Exhibit 10.2


 


 






 


OPERATING AGREEMENT


 


BY AND BETWEEN


 


APPLERA CORPORATION


 


AND


 


CELERA CORPORATION


 






 


DATED AS OF 
[                   ], 2008


 


[***] indicates material that
has been omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.


 

















 


 


TABLE OF CONTENTS


 


	
  ARTICLE I DEFINITIONS

  	
  2

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Section 1.1

  	
  Definitions

  	
  2

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE II GENERAL

  	
  4

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Section 2.1

  	
  Performance

  	
  4

  
	
   

  	
  Section 2.2

  	
  General Cooperation

  	
  4

  
	
   

  	
  Section 2.3

  	
  Research and Development Activities

  	
  4

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE III OPERATING PRINCIPLES

  	
  4

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Section 3.1

  	
  Capillary Electrophoresis Sequencers

  	
  4

  
	
   

  	
  Section 3.2

  	
  Kauai Project

  	
  5

  
	
   

  	
  Section 3.3

  	
  Next Generation Sequencing Technology

  	
  6

  
	
   

  	
  Section 3.4

  	
  Real-Time Instruments

  	
  6

  
	
   

  	
  Section 3.5

  	
  Reagents

  	
  8

  
	
   

  	
  Section 3.6

  	
  Maui Project

  	
  9

  
	
   

  	
  Section 3.7

  	
  Licenses and Licensing

  	
  10

  
	
   

  	
  Section 3.8

  	
  Applera Intellectual Property

  	
  10

  
	
   

  	
  Section 3.9

  	
  Application of Restrictions in Event of Acquisitions

  	
  11

  
	
   

  	
  Section 3.10 

  	
  Use and Restrictions of Confidential Information, Know-How and Trade
  Secrets

  	
  11

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE IV RELATIONSHIP TO OTHER DOCUMENTS

  	
  12

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE V DISPUTE RESOLUTION

  	
  13

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE VI INDEMNIFICATION

  	
  13

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE VII FORCE MAJEURE

  	
  13

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE VIII TERMINATION

  	
  13

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Section 8.1

  	
  Termination

  	
  13

  
	
   

  	
  Section 8.2

  	
  Termination for Default

  	
  13

  



 


 


[***] indicates material that
has been omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.


 


i

















 


 


 


	
   

  	
  Section 8.3

  	
  Return or Destruction of Material

  	
  14

  
	
   

  	
  Section 8.4

  	
  Effect of Termination

  	
  14

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE IX OTHER REPRESENTATIONS, WARRANTIES AND COVENANTS

  	
  14

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Section 9.1

  	
  Compliance with Laws

  	
  14

  
	
   

  	
  Section 9.2

  	
  Books and Records

  	
  14

  
	
   

  	
  Section 9.3

  	
  No Other Representations or Warranties

  	
  14

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE X MISCELLANEOUS

  	
  15

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Section 10.1

  	
  Relationship of the Parties

  	
  15

  
	
   

  	
  Section 10.2

  	
  Employees of the Parties

  	
  15

  
	
   

  	
  Section 10.3

  	
  Notices

  	
  15

  
	
   

  	
  Section 10.4

  	
  Governing Law

  	
  16

  
	
   

  	
  Section 10.5

  	
  Parties in Interest; Assignment; Successors

  	
  16

  
	
   

  	
  Section 10.6

  	
  Entire Agreement

  	
  16

  
	
   

  	
  Section 10.7

  	
  Exhibits

  	
  16

  
	
   

  	
  Section 10.8

  	
  Waivers of Default

  	
  16

  
	
   

  	
  Section 10.9

  	
  Amendments

  	
  16

  
	
   

  	
  Section 10.10

  	
  Headings

  	
  16

  
	
   

  	
  Section 10.11

  	
  Severability; Enforcement

  	
  17

  
	
   

  	
  Section 10.12

  	
  No Third-Party Beneficiaries

  	
  17

  
	
   

  	
  Section 10.13

  	
  Remedies

  	
  17

  
	
   

  	
  Section 10.14

  	
  Expenses

  	
  17

  
	
   

  	
  Section 10.15

  	
  Counterparts

  	
  17

  
	
   

  	
  Section 10.16

  	
  No Set-Off

  	
  17

  
	
   

  	
  Section 10.17

  	
  Confidentiality

  	
  17

  
	
   

  	
  Section 10.18

  	
  Facilities and Systems Security

  	
  17

  
					



 


Exhibit A – Definition of HIVD Field


Exhibit B – Specified Country List


Exhibit C – Forensics and Applied
Markets


 


[***] indicates material that
has been omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.


 


ii

















 


 


OPERATING AGREEMENT


 


This Operating Agreement (this “Agreement”),
dated as of                 ,
2008 (the “Effective Date”), by and between Applera Corporation, a
Delaware corporation (“Applera”), and Celera Corporation, a Delaware
corporation (“Celera” and, collectively with Applera, the “Parties,”
and each individually, a “Party”).


 


R E C I T A L S


 


WHEREAS, prior to the Separation (as defined
below) Applera conducted its business through two business segments – the
Applied Biosystems Group, which primarily serves the life science industry,
research community and other markets, including human identity testing, biosecurity,
and quality and safety testing, by developing and marketing instrument-based
systems, consumables, software, and services (the “Applied Biosystems
Business”), and the Celera Group, which is primarily a human in vitro
diagnostics business that delivers personalized disease management through a
combination of products and services  (the “Celera
Business”); and


 


WHEREAS, the Board of Directors of Applera
has determined that it is advisable and in the best interests of Applera and
its stockholders to separate the Celera Group from Applera by way of a
redemption of all of the issued and outstanding Celera Group Common Stock
pursuant to Article IV, Section 2.4(d) of Applera’s Restated
Certificate of Incorporation (the “Separation”), so that, from and after
the date hereof, the Celera Business will be conducted through Celera, which
will be a separate, independent publicly traded company; and


 


WHEREAS, to effectuate the Separation, the
Parties have entered into that certain Separation Agreement dated as of May 8,
2008 (the “Separation Agreement”) setting forth, among other things, the
terms and conditions of the Separation (capitalized terms used herein but not
defined herein shall have the meanings set forth in the Separation Agreement);
and


 


WHEREAS, in connection with the Separation,
Applera intends to effect a name change from Applera Corporation to Applied
Biosystems Inc.; and


 


WHEREAS, in connection with the Separation,
Applera and Celera desire to enter into this Agreement to memorialize their
mutual understanding and agreement with respect to the conduct of certain
aspects of their businesses following the date hereof.


 


NOW, THEREFORE, in consideration of the
premises and the mutual covenants and agreements set forth herein and for other
good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the Parties, intending to be legally bound hereby, agree
as follows:


 


[***] indicates material that
has been omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.


 


1

















 


 


ARTICLE I


DEFINITIONS


 


Section 1.1                                      Definitions.
For purposes of this Agreement, the following terms shall have the meanings set
forth below:


 


(a)                               “Abbott
Alliance” means the strategic alliance among Abbott Laboratories,
Applera, and Celera Diagnostics, LLC, pursuant to the Abbott Alliance
Agreement.


 


(b)                                 “Abbott Alliance Agreement”
means the Restated Strategic Alliance Agreement, effective as of January 9,
2006, among Applera, Celera Diagnostics, LLC, and Abbott Laboratories.


