherwise verify all System
Components before shipment to ensure that all System Components meet or exceed Specifications as
described in Exhibit B. Upon request by AB, BT shall provide AB with a certified true copy of BT’s
test results.
Section 7.07 Acceptance. AB shall [***] all System Components prior to acceptance.
Any acceptance testing or inspection of System Component shall occur within [***], after which
System Components will by default be deemed accepted (unless rejected by AB prior to the end of
such period); provided, however, that acceptance of a System Component shall not limit any of the
warranties for the System Component provided by BT hereunder. Payment, in whole or part, with
respect to any System Component will not constitute acceptance. AB may reject any
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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non-Conforming System Components (as defined in Section 7.14) within [***] and return them to
BT at BT’s risk and expense at the full invoice price plus all applicable boxing, packing, crating,
transportation and other related costs along with a statement detailing the reason for
non-Conformance. BT will replace non-Conforming System Components within [***]. The fact that AB
[***], shall not affect any of AB’s rights at law or equity under this Agreement.
Section 7.08 System Component Changes. BT shall comply with AB’s Change Notification
Procedure attached hereto as Exhibit I (Change Notification Procedure) to introduce any
kind of change to any System Component during the term of this Agreement. Notwithstanding anything
to the contrary above, BT agrees that it shall not make changes to System Components without prior
notice and written authorization from AB unless such change is required due to a defect, in which
event BT shall still notify AB of the change, but will not require AB’s authorization to make such
change.
Section 7.09 Quality Requirements. For purposes of quality assurance, BT shall
strictly adhere to all aspects of the Specifications for each System Component manufactured or
supplied by BT as described in Exhibit B, and will provide a Certificate of Analysis (COA), a
sample of which is provided in Exhibit D (Form of Certificate of Analysis), for each System
Component that is shipped to AB by BT. The COA will demonstrate and certify that such System
Component meets the Specifications and will describe recommended storage conditions.
Section 7.10 System Component Defects. All System Components found to be
Nonconforming (as defined in Section 7.14) shall be accounted for under AB’s then applicable
procedure, as established within the sole reasonable discretion of AB, for return of Nonconforming
System Components and replacement [***], or, at AB’s request, BT shall issue a credit to AB for any
payment made for such Non-conforming System Components. Notification of any Non-conformance shall
include an adequate description of the defect.
Section 7.11 System Component Recall. In the event that any System Component
manufactured or supplied by BT is found to not be in compliance with any governmental standard,
law, or requirement (“Regs”), so as to make necessary or advisable that such System Component be
reworked or recalled in order to bring the System Component into compliance with Regs, then BT will
undertake all corrective actions necessary to effect compliance with Regs and file all necessary
documents to establish compliance with Regs and will bear all expenses related thereto, unless such
non-compliance is attributable to AB, in which case AB shall make proportional contributions to the
corrective actions.
Section 7.12 Hazardous Conditions. In the event that AB or BT learns of any issue
relating to a potential safety hazard or unsafe condition involving any System Component of a
Collaboration Product, or is advised of such by competent authorities of any government having
jurisdiction over such System Component, it will immediately advise the other party by the most
expeditious means of communication. The parties shall cooperate to correct any such condition that
is found to exist; and in accordance with the decision of the JDC, provided, however, BT shall bear
and shall reimburse AB for those costs and expenses incurred by AB with respect to System
Components supplied by BT to AB hereunder, unless such potential safety hazard or
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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unsafe condition is attributable to AB, in which case AB shall make proportional contributions
to the corrective actions.
Section 7.13 Manufacturing Site Inspection. Upon the request of and with advance
notice from AB, authorized AB representatives will be allowed by BT to arrange date(s) for on-site
inspection visit(s) with BT. BT agrees to permit AB authorized purchasing, technical and quality
assurance representative(s) to visit BT’s manufacturing facility(s) for the purpose of maintaining
quality control of any System Component.
Section 7.14 Product Warranty. WITHOUT LIMITING OTHER WARRANTIES EXPRESSLY STATED
HEREIN, BT WARRANTS THAT: (1) ALL SYSTEM COMPONENTS SUPPLIED TO AB HEREUNDER COMPLY IN ALL RESPECTS
WITH THE SPECIFICATIONS THEREFORE, AS SET FORTH ON ATTACHMENT B (AS AMENDED BY AGREEMENT OF THE
PARTIES FROM TIME TO TIME); (2) ALL SUCH SYSTEM COMPONENTS WILL BE FREE FROM DEFECTS IN MATERIALS
AND WORKMANSHIP FOR A PERIOD OF AT LEAST TWELVE (12) MONTHS (BUT IN THE CASE OF ARRAYS, SIX (6)
MONTHS) FROM THE DATE OF INSTALLATION AT AB’S CUSTOMER’S FACILITY; (3) BT WILL DELIVER PRODUCTS IN
ACCORDANCE WITH THE APPLICABLE ORDER; AND (4) SUCH SYSTEM COMPONENTS SHALL BE PACKAGED AND LABELED
PROPERLY AND IN ACCORDANCE WITH ALL APPLICABLE PACKING SPECIFICATIONS, LABELING REQUIREMENTS, AND
APPLICABLE LAWS. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NEITHER BT NOR AB MAKES ANY, AND
EACH PARTY EXPRESSLY DISCLAIMS ALL, REPRESENTATIONS AND WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. A System
Component that conforms with all the foregoing warranties of this Section 7.14 shall be referred to
herein as a “Conforming” System Component; a System Component that does not confirm with one or
more of the foregoing warranties of this Section 7.14 shall be referred to herein as a
“Non-conforming” System Component, with cognates of Conforming and Non-conforming having the same
respective meanings. AB’s sole remedy under this warranty shall be the replacement or repair by BT
of any component or product not conforming to this warranty or if such component or product can not
be repaired or replaced, then a refund of the purchase price paid. All warranty claims must be
made prior to one year from the date such product or component is delivered.
Section 7.15 Limitation on Liability. EXCEPT AS EXPRESSLY PROVIDED UNDER THIS
AGREEMENT AND EXCLUDING ANY LIABILITY ARISING UNDER ARTICLES XIII (“CONFIDENTIALITY”) AND SECTIONS
9.01 THROUGH 9.02, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR INDIRECT,
SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION LOSS OF PROFITS, LOSS
OF USE, OR OTHER ECONOMIC LOSS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE AND REGARDLESS OF
WHETHER THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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ARTICLE VIII. TERM AND TERMINATION
Section 8.01 Term of the Agreement. This Agreement shall remain in effect for at
least an initial term of seven (7) years from the Effective Date (subject to automatic renewal as
provided below) unless earlier terminated as provided below.
Section 8.02 Renewal. After the initial seven year term or any renewal term, unless
earlier terminated as provided below, this Agreement shall automatically renew on an annual basis
if (a) the following performance metrics are fulfilled: if AB’s sales of Genotyping Arrays from the
Genotyping Commercialization Phase through the end of such term of the Agreement are at least 50% of the corresponding quantity of Genotyping Arrays forecasted by AB as per
Section 7.03 over such period of time; (b) AB, at its sole discretion, makes an annual extension
payment to BT of two hundred and fifty thousand dollars ($250,000) due within thirty (30) days prior to the end of such then current term; or (c) the Parties
mutually agree.
Section 8.03 Termination at Will. AB will have the right to terminate this Agreement
at any time during the initial term or any renewal thereof, with or without cause and in its sole
discretion, upon sixty (60) days notice to BT.
Section 8.04 Transition. One year prior to the end of the initial term of this Agreement
or any renewal term (which, in either case, is not extended in accordance with Section 8.02), a
Party may give notice to the other Party that the Agreement shall not be renewed for another term,
and the period from the date of such notice to the end of the term shall be the “Transition
Period”. If AB terminates this Agreement pursuant to Section 8.03, AB shall also provide a one year transition period
from the date this Agreement is terminated. During the Transition Period, AB’s licenses under BT
Intellectual Property shall become non-exclusive, and BT will have the right to sell BT Open Arrays
in the manner set forth in Section 2.02 (b) during the Early Access Period, subject to the terms of
the License Agreement. AB will use reasonable efforts to transition certain mutually agreed and
applicable customer and supplier accounts to BT to permit uninterrupted servicing of customer
accounts for BT Open Arrays by BT. If this Agreement is terminated for convenience by AB or by BT
pursuant to Section 8.05 due to material breach of AB, then AB will use reasonable efforts (at BT’s
expense and provided that AB can contractually do so pursuant to the agreement with such Third
Party): (i) to transition certain (mutually agreed upon by BT and AB) customer and supplier
accounts so as to BT to permit uninterrupted servicing of customer accounts for BT Open Arrays by
BT; and (ii) for one year after the end of the initial term of this Agreement or any renewal term (which, in
either case, is not extended in accordance with Section 8.02), any AB manufactured component of the
Collaboration Products shall, to the extent AB is reasonably able to continue doing so without
incurring liability and as permitted by applicable law, be manufactured and supported by AB upon
the same terms and conditions including AB’s then current sales price for one year following the
Termination Date.
Section 8.05 Breach. If either Party hereto is in material breach of any of the terms
under this Agreement, the other Party, at its option, may give written notice to such breaching
Party stating the nature of the breach and that such other Party intends to terminate this
Agreement if the breach is not cured. If such breaching Party does not cure such breach within
[***] of receipt of such notice, then the other Party may terminate this Agreement by written
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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notice to the other Party. In the event of any good faith dispute as to the existence of a
material breach hereunder, this Agreement shall remain in full force and effect pending resolution
of such dispute.
Section 8.06 Insolvency. A Party may terminate this Agreement by written notice to
the other Party upon (a) the insolvency of the other Party, an adjudication of the other Party as
bankrupt or insolvent, or an admission by the other Party in writing of its inability to pay its
obligations as they mature; (b) an assignment by the other Party for the benefit of creditors; (c)
the appointment of a receiver, trustee or similar officer for a substantial part of the property of
the other Party, or the other Party applying for or consenting to such appointment; (d) the
institution of any bankruptcy, insolvency arrangement, or similar proceeding by or against the
other Party (which has not been dismissed within sixty (60) days with respect to such proceedings
brought against the other Party); or (e) the issuance or levy of any judgment, writ, warrant of
attachment or execution or similar process against a substantial part of the property of the other
Party.
Section 8.07 Other Remedies. Termination of this Agreement by reason of a material
breach thereof shall not prevent or prohibit the terminating Party from pursuing any other legal
remedies it may have for such breach or which may have otherwise accrued under this Agreement.
Section 8.08 Know-How Escrow. Within thirty (30) days of the Effective Date, BT shall
deposit all manufacturing know-how (including, without limitation, technical information,
manufacturing processes, specifications, raw materials and vendor information) relating to BT Open
Arrays, Arrays, Reformatters and other System Components to be manufactured by or for BT hereunder
(the ‘Escrowed Know-How”) with a mutually agreed escrow agent. BT shall supplement and update such
escrow on a quarterly basis to reflect the most current know-how employed with respect to the
foregoing by BT. Such supplements and updates shall be deemed within the definition of Escrowed
Know-How. Escrowed Know-How relating to such System Components (including, without limitation, BT
Open Arrays), shall be available to AB or its contractor only upon failure by BT to meet its
manufacturing and supply obligations with respect any System Component as described in Section 7.02
of this Agreement. Notwithstanding the foregoing, Escrowed Know-How relating to BT Manufactured
Instruments shall be made available to AB upon AB’s notice to BT that AB desires to commence
manufacture of such Instruments. BT shall provide reasonable assistance to AB or its contractor in
migrating manufacturing of the BT Manufactured Instruments from BT or its contractor to AB or its
contractor. BT shall provide continued support for implementation of such technology and know-how,
including making available to AB or AB’s designated contractor BT employees having expertise in the
design, manufacture and use of the System Components and associated other consumables. AB shall
have the right to audit BT’s compliance with the foregoing escrow deposit requirements. Without
limiting BT’s obligations, BT shall pay for the costs of such audit in the event of any material
discrepancy with its compliance with the foregoing escrow deposit obligations and BT shall promptly
rectify any noncompliance identified by AB or AB’s auditor with such escrow deposit requirements.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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Section 8.09 Post-Termination Rights. Each Party grants to the other the following
post-termination rights:
(a) In the event of termination due to breach by BT, BT shall grant to AB an exclusive,
worldwide, royalty bearing sublicensable license (in an amount not to exceed 10% of Net
Sales for Arrays, with 5% thereof being applicable to BT IP, and 5% applicable to BT
Know-how, and amounts set forth in 5.04 for Instruments) under BT’s Intellectual Property to
develop, make, have made, use, import, sell and offer for sale any Collaboration Products in
the Field. Terms of such license shall not be less favorable than BT offers to any other
licensee.
