Custom manufacturing solutions

[ c G M P O l i g o n u c l e o t i d e s - Ta q D N A P o l y m e r a s e s ]

B R O A D

e x p e r t i s e

M A N u f A C T u R i N G

c a p a b i l i t i e sC l A s s i f i E D

c l e a n r o o m s

Custom Manufacturing solutionsfor Molecular Diagnostics Dx

R e a c h Dx c e l l e n c e

[ C u s t o m M a n u f a c t u r i n g s o l u t i o n s f o r M o l e c u l a r D i a g n o s t i c s ]

Table of conTenTs

experience True parTnership p.2

QualiTy ManageMenT sysTeM p.6

oligonucleoTide ManufacTuring p.10

ulTra pure diaMond Taq® p.14

conTacT us p.20

i v d @ e u r o g e n T e c . c o M w w w . e u r o g e n T e c . c o M

Experience true partnership

With over 25 years experience, eurogentec [part of

Kaneka corporation] is a leading supplier of high-

quality reagents for the life science community,

Diagnostic and pharmaceutical industries.

We offer a wide range of gMp oligonucleotide-

based components and gMp taq Dna polymerases

for Molecular Diagnostic [Dx] applications, such as

Molecular Diagnostic kits, lab Developed tests [asrs]

and companion Diagnostics.

eurogentec’s Quality Management system (QMs)

is compliant with the cgMp Quality system

regulation (Qsr). We are also iso 13485 certified for

oligonucleotide production and iso 13485 compliant

for production of Diamond taq® Dna polymerases.

our state-of-the-art cleanroom facilities meet class

100,000 (iso 8) and class 10,000 (iso 7) standards with

class 100 [iso 5] working zones.

Manufacturing sites located in europe, Belgium and

usa, san Diego offer redundancy and harmonization

of experience.

D i s c o v e r E u r o g e n t e c E x p e r t i s e … R e a c h Dx c e l l e n c e .

R e a c h Dx c e l l e n c e 2

Eurogentec's ability to provide complete custom solutions makes us unique

Testimonial

“

”

During the past months our

team has carefully evaluated

many different (suppliers)... A

few of the key success criteria

which your team impressed us

with (were): quality of

your products, your

responsiveness and receptivity

in addressing our many

questions and your impressive

GMP facilities and Quality

Management Systems.

Quote from a major North American diagnostic client

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want to visit our facilities? check out our virtual Touron www.eurogentec.com/egt/virtual_tour/virtual-tour-ivd.html

Eurogentec's ability to provide complete custom solutions makes us unique

s Over 25 Years in Oligonucleotide

Synthesis

s Over 18 Years GMP Experience

s Complex Chemistry Expertise

s Proprietary Dyes & Quenchers

s From Small to Large Scale Oligonucleotide

Production

s GMP Taq DNA Polymerases

s Highly Qualified Production Teams

s Controlled Key Card Access

s Prevention of Cross Contamination

s Controlled Environment

s ISO 13485 Certified [Oligonucleotide

Production]

s ISO 13485 Compliant [GMP Taq DNA Polymerases Production]

s Compliance to FDA cGMP/QSR [21 CFR Part 820]

s EU IVD Directive 98/79 EC Compliance

for QMS

s Full Traceability

s Harmonized Production Sites

s Market Proximity

s Back-up Solutions

s Research, Pre-Diagnostic,

Diagnostic Grades

s ASRs

s Collaborative Project Development

s Fill and Finish

s Assay Set Assembly



Regulatory

Compliance

Supply Chain

Reliability

Flexible

Custom

Solutions

Broad

Expertise

Manufacturing

Capabilities

Classified

Cleanrooms

4


eurogenTec is iso 13485 cerTified for producTion

and sales of ivd oligonucleoTides.



Quality Management

Systemthe quality of each Diagnostic test component is

critical to perform accurate and trustworthy assays.

a QMs certified by an independent organization against

an international standard is an appropriate means

to assess the quality of a supplier’s manufacturing

process and the level of gMp compliance. good quality

must be built in during the manufacturing process

and gMp prevents errors.

as required by the iso 13485 standard, eurogentec

has implemented a comprehensive risk management

system based on the fMea (failure Mode and effects

analysis) to identify possible failure modes, determine

their potential effect(s) on product manufacturing and

identify actions to mitigate those failures.

in addition, all eurogentec's iVD oligonucleotides are

manufactured in classified cleanrooms.