 


(c)                                  “Abbott Supply Agreement”
means the Abbott Real-Time PCR Instrument Supply Agreement, effective as of September 14,
2004, between Applera and Abbott Laboratories.


 


(d)                                 “ASR” means an analyte
specific reagent as defined under 21 CFR §864.4020(a), as the same may be
amended or replaced from to time.


 


(e)                                  “CE” means capillary
electrophoresis.


 


(f)                                    “CE-Marked” means CE marking
in accordance with the In Vitro Diagnostics Directive (IVDD) 98/79/EC.


 


(g)                                 “CE Assays” means consumable
products used on CE sequencers for HIV genotyping, HCV genotyping, HBV
genotyping, CF, Fragile X, and HLA typing assays for the analysis of nucleic
acids in the HIVD Field.


 


(h)                                 “CF” means cystic fibrosis.


 


(i)                                     “CT” means Chlamydia
trachomatis.


 


(j)                                     “Factor II” means
prothrombin, a protein involved in blood clotting, and the gene that encodes it
or a variant thereof.


 


(k)                                  “Factor V” means a protein
involved in blood clotting, and the gene that encodes it or a variant thereof, such as factor V Leiden.


 


(l)                                     “Fragile X” means Fragile X
syndrome.


 


(m)                               “GPR” or “General Purpose
Reagent” means a chemical or biological reagent that (i) is not an ASR
and (ii) has general laboratory application.


 


(n)                                 “Group” means either the
Applied Biosystems Group or the Celera Group.


 


(o)                                 “[***]” means [***].


 


(p)                                 “HBV” means hepatitis B
virus.


 


[***] indicates material that
has been omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.


 


2

















 


 


(q)                                 “HCV” means hepatitis C
virus.


 


(r)                                    “HIV” means human
immunodeficiency virus.


 


(s)                                  “HIVD Field” means the field
of human in vitro diagnostics as defined on Exhibit A
attached hereto.


 


(t)                                    “HLA” means human leukocyte
antigen.


 


(u)                                 “[***]” means [***].


 


(v)                                 “Kauai Project” means the
Celera instrument development project code-named “Kauai” by the Parties for
internal reference purposes.


 


(w)                               “Licensed IP” means any
Applera intellectual property previously licensed by Celera under the terms of (i) the
Real-Time Instrument Patent License Agreement, effective as of April 5,
2004, between Applera and Cepheid, (ii) the Real-Time Instrument Patent
License Agreement, effective as of April 25, 2006, and Diagnostics Field
DNA Sequencing Sublicense Agreement, effective as of April 25, 2006,
between Applera and Beckman Coulter, Inc., or (iii) the License
Agreement, effective as of July 1, 2007, and Sequence Analysis License
Agreement, effective as of April 20, 2000, between Applera and Siemens
Medical Solutions Diagnostics.


 


(x)                                   “Maui Assays” means
consumable products resulting from the Maui Project for HIV genotyping, HCV
genotyping, HBV genotyping, CF, Fragile X, and HLA typing assays for the
analysis of nucleic acids in the HIVD Field.


 


(y)                                 “Maui Project” means the
Applera instrument development project code-named “Maui” by the Parties for
internal reference purposes.


 


(z)                                   “[***]” means [***].


 


(aa)                                      “NG” means Neisseria
gonorrhoeae.


 


(bb)                                    “OEM” means a supply
arrangement whereby Applera supplies a product to a third party that (i) is
not a distributor, agent or wholesaler for Applera, and (ii) resells such
product.  A specific example of a company
that is not a distributor, agent or wholesaler for Applera is a company that
commercializes diagnostic products globally.


 


(cc)                                      “Real-Time Assays” means
real-time PCR-based assays for the analysis of nucleic acids of HIV, HCV, HBV, [***],
CT, NG, [***], and [***] in the HIVD Field.


 


(dd)                                    “Real-Time Instrument” means
a real-time PCR thermal cycler covered by the claims of US Patent No. 6,814,934.


 


(ee)                                      “Specified Countries” means
the countries and territories, as commonly recognized as of the Effective Date,
including any such country and territory as may be 


 


[***] indicates material that
has been omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.


 


3

















 


 


subsequently recognized by a different name,
set forth on the “Specified Country List” attached hereto as Exhibit B.


 


(ff)                                          “Specified Supplier” means
[***].


 


(gg)                                    “Supply Agreement” means that
certain Master Purchase Agreement between the Parties of even date with this
Agreement pursuant to which Applera is to supply certain products to Celera.


 


ARTICLE II


GENERAL


 


Section 2.1                                      Performance.  Applera and Celera hereby agree that each
Party shall use commercially reasonable efforts to take, or cause to be taken,
all actions, and to do, or cause to be done, all things necessary, proper or
advisable under applicable laws to comply with the terms of this Agreement,
including the operating principles set forth in Article III hereof.


 


Section 2.2                                      General
Cooperation.  Subject to the terms
and conditions set forth in this Agreement, Applera and Celera shall each use
commercially reasonable efforts to provide to the other Party any information
and documentation reasonably required in the performance of such other Party’s
obligations hereunder, and make available, as reasonably requested by the other
Party, sufficient resources and timely decisions, approvals and acceptances in
order that each Party may fulfill its obligations under this Agreement in a
timely and efficient manner.


 


Section 2.3                                      Research and
Development Activities.  Applera and
Celera agree that (i) the human in vitro diagnostics business of Celera
includes research and development activities toward commercialization of
products and services in the HIVD Field and (ii) the restrictions imposed
on Applera pursuant to this Agreement shall not prevent Applera from conducting
its own research and development activities in the HIVD Field at any time
during the term of this Agreement.


 


ARTICLE
III


OPERATING PRINCIPLES


 


Section 3.1                                      Capillary Electrophoresis Sequencers.


 


(a)                                  Abbott Alliance. 
From and after the Effective Date, Applera shall provide to Abbott
Laboratories (“Abbott”), as provided for in the Abbott Alliance
Agreement, and/or Celera the current (as of the Effective Date) CE sequencers
of Applera and associated consumables, in each case, as they have been provided
by Applera to Abbott and/or Celera in connection with the Abbott Alliance prior
to the Effective Date or as otherwise provided under a separate supply
agreement between Applera and Celera.


 


(b)                                 Rights of Celera. 
From and after the Effective Date and to the extent not otherwise
provided to Abbott and/or Celera, Applera shall provide Celera with CE sequencers
and associated consumables in the same manner as provided to other third party
customers of 


 


[***] indicates material that
has been omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.


 


4

















 


 


Applera.  In the event that Celera wishes to purchase
CE sequencers developed by Applera but not otherwise offered for sale, the
Parties shall negotiate in good faith the terms and conditions of such access.


 


(c)                                  Restrictions on Celera


 


(i)                                             Celera shall purchase CE sequencers
described in (a) and (b), above, and associated consumables, pursuant to
the Supply Agreement.


 


(ii)                                          Celera may only sell such CE
sequencers and associated consumables in the HIVD Field.


 


(d)                                 Rights of Applera. 
Applera may:


 


(i)                                   sell any CE sequencer to any
end-user for any purpose; and


 


(ii)                                OEM any CE sequencer to any customer
(an “OEM Customer”) for any purpose; provided, however,
that any such OEM Customer shall agree that it shall not commercialize any CE
Assay on such CE sequencer in any country or territory other than the Specified
Countries for a period of three (3) years following the Effective Date,
subject to Section 3.9(c) hereof.