(b) Upon termination of this Agreement in accordance with Section 8.03 (and provided
that AB is not otherwise in breach of any material teens of this Agreement), BT shall grant
to AB a worldwide, royalty bearing non-exclusive license (in an amount not to exceed [***]
of Net Sales for Arrays, with [***] thereof being applicable to BT IP, and [***] applicable
to BT Know-how, and amounts set forth in 5.04 for Instruments) to make, use, import, sell
and offer for sale versions of Collaboration Products existing as of the date of expiration
or termination, within the Field. Terms of such license shall not be less favorable than BT
offers to any other licensee.
(c) In any event, upon any expiration of the Agreement, BT shall grant to AB a
worldwide, royalty bearing, non-exclusive, license (in an amount not to exceed [***] of Net
Sales for Arrays, with [***] thereof being applicable to BT IP, and [***] applicable to BT
Know-how, and amounts set forth in 5.04 for Instruments) under the BT Intellectual Property
(including any know-how or information provided by BT) to develop, make, use, import, sell
and offer for sale Collaboration Products within the Field. Terms of such license shall not
be less favorable than BT offers to any other licensee.
(d) BT will have a right of first negotiation post-termination to obtain a nonexclusive
royalty bearing license to make, use and sell BT Open Array improvements made by AB using BT
Confidential Information.
Section 8.10 Survival. Termination or expiration of this Agreement for any reason
shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to
or on account of such termination or expiration. Without limiting the foregoing, the provisions of
Articles IX, X, XII, and XIII and Sections 7.14, 7.15, 8.04, 8.09, and 11.03 shall survive any
expiration or termination of this Agreement.
Section 8.11 Bankruptcy. All rights and licenses granted under or pursuant to this
Agreement by from one Party to the other Party are, and shall irrevocably be deemed to be,
“Intellectual Property” as defined in Section 101(35A) of the U.S. Bankruptcy Code. Each Party
shall be entitled to all rights and benefits accorded to such Party as a licensee of Intellectual
Property pursuant to Section 365(n) of the U.S. Bankruptcy Code. Except as expressly permitted by
the Agreement, this Agreement and the rights hereunder are non-delegable and non-assignable by the
licensee Party. Without limiting the foregoing, except as expressly permitted
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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by this Agreement, this Agreement cannot be assumed or assumed and assigned by a trustee or
debtor-in-possession in bankruptcy as set forth in Section 365(c)(1) of the United States
Bankruptcy Code or any similar provisions of state or federal law.
Section 8.12 Reformatter. In the event (i) BT materially breaches this Agreement and
does not cure such breach [***] of receipt of such notice or (ii) in the event of an event
triggering AB’s right to terminate this Agreement pursuant to Section 8.06 herein, BT shall use
reasonable business efforts to provide AB full access to BT’s Reformatters that are required to
manufacture Open Array products covered under the Commercialization Phase of this Agreement,
including the required training and production assistance in undertaking Open Array production.
ARTICLE IX. INDEMNIFICATION AND INSURANCE
Section 9.01 AB Indemnity. AB agrees to indemnify and hold harmless BT, its agents,
employees, successors, and assigns from and against all liabilities, losses, damages, claims, and
expenses, including legal expenses and fees (collectively, “Losses”) resulting from third party
actions, suits or proceedings resulting from or arising out of (i) a material breach by AB of the
terms and conditions of this Agreement; (ii) the possession, use, sale or manufacture of System
Components by or for AB, to the extent not subject to BT’s indemnification obligations and not
caused by BT or resulting from BT’s failure to comply with its obligations, warranties and
covenants herein; (iii) the gross negligence or willful misfeasance of AB; or (iv) the failure of
AB to comply with all applicable law, rules and regulations applicable to or in connection with the
performance of its obligations hereunder.
Section 9.02 BT Indemnity. BT agrees to indemnify and hold harmless AB, its agents,
employees, successors, and assigns from and against all Losses resulting from third party actions,
suits or proceedings resulting from or arising out of (i) a material breach by BT of its
obligations, warranties and covenants set forth in this Agreement; (ii) defects or negligence in
the design, development, formatting or manufacturing of any System Component supplied to AB
hereunder; (iii) the possession, use, sale or manufacture of System Components by or for BT, to the
extent not subject to BT’s indemnification obligations and not caused by AB or resulting from AB’s
failure to comply with its obligations, warranties and covenants herein; (iv) the gross negligence
or willful misfeasance of BT; or (v) the failure of BT to comply with all applicable law, rules and
regulations applicable to or in connection with the performance of its obligations hereunder. In
addition, BT shall indemnify, hold harmless and defend AB from any Losses resulting from a claim
that making, using or selling of System Components supplied by BT under this Agreement infringes or
misappropriates any intellectual property rights of Third Parties.
(a) Exclusions. BT shall not be liable to AB for the indemnification required
in the last sentence of 9.02 above if such infringement: (a) is caused by modification of
the System Component by AB without BT’s approval, where and only to the extent such
modification is the basis or grounds for infringement; (b) arises due to System Component
that is entirely manufactured and/or supplied according to specifications originating solely
with and required by AB, to the extent such specifications are the basis
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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or grounds for infringement; or (c) arises due to use of a System Component by AB in a
manner that the parties have previously agreed in writing is forbidden.
(b) Remedies. Without limiting in any manner AB’s indemnification rights under
this Section 9.02 and prior to the inception of any actual lawsuit or similar action against
AB, if any System Component is in BT’s reasonable and good-faith opinion likely to become
subject to a claim of infringement, BT shall immediately inform the JDC and may consider
remedy options including, BT may, at its option and following notice to AB (a) procure for
AB the right to continue using the System Component; (b) replace or modify the System
Component so that such System Component becomes non-infringing, provided AB previously
approves such replacement or modification in writing; and/or (c) recover the System
Component and refund to AB the price actually paid for the infringing System Component.
Notwithstanding the foregoing, AB shall have the right to require BT to procure (at BT’s
expense) a license to make, have made, use, sell, offer for sale and import such System
Components under Third Party Intellectual Property rights (but for the avoidance of doubt
excepting any patent rights that solely cover Assay chemistry and Assay methods as opposed
to patents that also cover Arrays, Instruments or Reformatters) to the extent deemed
reasonably necessary by AB to avoid infringement liability at BT’s expense and if BT fails
to do so within a reasonable period of time [***] after AB’s request, then AB shall have the
right to procure such license and to credit all expenses including royalties paid to such
third party against AB’s payment obligations (including, without limitation, Revenue Sharing
Payments) under this Agreement.
(c) With respect to Third Party patent rights that solely cover Assay chemistry and
Assay methods, but that do not also cover devices or an apparatus, the JDC will determine
which of the Parties shall procure rights to continue using the System Component and
determine a reasonable sharing of the cost of such rights procurement.
Section 9.03 Indemnification Procedures. In any claim for indemnification relating to
Losses arising in connection with any action, suit or proceeding asserted by one or more Third
Parties against an indemnified party (a “Third Party Claim”), the indemnified party agrees to give
the indemnifying Party prompt written notice of such Third Party Claim. The indemnifying Party
shall, if it so chooses and acknowledges in writing its obligation to indemnify the indemnified
party for a Third Party Claim, be entitled to assume the defense of such Third Party Claim with
counsel selected by the indemnifying Party and reasonably satisfactory to the indemnified party.
Should the indemnifying Party so elect to assume the defense of a Third Party Claim, the
indemnifying Party shall not be liable to the indemnified party for legal expenses subsequently
incurred by such indemnified party in connection with the defense thereof unless (i) the
indemnifying Party has failed to defend, contest or otherwise protest in a timely manner against
such Third Party Claim or (ii) a conflict of interest exists such that separate representation of
the indemnified party is appropriate (and in each of case (i) and (ii) the indemnifying Party shall
be liable for the reasonable fees and expenses of counsel employed by the indemnified party during
such period). If the indemnifying Party assumes such defense, the indemnified party may, at its
sole option and expense, participate in such defense and employ
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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separate counsel, and further agrees to cooperate in the conduct of any such defense. If the
indemnifying Party assumes such defense, the indemnifying Party shall have the right to settle such
Third Party Claim, in its discretion, with a full release of the indemnified party and no admission
of liability; provided that the indemnifying Party shall obtain the written consent of the
indemnified party, such consent not to be unreasonably withheld, prior to settling any Third Party
Claim if as a result thereof the indemnified party would become subject to injunctive or other
equitable relief or any remedy other than the payment of money by the indemnifying Party, or if the
business of the indemnified party would be adversely affected in any manner. For the avoidance of
doubt, the indemnified party may not settle any action, suit or proceeding for which
indemnification is sought hereunder without the indemnifying party’s prior written consent.
Section 9.04 Insurance. BT shall, at its own expense, provide and maintain insurance
with a financially sound insurance company having an A.M. Best Rating of A+ or better in the areas
of worker’s compensation; employer’s liability for bodily injury suffered through accident or
disease; commercial general liability, and other areas of coverage to the reasonable satisfaction
of AB, but in no event shall BT carry coverage with limits of less than [***]. BT shall furnish AB
certificate(s) of insurance evidencing the coverage required for BT by AB and the insurer’s
agreement to provide thirty (30) days’ prior written notice to AB in the event of cancellation or
material change in coverage. BT’s insurance policies shall also name AB as an additional insured
with coverage for AB at least as broad as provided to BT for liability arising out of System
Component supplied pursuant to this Agreement. Such insurance shall be primary to any insurance
carried by AB and BT will furnish AB a certificate of insurance evidencing the same.
ARTICLE X. INTELLECTUAL PROPERTY
Section 10.01 Ownership. Subject to the express licenses granted hereunder to AB, BT
will retain all right, title and interest in and to any Intellectual Property rights Controlled BT
as of the Effective Date and to any BT Technology (and any Intellectual Property rights therein).
Subject to the express licenses granted to BT pursuant to the License Agreement, AB will own all
right, title and interest in and to any Intellectual Property rights Controlled by AB as of the
Effective Date and to any AB Technology (and any Intellectual Property rights therein). AB and BT
will jointly own all Joint IP (and all Intellectual Property rights therein) and, subject to the
terms and condition of this Agreement, each Party shall have the right to exploit its undivided
one-half interest in such Joint IP (and all Intellectual Property rights therein) without the
obligation to account to the other Party, to obtain the other Party’s consent to license or assign
such Joint IP (and Intellectual Property rights therein) or to share proceeds from exploitation
thereof.
