Exhibit 10.1

 

SERVICES, MANUFACTURING AND SUPPLY AGREEMENT

 

This SERVICES, MANUFACTURING AND SUPPLY AGREEMENT (the “Agreement”), dated as of
the 7th day of April, 2003 (the “Effective Date”), by and between EXACT Sciences
Corporation (“EXACT”), a Delaware corporation doing business at 63 Great Road,
Maynard, Massachusetts 01754; and Discovery Labware Inc. (“Discovery”), a wholly
owned subsidiary of Becton Dickinson and Company (“Becton Dickinson”), doing
business at 296 Concord Road, Billerica, MA  01821.

 

WHEREAS, EXACT owns and has developed proprietary technologies directed to,
among other things, the recovery of DNA from biological samples and in
particular for use in the diagnosis of colon cancer and is producing
improvements, enhancements and inventions related to all of its technologies,
including a proprietary device having [CONFIDENTIAL TREATMENT REQUESTED]/*/
components, that includes a treated membrane-like material,

 

WHEREAS, Becton Dickinson owns and has developed proprietary technologies and
equipment directed to, among other things, manufacturing, tooling, molding,
packaging, labeling, processes, equipment, know-how and methods, including but
not limited to, molding of consumables, molds, tooling, core pins and attaching
membrane and membrane-like materials to all types of objects or other materials,
and is producing improvements, enhancements and inventions related to all of
these proprietary technologies; and

 

WHEREAS, EXACT desires to engage the services of Discovery to use Becton
Dickinson’s proprietary technology to design, develop, use and deliver the
tooling to manufacture and produce [CONFIDENTIAL TREATMENT REQUESTED]/*/
components of EXACT’s proprietary consumable;

 

WHEREAS, EXACT desires Discovery to use Becton Dickinson’s proprietary
technologies to manufacture and produce the [CONFIDENTIAL TREATMENT
REQUESTED]/*/ components of EXACT’s proprietary consumable, for Discovery to
attach a treated membrane material which is to be supplied by EXACT, or EXACT’s
designee, to one of these components, and for Discovery to supply to EXACT the
completed proprietary consumable in a certain package and with a certain label,
all in accordance with the Hybrigel Consumable Specifications; and

 

WHEREAS, Discovery is willing to provide services to EXACT to design, research
and develop tooling to manufacture and produce the [CONFIDENTIAL TREATMENT
REQUESTED]/*/ components of EXACT’s proprietary consumable and to manufacture
and produce the [CONFIDENTIAL TREATMENT REQUESTED]/*/ components of EXACT’s
proprietary consumable, to receive the treated membrane

 

*CONFIDENTIAL TREATMENT REQUESTED

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materials from EXACT, to use Becton Dickinson’s proprietary technology to
process and attach the treated membrane material to one of the [CONFIDENTIAL
TREATMENT REQUESTED]/*/ components and to package and label EXACT’s completed
Hybrigel Consumable for supply to EXACT, in accordance with EXACT’s Hybrigel
Consumable Specifications.

 

NOW, THEREFORE, in consideration of the premises and the mutual promises and
covenants contained below, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the parties agree as
follows:

 

ARTICLE 1:  DEFINITIONS.

 

1.1                                 “Act” shall mean the Food, Drug and Cosmetic
Act (21 U.S.C. § § 301 et seq.) and the regulations promulgated thereunder.

 

1.2                                 “Affiliates” of a party as used herein shall
mean any entity which, at any time during the Term of this Agreement, directly
or indirectly, through one or more intermediaries, controls such party, is
controlled by such party, or is under common control of such party, (including
subsidiaries) and another entity, or is controlled by an entity that controls
such party.

 

1.3                                 “Analyte Specific Reagent” shall have the
meaning ascribed to it by 21 C.F.R. § 809.30 and 864.4020(a), (B - class 1), to
include a Class 1 designation.

 

1.4                                 “Discovery” shall mean Discovery Labware
Inc.

 

1.5                                 “Discovery Bonding” shall mean the specific
Discovery proprietary method developed by Discovery for affixing or attaching
the Membrane to the Hybrigel Consumable.

 

1.6                                 “Discovery Certificate of Conformance” shall
mean the certificate of analysis report in the form attached hereto as Appendix
A setting forth the results of the quality control analyses performed on the
Hybrigel Consumables by Discovery to confirm conformity to the Hybrigel
Consumable Specifications.

 

1.7                                 “Discovery Technology and Equipment” shall
mean all technology and equipment relating to manufacturing processes,
techniques and methods, including but not limited to all molds, tooling, core
pins, molding, packaging, labeling and attaching all types of materials,
including but not limited to membrane materials and the like attached to all
types of objects and materials, Discovery Bonding techniques, practices and
methods, and any other intellectual property belonging to or licensed (other
than as pursuant to this Agreement ) by Discovery or its Affiliates, whether or
not patented, in any form, tangible or intangible, including, without
limitation, all manufacturing specifications, mold specifications,  all ideas,
concepts, know-how, trade secrets, inventions, developments, discoveries, works
of authorship, algorithms, systems, processes, methods, techniques, bonding
methods, and research and technical information. Discovery Technology and
Equipment does not mean or include EXACT Technology or EXACT Tooling.

 

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1.8                                 “EXACT” shall mean EXACT Sciences
Corporation and its Affiliates, unless the context indicates otherwise.

 

1.9                                 “EXACT Certificate of Analysis” means the
certificate of performance report in the form attached hereto as Appendix B
setting forth the results of the quality control analyses performed on the
Membranes by Exact or its designee to confirm conformity to the Membrane
Specifications.

 

1.10                           “EXACT Technology” shall mean the Hybrigel
Consumable and technology, the purification of biological samples using the
Hybrigel Consumable, and the diagnosis of disease using a Hybrigel Consumable,
and any other EXACT intellectual property that was created, developed or
otherwise acquired by or on behalf of EXACT as of the Effective Date of this
Agreement, or developed or otherwise acquired by or on behalf of EXACT
subsequent to the Effective Date of this Agreement, whether or not patented, in
any form, tangible or intangible, including, without limitation, all
specifications (including the Specifications in Appendix D of this Agreement),
ideas, designs, concepts, know-how, trade secrets, inventions, developments,
discoveries, works of authorship, formulae, algorithms, systems, processes,
methods, techniques, consumables, research information, bonding methods,
evaluations, studies, analytical results, assays, data, technical information,
and samples.  EXACT Technology does not mean or include the Discovery Technology
and Equipment (including Discovery Bonding) and the EXACT Tooling.

 

1.11                           “EXACT Tooling” shall mean the molds and core
pins, necessary to manufacture and produce [CONFIDENTIAL TREATMENT REQUESTED]/*/
components of EXACT’s Hybrigel Consumable as described in Phase I of the
Manufacturing Plan included in Appendix C.

 

1.12                           “FDA” means the United States Food and Drug
Administration or any successor agency.

 

1.13                           “GMP” shall mean the current good manufacturing
practices and QSRs for Class 1 Analyte Specific Reagents promulgated from time
to time by the FDA in accordance with the Act.

 

1.14                           “HybrigelÔ Consumable” shall mean the EXACT
proprietary HybrigelÔ Consumable as described in Appendix D of this Agreement.

 

1.15                           “Hybrigel Consumable Specifications” shall mean
the description, physical description and drawings, dimensions, materials,
processes and testing and inspection information for the HybrigelÔ Consumable as
contained in Appendix D of this Agreement, excluding any Membrane information or
specifications, and any labeling or packaging information or specifications and
excluding any characteristic caused in whole or in part by the failure of the
Membrane to meet the Membrane Specifications.

 

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1.16                           “Manufacturing Plan”, shall mean the milestones
and parameters as set forth in Appendix C hereto for the design, development and
use of the EXACT Tooling.

 

1.17                           “MDR” shall mean medical device reporting
promulgated by FDA, requiring event malfunction, serious injury and death to be
reported to FDA.

 

1.18                           “Membrane” shall mean the Hybrigel membrane in
the form supplied by EXACT or EXACT’s designee to Discovery.

 

1.19                           “Membrane Specifications” shall mean the
description, physical description and drawings, dimensions, materials, processes
and testing and inspection information for the Membranes as contained in
Appendix D of this Agreement.

 

1.20                           “QSR” shall mean the Quality System Regulation as
defined in 21 C.F.R. § 820.

 

1.21                           “Party” or “Parties” shall mean EXACT and/or
Discovery, as the context requires.

 

1.22                           “Reporting Period” means a three (3) month period
ending January 31, April 30, July 31 and October 31 of each calendar year.

 

ARTICLE 2: SERVICES TO PERFORMED AND
EVALUATION OF MEMBRANE

 

2.1                                 EXACT Tooling.  Discovery shall design,
research, develop, and, deliver to EXACT, the EXACT Tooling.

 

2.2                                 Discovery Point of Contact.  Discovery’s
point of contact at EXACT is David Deems, Vice President of Product Development.

 

2.3                                 EXACT Point of Contact.  EXACT’s point of
contact at Discovery is Blake S. Perkins, Marketing Manager, Drug Discovery.

 

2.4                                 Rights to the EXACT Tooling.  Upon EXACT and
Discovery’s validation of the EXACT Tooling, Discovery shall and does hereby
irrevocably grant and assign to EXACT the entire right, title and interest, in
and to the EXACT Tooling.  Discovery shall hold the EXACT Tooling at its
facilities, as requested by EXACT, and Discovery shall at all times maintain
adequate insurance to protect against risk of loss for the EXACT Tooling at
Discovery’s facilities.

 

2.5                                 Discovery agrees to use and operate the
EXACT Tooling solely for the purposes of this Agreement.

 

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2.6           Delivery of the EXACT Tooling at Termination. In the event that
this Agreement is to be terminated or expire, (i) Discovery shall pack the EXACT
Tooling and ship it to an EXACT designated facility, so long as EXACT has met
its payment obligations under Article 3 hereof.  Discovery shall not be
responsible for the implementation of the EXACT Tooling.  Discovery agrees to
provide EXACT with one (1) full time equivalent (FTE) person(s) for a time
period of sixty (60) consecutive business days, such period not to exceed the
day that is four (4) months from delivery of the EXACT Tooling to the EXACT
designated facility, to support the implementation of the EXACT Tooling per
EXACT’s instructions and with a vendor of EXACT’s choosing.  The FTE shall work
only during regular business hours.  EXACT shall pay Discovery, on a prospective
basis each month for work to be performed in the coming month, for the FTE’s
salary and all related time, material, travel and expenses and shall indemnify
and hold harmless Discovery against any claims of the FTE based upon his or her
work with EXACT.  EXACT shall reimburse Discovery for the FTE’s salary and all
related time, material, travel and expenses, at rates that are then in effect
for Discovery and the FTE.  EXACT covenants that it will provide a safe working
environment for the FTE, whether at its own facility or at that of a contractor,
and that it will ensure that any facilities to which the FTE is sent will comply
with all applicable health and safety and environmental regulations.  EXACT
assumes all risk of the FTE’s presence at such facility and agrees to indemnify
and hold harmless Discovery, it’s employees, officers and directors and its
Affiliates and their employees, officers and directors from and against any
claims, damages, losses or liability resulting directly or indirectly from the
FTE’s presence at such facility and his or her work at such facility, other than
as related to such FTE’s gross negligence or misconduct.  In addition, EXACT
will maintain insurance adequate to cover any claims resulting from the FTE’s
presence at such facility and his or her work at such facility.  EXACT agrees to
assume full responsibility for any injury or death caused to the FTE, while the
FTE is working at the EXACT designated facility, other than as related to such
FTE’s gross negligence or misconduct.  EXACT agrees to provide Discovery’s FTE
with all safety and other protections required by law, including, without
limitation, all Occupational Health and Safety Administration rules and
regulations.  The FTE shall not be required to execute any agreement, waiver or
release which in any way purports to affect the legal rights or obligations of
the FTE.  If the FTE signs such an agreement, waiver or release, it shall be
considered void and have no force and effect.