 


(e)                                  Restrictions on Applera. 
Applera shall not:


 


(i)                                   [***];


 


(ii)                                commercialize any CE Assay for a
period of three (3) years following the Effective Date, subject to Section 3.9
hereof; or


 


(iii)                             enter into an agreement with a third
party to co-promote or co-market CE sequencers to be used with CE Assays, in
any country or territory other than the Specified Countries for a period of
three (3) years following the Effective Date, subject to Section 3.9
hereof.


 


Section 3.2                                    Kauai
Project.


 


(a)                                  Project Development. 
Celera may develop products under the Kauai Project that comply with the
requirements of the United States Food and Drug Administration (the “FDA”),
and shall pay all costs associated with meeting such requirements.  Celera and Applera shall enter into good
faith negotiations to conclude an agreement regarding the Kauai Project, on
mutually agreed upon terms, covering, among other things, support of Celera’s
development activities (“Kauai Agreement”).


 


 


[***] indicates material that
has been omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.


 


5

















 


 


 


(b)                                 Kauai Products.


 


(i)                                   The products resulting from the
Kauai Project shall be intended for use in the HIVD Field, but not intended for
use outside the HIVD Field.


 


(ii)                                Celera shall be the manufacturer of
record for products resulting from the Kauai Project.


 


(iii)                             Products resulting from the Kauai
Project may only be sold by Celera and only for use in the HIVD Field.


 


(iv)                            Except as otherwise agreed by the
Parties, Applera shall not sell any instrument resulting from the Kauai
Project.


 


(c)                                  Access to Specified
Supplier.  Applera agrees to use commercially
reasonable efforts to facilitate Celera access to the Specified Supplier for
the purpose of development and commercialization of products under the Kauai
Project.


 


(i)                                   In the event that Celera is legally
required to source products resulting from the Kauai Project directly from the
Specified Supplier, it shall be permitted to do so, and in such event Applera
shall be entitled to receive compensation from Celera in an amount equal to the
amount of incremental proceeds Applera would have received had the products been
sourced directly from it.  The amount of
such incremental proceeds would be calculated in accordance with the provisions
of the Kauai Agreement.


 


Section 3.3                                    Next Generation
Sequencing Technology.  It is the
intent and mutual understanding of the Parties that this Agreement shall not
constitute or be deemed to constitute any commitment or obligation for the
Parties to collaborate on any “next generation” sequencing instrument.  Specifically, this Agreement places no
restrictions whatsoever on either Party relating to the development or
commercialization of next generation sequencing instruments.


 


Section 3.4                                    Real-Time
Instruments.


 


(a)                                  Real-Time Instruments.


 


(i)                                   Except for the restrictions under
the Abbott Supply Agreement in effect as of the Effective Date or as such
agreement may be amended by the parties to that agreement with Celera’s
approval (not to be unreasonably withheld or delayed), Applera shall be
permitted to sell Real-Time Instruments, including instruments registered with
a regulatory authority, to any end user for any purpose; and


 


 


[***] indicates material that
has been omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.


 


6

















 


 


 


(ii)                                Except for the Abbott Supply
Agreement in effect as of the Effective Date or as such agreement may be
amended by the parties to that agreement with Celera’s approval (not to be
unreasonably withheld or delayed), Applera shall not OEM Real-Time Instruments
to any OEM Customer for use in the HIVD Field unless such OEM Customer has
obtained a license to the relevant


 


Licensed IP for real-time technology in the
HIVD Field; provided, however, that any such OEM Customer shall
also agree that it shall not commercialize any Real-Time Assay on such
Real-Time Instruments, unless otherwise agreed to by Applera and Celera, for a
period of three (3) years following the Effective Date, subject to Section 3.9(c)
hereof.


 


(iii)                             Applera shall not enter into an
agreement with a third party to co-promote or co-market Real-Time Instruments
to be used with Real-Time Assays,  in
any country or territory other than the Specified Countries for a period of
three (3) years following the Effective Date, subject to Section 3.9
hereof.


 


(b)                                 Preferred Supplier Designation. 
Applera will be the preferred supplier of Celera’s next generation
Real-Time Instrument, subject to the following terms and conditions:


 


(i)                                   The Parties agree to negotiate in
good faith the terms of a supply agreement for such instrument; and


 


(ii)                                If, after negotiating in good faith, the
Parties are unable to enter into such supply agreement within [***] following
receipt of a notice from Celera specifying the date on which the Parties shall
commence such negotiation (which date may not be prior to the date of the
notice), the Parties may agree to a [***] extension.  If the Parties are unable or unwilling to agree to an
extension or if no agreement is reached during any such extension, Celera shall
be granted [***] to all intellectual property owned by Applera and all
intellectual property which Applera has the right to sublicense (and Celera
shall bear the cost of any pass through royalties that would be associated with
that sublicense) as of the Effective Date that is necessary to make or to have
a next generation Real-Time Instrument made and supplied by a third party only
to Celera; provided, however, that the terms of any such
third-party supply relationship shall be no less favorable to Celera than the
terms last proposed by Applera; and, provided  further, that such
third party shall not be infringing or challenging any patents of Applera
related to such next generation real-time instruments at the time when Celera
enters into a supply agreement with such third party.


 


 


 


[***] indicates material that
has been omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.


 


7

















 


 


Section 3.5                   Reagents.


 


(a)                                  Sequence Specific Primers and
Probes.  Applera agrees that it will not knowingly
commercialize any sequence-specific primers and probes (i) for
incorporation by a third party product manufacturer into its products for
performing testing in the HIVD Field or (ii) to a clinical laboratory for
performing home-brew testing, in either case, for HIV, HCV, HBV, [***], CT, NG,
Factor V, Factor II, [***], CF, HLA, Fragile X, and [***], for a period of
three (3) years following the Effective Date, subject to Section 3.9
hereof; provided, however, that:


 


(i)                                   Applera may request that Celera
waive this restriction for Applera to commercialize such primers and probes
during the three (3) year period following the Effective Date for specific
opportunities, it being understood that the decision to so waive this
restriction shall be made by Celera in its sole discretion;


 


(ii)                                Applera shall not be obligated to
actively monitor third party conduct for any inadvertent violation, but Applera
and Celera shall discuss an appropriate course of action upon notice from
Celera with reasonable evidence of violation of this provision or if Applera
otherwise becomes aware of such a violation; and


 


(iii)                             The restrictions set forth in this Section 3.5
shall not apply to sales to any third party for sale or use within any
Specified Country.


 


(b)                                 Analyte Specific Reagents (ASRs). 
Applera shall not commercialize, directly or through a distributor, ASRs
or kits for performing human testing in the HIVD Field for HIV, HCV, HBV,
[***], CT, NG, Factor V, Factor II, [***], CF, HLA, Fragile X, and [***], for a
period of three (3) years following the Effective Date, subject to Section 3.9
hereof.


 


(c)                                  General Purpose Reagents (GPRs). 
This Agreement provides no restrictions or limitations on the ability of
Applera to sell GPRs.


 


(d)                                 Other Limitations.