Section 10.02 Grant-Back Non-Exclusive License. If and to the extent that in the
course of this Collaboration Program AB invents, develops or creates an improvement or modification
to BT’s design (that incorporates BT’s know-how and designs that are Confidential Information of
BT) of BT Open Array™, Reformatter or sample loader for BT Open Array™, the practice of which would
require a license to avoid infringing BT’s Intellectual Property rights (such improvement or
modification, “AB Improvements”), AB will promptly notify BT of the
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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existence of such AB Improvements to BT. BT shall for [***] after such notification have a
right to negotiate with AB a non-exclusive, royalty bearing license in the Field under such AB
Improvements to make, have made, use, offer for sale and import any products and to practice any
methods claimed by or embodied in such AB Improvements on mutually agreed upon terms and
conditions. Such license shall include the right to grant sublicenses to BT’s customers solely to
the extent necessary to use such products and/or practice such methods. Such license shall be
non-transferable except in connection with the acquisition of substantially all of the assets or
equity of BT, whether by sale of assets, merger, stock purchase or otherwise. Such right of
negotiation shall expire if the Parties fail to reach agreement within such [***] as may be
extended by mutual agreement of the Parties.
Section 10.03 Disclosure. AB shall promptly disclose in writing to BT all AB
Technology and BT shall promptly disclose in writing to AB all BT Technology, in each case through
the Joint Development Committee. Each Party shall promptly disclose in writing to the other Party,
through the Joint Development Committee, all Joint IP. Without limiting the foregoing, each Party
shall disclose in writing to the other Party, through the Joint Development Committee, any such
inventions at least [***] prior to filing any patent application that claims or discloses such
invention and indicate in such disclosure to the best of its knowledge the identity of the
inventors and when the Party proposes to file such patent application. For the avoidance of doubt,
all such disclosures shall be subject to the confidentiality obligations set forth in Article 13
herein.
Section 10.04 Prosecution.
(a) AB will have the sole right, in its discretion, to file, prosecute and maintain
Intellectual Property rights in and to any AB Technology.
(b) BT will have the sole right, in its discretion, to file, prosecute and maintain
Intellectual Property rights in and to any BT Technology.
(c) AB and BT shall jointly determine the strategy for prosecution and maintenance of
Patents (or other intellectual property rights) with respect to Joint IP. The Joint
Development Committee, as appropriate, shall determine the most effective means of
implementing that strategy, and shall assign the Parties specific responsibility with
respect thereto. The Parties shall share equally all reasonable out-of-pocket attorneys
fees and prosecution costs (including, without limitation, filing fees, maintenance fees)
incurred in connection with such prosecution and maintenance activities, provided that
either Party may avoid its responsibility for such costs by assigning its rights in such
Joint IP to the other Party. If either Party assigns to the other its rights in such Joint
IP, the other Party shall use reasonable efforts to implement the prosecution and
maintenance strategy that was previously promulgated by the Joint Development Committee.
(d) Each Party shall keep the other Party promptly and fully informed of the course of
patent prosecution, maintenance or other proceedings pertaining to Joint IP including by
providing the other Party with copies of important, substantive communications, search
reports and third party observations submitted to or received
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
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from patent offices throughout the world. Without limiting the foregoing, a Party
shall promptly share with the other Party all patent applications to be filed (as well as
drafts thereof) on Joint IP, together with copies of all communications (including, without
limitation, office actions, notices of rejection or allowance) with or from patent offices
in connection with prosecution and maintenance efforts with respect to such Joint IP.
Without limiting the foregoing, each Party shall promptly share with the other receives the
complete texts of all Patents filed on Joint IP, interference, opposition, reexamination,
reissue, revocation, nullification or any official proceeding involving such Patents
anywhere in the world. The other Party shall have the right to assume responsibility for
any patent or any part thereof, which the responsible Party intends to abandon or otherwise
cause or allow to be forfeited.
Section 10.05 Third Party Licenses. Subject to the licenses granted hereunder to the
other Party (including, any exclusive licenses or exclusive rights granted hereunder by BT to AB)
and to any expressly stated restrictions or express stated limitations on the same set forth in
this Agreement, each Party shall have the right to grant licenses to Third Parties under
Intellectual Property Controlled by such Party.
Section 10.06 Marking. Each Party will xxxx Collaboration Products with a patent
notice regarding each Party’s patent rights as required by applicable law to preserve the right of
the Parties to recover damages for infringement of such intellectual property rights. In addition,
the Parties shall agree upon a label license to be affixed to such Collaboration Products,
consistent with current practice and the requirements of the License Agreement, to provide Third
Party purchasers with limited rights to use such Collaboration Products.
Section 10.07 Trademark Usage. Each Party hereby grants to the other a royalty-free
license to use Trademarks of such Party solely in order to affix to applicable Systems Components
distributed hereunder as provided for and in accordance with the terms and conditions of this
Agreement and in accordance with the instructions supplied to such other Party by the Party owning
or Controlling such Trademark.
Section 10.08 No Implied Licenses. NOTWITHSTANDING ANYTHING HEREIN TO THE CONTRARY,
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE LICENSE AGREEMENT AND TCSA, BT SHALL HAVE NO
LICENSE, RIGHT OR IMMUNITY FROM SUIT, WHETHER EXPRESS, IMPLIED, BY ESTOPPEL OR OTHERWISE, UNDER ANY
AB INTELLECTUAL PROPERTY (WHETHER IN-LICENSED OR OWNED BY AB) WHETHER OR NOT THE SAME IS NECESSARY
IN ORDER FOR BT TO HAVE FREEDOM TO OPERATE IN CONNECTION WITH ITS CURRENT OR FUTURE BUSINESS.
ARTICLE XI. INFRINGEMENT ACTIONS
11.01 Defense of Third Party Claims. If a Party learns of any claim or potential
claim by any Third Party that any activities within the Collaboration Program infringe any
Intellectual Property rights of such Third Party, that Party shall promptly notify the Joint
Development Committee, which will develop an appropriate response to be taken. If the claim or
potential claim involves a Collaboration Product, then subject to approval of the Joint Development
Committee, AB or BT may negotiate with such Third Party for an appropriate in-license on behalf of
both AB and BT on terms and conditions approved by the Joint Development Committee.
Notwithstanding the foregoing, in the event that the Parties are unable to agree upon such a
response or such license terms within a reasonable time, in any event not to exceed sixty (60)
days, either Party shall have the right to procure a license or defend such claim of infringement
of such Third Party Intellectual Property rights.
11.02 Infringement by Third Parties. Each Party shall notify the other if it believes
that a Third Party may be infringing upon or misappropriating any Intellectual Property of such
other Party with respect to products that are competitive with Collaboration Products in the Field.
The Party Controlling such Intellectual Property shall have the sole right, but not any
obligation, to institute and prosecute any action or proceeding with respect to such infringement,
by counsel of its own choice, and recover for its own benefit any damages or other monetary awards.
11.03 Infringement of Joint IP Rights. If a Party believes that a Third Party may be
infringing upon or misappropriating any Joint IP (including any Intellectual Property rights
therein), that Party shall notify the other Party. Without limiting either Party’s right to
license Joint IP (subject to the licenses granted herein), each Party will cooperate with the other
Party in enforcement of any Intellectual Property rights in or to such Joint IP, including joining
as a party in any enforcement action thereunder to the extent required to confer standing in such
action. Each Party shall have the right to assert the Intellectual Property rights in or to such
Joint IP against such Third Party, provided however that, unless otherwise agreed by the Parties,
the Party initiating the enforcement action shall control such enforcement action. Each Party will
bear its own costs and expenses (including, without limitation, attorney’s fees) in such
litigation. Subject to agreement of both Parties to the terms and conditions of such settlement,
either Party may settle such claim of infringement or misappropriation of the Intellectual Property
rights in or to Joint IP with such Third Party. The proceeds of such enforcement action or award
entered against such Third Party or any such settlement shall first be used to reimburse each Party
for its out of pocket attorney’s fees and other litigation costs and the remainder shall then be
shared equally by the Parties.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
31
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ARTICLE XII. INTELLECTUAL PROPERTY RELATED
WARRANTIES; CERTAIN OTHER REPRESENTATIONS &
WARRANTIES.
WARRANTIES; CERTAIN OTHER REPRESENTATIONS &
WARRANTIES.
Section 12.01 Warranty. Each Party represents, warrants and covenants (i) that it
owns or Controls the Intellectual Property licensed to the other Party hereunder, (ii) that it has
the legal right and authority to enter into this Agreement and perform its obligations hereunder,
(iii) that it has not entered into and will not enter into any contracts, assignments, grants,
licenses, encumbrances, obligations or agreements, written or oral, that are inconsistent with this
Agreement.
Section 12.02 Disclaimer. Nothing in this Agreement shall be construed as:
(a) a warranty or representation by either Party as to the validity, enforceability or
scope of any intellectual property rights;
(b) a warranty or representation that anything made, used, sold, or otherwise disposed
of pursuant to this Agreement is or will be free from infringement of Patents or other
intangible rights of Third Parties;
(c) except as expressly provided herein, a requirement that a Party shall file any
patent application, secure any patent, or maintain any patent in force;
(d) an obligation on either Party to bring or prosecute actions or suits against Third
Parties for infringement of any intellectual property rights;
(e) except as expressly provided herein, an obligation to furnish any manufacturing or
technical information; or
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
32
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(f) except as expressly provided herein, granting by implication, estoppel, or
otherwise, any license or rights under Patents, trade secrets, know-how, copyrights, or
other intangible rights of either Party.
Section 12.03 No Implied Warranties. Except as otherwise expressly provided in this
Agreement, neither Party makes any representation or warranties, express or implied with respect to
the intellectual property rights licensed granted hereunder or the practice of such licenses
(including, without limitation, any express or implied representation or warranty that the practice
of such licenses would be free from claims of infringement of Third Party intellectual property
rights).
ARTICLE XIII. CONFIDENTIALITY
Section 13.01 Confidentiality Obligations. Each of BT and AB, as a Receiving Party,
agrees to hold in confidence, by using the same degree of care as each uses for information of like
importance, but not less than a reasonable degree of care, any Confidential Information disclosed
to it by the other Party, the Disclosing Party, hereunder, and agrees not to disclose any
Confidential Information of the Disclosing Party to any Third Party without the express written
consent of the Disclosing Party. The terms and conditions of this Agreement and Joint IP shall be
deemed and treated as the Confidential Information of both Parties (subject only to the exceptions
set forth in parts (a) and (b) of Section 1.12) until published with the written consent of both
Parties or until such time as the same may publish in a published patent application or issue into
Patents or other mutually agreed upon statutory forms of intellectual property rights.
Notwithstanding the foregoing, if the Receiving Party is compelled by legal process to disclose
such Confidential Information, the Receiving Party shall be permitted to do so, but shall give
notice to the Disclosing Party of such requirement for disclosure as soon as possible to enable the
Receiving Party to take steps to prevent disclosure, and, in absence of any action of the
Disclosing Party, shall use its best efforts to restrict such disclosure to the extent reasonably
possible. The Receiving Party shall use such Confidential Information only for purposes of the
Collaboration Program (or to otherwise exercise any licenses granted hereunder). The Receiving
Party may disclose Confidential Information to Third Parties under confidentiality obligations at
least as restrictive as those set forth herein to the limited extent necessary to have
Collaboration Products made, or to distribute Collaboration Products, as such manufacturing or
distribution activities shall otherwise be permitted hereunder. The obligations imposed under this
Article shall remain in force for a period of five (5) years following termination or expiration of
this Agreement. Notwithstanding the foregoing, with respect to any Confidential Information that
consists of a trade secret, that is identified by the Disclosing Party in a written notice
delivered to the Receiving Party prior to the date of termination or expiration of this Agreement,
the obligations imposed under this Article shall survive (without any temporal limitation) any
termination or expiration of this Agreement.
