Exhibit 10.1


 


Distribution


 


and


 


Development


 


Agreement


 




 





 


 


DakoCytomation Denmark A/S


(Ref. no. 2967)


 


Clarient, Inc.


 




 





 


Confidential treatment has been requested for portions
of this exhibit.  The copy filed herewith
omits the information subject to the confidentiality request.  Omissions are designated as [***].  A complete version of this exhibit has been
field separately with the Securities and Exchange Commission pursuant to an
application for confidential treatment under Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.


 


1





















 


Table of contents


 


	
  Article 1

  	
  Definitions

  	
  4

  
	
  Article 2

  	
  Products

  	
  7

  
	
  Article 3

  	
  Field of Use

  	
  8

  
	
  Article 4

  	
  The Territory

  	
  8

  
	
  Article 5

  	
  Appointment as Exclusive / Nonexclusive Distributor / Minimum Ordering
  Requirements

  	
  8

  
	
  Article 6

  	
  Prices

  	
  10

  
	
  Article 7

  	
  Forecast

  	
  11

  
	
  Article 8

  	
  Ordering and Supply Procedure

  	
  11

  
	
  Article 9

  	
  Terms of
  Delivery

  	
  15

  
	
  Article 10

  	
  Packaging

  	
  15

  
	
  Article 11

  	
  Labelling

  	
  15

  
	
  Article 12

  	
  Terms of Payment

  	
  15

  
	
  Article 13

  	
  Currency

  	
  16

  
	
  Article 14

  	
  Trademarks and Trade Names

  	
  16

  
	
  Article 15

  	
  Regulatory Matters

  	
  17

  
	
  Article 16

  	
  Warranty

  	
  18

  
	
  Article 17

  	
  Liability; Indemnification

  	
  20

  
	
  Article 18

  	
  Complaints

  	
  21

  
	
  Article 19

  	
  Defects

  	
  21

  
	
  Article 20

  	
  Installation

  	
  22

  
	
  Article 21

  	
  After Sales
  Services

  	
  22

  
	
  Article 22

  	
  Training

  	
  23

  
	
  Article 23

  	
  Image Analysis
  Fee

  	
  24

  
	
  Article 24

  	
  Spare Parts

  	
  24

  
	
  Article 25

  	
  Software,
  Updates and Maintenance

  	
  25

  
	
  Article 26

  	
  Manuals,
  Brochures and Marketing Materials

  	
  25

  
	
  Article 27

  	
  Manufacturing

  	
  26

  
	
  Article 28

  	
  Inspection

  	
  26

  
	
  Article 29

  	
  Development
  projects

  	
  26

  
	
  Article 30

  	
  Intellectual Property

  	
  29

  
	
  Article 31

  	
  Confidentiality

  	
  30

  
	
  Article 32

  	
  Obligations to Inform

  	
  31

  
	
  Article 33

  	
  Term and Termination

  	
  31

  
	
  Article 34

  	
  General Provisions

  	
  32

  
	
  Article 35

  	
  Assignment

  	
  33

  
	
  Article 36

  	
  Right of First Refusal

  	
  33

  
	
  Article 37

  	
  Change of
  Control

  	
  33

  
	
  Article 38

  	
  Force Majeure

  	
  34

  
	
  Article 39

  	
  Invalidity of the Agreement

  	
  34

  
	
  Article 40

  	
  Relationship of the Parties

  	
  35

  
	
  Article 41

  	
  Severability

  	
  35

  
	
  Article 42

  	
  Management

  	
  35

  
	
  Article 43

  	
  Governing Law

  	
  35

  
	
  Article 44

  	
  Venue

  	
  36

  
	
  Article 45

  	
  Headings and Titles

  	
  36

  
	
  Article 46

  	
  Notice

  	
  36

  



 


2





















 


LIST
OF EXHIBITS


 


	
  Exhibit 1:

  	
   

  	
  ACIS II Hardware Specification (Doc.#69913 Rev B)

  	
   

  
	
  Exhibit 2:

  	
   

  	
  ACIS II Software Specification (Doc#77793 Rev A)

  	
   

  
	
  Exhibit 3:

  	
   

  	
  [omitted].

  	
   

  
	
  Exhibit 4:

  	
   

  	
  Prices, Payments and Forecast

  	
   

  
	
  Exhibit 5:

  	
   

  	
  [omitted].

  	
   

  
	
  Exhibit 6:

  	
   

  	
  Transport procedures and costs

  	
   

  
	
  Exhibit 7:

  	
   

  	
  List of Clarient Patents and Patent Applications

  	
   

  
	
  Exhibit 8:

  	
   

  	
  Licensed DakoCytomation trademarks

  	
   

  
	
  Exhibit 9:

  	
   

  	
  Trademark status report for Clarient Inc.

  	
   

  
	
  Exhibit 10:

  	
   

  	
  Installation Services and Prices

  	
   

  
	
  Exhibit 11:

  	
   

  	
  After Sales Support Services and Prices

  	
   

  
	
  Exhibit 12:

  	
   

  	
  [omitted].

  	
   

  
	
  Exhibit 13:

  	
   

  	
  [omitted].

  	
   

  
	
  Exhibit 14:

  	
   

  	
  Technical Specifications and
  Acceptance Criteria for the ACIS III Instrument and Software

  (Doc. #70180 Rev. A)

  	
   

  
	
  Exhibit 15:

  	
   

  	
  Project Plan for ACIS III

  	
   

  



 


3





















 


This Distribution and
Development Agreement is entered into


 


	
  between

  	
   

  	
  DakoCytomation Denmark A/S

  
	
   

  	
   

  	
  Produktionsvej 42

  
	
   

  	
   

  	
  DK-2600 Glostrup

  
	
   

  	
   

  	
  Denmark

  
	
   

  	
   

  	
  (CVR no. 33 21 13 17)

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (hereinafter referred to as “DakoCytomation”)

  
	
   

  	
   

  	
   

  
	
  and

  	
   

  	
  Clarient, Inc.

  
	
   

  	
   

  	
  33171 Paseo Cerveza

  
	
   

  	
   

  	
  San Juan Capistrano

  
	
   

  	
   

  	
  CA 92675 California

  
	
   

  	
   

  	
  United States of America

  
	
   

  	
   

  	
  A corporation incorporated in Delaware

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (hereinafter referred to as “Clarient”)

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (hereinafter individually
  referred to as “Party” and collectively referred to as “the Parties”)

  



 


W I T N E S S E T H:


 


WHEREAS
Clarient is a company in the business of, among other things, developing,
producing and selling of products within the field of image analysis and
virtual microscopy; and


 


WHEREAS DakoCytomation is a diagnostic company with world-wide
activities within the field of development, production and sale of reagents and
instruments within the field of pathology and has a world-wide marketing and
sales organization; and


 


WHEREAS
DakoCytomation desires to obtain an exclusive right to purchase the
Products from Clarient and to be appointed
as Clarient’s exclusive distributor
world wide; and


 


WHEREAS Clarient is willing to sell the
Products exclusively in certain areas to DakoCytomation and make such an
appointment, subject to the terms and conditions set forth in this Agreement;
and


 


WHEREAS the
Parties have agreed to enter into a collaboration with the purpose of further
developing Clarient’s present products and to develop new products subject to the terms and
conditions set forth in this Agreement.


 


NOW
THEREFORE in consideration of the mutual covenants and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
the Parties, intending to be legally bound, have entered into this Agreement on
the following terms and conditions:


 


Article 1               Definitions


 


1.1       “ACIS III”
shall mean: The further development of the Product as described in Exhibits
14 and 15.


 


1.2       “Adverse Event”
shall mean:


 


4





















 


1.2.1           Any
malfunction, failure or deterioration in the characteristics and/or performance
of a device/material, as well as any inadequacy in the labeling or the
instructions for use which, directly or indirectly, might lead to or might have
led to the death of a patient or user or of other persons or to a serious
deterioration in their state of health;


 


1.2.2           Any
technical or medical reason in relation to the characteristics or performance
of a device/material for the reasons referred to in Subclause 1.2.1 leading to
systematic recall of devices/materials of the same type by Clarient.


 


1.3       “Affiliate” shall mean any entity that
directly or indirectly controls, is controlled by or is under common control
with a Party to this Agreement, where “control” means direct or indirect
possession of at least fifty percent (50%) of the outstanding voting securities
of a corporation or at least fifty percent (50%) interest of the income of such
corporation or a comparable ownership in any other type of entity, provided,
however, that if the law of the jurisdiction in which such entity operates does
not allow fifty percent (50%) or greater ownership by a Party to this
Agreement, such ownership interest shall be at least forty percent (40%).


 


1.4       “Agreement” shall mean this entire Agreement and
all of its Exhibits attached hereto.


 


1.5       “Business Day(s)” shall mean any day other than a
Saturday, Sunday or public holiday in Denmark and/or the United States.


 


1.6       “Calendar Day(s)” shall mean any day and not
limited to Business Days.


 


1.7       “Calendar Quarter(s)” shall mean the three (3) month
periods ending on 31 March, 30 June, 30 September or 31 December.


 


1.8       “Calendar Year” shall mean the period 1 January to
31 December of a given year.


 


1.9       “Contract Year” shall mean the period 1 July to
30 June of a given year, except that the first Contract Year shall be the
period from the Effective Date to 30 June 2006.


 


1.10     “Certificate of Conformance” shall mean
documented evidence prepared by Clarient that a given Product meets the Product
Specifications and Acceptance Criteria stated in Exhibits 1 and 2.


 


1.11     “Defect” or “Defective” shall mean that the
Product does not substantially conform to the capital Product Specifications
and Acceptance Criteria, stated in Exhibits 1 and 2.


 


1.12     “Date of Invoice” shall mean the date the invoice
is issued by Clarient..


 


1.13     “Designated
Representative” shall mean a third party agreed upon by the Parties to review
or inspect essential and confidential information and/or documentation in order
to support regulatory requirements.


 


1.14     “Effective Date” shall mean the last date of
execution of this Agreement.


 


1.15     “Exclusive Field of Use” shall have the meaning
set forth in Article 3.1.


 


5





















 


1.16     “Field of Use” shall have the meaning set forth
in Article 3.


 


1.17     “Field
Service Engineering” shall have the meaning set forth in Exhibit 11.


 


1.18     “FDA”
shall mean the United States Food and Drug Administration and any successor
agency thereto.


 


1.19     “Instruments”
shall mean the Clarient ChromaVision ACIS II instrument for use within the
field of image analysis and virtual microscopy, as defined in the Product
Specifications in Exhibit 1 to
this Agreement and the ACIS III instrument described in Exhibits 14 and 15, which Product Specifications may from time to
time be amended by Clarient with DakoCytomation’s prior reasonable written
consent.


 


1.20     “Intellectual
Property” shall mean patents, trademarks, service marks, trade secrets,
copyrights, know-how and related rights and knowledge.


 


1.21     “IVD
Directive” shall mean Council Directive 98/79/EC of the European Parliament and
of the Council of 27 October 1998 on in vitro diagnostic medical devices,
as it may be amended from time to time.


 


1.22     “New
Price” shall mean the Price the Parties have agreed upon to be used during the
New Pricing Period.


 


1.23     “New
Pricing Period” shall mean the Contract Year following the Pricing Period.


 


1.24     “Nonexclusive
Field of Use” shall have the meaning set forth in Article 3.2.


 


1.25     “Order Confirmation” shall mean Clarient’s written
confirmation of DakoCytomation’s Purchase Orders for the Products.


 


1.26     “Phase 1 of the Agreement” shall mean the period
of time from 1 September 2005 until 30 June 2006 during which period
the Products will be launched in the United States of America and Canada with
DakoCytomation branding.


 


1.27     “Phase 2 of the Agreement” shall mean the period
of time from 1 July 2006 or such other date as the Parties offer for sale
on a world-wide basis the ACIS III Product, with DakoCytomation branding.


 


1.28     “Price(s)” shall mean the Prices specified in Exhibit 4
and Exhibit 11 and all subsequent changes hereto according to Article 6.


 


1.29     “Pricing Period” shall mean the period for which
the Price has been agreed and fixed.


 


1.30     “Products” shall mean the reference to the
Instruments and/or the Software delivered by Clarient to DakoCytomation under
this Agreement.


 


1.31     “Product Specifications” means the Clarient
internal manufacturing specifications, including technical and performance
specifications and Acceptance Criteria relating to the characterization of the
Products, a copy of which is attached hereto and incorporated herein by
reference as Exhibits 1 and 2.


 


6





















 


1.32     “Purchase Order” shall mean any request for
delivery of the Product.


 


1.33     “QSR” shall mean the Quality system regulation
set forth at 21 C.F.R §820, as may be amended, which includes current Good
Manufacturing Practices (“GMP”).


 


1.34     “Serious Incident” means an incident involving a
Product which is reportable to a Competent Authority as defined in Article 5
of Annex III of the IVD Directive and the European Commission Medical Device
Vigilance Guidelines or such other guidelines as may be issued from time to
time or FDA reporting requirements.


 


1.35     “Significant Change” shall mean a change in the
manufacturing, manufacturing procedures and/or in the production process that
alters the Product Specification or registration under the In-Vitro Diagnostic
Directive,  QSR or any other relevant
regulation.


 


1.36     “Software” shall mean the Clarient ChromaVision
Systems Automated Cellular Imaging System Software and all other included and
additional Software related to the Instruments as specified in Exhibit 2
to this Agreement which Product Specifications may from time to time be amended
by Clarient with DakoCytomation’s prior written reasonable consent that is
delivered by Clarient to DakoCytomation under this Agreement either alone or
together with the Instruments as well as any updates, upgrades and new generations
of such software for the Instruments.


 


1.37     “Spare Parts” shall have the meaning ascribed to
it is Article 24.1.


 


1.38     “Technical Services” shall have the meaning set
forth in Exhibit 11 to this Agreement.


 


1.39     “USD”
shall mean the official currency of the United States, US Dollars ($).


 


Article 2               Products


 


2.1       Clarient has developed the Instruments, and
manufactures and markets the Instruments in accordance with the Product
Specifications and Acceptance Criteria set forth in Exhibit 1.


 


2.2       Clarient has developed the Software, and
manufactures and markets the Software in accordance with the Product
Specifications and Acceptance Criteria set forth in Exhibit 2.


 


2.3       Clarient has marketed the Products in
packages/combinations such that such Products are ready to use upon Clarient’s
installation at end-user sites.


 


2.4       Exhibits 1 and 2 shall be amended and updated from time to time upon mutual
written agreement between the Parties as soon as changes in the Product
Specifications and Acceptance Criteria for the Instruments and the Software
occur, e.g. after the completion of the development project.


 


7





















 


Article 3               Field of Use


 


3.1        Exclusive
Field of Use.  The Parties agree that the
Exclusive Field of Use under this Agreement shall be research and clinical
applications in human in vitro diagnostics.


 


3.2       Nonexclusive
Field of Use.  The Parties agree that the
Nonexclusive Field of Use under this
Agreement shall be comprised of Biotech and Pharmaceutical companies and their
academic research partners using the Products for drug discovery and
development purposes in the United States.


 


3.3       DakoCytomation
shall have an exclusive option to extend the Exclusive Field of Use to cover
veterinary health care.  The Parties will
use commercially reasonable efforts to negotiate in good faith the terms for
such an extension.   DakoCytomation may
exercise such option at any time during the Term, provided, however, that the
Parties shall have six (6) months following DakoCytomation’s exercise of
such option to negotiate the terms of such extension.  If after such six (6) month period, the
Parties have failed to reach agreement on the terms of the extension, the
option shall expire and Clarient shall be free to offer the Products to one or
more third parties for use in the field of veterinary health care.


 


Article 4               The Territory


 


4.1       The Territory
shall be the whole world.


 


4.2       Notwithstanding
article 4.1, with regards to any proposed sale of any Product to be
installed in a country outside the United States, Canada, European Union and
Japan, the Parties agree to discuss risks and determine the conditions,
potential limitations and protections to be considered in connection with such
installations.


 


Article 5               Appointment as Exclusive /
Nonexclusive Distributor / Minimum Ordering Requirements


 


5.1        Clarient hereby appoints DakoCytomation and
DakoCytomation hereby agrees to act as the exclusive distributor for the
Products.  Clarient hereby agrees to
refrain from distributing the Products within the Exclusive Field of Use in the
Territory.


 


5.2        Clarient hereby appoints DakoCytomation and
DakoCytomation hereby agrees to act as the nonexclusive distributor for the
Products within the Nonexclusive Field of Use in the Territory.


 


5.3        DakoCytomation agrees to use commercially
reasonable efforts and good faith in marketing the Products to maximize the
sales of the Products.


 


5.4        From the Effective Date Clarient will refer to
DakoCytomation current and prospective customers outside the United States and
Canada within the Exclusive Field of Use. 
In the event the Parties do not agree on which Party is responsible for
a customer, then the Parties shall refer such dispute to the Head of US Sales
for Clarient and the Vice President for Sales in the US for DakoCytomation.


 


5.5        Clarient will make available to DakoCytomation
its sales force specialists in the Products to support DakoCytomation’s sales
team for the ongoing sales efforts of DakoCytomation for a period of
twenty-four (24) months or such other period as the Steering Committee
determines.


 


8





















 


5.6        Notwithstanding article 5.1, Clarient may
fulfill its obligations to those customers listed as Active Leads on the list
of Clarient’s current and prospective customers in the Exclusive Field of Use,
which shall be provided by Clarient to DakoCytomation within fifteen (15) Days
of the Effective Date, provided that such Active Leads do not have binding
offers from Clarient that expires more than ninety (90) days after the
Effective Date and that such Active Leads place binding orders before the
expiration of Clarient’s binding offers. 
After the expiration of such offers to Clarient’s Active Leads, Clarient
will refer to DakoCytomation its Active Leads within the Exclusive Field of
Use.


 


5.7       During the Term of this Agreement, DakoCytomation
may appoint third parties, including its Affiliates and independent
distributors, to sell Products in accordance with the terms and conditions of
this Agreement (collectively “Subdistributors”); provided that DakoCytomation
shall (i) take such action as shall be reasonably necessary to advise each
Subdistributor of DakoCytomation’s obligations under this Agreement; (ii) be
liable for any breach by any such Subdistributor of this Agreement (as if such
Subdistributors were parties to this Agreement) and for any violation of
applicable laws or regulations by such Subdistributors; (iii) indemnify
and hold Clarient harmless from and against any claims, causes of action, costs,
penalties, losses or liabilities incurred by Clarient as a result of any
breach, violation, use, infringement or misappropriation by or through such
Subdistributors; and (iv) not allow any competitor of Clarient (as
reasonably determined by Clarient) to be a Subdistributor.


 


5.8       Except as set forth in Article 5.6, neither
Clarient nor any Affiliate controlled by Clarient shall supply the Products or
competing products to the Products to end users or others for use within the
Exclusive Field of Use or for resale for such use unless otherwise expressly
stated in this Agreement or with the prior written consent of DakoCytomation.


 


5.9       During the Term, DakoCytomation shall purchase
the Products exclusively from Clarient, and will not purchase, market, distribute,
license or otherwise supply any competing products manufactured by any third
party to end users or others.


 


5.10     Except as otherwise provided herein,
DakoCytomation shall order (i) a minimum of 15 Instruments with included
Software (including the 10 Instruments mentioned in Article 8.1) from
Clarient in the first Contract Year of the Agreement; and (ii) a minimum
of 40 Instruments with included Software in every Contract Year thereafter (the
“Minimum Order Requirement”).


 


5.11     In the event DakoCytomation fails to fulfill the
Minimum Order Requirement set forth in Article 5.10 in a Contract Year,
DakoCytomation shall be entitled to cure such shortfall by issuing Purchase
Orders within thirty (30) Calendar Days of the end of such Contract Year. In
the event that DakoCytomation fails to cure such shortfall within such thirty
(30) day cure period, Clarient may at its option, upon thirty (30) days written
notice suspend or terminate the exclusive distribution relationship set forth
in Article 5.1, in which case DakoCytomation shall become a non-exclusive
distributor of the Products. Clarient shall provide such notice to
DakoCytomation within thirty (30) days after the end of DakoCytomation’s thirty
(30) day cure period.


 


9





















 


5.12     Article 5.11 shall not apply during the
first Contract Year.


 


5.13     Within the Nonexclusive Field of Use, Clarient
shall not directly or indirectly, through any subdistributor or otherwise
appoint any Companies that DakoCytomation regards as competitors as
subdistributors of the Products. Clarient shall notify DakoCytomation of the
proposed appointment of any subdistributor and DakoCytomation shall promptly
and reasonably determine whether such proposed subdistributor is a competitor.


 


5.14     To the extent Clarient has elected to suspend or
terminate DakoCytomation’s exclusive distributorship according to Article 5.11,
Article 5.13 shall apply only for Ventana Medical Systems Inc. and any of
its Affiliates.


 


Article 6               Prices


 


6.1       The Prices to be paid by DakoCytomation for the
Products are specified in the price list attached hereto and incorporated
herein by reference as Exhibit 4 and shall be exclusive of VAT and
transportation.


 


6.2       All Prices shall be stated in USD.


 


6.3       All Prices shall be renegotiated annually upon
the written request of either Party no later than three (3) months prior
to the beginning of every Contract Year and shall be valid for Pricing Periods
of one Contract Year, provided that the first Pricing Period shall begin on the
Effective Date and continue through 30 June 2006; thereafter a New Pricing
Period shall take effect covering the following Contract Year.


 


6.4       During the last Calendar Quarter of each Contract
Year of the Term after 2005, the Parties agree to enter into good faith
discussions with the objective to agree upon a New Price on or before 1 June of
such Contract Year.  During such
negotiations the Parties shall give due consideration to the cost variations in
raw materials and labor costs, quantities of the Products expected to be
delivered during the previous and subsequent Pricing Periods and the necessity
of marketing the Products at competitive prices.


 


6.5       If the Parties cannot reach an agreement on a New
Price in accordance with clause 6.4, the prices prevailing shall remain in
force for the New Pricing Period, provided that the Parties shall continue
their efforts to agree on a New Price. 
If agreement is not reached within the New Pricing Period, this
Agreement shall automatically terminate by the end of such New Pricing Period
and Clarient shall have no obligation to supply Products ordered prior to such
termination for delivery after such termination.


 


6.6       Should neither Party request a price adjustment
as described in 6.3, the prices then prevailing shall remain unchanged in the
subsequent Pricing Period.


 


6.7       Notwithstanding article 6.3, Clarient may
increase the Price Semi-Annually serving notice of two (2) months,
provided that such increase does not exceed four percent (4%) and is justified
by a significant change in price in raw materials and/or other documented
production costs.  In the event that
Clarient increases the Price of Products, DakoCytomation reserves the right to
conduct a market analysis for a period of ninety (90) days to determine quantities
of Products for purchase orders and forecasts.


 


10





















 


6.8       If Clarient increases
the Price pursuant to Article 6.7 by more than four percent (4%) during
any twelve (12) month period during the term of the Agreement, DakoCytomation
shall not thereafter be required to comply with any obligations set forth in Article 5.10
and the binding portion of any forecast under Article 7.1 for the
remainder of such Contract Year or such other period determined in good faith
by the Steering Committee.


 


6.9       In the event of significant reductions in the
price in raw materials and/or other documented production costs the Parties
agree to enter into good faith negotiations in order to reduce the Price
accordingly.


 


6.10     The Parties agree that DakoCytomation determines
its own retail prices


 


6.11     DakoCytomation shall bear all cost and risks of
collecting payments from its customers relating to the Products.


 


Article 7               Forecast


 


7.1        Once per
Calendar Quarter DakoCytomation shall provide Clarient with a twelve (12) month
rolling forecast for quantities of Instruments and Software required by
DakoCytomation during the following twelve (12) calendar months. The first
three months of such forecast will constitute a binding order of Instruments.
The last nine (9) months of the forecast will not be binding on either
Party and will be used only for planning purposes.  DakoCytomation’s binding forecasts will cover
each Calendar Quarter of the Calendar Year. DakoCytomation will provide
forecasts to Clarient not later than five (5) Business Days after the
beginning of the Calendar Month prior to each Calendar Quarter, i.e. December,
March, June and September.


 


7.2       Absent
agreement of the Parties, the quantities ordered by DakoCytomation pursuant to Article 8
may not be less than the forecasted quantities in the binding purchase order
portion of the forecast, but DakoCytomation may order pursuant to Article 8,
quantities greater than forecast and Article 8.7 will apply to any order
in excess of the forecast.


 


7.3       DakoCytomation’s first
forecast for the first twelve (12) months following the Effective Date is
described in Exhibit 4.


 


Article 8               Ordering and Supply Procedure


 


8.1       An
initial Purchase Order from DakoCytomation to Clarient for ten (10) Instruments
with included Software shall be issued upon the Parties’ signature of this
Agreement.  Clarient undertakes to make
delivery of such ten (10)  Instruments and Software within sixty (60)
Calendar Days after the Effective Date.


 


8.2       During the term of this
Agreement Purchase Orders issued are to be sent to:


 


Clarient, Inc.


33171 Paseo Cerveza


San Juan Capistrano


CA 92675 California


United States of America


 


11





















 


8.3       Purchase Orders shall be issued by DakoCytomation’s
purchasing department as defined by DakoCytomation and shall be consistent with
the quantities and lead time stated hereunder and shall specify:


 


a.     The Instrument and Software number of each unit
ordered.


b.     Quantities of each product number ordered.


c.     Price of each unit ordered.


d.     Delivery date for each unit ordered.


e.     Shipping address for each unit ordered.


 


8.4       All Purchase Orders shall refer to this
Agreement.  In all other respects, the
obligations and rights of the Parties will be governed by the terms and
conditions of this Agreement and not the terms and conditions of any Purchase
Order.


 


8.5       All Purchase orders shall be made by
DakoCytomation in lots of at least five (5) Instruments with included
Software at a time.


 


8.6       For Instruments with included Software in the
binding portion of the forecast as set forth in Article 7.1, Clarient
undertakes to meet such orders within sixty (60) Calendar Days from its receipt
of the Purchase Order.


 


8.7       In the event DakoCytomation orders additional
quantities of Products in excess of the quantities stated in the binding
portion of its Article 7 forecast, Clarient will produce and deliver to
DakoCytomation such additional quantities that (i) exceed DakoCytomation’s
binding forecast by up to fifty percent (50%) within ninety (90) days of its
receipt of the Purchase Order for such additional quantities, and (ii) within
one hundred twenty (120) days of its receipt of the Purchase Order for
additional quantities that exceed DakoCytomation’s binding forecast by more
than fifty percent (50%). Notwithstanding the foregoing, Clarient’s delay in
supplying Products under this Article shall be excused, if Clarient has
supplied twenty-five (25) or more Instruments with in the Calendar Month in
question or seventy-five (75) Instruments within the three (3) month
period prior to such delay.


 


8.8       Clarient shall confirm in writing all Purchase
Orders within three (3) Business Days of its receipt of such Purchase
Order.  Clarient may reject a Purchase
Order within two Business Days of its receipt of such Purchase Order, but
otherwise a Purchase Order shall be deemed accepted by Clarient.    DakoCytomation shall give
Clarient reasonably prompt written notice of any failure to supply Products
within the time periods permitted by Articles 8.6 and 8.7.


 


8.9       Clarient’s confirmation of DakoCytomation’s
Purchase Orders shall be faxed to the ordering DakoCytomation purchasing
department and shall, as a minimum, include the following information:


 


•      Serial number (if available at the date of acknowledgement)


•      Date of delivery from Clarient’s warehouse


•      DakoCytomation’s Purchase Order number and any applicable reference


•      Lead time from date of order.


•      Shipping address


•      Unit cost


•      Unit quantity


 


12





















 


8.10     Unless otherwise notified by Clarient upon
receipt of DakoCytomation’s Purchase Order, orders shall be delivered ready for
transportation to the address specified in DakoCytomation’s Purchase Order.


 


8.11     Clarient shall decide, at its own discretion,
which shipping agent to use and shall book shipment accordingly. However,
during Phase 1 of the Agreement, Clarient will use the transportation procedure
and invoice DakoCytomation the transport costs defined in Exhibit 6.


 


8.12     Clarient shall perform out-going quality control
to confirm that Products delivered to DakoCytomation comply with the Product
Specifications and Acceptance Criteria defined in Exhibits 1 and 2.


 


8.13     DakoCytomation shall not be obliged to perform incoming quality control,
but will rely on the quality control performed by Clarient. Clarient shall
perform quality control testing in accordance with the standards present in the
market to confirm that Products meet the Product Specifications and Acceptance Criteria.  Clarient shall maintain complete records to
the extent required by applicable laws and regulation, such as the IVD
Directive.


 


8.14     A Certificate of Conformance prepared by Clarient is to follow each
shipment of Products delivered to DakoCytomation under this Agreement.


 


8.15     Clarient hereby grants, and DakoCytomation
hereby accepts, a worldwide, fully paid up, perpetual (subject to Article 8.23),
non-transferable license to manufacture or have manufactured, use, develop and
market all Products covered by this Agreement (including all necessary licenses
and sub-licenses to any and all patents and patent applications, know-how and
other rights to develop and modify the Products held by Clarient which relate
to the Products) (i) exclusively as to the Exclusive Field of Use, and (ii) nonexclusively
as to the Nonexclusive Field of Use; provided that DakoCytomation shall not be
entitled to exercise any rights under the foregoing license:  (a) until DakoCytomation’s delivery of
written notice to Clarient of the occurrence of a Supply Failure, which notice
must be given before Clarient has cured such Supply Failure and within sixty
(60) Calendar Days of such occurrence; (b) until DakoCytomation’s delivery
of written notice to Clarient of the occurrence of a Supply Failure which has
otherwise been excused for more than six (6) consecutive months by
application of Article 38, which notice must be given before Clarient has
cured such Supply Failure and within sixty (60) Calendar Days of such
occurrence; or (c) (if not previously exercised) after the Term.  For the purposes of this Agreement a “Supply
Failure” shall mean Clarient’s failure to supply Products ordered by
DakoCytomation in accordance with Article 7 within sixty (60) Calendar
Days after the expiry of the time limits set forth in Articles 8.6 and 8.7 for
reasons other than (I) the cause or breach of DakoCytomation or a
Subdistributor, (II) a bona fide dispute over the validity of a Purchase Order,
(III) Clarient’s rejection of a defective Purchase Order, or (IV) as set forth
in Article 38.