 


(i)                                   Except for the rights granted
pursuant to the HLA License Agreement, Applera shall not have any rights to
Celera’s intellectual property assigned to it by Applera pursuant to the
Separation Agreement.  In the event that
Applera has a product that infringes Celera’s intellectual property, and upon
notice from Celera with reasonable evidence of unlicensed activity, Applera
shall stop selling such product.  Applera
may resume sales of such product if Applera or its customers are no longer (or
are not) infringing Celera’s intellectual property rights in the HIVD Field,
unless otherwise prohibited herein.


 


[***] indicates material that
has been omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.


 


8














 


	
  (ii)

  	
  Celera shall not commercialize, directly or through a distributor,
  products in the forensics and applied markets listed on Exhibit C hereto
  that incorporate intellectual property owned by Applera or which Applera has
  the exclusive right to sublicense, unless Celera obtains a license directly
  or indirectly to the relevant intellectual property from Applera under
  standard third party terms to be mutually agreed upon.

  



 


Section 3.6               Maui
Project.


 


(a)                                                     Project Development. 
Products developed by Applera under the Maui Project need not be
submitted by Applera for registration with the FDA in the United States, but
may be registered with any other regulatory authority.  Furthermore, it is understood by the Parties
that any instrument developed under the Maui Project shall not be “Alliance
Products” or “Alliance Technology” (as such terms are defined in the Abbott
Alliance Agreement) and shall be treated within the Abbott Alliance in the same
manner as other similar products of Applera that are not “Alliance Products” or
“Alliance Technology.”


 


(b)                                                    Rights of Applera. 
In connection with the Maui Project, Applera shall be free to:


 


	
  (i)

  	
  sell any product resulting from the Maui Project to any end-user for
  any purpose; and

  
	
   

  	
   

  
	
  (ii)

  	
  OEM any product resulting from the Maui Project to any customer for
  any purpose; provided, however, that any such OEM Customer
  shall agree that it shall not commercialize any Maui Assay in any country or
  territory other than the Specified Countries for a period of three (3) years
  following the Effective Date, subject to Section 3.9(c) hereof.

  



 


(c)                                                     Restrictions on Applera. 
In connection with the Maui Project, Applera shall not:


 


	
  (i)

  	
  supply or OEM any instrument resulting from the Maui Project to
  Abbott other than through the Abbott Alliance; or

  
	
   

  	
   

  
	
  (ii)

  	
  commercialize the Maui Assays for a period of three (3) years
  following the Effective Date, subject to Section 3.9 hereof.

  



 


(d)                                                    Celera Rights and Restrictions. 
Celera may purchase products resulting from the Maui Project through the
Supply Agreement.  In addition, Celera
may only sell products resulting from the Maui Project for use in the HIVD
Field.


 


(e)                                  US FDA Cleared or Approved
Version of Maui.  Applera agrees that if it obtains FDA
clearance or approval on an instrument developed under the Maui Project in the
United States, or any instrument that is substantially based on the design and
throughput of an 


 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.


 


9

















 


instrument developed under the Maui Project,
it will make such FDA cleared or approved version of the Maui product available
to Celera under the Supply Agreement.


 


Section 3.7             Licenses
and Licensing.


 


(a)                                                     Celera Licensing Rights. 
There shall be no restrictions on Celera’s ability to license any
intellectual property assigned to Celera by Applera as of the Effective Date.


 


(b)                                                    Licensed Intellectual Property. 
Subject to the following conditions, Celera and Applera shall work
together in good faith to license to third parties the Licensed IP in the HIVD
Field:


 


	
    (i)

  	
  All such licenses shall be consistent with existing licenses to the
  Licensed IP; provided, however, that the terms of a new HIVD
  Field license to an existing non-HIVD Field licensee shall use

  
	
   

  	
  language and terms that do not conflict with the terms (especially
  definitions of fields) of the existing license to said licensee.

  
	
   

  	
   

  
	
  (ii)

  	
  Celera  shall have
  primary responsibility for negotiation of the licenses, although Applera will
  be kept informed of, and have the right to participate in, all such
  negotiations.  Celera will provide
  Applera with reasonable prior notice of meetings, whether in person or by
  phone, with potential licensees. 
  Celera will also provide Applera with reasonable time to review
  documents prior to sending them to potential licensees.

  
	
   

  	
   

  
	
  (iii)

  	
  All revenue generated by such licenses shall be shared equally
  between Celera and Applera.

  
	
   

  	
   

  
	
  (iv)

  	
  The Parties have agreed on a list of approved licensees and a general
  framework for licenses.  Transactions
  by either Party with such licensees and consistent with such general
  framework shall not require any further approval of the other Party.  Other licensees and/or changes from the
  framework shall require approval of both Parties.

  
	
   

  	
   

  
	
  (v)

  	
  From and after the Effective Date, Celera and Applera shall share
  costs associated with the Licensed IP, which costs include maintenance,
  prosecution, enforcement, and defense costs, in such proportion as may be
  agreed by the Parties or as is necessary and appropriate to reflect the
  relative financial and other benefits received by each Party.  Any disagreement regarding the allocation
  of such costs shall be resolved in accordance with the dispute resolution
  procedures set forth in Article XIII of the Separation Agreement.

  



 


Section 3.8                                                Applera Intellectual Property. Except as otherwise provided
herein, ownership of, and all rights in all fields to, Applera intellectual
property shall remain with the 


 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.


 


10

















 


Party that is the successor to the Group
(including by way of name change) responsible for prosecuting or maintaining
such intellectual property prior to the Separation.


 


Section 3.9                                      Application of Restrictions in Event
of Acquisitions.


 


(a)                                            Acquisition of Competing
Product.  Notwithstanding any other provision
hereof, the restrictions relating to assays described in Section 3 above do not
apply to, and shall not restrict, on a product-by-product basis, the commercialization
of an Existing Competing Product (as defined below) acquired as part of an
acquisition of a third party or business by Applera or any Affiliate, nor shall
any such provision prohibit an acquirer of Applera from continuing to
commercialize an Existing Competing Product following its acquisition of
Applera.


 


(b)                                          Definition of Existing Competing
Product.  For purposes of this Agreement, “Existing
Competing Product” means a product that (i) a third party has: (w) commercialized
on or before the date of acquisition, or (x) submitted to a regulatory
authority for approval or clearance on or before the date of acquisition, or (y) initiated
clinical trials in connection with regulatory submission on or before the date
of acquisition, or (z) Quality System Regulation documentation showing
that such product was in development before May 1, 2008 and (ii) is a
CE Assay, Maui Assay, or Real-Time Assay.


 


(c)           Use of Applera Technology.  Notwithstanding any other
provision hereof, in the event Applera is acquired by a third party, and such
acquirer elects to produce a competing product that is not dependent on Applera
technology, it will be free from any restrictions on such competing product
under this Agreement.  For the avoidance
of doubt, the fact that an acquirer has obtained a license under rights from
Applera to make, have made, use and sell the competing product but that the
competing product is substantially the result of the design and development of
the acquirer, shall not be construed for purposes herein as being “dependent on
Applera technology.”


 


Section 3.10  Use and Restrictions of Confidential
Information, Know-How and Trade Secrets.