Section 13.02 Disclosure to Employees. Each of the Parties agrees to assume
individual responsibility for the actions and omissions of its respective employees, agents and
permitted assigns in conjunction with the Collaboration Program, and to inform such individuals of
the
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
33
Table of Contents
responsibilities for confidentiality and nondisclosure under this Agreement, and to obtain
their agreement to be bound in the same manner that the Party is bound.
ARTICLE XIV. MISCELLANEOUS
Section 14.01 Force Majeure. No failure or delay by either Party in the performance
of any obligation under this Agreement shall be deemed a breach of this Agreement if the same shall
arise from any cause or causes beyond the reasonable control of such Party, including but not
limited to the following: Acts of God, fire, storm, flood, earthquake, accident, acts of the public
enemy, war, rebellion, insurrection, riots, sabotage, invasions, quarantine, restrictions, strikes,
lockouts, transportation embargoes or failures or delay in transportation or public infrastructure
arising from any of above-cited causes.
Section 14.02 Choice of Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of California as applied to contracts between California
residents entered into and to be performed entirely within California, and without regard to any
conflicts of laws rules or principles.
Section 14.03 Notices. All notices to be given with respect to this Agreement shall
be in writing, in English, and sent to the other Party by registered, or certified mail, express
courier service, or by facsimile, to the addresses set forth below, or such other address as either
Party may hereafter designate by proper notice in writing to the other Party.
If to BT |
Biotrove, Inc. | |
00 Xxxx Xxxxxx | ||
Xxxxxx XX 0000 | ||
Atn.: President & CEO | ||
Fax: (000) 000-0000 | ||
If to AB |
Applied Biosystems | |
000 Xxxxxxx Xxxxxx Xxxxx | ||
Xxxxxx Xxxx, XX 00000 XXX | ||
Attn.: Vice President, Intellectual Property |
||
Fax. (000) 000-0000 |
Notice shall be effective upon receipt by the addressee, or if earlier, upon written
confirmation of delivery by the carrier.
Section 14.04 Assignment. Neither this Agreement nor any right or obligation arising
hereunder may be assigned, in whole or in part, by contract, by operation of law or otherwise, by a
Party without the prior written consent of the other Party. Notwithstanding the foregoing, either
Party may assign its right and obligations hereunder in their entirety to a purchaser or acquirer
of substantially all of such Party’s assets or equity (whether by asset purchase, merger or stock
acquisition). In the event of any permitted assignment, this Agreement shall remain
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
34
Table of Contents
binding on the assignor. Subject to the restrictions on assignment set forth herein, this
Agreement shall inure to the benefit of the successors and permitted assigns of each of the Parties
hereto.
Section 14.05 Complete Agreement. This Agreement sets forth and constitutes the
complete, final and exclusive agreement between AB and BT with respect to the subject matter hereof
and supersedes any and all prior agreements, understandings, promises and representations made by
AB or BT concerning the subject matter hereof and the terms applicable hereto. This Agreement may
not be released, discharged, amended or modified in any manner except by an instrument in writing
signed by duly authorized officers of AB and BT.
Section 14.06 Severability. If any provision of this Agreement is held or discovered
to both Parties’ satisfaction to be illegal, invalid or unenforceable in any jurisdiction or to
render any patent in that jurisdiction unenforceable, the provision, as it applies to that
jurisdiction only, shall be replaced automatically, as part of the document, by a provision as
similar in terms as possible but not subject to such infirmity, in order to achieve the intent of
the Parties to the extent possible. In any event, as to that jurisdiction, all other provisions of
this Agreement shall be deemed valid and enforceable to the full extent possible.
Section 14.07 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be an original and all of which shall constitute together but one
and the same document.
Section 14.08 Further Assurances. Each Party shall duly execute and deliver, or cause
to be duly executed and delivered, such further instruments and do and cause to be done such
further acts and things, including, without limitation, the filing of such assignments, agreements,
documents and instruments, as may be necessary or as the other Party may reasonably request in
connection with this Agreement or to carry out more effectively the provisions and purposes hereof,
or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
Section 14.09 No Waiver. Any delay or failure by either Party to enforce at any time
any of its rights under any provision of this Agreement shall not be deemed to be a waiver of that
Party’s right thereafter to enforce such rights or a waiver of such provision or of that Party’s
right to resort to any remedy available to it. A waiver on one occasion shall not be construed as
a waiver of any right an any other occasion.
Section 14.10 Construction. Except where the context otherwise requires, wherever
used, the singular shall include the plural, the plural the singular, the use of any gender shall
be applicable to all genders and the word “or” is used in the inclusive sense. The captions and
headings of this Agreement are for convenience of reference only and in no way define, describe,
extend or limit the scope or intent of this Agreement or the intent of any provision contained in
this Agreement. Both Parties and their counsel have participated equally in the formation of this
Agreement. The language of this Agreement shall not be presumptively construed against either
Party.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
35
Table of Contents
Section 14.11 Relationship. The relationship of AB and BT established by this
Agreement is that of independent contractors, and nothing contained in this Agreement shall be
construed to constitute the Parties as principal and agent, partners, co-owners or otherwise as
participants in common undertaking. Neither AB nor BT, as the case may be, nor any of either
Party’s Affiliates, agents or employees, are the representatives of the other Party for any purpose
nor do they have any power or authority as agents, employees or in any other capacity to represent,
act for, bind, or otherwise create or assume any obligation on behalf of the other Party for any
purpose whatsoever.
Section 14.12 Public Announcements. Except to the extent required by applicable law,
neither Party shall issue any press release or make any other public announcement or public
disclosure regarding this Agreement or the Collaboration Program without first consulting with the
other Party regarding the contents of such communication and obtaining the consent of the other
party regarding such communication (unless and to the extent such contents have previously been so
cleared for public disclosure).
Section 14.13 List of Exhibits:
Exhibit | Title | |
A
|
Project Plan (includes System Components) | |
B
|
Specifications (AB Product Requirement Document and Product Specification Document) | |
C
|
Safety Stock | |
D
|
Form of Certificate of Analysis | |
E
|
License Agreement | |
F
|
BT Third Party Commitments (pursuant to Section 2.02) | |
G
|
Certain BT Intellectual Property | |
H
|
Transfer Price Calculations | |
I
|
Change Notification Procedure |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
36
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IN WITNESS WHEREOF, the Parties hereto have duly executed this AGREEMENT as of the Effective
Date.
Applera Corporation, through its Applied Biosystems Group |
BioTrove, Inc. | |||||||||
By
|
/s/ Xxxx X. Xxxxxxxxx | By: | /s/ Xxxxxx X. Xxxxxxx | |||||||
Name: Xxxx X. Xxxxxxxxx | Name: Xxxxxx X. Xxxxxxx | |||||||||
Title: Executive Vice President | Title: President & Chief Executive Officer |
Applied Biosystems
Approved for Signature |
||||
By: | /s/ Xxxxxx X. Xxxxxxxx | |||
Name: | Xxxxxx X. Xxxxxxxx | |||
Date: | 11/9/07 | |||
Applied Biosystems Legal Department | ||||
Approved for Signature |
||||
By: | /s/ Xxxx Xxx | |||
Name: | Xxxx Xxx | |||
Date: | 11/9/07 | |||
Applied Biosystems Finance Department | ||||
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
Table of Contents
PRD/PSD/Traceability Matrix | Product Requirements |
EXHIBIT A
[Applied BioSystems Logo]
Xxxxxx
Integrated Project Plan
Integrated Project Plan
Version 0.7
Applied Biosystems
Project Manager: Xxxxxxx Xxxxxxxxx
October 11, 2007
October 11, 2007
For internal use only. This document contains confidential, proprietary information of Applied
Biosystems. It may not be reproduced or copied without prior written permission from Applied
Biosystems.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.
Page 2
Table of Contents
Table of Contents |
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27 |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
28 | ||||
28 | ||||
30 | ||||
31 | ||||
32 | ||||
32 | ||||
33 | ||||
00 | ||||
35 | ||||
36 |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
Revision History
Version | Date | Author | Notes | |||
0.6
|
28 Sep 07 | S2insight | ¨ Results of Sept.
26-28, 2007
IntensiveTM Session |
|||
0.7
|
11 Oct 07 | Xxxxxxx Xxxxxxxxx | ¨ Updated — noted TBDs |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page iii
Table of Contents
Introduction
This document defines the Integrated Project Plan (IPP) for the Definition stage of the Xxxxxx
project It includes the following sections:
§ | Project Scope |
Ø | Justification & Purpose | ||
Ø | Objectives | ||
Ø | Deliverables | ||
Ø | Constraints | ||
Ø | Assumptions |
§ | Work Breakdown Structure | ||
§ | Performance Measures |
Ø | High-level Timeline & Milestones | ||
Ø | High-level Cost Estimate |
§ | Organization |
Ø | Project Team | ||
Ø | Roles & Responsibilities | ||
Ø | Team Values |
§ | Monitoring and Control | ||
§ | Appendices |
Companion documents that complete the definition of this IPP include:
§ | Xxxxxx Schedule — Project schedule in Microsoft Project® format showing complete work breakdown structure, task owners, task dependencies and critical path. | ||
§ | Xxxxxx Risk Register — Risk Register in MS Excel® format showing risk identification and assessment as well as response plans. | ||
§ | Xxxxxx Issues & Action Log — A table of issues and actions in MS Excel® format showing date of identification and resolution, responsibility, and status. |
This plan was developed collaboratively by the project team and has been reviewed and approved
by the project Sponsor. All changes to the plan will be managed through the Change Management
Process.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 1
Table of Contents
Project Scope Statement
Project Justification & Purpose
This project has been chartered to meet the business and product needs as specified in the
Project Charter document. The primary needs are as follows:
§ | TBD |
As a consequence of these needs, the overall statement of purpose for the Xxxxxx project is as
follows:
Overall Statement of Purpose
To integrate AB’s Genotyping Assay Business with BioTrove’s OpenArray Technology
Platform to provide a new product for mid-density genotyping customers by [***].
The development of this IPP is an iterative process, with revised and updated IPP content for
each project stage. The statement of purpose for the current stage is as follows:
Statement of Purpose for the Definition Phase -
Decision to Commercialize (DtC) to Start Development Checkpoint (SDC)
Decision to Commercialize (DtC) to Start Development Checkpoint (SDC)
To define final product requirements in order to better understand the schedule,
resources and risks associated with meeting the requirements by [***].
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 2
Table of Contents
Project Success Criteria
The following table documents the criteria (quantifiable wherever possible) that must be met
for the project to be considered successful (i.e., what constitutes success for the project after
the fact).
Objectives Included | Objectives Not Included | |
§ Portal web configuration [***] |
||
§ AB is supplier [***] |
||
§ Qualification of customer order to receipt [***] BioTrove |
||
§ Predictable turnaround time [***] |
||
§ Manufacturing [***]
|
§ Formulation [***] |
|
§ Manufacturing qualification of
BioTrove [***]
|
§ AB development or manufacturing
of [***] |
|
§ Thorough understanding of system
performance [***]
|
§ Understanding [***] failures [***] |
|
§ Genotyping [***] |
||
§ Track [***] |
§ Change in [***] |
|
§ Competitive intelligence |
||
§ [***] QC changes |
||
§ Ability to import system data [***]
|
§ Development of [***] software [***] |
|
§ Commercializing [***] |
||
§ Enable AB global sales, service
and support for system |
||
§ Success [***] |
||
§ Validation [***]
|
§ Development [***] |
|
§ Product development [***] |
||
§ BioTrove scale-up [***]
requirements |
||
§ [***] shelf-life |
||
§ Processes compliant [***] |
Trade-Off Matrix
The following matrix documents the options available when critical trade-offs must be made
between the Scope, Schedule, and Resource/Cost parameters. This matrix captures both stakeholder
and project Sponsor guidance.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 3
Table of Contents
Parameter | Few Options | Some Options | Most Options | |||
Scope
|
Scope | |||||
Options | 1. [***] IT/Portal/Mfg requirements [***] | |||||
2. [***] confidence interval [***] | ||||||
Schedule
|
Schedule | |||||
Options | 1. Project [***] resources [***] | |||||
Resource/Cost
|
Resources | |||||
Options | 1. [***] R&D programs [***] |
Work Breakdown Structure and Ownership
The following categories represent the principal work groups of the Xxxxxx project and which
organization is primarily responsible. Refer to the Work Breakdown Structure and Ownership of
Deliverables for more details.