 


8.16     A list of patents and patent applications
related to the Products, specifying the owners, is attached to this Agreement
as Exhibit 7.


 


8.17     If DakoCytomation exercises the license granted
pursuant to Article 8.15, and the exercise of such license is permitted by
the occurrence of a Force Majeure event as set forth in Article 38,
DakoCytomation shall pay to Clarient a license fee of (i) USD five
thousand (5,000) for each Instrument delivered to DakoCytomation’s customers in
the first twelve (12) months after the grant of such license, (ii) USD
seven thousand five hundred (7,500) for each Instrument delivered to
DakoCytomation’s customers in the next twelve (12) months after the grant of
such license and (iii) USD ten thousand (10,000) for each Instrument
delivered to DakoCytomation’s customers in the period thereafter, plus in each
case make payment of the applicable Image Analysis Fee.


 


13





















 


8.18     If DakoCytomation exercises the license granted
pursuant to Article 8.15, and the exercise of such license is pursuant to
an event other than the occurrence of a Force Majeure event as set forth in Article 38,
DakoCytomation shall pay to Clarient a license fee of USD five thousand (5,000)
for each Instrument delivered to DakoCytomation’s customers after the exercise
of such license.


 


8.19     DakoCytomation shall keep complete and accurate
accounts of all Products used and marketed. 
DakoCytomation shall not engage any competitor of Clarient to
manufacture the products.


 


8.20     For so long as DakoCytomation manufactures or
has manufactured any Instruments pursuant to the exercise of the license
granted under Article 8.15, DakoCytomation shall provide Clarient with a
sales report within sixty (60) Calendar Days after the end of each Calendar
Year for each Instrument sold by DakoCytomation.


 


8.21     For a period of two (2) years after
receiving any of the aforementioned reports from DakoCytomation, Clarient shall
have the right to nominate an independent certified public accountant
acceptable to DakoCytomation who shall have access to DakoCytomation’s records
during business hours for the purpose of verifying the payments made to
Clarient under this Agreement in the above-mentioned period. If Clarient wishes
to audit DakoCytomation, such audit must be agreed with DakoCytomation. Such
information shall be subject to Article 31.


 


8.22     Clarient shall fully co-operate with and assist
DakoCytomation and/or third parties designated by DakoCytomation in such
manufacture of the Products under a license to DakoCytomation under Article 8.15,
e.g. by making available its personnel,
books, records and other technical data needed for the process.


 


8.23     Clarient shall give DakoCytomation reasonable
prior notice of any proposed cure of a Supply Failure.  In the event that Clarient believes it has
cured the cause of the Supply Failure after DakoCytomation has elected to
exercise its rights under the license granted in Article 8.15, then the
Parties agree to negotiate in good faith Clarient’s resumption of manufacturing
of the Products for DakoCytomation.  
Further, in the event Clarient demonstrates that it can supply Products
as required by Articles 8.6 and 8.7 after a Supply Failure caused by an event
of Force Majeure, DakoCytomation shall not be entitled to exercise its rights
under the license granted pursuant to Article 8.15 for such Supply Failure
after the earlier to occur of (i) thirty-six (36) Calendar Months after
such demonstration or (ii) Clarient’s payment to DakoCytomation of the
reasonable costs DakoCytomation incurred to begin manufacture of the Products.


 


8.24     The license granted under Article 8.15,
shall not affect Clarient’s right to use, have the right to manufacture or have
manufactured, use or market the Products within the Nonexclusive Field of Use.


 


14





















 


Article 9               Terms of Delivery


 


9.1       Delivery terms shall be FOB (Free On Board)
Clarient’s designated warehouse site (INCOTERMS 2000).


 


Article 10             Packaging


 


10.1     Clarient shall ensure that all Products are
appropriately boxed, crated and/or packaged in a professional manner sufficient
to ensure their integrity during transportation.


 


10.2     The cost of packaging is included in the Prices
set forth in Article 6 of this Agreement.


 


Article 11             Labelling


 


11.1     Clarient shall label and mark the Products in
accordance with the Product Specifications and in compliance with all
applicable current regulatory requirements.


 


11.2     The “Shipment Documentation” shall include the
following information (identification of the Product on delivery):


 


a)         Manufacturer


b)         Serial number


c)         Customer


d)         Safety notes and warnings


e)         Special instructions regarding handling and
storage


f)          Quantity per trading unit and description


g)         Weight


h)         Notes for customs.


 


11.3     The cost of labeling is included in the Prices set forth in Article 6
of this Agreement.


 


Article 12             Terms of Payment


 


12.1     Clarient shall invoice DakoCytomation with each
shipment of Products.


 


12.2     All invoices shall include the Price, VAT, local
taxes and costs for transportation of the Products and include the information
listed in Article 11.2.


 


12.3     All payments are due thirty (30) Calendar Days
from the Date of Invoice. DakoCytomation will make all payments by bank
transfer to Clarient’s bank:


 


	
  Name of bank

  	
   

  	
  Comerica Bank, 11512, El Camino Real, Suite 350,

  San Diego, CA 92130-4542, California, United States

  
	
  Account no.

  	
   

  	
  1892035202

  
	
  SWIFT code

  	
   

  	
  MNBDUS33

  



 


12.4     Initial banking and transfer costs relative to
payment of invoices shall be payable by DakoCytomation and receiving costs
shall be payable by Clarient.


 


15





















 


12.5     Interest shall accrue after 30 Calendar Days from
the Date of Invoice at the prevailing twelve (12) month London InterBank
Offered Rate plus five percent (5%).


 


Article 13             Currency


 


13.1     Clarient shall invoice DakoCytomation in USD, and
DakoCytomation shall make all payments in USD.


 


Article 14             Trademarks and Trade Names


 


14.1     DakoCytomation may sell and market the Products
in the Territory and within the Exclusive Field of Use and Nonexclusive Field
of Use under its own label, trade name/trademarks and in its own packaging
under no specific limitation; subject to Article 14.4 below.  DakoCytomation may furthermore, at its own
discretion, bundle the Products and market and sell the bundled Products in the
Territory.


 


14.2     Subject to Article 14.4 below, the Products
will be manufactured by Clarient and will carry the DakoCytomation trademarks “DAKOCYTOMATION”
and Drop logo as set forth in Exhibit 8.


 


14.3     DakoCytomation hereby grants Clarient a nonexclusive,
worldwide, fully paid-up free license to use the DakoCytomation trademarks and trade names set forth in Exhibit 8,
in the manufacture, packaging and labeling of the Products in accordance with
the terms of this Agreement.  This
Agreement does not imply the grant of a license from DakoCytomation to Clarient
to use any DakoCytomation trademarks or trade names for any other purpose.


 


14.4     Further, the Products will be sold by
DakoCytomation under a combination of DakoCytomation’s trademarks listed in Exhibit 8
and Clarient’s trademarks listed in Exhibit 9, during Phase 1 of
the Agreement e.g. as “DakoCytomation Clarient ChromaVision ACIS II”. The
Parties shall mutually agree on the use of trademarks/trade names for the
Products


 


14.5     Clarient hereby grants DakoCytomation a
nonexclusive, world-wide, fully paid up license to use Clarient’s trademarks in
Exhibit 9 for marketing, sale and support of the Products in
accordance with the terms of this Agreement. 
This Agreement does not imply the grant of a license from Clarient to
DakoCytomation to use any Clarient trademarks or trade names for any other
purpose. For the avoidance of doubt, the license granted by DakoCytomation to
Clarient only applies to Products sold by Clarient to DakoCytomation under this
Agreement.


 


14.6     A label and/or plate, not exceeding a size of 20
x 100mm, stating that “Manufactured by Clarient, Inc., California, United
States of America for DakoCytomation Denmark A/S”, is to be affixed to the back
of the Products.


 


14.7     The Parties shall mutually agree on the use of
trademarks/trade names for the ACIS III Products marketed under Phase 2 of the
Agreement.


 


16





















 


Article 15             Regulatory Matters


 


15.1     DakoCytomation
shall obtain the relevant marketing licenses and fulfill any regulatory
registration requirements for the Products to be marketed and sold by
DakoCytomation in the European Union (“EU”) and all countries other than the
United States (collectively, “ROW”).


 


15.2     For the ROW,
DakoCytomation shall determine, in consultation with Clarient,  for which countries DakoCytomation shall seek marketing licenses and product
registration.


 


15.3     For the ROW, all
product registrations shall be made in DakoCytomation’s name and DakoCytomation shall either serve as or retain a
third party, as appropriate in each such country, to be the Authorized
Representative (as defined in the IVD Directive).


 


15.4     For the ROW,
DakoCytomation shall pay all registration fees and DakoCytomation’s own costs
in connection with obtaining marketing licenses and fulfilling registration
requirements in each country.


 


15.5     In the event of any termination or expiration of
this Agreement, DakoCytomation shall use commercially reasonable efforts
to secure the transfer of all applicable registrations and licenses issued to
DakoCytomation or its agents under this Article 15 to Clarient.  In the event of termination of this Agreement
due to DakoCytomation’s breach, DakoCytomation shall pay any reasonable costs
and fees associated with the transfer of such registrations and licenses to
Clarient.


 


15.6     Clarient shall
make whatever information Clarient is holding of relevance to DakoCytomation’s
obtaining of relevant marketing licenses and/or fulfillment of regulatory
registration requirements available to DakoCytomation or its Designated
Representative upon demand in a timely manner at Clarient’s cost.


 


15.7     During Phase 1
of the Agreement, Clarient shall maintain FDA approvals and/or clearances
necessary to market and sell the Products as an in-vitro diagnostic device in
the United States.  All such
registrations shall be in Clarient’s name and shall be at Clarient’s cost.  At the completion of Phase 1 of the
Agreement, the Parties will mutually agree in writing whether the applicable
registrations and licenses issued to Clarient or its agents under this article shall
be transferred to DakoCytomation and the conditions for such transfer. For Phase
2 of this Agreement, the Parties shall mutually agree on the Party to be
responsible for the registration of the Products for in vitro diagnostic use
with FDA in the United States.  The
agreed upon terms for the ACIS III Products shall be set forth in a written
Amendment to this Agreement, signed by duly authorized representatives of the
Parties.


 


15.8     For purposes of
regulatory compliance, Clarient shall allow representatives of DakoCytomation or its Designated Party to
audit its facilities, quality systems and records related to the manufacture of
Products once per Contract Year, (or more frequently as required by applicable
law or regulation) upon 30 days prior written notification to Clarient.  Upon DakoCytomation’s
written request, in the event of a time sensitive audit DakoCytomation will
provide Clarient seventy-two (72) hour written notification.


 


17





















 


15.9     In the ROW,
DakoCytomation shall prepare, maintain and distribute Material Safety Data
Sheets for the Products.  In the United
States, Clarient shall prepare, maintain and provide such Material Safety Data
Sheets to DakoCytomation for any Clarient
Product that requires this documentation.  Clarient shall provide DakoCytomation or its Designated Representative
with information necessary for the preparation of such Material Safety Data
Sheets.


 


15.10   DakoCytomation
shall be responsible for all market surveillance activities, including
reporting substantial changes to Product Specifications and quality systems,
reporting Serious Incidents, handling complaints and customer notifications,
and conducting product recalls or removals issued by authorities or mutually
agreed upon by the Parties. If Clarient becomes aware of potential Serious
Incidents, customer complaints or other information relevant to market
surveillance activities, or the Product it shall provide this information to
DakoCytomation promptly. If DakoCytomation becomes aware of potential Serious
Incidents customer complaints or other information relevant to market
surveillance activities, or the Product it shall provide this information to
Clarient promptly.


 


15.11   Notwithstanding
the provision in article 15.10, during Phase 1 of the Agreement, Clarient
shall be responsible for all market surveillance activities in the United
States and Canada, including, the reporting requirements of FDA.  If DakoCytomation
becomes aware of information relevant to market surveillance activities,
including without limitation, Adverse Events or customer complaints, it shall
immediately notify Clarient.  If Clarient
receives a customer complaint regarding the Products or the Products are
subject to a product recall in the United States, Clarient shall investigate
such customer complaint or product recall. 
DakoCytomation shall assist Clarient as necessary in implementing any
corrective action required, including without limitation, providing Clarient
with a copy of its or its Affiliate or subdistributor’s customer list for
Products.  DakoCytomation shall further assist
Clarient in the notification, if any, to such customers related to such
customer complaints and/or product recalls.


 


15.12   The
Parties shall use commercially reasonable efforts to provide each other with the information required
to obtain and maintain CE marking in accordance with the IVD Directive or other
requirements enforced by a notified body or governmental authority. The other
party shall use commercially reasonable efforts to provide such information to
the other Party’s custody within ten Business Days upon the other Party’s
written request.


 


Article 16             Warranty


 


16.1     Clarient hereby warrants for a period of fifteen
(15) months from delivery to DakoCytomation or for a period of twelve (12)
months from the delivery to the end user that the Products delivered are in
conformity with the Product Specifications and Acceptance Criteria in Exhibits
1 and 2 and are free of Defects in workmanship and materials.


 


16.2     Clarient hereby warrants that the Products will
be manufactured in accordance with the applicable regulations and statutory
requirements in force in the United States, Canada, EU and Japan. In other
countries, the provision in Article 4.2 shall apply.


 


18





















 


16.3     Clarient hereby warrants that it is in possession
of all necessary rights, including but not limited to Intellectual Property
Rights, covering the grant and supply of the Products in the United States,
Canada, EU and Japan and warrants that it has the right and authority to supply
the Products to DakoCytomation for the use intended under this Agreement. For
Products delivered for other countries, the provision in Article 4.2 shall
apply.


 


16.4     Clarient shall maintain at all times during the
Term of this Agreement product liability insurance with a policy limit of not
less than USD ten million (10,000,000) covering the Products.  If DakoCytomation manufactures pursuant to
exercise of the license granted under Article 8.15, DakoCytomation
undertakes to maintain the same level of insurance.


 


16.5     Beyond the warranties expressly stated herein,
CLARIENT EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES, GUARANTEES, OBLIGATIONS,
LIABILITIES AND RIGHTS AND REMEDIES, EXPRESS OR IMPLIED, ARISING BY LAW OR
OTHERWISE WITH RESPECT TO THE MANUFACTURE AND USE OF THE PRODUCTS, INCLUDING
BUT NOT LIMITED TO (a) ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE AND (b) ANY OBLIGATION, RIGHT OR LIABILITY, CLAIM
OR REMEDY FOR (i) LOSS OF USE, REVENUE OR PROFIT OR ANY OTHER DAMAGES; AND
(ii) INDIRECT, SPECIAL CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY NATURE
WHATSOEVER, HOWEVER CAUSED, AND UNDER ANY THEORY OF LIABILITY WHETHER BASED IN
CONTRACT, WARRANTY, TORT (INCLUDING WITHOUT LIMITATION NEGLIGENCE), STRICT
LIABILITY, STATUTORY OR OTHERWISE, ARISING OUT OF OR IN CONNECTION WITH THIS
AGREEMENT, EVEN IF CLARIENT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES.


 


16.6     DakoCytomation
shall not provide any end user with any rights or licenses in conflict with, or
expansion of, the rights granted herein. 
In selling the Products to end users, DakoCytomation shall use written
agreements with use restrictions and other terms giving due consideration and
respect to each Party’s standard end-user terms and experience with end-users,
as well as the variations in risk and legal customs in different countries.  Without
limiting the generality of the foregoing, each DakoCytomation End-User
agreement relating to the Products shall (i) prohibit use of the Products
for or via remote access to external customers of the End-User, such that the
End-User may only use the Product for global cases (i.e.,
where the End-User’s staff physicians are performing prognosis, diagnosis or
similar professional services) (the “Remote Access Use Restriction”) and (ii) shall
permit Clarient (at its sole expense) to directly and independently enforce its
rights related to the Remote Access Use Restriction as an intended beneficiary
(unless prohibited by applicable law).  A
Party discovering (or reasonably suspecting) an End-User violation of the
Remote Access Use Restriction shall, within fifteen (15) days after such
discovery (or reasonable suspicion), notify the other Party, identifying the
End-User and the time, place and manner of the violation(s).  Except to the extent Clarient reasonably
believes that such a delay would cause irreparable harm to its business,
DakoCytomation shall have thirty (30) days after receipt of the foregoing
notice to encourage and allow such End-User to cure any violation (in a manner
reasonably satisfactory to Clarient) before Clarient may seek to independently
enforce its rights relating to the Remote Access Use Restriction.  DakoCytomation agrees to cooperate with
Clarient’s reasonable requests relating to the enforcement of Remote Access Use
Restriction.


 


19










 













 


Article 17             Liability; Indemnification


 


17.1     EXCEPT AS OTHERWISE SET FORTH HEREIN, UNDER NO
CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY THIRD
PARTY FOR INCIDENTAL, INDIRECT, CONSEQUENTIAL, PUNITIVE OR SPECIAL DAMAGES
(collectively “Damages”) ARISING IN CONNECTION WITH THIS AGREEMENT, THE SCOPE
OR ANY DOCUMENTS OR EXHIBITS RELATED THERETO. 
IN NO EVENT SHALL CLARIENT’S LIABILITY UNDER THIS AGREEMENT EXCEED THE
GREATEST OF (i) THE PAYMENTS RECEIVED BY CLARIENT UNDER THIS AGREEMENT IN THE
TWELVE (12) MONTH PERIOD PRIOR TO THE EVENT OF LIABILITY IN QUESTION OR (ii)
USD FOUR MILLION (4,000,000), OR (iii) USD TEN MILLION (10,000,000) IN THE CASE
OF CLARIENT’S LIABILITY HEREUNDER FOR INFRINGEMENT OF THIRD PARTY INTELLECTUAL
PROPERTY RIGHTS OR TO ANY LOSS ARISING OUT OF PRODUCT LIABILITY CLAIMS,
INCLUDING PERSONAL INJURY.


 


17.2     IN NO EVENT SHALL EITHER PARTY BE RESPONSIBLE FOR
ANY DAMAGES CAUSED BY THE OTHER PARTY’S (A) ILLEGAL CONDUCT, (B) WILLFUL
MISCONDUCT OR (C) VIOLATION OF THIS AGREEMENT (INCLUDING WITHOUT LIMITATION
PRESCRIBED USE OF THE PRODUCTS).


 


17.3     Clarient shall indemnify DakoCytomation, its
Affiliates and their respective officers from any loss, cost, damage or expense
(a “Loss”) from any lawsuit, action, claim, demand, assessment or proceeding (a
“Claim”) arising or occurring as a result of (i) infringement of third party
Intellectual Property Rights, (ii) product liability claims, including personal
injury or property damage proximately caused by Clarient’s gross negligence or intentional
misconduct (iii) other personal injury or property damage caused by Clarient’s
gross negligence or intentional misconduct, or any material Defect in a
Product, or (iv) any violation of applicable law, rule or regulation by
Clarient, in each case except to the extent (a) such Product was altered after
it left Clarient’s control or (b) of the negligence, gross negligence or
intentional misconduct of a party other than Clarient. Notwithstanding anything
herein to the contrary, Clarient shall have no obligation with respect to any
Loss or Claim to the extent that such Loss or Claim results from (I)
DakoCytomation’s combination, operation or use of the Products with products,
data or other materials not provided by Clarient outside the scope of this Agreement;
(II) modifications of the Products that were not made or authorized by
Clarient.


 


17.4     DakoCytomation shall indemnify Clarient, its
Affiliates and their respective officers, directors and employees from any Loss
or Claim arising or occurring as a result of (i) personal injury or property
damage proximately caused by DakoCytomation’s gross negligence or intentional
misconduct, or any modification by DakoCytomation or its agents to a Product,
(ii) any violation of applicable law, rule or regulation by DakoCytomation, in
each case except to the extent of the negligence, gross negligence or
intentional misconduct of a party other than DakoCytomation, or (iii)
infringement of third party Intellectual Property Rights by DakoCytomation. IN
NO EVENT SHALL DAKOCYTOMATION’S LIABILITY UNDER THIS AGREEMENT FOR MATTERS
OTHER THAN PAYMENT OF THE AMOUNTS INDICATED ON EXHIBIT 4 EXCEED THE
GREATEST OF (i) THE PAYMENTS RECEIVED BY CLARIENT UNDER THIS AGREEMENT IN THE
TWELVE (12) MONTH PERIOD PRIOR TO THE EVENT OF LIABILITY IN QUESTION OR (ii)
USD FOUR MILLION (4,000,000), OR (iii) USD TEN MILLION (10,000,000) IN THE CASE
OF DAKOCYTOMATION’S LIABILITY HEREUNDER FOR INFRINGEMENT OF THIRD PARTY
INTELLECTUAL PROPERTY RIGHTS OR TO ANY LOSS ARISING OUT OF PRODUCT LIABILITY CLAIMS,
INCLUDING PERSONAL INJURY.


 


20





















 


17.5     If a claim for damages is lodged by a third party
against one of the Parties, the affected Party shall forthwith inform the other
Party hereof.  Each Party agrees to give
prompt written notice to the other Party of the commencement of any action,
suit or proceeding for which indemnification may be sought, and the
indemnifying Party, through counsel reasonably satisfactory to the indemnified
Party shall assume the defense thereof. 
It has been agreed, however, that the indemnified Party shall be
entitled to participate in any such action, suit or proceeding with counsel of
its own choice, but at its own expense. 
The indemnifying party shall not make any settlement offer or compromise
without the indemnified party’s reasonable consent.


 


17.6     Each Party agrees to give promptly written notice
to the other Party of the commencement of any action, suit or proceeding for
which indemnification may be sought, and the indemnifying Party, through
counsel reasonably satisfactory to the indemnified Party shall assume the
defense thereof. It has been agreed, however, that the indemnified Party shall
be entitled to participate in any such action, suit or proceeding with counsel of
its own choice, but at its own expense.


 


Article 18             Complaints


 


18.1     DakoCytomation shall, no later than five (5)
Business Days from discovery, give Clarient
written notice of any Defect or other fault in or of a Product, and reject any
Product that does not comply with the Product Specifications set forth in Exhibits
1 and 2.


 


18.2     In case the Products do not substantially meet
the Product Specifications set forth in Exhibits 1 and 2 or
should otherwise be Defective, DakoCytomation is authorized to withhold payment
due without interest accruing until such Defect is cured.


 


18.3     Clarient shall repair or replace (at Clarient’s
option) any Products, which DakoCytomation identifies as Defective.  In the event Clarient elects to replace a
Defective product, DakoCytomation shall return such Defective Product clearly
marked with DakoCytomation’s name and address. 
Such returned Defective Products shall be carefully packed and sent to
Clarient accompanied by a copy of Clarient’s invoice.  Clarient shall pay all costs concerning the
return of such Defective product, thus Clarient shall be entitled to choose
means of transportation and book transportation accordingly.


 


Article 19             Defects


 


19.1     If a Product
is found to be Defective in accordance with the Product Specifications and
Acceptance Criteria in Exhibits 1 or 2 to this Agreement, or is
found to be Defective because of faulty workmanship or materials, and such
reason is reported by DakoCytomation to Clarient in accordance with Article
18.1 during the Warranty Period stated in Article 16.1, the following
provisions shall apply.


 


21





















 


19.2     During the Term, Clarient will repair Defects
free of charge.  Clarient shall initiate
such repairs as promptly as possible, but not more than one (1) week from
Clarient’s receipt of DakoCytomation’s notification of the Defect.  In the event that the Product cannot be
repaired within six (6) weeks after Clarient receives notice of the Defect,
Clarient will replace the Product free of charge.


 


19.3     Delivery terms for any replacement shipments are
DDP (Delivery Duty Paid) on the shipping address provided by DakoCytomation in
the relevant Purchase Order (INCOTERMS 2000). 
Clarient shall bear any freight, transportation and custom clearance
fees related to such replacements.


 


19.4     Failure by Clarient to replace any Defective
Product pursuant to Article 19.2 shall be deemed a material breach of the
Agreement, which shall entitle DakoCytomation to have the Product manufactured
at a third party’s production facility at Clarient’s choice for Clarient’s
account according to the procedure set forth in Article 8.15 to 8.24 of this
Agreement.


 


19.5     In case the delivered Product should not
substantially meet the Product Specifications or Acceptance Criteria in Exhibits
1 and 2 or should otherwise be Defective after the period specified
in Article 19.2, DakoCytomation may cancel the Purchase Order or the specific
part of the Purchase Order concerning such Product.


 


Article 20             Installation


 


20.1     During Phase 1 of the Agreement, Clarient shall
install the Products at end-user sites.


 


20.2     Clarient will invoice DakoCytomation for cost
of travel, accommodations, travel allowances and installation time connected to
installation services provided during Phase 1 of the Agreement according to the
price list in Exhibit 10 to this Agreement.


 


20.3     The Payment Terms set forth in Article 12 of
this Agreement shall apply to Installation Services.


 


20.4     During Phase 2 of the Agreement, DakoCytomation
shall make installation of the Products at end user sites.  DakoCytomation may elect to assume
responsibility for installation of Products at end user sites at any time
during the Term upon forty-five (45) days written notice to Clarient.


 


20.5     The Parties agree to discuss a continuation of
Clarient’s handling of the Installation Services during a transition period
after the commencement of Phase 2.


 


Article
21             After
Sales Services


 


21.1     During Phase 1 of the Agreement Clarient will
perform all After Sales Services described in Exhibit 11.


 


22





















 


21.2     During Phase 1 of the Agreement, DakoCytomation
may elect to assume the responsibility for performing After Sales Services. If
DakoCytomation chooses to do so, DakoCytomation will consider employing
Clarient personnel who performed such functions.


 


21.3     Clarient will invoice DakoCytomation for cost
of travel, accommodations, travel allowances and Clarient personnel time
connected to After Sales Services provided during Phase 1 of the Agreement
according to the price list in Exhibit 11.


 


21.4     During Phase 2 of the Agreement, DakoCytomation
will perform all After Sales Services worldwide.


 


21.5     Notwithstanding the above, Clarient will
provide access to the After Sales Services during the entire term of this
Agreement.


 


21.6     Clarient will invoice DakoCytomation for
Support Services according to the Price List in Exhibit 11.


 


21.7     The Payment Terms set forth in Article 12 of
this Agreement shall apply to all After Sales Services mentioned in this
article.


 


21.8     The Parties will mutually agree upon a
continuation of Clarient’s handling of the After Sales Services during a
transition period after the commencement of Phase 2.


 


Article 22             Training


 


22.1     During the Term of this Agreement Clarient
shall train DakoCytomation employees on the use of the Products free of
charge.  Clarient will provide training
for DakoCytomation’s customers at the DakoCytomation training center at the
DakoCytomation site located in Carpinteria, California (United States) for a
fee of five hundred dollars (USD 500) per training session (unlimited
participants) as described in Exhibit 10.


 


22.2     DakoCytomation shall request customer
Training in writing with thirty (30) days written notice.


 


22.3     Clarient will provide training of
DakoCytomation’s Service Engineers, including Service Engineers employed by
DakoCytomation’s external Service Partners once per year during the entire Term
for a fixed fee of one thousand five hundred dollars (USD $1,500) per training
session (unlimited participants). Training will be provided at the
DakoCytomation site determined by DakoCytomation.


 


22.4     DakoCytomation shall request Service Engineer
Training in writing with forty-five (45) days written notice.  Clarient shall provide training free of
charge to both sales and marketing employees of DakoCytomation in The United
States and Europe.


 


22.5     Clarient will provide a comprehensive “Service
Manual” for the Products to DakoCytomation’s Service Engineers within sixty
(60) Calendar Days prior to DakoCytomation’s assuming service responsibility.


 


23





















 


22.6     Clarient will provide a one-time theoretical
and hands-on training of a minimum of three days of DakoCytomation’s R&D
and Marketing Staff and Country Product Managers free of charge that will take
place in DakoCytomation’s location in Carpinteria, California, United States.


 


22.7     DakoCytomation is responsible for all additional expenses and providing
facilities for training.  DakoCytomation
will reimburse the travel and related expenses of Clarient’s representatives
(subject to DakoCytomation’s reasonable, prior approval) as well as all of its
own representatives.


 


Article
23             Image
Analysis Fee


 


23.1     The Parties have agreed that Clarient will
receive payment of an Image Analysis Fee as set forth on Exhibit 4 for
each use of an image analysis algorithm by DakoCytomation’s customers/end-users
in the United States.  The fee indicated
on Exhibit 4 applies only to the current algorithms, and the Image Analysis
Fee for any future assay algorithms shall be agreed upon by the Parties when
such algorithms are released.


 


23.2     DakoCytomation shall only pay the Image
Analysis Fee as long as DakoCytomation’s customers/end-users receive
reimbursements from Centers for Medicare and Medical Services and/or third
party payors (e.g. patient medical insurance).


 


23.3     In the event the reimbursement rate for Image
Analysis changes, the Parties will mutually determine an appropriate adjustment
to the Image Analysis Fee based principally on the ratio of the new
reimbursement rate (CMS Prevailing Rate) to the reimbursement rate on the
Effective Date.