 


(a)           Any Information Known solely by one
Group prior to the Effective Date (“Sole Information”) will be owned solely by
the Party that is the successor to that Group (including by way of name change)
after the Effective Date.  Neither Party
shall be permitted to use or disclose Sole Information of the other Party,
except to the extent that such Sole Information (i) is or becomes
generally available to the public, (ii) is independently developed after
the Effective Date by the Party that did not Know such Information prior to the
Effective Date, or (iii) becomes available after the Effective Date to the
Party that did not Know such Information prior to the Effective Date on a
nonconfidential basis from a source other than the other Party, provided that
such source is not subject to a confidentiality agreement or other obligation
of confidentiality to the other Party or any other Person with respect to any
of such Information.  For purposes of
this Section 3.10(a), “Know” shall mean actual knowledge, as well as
Information in a Party’s possession in written, electronic or other tangible or
intangible forms, stored in any medium.


 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.


 


11

















 


(b)           With respect to Information relating
to the Celera Business or the Applied Biosystems Business that is Known by both
Groups (“Joint Information”), Celera’s use of such Joint Information after the
Effective Date shall be limited to the HIVD Field.  However, Celera may use or disclose to third
parties for any purpose such Joint Information primarily generated by the
Celera Group using its resources prior to the Effective Date, except for those
assets and businesses that have been transferred to the Applied Biosystems
Group (including, by way of example, the assets transferred by Celera to the
Applied Biosystems Group related to the Celera Discovery System).  If the Joint Information relates to the
Applied Biosystems Business and was primarily generated by the Applied
Biosystems Group using its resources prior to the Effective Date, Celera may
not disclose such Joint Information without the approval of Applera.  For purposes of this Section 3.10(b),
Joint Information shall not include Information that (i) is or becomes
generally available to the public other than through any act in violation of
this Agreement by the Party seeking to use or disclose such Joint Information, (ii) is
independently developed after the Effective Date by the Party seeking to use or
disclose such Joint Information, or (iii) becomes available after the
Effective Date to the Party seeking to use or disclose such Joint Information
on a nonconfidential basis from a source other than the other Party, provided
that such source is not subject to a confidentiality agreement or other
obligation of confidentiality to the other Party or any other Person with
respect to any of such Information.


 


(c)           Applera shall not use or disclose
Information that specifically relates to FDA requirements for registration of
an instrument under the Kauai Project as of the Effective Date, that was
primarily generated by the Celera Group using its resources prior to the
Effective Date, and that is Known by both Groups (the “FDA Information”).  For purposes of this Section 3.10(c),
FDA Information shall not include Information that (i) is or becomes
generally available to the public other than through any act of Applera in
violation of this Agreement, (ii) is independently developed by Applera
after the Effective Date, or (iii) becomes available to Applera after the
Effective Date on a nonconfidential basis from a source other than Celera,
provided that such source is not subject to a confidentiality agreement or
other obligation of confidentiality to Celera or any other Person with respect
to any of such FDA Information.  In
addition, Applera shall not use or disclose: (i) Celera’s Quality Manual
and associated operating procedures for conformance to FDA’s Quality System
Regulation; (ii) strategic plans of the Celera Business as presented by
Celera’s executive management to Applera’s executive management; or (iii) Celera’s
diagnostic product designs and batch records. 
In the event that Applera elects to seek FDA registration for an
instrument under the Maui Project, it shall make a good faith effort to avoid
using the Celera Group’s Kauai design and specifications required for FDA
compliance that is Known to the Applied Biosystems Group prior to the Effective
Date.  Notwithstanding its use of good
faith efforts, in the event Applera should inadvertently use any of such
Information specified in this Section 3.10(c), the Parties will discuss an
appropriate course of action for such inadvertent use, prior to subjecting the
matter to the Dispute Resolution Procedures set forth in Article V of this
Agreement.


 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.


 


12

















 


ARTICLE IV


RELATIONSHIP TO
OTHER DOCUMENTS


 


If there is
any conflict or inconsistency between the terms and conditions of this
Agreement and the Separation Agreement, the provisions of this Agreement shall
control solely with respect to the rights and obligations of the Parties set
forth herein.


 


ARTICLE V


DISPUTE RESOLUTION


 


If a dispute
arises between the Parties with respect to the terms and conditions of this
Agreement, or any subject matter governed by this Agreement, the Parties agree
to use and follow the dispute resolution procedures set forth in Article XIII
of the Separation Agreement to resolve any such dispute.


 


ARTICLE VI


INDEMNIFICATION


 


Each Party shall indemnify, defend and hold
harmless the other Party, against and in respect of any and all Indemnifiable
Losses that result from, relate to or arise out of this Agreement, to the
extent and in the manner set forth in Article XI of the Separation
Agreement, except to the extent that any such Indemnifiable Losses arise out of
or result from the gross negligence or willful misconduct of such other Party.


 


ARTICLE VII


FORCE MAJEURE


 


No Party shall be in default of this
Agreement to the extent that any delay or failure in the performance of its
obligations under this Agreement results from any cause beyond its reasonable
control and without its fault or negligence, such as acts of God, acts of civil
or military authority, embargoes, epidemics, war, riots, insurrections, fires,
explosions, earthquakes, floods, unusually severe weather conditions, power
failures, communication failures including internet disruptions, equipment
failures, labor problems or unavailability of parts.  In the event of any such excused delay, the
time for performance shall be extended for a period equal to the time lost by
reason of the delay.


 


ARTICLE VIII


TERMINATION


 


Section 8.1          Termination.  This Agreement may be terminated at any time
by the mutual written consent of the Parties.


 


Section 8.2          Termination
for Default.  In the event: (i) either
Party shall default, in any material respect, in the due performance or
observance by it of any of the other terms, 


 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.


 


13

















 


covenants or
agreements contained in this Agreement or (ii) either Party shall become
or be adjudicated insolvent and/or bankrupt, or a receiver or trustee shall be appointed
for either Party or its property or a petition for reorganization or
arrangement under any bankruptcy or insolvency law shall be approved, or either
Party shall file a voluntary petition in bankruptcy or shall consent to the
appointment of a receiver or trustee, the non-defaulting Party shall have the
right, at its sole discretion, (A) in the case of a default under clause
(ii), to immediately terminate this Agreement, and (B) in the case of a
default under clause (i), to terminate this Agreement if the defaulting Party
has failed to (x) cure the default within thirty (30) days of written
notice of default or if the default (except for defaults as a result of failure
to make payment) is such that it will take more than thirty (30) days to cure,
within an extended time period which shall be not longer than what is
reasonably necessary to effect performance or compliance or (y) diligently
pursue the curing of the default.


 


Section 8.3          Return
or Destruction of Material.  Upon
termination of this Agreement, each of Applera and Celera will, and will cause
their respective Subsidiaries to, return or destroy any and all material and
property of a proprietary nature involving the other Party and its
Subsidiaries, in its possession or control, within thirty (30) days after the
termination of this Agreement. 
Notwithstanding anything to the contrary contained in this Agreement,
upon the termination or expiration of this Agreement, Celera shall no longer be
entitled to, and shall cease all access to Applera’s information, data, systems
and other assets that are not Celera Group Assets and Applera shall no longer
be entitled to, and shall cease all access to Celera’s information, data,
systems and other assets that are not Applied Biosystems Group Assets.


 


Section 8.4             Effect of Termination.  The provisions of Section 3.10 and
Articles IV, V, VI, VII, VIII and X shall survive the termination or expiration
of this Agreement.