 

2.7           [CONFIDENTIAL TREATMENT REQUESTED]/*/.  EXACT agrees [CONFIDENTIAL
TREATMENT REQUESTED]/*/ any of the life sciences business entities listed below
any [CONFIDENTIAL TREATMENT REQUESTED]/*/, and [CONFIDENTIAL TREATMENT
REQUESTED]/*/ relating to the [CONFIDENTIAL TREATMENT REQUESTED]/*/ during the
period from the [CONFIDENTIAL TREATMENT REQUESTED]/*/ through to and including
[CONFIDENTIAL TREATMENT REQUESTED]/*/, unless Discovery is unable to
[CONFIDENTIAL TREATMENT REQUESTED]/*/ as set forth herein, in which case this
Agreement shall become [CONFIDENTIAL TREATMENT REQUESTED]/*/ pursuant to Section
3.9 below.

 

The life science business entities are [CONFIDENTIAL TREATMENT REQUESTED]/*/.

 

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2.8                                 Maintenance of EXACT Tooling.  EXACT and
Discovery agree that Discovery will provide, at no cost to EXACT, any
maintenance that is necessary as a result of normal wear and tear while in
Discovery’s possession, as well as any other repairs that become necessary as a
result of Discovery’s negligence or breach of this Agreement. Any maintenance
and repairs beyond that described above will be at EXACT’s sole cost and
expense.  No repairs or maintenance, for which EXACT will be bearing the
expense, will be conducted without EXACT’s express prior written authorization.

 

2.9                                 New Tooling.  EXACT agrees that should
modifications to the EXACT Tooling or new tooling (collectively “New Tooling”)
be required in accordance with EXACT’s request, EXACT shall bear all direct
costs and expenses of such New Tooling.  EXACT may request Discovery to design,
manufacture or have manufactured New Tooling on its behalf.  EXACT and Discovery
agree to negotiate in good faith additional terms relating to the design and
manufacture of New Tooling including the amendment of Section 3.8 to include
provisions that allow for the purchase of Hybrigel Consumables relating to the
New Tooling to [CONFIDENTIAL TREATMENT REQUESTED]/*/ and the [CONFIDENTIAL
TREATMENT REQUESTED]/*/ as appropriate.

 

2.10         [CONFIDENTIAL TREATMENT REQUESTED]/*/ Additional EXACT Tooling. 
Should it become necessary to produce and use any EXACT Tooling in addition to
the one set of molds referred to in Section 2.4 in order to produce amounts in
[CONFIDENTIAL TREATMENT REQUESTED]/*/ (the “Additional EXACT Tooling”) and
satisfy Product Forecasts, the cost of such Additional EXACT Tooling will be
borne by EXACT.  Discovery agrees to use commercially reasonable efforts to
provide EXACT with reasonable notice of the need to produce Additional EXACT
Tooling based on the timing of the receipt of the Product Forecast for which
such Additional EXACT Tooling would be required.  EXACT may request Discovery to
manufacture or have manufactured the Additional EXACT Tooling on its behalf and
Discovery may accept or reject such request.  If Discovery rejects EXACT’s
request, or if Discovery requires payment for the Additional EXACT Tooling in an
amount in excess of 150% of the cost of the initial EXACT Tooling, then, so long
as EXACT has [CONFIDENTIAL TREATMENT REQUESTED]/*/ EXACT may [CONFIDENTIAL
TREATMENT REQUESTED]/*/.

 

2.11                           Possible [CONFIDENTIAL TREATMENT REQUESTED]/*/ by
Discovery.  Discovery agrees in good faith to [CONFIDENTIAL TREATMENT
REQUESTED]/*/ for Discovery of Discovery [CONFIDENTIAL TREATMENT REQUESTED]/*/
and to consider [CONFIDENTIAL TREATMENT REQUESTED]/*/ pursuant to which
Discovery may [CONFIDENTIAL TREATMENT REQUESTED]/*/ and to discuss whether such
[CONFIDENTIAL TREATMENT REQUESTED]/*/.  In the event Discovery determines that
it [CONFIDENTIAL TREATMENT REQUESTED]/*/ or other arrangement with [CONFIDENTIAL
TREATMENT REQUESTED]/*/, then Discovery shall so notify EXACT, and may
[CONFIDENTIAL TREATMENT REQUESTED]/*/ for EXACT’S review or consider any
documentation provided by EXACT.  This Section 2.11, shall not create any
[CONFIDENTIAL TREATMENT REQUESTED]/*/ and is merely intended to serve as an

 

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expression of Discovery's current intentions, and under no circumstances will
the [CONFIDENTIAL TREATMENT REQUESTED]/*/.

 

ARTICLE 3:  MANUFACTURE; SUPPLY; AND DELIVERY.

 

3.1                                 Manufacture of Hybrigel Consumables.  Upon
validation of the EXACT Tooling, Discovery agrees to manufacture, package and
label the Hybrigel Consumable for EXACT in accordance with the Hybrigel
Consumable Specifications and will deliver the Hybrigel Consumables to a United
States address for EXACT or EXACT’s designee in accordance with the quantities
and schedule set forth in any purchase order that has been delivered and
accepted in accordance with the terms of this Agreement.  Except and unless the
parties mutually agree in writing otherwise, EXACT shall deliver to Discovery
Membranes meeting the Membrane Specifications.  EXACT shall deliver such
Membranes to Discovery in the quantity and quality necessary for Discovery to
fulfill its obligations under the Purchase Orders.  Membranes shall be deemed of
adequate quality if they are delivered in accordance with the Certificate of
Analysis as described in Appendix B.  Such Membranes will be supplied at no cost
to Discovery, and solely for the purposes of carrying out Discovery’s
obligations under this Agreement.  EXACT shall provide to Discovery the
Membranes accompanied by an EXACT Certificate of Analysis confirming that the
Membranes meet the Membrane Specifications.  Discovery may reject any shipment
of Membranes that is not accompanied by such Certificate of Analysis or that it
determines does not meet the representations set forth in the Certificate of
Analysis and shall notify EXACT in writing of the rejection and, and if
applicable, the details regarding how the Membranes fail, in Discovery’s
opinion, to meet such representations.  In the event of the failure of EXACT to
deliver, or any material delays in EXACT’s delivery of any Membranes or the
failure of such Membranes to meet the Membrane Specifications, Discovery shall
not be required to deliver the Hybrigel Consumables for which such Membranes
were intended, Discovery shall not be deemed to have breached this Agreement,
and the parties will discuss in good faith an alternative delivery schedule, if
any.  Discovery agrees that it will not produce the [CONFIDENTIAL TREATMENT
REQUESTED]/*/ except in such lots as are reasonably necessary to meet EXACT’s
forecasts.

 

3.2                                 [CONFIDENTIAL TREATMENT REQUESTED]/*/. 
EXACT hereby agrees that, [CONFIDENTIAL TREATMENT REQUESTED]/*/, EXACT will
[CONFIDENTIAL TREATMENT REQUESTED]/*/, except as specified in sections 3.9 and
Article 9. 

 

3.3                                 Supply of Membranes and Tooling.  Discovery
shall not be responsible for the costs of the Membranes, which shall be supplied
by EXACT or EXACT’s designee without charge to Discovery, or the costs, if any,
of any Additional EXACT Tooling purchased by EXACT or any modifications thereto
under this Agreement.

 

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3.4                                 Analyte Specific Reagents.  EXACT shall
provide to Discovery all documents as appropriate and necessary for Discovery to
comply with all applicable governmental laws, requirements and regulations
relating to manufacturing using Analyte Specific Reagents, including without
limitation, compliance with the requirements under 21 C.F.R. § 809.30 and
864.4020 and QSR requirements under 21 C.F.R. § 820.  Documents provided by
EXACT pursuant to this section, as well as all label requirements, shall support
a Class 1 designation. So long as (i) the conditions of this section 3.4 are
met, and (ii) the components supplied to Discovery for use in connection with
the Hybrigel Consumable meet Discovery’s supplier qualifications as defined by
21 C.F.R. § 820 (and meet all current and future ASR Regulations, as
promulgated), Discovery agrees that it will label the Hybrigel Consumable as an
Analyte Specific Reagent.

 

3.5                                 Amendment of Manufacturing Plan and
Specifications.  The Hybrigel Consumable Specifications and Manufacturing Plan
may be amended by the Parties from time to time; provided, however, that no
change to the Manufacturing Plan or Hybrigel Consumable Specifications shall be
effective or binding upon the Parties unless an amendment incorporating such
change has been executed by the duly authorized representatives of the parties
hereto.  EXACT and Discovery agree that any such amendment shall include
provisions that allow the purchase of Hybrigel Consumables manufactured in
accordance with any changes in the Hybrigel Consumable Specifications and
Manufacturing Plan to [CONFIDENTIAL TREATMENT REQUESTED]/*/ and the
[CONFIDENTIAL TREATMENT REQUESTED]/*/ as appropriate.

 

3.6                                 Forecasts.  EXACT’s initial forecast by
Reporting Period of the quantity of the Hybrigel Consumables that EXACT expects
to purchase from Discovery during the first four Reporting Periods after the
Effective Date, is provided in Appendix E.  On or before the sixtieth (60th) day
preceding the first day of each Reporting Period, subsequent to the first, EXACT
shall submit a revised forecast by Reporting Period for the Hybrigel Consumables
for the next consecutive four Reporting Periods. Discovery shall not be required
to [CONFIDENTIAL TREATMENT REQUESTED]/*/ in any Reporting Period, unless EXACT
has [CONFIDENTIAL TREATMENT REQUESTED]/*/, pursuant to section 3.7 below.  To
the extent Discovery cannot [CONFIDENTIAL TREATMENT REQUESTED]/*/, this
Agreement shall [CONFIDENTIAL TREATMENT REQUESTED]/*/, in accordance with
Section 3.7 below.