 


23.4     In the event of significant changes in the
market situation the Parties agree to enter into good faith negotiations in
order to amend this Agreement accordingly.


 


Article 24             Spare Parts


 


24.1     For each Product, Clarient shall maintain at its
premises an appropriate stock level of Spare Parts, covering all components of
the Products.  Spare parts related to the
Products shall hereinafter be referred to as the “Spare Parts”. A list of
Clarient’s Spare Parts for the Instruments is included in Exhibit 4 to this Agreement.


 


24.2     Clarient shall have an unlimited obligation to
supply the Spare Parts for the Products to DakoCytomation during the Term of
this Agreement and five (5) years thereafter.


 


24.3     Clarient shall have an obligation to ship Spare
Parts not later than two (2) Business Days after DakoCytomation has ordered
them, to the destination specified by DakoCytomation.


 


24.4     The initial prices for the Spare Parts for Phase
1 are set forth in Exhibit 4. 
Prices for Spare Parts for Phase 2 shall be negotiated in good faith at
a later time.  Clarient shall notify any
changes in the Spare Part prices in writing sixty (60) days in advance.  Spare Part orders made prior to such
notification shall be made at previous prices.


 


24





















 


24.5     Clarient in Phase 1 of the Agreement shall make
shipment of Spare Parts to DakoCytomation customers/end-users.


 


24.6     During the Phase 2 of this Agreement,
DakoCytomation shall make shipment of Spare Parts to the end-users.


 


24.7     Clarient’s delivery of Spare Parts shall be
subject to the terms of this Agreement.


 


24.8     Clarient shall notify and receive DakoCytomation’s
written approval prior to using remanufactured parts in place of Spare Parts on
the Products.


 


24.9     DakoCytomation shall be responsible for all
Spare part obligations if it exercises its license under Article 8.15. In such
event, Clarient shall assist DakoCytomation with assuming the Spare Part
obligations by providing supplier lists and other reasonable documentation and
assistance.


 


Article
25             Software,
Updates and Maintenance


 


25.1     As stated in Article 2.2 of this Agreement,
Clarient has developed manufactures and markets the Software to be used with
the Instruments. The Product Specifications and Acceptance Criteria for the
Software is enclosed hereto as Exhibit
2.


 


25.2     Clarient agrees to provide the Software to
DakoCytomation and DakoCytomation’s customers subject to a perpetual,
revocable, nonexclusive, world-wide, fully paid up, license to use, execute,
display, perform and configure (within its designed parameters) the Software.


 


25.3     Clarient shall provide Software maintenance
during the applicable warranty period for the Product, including development
and creation of updates for the Software to cure software bugs and
malfunctioning at no charge to DakoCytomation or its customers/end-users.


 


25.4     Clarient shall develop and provide upgraded versions
of the Software, which may include additional or enhanced features, new
functionalities and interfaces as well as new algorithms on an ongoing basis.
The Parties will mutually agree upon the consideration, if any, that Clarient
receives for such development work from DakoCytomation.


 


Article
26             Manuals,
Brochures and Marketing Materials


 


26.1     Clarient shall provide for the Products:


 


i.      an appropriate “User Instruction/Operation
Manual”. Each delivery of an instrument shall include such Manual as an integrated
part of the Product which meets legal requirements.


 


ii.     an appropriate “Service Manual” allowing
DakoCytomation’s service organization to professionally implement preventive
and normal service interventions sixty (60) Calendar Days prior to DakoCytomation’s
assuming service responsibility.


 


25





















 


26.2     Clarient shall provide a new Service Manual
for each new instrument phase.


 


26.3     DakoCytomation shall have the right
to review and suggest changes to the manuals prior to final print.


 


26.4     The above Manuals shall be produced by
Clarient at Clarient’s cost and shall be supplied at Clarient’s cost in the
German, English and French languages. The Manuals shall be printed with
DakoCytomation branding


 


26.5     DakoCytomation
shall pay the cost of translation of the Manuals into other languages if such
translation is requested by DakoCytomation.


 


26.6     Brochures and
other marketing material are DakoCytomation’s responsibility, provided that
DakoCytomation shall provide advance copies of all such materials for Clarient’s
review.


 


Article 27             Manufacturing


 


27.1     Clarient
warrants manufacturing the Products according to FDA QSR Good Manufacturing
Practices Regulations and that records of such compliance are at any time
available for auditing by DakoCytomation or third party authorities.


 


27.2     Clarient
will notify DakoCytomation in writing prior to implementing any change in the
Products or manufacture thereof for DakoCytomation’s prior written approval.


 


27.3     Copies of the current and future “Bill of
Goods” listing all components and manufacturing procedures for the Products
will be officially transferred in escrow to the
International Chamber of Commerce in Copenhagen, Denmark, or to another escrow
agent, which can be approved by both Parties, such approval not to be
unreasonably withheld.


 


Article 28             Inspection


 


28.1     Clarient will allow DakoCytomation to inspect
Clarient’s facilities annually, upon reasonable prior notice, to determine
Clarient’s compliance with regulatory and/or quality assurance standards.


 


28.2     DakoCytomation may, once per Calendar
Quarter, have a DakoCytomation Quality Assurance/Quality Control responsible
person inspect Clarient’s manufacturing site to confirm that the Products are
manufactured according to the Good Manufacturing Practices Regulations set
forth in Article 27 .


 


28.3     Any
audit or inspection under this Article 28 or Article 15.8 shall be subject to
the provisions of Article 31 and
Clarient shall have the right to escort the inspection or audit team at its
premises.


 


Article
29             Development
project


 


29.1     In order to fulfill the evolving customer
requirements/needs and to cope with the rapidly changing technology advances,
Clarient and DakoCytomation have agreed to mutually develop the Products into
next generation Products.


 


26





















 


29.2     Clarient will perform the research and
development work under this Agreement. Clarient may engage subcontractors to
assist in such work but shall secure from each such subcontractor
confidentiality undertakings in accordance with Article 31.


 


29.3     The Parties have agreed to enter into a
Development Project with the goal to develop the ACIS III Instrument and
Software based on the current Clarient ChromaVision ACIS II instrument and
software. The Product and Technical Specifications for the ACIS III Instrument
and Software are set forth in Exhibit 14  to this Agreement. The Research and
Development Project is defined in the Project Plan in Exhibit 15 to this Agreement.


 


29.4     The Parties agree that the enclosed version of Exhibits
14 and 15 is only preliminary. The Parties agree to negotiate a
final version of Exhibits 14 and 15 within thirty (30) days of
the Effective Date and that the final version of Exhibits 14 and 15
will supersede the current version of Exhibits 14 and 15 as soon
as it is approved by both Parties in writing. 
Furthermore, the Parties agree that the entire Agreement will cease
(including cancellation of DakoCytomation’s initial Purchase Order described in
Article 8.1) should the Parties not be able to agree on a final version of Exhibits
14 and 15 within thirty (30) days of the Effective Date. Any
disputes regarding the finalization of Exhibits 14 and 15 shall
be solved according to the Dispute Resolution Procedure set forth in article
29.9 below.


 


29.5     Notwithstanding the provisions herein, Clarient
will initiate the research and development work within thirty (30) days of the
Effective Date.


 


29.6     The Parties will mutually agree to any changes
and amendments to Exhibits  14 and 15, including but not
limited to all design files, project milestones and phase gate documentation.
DakoCytomation shall participate in all design review, risk management and
other general project management.


 


29.7     Clarient and DakoCytomation will appoint an
individual as Project Executive to represent and bind Clarient and
DakoCytomation, respectively, in connection with all aspects of the Research
and Development Project described in Exhibits 14 and 15.


 


29.7.1         Before assigning an individual as Project Executive, Clarient and
DakoCytomation will (i) introduce the individual to each other, (ii) provide
the other with information reasonably requested regarding the work history and
experience of the individual and (iii) discuss reasonable objections to such
appointment.


 


29.7.2         Clarient and DakoCytomation will provide each other with at least thirty
(30) Calendar Days notice before assigning a new Project Executive, unless the
Project Executive (a) resigns from employment, (b) is dismissed by his
employer, (c) fails to perform his obligations or (d) is unable to work.


 


29.8     Clarient and DakoCytomation will create a joint
Steering Committee as described in Article 42 below.


 


29.9     If the Parties have a dispute regarding the
Research and Development Project under this agreement, the following Dispute
Resolution Procedure shall apply:


 


29.9.1         A dispute will initially be referred to the Project Executives.


 


27





















 


29.9.2         If the Project Executives cannot resolve the dispute within five (5)
Business Days after their referral, the dispute will be referred to the
Steering Committee.


 


29.9.3         If the Steering Committee cannot resolve the dispute within ten (10)
Business Days after the referral, the dispute will be referred in writing to
the CEO of DakoCytomation and the CEO of Clarient (jointly referred to as “Lead
Executives”) for their review and resolution.


 


29.9.4         The Parties agree that neither Party may initiate formal proceedings for
the resolution of such disputes before (i) the Lead Executives’ joint written
conclusion that an amicable resolution to a dispute is unlikely, or (ii) thirty
(30) days after the referral of a dispute to the Lead Executives.


 


29.9.5         The Parties will exercise good faith efforts to resolve any dispute
related to the Research and Development Project.


 


29.9.6         The Parties agree the all written or oral statements and offers of
settlement made in the course of the Dispute Resolution Procedure, , will (a)
be confidential, (b) not be offered as evidence, disclosed, or used for any
other purpose than the Dispute Resolution Procedure, and (c) not constitute an
admission or waiver of any rights.


 


29.9.7         Each Party will promptly return to the other upon request any such
written statements or offers including all copies hereof.


 


29.9.8         Except where clearly prevented by the nature of the dispute, Clarient and
DakoCytomation agree to continue performing their respective obligations under
this Agreement while a dispute is being resolved.+


 


29.10   The Parties have agreed that the following
procedure shall apply with respect to the fulfillment of the Development
Project and the Project Plan:


 


29.10.1       Clarient will give DakoCytomation written notice of fulfillment of
Acceptance Criteria’s and Milestones and present its results to DakoCytomation.


 


29.10.2       DakoCytomation will carry out an evaluation of the results presented by
Clarient within ten (10) Business Days.


 


29.10.3       DakoCytomation presents the results of the evaluation phase to Clarient,
i.e. whether the Acceptance Criteria and Milestone has been met.


 


29.10.4       If Clarient has not met a Milestone, the Parties agree to enter into
discussions in good faith with the purpose of accomplishing the outstanding
Milestone.


 


29.11   Clarient is responsible for meeting the
development Milestones and Acceptance Criteria set forth in Exhibits 14
and 15.


 


29.12   If Clarient fails to meet its objectives in each
development Milestone and/or Acceptance Criteria, for reasons other than
mutually agreed upon, the applicable Milestone payment shall be decreased by
ten percent (10%).


 


28





















 


29.13   If Clarient has delays in the total Development
Project timeline in excess of ninety (90) Calendar Days, (i) the Minimum Order
Requirement in Article 5.10 shall be suspended until the completion of the
Research and Development Project, and (ii) the total payments for Research and
Development work set forth in Exhibit 4 shall be reduced by twenty-five
percent (25%) after giving effect to any reductions already made pursuant to
Article 29.12.


 


29.14   If Clarient has delays in excess of ninety (90)
Calendar Days in the total Research and Development Project timeline or
Clarient fails to perform its Research and Development obligations set forth in
this Agreement caused by Clarient’s fault or gross negligence, DakoCytomation
shall have the right to take over the Research and Development Project in its
entirety according to the procedure stated in Articles 8.15 and 8.24


 


29.15   Clarient will receive compensation for Research
and Development work under this Agreement as described in Exhibit 4 to
this Agreement.


 


Article 30             Intellectual Property


 


30.1     Intellectual Property owned by or otherwise in
the possession of a Party on the Effective Date, as well as any derivative
works, enhancements or modifications thereof (“Pre-existing Intellectual
Property”), shall remain the absolute, unencumbered property of that Party.


 


30.2     The Parties agree to maintain and defend all
Pre-existing Intellectual Property owned by or otherwise in the possession of a
Party on the Effective Date related to the Products during the Term of this
Agreement.


 


30.3     The Parties agree to notify each other promptly
of material infringements or possible infringements of Pre-existing
Intellectual Property related to the Products , as well as any facts that may
materially affect the validity, scope and enforceability of such Pre-existing
Intellectual Property of which either Party becomes aware.


 


30.4     The Parties hereby grant each other rights to
initiate legal actions for infringement of Intellectual Property related to the
Products, including Intellectual Property created under this Agreement. If a
Party desires to initiate legal actions for infringement of the other Party’s Intellectual
Property related to the Products, the Party shall notify the other Party
immediately in writing. If the other Party does not notify the Party of its
intent to pursue legal actions within ninety (90) Calendar Days after receiving
notice of the Party’s desire to file a suit, the Party shall be free to
initiate the suit. The other Party shall have a continuing right to intervene
in such suit. Each Party will bear its own costs in connection with such suit.


 


30.5     Any Intellectual Property created under the
terms of this Agreement related to image analysis and execution hereof shall be
owned by Clarient.


 


30.6     Any Intellectual Property created under the
terms of this Agreement related to DakoCytomation’s specific implementation of
the Products or integration of the Products with a product supplied by
DakoCytomation shall be owned by to DakoCytomation (subject to Clarient’s
ownership of its Pre-existing Intellectual Property).


 


29





















 


30.7     Subject to the licenses granted herein, each
Party shall own all right, title and interest in and to its independently
developed Intellectual Property.  The
ownership to any other Intellectual Property created under the terms of this Agreement
(excluding Pre-existing Intellectual Property) shall be determined in good
faith by the Steering Committee, provided that if the Steering Committee cannot
reach agreement as to such ownership, such Intellectual Property shall be
jointly owned.  To the extent any
Intellectual Property is jointly owned, neither party shall directly or
indirectly use, distribute, sublicense market or disclose any such Intellectual
Property to the competitors of the other party.


 


30.8     The Party owning any Intellectual Property
created under the terms of this Agreement does hereby grant the other Party a
worldwide, perpetual, fully paid up, irrevocable, non-transferable license to
use such Intellectual Property (i) exclusively as to the Exclusive Field of
Use, and (ii) nonexclusively as to the Nonexclusive Field of Use; provided that
the licensee shall not directly or indirectly use, distribute, sublicense
market or disclose any such Intellectual Property to the competitors of its
owner.


 


30.9     In the event that a Party’s personnel are named
as inventors in a patent application for Intellectual Property owned by the
other Party, the Parties agree that they shall ensure that the patent rights
can be assigned to the other Party and to effect such assignment.


 


30.10   The Parties agree to prosecute, maintain and
defend their own Intellectual Property created under the terms of this
Agreement during the term of this Agreement. The Parties will mutually agree in
writing to the geographical scope of such prosecution. Each Party will bear its
own costs related to prosecution, maintenance and defence of their Intellectual
Property.


 


30.11   If Intellectual Property created under this
Agreement is to be jointly owned by both Parties, the obligations to prosecute,
maintain and defend such joint Intellectual Property will be determined in good
faith by the Steering Committee, provided that if the Steering Committee cannot
reach agreement as to such ownership, such obligations shall be joint and each
Party will bear half of the costs related to prosecution, maintenance and
defence of such joint Intellectual Property; provided further, however, that a
Party may assign its rights to such Intellectual Property to the other Party in
lieu of bearing any costs related to the prosecution, maintenance and defence
of such joint Intellectual Property.


 


Article 31             Confidentiality


 


31.1     Each Party shall keep all information and
know-how communicated to it or otherwise obtained from the other Party under or
in respect of this Agreement secret and confidential and shall not disclose the
same or any part thereof to any third party. Excepted here from is information:


 


a)         which is in the public domain at the time of
disclosure,


b)         which is published or otherwise becomes part of
the public domain through no fault of the Party receiving the information,


c)         which was in the possession of the receiving
Party at the time of disclosure, as shown by competent evidence, or becomes
available from a third party who has the right to disclose it,


d)         which has to be communicated to authorities or
customers for the purpose of sale of the Product and is agreed by both Parties
to be disclosed for those purposes.


 


30





















 


31.2     Both Parties hereto agree that this Agreement may
be disclosed to the supervision authorities at their request, provided that the
receiving party gives a reasonable prior notice to the disclosing party to
allow it to seek protective or other court orders.


 


Article 32             Obligations to Inform


 


32.1     When information regarding potential reporting
incidences has come to a Party’s knowledge, the Party shall inform the other
Party within three (3) Business Days.


 


32.2     The Parties undertake to inform each other about
any and all complaints related to the Products.


 


32.3     If a Party becomes aware of any other information
regarding the Product, intellectual property rights or infringements of such
regarding the Product that could be of importance to the other Party, such
Party must promptly report such information to the other Party.


 


Article 33             Term and Termination


 


33.1     This Agreement becomes effective on the Effective
Date and shall remain in force for 5 (five) years and shall be renegotiated
prior to the termination date (the “Term”).


 


33.2     Neither Party may terminate this Agreement during
the Term.


 


33.3     In the event that this Agreement is not extended
or superseded by the Parties then the Parties agree to negotiate in good faith
(i) the transfer, access or license to Pre-existing Intellectual Property, (ii)
the transfer of any results and know-how from the Development Project, (iii)
transfer of materials and documentation, and (iv) cooperation of the Parties in
order to secure that both Parties can exploit the results from the Development
collaboration within the Field of Use of this Agreement in the future.


 


33.4     In the event that either Party fails or becomes
unable to substantially perform any of its obligations or undertakings to be
performed under this Agreement, and such default is not otherwise addressed
herein, the other Party shall provide to the non-performing Party a written
notification of such default.


 


33.5     If such default is not cured within forty-five
(45) Calendar Days to the mutual satisfaction of both Parties, the other Party
shall have the right to terminate this Agreement without providing further notice
and opportunity to cure for the non-performing Party.  If the default mentioned in Article 33.3 is
lack of payment, the time frame defined in this Article 33.5 shall be ten (10)
Business Days.


 


33.6     Termination of this Agreement shall not in any
way affect the validity of any notice served to either Party prior to such
termination becoming effective. If termination is caused by lack of payment,
all Purchase Orders served and not yet delivered shall be terminated.


 


31





















 


33.7     The provisions of this Agreement shall without
restriction continue to apply to the execution of such orders.


 


33.8     Either Party may with immediate effect terminate
the Agreement in writing upon the occurrence of one or more of the events
specified in Article 33.9. This Article 33.8 shall be limited by statutory
rules applicable in the country where the situations listed below take effect.


 


33.9     The events are:


 


33.9.1         A Party passing a resolution for its winding-up or a court of competent
jurisdiction making an order for the Breaching Party’s winding-up or
dissolution.


 


33.9.2         The making of an administration order in relation to a Party or the
appointment of a receiver or receiver and manager over, or the taking
possession or sale by an encumbrance taking possession of or selling an asset
of a Party.


 


33.9.3         Lasting material violation on the part of either Party hereto of its
contractual obligations and failure to stop or remedy such violation despite a
hortatory letter from the other Party.


 


33.10   In the event that DakoCytomation’s termination of
this Agreement based on Clarient’s default or the existence of one of the
events listed in Article 33.9, the Parties agree to be bound by and to follow
the procedure in Articles 8.15 to 8.24 in order for DakoCytomation to maintain
and secure DakoCytomation’s continuing production and further development of
the Products and continuation of the Research and Development Projects
described in Article 29.


 


33.11   Exercise of the right of termination afforded to
either Party under this Agreement shall not prejudice any legal rights or
remedies either Party may have against the other in respect of any breach of
the terms of this Agreement.


 


33.12   The following Articles shall survive a
termination: Article 12, Article 15, Article 16, Article 19, Article 30,
Article 31, Article 32 and Article 43.


 


Article 34             General Provisions


 


34.1     This Agreement constitutes the entire
understanding between the Parties
with respect to the subject matter hereof, and supersedes and replaces all
prior agreements, understandings, writings and discussions between the Parties
relating to this subject matter.


 


34.2     Each of the Parties acknowledges and agrees that
in entering into this Agreement it cannot rely on and shall have no remedy in
respect of any statement, representation, warranty or understanding (whether
negligently or innocently made) of a person (whether Party to this Agreement or
not) other than expressly set out in this Agreement as a warranty.


 


32





















 


34.3     This Agreement shall be binding upon and inure to
the benefit of and be enforceable by the Parties hereto and their respective
successors and permitted assignees.


 


34.4     Any amendment
of this Agreement must be agreed
upon by both Parties and given in writing.


 


34.5     The failure of either Party at any time to
require performance of any provision hereof shall in no manner affect its
rights at a later time to enforce the same.


 


34.6     No term, provision or condition of this Agreement
shall be waived unless such waiver
is evidenced in writing and signed by the waiving Party.


 


34.7     Neither Party shall make any public statement or
announcement regarding this Agreement or the other Party during the Term
without the prior written consent of the other Party, provided that either may
make any public filing or statement required by applicable law or stock
exchange rule with prior written notice to the other Party.


 


Article 35             Assignment


 


35.1     The Parties shall not be entitled to transfer any
rights and/or obligations under this Agreement to directly or indirectly
affiliated companies or any third party without the other Party’s written
consent, unless such transfer of ownership occurs in accordance with a transfer
of entire business units.


 


Article 36             Right of First Refusal


 


36.1     If Clarient (i) intends to divest its entire
business or the part of the business that is connected to this Agreement (“the
Business”), or (ii) Clarient receives an unsolicited offer for the Business,
DakoCytomation will have the right of first refusal to consider an acquisition
of the Business.  In such case, Clarient
will notify DakoCytomation thereof as soon as permissible under applicable law,
fiduciary duties and other contractual obligations related to such divestiture.  Clarient shall provide DakoCytomation access
to customary and appropriate due diligence materials in order for
DakoCytomation to consider making a proposal to acquire the Business. If
DakoCytomation formally indicates interest in the acquisition of the Business,
Clarient shall evaluate such indications in good faith in light of applicable
law, fiduciary duties and other contractual obligations. Furthermore, the
Parties agree to separately negotiate detailed conditions for the acquisition
of the Business in good faith.


 


36.2     If Clarient intends to have a third-party
manufacture the Products under this Agreement, DakoCytomation shall have the
right of first refusal to undertake such manufacturing, provided that
DakoCytomation must meet the pricing, terms and conditions offered by a third
party. The Parties agree to negotiate the detailed conditions for such
manufacturing and necessary amendments to this Agreement in good faith.


 


Article
37             Change
of Control


 


37.1     The Parties will not sell or otherwise transfer
to a third party assets, which include the Products or the right to make, use,
sell, market, develop and distribute the Products unless the other Party has
first obtained an agreement from such transferee to be bound by the terms and
conditions of this Agreement.


 


33





















 


Article 38             Force Majeure


 


38.1     All cases of force majeure (i.e. any event beyond
the control of the Party concerned) which shall include, but not be restricted
to, fire, flood, earthquake, explosion, riots, strike, lockout, terror, war and
regulations of any governmental or local authority shall, for the duration of
and to the extent of the effects caused by such disturbances, release the
Parties from the performance of their contractual obligations herein.


 


38.2     Either Party shall notify the other Party without
undue delay if there are any indications of any such incidents occurring, and
the Parties shall discuss the effects of such incidents on this Agreement and
the measures to be taken.


 


38.3     Both Parties shall use reasonable efforts to
avoid or restrict any detrimental effects.


 


38.4     The Parties shall, as soon as it is reasonably
possible, resume performance of their obligations. As soon as the effect of the
obstacle arising from the force majeure has ended, the obligations of this
Agreement shall once again come into effect and shall remain in force
throughout the remainder of the duration thereof.


 


38.5     The duration of this Agreement shall not be
extended by a period equivalent to the period for which it has been suspended.


 


38.6     If the performance in whole or in part of any
obligation under this Agreement is delayed by reason of said force majeure
event for a period exceeding six (6) months, (i) the Parties shall meet and
review in good faith the desirability and conditions of terminating this
Agreement, it being understood that neither Party shall be obliged to
compensate the other in any way, and (ii) in lieu of termination of this
Agreement, DakoCytomation may elect to exercise the license granted in Articles
8.15.


 


 


Article 39             Invalidity of the Agreement


 


39.1     In the event of one or several of the provisions
of this Agreement being or becoming void or invalid, both Parties hereto
undertake to replace such void or invalid provision or provisions by relative
valid provisions, of which one would reasonably assume that the Parties hereto
would have concluded the Agreement anyway, had such substitute provision or
provisions been stipulated at the conclusion of this Agreement. Should it not
be possible to find such valid provisions, the invalidity or voidness of any
provision shall not affect the validity of this Agreement as a whole, unless
the invalid or void provision is of such essential importance that one would
reasonably assume that the Parties hereto would not have concluded this
Agreement without the void or invalid provision or provisions.


 


34





















 


Article 40             Relationship of the Parties


 


40.1     Each Party shall conduct its business in that
Party’s own name as an independent contractor. This Agreement does not create a
joint venture, partnership, employment, agency or similar arrangements between
the Parties. Neither Party has the right or power to act for or on behalf of
the other Party or to bind the other Party in any respect whatsoever.


 


Article 41             Severability


 


41.1     Should the legality of any provision of this
Agreement be brought into question because of a decision by a court of
competent jurisdiction of any country in which this Agreement applies,
DakoCytomation will discuss with Clarient in order to revise or delete the
provision in question so as to comply with the decision of said court.


 


41.2     In the event that the terms and conditions of
this Agreement are materially altered as a result of Article 41.1, the Parties
shall renegotiate the terms and conditions of this Agreement in order to
resolve any inequities.


 


Article 42             Management


 


42.1     Clarient and DakoCytomation will create a
Steering Committee consisting of two employees from DakoCytomation and two
employees from Clarient to provide the means of communication and oversee the
management of the relationship under this Agreement.  Within sixty (60) Calendar Days after the
Effective Date, the Parties will identify the members of the Steering Committee
and will agree upon a process for replacement of the Steering Committee’s
members.


 


42.2     The Steering Committee will meet on a quarterly
basis and will have the following responsibilities:


 


42.2.1         Approve and monitor joint development activities
during the Development Project described in Article 29,


 


42.2.2         Discuss and propose Prices, Costs of Goods Sold
(COGS) etc.,


 


42.2.3         Discuss and resolve issues arising during the
business relationship,


 


42.2.4         Discuss and propose possible amendments to this
Agreement,


 


42.2.5         Participate in the Dispute Resolution Procedure
described in article 29.9, and


 


42.2.6         Address issues as otherwise described in this Agreement.


 


Article 43             Governing Law


 


43.1     This Agreement is governed by and shall be construed
according to the laws of the State of California (U.S.A.) as between two
residents thereof without regard to the International Treaties and Conventions
on Conflict of Law or its other conflict of laws principles.


 


35





















 


Article 44             Venue


 


44.1     The Parties
agree that in case of a dispute between the Parties such dispute shall be
sought to be resolved through negotiations between the Parties in the Steering
Committee in good faith and in accordance with the Dispute Resolution Procedure
described in article
29.9.


 


44.2     If a dispute between the Parties cannot be
resolved by negotiations between the Parties such dispute shall be
brought before the Federal District Court for the Southern District of New
York, situated in New York, New York, U.S.A., which court shall have exclusive jurisdiction over any such dispute.


 


44.3     The language to be used in the proceedings shall
be English.


 


Article 45             Headings and Titles


 


45.1     Headings and titles in this Agreement are for convenience
purposes only and shall not in any way influence the construction, performance
and enforcement of any of its provisions.


 


Article 46             Notice


 


46.1      Written notices required to be given under this
Agreement shall be considered duly given (i) seven Calendar Days after the date
mailed if mailed by first class mail, postage prepaid or (ii) two Business Days
after the date dispatched by Federal Express or similar service, and addressed
as follows (or to such address as a Party may subsequently advise the other for
receipt of notices hereunder):


 


46.1.1         If to Clarient:


 


Clarient, Inc.


33171 Paseo Cerveza


San Juan Capistrano


CA 92675 California


United States of America


Att.: Ron A. Andrews


 


46.1.2         If to DakoCytomation:


 


DakoCytomation Denmark A/S


Produktionsvej 42


DK-2600 Glostrup


Denmark

Att.: Corporate Legal Affairs


 


With a copy to:


DakoCytomation California Inc.


6392 Via Real


93013 California


United States


Att: Corporate Legal Affairs


 


36





















 


*****


 


This
Agreement shall be made out in duplicate (2 originals) and each of the Parties
hereto shall be handed one copy.


 


 


	
  On behalf of DakoCytomation Denmark A/S

  	
  On behalf of Clarient,
  Inc.

  
	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
   

  	
  Date:

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  /s/ Erik Winther

  	
   

  	
   

  	
  /s/ Ron A. Andrews

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Erik Winther

  	
  Name:

  	
  Ron A. Andrews

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  CFO

  	
  Title:

  	
  CEO

  
						



 


37





















 


	
  

  	
  EXHIBIT 1

  ACIS II Hardware Specification
  Sheet

  69913 Rev B

   

  



 


Clarient ChromaVision Systems


Automated Cellular Imaging System


ACIS II


 


Hardware Specification


 


The following is a detailed hardware specification for the ChromaVision
ACIS 2. The purpose of this document is to specify the design and the
limitations of the physical portions of the system including but not limited to
the electronics, the optics, the mechanical functionality, the external
appearance, the operating environment, etc. This document is intended to give
guidance to the designers for future enhancements, to give information about
the performance capabilities of the product to the users and programmers, and
to give definitions of the capabilities for testing and verification purposes.