ARTICLE IX


OTHER
REPRESENTATIONS, WARRANTIES AND COVENANTS


 


Section 9.1             Compliance with Laws.  Each Party shall comply, at its own expense,
with the provisions of all laws applicable to the performance of its
obligations under this Agreement.


 


Section 9.2             Books and Records.  Each Party or its Affiliates will maintain
books and records substantially similar to those maintained prior to the date
hereof pertaining to that portion of the Applera businesses attributable to
such Party.  Each Party or its Affiliates
will provide the other Party with access to such books and records in
accordance with the provisions of Section 9.2 of the Separation
Agreement.  All such information shall be
subject to the terms of the confidentiality provisions set forth in Section 9.6
of the Separation Agreement.


 


Section 9.3             No Other Representations or
Warranties.  EXCEPT FOR THE
REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER
PARTY NOR ANY OTHER PERSON MAKES ANY OTHER EXPRESS OR IMPLIED REPRESENTATION OR
WARRANTY ON BEHALF OF EITHER PARTY WITH RESPECT TO THE APPLERA BUSINESSES, AT
LAW OR IN EQUITY, 


 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.


 


14

















 


INCLUDING,
WITHOUT LIMITATION, WITH RESPECT TO MERCHANTABILITY OR FITNESS FOR ANY
PARTICULAR PURPOSE, AND ANY SUCH OTHER REPRESENTATIONS OR WARRANTIES ARE HEREBY
EXPRESSLY DISCLAIMED.


 


ARTICLE X


MISCELLANEOUS


 


Section 10.1           Relationship of the Parties.  The Parties declare and agree that each Party
is engaged in a business that is independent from that of the other Party and
each Party shall perform its obligations as an independent contractor.  It is expressly understood and agreed that
Celera and Applera are not partners or joint venturers, and nothing contained
herein is intended to create an agency relationship or a partnership or joint
venture.  Neither Applera nor any of its
Affiliates is an agent of Celera or any of its Affiliates and has no authority
to represent Celera or any of its Affiliates as to any matters, except as
provided in Section 3.2(c) of this Agreement or in writing by Celera
from time to time.  Neither Celera nor
any of its Affiliates is an agent of Applera or any of its Affiliates and has no
authority to represent Applera or any of its Affiliates as to any matters,
except as authorized in this Agreement or in writing by Applera from time to
time.


 


Section 10.2           Employees of the Parties.  Applera shall be solely responsible for
payment of compensation to its employees and for any injury to them in the
course of their employment.  Applera
shall assume full responsibility for payment of all federal, state and local
taxes or contributions imposed or required under unemployment insurance, social
security and income tax laws with respect to such persons.  Celera shall be solely responsible for
payment of compensation to its employees and for any injury to them in the
course of their employment.  Celera shall
assume full responsibility for payment of all federal, state and local taxes or
contributions imposed or required under unemployment insurance, social security
and income tax laws with respect to such persons.


 


Section 10.3        Notices.  All notices, requests, demands, waivers and
communications required or permitted to be given under this Agreement shall be
in writing (which shall include notice by telecopy or like transmission) and
shall be deemed given (i) on the day delivered (or if that day is not a
Business Day, on the first following Business Day) when (x) delivered
personally against receipt or (y) sent by overnight courier, (ii) on
the day when transmittal confirmation is received if sent by telecopy (or if
that day is not a Business Day, on the first following Business Day) and (iii) on
the third Business Day after mailed by certified or registered first-class mail
to the Parties at the following addresses (or to such other addresses as a
Party may have specified by notice given to the other Party hereto pursuant to
this provision):


 


	
  If to Applera,
  to:

  
	
   

  	
   

  
	
   

  	
  Applera Corporation

  
	
   

  	
  301 Merritt 7

  
	
   

  	
  Norwalk, Connecticut 06851

  
	
   

  	
  Attention: General Counsel

  
	
   

  	
  Facsimile: (203) 840-2902

  



 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.


 


15

















 


	
  With a copy to:

  
	
   

  	
   

  
	
   

  	
  Applied Biosystems

  
	
   

  	
  850 Lincoln Centre Drive

  
	
   

  	
  Foster City, California 94404

  
	
   

  	
  Attention: Vice President Intellectual
  Property

  
	
   

  	
  Facsimile: (650) 638-6677

  
	
   

  	
   

  
	
  If to
  Celera, to:

  
	
   

  	
   

  
	
   

  	
  Celera Corporation

  
	
   

  	
  1401 Harbor Bay Parkway

  
	
   

  	
  Alameda, California 94502

  
	
   

  	
  Attention: President

  
	
   

  	
  Facsimile: (510) 749-4267

  



 


Section 10.4        Governing
Law.  This Agreement shall be governed
by, and construed in accordance with, the laws of Delaware, without reference
to choice of law principles, including matters of construction, validity and
performance.


 


Section 10.5        Parties
in Interest; Assignment; Successors. 
Neither this Agreement nor any of the rights, interests or obligations
hereunder shall be assigned by any of the Parties hereto (other than to a
successor of either Party by way of merger, consolidation, sale of all or
substantially all of such Party’s assets or similar transaction) without the
prior written consent of the other Parties. 
Subject to the preceding sentence, this Agreement shall inure to the
benefit of and be binding upon Celera and Applera and their respective
Subsidiaries, successors and permitted assigns. 
Nothing in this Agreement, express or implied, is intended to confer
upon any other Person any rights or remedies under or by reason of this
Agreement.


 


Section 10.6        Entire
Agreement.  This Agreement, including
the schedules, appendices, certificates, instruments and agreements delivered
pursuant hereto, contain the entire understanding of the Parties hereto and
thereto with respect to the subject matter contained herein and therein, and
supersede and cancel all prior agreements, negotiations, correspondence, undertakings
and communications of the Parties, oral or written, respecting such subject
matter.


 


Section 10.7        Exhibits.  All exhibits referenced in this Agreement and
attached hereto are incorporated into this Agreement by reference and made a
part hereof.


 


Section 10.8        Waivers
of Default.  Waiver by any Party of
any default by any other Party of any provision of this Agreement (a) shall
be effective only if in writing; and (b) if given, shall not be deemed a
waiver by the waiving Party of any subsequent or other default, nor shall it
prejudice the rights of the other Party.


 


Section 10.9           Amendments.  No provisions of this Agreement shall be
deemed amended, supplemented or modified by any Party, unless such amendment,
supplement or 


 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.


 


16

















 


modification is in writing and signed by the authorized representative
of the Party against whom such waiver, amendment, supplement or modification is
sought to be enforced.


 


Section 10.10      Headings  The article, section and paragraph headings
contained in this Agreement are for reference purposes only and shall not
affect in any way the meaning or interpretation of this Agreement.  All references herein to “Articles” or
“Sections” shall be deemed to be references to Articles or Sections hereof
unless otherwise indicated.


 


Section 10.11      Severability;
Enforcement.  The invalidity of any
portion hereof shall not affect the validity, force or effect of the remaining
portions hereof.  If it is ever held that
any restriction hereunder is too broad to permit enforcement of such
restriction to its fullest extent, each Party agrees that a court of competent
jurisdiction may enforce such restriction to the maximum extent permitted by
law, and each Party hereby consents and agrees that such scope may be
judicially modified accordingly in any proceeding brought to enforce such
restriction.