 

3.7                                 Purchase Orders and Supply.  On or before
the date that is thirty (30) days prior to the first day of the immediately
upcoming Reporting Period, EXACT shall place orders for the Hybrigel Consumables
by submitting written purchase orders to Discovery in the form attached hereto
as Appendix F and specifying a quantity that is consistent with the requirements
set forth herein (Discovery shall be entitled to reject any purchase order that
is not provided to Discovery in accordance with the requirements of this
Section 3.7).  The Parties agree to the following purchase order requirements:

 

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3.7.1  No later than sixty (60) days prior to the beginning of each Reporting
Period, EXACT shall provide Discovery with a rolling twelve-month forecast
describing EXACT’s anticipated Hybrigel Consumable needs;

 

3.7.2  No later than thirty (30) days prior to each immediately upcoming
Reporting Period, EXACT shall submit purchase orders for such Reporting Period. 
The purchase orders that are submitted to Discovery shall not contain requests
for Hybrigel Consumable amounts (a) [CONFIDENTIAL TREATMENT REQUESTED]/*/
submitted to Discovery for the immediately upcoming Reporting Period, or (b)
[CONFIDENTIAL TREATMENT REQUESTED]/*/ in accordance with Paragraphs 3.7.3 or
3.7.4;

 

3.7.3  For Reporting Periods in which EXACT wishes Discovery to [CONFIDENTIAL
TREATMENT REQUESTED]/*/ EXACT, in its rolling forecast to Discovery, shall
[CONFIDENTIAL TREATMENT REQUESTED]/*/ to Discovery;

 

3.7.4  For Reporting Periods in which EXACT wishes Discovery to [CONFIDENTIAL
TREATMENT REQUESTED]/*/ EXACT, in its rolling forecast to Discovery, shall
[CONFIDENTIAL TREATMENT REQUESTED]/*/ to Discovery;

 

3.7.5  Discovery will commence delivery of products ordered pursuant to a
purchase order meeting the requirements of this section 3.7 on the thirtieth
(30) day following the beginning of the applicable Reporting Period. Purchase
orders shall be submitted to the following facsimile number:  800-743-6200,
attention: Discovery Labware, Inc., Manager Customer Service, with a confirmed
receipt, and confirmed by mail to the following address:  Discovery Labware, 2
Oak Park, Bedford, Massachusetts 01730, Attention:  Customer Service.

 

Discovery shall be entitled to reject purchase orders not meeting the
requirements of this section 3.7, so long as Discovery provides EXACT with
written notice of such rejection within at least twenty (20) days of receipt of
the applicable purchase order from EXACT. Discovery shall make reasonable
business efforts to comply with unplanned changes in purchase orders but shall
not be required to accept orders that do not meet the guidelines set forth in
this section 3.7.

 

3.8                                 [CONFIDENTIAL TREATMENT REQUESTED]/*/
Provision.  Except as otherwise provided herein, EXACT agrees to [CONFIDENTIAL
TREATMENT REQUESTED]/*/ and Discovery agrees to [CONFIDENTIAL TREATMENT
REQUESTED]/*/ in accordance with the terms of Section 3.7 [CONFIDENTIAL
TREATMENT REQUESTED]/*/ during the period of time from [CONFIDENTIAL TREATMENT
REQUESTED]/*/ through the earlier of the [CONFIDENTIAL TREATMENT REQUESTED]/*/
or [CONFIDENTIAL TREATMENT REQUESTED]/*/.  During the period of time from
[CONFIDENTIAL TREATMENT REQUESTED]/*/ through [CONFIDENTIAL TREATMENT
REQUESTED]/*/ EXACT agrees to [CONFIDENTIAL TREATMENT

 

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REQUESTED]/*/, which shall be [CONFIDENTIAL TREATMENT REQUESTED]/*/.

 

3.8.1  If EXACT has not [CONFIDENTIAL TREATMENT REQUESTED]/*/ on or prior to
[CONFIDENTIAL TREATMENT REQUESTED]/*/, EXACT shall [CONFIDENTIAL TREATMENT
REQUESTED]/*/ on or prior to [CONFIDENTIAL TREATMENT REQUESTED]/*/ for the
purchase of Hybrigel Consumables in accordance with the terms of this Agreement
[CONFIDENTIAL TREATMENT REQUESTED]/*/ will be [CONFIDENTIAL TREATMENT
REQUESTED]/*/ of Hybrigel Consumables.

 

[CONFIDENTIAL TREATMENT REQUESTED]/*/  If EXACT has not [CONFIDENTIAL TREATMENT
REQUESTED]/*/ on or prior to the earlier of [CONFIDENTIAL TREATMENT
REQUESTED]/*/ or [CONFIDENTIAL TREATMENT REQUESTED]/*/, EXACT shall, in full
satisfaction of its obligations to Discovery hereunder, immediately
[CONFIDENTIAL TREATMENT REQUESTED]/*/ will be [CONFIDENTIAL TREATMENT
REQUESTED]/*/ relating to Reporting Periods subsequent to [CONFIDENTIAL
TREATMENT REQUESTED]/*/ in the event the Agreement is renewed beyond such date. 
EXACT shall [CONFIDENTIAL TREATMENT REQUESTED]/*/ prior to the earlier of
[CONFIDENTIAL TREATMENT REQUESTED]/*/ or [CONFIDENTIAL TREATMENT REQUESTED]/*/

 

3.8.3  If, other than (i) pursuant to Section 12.9, (ii) as a result of the
failure of, or delay by, EXACT to deliver Membranes complying with the
Specifications or (iii) as a result of breach of this Agreement on the part of
EXACT((i)-(iii) above are collectively referred to herein as the
“Contingencies”), Discovery is unable to deliver to EXACT for two Reporting
Periods in any 12 month period at least [CONFIDENTIAL TREATMENT REQUESTED]/*/ of
EXACT’s requirements for the Hybrigel Consumables in accordance with the
purchase orders delivered to and accepted by Discovery in accordance with the
terms of Section 3.7, EXACT shall no longer be obligated to [CONFIDENTIAL
TREATMENT REQUESTED]/*/

 

3.9                                 [CONFIDENTIAL TREATMENT REQUESTED]/*/
Provision.  If, other than as a result of the Contingencies Discovery is unable
to deliver to EXACT for two consecutive Reporting Periods at least [CONFIDENTIAL
TREATMENT REQUESTED]/*/ of EXACT’s requirements for the Hybrigel Consumables in
accordance with the purchase orders delivered to and accepted by Discovery in
accordance with the terms of section 3.7 provided in this Agreement, and meeting
the Hybrigel Consumable Specifications, EXACT will no longer be obligated to
[CONFIDENTIAL TREATMENT REQUESTED]/*/.  If, at any time during the Term of this
Agreement and other than as a result of the Contingencies, Discovery is unable
to deliver to EXACT at least [CONFIDENTIAL TREATMENT REQUESTED]/*/ of the
Hybrigel Consumables for a purchase order that Discovery has accepted in
accordance with the terms of section 3.7 of this Agreement, within 90 days of
delivery date set forth in such purchase order,

 

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EXACT will no longer be obligated to [CONFIDENTIAL TREATMENT REQUESTED]/*/

 

3.10                           Competitive Products.  Nothing in this Agreement
shall prohibit Discovery or any of its Affiliates from using Discovery
Technology and Equipment to manufacture or sell any products to third parties
that are competitive to products created hereunder including such products that
may be competitive with the Hybrigel Consumable and the EXACT Tooling or other
products that are sold by EXACT at any time.  Notwithstanding the foregoing,
without the prior written consent of EXACT during the term of this Agreement,
Discovery shall not sell products similar to the Hybrigel Consumable that have
as one or the sole intended use the isolation of DNA from stool samples.  At no
time may Discovery or its Affiliates use any EXACT Technology, the EXACT
Tooling, or the Hybrigel Consumables except for EXACT’s benefit in carrying out
Discovery’s obligations hereunder.

 

3.11                           Shipment.  Discovery agrees to ship Hybrigel
Consumables at Discovery’s cost by the common carrier and method of shipment
designated in the Manufacturing Plan.  Shipments will be made by the end of the
Reporting Period (or sooner as reasonably specified in the applicable purchase
order) to the United States locations specified in the Manufacturing Plan or as
otherwise agreed by the parties in writing.  Legal title and risk of loss shall
pass from Discovery to EXACT upon receipt of the Hybrigel Consumables by EXACT
or EXACT’s designee from the common carrier.

 

3.12                           Inspection and Rejection.  Within fifteen (15)
business days of receipt of any shipment, EXACT shall inspect the shipment and
EXACT shall notify Discovery in writing of any rejection of any Hybrigel
Consumables within the shipment that do not substantially meet the Hybrigel
Consumable Specifications.  Hybrigel Consumables may be rejected only to the
extent that EXACT can show that such failure to meet the Hybrigel Consumable
Specifications existed prior to delivery to EXACT and did not result from
EXACT’s negligence or misconduct or from any failure of the Membrane to meet the
Membrane Specifications.  If EXACT does not notify Discovery of rejection within
such fifteen (15) day period, it shall be deemed to have accepted the shipment
of any Hybrigel Consumables not so rejected.  If the Hybrigel Consumable is
rejected by EXACT for non-conformance to the Hybrigel Consumable Specifications,
EXACT shall, if so directed by Discovery, promptly return the rejected Hybrigel
Consumables to Discovery or dispose of the rejected Hybrigel Consumables at the
direction of Discovery, in either case at the expense of Discovery.  If
Discovery agrees with EXACT that the Hybrigel Consumable does not conform to the
Hybrigel Consumable Specifications, Discovery shall have thirty (30) days after
receipt of a notice from EXACT rejecting any Hybrigel Consumables to replace the
defective Hybrigel Consumables.  If Discovery shows that the Hybrigel
Consumables conform to the Hybrigel Consumable Specifications or that the
failure to so conform results from EXACT’s negligence or misconduct, then EXACT
shall accept shipment of the Hybrigel Consumable and EXACT shall

 

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reimburse Discovery for the cost of shipping and storage.  If EXACT does not
agree with Discovery’s showing, then Discovery shall replace the shipment in
dispute and pay the costs of reshipping and storing the disputed shipment,
provided that Discovery may obtain an independent analysis of the rejected
Hybrigel Consumables to determine whether they meet the Hybrigel Consumable
Specifications.  The outcome of such testing shall determine which party pays
the costs of such retesting and the costs of reshipping and storing the disputed
shipment.  If the independent analysis finds the Hybrigel Consumable conforms to
the Hybrigel Consumable Specifications or that the failure to so conform
resulted from EXACT’s negligence or misconduct, then EXACT shall accept delivery
and shall reimburse Discovery for the cost of the independent analysis and for
the cost and shipping and storing of the disputed shipment and any replacement
shipment.  If the independent analysis finds that the Hybrigel Consumable does
not conform to the Hybrigel Consumable Specifications and that the failure to so
conform does not result from EXACT’s negligence or misconduct, then Discovery
shall bear the cost for the shipping and storing of the disputed shipment.