 


 


33171 Paseo Cerveza  
San Juan Capistrano, CA 92675-4824  
Tel 949.443.3355   Fax
949.443.3366

www.clarientinc.com


 


1

















 


Block
diagram of system


 


[***]


 


1.              Identification


1.1.           Trade Name:       ChromaVision Medical Systems, Inc.


1.2.           System Trade Mark:   Automated Cellular Imaging SystemTM or ACIS 2TM


1.3.           Instrument Name:  ACIS 2TM


1.4.           FDA Classification: JOY


 


 


2.              General
Information


2.1.           Intended Use: The ChromaVision Automated Cellular Imaging
System is intended to automatically measure, count, and/or quantify various
colors and shapes in given specimens.


2.2.           Summary of System:   The system consists of: a host computer
system that controls the system operation and interfaces; a Microscope Assembly
(ACIS) that does the physical motions and optical collections required for
sample acquisition; a carrier that accepts and holds the sample slides while
the slides are processed.


2.3.           Brief Description of
operation:  The operation of the system
begins with the user first inserting appropriately stained microscope slides
into carriers and feeding these carriers into the system input hopper. The
input hopper separates and advances the bottom slide carrier to the XY-stage
system.   The slide carrier transport
mechanism then positions the carrier onto the microscope stage, where each
individual slide can be scanned sequentially according to a set of scanning
instructions that is pre-entered into the computer.  The XY stage provides the necessary
two-dimensional repositioning motion that allows the entire specimen area to be
examined by the optical system. The Z axis stage provides the ability to focus
on the specimen. The scanning process results in the creation and capture of
relevant data, which is then processed by ChromaVision’s proprietary image
processing software algorithms to yield a result/score for the slide.  Once the slides on a given carrier have been
scanned, the carrier transport mechanism moves the carrier to the outfeed
platform which deposits it into the output tray to complete the operation.  Data resulting from scans can be stored on
the Tower PC Unit’s hard drive or the accompanying mass storage device (tape,
DVD, etc).


2.4.           Limitations:  System only for use with slides prepared in
accordance with the instructions that accompany the system.


2.5.           Contraindications:   Not to be used as a diagnostic device.


2.6.           Human Interface:  Operator interface is via keyboard, trackball
(mouse), monitor and slide carrier.


 


 


3.              Classification:


3.1.           Regulatory:  Classified medical device to receive approval
from the appropriate domestic and worldwide bodies, including but not limited
to FDA, FCC, UL, CE, and ÓUL.


 


NOTE: The ACIS
consists of three separate system functions. These functions are: 1: The
Microscope system; 2: The Computer Tower system; 3: The Slide Carrier. Each of
these systems has their own interfaces and specifications and therefore will be
addressed separately for clarity.


 






[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.


 


2

















 


4.              Automated
Microscope Assembly (ACIS)


 


4.1.         Physical Characteristics


4.1.1.       Size:


4.1.1.1.       Width:   23”


4.1.1.2.       Depth:   20”


4.1.1.3.       Height:  18”


 


4.1.2.       Weight:     Not to exceed 125 lbs.


 


4.1.3.       Exterior Paint:  To match tower, or as required by CVSN


 


4.1.4.       Form/Shape:    Tabletop unit


 


4.1.5.       Exterior material:    Plastic (ABS, polycarbonate,
fiberglass/polyester, etc)  UL
Flammability rating 94V-2


 


4.1.6.       Labeling: Must be clearly
marked with:


Manufacturer


Address


Model
#


4.1.6.1.       Must have a location for
marking Serial # and Date of Manufacture


4.1.6.2.       Must be marked to indicate
UL & CE approvals


4.1.6.3.       Must be marked to indicate
AC Input Voltage range


4.1.6.4.       Must be marked with
Modification level


 


4.2.         Environment


 


4.2.1.       Operating Environment


4.2.1.1.       Temperature:  +65°F to +85°F
(18°C to +29°C)


4.2.1.2.       Humidity: 30-80% non-condensing


4.2.1.3.       Moisture protection:  Normal laboratory environment


4.2.1.4.       Altitude:      Altitude up to 10,000ft


 


4.2.2.       Storage Environment


4.2.2.1.       Temperature:  4°F to +140°F
(-15 to +60°C)


4.2.2.2.       Humidity: 10% to 90% non-condensing


4.2.2.3.       Altitude:      Altitude up to 15,000ft or pressure
equivalent


 


4.2.3.       Shipping Environment


4.2.3.1.       Temperature:  4°F to +140°F
(-15 to +60°C)


4.2.3.2.       Humidity: 10% to 90% non-condensing


4.2.3.3.       Shock:   20G (PK)


4.2.3.4.       Altitude:      [***] pressure equivalent


 


4.2.4.       Electrical Environments


4.2.4.1.       Input Voltage:   Ref. Section 4.3.2.1


4.2.4.2.       Surge/Transients:   Ref. Section 4.4


4.2.4.3.       Electromagnetic
Compatibility: Ref. Section 4.4


 






[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.


 


3

















 


4.3.         Interfaces


 


4.3.1.       Mechanical


4.3.1.1.       Carrier:  Reference Carrier Section 6


 


4.3.2.  Electrical Interface


4.3.2.1.   Input Power:  [***]


4.3.2.2.    Video
Interface:  [***]


4.3.2.2.1.         Pinout


 


[***]


 


4.3.2.3.    [***]
Serial interface, Standard, [***], [***]


4.3.2.4.    Motion
control Interface


4.3.2.4.1.  [***]


 


4.3.3.       Human


4.3.3.1.  Carrier
loading:   Easy and obvious access to
loading the carriers into the instrument with no safety hazards.  Must be easily loaded without damage to the
slide specimen. Must be polarized so that slide carrier is not installable
upside down or inverted.


4.3.3.2.  Carrier unloading:  Easy
unload access to carriers with no safety hazards to user or no damage to
carrier/slide assembly while unloading.


4.3.3.2.  Power
switch


4.3.3.2.1.                           Location:  Rear panel or sides of system so that it is
not easy to accidentally turn off instrument but is easy to intentionally turn
off.


4.3.3.2.2.                           Functionality:  Should completely remove all power from ACIS
other than at input power cord and internal to Power Switch.


 


4.3.4.                     Operational


4.3.4.1.            Bar Code Scanner:


4.3.4.1.1.                           Must be able to decode
standard bar codes on slides as carriers are passed through system


4.3.4.1.2.                           Standard bar codes includes:
[***]


4.3.4.1.3.                           Minimum bar code size of [***]


4.3.4.1.4.                           Communication       [***]


 


4.4.                   Regulatory
requirements


 


4.4.1.                     UL Safety,
Non-patient, Laboratory:   3101-1
Electrical Equipment for laboratory use


4.4.2.                     Shall meet
requirements to receive CE Mark


4.4.2.1.            EMC – EN 50081-1, EN
50082-1


4.4.2.2.            SAFETY IEC 1010-1:  Safety requirements for electrical equipment
for measurement, control and laboratory use.


4.4.3.                     FDA
laboratory instrument


4.4.4.                     FCC CFR 47,
Part 15, Subpart B for Class A digital devices


 


4.5.                   Subsection
requirements


 


4.5.1.                     Z-stage


4.5.1.1.            Motion


 






[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the omitted portions.


 


4

















 


4.5.1.1.1.         Minimum step resolution: [***]


4.5.1.1.2.         Accuracy/repeatability:  Return to within [***] micron of original point (backlash removed)


4.5.1.2.            Weight capability:  [***] including turret and objectives


4.5.1.3.            Actuator capability:  5 lbs. minimum


 


4.5.2.    XY stage


4.5.2.1.            Motion control


4.5.2.1.1.         Motion actuation: [***] step/rev, [***]mm pitch [***]


4.5.2.1.2.         Motion feedback:  [***]


4.5.2.1.3.         Motion
Accuracy/repeatability: [***]


4.5.2.1.4.         Minimum step resolution:      [***]


 


4.5.2.2.      Carrier interface


4.5.2.2.1.         [***]


4.5.2.2.2.         Loading: Must accept carrier meeting requirements in
Section 6


4.5.2.2.3.         Hold down:   [***]


4.5.2.2.4.         [***]


 


4.5.2.3.       Carrier Transport


4.5.2.3.1.         Positioning:  Must
be able to repeat carrier position to within [***] mirons in X direction, [***]
microns in Y direction or one field of view at [***] magnification.


4.5.2.3.2.         Speed: Must
be able to move the carrier across XY stage at minimum of [***]mm/sec


4.5.2.3.3.         Torque:   Must
be able to apply [***] oz-in of torque to the carrier for movement of the
carrier across the stage.


 


4.5.3.                     Input section


4.5.3.1.  Capacity:   Must
have capability to hold [***] carriers.


4.5.3.2.  Sense:  Must
be able to determine if there are any carriers available for evaluation.


4.5.3.3.  Separation:   Must
be able to separate and transport a single carrier at a time.


4.5.3.4.    Accessibility:    Easily loaded by user standing in the front
of the instrument. Should be easily recognized that the hopper is full as well
as empty. Should also have sufficient access to unload any unprocessed
carriers. Should present no safety hazards to the operator during loading or
unloading.


 


4.5.4.       Output section


4.5.4.1.            Carrier movement: Must accept defined carrier from XY stage and deposit into outfeed
tray.


4.5.4.2.            Sense:  Must
be able to recognize that the output tray is full and notify software/control
of full condition.


4.5.4.3.            Unloading:    User
must be able to easily access and unload processed carriers.


4.5.4.4.            Capacity:   Must
have the capability of storing the same number of carriers that the input
hopper can hold.


4.5.4.5.            Accessibility:  Easily unloaded by user standing in the front of
the instrument. Should be easily recognized that the hopper is full as well as
empty. Should present no safety hazards to the operator during loading or
unloading.


 


4.5.5.       Camera


4.5.5.1.            Minimum resolution:   [***] horizontal lines of resolution (TV lines).


4.5.5.2.            Signal/Noise:   [***] minimum.


4.5.5.3.            Pixel count:   minimum [***].


 






[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.


 


5

















 


4.5.5.4.            Frame count:    Must supply at least [***] complete frames per second (or [***]  fields in [***]  interlaced mode).


 


4.5.6.                     Optical path


4.5.6.1.            Objectives


4.5.6.1.1.                           Dry, cover slip corrected,
infinite conjugate design.


4.5.6.1.2.                           Min field coverage @ 4X:  [***].


4.5.6.1.3.                           Resolution at 60X: less than or equal to [***].


4.5.6.1.4.                           Transmission nonuniformity:   less than [***] objective to objective.


 


4.5.6.2.            Telan lens: [***]
mm focal distance.


4.5.6.3.            Adjustability:Optical path must have
adjustments to allow for optical path alignment throughout the entire optical
path.  All non-adjustable points must [***].


4.5.6.4.            Linearity : [***] scale at 40X and 60X.
Measurement made with camera’s [***].


 


4.5.7.                     Illumination source


4.5.7.1.            Light source:   Quartz Halogen light bulb, [***],[***],[***] lumens, [***] life
hours min.


4.5.7.2.            Condenser:   Adjustable
NA for F Number, Range [***] to [***] NA.


 


4.5.8.                     Turret assembly


4.5.8.1.            Objectives:   Minimum
[***] standard ports.


4.5.8.2.            Drive:   Internal
Drive for Objective selection.


4.5.8.3.            Weight:  Max
turret weight [***].


 


4.5.9.                     Power supply


4.5.9.1.            Switching Power supply:   [***] watts minimum


4.5.9.2.            Outputs: [***],[***]
minimum


4.5.9.3.            Approvals: UL, CE.


 


4.6.                         Maintenance
requirements


 


4.6.1.                     Accessibility


4.6.1.1.            Must be able to access
the following with cover in place (access door is acceptable):


Infeed
hopper


Outfeed
tray


Stage
area


Light
bulb


Power
switch and cable


 


4.6.1.2.            Must be able to access
the following with minimal difficulty (for adjustments, etc):


Camera


Objectives


XY stage


Motor Drivers


Fuses


Cabling


 


4.6.2.                     Adjustability


4.6.2.1.            XY stage


4.6.2.1.1.                           [***]


 






[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.


 


6

















 


4.6.2.1.2.                           [***]


4.6.2.1.3.                           [***]


4.6.2.2.            Z stage


4.6.2.2.1.                           [***]


4.6.2.3.            Input module


4.6.2.3.1.                           [***]


4.6.2.4.            Output module


4.6.2.4.1.                           [***]


4.6.2.4.2.                           [***]


4.6.2.5.            Camera


4.6.2.5.1.                           [***]


4.6.2.5.2.                           [***]


 


4.6.3.                     Alignment requirements


4.6.3.1.            System should not need
mechanical alignment more than [***] per year after initial installation
alignments.


 


4.6.4.                     Periodic maintenance


4.6.4.1.            Should not require
periodic maintenance more frequent than every [***] months, not including user
maintenance (bulb replacement, daily calibrations, etc.).


 


4.6.5.                     Serviceability


4.6.5.1.            Must have access to
all major components of instrument.


4.6.5.2.            Must be able to
replace any defective electronic card within [***] hours.


4.6.5.3.            Must be able to
replace any major component within [***] hours.


4.6.5.4.            Must have safe access
to necessary adjustment areas.


 


4.6.6.                     Factory setup


4.6.6.1.            Initial Factory setup
should take no longer than [***] hours to complete once instrument has been
assembled.


 


4.6.7.                     Maintenance tooling


4.6.7.1.            Requires a minimum of
tooling for periodic maintenance with very limited special tools needed.


4.6.7.2.            No tools required that
could not fit in a briefcase and be easily transported to sites.


 


4.7.               Reliability


4.7.1.                     Carrier Transport:   1 jam or misfeed per [***] feeds


4.7.2.                     Bulb life:  [***] hours average useful life (minimum)


4.7.3.                     System MTBF: [***] ([***]) Note: This excludes alignment,
calibration, or light bulb issues.


 


5.                   ACIS Host
Tower Assembly


 


5.1.         Physical Characteristics
- Tower Configuration


5.1.1.                     Weight:   Not to exceed 50 lbs.


5.1.2.                     Form/Shape:  Tower type PC case.


 






[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.


 


7

















 


5.1.3.                     Exterior material:  Formed Metal, Plastic, UL Flammability rating
94V-2.


 


5.2.     Environment:  Reference section 4.2


 


5.3.       Interfaces


5.3.1.                     Mechanical


5.3.1.1.            Internal Printed
circuit requirements


5.3.1.1.1.                           [***]


5.3.1.1.2.                           [***]


5.3.1.2.            External connections


5.3.1.2.1.                           Mouse/Trackball


5.3.1.2.2.                           Monitor


5.3.1.2.3.                           Serial
com ports: one 9 pin D-sub connectors


5.3.1.2.4.                           Parallel:    [***]


5.3.1.3.            Feet: Supports suitable for desktop or floor usage


 


5.3.2.                     Electrical


5.3.2.1.            Serial Communication: 1 Standard DB9 RS232 comm ports, Male pins


5.3.2.2.            [***]


5.3.2.3.            Ethernet: [***]


5.3.2.4.            Video:  [***]


5.3.2.5.            Modem:  [***] type connector configured for
destination country


5.3.2.6.            Input power: IEC320-C13 
type connector


5.3.2.6.   Motion Control:  [***]


5.3.2.6.1.Pinout:    [***]


 


5.3.3.                     Human


5.3.3.1.             Monitor


5.3.3.2.             Mouse/Trackball


5.3.3.3.             Keyboard


5.3.3.4.             Power switch


5.3.3.5.             Reset button


5.3.3.6.             DVD/CD Input


5.3.3.7.             Tape drive input
(opt)


5.3.3.8.             3 1/2 floppy input


 


5.3.4.                     Operational


5.3.4.1.      Serial port


5.3.4.2.      Video input card


 


5.4.    Regulatory requirements


 


5.4.1.                     UL Safety


5.4.2.                     CE Mark


5.4.3.                     FCC class A


5.4.4.                     CUL


5.4.5.                     Keyboard to meet local language
requirements


 






[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.


 


8

















 


5.5.         Operational requirements


 


5.5.1.                     CPU:  Dual Intel [***] minimum


5.5.2.                     Primary Hard
Drive: [***] minimum


5.5.3.                     Tape: Backup 10 Gigabyte or greater (opt)


5.5.4.                     3-1/2 Floppy
Drive:   1.44MB


5.5.5.                     DVD/CD +RW,
2.4x or greater, 4.7GB minimum


5.5.6.                     RAM:   512MB minimum


5.5.7.                     Monitor:  19” or greater, or digital flat screen


5.5.8.                     Keyboard:  Windows compatible


5.5.9.                     Mouse or
Trackball:  Windows compatible


 


5.6.         Power Supply requirements


 


5.6.1                        Output Voltages:    +12, +5, -5, -12 VOC


5.6.2.                     Total Wattage: 250 Watt minimum, 300 Watt preferred


5.6.3.                     Input Voltages:   120 VAC & 240 VAC capable, 50 or 60 Hz


 


6.                   Slide
Carrier 


 


6.1.    Physical
Characteristics


6.1.1.                     Size:    see figure 6.1.4.1


6.1.2.                     Weight:   .65 oz Minimum


6.1.3.                     Exterior:


6.1.3.1.            Color:   Bright
white


6.1.3.2.            Texture:  63
microinches


6.1.4.                     Form/Shape:  see figure 6.1.4.1


6.1.5.                     Exterior material:  Molded Plastic,  UL Flammability rating 94V-2


 


6.2.    Environment


Reference Section 4.2


 


6.3.    Interfaces


6.3.1.                     Mechanical


6.3.1.1.            External


6.3.1.1.1.                           Feed Cam: Carrier must have
accommodations to interact with feed cam.


6.3.1.1.2.                           Feed Belt: Carrier must
accommodate for tab feed.


6.3.1.1.3.                           Stage feed belt: Carrier
must have 1/5 pitch timing belt interface to feed onto stage.


6.3.1.1.4.                           Out feed tray: Carrier must
have accommodations to hang in out feed tray.


6.3.1.1.5.                           Contacting: Carrier surface
shall be made from a low friction material.


 






[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.


 


9

















 


6.4.    Operational
requirements


 


6.4.1.                     Must hold four slides.


6.4.2.                     Must be easy to handle as well as
load and unload from the Microscope.


6.4.3.                     Slides must be easily and safely
installed into carrier.


6.4.4.                     Slides must be easily and safely
removed from carrier.


6.4.5.                     Must remain flat while on stage.


6.4.6.                     Interface surface flatness .030”
(with slides loaded).


6.4.7.                     Slide retention method shall hold
slide in a fixed position.


 


[***]


 






[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.


 


10

















 


 


	
  

  	
  EXHIBIT 2

  ACIS II Software
  Specification

  77793 Rev A

   

  



 


Clarient
ChromaVision Systems


Automated
Cellular Imaging System


ACIS II


 


Software
Specification


 


The following is a
detailed software specification for the ChromaVision ACIS II. The purpose of
this document is to specify the use and the limitations of the software product
used to interface, control and manage the hardware portion(s) of the ACIS II
Device, including but not limited to, user interface, system controls, data management
and analysis capabilities. This document is intended to give guidance to the
designers for future enhancements, to give information about the intended uses
and performance capabilities of the product to the users, and to give
definitions of the capabilities for testing and verification purposes.


 


 


33171 Paseo Cerveza  
San Juan Capistrano, CA 92675-4824  
Tel 949.443.3355

Fax 949.443.3366   www.clarientinc.com


 


1

















 


Table of Contents


 


	
  1        Image
  Acquisition

  	
   

  	
  3

  
	
  1.1

  	
  Slide Scanning

  	
   

  	
  3

  
	
  1.2

  	
  Image Registration

  	
   

  	
  4

  
	
  1.3

  	
  System Calibration

  	
   

  	
  4

  
	
  1.4

  	
  Miscellaneous

  	
   

  	
  5

  
	
  2        Image
  Review

  	
   

  	
  5

  
	
  2.1

  	
  ACIS Add-In Support

  	
   

  	
  5

  
	
  2.2

  	
  Contrast Enhancement

  	
   

  	
  5

  
	
  2.3

  	
  Color Overlay

  	
   

  	
  5

  
	
  2.4

  	
  Image Sharpening

  	
   

  	
  5

  
	
  3        Image
  Analysis

  	
   

  	
  5

  
	
  3.1

  	
  Analysis Capabilities and User Options

  	
   

  	
  5

  
	
  4        Data
  Management

  	
   

  	
  7

  
	
  4.1

  	
  ACIS [***]

  	
   

  	
  7

  
	
  4.2

  	
  [***]

  	
   

  	
  7

  
	
  4.3

  	
  ACIS Data Manager

  	
   

  	
  7

  
	
  4.4

  	
  ACIS Report

  	
   

  	
  8

  
	
  5        ACIS
  Toolbar

  	
   

  	
  9

  
	
  6        Miscellaneous

  	
   

  	
  9

  
	
  6.1

  	
  ACIS Help File

  	
   

  	
  9

  
	
  6.2

  	
  Data Connectivity

  	
   

  	
  9

  
	
  6.3

  	
  Configuration Settings

  	
   

  	
  9

  
	
  7        Analysis
  Modules

  	
   

  	
  10

  
	
  7.1

  	
  Nuclear Application ([***])

  	
   

  	
  10

  
	
  7.2

  	
  Membrane Application

  	
   

  	
  10

  
	
  7.3

  	
  Rare Event Application

  	
   

  	
  11

  
	
  7.4

  	
  Tissue Micro Array

  	
   

  	
  11

  
	
  7.5

  	
  [***]

  	
   

  	
  11

  



 






[***] Certain information on this page has been redacted and filed
separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.


 


2

















 


1                       Image
Acquisition


 


1.1         Slide Scanning


 


1.1.1        Focus Points Distribution


 


Focus points will have multiple options for defining
distribution and selecting the [***].


 


•                    Focal Plane
[***]


 


The focus plane is derived by a [***].  The focus points must be well [***] about the [***]
to [***] a [***] that [***]
the [***] of the [***]
and the focus points must all be on [***].


 


The table below lists the depth of focus for each
objective.


 


[***]


 


•                    Focal Plan
[***]


 


The application has the choice
to:


 


1.               Have the user specify
the number of [***] (as is [***])


2.               Have [***] to [***] one
[***] (as [***] by [***])


3.               Derive a [***] and use
that to compute the [***] for every [***] (as is [***])


4.               Locate the [***] closest
to the [***] and use its [***].


 


Any of
these four combinations are allowed as illustrated in the following table.


 


[***]


 


1.1.2        Silhouette Scan


 


Silhouette scan will implement [***], [***], [***]
and collect [***] during
processing.  All applications (where
applicable) will use Silhouette scan and [***].


 


Silhouette Scan incorporates knowledge of [***] during [***]
Of [***] to define the silhouette of
the [***] to [***].  The [***] is
subdivided to improve
the [***] of the [***].


 


Silhouette Scan employs the information gathered
during the [***] to improve the
robustness of the [***] by selecting focus
points at [***] with [***]
and insuring that the focus points are well [***] the [***].


 


Silhouette Scan provides a mechanism to [***] the [***] for [***]
that [***] or know that there are valid
events outside the [***] (e.g. [***]). Alternatively one can [***] the [***]
for applications that want to work inside the [***] (e.g. [***]).


 


Silhouette Scan retains [***] of the [***] of [***]
which can be exploited for the [***] to [***].


 


Silhouette Scan can [***] that, when [***] the [***]
and [***] and the [***] on the [***].


 


1.1.3        Data Compression


 


[***] is executed automatically if [***] is
[***].  The [***] not [***] by [***],
where no images were grabbed and placed in the [***], are
[***] into a [***] and associated with a single [***] called the [***].


 


Performance: The [***] and [***] that [***]
provides is dependent upon the [***], the [***] and the shape
of the [***].


 






[***] Certain information on this page has been redacted and filed
separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.


 


3

















 


Example 2: The image below depicts a row of
[***] a [***].  Only the [***] are [***]
by [***] to [***], and thus only those [***] are [***].  [***] reduces the first [***], the [***], and
the [***].  If [***] is [***], the two
patches of 4 scanned [***] will be [***].


 





 


1.2         Image Registration


 


1.2.1        FOV Registration


 


[***] now go through a process to register [***] of
view to eliminate or mitigate the [***] by [***] due to inaccurate [***] or
[***].


 


FOV REGISTRATION KEYS


 


1) Display Registered


 


Review can display the [***] or [***].  When [***] is enabled (1) the [***] is
displayed. This [***] is created
[***] and [***] to [***].


 


2) Enable Registered Display Toggle


 


For non clinical user 1 users, the key [***] can
switch the [***] from [***] to [***]. 
When [***] is enabled (1)  the display state can be [***] with
[***].  This [***] is created [***] and
[***] to [***].


 


1.2.2        Self Registration


 


Image processing is done to [***] the
[***] with the [***] to make revisit [***]. 
This feature is important in applications where the [***] to be [***] at
a [***].


 


SELF REGISTRATION KEYS


 


1) [***]


 


Self Registration will search an ever [***] of the
[***] to locate the [***] and compute
the [***].  [***]defines the limits of
this [***].  This key is [***] and [***]
to [***].


 


1.3         System Calibration


 


1.3.1        Calibration Client


 


The system will provide a method of [***] to balance
the [***] and [***] of the [***].  The
results of this [***] will be [***] directly to the [***] where the [***] was
[***].  In the event of a [***], an [***]
will alert the user to the [***] of the system, with no new [***] being [***].


 


1.3.2        [***]


 


Because of the [***] of the [***], an ACIS system may
find [***] on a [***], such as [***]. 
This may present challenges to [***] to [***] of [***] and to measure
the [***] of [***].


 


A method will be present through a [***] to [***]
show the amount of [***] of a system, and allow for the results
of a [***] of the [***] to immediately reflect the impact
on the [***] of that [***].


 


The following [***] will be used to [***] and [***]
the [***] and [***] of [***].


 


[***]


 


[***] the [***] the [***] of [***].


 


[***] To [***], if [***] to [***], the [***] are
[***] to a [***],


 


[***].


 






[***] Certain information on this page has been redacted and filed
separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.


 


4

















 


[***], if [***] to [***], an [***] is [***] with
[***].  This is for [***].


 


[***] the [***]. 
This is for [***].


 


[***], if [***] to [***], an [***]
is [***] with a [***].


 


1.4         Miscellaneous


 


1.4.1        Carrier Unload Detection


 


The system will create a series of [***] of a [***] as it moves off of the [***].  These images will be [***] to create on
[***].  The [***] is then analyzed to
determine if the [***] was [***] in a [***] to the [***].  The [***] results are compared to an [***]
and [***].  The [***] is stored in [***]
in a [***] and, if there is a failure,
in [***].


 


2                       Image
Review


 


2.1         ACIS Add-In Support


 


[***] provide a method that allow
[***] to be added to the [***] without having to add any [***] to [***].  [***] extended [***] for both [***] and
[***].  An example of an ACIS add-in
would include the [***], or the [***].


 


2.2         Contrast Enhancement


 


The system supports the ability to [***] the [***] of
a [***] or [***].  The [***] provides a
default setting, and up to [***] settings that
may be specified by the user.


 


2.3         Color Overlay


 


The system provides a method to [***] the [***], the [***] of the review application associated
with that [***].


 


2.4         Image Sharpening


 


The [***] provides [***] of [***].  These are referred to as [***] and
[***].  [***] is the [***] of [***], and
[***] is the [***] of [***].  The [***] of [***] can be selected from either
the [***] or by [***] on the [***] and selecting the [***].


 


3                       Image Analysis


 


3.1         Analysis Capabilities and
User Options


 


3.1.1        User Drawing Tools


 


User specified drawing tools on the [***] and [***].  The [***] includes representative [***] of
[***] and [***].  The [***] regions
include [***] and [***] as well as a [***].


 


3.1.2        [***] of the [***]


 


The [***] may be [***] out to [***] and [***] of
[***].


 


3.1.3        [***] on [***]


 


When scoring slides that implement the [***] of
[***], it is possible to halt the [***] by pressing
the [***] all [***] is [***].


 


3.1.4        [***]


 


When scoring slides that implement the [***] of
[***], it is possible to [***] only [***] by pressing the [***] with the [***].


 


3.1.5        [***]


 


The ACIS Review program supports an [***] of
[***].  [***] are able to be adjusted to
extend the [***] as needed to accommodate
[***] of [***]


 






[***] Certain information on this page has been redacted and filed
separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.


 


5

















 


3.1.6        [***] in [***]


 


The Results View on the [***] uses a [***] to
indicate [***] between [***] on [***].  A
[***] is a region that is [***] on a p***]. 
The [***] of that [***] is the region on the main [***] that was [***]
to produce the [***].


 


3.1.7        [***]


 


Applications may be [***] to support the [***] of a
[***], which is the image included in the [***].  If so desired, an application may be [***] to
require the [***] to [***] through a right click [***] where and when to [***]
a [***].  This feature is especially
useful in those [***], where [***] and [***] may be associated to a [***].


 


3.1.8        Color Thresholds


 


3.1.8.1           [***]


 


The system provides a utility that [***] an
additional [***] from within the [***]. 
When [***], this interface provides the user with a [***] of the [***]
currently being used for analysis over the [***].  Additional [***] allow the user to modify
those [***], or to load previously [***]. 
As each [***] requires a separate [***] (e.g. [***], etc), a method
exists for users to apply [***] to those
[***] to [***] the amount of [***] being [***] or excluded by those [***].