# | Applied Biosystems | BioTrove | ||
F01
|
Project Management | |||
F02
|
Product Management | |||
F03
|
Portal | |||
F04
|
[***] R&D | |||
F05
|
Reagent [***] R&D | |||
F06
|
[***] R&D | |||
F07
|
Verification and Validation | |||
F08
|
[***] Mfg & Operations | |||
F09
|
[***] Manufacturing | |||
F10
|
[***] Manufacturing | |||
F11
|
Quality & Compliance | |||
F12
|
Service & Support | |||
F13
|
Legal | Legal | ||
F14
|
Documentation | |||
F15
|
Reagent Consumables Mfg & Operations | |||
F16
|
Business Systems | |||
F17
|
Systems Engineering | |||
F18
|
Alliance Management | |||
F19
|
[***] R&D |
Project Assumptions
The following are the critical assumptions on which the plan is built. Assumptions are factors
that are considered to be true, real, or certain.
These assumptions have been validated with the project Sponsor. Any change to these
assumptions will require re-evaluation of the plan.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 4
Table of Contents
1. | AB will sell [***]. | ||
2. | Freedom to Operate [***]. | ||
3. | [***]. | ||
4. | [***]. | ||
5. | [***]. | ||
6. | [***]. |
Organization
Project Team
The following identifies the Project Team. Included in the table below are:
§ | Stakeholders – The Sponsor and key stakeholders | ||
§ | Core Team – The Project Manager and all project team members who will be either deliverable leaders or deliverable contributors. Activities of the Core Team- |
Ø Represent Statue & Report | |||
Ø Cross-functional interfaces | |||
Ø Decision Making | |||
Ø Escalate appropriately | |||
Ø Responsible to deliver on contract | |||
Ø Problem solving/issue resolution | |||
Ø Communication | |||
Ø Execute alliance management |
§ | Partners & Extended Team – Includes subject matter experts, subcontractors, and consultants, as well as anyone who has input into the project but is not a Core Team member |
Role | Name | |
Stakeholders |
||
Project Sponsor
|
[***] | |
Working Team |
||
Project Manager
|
[***] | |
Product Management AB |
||
R&D AB |
||
Manufacturing Development AB |
||
Systems Engineer/V&V |
||
Quality |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 5
Table of Contents
Role | Name | |
Service |
||
IT Portal |
||
iDevAB |
||
Partners & Extended Team |
||
{Function 1} |
||
{Function 2} |
||
{SME 1} |
||
{SME 2} |
||
{Subcontractor} |
Roles & Responsibilities
The following identifies the major Roles and Responsibilities for the project, as well as the
most critical resource issues for each team. Only major contributors are identified, especially
where cross-functional support is required.
Function | Deliverable | Owner | Contributors | Resource Issues | ||||
[***] |
[***] | |||||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § [***] | § [***] | § | ||||
[***] |
§ [***] | § | ||||||
[***] |
§ [***] | § [***] | § [***] | § [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 6
Table of Contents
Function | Deliverable | Owner | Contributors | Resource Issues | ||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ [***] | |||||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ | § | § | § | ||||
[***]
|
§ [***] | § | § | |||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ [***] | § | ||||||
[***]
|
§ [***] | § [***] | § [***] | § [***] § [***] |
||||
§ [***] | § [***] | § [***] § |
§ [***] | |||||
[***]
|
§ [***] | § [***] | ||||||
[***]
|
§ [***] | § [***] | ||||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ | § [***] | § | § [***] | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ [***] | § [***] | § [***] | |||||
[***]
|
§ [***] | |||||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ [***] | § | ||||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ [***] | § | ||||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ [***] | § [***] | ||||||
[***]
|
§ [***] | § [***] | § | § | ||||
[***]
|
§ [***] | § [***] | § | § | ||||
[***]
|
§ [***] | § [***] | § | § | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ | § [***] | § | § | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ | § | § | § | ||||
[***]
|
§ [***] | § [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 7
Table of Contents
Function | Deliverable | Owner | Contributors | Resource Issues | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ | § [***] | § | § [***] | ||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ | § [***] | § | § [***] | ||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ | § [***] | § | § [***] | ||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ [***] | § [***] | § [***] | § [***] | ||||
[***]
|
§ | § [***] | § | § | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ | § [***] | § | § | ||||
[***]
|
§ [***] | § [***] | § [***] | § | ||||
[***]
|
§ [***] | § [***] | § [***] | § |
Performance Measures
High-Level Timeline & Milestones — TBD
The following major milestones constitute a high-level timeline for the Xxxxxx project.
This timeline is an integration of the top-down business requirements (target milestones)
imposed by business necessity, and the bottom-up realities documented in the detailed project
schedule.
Month, Year | Major Milestones | |
January, 2008
|
• | |
February, 2008
|
• | |
March, 2008
|
• | |
April, 2008
|
• | |
May, 2008
|
• | |
June, 2008
|
• | |
July, 2008
|
• | |
August, 2008
|
• |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 8
Table of Contents
Month, Year | Major Milestones | |
September, 2008
|
§ | |
October 2008
|
§ | |
November, 2008
|
§ | |
December, 2008
|
§ |
<Use
this table or the one on the following page — delete one or the other.>
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 9
Table of Contents
2004 | 2005 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Target Milestone | Schedule | Actual | J | F | M | A | M | J | J | A | S | O | N | D | J | F | M | A | M | J | J | A | S | O | N | D | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Milestone 1 SAMPLE |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Milestone 2 SAMPLE |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Milestone 3 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Milestone 4 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Milestone 5 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Milestone 6 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Project Deliverables |
Schedule | Actual | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 1 SAMPLE |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 2 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 3 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 4 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 5 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 6 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 7 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 8 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 9 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 10 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 11 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 12 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 13 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 14 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 15 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 16 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 17 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 18 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 19 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverable 20 |
[***] | [***] | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Milestones |
[***] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deliverables |
[***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 10
Table of Contents
High-Level Cost Estimate — TBD
The following table constitutes a high-level cost estimate for the Xxxxxx project. This cost estimate is based on:
o
|
Project schedule & associated resource requirements | |
o
|
Capital expenditures | |
o
|
Variable expenses |
This cost estimate shows both the target project cost estimate (Budget), along with the
forecast cost estimate (Forecast) based on the detailed project schedule.
<Example — Fill out and replace>
2004 | 2005 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PROJECT COSTS | J | A | S | O | N | D | J | F | M | A | M | J | J | A | S | O | N | D | Total | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
BUDGET |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FORECAST |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
*
|
[***] | |
[***] | ||
[***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 11
Table of Contents
Monitoring and Control
This section defines the critical processes for monitoring and controlling the Xxxxxx project.
Monitoring and Control Processes — TBD
The following are references to specific customizations of the Monitoring and Control
processes that will be used to control the project.
o [***]
o [***]
o [***]
o [***]
o [***]
o [***]
o [***]
Project-specific elements of the Monitoring and Control processes are contained below.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 12
Table of Contents
Project Meeting Matrix — TBD
Meeting | Meeting | Frequency - | Time & Time | Location or | ||||||||
Type | Owner | Day/Date | Zone | Teleconference # | Attendees | Objective | ||||||
Core Team
|
Project Manager | Weekly | [***] | [***] | ||||||||
Working Team
|
Project Manager | Weekly | [***] | [***] | ||||||||
Project Team
|
Project Manager | Bi-monthly & as needed | [***] | [***] | ||||||||
Sponsor Review
|
Project Manager | Monthly & as needed | [***] | [***] | ||||||||
Steering Committee
|
Project Sponsor | As Needed | [***] | [***] | ||||||||
Planning Session
|
Prior to the start of a new Stage of the project lifecycle | [***] | [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 13
Table of Contents
Project Document/Report Matrix — TBD
Report/Document | Report | Frequency - | Distribution | |||||||
Type | Owner | Day/Date | Method | Intended Recipients | Contents | |||||
Integrated Project
Plan (IPP)
|
Project Manager | By Stage or Following Update | [***] | [***] | [***] | |||||
Project Schedule
Xxxxx
|
Project Manager | Weekly | [***] | [***] | • [***] • [***] |
|||||
Risk Management Plan
|
Project Manager | Monthly | [***] | [***] | [***] | |||||
Project Issues & Actions Log
|
Project Manager | Weekly | [***] | [***] | [***] | |||||
Sponsor Status Report
|
Project Manager | Monthly | [***] | [***] | • [***] • [***] |
|||||
• [***] | ||||||||||
• [***] | ||||||||||
• [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 14
Table of Contents
Appendix A — Scope Definition
F01: Project Management
In Scope | Out Scope | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***] |
||
[***] |
||
[***] |
||
[***] |
||
[***] |
||
[***] |
||
[***] |
||
[***] |
||
[***] |
||
[***] |
Major Deliverables (for Start of SDC Checkpoint)
• | IPP & Schedule | |
• | Presentation to PAC- Checkpoint Checklist | |
• | Workplan | |
• | Project Contract |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 15
Table of Contents
F02: Product Management
In Scope | Out of Scope | |||||
§
|
[***] targets per configuration [***] | § | [***] requirements [***] | |||
§
|
Customer [***] experience | § | [***] requirements | |||
§
|
[***] forecast [***] | § | [***] requirements | |||
§
|
System definition | § | [***] Marketing plan | |||
§
|
[***] | § | [***] File [***] configuration |
|||
§
|
[***] workfloworder fulfillment | § | ||||
§
|
[***] configurations | § | ||||
§
|
[***] customer expected TAT | § | ||||
§
|
[***] workflow customer experience | § | ||||
§
|
[***] evaluate existing solutions [***] | § | ||||
§
|
Competitive analysis | § | ||||
§
|
[***] thermal cycler [***] | § | ||||
§
|
[***] customer support [***] | § | ||||
§
|
[***] any customer needs [***] | § | ||||
§
|
Financial processes & reporting | § | ||||
§
|
[***] order process | § | ||||
§
|
Labeling/branding/imagery [***] | § | ||||
§
|
Customer data [***] | § | ||||
§
|
[***] product components [***] | § | ||||
§
|
Shipping [***] | § |
Major Deliverables
[***] Compliance [***]
|
[***] product position [***] | |
Financial process [***]
|
Business [***] | |
Support [***]
|
Communication Plan to Customers | |
[***] plan
|
[***] | |
[***]
|
[***] | |
[***]
|
Financial analysis [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 16
Table of Contents
F03: Portal
In Scope | Out of Scope | |||||
§
|
Define methods [***] | § | [***] requirements | |||
§
|
[***] configurations | § | [***] | |||
§
|
[***] minimums [***] | § | [***] | |||
§
|
[***] customer order [***] | § | [***] | |||
§
|
[***] order notification [***] | § | [***] | |||
§
|
[***] product info [***] | |||||
§
|
[***] product pages [***] | |||||
§
|
[***] assays [***] | |||||
§
|
Order information | |||||
§
|
Assay information | |||||
§
|
[***] | |||||
§
|
[***] |
Major Deliverables
§
|
Web order requirements [***] | |
§
|
Customer order to receipt [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 17
Table of Contents
F04: OpenArray and HW/FW R&D
In Scope | Out of Scope | |||||
§
|
[***] subsystem requirements | § | Mfg [***] | |||