 

3.13                           Payment.  EXACT shall pay Discovery the purchase
price provided in Appendix G, as such may be amended from time to time, for each
Hybrigel Consumable supplied to EXACT and accepted by EXACT hereunder. 
Discovery may from time to time request an amendment to Appendix G at any time
in order to change prices, such amendments to only be effective upon mutual
written agreement of the Parties.  EXACT shall not unreasonably withhold consent
to any such amendment.  Discovery and EXACT agree that price increases in line
with increases in Discovery’s actual costs (including without limitation costs
resulting from changes to the labeling) shall be reasonable.  Discovery shall
provide EXACT with information reasonably requested to support the price changes
necessitated by the increase in Discovery’s actual costs, though it is agreed
that a showing of an increase in the market price of goods and services used by
Discovery in the manufacture and supply of the Hybrigel Consumables shall be
sufficient evidence of a corresponding increase in Discovery’s actual prices. 
EXACT understands and agrees that the purchase prices set forth in Appendix G do
not include sales and other taxes, all of which shall be borne exclusively by
EXACT.  Discovery shall invoice EXACT for each shipment of Hybrigel Consumables
that is not rejected by EXACT, and payment shall be due from EXACT within
thirty (30) days after the date of the invoice date.  Discovery will collect
applicable sales taxes from EXACT unless EXACT provides Discovery with
appropriate resale certificates.  EXACT agrees to send payment for the Hybrigel
Consumable on such terms to the following address:

 

 

BD Biosciences

Discovery Labware

P.O. Box 70187

Chicago, IL  60673-0187

 

12

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Or at such other address as may be provided by Discovery to EXACT.

 

3.14                           Quarterly Meetings: Reports. The points of
contact shall meet at least quarterly to discuss performance under this
Agreement, schedules of the points of contact permitting.

 

3.15                           Packaging, Labeling. Discovery shall package and
label the Hybrigel Consumable in final form for distribution in accordance with
the Hybrigel Consumable Specifications.  EXACT shall provide Discovery a sample
of the label and packaging information and direct how such label shall appear.

 

3.16                           Technical Support.  During the term of this
Agreement, Discovery will provide technical assistance to EXACT to assist EXACT
in responding to routine requests from EXACT’s customers for technical
assistance that requires information regarding the materials and manufacturing
of the Hybrigel Consumable. Discovery will respond to EXACT’s requests prior to
the third business day after receipt of such request, provided that a response
may not include a full answer or resolution of a problem and may require further
work beyond such three (3) business day time frame.  Technical assistance shall
not involve any Discovery Technology and Equipment (including Discovery
Bonding).  Such technical assistance shall be limited to matters involving the
materials and manufacture of the Hybrigel Consumables and shall not involve the
design, Hybrigel Consumable Specifications, use or functionality of the Hybrigel
Consumables, Membrane or Membrane Specifications, all of which are the sole
responsibility of EXACT.

 

3.17                           Markings.  Discovery shall not be responsible for
any patent and trademark requirements of EXACT, except with respect to labeling
in accordance with EXACT’s instructions.

 

ARTICLE 4:  LICENSE; OWNERSHIP.

 

4.1                                 EXACT Limited License.  Subject to the terms
and conditions of this Agreement, EXACT hereby grants to Discovery a
non-exclusive, non-transferable, non-sublicensable, royalty-free license to the
EXACT Technology, solely for use in connection with Discovery’s performance of
Discovery’s obligations under this Agreement for EXACT, with the exception that
Discovery may grant a limited non-exclusive, non-transferable,
non-sublicensable, royalty-free license to third party contractors, vendors and
consultants and the like that Discovery deems necessary to contract with in
fulfilling its obligations under this Agreement, with prior written consent of
EXACT, which shall not be unreasonably withheld. Additionally, EXACT hereby
grants to Discovery a non-exclusive, royalty-free license to the use of the
EXACT Tooling solely for the purposes of this Agreement for the term of this
Agreement. Any use of the EXACT Technology

 

13

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and EXACT Tooling by Discovery or by Discovery’s contractors, vendors, and/or
consultants that is not solely in connection with Discovery’s performance of
Discovery’s obligations under this Agreement is not licensed hereunder and shall
be considered a material breach of this Agreement by Discovery and such license
of EXACT Technology shall be deemed null and void.  However, Discovery
Technology and Equipment, if improved, modified, advanced, created, changed or
the like, because of the use and knowledge of EXACT Tooling by Discovery, or a
Designee of Discovery, is not considered a material breach of this Agreement.

 

4.2                                 EXACT Technology.  Discovery hereby
acknowledges and agrees that it acquires no rights in the EXACT Technology or
EXACT Tooling except as specifically provided in this Agreement, and that, as
between the Parties, EXACT retains all rights, including all intellectual
property rights, in and to the EXACT Technology.  Further, Discovery hereby
acknowledges and agrees that EXACT shall exclusively own all right, title and
interest, including all intellectual property rights, in and to all EXACT
Technology, EXACT Tooling and the Hybrigel Consumable.

 

4.3                                 Discovery Technology and Equipment.  EXACT
hereby acknowledges and agrees that, except as expressly provided elsewhere in
this Agreement, it shall acquire no rights in the Discovery Technology and
Equipment, including but not limited to, molds, mold technology, methods,
processes and techniques for attaching membranes or membrane like materials to
objects or materials, the methods, processes and techniques for packaging
products and the materials, methods, processes or techniques for labeling
products.  Further, EXACT hereby acknowledges and agrees that Discovery shall
own all right, title and interest, including all intellectual property rights,
in and to all Discovery Technology and Equipment, except as expressly provided
elsewhere in this Agreement.

 

4.4                                 Discovery Limited License.  In the event
this Agreement is terminated or expires and provided that EXACT has paid to
Discovery all amounts owing hereunder, Discovery agrees to grant to EXACT a
non-exclusive, non-transferable, sublicensable, perpetual, royalty-free license
to Discovery Bonding techniques for affixing or attaching the Membrane to the
Hybrigel Consumable only and, solely for use in connection with EXACT’s
manufacture of the Hybrigel Consumable as described in Appendix D.  EXACT may
grant a limited non-exclusive, non-transferable, non-sublicensable, royalty-free
license to Discovery Bonding techniques, not to exceed ten (10) years in
duration, to EXACT’s third party contractors, vendors and consultants and the
like with whom EXACT deems necessary to contract with in manufacturing the
Hybrigel Consumable, as described in Appendix D, [CONFIDENTIAL TREATMENT
REQUESTED]/*/.  EXACT’S grant of a limited non-exclusive, non-transferable,
non-sublicensable, royalty-free license to a third party described herein must
be approved in advance and in writing by Discovery, which approval shall not be
unreasonably withheld, and said third party must sign a confidentiality
agreement approved by the Parties hereto, which protects Discovery’s know-how or
trade secret information relating to Discovery Bonding.  Any use of Discovery’s
Bonding techniques by EXACT

 

14

*CONFIDENTIAL TREATMENT REQUESTED

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or EXACT’s licensee that is not solely for the manufacture of the Hybrigel
Consumable as described in Appendix D is not licensed hereunder and shall be
considered a material breach of this Agreement by EXACT.

 

4.5                                 No Implied License.  Discovery and EXACT
acknowledge that each maintains rights in and to intellectual property that may
be similar to the other’s intellectual property.  Nothing in this Agreement
shall be construed as expressly or impliedly granting either party any right or
license under any patent, patent application, trademark, service mark, or other
intellectual property right now or hereafter owned or controlled of the other
Party, except as expressly set forth in this Agreement.

 

4.6                                 Bonding Techniques.  Discovery and EXACT
each separately maintains intellectual property rights in certain techniques for
affixing or attaching membrane materials to objects and nothing in this
Agreement shall preclude Discovery or EXACT from continuing to use such
techniques.

 

4.7                                 Other.  Each Party hereto may currently or
in the future may be developing information internally or receiving information
from others that may be similar or competitive to the information received from
the other Party hereto.  Accordingly, nothing in this Agreement shall be
construed as a representation or inference that any Party hereto will not
develop products or processes, for itself or others, that compete with the
products or processes contemplated by the other Party hereto.

 

ARTICLE 5:  CONFIDENTIAL INFORMATION.

 

5.1                                 Confidential Information.  In the event the
parties disclose confidential information under this Agreement to the other,
during the term of this Agreement, the parties agree to the following terms and
conditions:

 

(A)                              The receiving party agrees not to disclose
confidential information it receives from the other party that is in writing and
marked confidential (“Confidential Information”) to anyone not employed by the
receiver or an Affiliate of the receiver without the discloser’s consent. 
Discovery and EXACT acknowledge that the Membrane Specifications and Hybrigel
Consumable Specifications shall be treated as confidential information without
regard to whether such information has been marked as such.

 

(B)                                The recipient of the Confidential Information
shall not be bound by the obligations of this section of the Agreement unless
the discloser provides the recipient such information reduced to writing and
marked as “Confidential” within thirty (30) days of such disclosure.  In the
event one of the parties orally or visually discloses any information to the
other in any discussion, the recipient shall not be bound by the obligations of
this Agreement unless the discloser provides to the recipient a summary of

 

15

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such information reduced to writing, marked as “Confidential,” within thirty
(30) days of such oral or visual disclosure.

 

5.2                                 Exclusions to Confidential Information. 
Confidential Information will not include information which (a) was in the
receiving party’s possession without a confidentiality restriction prior to the
disclosure by the disclosing party hereunder, as shown by the receiving party
with contemporaneous written records; (b) at or after the time of disclosure by
the disclosing party becomes generally available to the public through no act or
omission on the receiving party’s part; (c) is developed by the receiving party
independently of and without reference to any Confidential Information it
receives from the disclosing party, as shown by the receiving party with
contemporaneous written records; (d) has come into the possession of the
receiving party without a confidentiality restriction from a third party  or (e)
the disclosing party has given written permission to the receiving party to
disclose the Confidential Information.

 

5.3                                 Treatment of Confidential Information.  The
receiving party acknowledges the confidential and proprietary nature of the
disclosing party’s Confidential Information and agrees (i) to hold the
disclosing party’s Confidential Information in confidence and to take
precautions to protect such Confidential Information consistent with the
precautions the receiving party employs with respect to its own confidential
materials; (ii) not to divulge any such Confidential Information to any third
person.  The receiving party shall limit disclosure of Confidential Information
received from the disclosing party to those employees or agents (including
third-party contractors engaged by either party as such party deems advisable in
connection with the performance of its obligations under this Agreement) of the
receiving party whose use of or access to the Confidential Information is
necessary to carry out such party’s obligations under this Agreement, and shall
secure from all agents or contractors having access to the Confidential
Information agreements, at least as protective of the Confidential Information
as the provisions of this Article 5, to maintain such information in confidence.