 


3.1.8.2           [***]


 


A module of the [***] that is specific for [***] and
[***] the data around [***].  The [***]
requires that a [***] describing the number, [***] and [***] of the [***].   When
[***] the [***] of the slide, the user also
has the [***] to [***], or [***] the [***] that will automatically create and
[***] a [***] to each [***] on the [***]. 
Any [***] may be associated to any [***].  Once a [***] has [***] processed using a
[***], a [***] will be presented to segment the [***] into [***].  This [***], or [***], may be manually moved
and adjusted to [***] for a [***] prior to [***] of an [***].


 


3.1.9        Saving Images


 


3.1.9.1           [***]


 


The system will provide a [***] of [***] from the
[***] to a [***] and [***].  Optional
ACIS [***] to be [***] will include user specified [***] for [***], or
[***].  [***] will be capable of being
[***], for an entire [***], or for an entire [***].


 


3.1.9.2           [***] as [***]


 


An entire [***] may be [***] as a [***] or [***], as
specified by the user.  A representative [***] of the [***] may be
[***] to a [***] specified by the user in a
[***] of [***].


 


3.1.10  Miscellaneous


 


3.1.10.1     [***]


 


ACIS supports [***] for [***] that are drawn on a
[***].  [***] are implemented as [***],
and can be [***] in [***] or in [***]. 
Unlike [***] have full access to the entire suite of [***] that are
provided by the [***].


 


3.1.10.2     [***]


 


ACIS supports the [***] of [***].  When a [***] is opened, the [***] will check
for a [***] for the application that will score the [***].  If such a [***] does not exist, the [***] can
only be opened [***], meaning that the user can not [***] any [***] on the
[***].  Also, if no valid
[***], a [***] will not be automatically [***].


 


3.1.10.3     [***] on the [***]


 


A [***] as a specific type of user [***].  The purpose of a [***] is to exclude certain
[***] of [***] from [***] by the [***]. 
Any [***] will be available for use as a [***].


 






[***] Certain information on this page has been redacted and filed
separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.


 


6

















 


4                       Data
Management


 


4.1         ACIS [***]


 


The ACIS software provides [***].  The first of these is referred to as
[***].  This [***] steps the user through
the [***] of [***] to those batches, [***] to the
worklists, and [***] for [***].


 


4.2         [***]


 


Unlike the [***], which is [***], the new [***] is
[***].  The [***] is not [***], therefore
all of the [***] is performed on a single [***]. This results in less [***] to
[***] a new case.


 


Some features provided by the new [***] are:


 


•                  Users
can [***] for [***].


•                  Users
can [***] of [***] for [***].


•                  Users
have the ability to [***] their [***].


•                  [***]
can be linked to [***].


•                  [***]
can be done [***] over the [***].


•                  A [***] and [***] can be
generated and [***]


•                  Supports having the
[***] on the [***] as the patient [***]


•                  Supports ChromaVision
lab [***] such as [***] and [***]


•                  Supports auto- [***]


 


4.3         ACIS Data Manager


 


The ACIS [***] is the program that is used to
[***].  Batches may be [***] or [***]
through the [***].  [***] also supports
[***] and [***] from [***] and [***]. 
[***] and [***] can be performed on [***].  This can be very useful in a [***] where
[***] may have been generated on a different [***] and a [***] to [***] them
[***] a [***] to score them [***].


 


The [***] is [***] to all former [***] of the ACIS
platform.  Upon [***] an [***], they will
be automatically converted to the [***].


 


[***] supports selection of the
[***] to [***] to. This is useful in environments that have [***] on a
[***].  [***] can be [***] from [***] and
imported onto another [***].


 


4.3.1        [***]


 


The [***] verifies [***] after [***] an archive to
the [***].  The [***] ensures that the
[***] is [***].  If a [***] error occurs,
the [***] is [***], and the user is prompted to insert [***].  After the [***] is [***], the [***] is [***],
which is then verified. Any [***] that fails [***] should be [***], as it is
[***].  Problems with [***] that [***]
may be fixed by performing a [***] on them.


 


The [***] can
be disabled by [***] the [***] to [***]:


 


[***]


 


At any customer site, this [***] should be [***] to
[***], so that [***] are always [***]. 
Setting this [***] to [***] is not recommended because [***] to [***] a
[***] in the [***] of [***].


 


4.3.2        [***] for [***]


 


The ACISDataManager supports both [***] and [***] for
[***].  Previous versions supported only
[***].  A [***] may be able to correct
[***] with [***] that [***].  A [***],
which erases only the [***] of [***] on the [***] to [***].  A [***], which erases the [***] of the [***]
more than [***] to complete.


 


4.3.3        [***] for [***] in [***]
by [***]


 


The ACISDataManager now checks for the [***] being
used by another [***] before it attempts to perform any [***].  This will help prevent [***] if [***] or
[***] on the system and a [***] into the [***]. 
[***] are [***] by [***] and [***] to [***] and [***] for [***] and
[***].


 






[***] Certain information on this page has been redacted and filed
separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.


 


7

















 


4.3.4        [***] and [***] before
[***]


 


An option has been added to the ACISDataManager that
will cause the [***] to be opened and [***] to [***] the [***].  This may correct some verify errors that are
seen after [***] to [***].  This [***]
can be enabled or disabled in the [***] described below.


 


4.3.5        [***]


 


An options [***] has
been added to the ACISDataManager to allow the users to select [***] without
[***] to [***] the [***].  The [***] is
accessed by selecting the [***].


 


The available options on the [***] are:


 


•                  [***]
After[***]– if this option is set, the
ACISDataManager will [***] the [***]
by [***] the [***] on the [***] after it is [***].  It is recommended that this option [***] be
[***].


•                  [***] and [***] Before [***]– if this option is set, the
ACISDataManager will [***] and [***] the [***] to [***] the [***].  Set this option if you are [***].  In some cases this may [***].


•                  [***]– if this option is set, the
ACISDataManager will [***] the [***] the [***] and [***] found on the
[***].  Set this option only if you have
[***] on your [***].  Note that if you
set this option, you must [***] and [***] the [***].


•                  [***]– if this option is set, the
ACISDataManager software will run [***] of a [***].  This option should always be set when [***] a
[***].


 


4.3.6        [***] from [***]


 


The [***] allows for [***] located on a [***] to be
selected for [***].  A [***] is provided
to allow the user to [***] from any [***] on the [***].  [***] are displayed through a [***].   [***] may be selected for subsequent [***],
and will be [***] in the order with [***] in the [***].


 


4.4         ACIS Report


 


4.4.1        Description


 


ACISReport is a [***] that is used to [***] and [***]
from the ACIS [***].  The format of the
printed report is [***] by altering the [***]. 
ACISReport is delivered with [***]. 
These [***] can be modified on a per [***] to provide the [***] and
[***] the [***].


 


In addition to [***] and [***] from the [***],
ACISReport [***] can be [***] to [***] ([***], etc.) into
the ACISReport.


 


ACISReports can be [***] as
[***] or [***].  These [***] can then be
[***] into an [***] for [***] in [***] that are generated by the [***].  The [***] can also be [***] to [***].  ACISReport can also be [***] to [***] from the
[***] into [***] and [***].  These [***]
can be imported into [***] for [***] into [***].


 


4.4.1.1           [***]


 


[***] will automatically be
[***] on [***] that are generated from [***] ([***]) with [***] of the [***]:


 


•                   One or more [***] were
analyzed with [***] that are [***] as [***].


•                   One or more [***] were
[***] with a [***] other than [***].


 


This [***] will
be displayed [***] on the [***] in the middle as determined by [***].  The [***] is embedded in the [***].


 


The [***] that is displayed and
the [***] of [***] it [***] on the [***] can be configured/modified in the
[***].


 


A new [***] will be created the
first time [***] (with this [***]) is [***] and [***] at [***]


 


The [***] will be defined as
follows:


 


[***]


 






[***] Certain information on this page has been redacted and filed
separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.


 


8

















 


[***] is ([***]) by default and
therefore the [***] in the code will be [***]. 
If we need to customize this [***], a [***] with [***] can be specified
in this [***].


 


When customized [***] are [***]
within a [***], they will be displayed as [***] as the [***] hasn’t been
displayed.   In the case that the [***],
the [***] not [***].


 


4.4.2        Report Image Management


 


4.4.2.1           [***]


 


The [***] that is displayed by ACISReport when a user
selects [***] to be [***] the [***] will always start in the [***].  On normal ACIS systems, this [***].  [***] will be the current [***].


 


4.4.2.2           [***]


 


The type of [***] used by ACISReport when saving a
[***] by setting the [***]:


 


[***]


 


The [***] value can be set to either of the
following:


 


[***]


 


[***]


 


The default is [***].  You should generally leave the [***], unless a
customer is using a [***] that can not handle [***], in which case the [***].


 


5                       ACIS
Toolbar


 


The ACIS toolbar is used to launch the various
programs that make up the ACIS software suite. The ACIS toolbar can be docked
on any of the four edges of the screen, or it can float (be positioned anywhere
on the screen).


 


6                       Miscellaneous


 


6.1         ACIS Help File


 


An online help file will be distributed with the ACIS
device.  This help file will be viewable
from all major user interfaces, and will be opened by pressing the F1 key on
the keyboard, or by selecting the Help option from a dropdown selection on the
main toolbar.


 


6.2         Data Connectivity


 


6.2.1        [***]


 


The system will be capable of [***] to and [***] with
an [***].  This [***] will support [***] of [***] a [***].


 


Customers will be required to perform some [***] to
[***] this [***].  A [***] will be
created and maintained that will detail a [***] of [***] and [***].


 


6.3         Configuration Settings


 


6.3.1        [***]


 


The system will provide a method for the user to
[***] the [***] of [***] to the user.  The [***] will not change the
type of [***] but only the [***] of the [***] with the results [***].


 


An example is included
below.   Note: the words in italics are
required and the words in bold are configured by the [***].


 


[***]


 






[***] Certain information on this page has been redacted and filed
separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.


 


9

















 


6.3.2        [***]


 


The system will provide a method for the user to
[***] and [***] the [***] and [***] of the [***].


 


•                  The
[***] will be supported on an [***], where it may be [***] with a [***].


•                  The
[***] will be supported on the [***] as a [***].  In this case, the [***] may be configured to
look within a [***] specified by the user through a [***] the [***] being at
the [***] of the [***] or the [***] of the [***].


 


6.3.3        [***]


 


The system will allow users to specify [***] for an
[***] when [***] a [***] for [***].  The
default values for level of [***] and [***] will be set by a user from the
[***].


 


The group labeled [***] allows the user to specify
which [***] of [***] will appear on the [***] button of the [***].  The [***] controls whether or not the [***]
by [***].  When the [***] is on, and when
the [***].


 


The group labeled [***] allows
the user to specify which [***] is displayed on the [***] of the [***].


 


The group labeled [***] allows the user to specify
which [***] is displayed on the [***] of the [***].


 


The group labeled [***] allows the user to specify
the [***] for both the [***] and [***]. 
Note that for the [***], the application can [***] this [***].


 


The final check box on the user [***] is labeled [***] a [***].  When this checkbox is in effect, all [***]
that are [***] the [***] this [***].  If
a [***], and a [***], that changed [***] the [***].  If this [***], then if a [***] and a [***] the [***].  When this [***] is not [***] all of the other
[***] become [***] to indicate that they are no [***] the [***].


 


6.3.4        Threshold Label Manager


 


The integrated [***] allows users to create [***],
and to apply a [***] to [***].  The
system will allow a user to [***] and the associated [***] through a
[***].  Through this [***], the user can
either [***] a [***] or [***] an [***]. 
If the user has a question as to which [***] a [***], they will be
presented with a [***] of [***] and the [***] that they reside in.  In addition, if the user has a question as to
which [***] the [***] within the [***] on their system, this [***] that for
them as well.


 


[***]:


 


After an Application has been selected the [***] and
[***] the [***] that are configured in the [***] for the [***].


 


[***]:


 


If the user selects the [***], a [***] be displayed
allowing the user to [***] the [***].


 


[***]:


 


If the user selects the [***], they will see a
summary of all the [***] that [***] the [***] and which [***] the [***].


 


[***]:


 


If the user selects a [***] that
is not the current [***] or is not
being [***] or [***] may be deleted from the system.


 


7                       Analysis
Modules


 


7.1         Nuclear Application
([***])


 


[***] contained within the [***[ will consist of all
[***] to measure [***] and [***] on a [***] a [***].  (E.g. [***], etc)


 


7.2         Membrane Application


 


[***] contained within the [***] will consist of all
[***] to present a [***] into previously [***] when analyzing a [***].  (e.g. [***])


 






[***] Certain information on this page has been redacted and filed
separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.


 


10

















 


7.3         Rare Event Application


 


[***] contained with the [***] will consist of all
[***] to identify a [***] based on a [***] of [***] and [***].  These [***] will perform their [***] in one
of three ways;


 


•                  A [***] of [***]
will be presented to the user with no [***]. 
(e.g. [***])


•                  A [***] of a [***] of [***] along
with a [***] will be presented for the user to [***].  (e.g.
[***])


•                  A [***] will
enable a user to select [***] a [***] to be included in the [***].  (e.g. [***])


 


7.4         Tissue Micro Array


 


The Tissue Micro Array application will be [***] as a
[***] designed to be [***] by the user. 
This [***], when [***], will contain the [***] of the [***] to be
[***].  This [***] will describe the
[***] and [***] of the [***] to be labeled by the [***].  This application contains no [***] of its
[***], and must be [***] with any other [***] to provide [***].


 


7.5         [***]


 


Applications contained with the [***] will consist of
all [***] to identify an [***] by the user as a [***] a [***].  Additionally, all applications under this
[***] will be [***] and [***] as [***] to the ACIS device.


 






[***] Certain information on this page has been redacted and filed
separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.


 


11

















 


EXHIBIT 4 – Prices, Payments and Forecast


 


ACIS II
Instruments and Software:


 


The following product
listings and prices reflect the ACIS II instruments and products being shipped
from Clarient to DakoCytomation during and the agreed prices to be paid by
DakoCytomation for the ACIS II instrument and software.  This list will need to be revised prior to
the release of the ACIS III instrument.


 


ACIS II Product Part Numbers and Prices


 


	
  Instrument
  Type

  	
   

  	
  Included Components

  	
   

  	
  Optional Components

  	
   

  	
  Transfer Price

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  77787000 – New –
  110v

  77788000 – New – 220v

  	
   

  	
  ACIS Microscope

  ACIS Computer Tower

  •    [***]

  •     [***]

  •     DVD +RW Drive

  •     Keyboard

  •     Optical Mouse

  	
   

  	
   

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  77785000 -
  Refurbished – 110v

  77786000 - Refurbished – 220v

  	
   

  	
  Microsoft EXCEL 2003
  software

  •     Microsoft
  EXCEL Add-In’s

  •     Microsoft EXCEL Software License

  	
   

  	
   

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  77783000 -
  Upgrade – 110v

  77784000 - Upgrade – 220v

  	
   

  	
  2 lamps

  1 Box Carriers (50)

  1 Roll Barcode Labels (1000)

  5 DVD’s

  ACIS System Software

  [***]
[***]
[***]

  Flat Panel

  Hand Barcode Reader

  UPS (110v or 220v)

  Calibration Carrier

  DAKOCytomation Labels

  Printer

  Installation

  1 year warranty

  	
   

  	
  

  Select Research Analysis Modules [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  77789000 –
  Workstation – 110v

  77790000 – Workstation – 220v

  	
   

  	
  ACIS Computer Tower

  Flat Panel

  UPS (110v or 220v)

  Printer

  ACIS System Software

  [***]
[***]
[***]

  DAKOCytomation Labels

  10 DVD’s

  EXCEL 2003

  •     EXCEL Add-In’s

  Installation

  1 year warranty

  	
   

  	
  Select Research
  Analysis Modules [***]

  	
   

  	
  $

  	
  [***]

  	
   

  



 






[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.


 

















 


Optional Component Part Numbers and Prices


 


	
  Optional
  Component

  	
   

  	
  Includes

  	
   

  	
  Transfer Price

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  68253001
  – Sony AIT Tape Drive

  	
   

  	
   

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Analysis
  Modules

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Service
  Options

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Additional
  Years of After Sale Support Services

  	
   

  	
   

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Image
  Analysis Fee

  	
   

  	
   

  	
   

  	
  $

  	
  [***]

  	
   

  



 


ACIS II Spare Parts


 


The following part
numbers and prices reflect the fact that CLARiENT will be providing all on site
instrument repair support until the launch of the ACIS III instrument and
software.  A comprehensive parts list (with
pricing) will be generated for the ACIS III instrument and software when the
information becomes available.


 


ACIS II Spare Part Numbers and Prices


 


	
  Item

  	
   

  	
  Transfer Price

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  64059001 – Lamps

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  68109001 - Slide
  Carriers-box of 50

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  68866002 - Two up
  Barcodes-roll 1000

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  68254000 - [***] Tape Cartridges

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  69935000 – Calibration
  Carrier

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  69771001 - Flat Panel
  Display

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  68057001 - Hand Held
  Barcode Scanner

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  69481000 – Printer

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  68253001 – [***] Tape
  Drive

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  68044000 - Full ACIS
  Uninterruptible Power Supply – 110v

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  68160001 - Full ACIS
  Uninterruptible Power Supply - 220v w/configuration kit

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  68044002 - Workstation
  Uninterruptible Power Supply – 110v

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  68044003 - Workstation
  Uninterruptible Power Supply – 220v

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  XXXXXXXX – [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  XXXXXXXX – [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  XXXXXXXX – [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  XXXXXXXX – [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  XXXXXXXX – [***]

  	
   

  	
  $

  	
  [***]

  	
   

  



 






[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.


 

















 


Development Project – development
of the ACIS III instrument and software


 


As stated in Article 29
of the Agreement, Clarient and DakoCytomation have entered into a research and
development project with the goal to develop the ACIS III instrument and
software. The Product and Technical Specifications for the ACIS III instrument
and software are set forth in Exhibit 14 and 15 to the Agreement.


 


Clarient will receive a
total payment from DakoCytomation for the research and development work of USD$1,500,000.00
(one million five hundred thousand).


 


DakoCytomation’s total
payments to Clarient for the research and development work is divided as
follows:


 


Clarient
will receive an up front fee for Research and Development work under this
Agreement of USD  [***].


 


Furthermore, Clarient will receive compensation for the research and
development work by the following installments upon completion of the
Acceptance Criteria and Milestones set forth in Exhibit 14 and 15 and
DakoCytomation’s written approval of such completion:


 


[***]


 


DakoCytomation’s
First Forecast:


 


The following forecast is
intended for the ACIS II OEM System for Project Phase 1


 


ACIS
IIInstrument Placements 2005 - 2006 (Units)


 


	
   

  	
   

  	
  2005

  	
   

  
	
  Product

  	
   

  	
  Q1

  	
   

  	
  Q2

  	
   

  	
  Q3

  	
   

  	
  Q4

  	
   

  
	
  Clarient
  ChromaVision ACIS II Instrument (Phase I)

  	
   

  	
  0

  	
   

  	
  0

  	
   

  	
  2

  	
   

  	
  13

  	
   

  
	
  Optional
  Research Software*

  	
   

  	
  0

  	
   

  	
  0

  	
   

  	
  1

  	
   

  	
  2

  	
   

  
	
  Total:

  	
   

  	
  0

  	
   

  	
  0

  	
   

  	
  3

  	
   

  	
  15

  	
   

  



 


	
   

  	
   

  	
  2006

  	
   

  
	
  Product

  	
   

  	
  Q1

  	
   

  	
  Q2

  	
   

  	
  Q3

  	
   

  	
  Q4

  	
   

  
	
  Clarient
  ChromaVision ACIS II Instrument (Phase I)

  	
   

  	
  10

  	
   

  	
  5

  	
   

  	
  0

  	
   

  	
  0

  	
   

  
	
  Optional
  Research Software*

  	
   

  	
  5

  	
   

  	
  2

  	
   

  	
  0

  	
   

  	
  0

  	
   

  
	
  Total:

  	
   

  	
  15

  	
   

  	
  7

  	
   

  	
  0

  	
   

  	
  0

  	
   

  



 






* Optional Research
Software comprises of the Optional Analysis Modules from the ACIS II Price list
above, i.e. analysis modules [***] and [***].


 


[***] Certain information on this
page has been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.


 

















 


EXHIBIT 6 – Transportation Procedures and Costs


 


The following procedure
and prices reflect the fact that CLARIENT will be drop shipping the instruments
directly to the DakoCytomation customer site during Phase 1. This procedure
will need to be revisited prior to the release of the Phase 2 instrument.


 


Procedure


 


1.               DakoCytomation
will provide CLARiENT with a 12 month rolling forecast for instruments, work
stations and software applications.


2.               DakoCytomation
will place Purchase in accordance with the provisions of the Agreement


3.               The
forecast will be placed in FourthShift at CLARiENT for MRP scheduling.


4.               CLARiENT
Manufacturing will purchase parts to forecast, build to the PO, and have finished
goods ready to ship.


5.               CLARiENT
will provide the DakoCytomation Quality Control Department with Certificate of
Conformance (C of C) upon finishing manufacturing and testing.


6.               DakoCytomation
will review the C of C and confirm all approved products via a signed faxed C
of C to Clarient.


7.               CLARiENT
will provide DakoCytomation Purchasing with all serial numbers and the C of Cs
as confirmation of accepted product is moved into finished goods.


8.               DakoCytomation
will send Sales Contract Order to CLARiENT accompanied by a completed copy of
the Site Survey and Customer Profile, and instrument serial number assigned to
that customer.


9.               CLARiENT
order entry will confirm DakoCytomation Sales Contract Order with a written acknowledgement.


10.         CLARiENT
Field Service will contact the DakoCytomation Account Manager and the customer
to arrange a mutually convenient installation date.


11.         CLARiENT
Field Service will contact DakoCytomation with a projected shipment and installation
date for the system.


12.         CLARiENT
Manufacturing will contact the carrier to arrange pickup and delivery of the instrument.
CLARiENT is to use DakoCytomation’s shipping supplier account number.


13.         DakoCytomation
will be billed directly by the shipper for the shipping costs.


14.         CLARiENT
Field Services Engineer will install software applications requested by customer
(as indicated on the DakoCytomation Sales Contract order) at the customer site.


 


 


NOTE:
A procedure needs to be worked out when the installation of the ACIS needs to
be co-ordinated with the installation of an Autostainer.


 


1

















 


EXHIBIT 7: List of Clarient
Patents and Patent Applications


 


	
  F &
  R Matter ID

  	
   

  	
  IP Cap Code

  	
   

  	
  Status

  	
   

  	
  Title

  	
   

  	
  Country

  	
   

  	
  Filing Date

  	
   

  	
  Serial No.

  	
   

  	
  Issue Date

  	
   

  	
  Patent No.

  	
   

  	
  Inventors

  	
   

  
	
  10225/003001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  AUTOMATED METHOD FOR IMAGE ANALYSIS OF RESIDUAL
  PROTEIN

  	
   

  	
  United States

  	
   

  	
  7/7/2000

  	
   

  	
  09/612,022

  	
   

  	
  12/11/2001

  	
   

  	
  6,330,349

  	
   

  	
  Presley Hays; Michal Peri; Douglas Harrington

  	
   

  
	
  10225/003002

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  AUTOMATED METHOD FOR IMAGE ANALYSIS OF RESIDUAL PROTEIN

  	
   

  	
  United States

  	
   

  	
  12/10/2001

  	
   

  	
  10/014,006

  	
   

  	
  12/30/2003

  	
   

  	
  6,671,393B2

  	
   

  	
  Presley Hays; Michal Peri; Douglas Harrington

  	
   

  
	
  10225/003003

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  AUTOMATED METHOD FOR IMAGE ANALYSIS OF RESIDUAL
  PROTEIN

  	
   

  	
  United States

  	
   

  	
  12/5/2003

  	
   

  	
  10/728,698

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Presley Hays; Michal Peri; Douglas Harrington

  	
   

  
	
  10225/004001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  HISTOLOGICAL RECONSTRUCTION AND AUTOMATED IMAGE
  ANALYSIS

  	
   

  	
  United States

  	
   

  	
  6/24/1999

  	
   

  	
  09/344,308

  	
   

  	
  7/9/2002

  	
   

  	
  6,418,236

  	
   

  	
  Bob Ellis; William Decker; Gina McLaren

  	
   

  
	
  10225/004002

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  HISTOLOGICAL RECONSTRUCTION AND AUTOMATED IMAGE
  ANALYSIS

  	
   

  	
  United States

  	
   

  	
  2/20/2002

  	
   

  	
  10/081,714

  	
   

  	
  10/7/2003

  	
   

  	
  6,631,203

  	
   

  	
  Bob Ellis; William Decker; Gina McLaren

  	
   

  
	
  10225/004003

  	
   

  	
   

  	
   

  	
  Allowed

  	
   

  	
  HISTOLOGICAL RECONSTRUCTION AND AUTOMATED IMAGE
  ANALYSIS

  	
   

  	
  United States

  	
   

  	
  10/2/2003

  	
   

  	
  10/679,122

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Bob Ellis; William Decker; Gina McLaren

  	
   

  
	
  10225/004EP1

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  HISTOLOGICAL RECONSTRUCTION AND AUTOMATED IMAGE
  ANALYSIS

  	
   

  	
  Europe

  	
   

  	
  4/10/2000

  	
   

  	
  925912.8

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Bob Ellis; William Decker; Gina McLaren

  	
   

  
	
  10225/004HK1

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  HISTOLOGICAL RECONSTRUCTION AND AUTOMATED IMAGE
  ANALYSIS

  	
   

  	
  Hong Kong

  	
   

  	
  4/10/2000

  	
   

  	
  3103433.6

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Bob Ellis; William Decker; Gina McLaren

  	
   

  
	
  10225/004JP1

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  HISTOLOGICAL RECONSTRUCTION AND AUTOMATED IMAGE
  ANALYSIS

  	
   

  	
  Japan

  	
   

  	
  4/10/2000

  	
   

  	
  2000-611240

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Bob Ellis; William Decker; Gina McLaren

  	
   

  
	
  10225/005001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  United States

  	
   

  	
  2/1/2000

  	
   

  	
  09/495,461

  	
   

  	
  4/6/2004

  	
   

  	
  6,718,053

  	
   

  	
  Bob Ellis; Gina McLaren; William Decker

  	
   

  
	
  10225/005002

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  United States

  	
   

  	
  12/24/2003

  	
   

  	
  10/746,515

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Bob Ellis; Gina McLaren; William Decker

  	
   

  
	
  10225/005EP1

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  Europe

  	
   

  	
  2/1/2001

  	
   

  	
  1906915.2

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Bob Ellis; Gina McLaren; William Decker

  	
   

  
	
  10225/006001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  AUTOMATED DETECTION OF OBJECTS IN A BIOLOGICAL SAMPLE

  	
   

  	
  United States

  	
   

  	
  7/12/2000

  	
   

  	
  09/616,817

  	
   

  	
  4/8/2003

  	
   

  	
  6,546,123

  	
   

  	
  Gina McLaren; Bob Ellis

  	
   

  
	
  10225/006002

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  AUTOMATED DETECTION OF OBJECTS IN A BIOLOGICAL SAMPLE

  	
   

  	
  United States

  	
   

  	
  2/3/2003

  	
   

  	
  10/358,114

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Gina McLaren; Bob Ellis

  	
   

  
	
  10225/006EP1

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  AUTOMATED DETECTION OF OBJECTS IN A BIOLOGICAL SAMPLE

  	
   

  	
  Europe

  	
   

  	
  7/12/2000

  	
   

  	
  947299.4

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Gina McLaren; Bob Ellis

  	
   

  
	
  10225/006JP1

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  AUTOMATED DETECTION OF OBJECTS IN A BIOLOGICAL SAMPLE

  	
   

  	
  Japan

  	
   

  	
  7/12/2000

  	
   

  	
  not yet assigned

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Gina McLaren; Bob Ellis

  	
   

  
	
  10225/010001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  DEVICE FOR APPLYING ACCURATE COLOR THRESHOLDS IN REAL
  TIME

  	
   

  	
  United States

  	
   

  	
  7/13/2000

  	
   

  	
  09/615,262

  	
   

  	
  1/6/2004

  	
   

  	
  6,674,896

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/011001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  APPARATUS FOR COUNTING COLOR TRANSITIONS AND AREAS IN
  REAL TIME CAMERA IMAGES

  	
   

  	
  United States

  	
   

  	
  7/13/2000

  	
   

  	
  09/615,263

  	
   

  	
  9/3/2002

  	
   

  	
  6,445,817

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/013001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  A METHOD OF APPLYING COLOR THRESHOLDS IN LIGHT
  MICROSCOPY

  	
   

  	
  United States

  	
   

  	
  8/4/2000

  	
   

  	
  09/631,611

  	
   

  	
  6/11/2002

  	
   

  	
  6,404,916

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/013JP1

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  A METHOD OF APPLYING COLOR THRESHOLDS IN LIGHT
  MICROSCOPY

  	
   

  	
  Japan

  	
   

  	
  8/4/2000

  	
   

  	
  2001-516126

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/014001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  SYSTEM AND METHOD FOR CELLULAR SPECIMEN GRADING

  	
   

  	
  United States

  	
   

  	
  3/28/1997

  	
   

  	
  08/827,268

  	
   

  	
  11/21/2000

  	
   

  	
  6,151,405

  	
   

  	
  James Douglass; Thomas Riding; William Decker

  	
   

  
	
  10225/014DE1

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  SYSTEM AND METHOD FOR CELLULAR SPECIMEN GRADING

  	
   

  	
  Germany

  	
   

  	
  3/26/1998

  	
   

  	
  98913124.8

  	
   

  	
  5/28/2003

  	
   

  	
  970,364

  	
   

  	
  James Douglass; Thomas Riding; William Decker

  	
   