§
|
[***] SS requirements | § | [***] workflow | |||
§
|
[***] SS requirements | § | System [***] | |||
§
|
[***] thermal cycler [***] | § | [***] variation [***] | |||
§
|
[***] SS requirements | § | [***] documentation [***] | |||
§
|
[***] consumables SS requirements | |||||
§
|
[***] QC documents | |||||
§
|
Customer workflow | |||||
§
|
Train [***] | |||||
§
|
Collect data [***] |
Major Deliverables
§
|
Subsystem requirements | |
§
|
Customer workflow protocol |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 18
Table of Contents
F05: Reagent Consumables R&D
In Scope | Out of Scope | |||||
§
|
[***] | § | [***] | |||
§
|
[***] Requirements | § | [***] Instructions (F15) | |||
§
|
[***] Stability [***] | § | [***] Qualification (F15) | |||
§
|
[***] Configuration | § | Draft BOM’s (next phase) | |||
§
|
Guard Band [***] |
Major Deliverables
§
|
[***] Performance Requirements | |
§
|
[***] Stability Plan |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 19
Table of Contents
F06: Software R&D
In Scope | Out of Scope | |||||
§
|
[***] interface [***] | § | [***] | |||
§
|
[***] software requirements | § | Software [***] | |||
§
|
[***] changes required |
Major Deliverables
§
|
Software functional requirements |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 20
Table of Contents
F07: Verification and Validation
In Scope | Out of Scope | |||||
§
|
[***] test & data [***] | § | Characterization [***] | |||
§
|
[***]subsystem [***] | § | Customer [***] | |||
§
|
[***] test strategy | § | [***] validation | |||
§
|
[***] infrastructure | § | System [***] | |||
§
|
Forecast [***] | |||||
§
|
Forecast instrument [***] | |||||
§
|
Determine Assay [***] |
Major Deliverables
§
|
[***] | |
§
|
[***] | |
§
|
[***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 21
Table of Contents
F08: Assay Mfg & Operations
In Scope | Out of Scope | |
§ Define format(s) [***]
|
§ [***] customer specs [***] | |
§ Evaluate AB [***]
|
§ [***] Targets & Metrics [***] | |
§ [***] forecast/volume [***] |
||
§ [***] process review |
||
§ [***] process risk assessment |
||
§ [***] architecture [***] |
||
§ [***] security [***] |
||
§ [***] reporting needs [***] |
||
§ [***] system implementation |
||
Major Deliverables |
||
§ Mfg process design FMEA |
||
§ [***] supply chain [***] |
||
§ [***] interface design |
||
§ [***] |
||
§ [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 22
Table of Contents
F09: OpenArray Consumables Manufacturing
In Scope | Out of Scope | |
§ [***] forecast
|
§ [***] assay format [***] | |
§ [***] process review
|
§ [***] architecture [***] | |
§ [***] system/order [***]
|
§ Product labeling & packaging [***] | |
§ [***] mfg scale up [***]
|
§ [***] shipping requirement [***] | |
§ [***] feedback process
|
§ [***] | |
§ [***] risk assessment |
||
Major Deliverables
§ Mfg scale up plan & schedule
|
||
§ Mfg process FEMA report |
||
§ BT QC Plan |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 23
Table of Contents
F10: OpenArray Instrumentation Manufacturing
In Scope | Out of Scope | |
§ [***] forecast
|
§ [***] requirements [***] | |
§ [***] feedback process
|
§ [***] inventory [***] | |
§ [***] process review
|
§ [***] labeling & packaging [***] | |
§ [***] spare parts [***]
|
§ [***] spare parts [***] | |
§ [***] service systems [***][***] | ||
§ [***] new instrument [***] | ||
§ [***] management systems [***] |
Major Deliverables
§ Mfg & QC plan schedule
|
||
§ Spare parts plan |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 24
Table of Contents
F11: Quality & Compliance
In Scope | Out of Scope | |
§ [***] qualification [***]
|
§ Product quality [***] | |
§ [***] compliance [***] |
||
§ Quality system [***] |
||
§ QC (confirmation) [***] |
||
§ [***] quality data [***] |
||
§ [***] change control |
||
§ [***] documentation |
||
§ [***] change control |
||
Major Deliverables
§ Quality plan [***]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 25
Table of Contents
F12: Service & Support
In Scope (Instruments Only) | Out of Scope | |
§ Warranty & contract [***]
|
§ Location [***] | |
§ [***]
|
§ Sustaining engineering [***] | |
§ Upgrades [***] |
§ [***] tracking [***] | |
§ [***] spare parts [***] |
||
§ [***] Forecast/demand [***] |
||
§ Problem solving tools [***] |
||
§ DOA [***] |
||
§ ECO communications |
||
§ [***] troubleshoot [***] |
||
§ Customer training |
||
§ [***] knowledge [***] |
||
§ Depot Repair [***] |
||
§ [***] web download |
||
§ [***] part usage at install, [***] |
||
§ Software [***] |
||
§ [***] Parts & instruments |
||
§ Service Bulletin[***] |
||
§ [***] support structure [***] |
||
§ Installation [***] |
||
§ Escalations FPR’s [***] |
||
Major Deliverables
§ [***]
|
||
§ [***] |
||
§ Service & support plan |
F13: Legal
In Scope | Document Review | |
§ Document [***]
|
§ [***] Compliance [***] | |
§ IP [***]
|
§ [***] Patent Applications [***] | |
§ Invention [***] |
||
§ [***] [FTO] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 26
Table of Contents
Major Deliverables
§ FTO [***]
§ [***] Contract [***]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 27
Table of Contents
F14: Field & Customer Documentation
Scope | Out of Scope | |
§ [***]
|
§ Mfg [***] | |
§ [***]
|
§ Marketing [***] | |
§ [***] Bulletins [***]
|
§ Packing Kit [***] | |
§ Service guide [***]
|
§ Labels [***] | |
§ [***]
|
§ [***] | |
§ Training [***]
|
§ [***] | |
§ [***] guides [***]
|
§ [***] Drawings/schematics [***] | |
§ [***] |
||
§ Document [***] |
Major Deliverables
§ | [***] Document Plan [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 28
Table of Contents
F15: Reagent Consumables Mfg & Operations
In Scope | Out of Scope | |
§ [***] forecast
|
§ [***] shipping [***] | |
§ [***] components
|
§ [***] labeling [***] | |
§ QC process [***]
|
§ [***] formulation of [***] | |
§ Mfg process [***] |
Major Deliverables
§ | [***] QC test [***] | |
§ | Mfg supply chain [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 29
Table of Contents
F16: Business Systems
In Scope | Out of Scope | |
§ [***] forecasts [***]
|
§ | |
§ [***] new part numbers [***]
|
§ | |
§ [***] communication [***]
|
§ | |
§ [***]
|
§ | |
§ Order tracking
|
§ | |
§ [***] order [***]
|
§ | |
§ [***] access [***]
|
§ | |
§ [***] access [***]
|
§ | |
§ AB/BT reporting [***]
|
§ | |
§ [***] escalate customer [***]
|
§ | |
§ [***] email routing?
|
§ | |
§ Modifications required [***]
|
§ | |
§ [***] portal links [***]
|
§ |
Major Deliverables
§ | [***] process workflows? [***] | |
§ | Develop systems architecture [***] |
F17: Systems Engineering
In Scope | Out of Scope | |
§ [***] Specifications
|
§ | |
§ [***] Risk Analysis
|
§ | |
§ [***] Characterization
|
§ | |
§ Troubleshooting
|
§ |
Major Deliverables
§ | [***] | |
§ | Traceability Matrix |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 30
Table of Contents
F18: Affiance Management
In Scope | Out of Scope | |
§ Alliance [***]
|
§ | |
§ Communication [***]
|
§ | |
§ [***] Mgmt
|
§ | |
§ Roles & Responsibilities
|
§ | |
§ [***] Members
|
§ | |
§ [***] Management
|
§ |
Major Deliverables
§ | Steering Committee [***] | |
§ | Governance Plan |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 31
Table of Contents
F19: Assay R&D
In Scope | Out of Scope | |
§ Characterization & analysis [***]
|
§ Assay [***] |
Major Deliverables
§ | [***] characterization plan | |
§ | [***] performance review [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 32
Table of Contents
Appendix B — Schedule and Cost Improvement Ideas
Idea | Advantages | Disadvantages | ||
§
|
§ | § | ||
§
|
§ | § | ||
§
|
§ | § | ||
§
|
§ | § | ||
§
|
§ | § | ||
§
|
§ | § | ||
§
|
§ | § | ||
§
|
§ | § | ||
§
|
§ | § | ||
§
|
§ | § |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 33
Table of Contents
Appendix C — Glossary of Terms
Abbreviation | Definition | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
EH&S
|
Environmental Health & Safety | |
FTD
|
Freedom to Operate | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
SOX
|
Sarbanes Oxley |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 34
Table of Contents
EXHIBIT B
PRD 1 PSD / TRACEABILITY MATRIX
Project Name: Xxxxxx
Project Number: 810003350
Document Version:
Project Name: Xxxxxx
Project Number: 810003350
Document Version:
Note: Product Requirements and Products Specifications are finalized prior to the Start
Development Checkpoint (SDC). Xxxxxx anticipate SDC in March 2008.
Product | ||||||||||
Customer Req. | Req. | |||||||||
Number | Customer Requirement Description | VOC Mapping | Priority | Number | Product Requirement Description | |||||
Product Configuration Requirements (10) | Product Configuration Requirements (10) | |||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | |||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | |||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***]
|
[***] | |||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 1 of 7
Table of Contents
Product | ||||||||||
Customer Req. | Req. | |||||||||
Number | Customer Requirement Description | VOC Mapping | Priority | Number | Product Requirement Description | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | |||||||||
Usability and Reliability Requirements (30) | Usability and Requirements (30) | |||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 2 of 7
Table of Contents
Product | ||||||||||
Customer Req. | Req. | |||||||||
Number | Customer Requirement Description | VOC Mapping | Priority | Number | Product Requirement Description | |||||
[***] | [***] | [***] | ||||||||
User Interface Requirements (40) | User Interface Requirements (40) | |||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
Non-user-Interface Requirements (50) | Non-user-Interface Requirements (50) | |||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | |||||||||
[***] | [***] | |||||||||
[***] | [***] | |||||||||
Security Requirements (60) | Security Requirements (60) | |||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***] | [***] | |||||||||
Cost Requirements (70) | Cost Requirements (70) | |||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 3 of 7
Table of Contents
Product | ||||||||||
Customer Req. | Req. | |||||||||
Number | Customer Requirement Description | VOC Mapping | Priority | Number | Product Requirement Description | |||||
Product Quality Requirements (80) | Product Quality Requirements (80) | |||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
Environmental Health & Safety Requirements (90) | Environmental Health & Safety Requirements (90) | |||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
Regulatory Requirements (100) | Regulatory Requirements (100) | |||||||||
[***]
|
[***] | |||||||||
Documentation Requirements (110) | Documentation Requirements (110) | |||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
Packaging Labeling & Shipping Requirements (120) | Packaging Labeling & Shipping Requirements (120) | |||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 4 of 7
Table of Contents
Product | ||||||||||
Customer Req. | Req. | |||||||||
Number | Customer Requirement Description | VOC Mapping | Priority | Number | Product Requirement Description | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | |||||||||
Testing Requirements (130) | Testing Requirements (130) | |||||||||
[***]
|
[***] | |||||||||
Installation Requirements (140) | Installation Requirements (140) | |||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | ||||||||
[***] | [***] | [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 5 of 7
Table of Contents
EXHIBIT C
INSTRUMENTS
PART NUMBER | DRAWING NUMBER | DESCRIPTION | SAFETY STOCK | COMMENT | ||||||
20001-100 |
BLK PEARL BOM-1 | OpenArrayTM NT Imager | [***] | |||||||
20253 |
20253 | OpenArrayTM Case Sealing Station | [***] | |||||||
20456 |
20456 | OpenArrayTM NT Instrument Installation Kit | [***] | |||||||
20249 |
20249 | Data Processing Module (Computer) | [***] | |||||||
20250 |
20250 | Monitor | [***] | |||||||
20353 |
20353 | OpenArrayTM AutoLoader System | [***] | |||||||
20322 |
20322 | OpenArrayTM AutoLoader Tip Block | [***] | |||||||
20384 |
20384 | OpenArrayTM AutoLoader Plate Holder | [***] | |||||||
20441 |
20441 | OpenArray”, SNP Genotyping Analysis Software Kit | [***] |
CONSUMABLES
DRAWING | ||||||||
PART NUMBER | NUMBER | DESCRIPTION | SAFETY STOCK | COMMENT | ||||
10025 |
10025 | Finished Coated Sheet - SNP | [***] | [***] | ||||
10053 |
10053 | OpenArrayTM Genotyping Case | [***] | |||||
10055-1 |
10055-1 | OpenArrayTM Immersion Fluid - 1 Pack | [***] | |||||
10058-3 |
10058-3 | OpenArrayTM Case Sealing Glue - 3mL | [***] | |||||
10169 |
10169 | OpenArrayTM Loader Tips | [***] | |||||
10325 |
10325 | OpenArrayTM Sample Loading Plates | [***] | |||||
10024 |
10024 | OpenArray™ SNP Demo Plate | [***] | |||||
10220 |
10220 | OpenArray™ SNP Training & Test Plate | [***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Page 1 of 1
Table of Contents
EXHIBIT D
Certificate of Analysis
Product
|
: Applied Biosystems 7900HT Gene Expression Micro Fluidic Card, Configuration 4 | |
Part No.