 

5.4                                 Disclosure Required by Judicial or
Governmental Order and Regulatory Filings.  In the event that the receiving
party is ordered to disclose the disclosing party’s Confidential Information
pursuant to a judicial or government request, requirement or order, the
receiving party shall promptly notify the disclosing party. Either party shall
be permitted to disclose Confidential Information if required by law. EXACT
acknowledges that certain specifications and pricing information included in
this Agreement are confidential and agrees as an express condition to Discovery
entering into this Agreement that, if it is ever required to include such
information in a U.S. Securities and Exchange Commission or other public filing
or submission, it will pursue and use its best efforts to obtain confidential
treatment of all information for which Discovery requests such treatment after
consultation, and will file or submit, as permitted by law, only a redacted
version publicly.  EXACT shall notify Discovery within ten (10) days before such
disclosure.

 

16

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5.5                                 Archival Copy.  Subject to the various
provisions hereof, all written information (including electronic information
only if reduced to print) delivered by the discloser to the recipient pursuant
to this Agreement shall be and remain the discloser’s property, and all such
written information, and copies thereof, shall be promptly returned to the
discloser upon written request of the discloser.  However, the recipient shall
be entitled to retain one (1) archival copy of all such information strictly for
legal purposes.

 

5.6                                 Exception Not Applicable to All Confidential
Information.  If a particular portion or aspect of Confidential Information
becomes subject to any of the exceptions set forth in section 5.2, all other
portions or aspects of such information shall remain subject to all of the
provisions of this Agreement.

 

5.7                                 Survival of This Article.  The provisions of
this Article 5 will survive any termination or expiration of this Agreement.

 

5.8                                 Terms of Agreement Confidential.  Neither
Party shall disclose to any third party the specific terms of this Agreement
except as may be required by law without first obtaining the prior written
consent of the other Party which shall not be unreasonably withheld, except as
may be required to perform this Agreement as may be required by law. 
Notwithstanding the foregoing, with prior written consent of the other Party,
which shall not be unreasonably withheld, each Party may disclose this Agreement
or its content to its professional advisors, investors, potential investors and
prospective permitted assignees, and each party may disclose this Agreement to
third party contractors that it engages as it deems advisable, provided however,
that any such third party has entered into a written agreement at least as
protective of the Confidential Information as the provisions of this Article 5,
to maintain such information in confidence.

 

5.9                                 Capacity Information.  Notwithstanding
anything herein to the contrary, and not withstanding whether such information
has been marked “Confidential” or has been provided in the absence of a
confidentiality restriction, any information relating directly or indirectly to
Discovery’s capacity received by EXACT prior to, on or after the Effective Date,
shall be considered Confidential Information.

 

17

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ARTICLE 6:  REPRESENTATIONS AND WARRANTIES.

 

6.1                                 Discovery Representations and Warranties. 
Discovery represents and warrants to EXACT that:

 

6.1.1             Discovery is a duly organized and validly existing corporation
under the laws of Delaware, and has all requisite corporate power and authority
to execute, deliver and perform its obligations under this Agreement and any
other agreements contemplated hereby, and to consummate the transactions
contemplated hereby;

 

6.1.2             This Agreement does not contravene or constitute a default
under or violation of any provision of applicable law binding upon Discovery or
any agreement, commitment, instrument or other arrangement to which Discovery is
a Party;

 

6.1.3             Any Hybrigel Consumables and EXACT Tooling supplied under this
Agreement shall be delivered free and clear of all liens and encumbrances that
would arise as a result of actions taken by Discovery.

 

6.1.4             To the extent applicable, Discovery’s manufacturing processes
shall comply with all United States governmental laws, requirements, and
regulations that relate to Analyte Specific Reagents as a Contract Manufacturer,
as such term is defined by the FDA in “Guidance for Industry: Instruction for
Completion of Medical Consumable Registration and Listing Forms.”

 

6.1.5             The Hybrigel Consumables shall comply with the Hybrigel
Consumable Specifications at the time they are delivered to the common carrier
and shall be free from material defects in materials and workmanship; provided,
however, that Discovery makes no representation whatsoever as to the Membrane,
inserts (if any), labels and packaging.

 

6.1.6             Discovery warrants that all Hybrigel Consumables, apart from
the Membrane, shall, at the time of shipment, (a) not be products that are
adulterated or misbranded within the meaning of the Act; and (b) have been
manufactured, packaged, stored and shipped in conformity with the Specifications
and QSR 820 Class 1 medical Consumables.

 

6.1.7             Discovery does not represent and warrant that the purchase or
use by EXACT of the Hybrigel Consumable or the EXACT Tooling shall not infringe
the patent rights of any third party.

 

6.1.8             Discovery represents and warrants that it maintains insurance
at levels adequate to protect against risk of loss and damage to the Hybrigel
Consumables and the EXACT Tooling at Discovery’s facilities.

 

18

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6.1.9             Discovery represents and warrants that the one set of molds
comprising the EXACT Tooling is sufficient to produce at least the Minimum
Quantity.

 

6.2                                 EXACT Representations and Warranties.  EXACT
represents and warrants to Discovery that:

 

6.2.1             EXACT is a corporation duly organized and validly existing
under the laws of the State of Delaware and has all requisite corporate power
and authority to execute, deliver and perform its obligations under this
Agreement and any other agreements contemplated hereby, and to consummate the
transactions contemplated hereby; and

 

6.2.2             This Agreement does not contravene or constitute a default or
violation of any provision of applicable law binding upon EXACT or any
agreement, commitment, or instrument to which EXACT is a Party.

 

6.2.3             EXACT has filed, prosecuted or obtained any necessary
authorizations or approvals for the design, manufacture, marketing, sale and use
of the Hybrigel Consumables to its customers, other than any such authorizations
or approvals that Discovery shall obtain as a result of its compliance with
section 6.1.5 above, and EXACT shall, following acceptance of the Hybrigel
Consumables, be responsible for maintaining all such authorizations and
approvals.

 

6.2.4             EXACT represents and warrants that it is under no obligation
to any third party that would interfere with its representations or obligations
under this Agreement.

 

6.2.5             EXACT shall comply with and give all notices required by, all
laws, ordinances, rules, regulations and lawful orders of any public authority
bearing on the performance of this Agreement or the design, manufacture,
marketing, sale and use of the Hybrigel Consumables, provided that in relation
to United States governmental laws, requirements, and regulations that relate to
Analyte Specific Reagents, EXACT shall be able to rely on Discovery’s compliance
with section 6.1.6 above.

 

6.2.6             EXACT represents and warrants that, to its knowledge, the
Hybrigel Consumable and the Membrane do not infringe any claims of any issued
patent or other intellectual or industrial property rights of any third parties.

 

6.2.7             EXACT acknowledges that the Hybrigel Consumables are subject
to the laws and regulations of the United States, including but not limited to
the U.S. Export Administration Regulations (collectively, “U.S. Laws”).

 

(a)          In selling, reselling, exporting or reexporting any Hybrigel, EXACT
agrees to comply fully with all applicable U.S. Laws as

 

19

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(b)         well as all applicable export control laws and regulations of any
other foreign government (collectively, “Export Control Laws”).

 

(c)          EXACT expressly agrees that it shall not directly or indirectly
export, re-export, divert, lease, disclose, or otherwise transfer Hybrigel
Consumables to any destination, entity or individual restricted or prohibited by
Export Control Laws.

 

(d)         With respect to the export, re-export, diversion, sale, lease,
disclosure, or other transfer of Hybrigel Consumables, EXACT is responsible for
complying with all applicable Export Control Laws, including obtaining any
necessary export authorizations.

 

(e)          EXACT attests that the Hybrigel Consumables will not be used
directly or indirectly in the development, production or proliferation of
weapons of mass destruction (nuclear, chemical, or biological) or missile
delivery systems, and/or in terrorist activities.  Further, EXACT will comply
with all applicable U.S. Laws, including Part 744 of the U.S. Export
Administration Regulations, and other government laws and regulations
restricting exports to persons or countries engaging in any of the above
activities.  EXACT shall not knowingly sell Hybrigel Consumables to any party
that is involved in such activities.

 

(f)            EXACT agrees that it will notify its representatives, agents,
distributors, customers and any other person to which it transfers Hybrigel
Consumables of the restrictions set forth in this section 6.2.7, and that it
will use best efforts to cause any such persons to agree to these restrictions.

 

(g)         EXACT understands and agrees that Discovery’s obligation to supply
Hybrigel Consumables to EXACT is subject to Discovery’s receipt of any licenses
or other authorizations required by Export Control Laws.

 

(h)         Upon Discovery’s request, EXACT will furnish all information and
documentation concerning EXACT, consignees and/or final end-users necessary for
Discovery to obtain any export authorizations required by Export Control Laws.

 

6.3                                 DISCLAIMER:  THE WARRANTIES SET FORTH IN
THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED.  ALL
SUCH OTHER WARRANTIES, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF
TITLE, NON-INFRINGEMENT, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE
ARE HEREBY EXPRESSLY EXCLUDED.  DISCOVERY EXPRESSLY DISCLAIMS ANY
REPRESENTATIONS AND WARRANTIES REGARDING

 

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THE PERFORMANCE AND SAFETY AND EFFICACY OF THE HYBRIGEL CONSUMABLES.

 

ARTICLE 7:  LIMITATION OF LIABILITY.

 

7.1                                 CONSEQUENTIAL DAMAGES.  NEITHER EXACT NOR
DISCOVERY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, INCIDENTAL, INDIRECT, OR
CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO LOSS OF ACTUAL OR
ANTICIPATED PROFITS OR REVENUES, LOSS BY REASON OF SHUTDOWN, LOSS OF USE, LOSS
OF ACCRUING INTEREST, DELAY OR ANY LOSS OF REPUTATION OR PUBLIC IMAGE WHETHER
SUCH DAMAGES ARISE UNDER THIS AGREEMENT, IN TORT, UNDER STATUTE, IN EQUITY, AT
LAW, OR OTHERWISE.  IN ADDITION, DISCOVERY SHALL NOT BE LIABLE FOR ANY DAMAGES
ARISING FROM CLAIMS OF THIRD PARTIES FOR INJURY, DEATH OR PROPERTY DAMAGE
SUFFERED AS A RESULT OF THE USE OF THE HYBRIGEL CONSUMABLES OR THE EXACT
TOOLING, OR FAILURE OF DISCOVERY TO WARN, OR TO ADEQUATELY WARN, AGAINST THE
DANGERS OF THE HYBRIGEL CONSUMABLES OR EXACT TOOLING OR FAILURE OF DISCOVERY TO
INSTRUCT OR TO ADEQUATELY INSTRUCT, ABOUT THE SAFE AND PROPER USE OF THE
HYBRIGEL CONSUMABLES OR EXACT TOOLING.