  
	
  10225/014EP1

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  SYSTEM AND METHOD FOR CELLULAR SPECIMEN GRADING

  	
   

  	
  Europe

  	
   

  	
  3/26/1998

  	
   

  	
  98913124.8

  	
   

  	
  5/28/2003

  	
   

  	
  970364

  	
   

  	
  James Douglass; Thomas Riding; William Decker

  	
   

  
	
  10225/014GB1

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  SYSTEM AND METHOD FOR CELLULAR SPECIMEN GRADING

  	
   

  	
  United Kingdom

  	
   

  	
  3/26/1998

  	
   

  	
  98913124.8

  	
   

  	
  5/28/2003

  	
   

  	
  970,364

  	
   

  	
  James Douglass; Thomas Riding; William Decker

  	
   

  
	
  10225/014JP1

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  SYSTEM AND METHOD FOR CELLULAR SPECIMEN GRADING

  	
   

  	
  Japan

  	
   

  	
  3/26/1998

  	
   

  	
  10-541786

  	
   

  	
  10/3/2003

  	
   

  	
  3479309

  	
   

  	
  James Douglass; Thomas Riding; William Decker

  	
   

  
	
  10225/015001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  United States

  	
   

  	
  11/27/1996

  	
   

  	
  08/758,436

  	
   

  	
  4/10/2001

  	
   

  	
  6,215,892

  	
   

  	
  James Douglass; Thomas Riding; James Ring

  	
   

  
	
  10225/015002

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  United States

  	
   

  	
  2/14/2000

  	
   

  	
  09/492,101

  	
   

  	
  4/22/2003

  	
   

  	
  6,553,135

  	
   

  	
  James Douglass; Thomas Riding; James Ring

  	
   

  
	
  10225/015003

  	
   

  	
   

  	
   

  	
  Allowed

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  United States

  	
   

  	
  3/31/2003

  	
   

  	
  10/404,921

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  James Douglass; Thomas Riding; James Ring

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  [***]

  	
   

  
	
  10225/015AU1

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  Australia

  	
   

  	
  11/27/1996

  	
   

  	
  724393

  	
   

  	
  11/21/2000

  	
   

  	
  724,393

  	
   

  	
  James Douglass; Thomas Riding; James Ring

  	
   

  
	
  10225/015BE1

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  Belgium

  	
   

  	
  11/27/1996

  	
   

  	
  96940930.9

  	
   

  	
  4/2/2003

  	
   

  	
  864,082

  	
   

  	
  James Douglass; Thomas Riding; James Ring

  	
   

  
	
  10225/015DE1

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  Germany

  	
   

  	
  11/27/1996

  	
   

  	
  96940930.9

  	
   

  	
  4/2/2003

  	
   

  	
  864,082

  	
   

  	
  James Douglass; Thomas Riding; James Ring

  	
   

  
	
  10225/015EP1

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  Europe

  	
   

  	
  11/27/1996

  	
   

  	
  96940930.9

  	
   

  	
  4/2/2003

  	
   

  	
  864082

  	
   

  	
  James Douglass; Thomas Riding; James Ring

  	
   

  
	
  10225/015EP2

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  Europe

  	
   

  	
  11/27/1996

  	
   

  	
  2028849.4

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  James Douglass; Thomas Riding; James Ring

  	
   

  
	
  10225/015FR1

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF
  BIOLOGICAL SPECIMENS

  	
   

  	
  France

  	
   

  	
  11/27/1996

  	
   

  	
  2028849.4

  	
   

  	
  4/2/2003

  	
   

  	
  864,082

  	
   

  	
  James Douglass; Thomas Riding; James Ring

  	
   

  
	
  10225/015GB1

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  METHOD AND APPARATUS FOR AUTOMATED IMAGE ANALYSIS OF BIOLOGICAL
  SPECIMENS

  	
   

  	
  United Kingdom

  	
   

  	
  11/27/1996

  	
   

  	
  96940930.9

  	
   

  	
  4/2/2003

  	
   

  	
  864,082

  	
   

  	
  James Douglass; Thomas Riding; James Ring

  	
   

  
	
  10225/022001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  REVERSE FOCUSING METHODS AND SYSTEMS

  	
   

  	
  United States

  	
   

  	
  5/24/2000

  	
   

  	
  09/578,350

  	
   

  	
  2/11/2003

  	
   

  	
  6,518,554

  	
   

  	
  Hai Zhang

  	
   

  
	
  10225/022002

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  REVERSE FOCUSING METHODS AND SYSTEMS

  	
   

  	
  United States

  	
   

  	
  1/27/2003

  	
   

  	
  10/353,773

  	
   

  	
  5/31/2005

  	
   

  	
  6,900,426

  	
   

  	
  Hai Zhang

  	
   

  
	
  10225/023001

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  REMOTE INTERPRETATION OF MEDICAL IMAGES

  	
   

  	
  United States

  	
   

  	
  4/3/2000

  	
   

  	
  09/542,091

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/023EP1

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  REMOTE INTERPRETATION OF MEDICAL IMAGES

  	
   

  	
  Europe

  	
   

  	
  4/3/2001

  	
   

  	
  1923108.3

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/023JP1

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  REMOTE INTERPRETATION OF MEDICAL IMAGES

  	
   

  	
  Japan

  	
   

  	
  4/3/2001

  	
   

  	
  2001-57339

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/024001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  METHOD AND APPARATUS FOR SCORING THE UPTAKE OF
  MARKERS IN CELLS

  	
   

  	
  United States

  	
   

  	
  10/4/2001

  	
   

  	
  09/972,067

  	
   

  	
  2/24/2004

  	
   

  	
  6,697,509

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/024WO1

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  METHOD AND APPARATUS FOR SCORING THE UPTAKE OF
  MARKERS IN CELLS

  	
   

  	
  WIPO

  	
   

  	
  10/4/2002

  	
   

  	
  US02/31960

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/027001

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  APPARATUS AND METHOD FOR LABELING ROWS AND COLUMNS IN
  AN IRREGULAR ARRAY

  	
   

  	
  United States

  	
   

  	
  3/8/2002

  	
   

  	
  10/094,900

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Jose de la Torre-Bueno; Peter Salamon

  	
   

  
	
  10225/028001

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  SYSTEM FOR TRACKING SAMPLES SLIDES AND IMAGES IN
  ANATOMIC PATHOLOGY

  	
   

  	
  United States

  	
   

  	
  11/13/2002

  	
   

  	
  10/294,996

  	
   

  	
  —

  	
   

  	
  —

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/029001

  	
   

  	
   

  	
   

  	
  Issued

  	
   

  	
  Automated Slide Staining Apparatus

  	
   

  	
  United States

  	
   

  	
  6/12/2003

  	
   

  	
  10/461,733

  	
   

  	
  10/5/2004

  	
   

  	
  6,800,249

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
  10225/029W01

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  Automated Slide Staining Apparatus

  	
   

  	
  WIPO

  	
   

  	
  6/12/2003

  	
   

  	
  US03/18783

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/030001

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  An Automated system for combining bright field and
  fluorescent microscopy

  	
   

  	
  United States

  	
   

  	
  6/12/2003

  	
   

  	
  10/461,786

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/038001

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  AUTOMATED MEASUREMENT OF CONCENTRATION AND/OR AMOUNT
  IN A BIOLOGICAL SAMPLE

  	
   

  	
  United States

  	
   

  	
  4/10/2003

  	
   

  	
  10/822,561

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jose de la Torre-Bueno

  	
   

  
	
  10225/040001

  	
   

  	
  CV105

  	
   

  	
  Pending

  	
   

  	
  SILHOUETTE IMAGE ACQUISITION

  	
   

  	
  United States

  	
   

  	
  4/11/2003

  	
   

  	
  10/413,493

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Cynthia Perez; Jose de la Torre-Bueno; Robert Ellis;
  Gina McLaren; Mary Jean Smith

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
  10225/042001

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  METHOD FOR DETECTING RARE EVENT

  	
   

  	
  United States

  	
   

  	
  7/11/2003

  	
   

  	
  10/618,577

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Blaise Bossy, Robert Ellis, Kenneth Bauer

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  Pending

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  Pending

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
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  Pending

  	
   

  	
  [***]

  	
   

  	
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  [***]

  	
   

  
	
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  Pending

  	
   

  	
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  [***]

  	
   

  
	
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  Pending

  	
   

  	
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[***] Certain information
on this page has been redacted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested to the
omitted portions.













 


EXHIBIT 8
– Licensed DakoCytomation Trademarks


 


	
  Exhibit 8.1:

  	
  United States
  Trademark/Service Mark Application, Principal Register – “DAKOCYTOMATION”
  word mark, Serial number 78458911, filing date 29 July 2004

  
	
   

  	
   

  
	
  Exhibit 8.2: 

  	
  United States
  Trademark/Service Mark Application, Principal Register – Drop logo elliptic
  figurative mark, serial number 78459068, filing date 29 July 2004 

  
	
   

  	
   

  
	
  Exhibit 8.3

  	
  Danish trademark
  registration number VR 2002 02468 - the elliptic drop logo figurative mark

  



 


 





















 


Trademark/Service
Mark Application, Principal Register


 


Serial
Number: 78458911


Filing
Date: 07/29/2004


 


The
table below presents the data as entered.


 


	
  Input
  field

  	
   

  	
  Entered

  
	
   

  	
   

  	
   

  
	
  MARK SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  MARK

  	
   

  	
  DAKOCYTOMATION

  
	
   

  	
   

  	
   

  
	
  STANDARD CHARACTERS

  	
   

  	
  YES

  
	
   

  	
   

  	
   

  
	
  USPTO-GENERATED IMAGE

  	
   

  	
  YES

  
	
   

  	
   

  	
   

  
	
  LITERAL ELEMENT

  	
   

  	
  DAKOCYTOMATION

  
	
   

  	
   

  	
   

  
	
  MARK STATEMENT

  	
   

  	
  The mark consists of
  standard characters, without claim to any particular font, style, size, or
  color.

  
	
   

  	
   

  	
   

  
	
  OWNER SECTION 

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  NAME

  	
   

  	
  DakoCytomation Denmark
  A/S

  
	
   

  	
   

  	
   

  
	
  STREET

  	
   

  	
  Produktionsvej 42

  
	
   

  	
   

  	
   

  
	
  CITY

  	
   

  	
  Glostrup

  
	
   

  	
   

  	
   

  
	
  ZIP/POSTAL CODE

  	
   

  	
  DK-2600

  
	
   

  	
   

  	
   

  
	
  COUNTRY

  	
   

  	
  Denmark

  
	
   

  	
   

  	
   

  
	
  AUTHORIZED EMAIL
  COMMUNICATION

  	
   

  	
  No

  
	
   

  	
   

  	
   

  
	
  LEGAL ENTITY SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  TYPE

  	
   

  	
  CORPORATION

  
	
   

  	
   

  	
   

  
	
  STATE/COUNTRY OF
  INCORPORATION

  	
   

  	
  Denmark

  
	
   

  	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
   

  	
  001

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
  Chemicals used in
  industry and science, including, chemical reagents and diagnostic
  preparations for use in research laboratories and for use in industry.

  
	
   

  	
   

  	
   

  
	
  FILING BASIS

  	
   

  	
  Section l(a)

  
	
   

  	
   

  	
   

  
	
  FIRST
  USE ANYWHERE DATE

  	
   

  	
  07/01/2002

  
	
   

  	
   

  	
   

  
	
  FIRST
  USE IN COMMERCE DATE

  	
   

  	
  07/01/2002

  



 





















 


	
  GOODS AND/OR SERVICES SECTION

  	
   

  
	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
  005

  
	
   

  	
   

  
	
  DESCRIPTION

  	
  Pharmaceutical and
  veterinary preparations, chemicals reagents and diagnostic preparations for
  medical and veterinary purposes.

  
	
   

  	
   

  
	
  FILlNG BASIS

  	
  Section 1(a)

  
	
   

  	
   

  
	
  FIRST
  USE ANYWHERE DATE

  	
  07/01/2002

  
	
   

  	
   

  
	
  FIRST
  USE IN COMMERCE DATE

  	
  07/01/2002

  
	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION

  	
   

  
	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
  009

  
	
   

  	
   

  
	
  DESCRIPTION

  	
  Diagnostic apparatus
  and instruments, not for medical purposes, including apparatus for staining
  and/or visualization of samples, analysis and measuring apparatus, software
  for diagnostic apparatus.

  
	
   

  	
   

  
	
  FILING BASIS

  	
  Section l(a)

  
	
   

  	
   

  
	
  FIRST
  USE ANYWHERE DATE

  	
  07/01/2002

  
	
   

  	
   

  
	
  FIRST
  USE IN COMMERCE DATE

  	
  07/01/2002

  
	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION

  	
   

  
	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
  010

  
	
   

  	
   

  
	
  DESCRIPTION

  	
  Diagnostic apparatus
  and instruments for medical purposes, including, apparatus for staining
  and/or visualization of samples, analysis and measuring apparatus.

  
	
   

  	
   

  
	
  FILING BASIS

  	
  Section l(a)

  
	
   

  	
   

  
	
  FIRST
  USE ANYWHERE DATE

  	
  07/01/2002

  
	
   

  	
   

  
	
  FIRST
  USE IN COMMERCE DATE

  	
  07/01/2002

  
	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION

  	
   

  
	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
  044

  
	
   

  	
   

  
	
  DESCRIPTION

  	
  Services relating to
  the medical, the health care and the veterinary sector, including medical
  analysis and diagnosis.

  
	
   

  	
   

  
	
  FILING BASIS

  	
  Section l(a)

  
	
   

  	
   

  
	
  FIRST
  USE ANYWHERE DATE

  	
  07/01/2002

  
	
   

  	
   

  
	
  FIRST
  USE IN COMMERCE DATE

  	
  07/01/2002

  
	
   

  	
   

  
	
  ADDITIONAL STATEMENTS SECTION

  	
   

  
	
   

  	
   

  
	
  PRIOR REGISTRATION(S)

  	
  Applicant claims
  ownership of U.S. Registration Number(s) 1220474, 2006857, 2859431, and
  others.

  
	
   

  	
   

  
	
  SIGNATURE SECTION

  	
   

  
	
   

  	
   

  
	
  SIGNATURE

  	
  /jas/

  
	
   

  	
   

  
	
  SIGNATORY NAME

  	
  Jeffrey A. Smith

  
	
   

  	
   

  
	
  SIGNATORY DATE

  	
  07/29/2004

  



 





















 


	
  SIGNATORY POSITION

  	
  Applicant’s Attorney

  
	
   

  	
   

  
	
  PAYMENT SECTION

  	
   

  
	
   

  	
   

  
	
  NUMBER OF CLASSES

  	
  5

  
	
   

  	
   

  
	
  NUMBER OF CLASSES PAID

  	
  5

  
	
   

  	
   

  
	
  SUBTOTAL AMOUNT

  	
  1675

  
	
   

  	
   

  
	
  TOTAL AMOUNT

  	
  1675

  
	
   

  	
   

  
	
  ATTORNEY

  	
   

  
	
   

  	
   

  
	
  NAME

  	
  Jeffrey A. Smith

  
	
   

  	
   

  
	
  FIRM NAME

  	
  Millen, White, Zelano &
  Branigan, P.C.

  
	
   

  	
   

  
	
  INTERNAL ADDRESS

  	
  Suite 1400

  
	
   

  	
   

  
	
  STREET

  	
  2200 Clarendon
  Boulevard

  
	
   

  	
   

  
	
  CITY

  	
  Arlington

  
	
   

  	
   

  
	
  STATE

  	
  VA

  
	
   

  	
   

  
	
  ZIP/POSTAL CODE

  	
  22201

  
	
   

  	
   

  
	
  COUNTRY

  	
  United States

  
	
   

  	
   

  
	
  PHONE

  	
  (703) 465-5355

  
	
   

  	
   

  
	
  FAX

  	
  (703) 243-6410

  
	
   

  	
   

  
	
  AUTHORIZED EMAIL
  COMMUNICATION

  	
  No

  
	
   

  	
   

  
	
  ATTORNEY DOCKET NUMBER

  	
  DAKO-0062-T

  
	
   

  	
   

  
	
  OTHER APPOINTED
  ATTORNEY(S)

  	
  Scott J. Major; Jeffrey
  R. Cohen

  
	
   

  	
   

  
	
  DOMESTIC REPRESENTATIVE SECTION

  	
   

  
	
   

  	
   

  
	
  NAME

  	
  Jeffrey A. Smith

  
	
   

  	
   

  
	
  FIRM NAME

  	
  Millen, White, Zelano &
  Branigan, P.C.

  
	
   

  	
   

  
	
  INTERNAL ADDRESS

  	
  Suite 1400

  
	
   

  	
   

  
	
  STREET

  	
  2200 Clarendon
  Boulevard

  
	
   

  	
   

  
	
  CITY

  	
  Arlington

  
	
   

  	
   

  
	
  STATE

  	
  VA

  
	
   

  	
   

  
	
  ZIP/POSTAL CODE

  	
  22201

  
	
   

  	
   

  
	
  COUNTRY

  	
  USA

  
	
   

  	
   

  
	
  PHONE

  	
  (703) 465-5355

  
	
   

  	
   

  
	
  FAX

  	
  (703) 243-6410

  
	
   

  	
   

  
	
  AUTHORIZED EMAIL
  COMMUNICATION

  	
  No 

  



 





















 


	
  CORRESPONDENCE SECTION

  	
   

  
	
   

  	
   

  
	
  NAME

  	
  Jeffrey A. Smith

  
	
   

  	
   

  
	
  FIRM NAME

  	
  Millen, White, Zelano &
  Branigan, P.C.

  
	
   

  	
   

  
	
  INTERNAL ADDRESS

  	
  Suite 1400

  
	
   

  	
   

  
	
  STREET

  	
  2200 Clarendon
  Boulevard

  
	
   

  	
   

  
	
  CITY

  	
  Arlington

  
	
   

  	
   

  
	
  STATE

  	
  VA

  
	
   

  	
   

  
	
  ZIP/POSTAL CODE

  	
  22201

  
	
   

  	
   

  
	
  COUNTRY

  	
  USA

  
	
   

  	
   

  
	
  PHONE

  	
  (703) 465-5355

  
	
   

  	
   

  
	
  FAX

  	
  (703) 243-6410

  
	
   

  	
   

  
	
  AUTHORIZED EMAIL
  COMMUNICATION

  	
  No

  
	
   

  	
   

  
	
  FILING INFORMATION

  	
   

  
	
   

  	
   

  
	
  SUBMIT DATE

  	
  Thu Jul 29 15:30:39 EDT
  2004

  
	
   

  	
   

  
	
  TEAS STAMP

  	
  USPTO/BAS-20913520066-200

  40729153039628386-7845891

  1 -20086caa3c530f72a92f3b6

  3ef755bd5-DA-98-200407291

  52601995476

  



 


 


Trademark/Service
Mark Application, Principal Register


 


Serial
Number: 78458911


Filing
Date: 07/29/2004


 


To
the Commissioner for Trademarks:


 


MARK:
(Standard Characters, see mark)


 


The mark consists of
standard characters, without claim to any particular font, style, size, or
color.


 


The literal element of
the mark consists of DAKOCYTOMATION.


 


The applicant,
DakoCytomation Denmark A/S, a corporation of Denmark, residing at
Produktionsvej 42, Glostrup, Denmark, DK-2600, requests registration of the
trademark/service mark identified above in the United States Patent and
Trademark Office on the Principal Register established by the Act of July 5,
1946 (15 U.S.C. Section 1051 et seq.), as amended.


 


The applicant, or the
applicant’s related company or licensee, is using the mark in commerce, and
lists below the dates of use by the applicant, or the applicant’s related
company, licensee, or predecessor in interest, of the mark on or in connection
with the identified goods and/or services. 15 U.S.C. Section 1051 (a), as
amended.


International Class 001:
Chemicals used in industry and science, including, chemical reagents and
diagnostic preparations for use in research laboratories and for use in
industry.


 





















 


 


International
Class 005: Pharmaceutical and veterinary preparations, chemicals reagents
and diagnostic preparations for medical and veterinary purposes.


 


International
Class 009: Diagnostic apparatus and instruments, not for medical purposes,
including apparatus for staining and/or visualization of samples, analysis and
measuring apparatus, software for diagnostic apparatus.


 


International
Class 010: Diagnostic apparatus and instruments for medical purposes,
including, apparatus for staining and/or visualization of samples, analysis and
measuring apparatus.


 


International
Class 044: Services relating to the medical, the health care and the
veterinary sector, including medical analysis and diagnosis.


 


In International Class 001,
the mark was first used at least as early as 07/01/2002, and first used in
commerce at least as early as 07/01/2002, and is now in use in such commerce.
The applicant is submitting or will submit one specimen for each class showing the mark as used in
commerce on or in connection with any item in the class of listed goods and/or
services.


 


In International Class 005,
the mark was first used at least as early as 07/01/2002, and first used in
commerce at least as early as 07/01/2002, and is now in use in such commerce.
The applicant is submitting or will submit one specimen for each class showing the mark as used in
commerce on or in connection with any item in the class of listed goods and/or
services.


 


In International Class 009,
the mark was first used at least as early as 07/01/2002, and first used in
commerce at least as early as 07/01/2002, and is now in use in such commerce.
The applicant is submitting or will submit one specimen for each class showing the mark as used in
commerce on or in connection with any item in the class of listed goods and/or
services.


 


In International Class 010,
the mark was first used at least as early as 07/01/2002, and first used in
commerce at least as early as 07/01/2002, and is now in use in such commerce.
The applicant is submitting or will submit one specimen for each class showing the mark as used in
commerce on or in connection with any item in the class of listed goods and/or
services.


 


In International Class 044,
the mark was first used at least as early as 07/01/2002, and first used in
commerce at least as early as 07/01/2002, and is now in use in such commerce,
The applicant is submitting or will submit one specimen for each class showing the mark as used in
commerce on or in connection with any item in the class of listed goods and/or
services.


 


Applicant claims
ownership of U.S. Registration Number(s) 1220474, 2006857, 2859431, and others.


 


The applicant hereby
appoints Jeffrey A. Smith and Scott J. Major; Jeffrey R. Cohen of Millen,
White, Zelano & Branigan, P.C., Suite 1400, 2200 Clarendon
Boulevard, Arlington, VA, United States, 22201 to submit this application on
behalf of the applicant. The attorney docket/reference number is DAKO-0062-T.


 


The applicant hereby
appoints Jeffrey A. Smith of Millen, White, Zelano & Branigan, P.C., Suite 1400,
2200 Clarendon Boulevard, Arlington, VA, USA 22201 as applicant’s
representative upon whom notice or process in the proceedings affecting the
mark may be served, A fee payment in the amount of $1675 will be submitted with
the application, representing payment for 5 class(es).


 


Declaration


 


The undersigned, being
hereby warned that willful false statements and the like so made are punishable
by fine or imprisonment, or both, under 18 U.S.C. Section 1001, and that
such willful false statements, and the like, may jeopardize the validity of the
application or any resulting registration, declares that he/she is properly
authorized to execute this application on behalf of the applicant; he/she
believes the applicant to be the owner of the trademark/service mark sought to
be registered, or, if the application is being filed under 15 U.S.C. Section 1051
(b), he/she believes applicant to be entitled to use such mark in commerce; to
the best of his/her knowledge and belief no other person, firm, corporation, or
association has the right to use the mark in commerce, either in the identical
form thereof or in such near resemblance thereto as to be likely, when used on
or in connection with the goods/services of such other person, to cause
confusion, or to cause mistake, or to deceive; and that all statements made of
his/her own knowledge are true; and that all statements made on information and
belief are believed to be true.


 


Signature: /jas/  Date: 07/29/2004


Signatory’s Name: Jeffrey
A. Smith


Signatory’s Position:
Applicant’s Attorney


Mailing Address:


Jeffrey A. Smith


Suite 1400


2200 Clarendon Boulevard


Arlington, VA 22201


 





















 


RAM Sale Number: 98


RAM Accounting Date:
07/30/2004


Serial Number: 78458911


Internet Transmission
Date: Thu Jul 29 15:30:39 EDT 2004


TEAS Stamp:
USPTO/BAS-20913520066-200407291530396283


86-7845891
l-20086caa3c530f72a92f3b3ef75


5bd5-DA-98-20040729152601995476


 





















 


DAKOCYTOMATION


 





















 


Exhibit 8.2


 


Trademark/Service
Mark Application, Principal Register


 


Serial
Number : 78459068


Filing
Date: 07/29/2004


 


The table
below presents the data as entered.


 


	
  Input
  Field

  	
   

  	
  Entered

  
	
   

  	
   

  	
   

  
	
  MARK SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  MARK FILE NAME

  	
   

  	
  \\tiers\EXPORT10\IMAGEOUT
  10\784\590\78459068\xmll\AP0002.JPG

  
	
   

  	
   

  	
   

  
	
  STANDARD CHARACTERS

  	
   

  	
  NO

  
	
   

  	
   

  	
   

  
	
  USP10-GENERATED IMAGE

  	
   

  	
  NO

  
	
   

  	
   

  	
   

  
	
  COLOR MARK

  	
   

  	
  NO

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION OF THE MARK

  	
   

  	
  The mark consists of a
  small upside down droplet inside of a larger right side up droplet; all
  enclosed in a shaded oval.

  
	
   

  	
   

  	
   

  
	
  PIXEL COUNT ACCEPTABLE

  	
   

  	
  YES

  
	
   

  	
   

  	
   

  
	
  PIXEL COUNT

  	
   

  	
  513 x 440

  
	
   

  	
   

  	
   

  
	
  OWNER SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  NAME

  	
   

  	
  DakoCytomation Denmark
  A/S

  
	
   

  	
   

  	
   

  
	
  STREET

  	
   

  	
  Produktionsvej 42

  
	
   

  	
   

  	
   

  
	
  CITY

  	
   

  	
  Glostrup

  
	
   

  	
   

  	
   

  
	
  ZIP/POSTAL CODE

  	
   

  	
  DK-2600

  
	
   

  	
   

  	
   

  
	
  COUNTRY

  	
   

  	
  Denmark

  
	
   

  	
   

  	
   

  
	
  AUTHORIZED EMAIL
  COMMUNICATION

  	
   

  	
  No

  
	
   

  	
   

  	
   

  
	
  LEGAL ENTITY SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  TYPE

  	
   

  	
  CORPORATION

  
	
   

  	
   

  	
   

  
	
  STATE/COUNTRY OF
  INCORPORATION

  	
   

  	
  Denmark

  
	
   

  	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
   

  	
  001

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
  Chemicals used in
  industry and science, including, chemical reagents and diagnostic
  preparations for use in research laboratories and for use in industry.

  
	
   

  	
   

  	
   

  
	
  FILING BASIS

  	
   

  	
  Section 1(a)

  
	
   

  	
   

  	
   

  
	
  FIRST
  USE ANYWHERE DATE

  	
   

  	
  07/01/2002

  



 





















 


	
  FIRST
  USE IN COMMERCE DATE

  	
   

  	
  07/01/2002

  
	
   

  	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION 

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
   

  	
  001

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
  Chemicals used in
  industry and science, including, chemical reagents and diagnostic
  preparations for use in research laboratories and for use in industry.

  
	
   

  	
   

  	
   

  
	
  FILING BASIS

  	
   

  	
  Section 44(e)

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION NUMBER

  	
   

  	
  VR 2002 02468

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION COUNTRY NAME

  	
   

  	
  Denmark

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION DATE

  	
   

  	
  07/08/2002

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  EXPIRATION DATE

  	
   

  	
  07/08/2012

  
	
   

  	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
   

  	
  005

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
  Pharmaceutical and
  veterinary preparations, chemicals reagents and diagnostic preparations for
  medical and veterinary purposes.

  
	
   

  	
   

  	
   

  
	
  FILING BASIS

  	
   

  	
  Section 1(a)

  
	
   

  	
   

  	
   

  
	
  FIRST
  USE ANYWHERE DATE

  	
   

  	
  07/01/2002

  
	
   

  	
   

  	
   

  
	
  FIRST
  USE IN COMMERCE DATE

  	
   

  	
  07/01/2002

  
	
   

  	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
   

  	
  005

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
  Pharmaceutical and
  veterinary preparations, chemicals reagents and diagnostic preparations for
  medical and veterinary purposes.

  
	
   

  	
   

  	
   

  
	
  FILING BASIS

  	
   

  	
  Section 44(e)

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION NUMBER

  	
   

  	
  VR 2002 02468

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION COUNTRY NAME

  	
   

  	
  Denmark

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION DATE

  	
   

  	
  07/08/2002

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  EXPIRATION DATE

  	
   

  	
  07/08/2112

  
	
   

  	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
   

  	
  009

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
  Diagnostic apparatus
  and instruments, not for medical purposes, including apparatus for staining
  and/or visualization of samples, analysis and measuring apparatus, software
  for diagnostic apparatus.

  
	
   

  	
   

  	
   

  
	
  FILING BASIS

  	
   

  	
  Section 1(a)

  
	
   

  	
   

  	
   

  
	
  FIRST
  USE ANYWHERE DATE

  	
   

  	
  07/01/2002

  
	
   

  	
   

  	
   

  
	
  FIRST
  USE IN COMMERCE DATE

  	
   

  	
  07/01/2002

  



 





















 


	
  GOODS AND/OR SERVICES SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
   

  	
  009

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
  Diagnostic apparatus
  and instruments, not for medical purposes, including apparatus for staining
  and/or visualization of samples, analysis and measuring apparatus, software
  for diagnostic apparatus.