 


Section 10.12      No
Third-Party Beneficiaries.  Nothing
in this Agreement shall confer any rights upon any Person or entity other than
the Parties and their respective heirs, successors and permitted assigns.


 


Section 10.13         Remedies.  The Parties agree that money damages or other
remedy at law would not be a sufficient or adequate remedy for any breach or
violation of, or a default under, this Agreement by them and that in addition
to all other remedies available to them, each of them shall be entitled to the
fullest extent permitted by law to an injunction restraining such breach,
violation or default or threatened breach, violation or default and to any
other equitable relief, including specific performance, without bond or other
security being required.


 


Section 10.14         Expenses.  Except as otherwise provided in this
Agreement, the Parties shall bear their own expenses (including all time and
expenses of counsel, financial advisors, consultants, actuaries and independent
accountants) incurred in connection with this Agreement.


 


Section 10.15         Counterparts.  This Agreement may be executed in one or more
counterparts, which may be delivered by facsimile or scanned electronic copy in
pdf format, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.


 


Section 10.16         No Set-Off.  The obligations under this Agreement shall
not be subject to set-off for non-performance or any monetary or non-monetary
claim by any Party or any of their respective Affiliates under any other
agreement between the Parties or any of their respective Affiliates.


 


Section 10.17         Confidentiality.  Disclosure and use of Confidential
Information by the Parties shall be governed by Section 9.6 of the Separation
Agreement and Section 3.10 of this Agreement.


 


Section 10.18         Facilities
and Systems Security.  If either
Party or its personnel shall be given access to the other Party’s facilities,
premises, equipment or systems, such Party 


 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.


 


17

















 


 


shall comply with all such
other Party’s written security policies, procedures and requirements made
available by each Party to the other, and shall not tamper with, compromise, or
circumvent any security or audit measures employed by such other Party.  Each Party shall use its reasonable best
efforts to ensure that only those of its personnel who are specifically
authorized to have access to the facilities, premises, equipment or systems of
the other Party gain such access, and to prevent unauthorized access, use,
destruction, alteration or loss in connection with such access.


 


[SIGNATURE PAGE FOLLOWS]


 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.


 


18














 


IN WITNESS
WHEREOF, the Parties hereto have executed and delivered this Agreement as of
the date first above written.


 


 


	
   

  	
  APPLERA CORPORATION

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
  Name:

  
	
   

  	
   

  	
  Title:

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  CELERA CORPORATION

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
  Name:

  
	
   

  	
   

  	
  Title:

  



 






[***]
indicates material that has been omitted pursuant to a request for confidential
treatment. The omitted material has been filed separately with the Securities
and Exchange Commission.


 

















 


Exhibit A


 


Definition of HIVD Field


 


Human
In Vitro Diagnostics Field.  The phrase “Human In Vitro Diagnostics Field”
shall mean the field of use comprising products, technologies, services and/or
processes for use in the measurement, observation or determination of
attributes, characteristics, diseases, traits or other conditions of a human
being:


 


	
  ·

  	
   

  	
  for the
  medical management of a human being; and/or

  
	
  ·

  	
   

  	
  for quality
  control or testing of human blood or tissue for transfusion or blood banking,
  bone marrow transplantation or banking, or tissue typing for transplantation
  (where “banking” refers to human samples that are stored in anticipation of
  future implantation into the donor or transplantation into another human
  recipient).

  



 


Examples of activities in the HIVD Field:


 


	
  ·

  	
   

  	
  Development, manufacture, or sale of anything labeled for in vitro
  diagnostic use or any testing products labeled for investigational
  use;

  
	
  ·

  	
   

  	
  Development, manufacture, or sale of products designated as Analyte
  Specific Reagents (ASRs) by FDA or corresponding reagent products in foreign
  regulatory jurisdictions and general purpose reagents (GPRs) that are
  specifically sold for use with ASRs or such reagent products;

  
	
  ·

  	
   

  	
  Development or sale of software products for the interpretation of
  data to provide an HIVD clinical test result;

  
	
  ·

  	
   

  	
  Development, manufacture, or sale of products that convey
  amplification, sequencing, or other patent rights in the HIVD Field, or
  products that are designated specifically for use with products that convey
  amplification, sequencing, or other patent rights in the HIVD Field;

  
	
  ·

  	
   

  	
  Genetic testing for sample tracking in a clinical laboratory;

  
	
  ·

  	
   

  	
  Sale of any in vitro testing
  products regulated by the FDA, including products claimed to be produced
  under Quality System Regulation to be sold to IVD companies or clinical
  testing laboratories;

  
	
  ·

  	
   

  	
  In- and out-licensing or other transfer of patents, technology, or
  know-how for HIVD use (including any accompanying contract manufacture of
  custom reagents for specific diagnostic customers’ homebrew testing, whether
  or not the reagents are produced under Quality System Regulation);

  
	
  ·

  	
   

  	
  Development, manufacture, or sale of, or providing service and
  support for, systems (reagents, components and/or instruments) developed and
  manufactured for HIVD use or developed specifically for use with ASRs (or
  their counterparts outside the US); and

  
	
  ·

  	
   

  	
  Provision of
  HIVD testing services.

  



 


Examples of
activities not in the HIVD Field:


 






[***] indicates material
that has been omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.


 

















 


	
  ·

  	
   

  	
  Development,
  manufacture, or sale of products or services for basic and applied research,
  including clinical research where the medical management of a patient is not
  involved, unless the product or service is regulated as an in vitro
  diagnostic test or ASR by the FDA or its foreign counterparts;

  
	
  ·

  	
   

  	
  Development,
  manufacture, or sale of products or services for quality assurance and
  quality control, including testing to determine conformance with
  specifications, purity and batch-to-batch consistency, but excluding human
  plasma or tissue-derived samples for the pharmaceutical industry;

  
	
  ·

  	
   

  	
  Testing of
  environmental samples, including the detection of organisms, where the
  medical management of a human is not involved;

  
	
  ·

  	
   

  	
  Identity
  testing applications for forensic purposes or determination of paternity,
  excluding genotyping or other identification testing for medical management
  of a human being or sample tracking in a clinical laboratory;

  
	
  ·

  	
   

  	
  In vitro  diagnostic
  testing of non-human (plant or animal) samples, including animal breeding,
  pedigree determination, or gender determination;

  
	
  ·

  	
   

  	
  Testing for
  the agricultural or food industries, including the identification of
  genetically modified organisms (GMOs) for these industries;

  
	
  ·

  	
   

  	
  Sale or
  service of general purpose (“open”) instrument systems or general purpose
  reagents, including enzymes; unless such GPRs are specifically sold for use
  with ASRs or other products regulated by the FDA or its foreign counterparts;

  
	
  ·

  	
   

  	
  Sale of
  non-exclusive information products and services not regulated by FDA (such as
  the Celera Discovery System) to any customers, including those customers
  operating in the HIVD Field;

  
	
  ·

  	
   

  	
  Sale of
  anything labeled for therapeutic or prophylactic use;

  
	
  ·

  	
   

  	
  Sale of
  products or services that convey therapeutic or research patent rights;

  
	
  ·

  	
   

  	
  In- and out-
  licensing or other transfer of patents, technology or know-how for use in the
  therapeutic, research, or applied fields;

  
	
  ·

  	
   

  	
  Embryonic
  stem cell and recombinant cell characterization, testing, and quality control
  applications; and

  
	
  ·

  	
   

  	
  Epidemiology
  testing (the screening or testing of groups of people or populations for the
  study of the patterns, causes, or control of disease in groups of people) and
  biosecurity testing (the detection of biological or chemical agents,
  pathogens, microorganisms or other infectious agents in the environment,
  agriculture, food or water), where the medical management of a human is not
  involved.