|
: 4342253 | |
Lot No.
|
: A0349 | |
Release Date
|
: 17 Jun 04 | |
Expiration Date
|
: 18 Jun 05 |
Each lot of material is tested to the following specifications:
Test | Result | |
[***] SDS system Functional Test
|
Pass | |
[***] SDS system Functional Test
|
Pass |
WARRANTY STATEMENT
Every consumable product provided by Applied Biosystems is guaranteed to perform as specified for
one year from the date of shipment, unless otherwise indicated on the
product label. If you have a
question, call your local Applied Biosystems Customer Service Representative for assistance.
Approved by:
|
/s/ Illegible | |||||
[Applied Biosystems logo] |
||||||
Quality Assurance Manager |
Notice: For Research Use Only. Not for use in diagnostic procedures.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
EXHIBIT E
PATENT LICENSE AGREEMENT
See Exhibit 10.5 to the Registrant’s S-1 Registration Statement
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
EXHIBIT F
Current Customer Commitments:
11-08-07
11-08-07
ARTICLE XV. SERVICE AND SUPPLY AGREEMENT WITH [***] AND AFFILIATES. CURRENT
AGREEMENT EXPIRES [***] AB, BIOTROVE AND [***] AND BIOTROVE WILL COORDINATE TO
DETERMINE APPROPRIATE RENEWAL CONDITIONS AND TRANSITION TIMING TO AB.
ARTICLE XVI. DISTRIBUTION AGREEMENT FOR ALL BIOTROVE OPENARRAY PRODUCTS WITH
[***] COVERS [***] (EXCLUSIVE DISTRIBUTION). EXPIRES [***] AND IS RENEWABLE.
BIOTROVE MAY RENEW THIS AGREEMENT FOR [***].
ARTICLE XVII. DISTRIBUTION AGREEMENT FOR ALL BIOTROVE OPENARRAY PRODUCTS WITH
[***]. COVERS [***]. (IN DISCUSSION — PENDING). AGREEMENT WOULD EXPIRE [***].
CLAUSE TO BE INCLUDED IN DISTRIBUTION AGREEMENT STATING 30 DAY NOTICE FOR
TERMINATION OF AGREEMENT FOR [***].
ARTICLE XVIII. DISTRIBUTION AGREEMENT FOR ALL BIOTROVE OPENARRAY PRODUCTS WITH
[***]. COVERS [***]. (PENDING) AGREEMENT WOULD EXPIRE [***]. CLAUSE TO BE
INCLUDED IN DISTRIBUTION AGREEMENT STATING 30 DAY NOTICE FOR TERMINATION OF
AGREEMENT FOR [***].
ARTICLE XIX. COLLABORATION AGREEMENT WITH [***]. COVERS [***]. EXPIRES IN
[***]. BIOTROVE TO CONTINUE SUPPLYING [***] AS AGREED UNDER COLLABORATION.
ARTICLE XX. COLLABORATION AGREEMENT WITH [***]. EXPIRES [***]. COLLABORATING ON
[***] TO BE USED IN [***]. BT PROVIDES [***] AND [***] ON LOAN. AB TO PICK UP
COLLABORATION AND CONVERT TO COMMERCIAL BUSINESS.
ARTICLE XI. COLLABORATION AGREEMENT WITH [***]. EXPIRES [***]. PRICING DEAL FOR
[***]. INSTRUMENT HAS BEEN PURCHASED. LEGACY AGREEMENT. PRICING TO BE
RE-NEGOTIATED UPON TRANSITION TO AB.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
ARTICLE XXII. SERVICE AND SUPPLY AGREEMENT WITH [***].[***] TERM. COVERS [***],
BIOTROVE TO CONTINUE TO MANAGE.
ARTICLE XXIII. PRICING QUOTATIONS FOR [***] AS FOLLOWS: ALL PRICING QUOTATIONS
FOR [***] TO BE RE-NEGOTIATED UPON TRANSITION OF CUSTOMER TO AB.
Section 23 01 |
Pricing agreement for [***]. | |||
Section 23.02 |
Pricing agreement for [***]. | |||
Section 23.03 |
Pricing agreement for [***]. | |||
Section 23.04 |
Pricing agreement for [***]. | |||
Section 23.05 |
Pricing agreement for [***] | |||
Section 23.06 |
Pricing agreement for [***]. | |||
Section 23.07 |
Pricing agreement for [***]. | |||
Section 23.08 |
Pricing agreement for [***]. |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
EXHIBIT G
BioTrove OpenArray IP Portfolio — September 2007
Case 65643
Status | Serial Number | Priority Information | Patent No. | Title | Filed | Issued | Country/Region | |||||||||||
Issued
|
09/272,122 | 6,027,873 | Multi-Through Hole Testing Plate for High Throughput Screening | 3/19/1999 | 2/22/2000 | United States | ||||||||||||
Issued
|
09/528,085 | CIP of 09/471,852 | 6,306,578 | Multi-Through Hole Testing Plate for High Throughput Screening | 3/17/2000 | 10/23/2001 | United States | |||||||||||
Issued
|
37583/00 | National Phase of PCT/US00/07140 | 756982 | Multi-Through Hole Testing Plate for High Throughput Screening | 3/17/2000 | 1/30/2003 | Australia | |||||||||||
Pending
|
PI0009164-2 | National Phase of PCT/US00/07140 | Multi-Through Hole Testing Plate for High Throughput Screening | 3/17/2000 | Brazil | |||||||||||||
Pending
|
2,367,912 | National Phase of PCT/US00/07140 | Multi-Through Hole Testing Plate for High Throughput Screening | 3/17/2000 | Canada | |||||||||||||
Pending
|
916485.6 | National Phase of PCT/US00/07140 | Multi-Through Hole Testing Plate for High Throughput Screening | 3/17/2000 | European Patent Convention | |||||||||||||
Pending
|
XX/X/0000 | Xxxxxxxx Xxxxx xx XXX/XX00/00000 | Multi-Through Hole Testing Plate for High Throughput Screening | 3/17/2000 | Mexico | |||||||||||||
Issued
|
513390 | National Phase of PCT/US00/07140 | 513390 | Multi-Through Hole Testing Plate for High Throughput Screening | 3/17/2000 | 5/12/2003 | New Zealand | |||||||||||
Issued
|
2001128215 | National Phase of PCT/US00/07140 | 2246349 | Multi-Through Hole Testing Plate for High Throughput Screening | 3/17/2000 | 2/20/2005 | Russia | |||||||||||
Issued
|
09/970,578 | CON of 09/528,085 | 6,436,632 | Multi-Through Hole Testing Plate for High Throughput Screening | 10/4/2001 | 8/20/2002 | United States | |||||||||||
Pending
|
10/223,893 | CON of 09/970,578 | Multi-Through Hole Testing Plate for High Throughput Screening | 8/20/2002 | United States |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
Case 65647 Stanford
Status | Serial Number | Priority Information | Patent No, | Title | Filed | Issued | Country/Region | |||||||||||||
Allowed
|
09/789,601 | 60/229,357 | Apparatus and Method for Parallel Processing of Micro-Volume Liquid | 2/20/2001 | United States | |||||||||||||||
Pending
|
2,400,644 | National Phase of PCT/US01/05550 | Apparatus and Method for Parallel Processing of Micro-Volume Liquid Reactions | 2/20/2001 | Canada | |||||||||||||||
Pending
|
11/054,184 | CON of 09/935,455 | Apparatus and Method for Parallel Processing of Micro-Volume Liquid Reactions | 2/9/2005 | United States | |||||||||||||||
Issued
|
6,716,629 | Cell Culture in OA | United States | |||||||||||||||||
Pending
|
2005-0148066 | CON of 09/935,455 | Device claims on PCR in a through-hole structure | |||||||||||||||||
Pending
|
11/503,401 | CIP of 09/789,601 | Manufacturing Methods and Coatings | 0000 | Xxxxxx Xxxxxx | |||||||||||||||
Pending
|
60/707,501 | Rollied nto 11/503,401 | Manufacturing Methods and Coatings | United States |
Case 65649
Status | Serial Number | Priority Information | Patent No. | Title | Filed | Issued | Country/Region | |||||||||
Pending
|
10/227,179 | Voltage-Aided Transfer Pins | 8/23/2002 | United States | ||||||||||||
Pending
|
2,495,704 | CIP of 10/227,179 National Phase of PCT/US2003/02644 1 | Capillary Action Transfer Pins | 8/22/2003 | Canada | |||||||||||
Pending
|
3793336.3 | CIP of 10/227,179 National Phase of PCT/US2003/02644 1 | Capillary Action Transfer Pins | 8/22/2003 | European Patent Convention | |||||||||||
Pending
|
2004-529909 | CIP of 10/227,179 National Phase of PCT/US2003/02644 1 | Capillary Action Transfer Pins | 8/22/2003 | Japan |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
Case 65663-
US1
Status | Serial Number | Priority Information | Patent No. | Title | Filed | Issued | Country/Region | |||||||||
Pending
|
10/744,580 | 60/434,988; 60/461,559; 60/461,556; 60/528,461 | Assay Apparatus and Method Using Microfluidic Arrays | 12/22/2003 | Pending | United States | ||||||||||
Pending
|
2,521,999 | National Phase of PCT/US2003/041356 | Assay Apparatus and Method Using Microfluidic Arrays | 12/22/2003 | Canada | |||||||||||
Pending
|
3810080.6 | National Phase of PCT/US2003/041356 | Assay Apparatus and Method Using Microfluidic Arrays | 12/22/2003 | European Patent Convention | |||||||||||
Pending
|
11/227,425 | CIP of 10/744,580 | Thermal Cycler for Microfluidic Array Assays | 9/15/2005 | United States |
Case 65671
Status | Serial Number | Priority Information | Patent No. | Title | Filed | Issued | Country/Region | |||||||
Pending
|
11/198,882 | 60/599,217; 60/608,231 | Coating Process for Microfluidic Sample Arrays | 8/4/2005 | United States |
Case 65672
Status | Serial Number | Priority Information | Patent No. | Title | Filed | Issued | Country/Region | |||||||
Pending
|
11/078,196 | 60/552,267; 60/607,838; 60/627,334 | Nanoliter Xxxxx Xxxxxxx | 0/00/0000 | Xxxxxx Xxxxxx | |||||||||
Pending
|
Not yet assigned | National Phase of PCT/US2005/00824 8 | Nanoliter Array Loading | 3/11/2005 | Australia | |||||||||
Pending
|
Not yet assigned | National Phase of PCT/US2005/00824 8 | Nanoliter Array Loading | 3/11/2005 | Canada | |||||||||
Pending
|
Not yet assigned | National Phase of PCT/US2005/00824 8 | Nanoliter Array Loading | 3/11/2005 | European Patent Convention | |||||||||
Pending
|
Not yet assigned | National Phase of PCT/US2005/00824 8 | Nanoliter Array Loading | 3/11/2005 | Japan |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
Case 65689 MIT
Status | Serial Number | Priority Information | Patent No. | Title | Filed | Issued | Country/Region | |||||||||||
Issued
|
09/225,583 | 60/071,179 | 6,387,331 | Method and Apparatus for Performing Microassays | 1/5/1999 | 5/14/2002 | United States | |||||||||||
Pending
|
2316912 | National Phase | Method and Apparatus for Performing Microassays | 1/5/1999 | Canada | |||||||||||||
Issued
|
99901294 | National Phase | 1,051,259 | Method and Apparatus for Performing Microassays | 1/5/1999 | 4/5/2006 | European Patent Convention | |||||||||||
Issued
|
99901294 | National Phase | 1,051,259 | Method and Apparatus for Performing Microassays | 1/5/1999 | 4/5/2006 | France | |||||||||||
Issued
|