  
	
   

  	
   

  	
   

  
	
  FILING BASIS

  	
   

  	
  Section 44(e)

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION NUMBER

  	
   

  	
  VR 2002 02468

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION COUNTRY NAME

  	
   

  	
  Denmark

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION DATE

  	
   

  	
  07/08/2002

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  EXPIRATION DATE

  	
   

  	
  07/08/2012

  
	
   

  	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
   

  	
  010

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
  Diagnostic apparatus
  and instruments for medical purposes, including apparatus for staining and/or
  visualization of samples, analysis and measuring apparatus.

  
	
   

  	
   

  	
   

  
	
  FILING BASIS

  	
   

  	
  Section 1(a)

  
	
   

  	
   

  	
   

  
	
  FIRST
  USE ANYWHERE DATE

  	
   

  	
  07/01/2002

  
	
   

  	
   

  	
   

  
	
  FIRST
  USE IN COMMERCE DATE

  	
   

  	
  07/01/2002

  
	
   

  	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
   

  	
  010

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
  Diagnostic apparatus
  and instruments, not for medical purposes, including apparatus for staining
  and/or visualization of samples, analysis and measuring apparatus.

  
	
   

  	
   

  	
   

  
	
  FILING BASIS

  	
   

  	
  Section 44(e)

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION NUMBER

  	
   

  	
  VR 2002 02468

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION COUNTRY NAME

  	
   

  	
  Denmark

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION DATE

  	
   

  	
  07/08/2002

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  EXPIRATION DATE

  	
   

  	
  07/08/2012

  
	
   

  	
   

  	
   

  
	
  GOODS AND/OR SERVICES SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
   

  	
  044

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
  Services relating to
  the medical, the health care and the veterinary sector, including medical
  analysis and diagnosis.

  
	
   

  	
   

  	
   

  
	
  FILING BASIS

  	
   

  	
  Section 1(a)

  
	
   

  	
   

  	
   

  
	
  FIRST
  USE ANYWHERE DATE

  	
   

  	
  07/08/2002

  
	
   

  	
   

  	
   

  
	
  FIRST
  USE IN COMMERCE DATE

  	
   

  	
  07/08/2002

  



 





















 


	
  GOODS AND/OR SERVICES SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  INTERNATIONAL CLASS

  	
   

  	
  044

  
	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
  Services relating to
  the medical, the health care and the veterinary sector, including medical
  analysis and diagnosis.

  
	
   

  	
   

  	
   

  
	
  FILING BASIS

  	
   

  	
  Section 44(e)

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION NUMBER

  	
   

  	
  VR 2002 02468

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION COUNTRY NAME

  	
   

  	
  Denmark

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  REGISTRATION DATE

  	
   

  	
  07/08/2002

  
	
   

  	
   

  	
   

  
	
  FOREIGN
  EXPIRATION DATE

  	
   

  	
  07/08/2012

  
	
   

  	
   

  	
   

  
	
  ADDITIONAL STATEMENTS SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  PRIOR REGISTRATION(S)

  	
   

  	
  Applicant claims
  ownership of U.S. Registration Number(s) 1759331.

  
	
   

  	
   

  	
   

  
	
  SIGNATURE SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  SIGNATURE

  	
   

  	
  /jas/

  
	
   

  	
   

  	
   

  
	
  SIGNATORY NAME

  	
   

  	
  Jeffrey A. Smith

  
	
   

  	
   

  	
   

  
	
  SIGNATORY DATE

  	
   

  	
  07/29/2004

  
	
   

  	
   

  	
   

  
	
  SIGNATORY POSITION

  	
   

  	
  Applicant’s Attorney 

  
	
   

  	
   

  	
   

  
	
  PAYMENT SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  NUMBER OF CLASSES

  	
   

  	
  5

  
	
   

  	
   

  	
   

  
	
  NUMBER OF CLASSES PAID

  	
   

  	
  5

  
	
   

  	
   

  	
   

  
	
  SUBTOTAL AMOUNT

  	
   

  	
  1675

  
	
   

  	
   

  	
   

  
	
  TOTAL AMOUNT

  	
   

  	
  1675

  
	
   

  	
   

  	
   

  
	
  ATTORNEY

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  NAME

  	
   

  	
  Jeffrey A. Smith

  
	
   

  	
   

  	
   

  
	
  FIRM NAME

  	
   

  	
  Millen, White, Zelano &
  Branigan, P.C.

  
	
   

  	
   

  	
   

  
	
  INTERNAL ADDRESS

  	
   

  	
  Suite 1400

  
	
   

  	
   

  	
   

  
	
  STREET

  	
   

  	
  2200 Clarendon
  Boulevard

  
	
   

  	
   

  	
   

  
	
  CITY

  	
   

  	
  Arlington

  
	
   

  	
   

  	
   

  
	
  STATE

  	
   

  	
  VA

  
	
   

  	
   

  	
   

  
	
  ZIP/POSTAL CODE

  	
   

  	
  22201

  
	
   

  	
   

  	
   

  
	
  COUNTRY 

  	
   

  	
  United States

  
	
   

  	
   

  	
   

  
	
  PHONE

  	
   

  	
  (703) 465-5355

  
	
   

  	
   

  	
   

  
	
  FAX

  	
   

  	
  (703) 243-6410

  
	
   

  	
   

  	
   

  
	
  AUTHORIZED EMAIL
  COMMUNICATION

  	
   

  	
  No

  
	
   

  	
   

  	
   

  
	
  ATTORNEY DOCKET NUMBER

  	
   

  	
  DAKO-0061-T

  



 





















 


	
  OTHER APPOINTED
  ATTORNEY(S)

  	
   

  	
  Scott J. Major; Jeffrey
  R. Cohen

  
	
   

  	
   

  	
   

  
	
  DOMESTIC REPRESENTATIVE SECTION 

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  NAME

  	
   

  	
  Jeffrey A. Smith

  
	
   

  	
   

  	
   

  
	
  FIRM NAME

  	
   

  	
  Millen, White, Zelano &
  Branigan, P.C.

  
	
   

  	
   

  	
   

  
	
  INTERNAL ADDRESS

  	
   

  	
  Suite 1400

  
	
   

  	
   

  	
   

  
	
  STREET

  	
   

  	
  2200 Clarendon
  Boulevard

  
	
   

  	
   

  	
   

  
	
  CITY

  	
   

  	
  Arlington

  
	
   

  	
   

  	
   

  
	
  STATE

  	
   

  	
  VA

  
	
   

  	
   

  	
   

  
	
  ZIP/POSTAL CODE

  	
   

  	
  22201

  
	
   

  	
   

  	
   

  
	
  COUNTRY 

  	
   

  	
  USA

  
	
   

  	
   

  	
   

  
	
  PHONE

  	
   

  	
  (703) 465-5355

  
	
   

  	
   

  	
   

  
	
  FAX

  	
   

  	
  (703) 243-6410

  
	
   

  	
   

  	
   

  
	
  AUTHORIZED EMAIL
  COMMUNICATION

  	
   

  	
  No

  
	
   

  	
   

  	
   

  
	
  CORRESPONDENCE SECTION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  NAME

  	
   

  	
  Jeffrey A. Smith

  
	
   

  	
   

  	
   

  
	
  FIRM NAME

  	
   

  	
  Millen, White, Zelano &
  Branigan, P.C.

  
	
   

  	
   

  	
   

  
	
  INTERNAL ADDRESS

  	
   

  	
  Suite 1400

  
	
   

  	
   

  	
   

  
	
  STREET

  	
   

  	
  2200 Clarendon
  Boulevard

  
	
   

  	
   

  	
   

  
	
  CITY

  	
   

  	
  Arlington

  
	
   

  	
   

  	
   

  
	
  STATE

  	
   

  	
  VA

  
	
   

  	
   

  	
   

  
	
  ZIP/POSTAL CODE

  	
   

  	
  22201

  
	
   

  	
   

  	
   

  
	
  COUNTRY 

  	
   

  	
  USA

  
	
   

  	
   

  	
   

  
	
  PHONE

  	
   

  	
  (703) 465-5355

  
	
   

  	
   

  	
   

  
	
  FAX

  	
   

  	
  (703) 243-6410

  
	
   

  	
   

  	
   

  
	
  AUTHORIZED EMAIL
  COMMUNICATION

  	
   

  	
  No

  
	
   

  	
   

  	
   

  
	
  FILING INFORMATION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  SUBMIT DATE

  	
   

  	
  Thu Jul 29 17:18:37 EDT
  2004

  
	
   

  	
   

  	
   

  
	
  TEAS STAMP

  	
   

  	
  USPTO/BAS-20913520066.200

  
	
   

  	
   

  	
  40729171837168540-7845906

  
	
   

  	
   

  	
  8-200cc10a791fde9d9d89ed4

  
	
   

  	
   

  	
  ab3de89a155-DA-329-200407

  
	
   

  	
   

  	
  29171635994400

  



 





















 


Trademark/Service
Mark Application, Principal Register


 


Serial
Number: 78459068


Filing
Date: 07/29/2004


 


To the Commissioner for
Trademarks:


 


Mark: (Stylized
and/or Design, see mark)


 


The mark consists of a
small upside down droplet inside of a larger right side up droplet; all
enclosed in a shaded oval.


 


The applicant,
DakoCytomation Denmark A/S, a corporation of Denmark, residing at
Produktionsvej 42, Glostrup, Denmark,

DK-2600, requests registration of the trademark/service mark identified above
in the United States Patent and Trademark Office on the Principal Register
established by the Act of July 5, 1946 (15 U.S.C. Section 1051 et
seq.), as amended.


 


The applicant, or the
applicant’s related company or licensee, is using the mark in commerce, and
lists below the dates of use by the applicant, or the applicant’s related
company, licensee, or predecessor in interest, of the mark on or in connection
with the identified goods and/or services, 15 U.S.C. Section 1051(a), as
amended.


 


International Class 001:
Chemicals used in industry and science, including, chemical reagents and
diagnostic preparations for use in research laboratories and for use in
industry.


 


International Class 005:
Pharmaceutical and veterinary preparations, chemicals reagents and diagnostic
preparations for medical and veterinary purposes.


 


International Class 009:
Diagnostic apparatus and instruments, not for medical purposes, including apparatus
for staining and/or visualization of samples, analysis and measuring apparatus,
software for diagnostic apparatus.


 


International Class 010:
Diagnostic apparatus and instruments for medical purposes, including apparatus
for staining and/or visualization of samples, analysis and measuring apparatus.


 


International Class 044:
Services relating to the medical, the health care and the veterinary sector,
including medical analysis and diagnosis.


 


In International Class 001,
the mark was first used at least as early as 07/01/2002, and first used in
commerce at least as early as 07/01/2002, and is now in use in such
commerce.  The applicant is submitting or
will submit one specimen for each class showing
the mark as used in commerce on or in connection with any item in the class of
listed goods and/or services.


 


In International Class 005,
the mark was first used at least as early as 07/01/2002, and first used in
commerce at least as early as 07/01/2002, and is now in use in such
commerce.  The applicant is submitting or
will submit one specimen for each class showing
the mark as used in commerce on or in connection with any item in the class of
listed goods and/or services.


 


In International Class 009,
the mark was first used at least as early as 07/01/2002, and first used in
commerce at least as early as 07/01/2002, and is now in use in such
commerce.  The applicant is submitting or
will submit one specimen for each class showing
the mark as used in commerce on or in connection with any item in the class of
listed goods and/or services.


 


In International Class 010,
the mark was first used at least as early as 07/01/2002, and first used in
commerce at least as early as 07/01/2002, and is now in use in such
commerce.  The applicant is submitting or
will submit one specimen for each class showing
the mark as used in commerce on or in connection with any item in the class of
listed goods and/or services.


 


In International Class 044,
the mark was first used at least as early as 07/01/2002, and first used in
commerce at least as early as 07/01/2002, and is now in use in such commerce.  The applicant is submitting or will submit one
specimen for each class showing the mark as
used in commerce on or in connection with any item in the class of listed goods
and/or services.


 


Based on Foreign
Registration:  Applicant has a bona fide
intention to use the mark in commerce on or in connection with the identified
goods and/or services, and will submit a copy of Denmark registration number VR
2002 02468, registered 07/08/2002 with a renewal date of __________ and an
expiration date of 07/08/2012, and translation thereof, if appropriate,

15 U.S.C. Section 1126(c), as amended.


 


International Class 001:
Chemicals used in industry and science, including, chemical reagents and
diagnostic preparations for use in research laboratories and for use in industry.


 





















 


Based on Foreign
Registration:  Applicant has a bona fide
intention to use the mark in commerce on or in connection with the identified
goods and/or services, and will submit a copy of Denmark registration number VR
2002 02468, registered 07/08/2002 with a renewal date of __________ and an
expiration date of 07/08/2012, and translation thereof, if appropriate, 15
U.S.C. Section 1126(c), as amended.


 


International Class 005:
Pharmaceutical and veterinary preparations, chemicals reagents and diagnostic
preparations for medical and veterinary purposes.


 


Based on Foreign
Registration:  Applicant has a bona fide
intention to use the mark in commerce on or in connection with the identified
goods and/or services, and will submit a copy of Denmark registration number VR
2002 02468, registered 07/08/2002 with a renewal date of __________ and an
expiration date of 07/08/2012, and translation thereof, if appropriate, 15
U.S.C. Section 1126(c), as amended.


 


International Class 009:
Diagnostic apparatus and instruments, not for medical purposes, including
apparatus for staining and/or visualization of samples, analysis and measuring
apparatus, software for diagnostic apparatus.


 


Based on Foreign
Registration:  Applicant has a bona fide
intention to use the mark in commerce on or in connection with the identified
goods and/or services, and will submit a copy of Denmark registration number VR
2002 02468, registered 07/08/2002 with a renewal date of __________ and an
expiration date of 07/08/2012, and translation thereof, if appropriate, 15
U.S.C. Section 1126(c), as amended.


 


International Class 010:
Diagnostic apparatus and instruments for medical purposes, including apparatus
for staining and/or visualization of samples, analysis and measuring apparatus.


 


Based on Foreign
Registration:  Applicant has a bona fide
intention to use the mark in commerce on or in connection with the identified
goods and/or services, and will submit a copy of Denmark registration number VR
2002 02468, registered 07/08/2002 with a renewal date of __________ and an
expiration date of 07/08/2012, and translation thereof, if appropriate, 15
U.S.C. Section 1126(e), as amended.


 


International Class 044:
Services relating to the medical, the health care and the veterinary sector,
including medical analysis and diagnosis. Applicant claims ownership of U.S.
Registration Number(s) 1759331.


 


The applicant hereby
appoints Jeffrey A. Smith and Scott J. Major; Jeffrey R. Cohen of Millen,
White, Zelano & Branigan, P.C., Suite 1400, 2200 Clarendon
Boulevard, Arlington, VA. United States, 22201 to submit this application on
behalf of the applicant.  The attorney
docket/reference number is DAKO-0061-T


 


The applicant hereby
appoints Jeffrey A. Smith of Millen, White, Zelano & Branigan, P.C., Suite 1400,
2200 Clarendon Boulevard, Arlington, VA. USA 22201 as applicant’s
representative upon whom notice or process in the proceedings affecting the
mark may be served.


 


A fee payment in the
amount of $1675 will be submitted with the application, representing payment for
5 class(es).


 


Declaration


 


The undersigned, being
hereby warned that willful false statements and the like so made are punishable
by fine or imprisonment, or both, under 18 U.S.C. Section 1001, and that
such willful false statements, and the like, any jeopardize the validity of the
application or any resulting registration, declares that he/she is properly
authorized to execute this application on behalf of the applicant; he/she
believes the applicant to be the owner of the trademark/service mark sought to
be registered, or, if the application is being filed under 15 U.S.C. Section 1051(b),
he/she believes applicant to be entitled to use such mark in commerce; to the
best of his/her knowledge and belief no other person, firm, corporation, or
association has the right to use the mark in commerce, either in the identical
form thereof or in such near resemblance thereto as to he likely, when used on
or in connection with the goods/services of such other person, to cause
confusion, or to cause mistake, or to deceive; and that all statements made of
his/her own knowledge are true; and that all statements made on information and
belief are believed to be true.


 


Signature:/jas/ Date:
07/29/2004


Signatory’s Name: Jeffrey
A. Smith


Signatory’s Position:
Applicant’s Attorney


Mailing Address:


Jeffrey A. Smith


Suite 1400


2200 Clarendon Boulevard


Arlington, VA 22201


RAM Sale Number: 329


RAM Accounting Date:
07/30/2004


 





















 


Serial Number: 78459068


Internet Transmission
Date: Thu Jul 29 17:18:37 EDT 2004


TEAS Stamp: USPTO/BAS - 20913520066


 





















 





 


 





















 





 


 


Kongeriget
Danmark


 


VR 2002 02468


 


De anmeldte ændringer
vedrorende ovennævnte varemærke er nu noteret i varemærkeregisteret. De
oplysninger, der herefter gælder, fremgär af registerudskriften.


 


The notified changes
concerning the above-mentioned trade mark are now noted in the Registor of
Trade Marks. The information which hereafter is valid appears on the
registration extract.


 


 


16. oktober 2002


 


 


	
   

  	
  Patent- og
  Varemærkestyrelsen

  	
   

  
	
   

  	
  Okonomi- og Erkvervsministeriet

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  /s/ Mogens Kring

  	
   

  
	
   

  	
  Mogens Kring

  	
   

  
	
   

  	
  Direktor

  	
   

  



 





PATENT-
OG VAREMERKESTYRELSEN


 





















 


 


	
  Rekvirent     :MLI

  	
  Dato: 16.
  oktober 2002

  
	
  Reference     :VA
  2002 02660

  	
  Side: 2 af 4

  



 


Registerudskrift


(Extract of
Register)


 


	
  (111)        :

  	
  VR 2002 02468

  	
  (100)       :

  	
  24. september 2002

  
	
  (210)        :

  	
  VA 2002 02660

  	
  (151)       :

  	
  8, juli 2002

  
	
   

  	
   

  	
  (220)       ;

  	
  28. juni 2002

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (180)       :

  	
  8. juli 2012

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  (730)        :

  	
  DakoCylomation Denmark
  A/S

  Produktionsvej 42

  2600 Glostrup

  Danmark

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  (540)        :

  	
   

  	
   

  	
   

  



 





 


	
  (511)        :

  	
  Klasse 01:  Kemiske produkter og præparater til
  industrielle og videnskabelige formál og anvendelse, herunder kemiske
  reagensmidler og diagnosepræparater til brug i forskningskaboratorier samt
  til brug i industrien. 

  
	
   

  	
   

  
	
   

  	
  Klasse 05:  Farmaceutiske og veterinærmedicinske
  præparater, herunder kemiske reagensmidler og diagnosepræparater til
  medicinsk eller veterintærmedicinsk brug.

  
	
   

  	
   

  
	
   

  	
  Klasse- 09:  Diagnoseapparater og -instrumenter, ikke
  til medicinsk brug, herunder apparater till farvning og/eller visualisering
  af præparater samt analyse- og maleapparater. software till
  diagnoseapparater.

  
	
   

  	
   

  
	
   

  	
  Klasse 10:
  Diagnoseapparater og -instrumenter til medicinsk brug, herunder apparater til
  farvning og/ eller visualisering af præparater samt analyse- og máleapparater.

  



 





















 


	
   

  	
  Klasse 44: Læge-,
  sundheds- og veterinærvirksomhed, herunder medicinsk analyse og diagnose.

  



 


Historiske
oplysninger


(Historical
Information)


 


	
  (730/580):

  	
  DAKO A/S

  
	
   

  	
  Produktionsvej 42

  
	
   

  	
  2600 Glostrup

  
	
   

  	
  Danmark

  
	
   

  	
  Udgäet: 16. oktober
  2002

  
	
   

  	
  Fejlopret: Nej

  



 


 


Udskrift slut


(End of Extract)


 





















 


INID-koder


 


	
  Internationally agreed
  Numbers for the Identification of Data (INID)

  	
   

  	
  Internationalt vedtagne
  Numre til Identifikation at Data (INID)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (100)

  	
   

  	
  Date of termination of
  the procedure regarding registration

  	
   

  	
  Dato for registreringsprocedurens
  afslutning.

  
	
  (111)

  	
   

  	
  Registration Number

  	
   

  	
  Registreringsnummer

  
	
  (141)

  	
   

  	
  Date of termination of
  the registration of the Mark

  	
   

  	
  Dato for udslettelse af
  registreringen

  
	
  (151)

  	
   

  	
  Registration date

  	
   

  	
  Registreringsdato

  
	
  (180)

  	
   

  	
  Date of expected
  expiration of the registration/renewal

  	
   

  	
  Dato for registrerings-/fomyelsesperiodens
  udlob

  
	
  (210)

  	
   

  	
  Application number

  	
   

  	
  Ansogningsnummer

  
	
  (220)

  	
   

  	
  Application filing date

  	
   

  	
  Ansogningsdato

  
	
  (230)

  	
   

  	
  Exhibition filing date

  	
   

  	
  Udstillingsprioritetsoplysninger

  
	
  (300)

  	
   

  	
  Data relating to
  priority under the Paris Convention

  	
   

  	
  Prioritetsoplysninger

  
	
  (390)

  	
   

  	
  Data relating to the
  registration in the country of origin

  	
   

  	
  Hjemlandsregistrering

  
	
  (442)

  	
   

  	
  Date of publication of
  the application

  	
   

  	
  Bekendtgorelsesdato

  
	
  (450)

  	
   

  	
  Date of publication of
  the registration

  	
   

  	
  Offentliggorelsesdato

  
	
  (500)

  	
   

  	
  Various information

  	
   

  	
  Bernærkninger

  
	
  (511)

  	
   

  	
  Class or classes
  (and list of goods/services

  	
   

  	
  Vare eller tjenesfeydelsesklasser
  (og lisle over varer/ tjenesteydelser)

  
	
  (540)

  	
   

  	
  Reproduction of the
  mark

  	
   

  	
  Varemærket

  
	
  (551)

  	
   

  	
  Indication of the
  effect that the mark is a collective mark, a certification mark or a
  guarantee mark

  	
   

  	
  Fællesmærkeoplysninger

  
	
  (580)

  	
   

  	
  Date of recording of
  amendment/change

  	
   

  	
  Dato for notering af
  tilforsel

  
	
  (591)

  	
   

  	
  Information concerning
  colors claimed

  	
   

  	
  Farvetekst

  
	
  (641)

  	
   

  	
  Number(s) and date(s)
  of other legally related applications

  	
   

  	
  Data vedrorende
  delte/udskilte ansogninger

  
	
  (646)

  	
   

  	
  Number(s) and date(s)
  of other legally related registrations

  	
   

  	
  Data vedrorende delte/udskilte
  registreringer

  
	
  (730)

  	
   

  	
  Name and address of the
  applicant/holder of the registration

  	
   

  	
  Indehaveroplysninger

  
	
  (740)/

  	
   

  	
  Name and address of the
  representative/Corresponding address

  	
   

  	
  Fuldmægtigoplysninger/korrespondanceadresse

  
	
  (750)

  	
   

  	
  Representative/Corresponding
  address

  	
   

  	
   

  
	
  (791)/

  	
   

  	
  Data concerning license

  	
   

  	
  Licansoplysninger

  
	
  (793)

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  



 


	
  Domestic Codes for the
  Identification of Data

  	
   

  	
  Interne koder till
  Identification at data

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (DC)

  	
   

  	
  Data of
  shelving/withdrawal

  	
   

  	
  Henlæggelses/tilbagetagelsesdato

  
	
  (DP)

  	
   

  	
  Data concerning pawning

  	
   

  	
  Pantsætningsoplysninger

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Where there is only an
  indication of the class number (511), the application or registration covers
  all goods or services within the class in question.

  	
   

  	
  Hvor der alene er
  angivet klassenummer (511), omfatter ansogningen eller registeringen alle
  varer eller tjenesteydelser i den pagaeldende klasse

  
	
   

  	
   

  	
   

  
	
  Where the class number
  in the case of code (511)/(510) is followed by a “:”, the application or
  registration covers only the goods or services specifically mentioned.

  	
   

  	
  Hvor klassenummeret
  efter kode (511)(510) efterfolges af et “:”, omfatter ansegningen eller
  registeringen kun de soerligt noeunte varer eller tjenesteydelser

  
	
   

  	
   

  	
   

  
	
  Where (540) the “Reproduction
  of the Mark is followed by “<w>“, the application or registration
  concerns a word Mark.

  	
   

  	
  Hvor (540) “Varemarket”
  efterfolges af “<w>“, angär ansogningen eller registreringen et
  ordmaarke.

  
	
   

  	
   

  	
   

  
	
  Where (540) the “Reproduction
  of the Mark” is followed by “<fig>“, the trade mark involves non-standard
  letters and/or figurative elements.

  	
   

  	
  Hvor (540) “Varemarket”
  efferfelges af “<fig>“, er der i Varemarket figurelementer og/eller
  bogstaver med saerlig skrifttype.

  



 





















 


EXHIBIT 9
– Trademark status for Clarient Inc.


 


	
  Exhibit 9.1:

  	
  Trademark Status report
  Clarient Inc. (10225)

  	
   

  
	
   

  	
   

  	
   

  
	
  Exhibit 9.2:

  	
  Printout from the TARR
  server of 22 June 2005

  	
   

  



 


 


1





















 


Trademark Status Report


 


CLARIENT, INC. (10225)


 


For All Countries Include All
Statuses


 


	
  Mark

  	
   

  	
  Ref #

  	
   

  	
  Class(es)

  	
   

  	
  Filed

  	
   

  	
  Appln #

  	
   

  	
  Reg Date

  	
   

  	
  Reg #

  	
   

  	
  Status

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CANADA

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ACR

  	
   

  	
  10225-060CAI

  	
   

  	
  N/A

  	
   

  	
  09/02/04

  	
   

  	
  1,229,044

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PENDING

  
	
   

  	
   

  	
  N/A: algorithms used on a computer controlled microscopy
  system for the purpose of analyzing and processing images of specimens
  mounted on slides; providing a service bureau reference lab for reading
  specimen slides on a computer controlled microscopy system

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  EUROPEAN UNION (CTM)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ACR

  	
   

  	
  10225-060EU1

  	
   

  	
  9, 16, 42

  	
   

  	
  09/08/04

  	
   

  	
  4026894

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PENDING

  
	
   

  	
   

  	
  9: Scientific, nautical, surveying, photographic,
  cinematographic, optical, weighing, measuring, signalling, checking
  (supervision), life-saving and teaching apparatus and instruments; apparatus
  and instruments for conducting, switching, transforming, accumulating,
  regulating or controlling electricity; apparatus for recording, transmission
  or reproduction of sound or images; magnetic data carriers, recording discs;
  automatic vending machines and mechanisms for coin operated apparatus; cash
  registers; calculating machines, data processing equipment and computers;
  fire-extinguishing apparatus; software feature of a computer controlled
  microscopy system for the purpose of analyzing and processing images of
  specimens mounted on slides.

  
	
   

  	
   

  	
  16: Paper, cardboard and goods made from these materials,
  not included in other classes; printed matter; book binding material;
  photographs; stationery; adhesives for stationery or household purposes;
  artists’ materials; paint brushes; typewriters and office requisites (except
  furniture); instructional and teaching material (except apparatus); plastic
  materials for packaging (not included in other classes); printers’ type;
  printing blocks; printed publications, brochures and leaflets; user and
  instruction manuals.

  
	
   

  	
   

  	
  42: Scientific and technological services and research and
  design relating thereto; industrial analysis and research services; design
  and development of computer hardware and software; legal services; providing
  a service bureau reference lab for reading specimen slides on a computer
  controlled microscopy system (laboratory services).