  



 






[***] indicates material
that has been omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and Exchange
Commission.


 

















 


Exhibit B


 


Specified Country List


 


Africa


 


	
  ·

  	
  Algeria

  	
  ·

  	
  Guinea

  	
  ·

  	
  Senegal

  
	
  ·

  	
  Angola

  	
  ·

  	
  Ivory Coast

  	
  ·

  	
  Seychelles

  
	
  ·

  	
  Benin

  	
  ·

  	
  Kenya

  	
  ·

  	
  Sierra Leone

  
	
  ·

  	
  Botswana

  	
  ·

  	
  Lesotho

  	
  ·

  	
  Somalia

  
	
  ·

  	
  Burkina Faso

  	
  ·

  	
  Liberia

  	
  ·

  	
  South Africa

  
	
  ·

  	
  Burundi

  	
  ·

  	
  Libya

  	
  ·

  	
  Sudan

  
	
  ·

  	
  Cameroon

  	
  ·

  	
  Madagascar

  	
  ·

  	
  Swaziland

  
	
  ·

  	
  Cape Verde

  	
  ·

  	
  Malawi

  	
  ·

  	
  Tanzania

  
	
  ·

  	
  Central African Republic

  	
  ·

  	
  Mali

  	
  ·

  	
  Togo

  
	
  ·

  	
  Chad

  	
  ·

  	
  Mauritania

  	
  ·

  	
  Tunisia

  
	
  ·

  	
  Comoros

  	
  ·

  	
  Mauritius

  	
  ·

  	
  Uganda

  
	
  ·

  	
  Congo

  	
  ·

  	
  Mayotte (France)

  	
  ·

  	
  Western Sahara

  
	
  ·

  	
  Dem. Republic of Congo (Zaire)

  	
  ·

  	
  Morocco

  	
  ·

  	
  Zambia

  
	
  ·

  	
  Djibouti

  	
  ·

  	
  Mozambique

  	
  ·

  	
  Zanzibar

  
	
  ·

  	
  Egypt

  	
  ·

  	
  Namibia

  	
  ·

  	
  Zimbabwe

  
	
  ·

  	
  Equatorial Guinea

  	
  ·

  	
  Niger

  	
   

  	
   

  
	
  ·

  	
  Eritrea

  	
  ·

  	
  Nigeria

  	
   

  	
   

  
	
  ·

  	
  Ethiopia

  	
  ·

  	
  Réunion

  	
   

  	
   

  
	
  ·

  	
  Gabon

  	
  ·

  	
  Rwanda

  	
   

  	
   

  
	
  ·

  	
  Gambia

  	
  ·

  	
  Saint Helena (UK)

  	
   

  	
   

  
	
  ·

  	
  Ghana

  	
  ·

  	
  Sao Tome and Principe

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Asia

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Afghanistan

  	
  ·

  	
  Hong Kong

  	
  ·

  	
  North Korea

  
	
  ·

  	
  Bangladesh

  	
  ·

  	
  India

  	
  ·

  	
  Oman

  
	
  ·

  	
  Bhutan

  	
  ·

  	
  Indonesia

  	
  ·

  	
  Pakistan

  
	
  ·

  	
  Brit. Ind. Ocean Territory

  	
  ·

  	
  Japan

  	
  ·

  	
  Philippines

  
	
  ·

  	
  Brunei

  	
  ·

  	
  Laos

  	
  ·

  	
  Singapore

  
	
  ·

  	
  Cambodia

  	
  ·

  	
  Macau

  	
  ·

  	
  South Korea

  
	
  ·

  	
  China

  	
  ·

  	
  Malaysia

  	
  ·

  	
  Sri Lanka

  
	
  ·

  	
  Christmas Island

  	
  ·

  	
  Maldives

  	
  ·

  	
  Taiwan

  
	
  ·

  	
  Cocos Islands

  	
  ·

  	
  Mongolia

  	
  ·

  	
  Thailand

  
	
  ·

  	
  Cyprus

  	
  ·

  	
  Myanmar

  	
  ·

  	
  Vietnam

  
	
  ·

  	
  East Timor

  	
  ·

  	
  Nepal

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Middle East

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Bahrain

  	
  ·

  	
  Lebanon

  	
  ·

  	
  West Bank

  
	
  ·

  	
  Gaza Strip

  	
  ·

  	
  Qatar

  	
  ·

  	
  Yemen

  
	
  ·

  	
  Iran

  	
  ·

  	
  Saudi Arabia

  	
   

  	
   

  
	
  ·

  	
  Iraq

  	
  ·

  	
  Syria

  	
   

  	
   

  
	
  ·

  	
  Israel

  	
  ·

  	
  Tunisia

  	
   

  	
   

  
	
  ·

  	
  Jordan

  	
  ·

  	
  Turkey

  	
   

  	
   

  
	
  ·

  	
  Kuwait

  	
  ·

  	
  United Arab Emirates

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  South America

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Argentina

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Bolivia

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Brazil

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Chile

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Colombia

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Ecuador

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Falkland Islands (UK)

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  French Guiana (France)

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Guyana

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Paraguay

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Peru

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Suriname

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Uruguay

  	
   

  	
   

  	
   

  	
   

  
	
  ·

  	
  Venezuela

  	
   

  	
   

  	
   

  	
   

  



 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.


 

















 


Exhibit C


 


Forensics and Applied Markets


 


	
  ·

  	
   

  	
  Basic or applied research within academic,
  government, biotech, or pharmaceutical institutions;

  
	
  ·

  	
   

  	
  Quality assurance and quality control,
  including testing to determine conformance with specifications, purity, and
  batch-to-batch consistency within pharmaceutical institution’s Process
  Development, Manufacturing, or Quality Control departments;

  
	
  ·

  	
   

  	
  Testing of environmental samples, including
  the detection of organisms where the medical management of a human is not
  involved;

  
	
  ·

  	
   

  	
  Human identity testing applications for
  forensic purposes or determination of paternity;

  
	
  ·

  	
   

  	
  In vitro diagnostic testing of non-human (plant
  or animal) samples, including animal breeding, pathogen detection, pedigree
  determination, or gender determination;

  
	
  ·

  	
   

  	
  Testing for the agriculture or food
  industries, including pathogen detection and the identification of
  genetically modified organisms (GMOs) for these industries;

  
	
  ·

  	
   

  	
  Stem cell and recombinant cell
  characterization, testing, and quality control applications; and

  
	
  ·

  	
   

  	
  Epidemiology testing (the screening or testing
  of groups of people or populations for the study of patterns, causes, or
  control of disease in groups of people) and biosecurity testing (the
  detection of biological or chemical agents, pathogens, microorganisms or
  other infectious agents in the environment, agriculture, food or water),
  where the management of a human is not involved.

  



 






[***] indicates material that has been
omitted pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.