99901294 | National Phase | 1,051,259 | Method and Apparatus for Performing Microassays | 1/5/1999 | 4/5/2006 | Germany | |||||||||||
Issued
|
99901294 | National Phase | 1,051,259 | Method and Apparatus for Performing Microassays | 1/5/1999 | 4/5/2006 | United Kingdom | |||||||||||
Issued
|
99901294 | National Phase | 1,051,259 | Method and Apparatus for Performing Microassays | 1/5/1999 | 4/5/2006 | Italy | |||||||||||
Pending
|
2000-527355 | National Phase | Method and Apparatus for Performing Microassays | 1/5/1999 | Japan | |||||||||||||
Pending
|
10/796,856 | DIV of 09/710,082 | Method and Apparatus for Performing Microassays | 3/9/2004 | United States | |||||||||||||
Issued
|
09/850,123 | CIP of 09/225,583 | 6,893,877 | Methods for Screening Substances in a Xxxxxxxxx Xxxxx | 0/0/0000 | 0/0/0000 | Xxxxxx Xxxxxx | |||||||||||
Issued
|
2002-0001546 | National Phase | 6,893,877 | Methods for Screening Substances in a Microwell Array | ||||||||||||||
Pending
|
2446157 | National Phase | Methods for Screening Substances in a Microwell Array | 5/7/2002 | Canada | |||||||||||||
Pending
|
2769365 | National Phase | Methods for Screening Substances in a Microwell Array | 5/7/2002 | European Patent Convention | |||||||||||||
Pending
|
2000-587105 | National Phase | Methods for Screening Substances in a Microwell Array | 5/7/2002 | Japan | |||||||||||||
Pending
|
10/820,679 | DIV of 09/850,123 | Reformatted Through-Hole Xxxxx | 0/0/0000 | Xxxxxx Xxxxxx | |||||||||||||
Pending
|
10/958,969 | DIV of 10/820,679 | Methods for Filling a Sample Array by Droplet Dragging | 10/5/2004 | United States | |||||||||||||
Issued
|
DIV of 98/850,123 | 6,743,633 | Analyzing the plurality of substances in the OA | United States | ||||||||||||||
Pending
|
10/796,856 | DIV of 6,743,633 | Analyzing the plurality of substances in the OA | United States | ||||||||||||||
Pending
|
2004-0171166 | National Phase | Analyzing the plurality of substances in the OA |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
ATTACHMENT D-1
Supplier Change Request (SCR) Procedure
Scope:
The purpose of the Supplier Change Request (SCR) Form is to ensure the appropriate level of
communication regarding Inventory-related changes between the Applied Biosystems Group (ABG) and
Supplier. Supplier will utilize this form to communicate changes as defined in the Change
Notification Procedure.
Procedure:
The key contacts between ABG and the Supplier should be in regular contact with
each other so that changes raised by the Supplier are discussed before any formal
paperwork is submitted.
The Supplier completes the SCR Form and sends it electronically to the ABG
personnel specified in the Change Notification Procedure (Buyer, Procurement
Manager & Supplier Quality Manager). The Supplier contact will call the ABG Buyer
to confirm receipt of the SCR Form.
The ABG Buyer must respond to the Supplier contact in writing within 2 business
days of receipt to confirm receipt of the SCR Form. The ABG Buyer is responsible
for using the Form to initiate the review and evaluation of the change within ABG.
The Buyer and other necessary ABG contacts will work with the supplier, as
necessary, to ensure the SCR Form is sufficiently complete within 5 business days
of receipt of the SCR Form.
ABG performs internal review and evaluation.
If ABG approves the change, the ABG Buyer and ABG Technical Contact note the
internal qualification reference # (DR #) and sign their approval on the SCR Form
and submit to the Supplier. The Supplier must confirm receipt of approval within 2
business days. If there is any change to the original planned Implementation Date /
Lot Number, the Supplier must request that ABG approve the change in plan.
• | The final approved and signed SCR Form is retained in official files for future reference by both ABG and the Supplier. |
If ABG does not approve the change, the ABG Buyer and other necessary ABG contacts
provide feedback to the Supplier with regard to ABG’s evaluation and collaborate,
as appropriate, to reach an alternative solution (e.g. alternative specification;
lifetime buy of current specification).
Excel Version of Form (Embedded below):
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
EXHIBIT H
Transfer Price Calculations:
These calculations are based on agreed to transfer prices for estimated work plan requirements.
Prices below do not include extra accessories that may also be needed. Prices for all equipment and
accessories are outlined below.
[***]
|
$[***] | |
[***]
|
$[***] | |
[***]
|
$[***] | |
[***]
|
$[***] | |
TOTAL
|
$[***] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
Exhibit I
CHANGE NOTIFICATION PROCEDURE
This procedure describes the responsibilities of the parties to assure proper notification of any
changes to the Inventory or changes to the process for manufacturing the Inventory in accordance
with the procedures detailed below.
(b) Supplier shall notify ABG of any changes to the Inventory or to the process for manufacturing
the Inventory by providing a written notice (“Supplier Change Request (SCR) Form” (Attachment D-1))
at least six (6) months prior to the date the change will take effect. The procedure for the use of
the SCR Form is defined in Attachment D-1. A change includes but is not limited to a change in one
or more of the following:
Manufacturing process
Formulation or design
Raw material or component suppliers
Manufacturing location (change or closure)
Part number
Packaging
Inventory documentation (e.g. Certificate of Analysis)
Inventory specification change
Formulation or design
Raw material or component suppliers
Manufacturing location (change or closure)
Part number
Packaging
Inventory documentation (e.g. Certificate of Analysis)
Inventory specification change
(c) The SCR Form must include (i) a complete description of the change; (ii) an outline of the
underlying reason for the change; and (iii) any and all supporting data or documentation for the
change.
(d) Supplier shall deliver sufficient sample Inventory for evaluation by ABG within 30 calendar
days of the SCR Form. The sample Inventory must be completely representative of the change
identified in the SCR Form.
(e) In addition to the SCR Form, Supplier agrees to provide immediate notification of any
regulatory recall of the Inventory. Supplier further agrees to provide immediate notification of
any voluntary recalls of Inventory.
(f) All notifications as described in this Agreement shall be sent via Certified Mail, overnight
courier service or electronic document transmittal to the ABG personnel listed below, or their
designee.
Electronic document transmittal is preferred and to be sent via email to: < INSERT EMAIL
DISTRIBUTION LIST ADDRESS >
Procurement Manager
Applied Biosystems, Inc.
<INSERT MAILING ADDRESS OF THE
APPROPRIATE PROCUREMENT
Applied Biosystems, Inc.
<INSERT MAILING ADDRESS OF THE
APPROPRIATE PROCUREMENT
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
MANAGER>
Buyer
Applied Biosystems, Inc.
<INSERT MAILING ADDRESS OF THE
APPROPRIATE BUYER>
Applied Biosystems, Inc.
<INSERT MAILING ADDRESS OF THE
APPROPRIATE BUYER>
Supplier Quality Manager
Applied Biosystems, Inc.
000 Xxxxxxx Xxxxxx Xxxxx
Xxxxxx Xxxx, XX 00000
Applied Biosystems, Inc.
000 Xxxxxxx Xxxxxx Xxxxx
Xxxxxx Xxxx, XX 00000
(g) ABG will make its best efforts to respond promptly to the Supplier regarding the acceptance or
rejection of the change, as defined in Attachment D-1. The change must be approved by ABG prior to
delivery of any Inventory wherein the change has taken effect.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
[Applied Biosystems logo]
Supplier Change Request Form
ABG Part No. |
Revision Level | |
Part Description |
||
Requestor’s Organization |
||
Vendor Document Number |
Vendor Document Title | |
Name of
Requestor
|
Signature/Date | |
E-Mail
|
Telephone | Fax |
Part Change Information |
||||
Existing Manufacturer’s Part No
|
||||
New Manufacturer’s Part No
|
||||
Name of Existing
Manufacturer
|
Name of New Manufacturer | |||
Purchased from (Name of Distributor)
|
||||
Address of
Distributor
|
||||
Contact Person
|
Telephone | Fax |
Description of
Change
Please check “X” where appropriate and provide detailed information of proposed change
o
|
Machine / Test Settings | o | Processs Flow | o | Raw Material | |||||
o
|
Design | o | Other |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
o Subcontractor (New)
Address
|
||||
Contact Person |
Telephone |
Fax |
||
Type of Sub-contracted
Service
|
Reason for Change (check “X” where appropriate)
o Cost reduction
|
o Obsolescence | o Engineering Change | o Process Improvement | |||
o To include as Alternate Option
|
o Others |
Target Implementation Date / Xxx #
Xxxx
|
Xxx # |
Xxxxxxxxx Position
Stock
|
Open Purchase Order | |||
Level
|
Qty | Project Cost Savings |
Verification Protocol (check “X” if protocol attached)
o Protocol attached
Description of Verification Protocol: |
||||
ABG Response to Change Request (check “X” where appropriate)
Note: Acceptance required prior to proceeding with verification and/or validation studies per above
described protocol.
oReject |
||
oAccept (Submit First Article for Approval)
|
First Article Qty | |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.
Table of Contents
o Accept With Change (Submit First Article for Approval)
|
First Article Qty | |
Changes
Required: |
||
Supplier to provide the following information to facilitate approval | ||
Reviewed By: | ||
ABG Technical Contact | ||
ABG Buyer/Planner | ||
<ONCE AVAILABLE, INSERT PROCEDURE> | Applied Biosystems Group |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of
the Securities Act.