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  UNITED STATES

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ACIS

  	
   

  	
  10225-017001

  	
   

  	
  9

  	
   

  	
  03/04/98

  	
   

  	
  75/444,713

  	
   

  	
  05/08/01

  	
   

  	
  2,449,518

  	
   

  	
  REGISTERED

  
	
   

  	
   

  	
  9: computer controlled microscopy systems comprising an
  automated microscope, camera and image processing computer software for use
  in processing images of specimens mounted on slides

  



 


1





















 


	
  ACIS

  	
   

  	
  10225-025001

  	
   

  	
  42

  	
   

  	
  11/30/00

  	
   

  	
  76/175,358

  	
   

  	
  05/13/03

  	
   

  	
  2,736,264

  	
   

  	
  REGISTERED

  
	
   

  	
   

  	
  42: Leasing of computer controlled microscopy systems used
  to process images of specimens mounted on slides

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ACR

  	
   

  	
  10225-059001

  	
   

  	
  042

  	
   

  	
  03/11/04

  	
   

  	
  78/382,455

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PENDING

  
	
   

  	
   

  	
  042: providing a service bureau reference lab for reading
  specimen slides on a computer controlled microscopy system

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ACR

  	
   

  	
  10225-060001

  	
   

  	
  009

  	
   

  	
  03/11/04

  	
   

  	
  78/382,448

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PENDING

  
	
   

  	
   

  	
  009: Algorithm used on a computer controlled microscopy
  system for the purpose of analyzing and processing images of a specimen
  mounted on slides

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  AUTOMATED CELLULAR IMAGING SYSTEM

  	
   

  	
  10225-068001

  	
   

  	
  9,42

  	
   

  	
  07/02/04

  	
   

  	
  78/445,339

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PENDING

  
	
   

  	
   

  	
  9: Computer controlled microscopy systems used to process
  images of specimens mounted on slides

  
	
   

  	
   

  	
  42: Leasing of computer controlled microscopy systems used
  to process images of specimens mounted on slides

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CHROMAVISION COLOR SPACE TRANSFORMATION

  	
   

  	
  10225-016001

  	
   

  	
  9, 42

  	
   

  	
  03/04/98

  	
   

  	
  75/444,712

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  TRANSFER

  
	
   

  	
   

  	
  9: computer controlled microscopy systems comprising an
  automated microscope, camera and image processing computer software for use
  in processing images of specimens mounted on slides

  
	
   

  	
   

  	
  42: leasing of computer controlled microscopy systems used
  to process images of specimens mounted on slides

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLARIENT

  	
   

  	
  10225-087001

  	
   

  	
  9, 10, 16, 42

  	
   

  	
  02/23/05

  	
   

  	
  78/573,774

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PENDING

  
	
   

  	
   

  	
  9: computer controlled microscopy systems used to process
  images of specimens mounted on slides; algorithm used on a computer
  controlled microscopy system for the purposes of analyzing and processing
  images of specimens mounted on slides

  
	
   

  	
   

  	
  10: automated microscope and related software sold as a
  unit for use in diagnostics

  
	
   

  	
   

  	
  16: printed medical reports

  
	
   

  	
   

  	
  42: leasing of medical equipment; diagnostic laboratory
  services performed for third parties; image analysis services performed for
  third parties; remote cellular imaging services provided via a password-protected
  communications connection on the Internet

  
	
   

  	
   

  	
   

  
	
  CLARIENT & Design

  	
   

  	
  10225-086001

  	
   

  	
  9, 10, 16, 42

  	
   

  	
  02/23/05

  	
   

  	
  78/573,779

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PENDING

  
	
   

  	
   

  	
  9: computer controlled microscopy systems used to process
  images of specimens mounted on slides; algorithm used on a computer
  controlled microscopy system for the purposes of analyzing and processing
  images of specimens mounted on slides

  
	
   

  	
   

  	
  10: automated microscope and related software sold as a
  unit for use in diagnostics

  
	
   

  	
   

  	
  16: printed medical reports

  
	
   

  	
   

  	
  42: leasing of medical equipment; diagnostic laboratory
  services performed for third parties; image analysis services performed for
  third parties; remote cellular imaging services provided via a
  password-protected communications connection on the Internet

  



 


2





















 


	
  Panel Report (with DNA Ploidy Assay Results)
  Trade Dress

  	
   

  	
  10225-070001

  	
   

  	
  16

  	
   

  	
  05/05/04

  	
   

  	
  76/612,925

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  ABANDONED

  
	
   

  	
   

  	
  16: printed medical reports

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Panel Report Trade Dress

  	
   

  	
  10225-069001

  	
   

  	
  16

  	
   

  	
  05/05/04

  	
   

  	
  78/413,728

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PEND/DROP

  
	
   

  	
   

  	
  16: printed medical reports

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PATHSITE

  	
   

  	
  10225-085001

  	
   

  	
  42

  	
   

  	
  02/23/05

  	
   

  	
  78/573,777

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PENDING

  
	
   

  	
   

  	
  42: remote cellular imaging services provided via a
  password-protected communications connection on the Internet

  
	
   

  	
   

  	
   

  
	
  TAKING CANCER PERSONALLY

  	
   

  	
  10225-088001

  	
   

  	
  9, 10, 16, 42

  	
   

  	
  02/23/05

  	
   

  	
  78/573,775

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PENDING

  
	
   

  	
   

  	
  9: computer controlled microscopy systems used to process
  images of specimens mounted on slides; algorithm used on a computer
  controlled microscopy system for the purposes of analyzing and processing
  images of specimens mounted on slides

  
	
   

  	
   

  	
  10: automated microscope and related software sold as a
  unit for use in diagnostics

  
	
   

  	
   

  	
  16: printed medical reports

  
	
   

  	
   

  	
  42: leasing of medical equipment; diagnostic laboratory
  services performed for third parties; image analysis services performed for
  third parties; remote cellular imaging services provided via a
  password-protected communications connection on the Internet

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TRIPLE PLUS

  	
   

  	
  10225-018001

  	
   

  	
  03/25/97

  	
   

  	
  75/263,485

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  ABANDONED

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TRIPLE PLUS

  	
   

  	
  10225-019001

  	
   

  	
  5

  	
   

  	
  03/25/97

  	
   

  	
  75/263,486

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  ABANDONED

  
	
   

  	
   

  	
  5: Medical diagnostic test kit, comprised of
  diagnostic reagents used for prenatal screening for Downs Syndrome.

  



 


3





















 


Exhibit 9.2


 


Thank
you for your request. Here are the latest results from the TARR web server.


 


This page was generated by the TARR system on 2005-06-22 14:46:45 ET


 


Serial Number: 75282022 


 


Registration Number: 2235101 


 


Mark (words only): CHROMAVISION


 


Standard Character claim: No


 


Current Status: Registered.


 


Date of Status: 2000-03-24


 


Filing Date: 1997-04-25


 


Transformed into a National Application: No


 


Registration Date: 1999-03-23


 


Register: Principal


 


Law Office Assigned: LAW OFFICE 103


 


If you
are the applicant or applicant’s attorney and have questions about this file,
please contact the Trademark Assistance Center at
TrademarkAssistanceCenter@uspto.gov


 


Current
Location: 900 -File Repository
(Franconia)


 


Date In
Location: 2002-01-30


 


LAST APPLICANT(S)/OWNER(S) OF RECORD


 


1. ChromaVision Medical Systems, Inc.


 


Address: 


ChromaVision Medical Systems, Inc.


33171 Paseo Cerveza


San Juan Capistrano, CA 92690


United States


Legal Entity Type: Corporation


State or Country of Incorporation: Delaware


 


GOODS AND/OR SERVICES


 


International Class: 010


automated microscope and related software sold as a unit for use in medical
diagnostics


 


1





















 


First Use Date: 1998-07-07


First Use in Commerce Date: 1998-07-07


 


Basis: 1(a)


 


ADDITIONAL INFORMATION


 


(NOT AVAILABLE)


 


MADRID PROTOCOL INFORMATION


 


(NOT AVAILABLE)


 


PROSECUTION HISTORY


 


2002-01-29 - Cancellation terminated for Proceeding


 


2002-01-29 - Cancellation dismissed for Proceeding


 


2000-03-24 - Cancellation Instituted No. 999999


 


1999-03-23 - Registered - Principal Register


 


1999-01-08 - Allowed for Registration - Principal Register (SOU accepted)


 


1999-01-08 - Case file assigned to examining attorney


 


1998-12-21 - Statement of use processing complete


 


1998-11-24 - Amendment to Use filed


 


1998-05-26 - Notice of allowance - mailed


 


1998-03-03 - Published for opposition


 


1998-01-30 - Notice of publication


 


1997-12-30 - Approved for Pub - Principal Register (Initial exam)


 


1997-12-23 - Examiner’s amendment mailed


 


1997-12-10 - Case file assigned to examining attorney


 


2





















 


CORRESPONDENCE INFORMATION


 


Correspondent 


ROGER W HERRELL (Attorney of record)


 


JAMES P. CLARK 


GIBSON DUNN & CRUTCHER LLP 


2029 CENTURY PARK EAST, SUITE 4000 


LOS ANGELES, CA 90067-3026


 


3





















 


 


Thank
you for your request. Here are the latest results from the TARR web server.


 


This page was generated by the TARR system on 2005-06-22 14:47:46 ET


 


Serial Number: 76272496 


 


Registration Number: 2769787 


 


Mark (words only): CHROMAVISION


 


Standard Character claim: No


 


Current Status: Registered.


 


Date of Status: 2003-09-30


 


Filing Date: 2001-06-15


 


Transformed into a National Application: No


 


Registration Date: 2003-09-30


 


Register: Principal


 


Law Office Assigned: LAW OFFICE 105


 


If you
are the applicant or applicant’s attorney and have questions about this file,
please contact the Trademark Assistance Center at
TrademarkAssistanceCenter@uspto.gov


 


Current
Location: 900 -File Repository
(Franconia)


 


Date In
Location: 2003-10-06


 


LAST APPLICANT(S)/OWNER(S) OF RECORD


 


1. ChromaVision Medical Systems, Inc.


 


Address: 


ChromaVision Medical Systems, Inc.


33171 Paseo Cerveza


San Juan Capistrano, CA 92675


United States


Legal Entity Type: Corporation


State or Country of Incorporation: Delaware


 


GOODS AND/OR SERVICES


 


International Class: 042


Leasing of medical equipment in the nature of automated microscopes for
usage at customer locations; 


 


1





















 


and medical services in the nature of providing an online interactive
analysis of cellular images from automated microscopes utilizing distributed
computer network


First Use Date: 2000-01-00


First Use in Commerce Date: 2000-01-00


 


Basis: 1(a)


 


ADDITIONAL INFORMATION


 


Prior Registration Number(s):


2235101


 


MADRID PROTOCOL INFORMATION


 


(NOT AVAILABLE)


 


PROSECUTION HISTORY


 


2003-09-30 - Registered - Principal Register


 


2003-07-25 - Allowed for Registration - Principal Register (SOU accepted)


 


2003-07-24 - Case file assigned to examining attorney


 


2003-07-23 - Case File in TICRS


 


2003-07-09 - Statement of use processing complete


 


2003-06-03 - Amendment to Use filed


 


2003-06-05 - PAPER RECEIVED


 


2002-12-03 - Notice of allowance - mailed


 


2002-09-10 - Published for opposition


 


2002-08-21 - Notice of publication


 


2002-05-08 - Approved for Pub - Principal Register (Initial exam)


 


2002-03-18 - Communication received from applicant


 


2002-03-18 - PAPER RECEIVED


 


2001-10-01 - Non-final action mailed


 


2001-08-20 - Case file assigned to examining attorney


 


2





















 


CORRESPONDENCE INFORMATION


 


Correspondent 


Scott A. Edelman (Attorney of record)


 


SCOTT A EDELMAN 


GIBSON DUNN & CRUTCHER LLP 


2029 CENTURY PARK EAST SUITE 4000 


LOS ANGELES CA 90067-3026 


 


Phone Number: 310-557-8061 


Fax Number: 310-552-7041


 


3





















 


Thank
you for your request. Here are the latest results from the TARR web server.


 


This page was
generated by the TARR system on 2005-06-22 14:45:37 ET


 


Serial
Number: 78442565 


 


Registration
Number: (NOT
AVAILABLE) 


 


Mark 


 





 


(words
only): QUIHC


 


Standard
Character claim:
Yes


 


Current
Status: Application
has been published for opposition.


 


Date
of Status: 2005-05-03


 


Filing
Date: 2004-06-28


 


The Information will be/was
published in the Official Gazette on 2005-05-03


 


Transformed
into a National Application: No


 


Registration
Date: (DATE NOT
AVAILABLE) 


 


Register:
Principal


 


Law
Office Assigned: LAW
OFFICE 106


 


Attorney Assigned:


ANKRAH NAAKWAMA S Employee Location


 


Current
Location: 650 -Publication And Issue
Section


 


Date In
Location: 2005-03-24


 


1





















 


LAST APPLICANT(S)/OWNER(S) OF RECORD


 


1. ChromaVision Medical Systems, Inc.


 


Address: 


ChromaVision Medical Systems, Inc.


33171 Paseo Cerveza


San Juan Capistrano, CA 92675


United States


Legal Entity Type: Corporation


State or Country of Incorporation: Delaware


 


GOODS AND/OR SERVICES


 


International Class: 042


Histology preparation, interpretation and cell and tissue specialty
staining services, namely, molecular and immunohistochemical staining


First Use Date: 2004-06-00


First Use in Commerce Date: 2004-06-00


 


Basis: 1(a)


 


ADDITIONAL INFORMATION


 


(NOT AVAILABLE)


 


MADRID PROTOCOL INFORMATION


 


(NOT AVAILABLE)


 


PROSECUTION HISTORY


 


2005-05-03 - Published for opposition


 


2005-04-13 - Notice of publication


 


2005-02-12 - Law Office Publication Review Completed


 


2005-02-04 - Assigned To LIE


 


2005-02-02 - Approved for Pub - Principal Register (Initial exam)


 


2005-02-02 - Examiners amendment e-mailed


 


2005-02-02 - Examiners Amendment -Written


 


2005-02-02 - Case file assigned to examining attorney


 


2004-07-06 - New Application Entered In Tram


 


2





















 


CORRESPONDENCE INFORMATION


 


Correspondent 


John E. Russell (Attorney of record)


 


JOHN E. RUSSELL 


ALLMARK TRADEMARK 


4041 SUGAR MAPLE DR STE A 


DANVILLE CA 94506-4640


 


Phone Number: 925-648-4839 


Fax Number: 925-648-4358


 


3





















 


EXHIBIT 10 – Installation Services and Prices


 


The following service
listings and prices reflect the fact that CLARiENT will be providing all on
site instrument installation support during Phase 1. This list will need to be
revisited prior to the release of the ACIS III instrument and software as
DakoCytomation will assume service, support and installation responsibilities
at that time. Installation Services shall be ordered by DakoCytomation only.
DakoCytomation’s Director of Field Service for the United States will issue
orders for Installation Services.


 


INSTALLATION SERVICES 


 


Field Service Installation Support


 


1)           CLARiENT will provide
instrument installation support which includes the following:


a)              Unpacking of the
instrument.


b)             Setup of the
instrument in its final installation location.


c)              Calibration of the
instrument.


d)             Verification of
normal instrument operation.


e)              Loading of
additional software (as required).


 


Field Service
Installation Support will be provided by Clarient at end-user sites at a fixed
price of USD $1100 plus expenses approved by DakoCytomation.


 


Technical
Services Support


 


1)           CLARiENT will offer
post training on site startup support which can be used as follows:


a)              Pathologist
training or additional system training for individuals already trained at
DakoCytomation’s California facility.


b)             Instrument
optimization support for DakoCytomation supported imaging applications. Onsite
support requests require scheduling two weeks in advance.


 


Clarient will provide
training sessions at end-user sites at a fixed price per day of USD $1400 plus
expenses approved by DakoCytomation.


 


Customer
Service Support


 


1)           CLARiENT will configure
(with customer input) the report templates, generated via ACIS Reports,
required to print patient results for tests
and panels that have been run on the ACIS. This service will be
available during the entire warranty period without costs for DakoCytomation. 


a)              This
configuration will include:


i)                 Adding
the customer logo to the report.


ii)              Configuring
reference ranges to customer laboratory ranges.


iii)           Configuring
test results to be printed on the reports.


 


PRICING


 


All additional services
and on site support will be
billed at the following rates. Travel hours will be billed from the time the
field engineer arrives at his/her home airport until (s)he arrives at the
customer site and from the customer site back to the field engineer’s home
airport. Actual costs for transportation to and from the customer site, local
transportation, lodging and meals will be billed to DakoCytomation. Travel
expenses will conform to the current CLARiENT travel policy (Hotel <
$100/day, meals $40/day - $8 breakfast, $12 lunch, $20 dinner). All travel
shall be made at economy class and at the lowest possible rates. All costs
shall be approved by DakoCytomation in advance.


 


1)             Technical Services
(Onsite support / Instrument optimization);


	
   

  	
  a)

  	
  Normal working hours
  support (8:00 a.m. to 5:00 p.m. M/F)

  	
   

  	
  $

  	
  175.00 per hour

  
	
   

  	
  b)

  	
  Overtime and weekend
  support (5:00 p.m. to 8:00 a.m. M/F, Sat. & Sun.)

  	
   

  	
  $

  	
  300.00 per hour

  



 


2)             Travel time to and
from the customer site will be billed at the rate of $100 per hour.


 


1





















 


EXHIBIT 11 – After Sale Support Services and Prices


 


The following service
listings and prices reflect the fact that CLARiENT will be providing all on
site instrument repair support during Phase 1. This list will need to be
revised prior to the release of the ACIS III instrument and software as DakoCytomation
will assume service and support responsibilities at that time.


 


POST INSTALLATION WARRANTY SERVICES


 


Clarient will provide
Post Installation Warranty Services without cost to DakoCytomation or
DakoCytomation’s customers/end-users, including the following:


 


Field Service Support


 


1)           CLARiENT will provide
post sale instrument support which includes the following:


a)             Instrument repair
(Monday through Friday, 8:00 a.m. to 5:00 p.m. based on local time
zone).


b)            Mandatory software
upgrades (both on site and remotely performed).


c)             All parts and labor
required to return the instrument to operating condition


d)            Periodic maintenance
as required.


e)             Instrument
relocations are not covered under the warranty but are available at prices
listed below.


 


Technical Services Support


 


1)           CLARiENT will offer 16
hours (Monday through Friday, 8:00 a.m. to 5:00 p.m. based on local
time zone) of post installation on site support which can be used as follows:


a)              Pathologist
training or additional system training for individuals already trained at
DakoCytomation’s California facility.


b)             Instrument
optimization support for DakoCytomation supported imaging applications. Onsite
support requests require scheduling two weeks in advance.


 


Customer Service Support


 


1)           CLARiENT telephone
support to the customers and technical service employees of DakoCytomation,
during the warranty period, (Monday through Friday, 8:00 a.m. to 5:00 p.m.
based on local time zone).


 


POST WARRANTY SERVICES PRICING


 


All post warranty
services and on site support will be billed at the following rates. Travel
hours will be billed from the time the field engineer arrives at his/her home
airport until (s)he arrives at the customer site and from the customer site
back to the field engineer’s home airport. Actual costs for transportation to
and from the customer site, local transportation, lodging and meals will be
billed to DakoCytomation. Travel expenses will conform to the current CLARiENT
travel policy (Hotel < $100/day, meals $40/day - $8 breakfast, $12 lunch,
$20 dinner). All travel shall be made at economy class and at the lowest
possible rates. All costs shall be approved by DakoCytomation in advance.


 


	
  1.

  	
   

  	
  Field Service
  (Instrument repair / Preventative maintenance / Software upgrades /
  Relocations):

  
	
  •

  	
   

  	
   

  	
  Normal working hours
  support (8:00 a.m. to 5:00 p.m. M/F)

  	
   

  	
  $175.00 per hour

  
	
  •

  	
   

  	
   

  	
  Overtime and weekend
  support (5:00 p.m. to 8:00 a.m. M/F, Sat. & Sun.)

  	
   

  	
  $300.00 per hour

  
	
  •

  	
   

  	
   

  	
  Instrument Relocations

  	
   

  	
  Actual cost of travel
  to and from the site, local transportation, lodging, meals, travel time and
  labor hours.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.

  	
   

  	
  Technical Services
  (Onsite support):

  	
   

  	
   

  
	
   

  	
   

  	
  •

  	
  Normal working hours
  support (8:00 a.m. to 5:00 p.m. M/F)

  	
   

  	
  $175.00 per hour

  
	
   

  	
   

  	
  •

  	
  Overtime and weekend
  support (5:00 p.m. to 8:00 a.m. M/F, Sat. & Sun.)

  	
   

  	
  $300.00 per hour

  
	
  3.

  	
   

  	
  Travel time to and from
  the customer site will be billed at the rate of $100 per hour.

  	
   

  	
   

  



 


1





















 


	
  

  	
  EXHIBIT 14

  Technical Specifications and
  Acceptance Criteria for the ACIS III Instrument and Software

  Doc #: 70180

  Revision: A

   

  
	
  TITLE:
  DakoCytomationACIS III System

  



 


June 28,
2004


 


Signature
Approvals


 


	
   

  	
  Clarient, Inc.

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Karen Garza

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Senior Vice President,
  Marketing

  	
  Signature

  	
   

  	
   

  	
  Date

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Jim Cureton

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Vice President,
  Instrument Operations

  	
  Signature

  	
   

  	
   

  	
  Date

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Dave Davis

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Director, Regulatory
  Affairs

  	
  Signature

  	
   

  	
   

  	
  Date

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  DakoCytomation

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Ann Frederick

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Program Manager

  	
  Signature

  	
   

  	
   

  	
  Date

  	
   

  



 


 


	
  Revision
  History

  	
   

  	
  Description of Change

  	
   

  	
  Date

  
	
  Rev A

  	
   

  	
  Original
  Document

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  



 


1





















 


Table of Contents


 


	
  1.

  	
  Executive Summary

  	
  3

  
	
   

  	
   

  	
   

  
	
  2.

  	
  Strategy and Overview

  	
  3

  
	
   

  	
   

  	
   

  
	
  2.1.

  	
  Strategic Roadmap

  	
  3

  
	
   

  	
   

  	
   

  
	
  2.2.

  	
  Customer Categories

  	
  3

  
	
  2.2.1.

  	
  Anatomic
  Pathology

  	
  3

  
	
  2.2.2.

  	
  Education
  (Medical / Dental Schools)

  	
  3

  
	
  2.2.3.

  	
  Veterinary
  labs

  	
  3

  
	
   

  	
   

  	
   

  
	
  2.3.

  	
  Competitive Strengths and Weaknesses

  	
  3

  
	
   

  	
   

  	
   

  
	
  3.

  	
  Affected Groups

  	
  3

  
	
   

  	
   

  	
   

  
	
  3.1.

  	
  Clarient, Inc.

  	
  3

  
	
  3.1.1.

  	
  Marketing

  	
  3

  
	
  3.1.2.

  	
  Operations

  	
  4

  
	
  3.1.3.

  	
  Sales

  	
  4

  
	
   

  	
   

  	
   

  
	
  3.2.

  	
  DakoCytomation

  	
  4

  
	
  3.2.1.

  	
  Marketing

  	
  4

  
	
  3.2.2.

  	
  Logistics

  	
  4

  
	
  3.2.3.

  	
  Regulatory

  	
  4

  
	
  3.2.4.

  	
  Sales

  	
  4

  
	
  3.2.5.

  	
  Service
  and Support

  	
  4

  
	
   

  	
   

  	
   

  
	
  4.

  	
  Requirements

  	
  4

  
	
   

  	
   

  	
   

  
	
  4.1.

  	
  Definitions and Acronyms

  	
  4

  
	
   

  	
   

  	
   

  
	
  4.2.

  	
  System Requirements

  	
  5

  
	
  4.2.1.

  	
  General
  Requirements

  	
  5

  
	
  4.2.2.

  	
  Computer
  Requirements

  	
  5

  
	
  4.2.3.

  	
  User
  Interface Requirements

  	
  5

  
	
  4.2.4.

  	
  Acquisition
  Requirements

  	
  5

  
	
  4.2.5.

  	
  Review
  Requirements

  	
  5

  
	
  4.2.6.

  	
  Analysis
  Requirements

  	
  5

  
	
  4.2.7.

  	
  Data
  Management

  	
  5

  
	
  4.2.8.

  	
  Reporting
  Requirements

  	
  5

  
	
   

  	
   

  	
   

  
	
  5.

  	
  Addendum 1 – Future Design
  Considerations

  	
  5

  
	
   

  	
   

  	
   

  
	
  5.1.

  	
  System

  	
  5

  
	
  5.1.1.

  	
  Review

  	
  5

  
	
  5.1.2.

  	
  Analysis

  	
  5

  
	
  5.1.3.

  	
  Management

  	
  5

  
	
  5.1.4.

  	
  Reporting

  	
  5

  
	
   

  	
   

  	
   

  
	
  5.2.

  	
  Legal & Regulatory Requirements

  	
  6

  
	
  5.2.1.

  	
  FDA 21 CFR Part 11

  	
  6

  
					



 










[***] Certain information on this page has been redacted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.


 


2





















 


1.     Executive Summary


 


This requirements
document is intended to define a joint compilation of needs identified through
market research by both Clarient, Inc. and DakoCytomation.  This research has been conducted by both
companies through independent analysis as well as a joint project mediated by
an independent market analysis consultant. 
These requirements represent a minimal set of improvements to be made to
the ACIS II device, as well as to the software to enhance customer usability,
improve key features, enhance marketability of the existing product and to
better align the imaging system with the DakoCytomation line of automated
immunostainers.


 


The ACIS III interim
product being described here is intended to take approximately [***] to
develop, with the target launch date to the market place in [***].  The intent of this product is to provide a
competitive platform for a period of [***], allowing for the concurrent
definition and development of a replacement imaging platform and accompanying
software.


 


2.     Strategy and Overview


 


2.1.    Strategic Roadmap


 


The intent of this product is to position
DakoCytomation as a market leader in their target markets through the addition
of imaging technology to their expanding automated staining portfolio.   Image analysis technology will drive the
system solution advantage for DakoCytomation to support both the pharmDx and
instrument products.


 


[***]


 


2.2.    Customer Categories


 


2.2.1.       Anatomic
Pathology


 


Clinical and research
laboratories will be a primary focus for DakoCytomation.  [***].


 


2.2.2.       Education
(Medical / Dental Schools)


 


[***]


 


2.2.3.       Veterinary
labs


 


[***]


 


2.3.    Competitive Strengths and Weaknesses


 


A
recent alignment between Ventana and TriPath signified the importance of
aligning an imaging system with a supplier of reagents and automated
staining.  While the links between these
systems and workflows has been long understood, this relationship expedited the
need for a direct relationship for both Clarient as well as DakoCytomation.  [***]  Furthermore, the recent expansion of the
Clarient business model to include the build-out of an oncology reference lab,
exemplifies the need for Clarient to formulate a partnership with a reagent
manufacturer as a method of developing new algorithms on the imaging platform
that may be directly tied to new protocols on the Autostainers.


 


The
TriPath imaging system which is sold by Ventana Medical Systems under the
Trademark “VIAS”, is a single slide processing platform [***]. [***]


 


Through the
implementation of the requirements described in this document, Clarient and
DakoCytomation will have the opportunity to answer this competitive threat with
a technological and market proven product that will be superior to that
observed through the Ventana / TriPath offering.  [***]


 


3.     Affected Groups


 


3.1.    Clarient, Inc.


 


3.1.1.       Marketing


 


The Clarient Marketing
department will assist in training the DakoCytomation sales force, the
transition of responsibilities, creation and approval of marketing collateral
as well as other responsibilities as defined in the final terms of a binding
agreement between Clarient and DakoCytomation.


 










[***] Certain information on this page has been redacted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.


 


3





















 


3.1.2.       Operations


 


The Clarient Operations
department will be responsible for engineering, manufacturing, service and support
activities for the ACIS III device in accordance with these requirements as
well as the final terms of a binding agreement between Clarient and
DakoCytomation.


 


3.1.3.       Sales


 


The Clarient Sales
department will be responsible for assistance in training and guidance to the
DakoCytomation sales force, assisting in the transition of responsibilities as
well as other responsibilities as defined in the final terms of a binding
agreement between Clarient and DakoCytomation.


 


3.2.    DakoCytomation


 


3.2.1.       Marketing


 


The DakoCytomation
Marketing department will be responsible for all commercialization activities,
product specification input, competitive trending as well as other
responsibilities as defined in the final terms of a binding agreement between
Clarient and DakoCytomation.


 


3.2.2.       Logistics


 


The DakoCytomation
Logistics department will be responsible for all purchasing of finished goods
and will share inventory management responsibilities with Clarient personnel as
well as other responsibilities as defined in the final terms of a binding
agreement between Clarient and DakoCytomation.


 


3.2.3.       Regulatory


 


The DakoCytomation
Regulatory department will be responsible for all future regulatory
submissions, share in market surveillance and regulatory planning activities as
well as other responsibilities as defined in the final terms of a binding
agreement between Clarient and DakoCytomation.


 


3.2.4.       Sales


 


The DakoCytomation Sales
department will be responsible for worldwide sales activities (instrumentation and
software) as well as other responsibilities as defined in the final terms of a
binding agreement between Clarient and DakoCytomation.


 


3.2.5.       Service
and Support


 


The DakoCytomation
Service and Support department will be responsible for worldwide service and
support (instrumentation and software) as well as other responsibilities as
defined in the final terms of a binding agreement between Clarient and
DakoCytomation.


 


4.     Requirements


 


4.1.    Definitions and Acronyms


 


•      [***]


 


•      [***]


 


•      [***]


 










[***] Certain information on this page has been redacted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.


 


4





















 


4.2.    System Requirements


 


•      When the word shall is used in a statement in this document, the statement
is a testable requirement.


 


•      When the word may is used in this document, the statement is not a testable requirement.  It is merely a suggestion or example.


 


•      When the word will
is used in this document, the statement is not a testable
requirements; it is a statement of fact.


 


4.2.1.     General
Requirements


 


[***]


 


4.2.2.     Computer
Requirements


 


[***]


 


4.2.3.     User
Interface Requirements


 


[***]


 


4.2.4.     Acquisition
Requirements


 


[***]


 


4.2.5.     Review
Requirements


 


[***]


 


4.2.6.     Analysis
Requirements


 


[***]


 


4.2.7.     Data
Management


 


[***]


 


4.2.8.     Reporting
Requirements


 


[***]


 


5.     Addendum
1 – Future Design Considerations


 


The
following features and capabilities exist as future design considerations, and
are desired in the system being described here. 
While these features are not requirements for the product being
described here, they will transition to requirements in future versions of this
product.


 


5.1.    System


 


5.1.1.     Review


 


[***]


 


5.1.2.     Analysis


 


[***]


 


5.1.3.     Management


 


[***]


 


5.1.4.     Reporting


 


[***]


 










[***] Certain information on this page has been redacted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.


 


5





















 


5.2.    Legal & Regulatory Requirements


 


5.2.1.     FDA
21 CFR Part 11


 


5.2.1.1               The
product will comply with FDA 21CFR part 11 requirements pertaining to electronic
transfer of information and electronic signature.


 


5.2.1.2               Part 11
compliance will be enforced regardless of user interaction on the acquisition
instrument, or from any location utilizing the remote viewing client.


 










[***] Certain information on this page has been redacted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.


 


6





















 


 


Exhibit 15 Project Plan for ACIS III


 


[***]


 


 










[***]
Certain information comprising 1 page has been redacted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.