 

7.2                                 Limitation of Liability.  Except for the
parties obligations under Article 8, notwithstanding anything else to the
contrary set forth in any agreement, the maximum liability of Discovery and
EXACT under this Agreement for all claims, whether in connection with a warranty
claim, an indemnity claim, a combination thereof, or otherwise and whether
arising under contract, warranty, tort (including negligence), strict liability,
product liability, a combination thereof, or any other theory of liability or
indemnification shall not exceed, in the aggregate, an amount equal to
[CONFIDENTIAL TREATMENT REQUESTED]/*/ means an amount equal to [CONFIDENTIAL
TREATMENT REQUESTED]/*/ during each calendar year during which the Agreement has
been in effect.  Except as provided in Article 8, neither party shall have any
obligation to indemnify the other, regardless of the theory of liability.

 

ARTICLE 8:  INDEMNIFICATION.

 

[CONFIDENTIAL TREATMENT REQUESTED]/*/ Infringement Actions.  Discovery shall
indemnify, hold harmless and defend EXACT, its officers, directors, employees
and agents, from any and all suits, actions, damages, costs, losses, expenses
(including settlement awards and reasonable attorneys’ fees) and other
liabilities arising from or in connection with [CONFIDENTIAL TREATMENT
REQUESTED]/*/ except to the extent that [CONFIDENTIAL TREATMENT REQUESTED]/*/. 
EXACT shall indemnify, hold harmless and defend Discovery, its officers,
directors, employees and agents, from and against any and all suits, actions,
damages, costs, losses, expenses (including settlement awards and reasonable
attorneys’ fees) and other liabilities arising from or in connection with
[CONFIDENTIAL TREATMENT REQUESTED]/*/ except to the extent that [CONFIDENTIAL
TREATMENT REQUESTED]/*/.

 

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8.2                                 Further Indemnification by EXACT.  Subject
to the limitations on liability contained herein, EXACT shall indemnify, defend
and hold harmless Discovery, its officers, directors, employees and agents, from
[CONFIDENTIAL TREATMENT REQUESTED]/*/ in each case except to the extent that
[CONFIDENTIAL TREATMENT REQUESTED]/*/.

 

8.3                                 Further Indemnification by Discovery. 
Discovery shall indemnify, defend and hold harmless EXACT, its officers,
directors, employees and agents, from [CONFIDENTIAL TREATMENT REQUESTED]/*/
except to the extent [CONFIDENTIAL TREATMENT REQUESTED]/*/.

 

8.4                                 Control of Defense. In the case of any claim
under Section 8.1 or 8.1 hereof, the indemnified party shall promptly notify the
indemnifying party of any such claim of which the indemnified party is aware. 
The indemnifying party, at its sole expense, shall maintain control and
direction of the defense of any such claim brought against the indemnified
party; provided, however, that the indemnified party shall have the right to
participate in such defense at the indemnified party’s expense.

 

8.5                                 Discovery’s Compliance With EXACT’s
Instructions.  Discovery’s obligations under this Article 8 shall not extend to
[CONFIDENTIAL TREATMENT REQUESTED]/*/, or any specific or direct written
instructions from EXACT if such [CONFIDENTIAL TREATMENT REQUESTED]/*/ would have
been avoided but for such compliance.

 

ARTICLE 9:  TERM AND TERMINATION.

 

9.1                                 Term.  This Agreement shall commence on the
[CONFIDENTIAL TREATMENT REQUESTED]/*/ and shall continue until [CONFIDENTIAL
TREATMENT REQUESTED]/*/, unless terminated pursuant to sections 9.2 or 9.3
hereof, and thereafter this Agreement shall [CONFIDENTIAL TREATMENT
REQUESTED]/*/ upon mutual, written agreement of the parties on or before on
hundred eighty (180) days prior to the expiration of the then current term.

 

9.2                                 Termination for Cause.  Subject to the
conditions contained in Section 9.4, either Party may terminate this Agreement:

 

9.2.1             At any time, if the other Party breaches any representation or
warranty of this Agreement material to its performance or fails to perform any
material obligation hereunder, and such breach is not remedied within the terms
set forth in this Agreement providing for a remedy or, if no such terms are set
forth, within thirty (30) business days after written notice thereof to the
Party in default; or

 

9.2.2             At any time if the other Party becomes insolvent, or makes an
assignment for the benefit of creditors, or a receiver or similar officer is
appointed to take charge of all or part of such Party’s assets and, as a result
thereof, such Party is unable or unwilling to perform is obligations under this
Agreement.

 

22

*CONFIDENTIAL TREATMENT REQUESTED

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9.3                                 Termination without Cause. At any time on or
after [CONFIDENTIAL TREATMENT REQUESTED]/*/, either Party may, at is sole
discretion, terminate this Agreement at any time, upon ninety (90) days’ prior
written notice to the other Party, or at any time upon sixty (60) days’ prior
written notice to the other Party in an event of Force Majeure.

 

9.4                                 Obligations Upon Expiration or Termination. 
Upon the expiration or termination of this Agreement, the Parties shall comply
with the following:

 

9.4.1             If this Agreement should terminate or expire as a result of
EXACT’s termination without cause or Discovery’s termination for cause:

 

(a)                                  prior to EXACT [CONFIDENTIAL TREATMENT
REQUESTED]/*/, EXACT shall be obligated to [CONFIDENTIAL TREATMENT REQUESTED]/*/
pursuant to Section 3.8.2 on or prior to the date such expiration or termination
takes effect, and

 

(b)                                 EXACT shall be obligated to purchase and
Discovery shall be obligated to sell the number of Hybrigel Consumables that
were forecast by EXACT for the period through the Reporting Period during which
such termination shall become effective (provided that [CONFIDENTIAL TREATMENT
REQUESTED]/*/ if appropirate).

 

9.4.2             If this Agreement shall terminate as a result of Discovery’s
termination without cause or EXACT’s termination for cause:

 

(a)                                  EXACT shall be under no obligation to
[CONFIDENTIAL TREATMENT REQUESTED]/*/ other than with respect to Hybrigel
consumables that have been or are delivered to EXACT, and

 

(b)                                 Discovery shall be obligated to sell and
EXACT shall be obligated to purchase the number of Hybrigel Consumables that
were forecast by EXACT for the period through the Reporting Period during which
such termination shall become effective,

 

9.4.3.          In addition to the foregoing, at any time this Agreement shall
terminate or expire:

 

(a)                                  Discovery shall (i) discontinue its
performance hereunder (except as provided herein) and (ii) comply with its
obligations, if any, under Section 2.7.

 

23

*CONFIDENTIAL TREATMENT REQUESTED

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(b)                                 EXACT shall (i) pay all amounts then
outstanding under this Agreement and (ii) comply with its obligations, if any,
under Section 2.7.

 

9.5                                 Survival.  Sections 1, 2.4, 2.5, 2.6, 2.7,
3.10, 3.11, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 5, 6, 7, 8, 9, 10.2, 11.1, 11.2, 11.3,
11.4, 11.5, 11.6, 11.7 and 12 shall survive the termination or expiration of
this Agreement for any reason.

 

ARTICLE 10:  ASSIGNMENT.

 

10.1                           No Assignment.  Neither Discovery nor EXACT shall
assign its rights or delegate its obligations under, or otherwise transfer, this
Agreement, in whole or in part, other than to an Affiliate, without the prior
written consent of the other party hereto.  The term “assign” shall include the
assignment of any rights or duties under this Agreement, and shall also include
any purported transfer of this Agreement pursuant to a merger or consolidation
of Discovery; the sale, lease or other disposal of all or substantially all of
the assets or business of Discovery; or the liquidation, dissolution,
recapitalization or reorganization of Discovery.  Any purported assignment or
delegation in violation of this provision shall be null and void.
Notwithstanding the foregoing, either party shall have the right to assign this
Agreement in connection with a merger, acquisition or sale of all or
substantially all of its stock or assets to which this Agreement pertains.

 

10.2                           Binding Upon Successors.  Subject to section 10.1
hereof, this Agreement shall be binding upon and inure to the benefit of the
successors and assigns of the Parties hereto.

 

ARTICLE 11:  REGULATORY COMPLIANCE

 

11.1                           Registrations.  EXACT shall obtain and maintain
all applicable regulatory approvals, product registrations and requirements for
it to sell Hybrigel Consumables as the Specification Developer as such term is
defined by the FDA in “Guidance For Industry - Instructions For Completion of
Medical Device Registration And Listing Forms”.  Discovery agrees to cooperate
with EXACT in any regulatory registration process to permit EXACT to participate
in such process when necessary. Discovery shall promptly provide to EXACT copies
when necessary of all required Hybrigel Consumable notifications and
registrations to regulatory agencies that are its obligation as the Contract
Manufacturer as such term is defined by the FDA in “Guidance For Industry -
Instructions For Completion of Medical Device Registration And Listing Forms.”

 

24

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11.2                           Reporting Obligations.  EXACT and Discovery shall
maintain, all complaint files and other records required to be maintained by the
FDA and other regulatory agencies with respect to Hybrigel Consumables. 
Discovery shall promptly provide to EXACT copies of all complaints received,
resultant investigations and follow-up communications with respect to the
Hybrigel Consumables sold to EXACT.  EXACT shall promptly provide Discovery with
copies of any complaints relating to Hybrigel Consumables received by EXACT. 
Except as otherwise required by law, EXACT will be responsible for information
about Hybrigel Consumables required to be submitted to any regulatory agency,
including the reports required under FDA’s MDR rule, 21 CFR Parts 803 and 804,
and other adverse reporting requirements applicable to Hybrigel Consumables. All
potential reports relating to EXACT labeled products, will be reviewed jointly
by EXACT and Discovery and approved by EXACT prior to submission to the FDA or
other regulatory agencies.

 

11.3                           Manufacturing.  Discovery shall comply with all
applicable QSR requirements, including all quality standards applicable to the
Hybrigel Consumables (including ISO 9001 – 2000 and/or ISO 13485 where
applicable).  Upon EXACT’s execution of Discovery’s Site Visit Confidentiality
Agreement, attached hereto as Appendix H, EXACT may inspect Discovery’s
facilities and review Discovery’s documentation required under the QSR and any
other documentation necessary for EXACT and Discovery to comply with United
States laws and regulations.  Discovery shall provide access to the portion of
Discovery’s manufacturing operations associated with the manufacture of the
Hybrigel Consumable in order to conduct an inspection, at reasonable times
determined by Discovery and upon reasonable notice by EXACT to Discovery.  Only
EXACT employees may conduct an audit under this section.  For the site(s) where
Hybrigel Consumables are manufactured, Discovery must inform EXACT of all audits
conducted by the FDA and other regulatory agencies and provide audit outcomes,
correspondence and corrective actions, if required.

