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

















 


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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TREATMENT REQUESTED

















 


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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TREATMENT REQUESTED

















 


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.


 


4

















 


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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*CONFIDENTIAL
TREATMENT REQUESTED

















 


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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TREATMENT REQUESTED

















 


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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TREATMENT REQUESTED

















 


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 


 


11


*CONFIDENTIAL
TREATMENT REQUESTED

















 


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

















 


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

















 


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

















 


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

















 


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

















 


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

















 


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

















 


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

















 


(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 


 


20

















 


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]/*/.


 


21


*CONFIDENTIAL
TREATMENT REQUESTED

















 


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

















 


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

















 


(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

















 


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

















 


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

















 


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

















 


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

















 


[SIGNATURES
APPEAR ON FOLLOWING PAGE]


 


31

















 


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

















 


APPENDIX A


 





 


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

  
	
  

  






 


33

















 


APPENDIX B


 





 


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

















 


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

















 


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

















 


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

















 


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:


 


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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

  
					



 


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