 

11.4                           Samples.  Discovery shall retain samples of each
lot of Hybrigel Consumables for time periods that are in accordance with agreed
EXACT specification.

 

11.5                           Product Recalls and Field Corrective Actions.  In
the event (i) any government authority issues an order that Hybrigel Consumables
be recalled, (ii) a court of jurisdiction orders such a recall or (iii)
Discovery or EXACT determines that Hybrigel Consumables should be recalled
(including for reason of performance, reliablity or defects) or that a field
corrective action or removal should occur, the parties shall take all
appropriate corrective action.  Discovery and EXACT will review any
recommendation and agree to the appropriateness of the corrective action prior
to its initiation and the notification to the affected customer(s).  In the
event the parties cannot agree on the corrective action, EXACT may act at its
discretion.  EXACT will provide notice to its customer(s) of the required
corrective action for Hybrigel Consumables.  EXACT shall be responsible for the

 

25

--------------------------------------------------------------------------------

 

cost of notifying end users, for the replacement of the defective part, and for
determining the corrective actions to be taken and the costs associated with
such actions.  Discovery shall be responsible only for costs associated with
Hybrigel Consumables supplied to EXACT that did not substantially meet the
Hybrigel Consumable Specifications when delivered to the common carrier and only
if such failure to meet the Hybrigel Consumable Specifications is the direct
cause of the recall or field corrective action and only up the amount received
by EXACT in payment for such Hybrigel Consumables.  Discovery and EXACT shall
fully cooperate with one another and provide all reasonable assistance in
conducting any recall or field corrective action under this section.  EXACT
shall maintain records of all sales of Hybrigel Consumables sufficient to carry
out a recall with respect to Hybrigel Consumables purchased under the
Agreement.  If the recall meets the definition of corrective action and removal,
and constitutes a risk to health, as defined by 21 CFR 806, corrective action
shall be carried out in accordance with regulations including reporting to the
FDA and other applicable regulatory agencies.

 

11.6                           Records.  Discovery shall maintain complete and
accurate written records of all information relating to the manufacture of the
Hybrigel Consumable, and shall retain such records for not less than seven (7)
years after delivery to EXACT of the Hybrigel Consumable from the lot to which
such records pertain.  Upon EXACT’s reasonable request, Discovery will allow
EXACT to review Discovery’s documentation required under the QSR and any other
documentation necessary for EXACT and Discovery to comply with United States
laws and regulations.  Discovery.

 

11.7                           General Obligations of Discovery and EXACT.

 

11.7.1            Discovery shall manufacture and ship the Hybrigel Consumables
in accordance with the Hybrigel Consumable Specifications, and shall comply with
the QSR requirements set forth in 21 CFR 820.

 

11.7.2            Each party shall promptly notify the other party of, and shall
provide the other party with copies of, any correspondence and other
documentation received or prepared in connection with any of the following
events: (1) receipt of any material correspondence from the FDA in connection
with the manufacture of Hybrigel Consumables; (2) any recall of Hybrigel
Consumables; (3) the withdrawal of Hybrigel Consumables from the market; (4) any
regulatory comments relating to the manufacture of Hybrigel Consumables
requiring a response or action by either party.

 

11.7.3            Discovery shall maintain all manufacturing, quality assurance
and analytical records; all records of shipments of Hybrigel Consumables from
Discovery; and all validation data relating to Hybrigel Consumables for a period
of seven (7) years.  Discovery shall make such data available to the FDA upon
request of the FDA, such request being made either directly to EXACT or to
Discovery, or otherwise as required by applicable law.

 

26

--------------------------------------------------------------------------------

 

11.8                           Acceptance of Products.  Discovery shall test
each newly manufactured lot of Hybrigel Consumables for conformance with the
Hybrigel Consumable Specifications.  Each lot meeting the Hybrigel Consumable
Specifications shall be deemed accepted and Discovery shall complete and forward
to EXACT a Discovery Certificate of Conformance for such lot.

 

11.9                           Packaging.  All labels and labeling produced by
Discovery for Hybrigel Consumables, including packaging layout, design and
color, shall be supplied by EXACT.

 

11.10                     Quality.  The Parties agree to cooperate in good faith
and use commercially reasonable efforts to develop and implement a quality plan
designed to minimize or eliminate Hybrigel Consumable defects and provide for
improvement during this Agreement’s Term in Hybrigel Consumable quality based
upon implementation of improvements resulting from customer feedback or relating
to EXACT design improvements.

 

ARTICLE 12:  GENERAL.

 

12.1                           Publicity.  Neither party shall originate any
publicity, news release or public announcement, written or oral, whether to the
public, press or otherwise, relating to this Agreement, to any amendment hereto
or performance hereunder, or the relationship between the Parties, without prior
written approval of the other Party.  Notice of any such publicity, news release
or public announcement will be given to the other party at least ten (10) days
in advance of release.

 

12.2                           Headings.  All headings used in this Agreement
and its attachments are intended for convenience of reference only and shall not
affect the construction or interpretation of the Agreement

 

12.3                           Choice of Law.  The validity and interpretation
of this Agreement and the legal relations of the Parties to it are governed by
the laws of the Commonwealth of Massachusetts without regard to any choice of
law principal that would dictate the application of the law of another
jurisdiction.  The Parties agree that any legal action arising out of or in
connection with this Agreement shall be brought in the federal or state courts
of Massachusetts, and the Parties irrevocably submit for all purposes to the
jurisdiction of such court.

 

12.4                           Independent Contractors.  The Parties agree that,
in the performance of this Agreement, they are and shall be independent
contractors.  Nothing herein shall be construed to constitute a partnership or
joint venture between the Parties nor shall either Party be construed as the
agent of the other Party for any purpose whatsoever, and no Party shall bind or
attempt to bind the other Party to any contract or the performance of any
obligation, or represent to any third party that it has any right to enter into
any binding obligation on the other Party’s behalf.

 

12.5                           Amendments in Writing.  No waiver, alteration or
modification of any of the provisions of this Agreement shall be binding unless
made in writing and signed

 

27

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by both of the Parties hereto.

 

12.6                           Failure to Enforce.  If either Party fails to
enforce any term of this Agreement or fails to exercise any remedy, such failure
to enforce or exercise on that occasion shall not prevent enforcement or
exercise on any other occasion.

 

12.7                           Exercise of Rights and Remedies.  All rights and
remedies, whether conferred by this Agreement or by any other instrument or by
law shall be cumulative, and may be exercised singularly or concurrently.

 

12.8                           Severability.  If any provision of this Agreement
is held invalid by any law, rule, order, or regulation of any government or by
the final determination of any court of competent jurisdiction, such invalidity
shall not affect the enforceability of any other provisions and such provisions
shall be interpreted so as to best accomplish the objectives of such invalid
provisions within the limits of applicable law or applicable court decision.

 

12.9                           Inability to Perform.  Neither Party to this
Agreement shall be liable for its failure to perform or any delay in its
performance of any of its obligations hereunder caused by an event outside the
affected Party’s reasonable control (“Force Majeure”) and the time required for
such performance shall be extended for a period equal to the period of such
delay.  Force Majeure shall include fire, flood, earthquake, other natural
disaster, war, embargo, acts of terrorism, riot, or the intervention of any
government authority, acts of the public enemy, acts of God or other
unforeseeable causes beyond the reasonable control, and without the fault or
negligence of, the affected Party, provided that the Party that is unable to
perform notifies the other Party of such inability as soon as practicable.  If,
however, a Party’s performance is delayed as a result of any of the foregoing
situations for a period of sixty (60) days or more from the date of such
notification, then the other Party may terminate this Agreement in accordance
with section 9.3 hereof, provided that notice of only 60 days rather than 90
days will be required.

 

12.10                     Notice.  Notices to be given under this Agreement
shall be in writing, and sent by prepaid registered or certified mail, return
receipt requested, or by prepaid overnight courier service, or by facsimile, to
the addresses set forth immediately below (or to such other addresses as the
Parties may designate by notice given in accordance with this provision):

 

For EXACT:

 

President

EXACT Sciences Corporation

63 Great Road

Maynard, MA 01754

Fax: (978) 897-3481

 

28

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With a copy to:

 

General Counsel

EXACT Sciences Corporation

63 Great Road

Maynard, MA 01754

Fax: (978) 897-3481

 

For Discovery:

 

Discovery Labware, Inc.

296 Concord Road

Billerica, MA 01821

Attention: Vice President and General Manager

Manager Fax: (978) 901-7490

 

With a copy to:

 

Becton Dickinson and Company

1 Becton Drive

Franklin Lakes, NJ 07417

Attention:  Vice President and General Counsel

Fax:  (201) 847-7445

 

All such notices, if properly addressed, shall be effective when received.

 

12.11                     Entire Agreement.  This Agreement (including all
Attachments and Appendices, which are incorporated by reference herein)
constitutes the complete and exclusive statement of the agreement between the
Parties, and supersedes all prior agreements, proposals, negotiations and
communications between the Parties, (except with respect to EXACT’s purchase
order No. 9192), both oral and written, regarding the subject matter hereof.

 

12.12                     Counterparts.  This Agreement may be executed in one
or more counterparts, each of which when executed shall be deemed to be an
original but all of which taken together shall constitute one and the same
Agreement.

 

29

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12.13                     No Other Terms.  In the event of a conflict between
the terms of this Agreement and any Purchase Order, acceptance, specification,
EXACT’s supplier agreement or acknowledgement, sales acknowledgement document,
packing slip, invoice, or other document, the parties hereby reject such terms
and conditions, and the terms and conditions of this Agreement shall prevail
unless otherwise expressly agreed to in writing by both parties.

 

30

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[SIGNATURES APPEAR ON FOLLOWING PAGE]

 

31

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IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly
authorized representatives under seal as of the Effective Date.

 

 

EXACT SCIENCES CORPORATION

DISCOVERY LABWARE, INC.

 

 

 

 

BY:

/S/ DON M. HARDISON

 

BY:

/S/ JOSEPH S. GENTILE

 

 

 

 

 

Name:

Don M. Hardison

 

Name:

Joseph S. Gentile

 

 

 

 

 

Title:

President and CEO

 

Title:

Vice President and General Manager

 

 

32

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APPENDIX A

 

[g14731jeimage003.gif]

 

FORM OF DISCOVERY CERTIFICATE OF CONFORMANCE

 

BD Biosciences
Discovery Labware
296 Concord Road, Suite 280,
Billerica, MA 01821

 

BD France S.A.
BD Biosciences
Labware Europe
11 rue Aristide Bergès - BP 4
38800 Le Point De Claix, France

 

CERTIFICATE OF QUALITY

 

Date:

 

 

 

 

BD Biosciences - Labware certifies that the product listed below meets the
following criteria:

 

BD Falcon Catalog No:

 

LOT #:

 

 

QSR (GMP) Compliance – BD Falcon Products are manufactured in accordance with
the current Quality System Requirements Standards as specified in Chapter 1,
Title 21 of the USA Federal Regulations, Section 820 titled “Good Manufacturing
Practices for Medical Devices”.

 

Quality Control Testing - Representative production samples are collected and
inspected in accordance with current applicable product specifications. 
Inspection records are reviewed and signed off by qualified personnel for
product release.

 

Cytotoxicity – Quality Control testing is conducted to qualify all material
resins using USP and ISO 10993 standards for cytotoxicity and have been shown to
be non-toxic.

 

DNA / DNase Free - Representative production samples are collected and tested in
accordance with current applicable product specifications.  Test results are
reviewed and signed off by qualified personnel for product release.

 

VERIFICATION:

 

 

 

Treyburn Quality Representative

[g14731jeimage005.gif]

 

33

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APPENDIX B

 

[g14731jeimage007.gif]

 

CERTIFICATE OF ANALYSIS

 

Exact Sciences certifies that the membrane lot listed below has been tested and
has met all of the following criteria.

 

Membrane Type:

Membrane Lot#:

 

 

Membrane qty:

Date of manufacture:

 

 

Shipping date:

Qty tested:

 

 

BD SAP number: tbd

 

 

Test data

 

TEST

 

SPECIFICATION

 

RESULT

 

PASS/FAIL

 

 

 

 

 

 

 

Dimensions

 

7.5” x 5.5” sheet

 

 

 

 

 

 

 

 

 

 

 

Visual – free of dust and dirt

 

 

 

 

 

 

 

 

 

 

 

 

 

Visual – No tears or cuts

 

 

 

 

 

 

 

 

 

 

 

 

 

Packaging – free of dirt, dust

 

 

 

 

 

 

 

 

 

 

 

 

 

Packaging – not damaged

 

 

 

 

 

 

 

 

 

 

 

 

 

Results of Membrane QC

 

 

 

 

 

 

 

 

Certified by:

 

 

Title:

 

 

Date:

 

 

 

34

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APPENDIX C

 

MANUFACTURING PLAN

 

 

PHASE I:

 

Tooling construction design, development, and validation of the following:

 

[CONFIDENTIAL TREATMENT REQUESTED]/*/

 

PHASE II

 

[CONFIDENTIAL TREATMENT REQUESTED]/*/

 

PHASE III:

 

The earlier of [CONFIDENTIAL TREATMENT REQUESTED]/*/.

 

35

*CONFIDENTIAL TREATMENT REQUESTED

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APPENDIX D

 

SPECIFICATIONS

 

[CONFIDENTIAL TREATMENT REQUESTED]/*/

 

36

*CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

 

APPENDIX E

 

EXACT’S INITIAL FORECAST

 

[CONFIDENTIAL TREATMENT REQUESTED]/*/

 

37

*CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

 

APPENDIX F

 

FORM OF PURCHASE ORDER

 

Exact Sciences, Inc.

Address and contact information

 

(Vendor)

 

Discovery Labware, Inc.

2 Oak Park

Bedford, MA  01730-9902

 

Tel: 781-275-0004, 800-343-2035

Fax:  800-743-6200

 

Fed ID #22-3124058

 

Purchase Order Number

Order Date

Requestor

Deliver To:

 

Vendor Code

Buyer

Terms:  30 days net of receipt

Ship Via:

FOB

Freight

Taxable

Account Number

Confirm To:

 

Item

Part Number/Description

Exact Sciences PreGen Pure Consumable

Membrane Type and Designation

 

Quantity

Unit of Measure (Case / Unit) TBD

Unit Price TBD

Extension

Total Order

 

Membrane Type - Identifier

Unit identifier TBD

Estimated 8 to 12 week delivery term upon receipt of order

 

38

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APPENDIX G

 

PURCHASE PRICE

 

[CONFIDENTIAL TREATMENT REQUESTED]/*/

 

39

*CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

 

APPENDIX H

 

FORM OF SITE VISIT CONFIDENTIALITY AGREEMENT

 

CONFIDENTIALITY AGREEMENT

(Plant/Facility Visit)

 

This AGREEMENT, made and effective May 1st, 2003 by and between EXACT Sciences
Corporation, with a place of business at 63 Great Road, Maynard, Massachusetts
01754 (“RECIPIENT”) and Becton, Dickinson and Company, a New Jersey corporation,
with a place of business at 1 Becton Drive, Franklin Lakes, New Jersey 07417
(“BD”).

 

WHEREAS, RECIPIENT wishes to visit BD’s facilities located in Bedford,
Massachusetts and Treyburn, North Carolina, to discuss BD’s proprietary
information and documentation limited to BD’s General Quality System
Information.  The parties recognize that during the visit and in discussions
between the parties in connection with or related to the visit (which
conversations may be before, during or after the visit), there may be disclosure
by BD of certain confidential, proprietary, trade secret or like previously
undisclosed information (“CONFIDENTIAL INFORMATION”).

 

 

In consideration of the premises and mutual covenants contained herein, BD and
RECIPIENT agree as follows:

 

1.                    All CONFIDENTIAL INFORMATION disclosed by BD (including
but not limited to in-writing or other permanent visual form or orally or by
visual observation) shall be deemed and shall remain the property of BD, and the
RECIPIENT shall not be allowed to make any copies, drawings, sketches, designs,
take photographs or videos of the facilities, equipment or processes of BD or
its affiliates and other type of tangible way of reproducing information
furnished by BD, nor use any other audiovisual recording equipment in any way
while in BD’s facilities or its affiliates.

 

2.                    Unless expressly authorized by BD in writing, which refers
by name and date to this Agreement, RECIPIENT shall retain all CONFIDENTIAL
INFORMATION in confidence, shall not disclose such CONFIDENTIAL INFORMATION or
any part thereof to any third-party and shall not use the CONFIDENTIAL
INFORMATION for its benefit or for the benefit of any third-party except
generally for background purposes with respect to examples of good manufacturing
procedures.  However, the obligation of confidentiality with respect to the
CONFIDENTIAL INFORMATION shall not apply to any information which:

 

(a)        is already known to RECIPIENT and its value appreciated at the time
of disclosure as evidenced by written documents; or

(b)          is generally available to the public without restriction or becomes
publicly known through no wrongful act of RECIPIENT; or

(c)           is received by RECIPIENT through no fault of RECIPIENT from a
third-party who had a legal right to provide it.

 

3.                    Specific CONFIDENTIAL INFORMATION disclosed by BD will not
be deemed within any exceptions set forth in (a), (b) or (c) above merely
because it is embraced by more general information to which one or more of those
exceptions may apply.

 

40

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Even though CONFIDENTIAL INFORMATION is within one of the above exceptions,
RECIPIENT will not disclose to third parties that the excepted CONFIDENTIAL
INFORMATION was received from BD.

 

4.                    Nothing contained herein shall be construed, either
expressly or implicitly, to grant to RECIPIENT any rights to technology or
license under any patent, copyright or trademark or other proprietary right now
or hereinafter in existence, owned or controlled by BD.

 

5.                    In the event the parties make a later contract or
agreement concerning anything covered by this Agreement, this Agreement shall
continue to remain in full force and effect unless specifically stated to the
contrary in such later contract.

 

6.                    RECIPIENT agrees that nothing herein shall obligate BD to
disclose information by virtue of this Agreement, and that nothing in this
Agreement shall be construed or otherwise interpreted by RECIPIENT as an
obligation or intent to enter into any business relationship with each other,
and no decisions should be made in reliance on entry into such a relationship. 
However, RECIPIENT recognizes that from time to time BD may wish to disclose
information, which is of a character considered to be so highly proprietary and
sensitive that additional restrictions on use and/or disclosure are necessary
before such information can be disclosed.  In such event, if mutually desired,
the parties will attempt to negotiate a separate agreement governing the
disclosure of such information.

 

7.                    This Agreement constitutes the complete understanding
between the parties of each party’s obligations to the other party relating to
the CONFIDENTIAL INFORMATION.  This Agreement can be modified only by a written
document executed by an authorized representative of the parties, which refers
to this Agreement and includes a copy of this Agreement as an attachment.

 

8.                    The parties understand and agree that there is neither an
expressed nor implied expectation of any kind or type of payment or other
compensation by BD to RECIPIENT arising out of this Agreement or anything
carried out under this Agreement, except as may be set forth in any subsequent
written agreement between the parties.  Further, there is no obligation or
commitment by the parties hereto to enter into any agreement subsequent to this
Agreement.

 

9.                    BD personnel are not authorized to receive information in
confidence.  RECIPIENT shall not disclose any of its trade secrets or
proprietary information to BD, and all communications from RECIPIENT to BD shall
be made on a non-confidential basis.

 

10.              This Agreement shall become effective on the date first set
above and has no termination date.  The obligations undertaken herein as the
RECIPIENT shall survive and continue with no expiration date.

 

11.              Any notice or other communication made or given by either party
in connection with this Agreement shall be sent via facsimile (with
confirmation) or by registered certified mail, postage prepaid, return receipt
requested, or by courier service addressed or the other party at its address set
forth below:

 

41

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Becton, Dickinson and Company

 

EXACT Sciences Corporation

1Becton Drive
Franklin Lakes, New Jersey 07417
Attn: David W. Highet
VP & Chief Intellectual Property Counsel
Fax: (201) 848-9228

 

63 Great Road
Maynard, Massachusetts 01754
Attn: President

 

12.              This Agreement shall be governed by the laws of the State of
New Jersey, without reference to choice or conflict of law principles, otherwise
applicable.  The parties consent and agree that the United States Federal
District Court for the District of New Jersey shall have sole and exclusive
jurisdiction to resolve any interpretation, construction, breach, dispute or
other controversy arising out of, connected with or associated with this
Agreement.

 

This Agreement shall be executed in two or more identical counterparts, each of
which shall be deemed to be an original and all of which taken together shall be
deemed to constitute the Agreement when a duly authorized representative of each
party has signed a counterpart.  The parties intend to sign and deliver this
Agreement by facsimile transmission.  Each party agrees that the delivery of the
Agreement by facsimile shall have the same force and effect as delivery of
original signatures and that each party may use such facsimile signatures as
evidence of the execution and delivery of the Agreement by all parties to the
same extent that an original signature could be used.

 

Each person executing this Agreement represents and warrants that they are
acting on behalf of a Party, as identified in the first paragraph of this
Agreement, and not in an individual capacity.  Each person executing this
Agreement further represents and warrants that they are authorized to enter into
such Agreements for and on behalf of their respective Party.

 

 

EXACT Sciences Corporation:

 

 

BECTON, DICKINSON AND COMPANY

 

 

 

 

By:

 

 

By:

 

 

 

 

Joseph S. Gentile
Vice President & General Manager
Discovery Labware
BD Biosciences

 

42

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