6

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Eurogentec is ISO I3485 certified by an FDA accredited organization

eurogentec is registered

with the fda under the

license registration number

3003830126 [eu]/3008004341

[us] as an analyte specific

reagent [asr] manufacturer. eurogentec is also registered

with the california departement

of public health fdb under

license number 52386.

iso 13485 certificate

is available on our website:

www.eurogentec.com/reach-dxcellence.html


chooSe gMp prevenT faiLureS avoid conTaMinaTion

8

Eurogentec is ISO I3485 certified by an FDA accredited organizationfor the Production and Sales of IVD Oligonucleotides

if you have

additionnal needs

that exceed our

standard regulatory

compliance systems,

custom-tailored plans

can be accomodated

to your requirements.

GMP Oligonucleotides✔ ISO 13485 Certified

✔ 21 CFR 820 Compliant✔ Knowledgeable & Experienced team

GMP Diamond Taq ®

✔ ✔ ISO 13485 Compliant✔ ✔ FDA cGMP/QSR [21 CFR Part 820] Compliant

✔ ✔ Stringent Document Change Control Procedures

Controlled Process & Full Traceability

✔ Rigorous Risk Analysis✔ Incoming QC of Raw Materials

✔ Checklists & SOPs✔ Extensive Batch Record with CoA

Released by QC-Authorized Persons✔ Qualification/Validation program

✔ Sample Retention

Constant Improvement✔ Audits from Internal,

Certification Body & Customers✔ CAPA Management

Exhaustive Environment Controls

✔ Class 100,000 and 10,000 Cleanrooms with Class 100 Hoods

✔ Strict Process Segregation

Strict Access Policy✔ Key Card Airlock Access

✔ Mandatory Gowning



eurogenTec is developing efficienT

proprieTary dyes and Quenchers.



Oligonucleotide Manufacturing

With over 25 years experience in oligonucleotide

manufacturing, eurogentec provides exceptional quality

products. the wide range of oligonucleotides proposed

is suitable from research to commercialization. all

oligonucleotides are manufactured by fully trained and

skilled chemists in an appropriate environment.

10

feaTureS BenefiTS

fda 21 cfr 820 compliant & iso 13485 certified c regulatory compliance

classified cleanroom manufacturing environment c contamination mitigation

continuous risk management process c Mitigate manufacturing errors

stringent product release Qc criteria c consistent lot-to-lot reproducibility

customized processes [synthesis scale, purification, fill & finish, Qc] c flexibility

appropriate grades following phases of development c cost-effective client solutions

comprehensive batch records c full process traceability

dedicated account contact person c continuous project oversight and real-time status updates

coMpLeTe cuSToM SoLuTionS

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A flexible process that accomodates your requirements

in need

of gram scale

quantities of your

oligonucleotides?

eurogentec's large

scale oligonucleotide

production offers

a comprehensive

flexible service

adapted to your

needs.

1 2 3

Synthesis Purification Qc release Methods

> Synthesis scale from µg to multi-grams > Dedicated equipment and reagents> Development of custom modifications> Custom mixes of backbones

> Ion Exchange HPLC (IE-HPLC)> Reverse-Phase HPLC (RP-HPLC)> Dual HPLC> PAGE [Research grade only]> Ultrafiltration [Large scale only]> Dedicated purification columns

Typical QC Release Methods> Final mass (µmol, µg, OD)> Physical inspection> MALDI-TOF, ESI- and LC-Mass Spectrometry> Ion Exchange HPLC (IE-HPLC)> Reverse-Phase HPLC (RP-HPLC)> Capillary Gel Electrophoresis (CGE) Optional QC Release Methods > Direct sequencing using enzymatic cleavage and

MALDI-TOF MS> Enzymatic tests for DNA-enzyme conjugates> Probe/dye activity: fluorescence signal-to-noise

ratio, melting profile for Molecular Beacons> Bioburden

Customized QC Release Methods > QC release methods based on specific client

requirements

Product Stability Testing > Stability testing of oligonucleotides following

customized procedures

we offer

a selection of Qc

release methods,

any of which can be

incorporated into

the final Qc release

documentation.

visit our website for a complete list of modifications:http://www.eurogentec.com/gmp-oligos.html


12

5

A flexible process that accomodates your requirements

Your oLigo

Backbones Modifications qPCR ProbesDna, rna, lna®, 2’ o-Me rna, phosphorothioate and other chemistries

> 250 modifications availableDigoxigenin, thiol, Biotin, Dnp, fluorescent dyes, Quenchers, Wobbles...

Double-Dye probes,Molecular Beacons

Purificationsrp and ie-hplc (single or dual), page

Validated QC MethodsMs, hplc, cge…

Additional ServicesDedicated purification columns

tangential filtrationsterile filtration

optional Qc custom formulation

4

custom formulation options

Custom Formulation Options > Customized mixtures of individual oligonucleotides> Conjugated oligonucleotides (HRP, AP, synthetic peptides, proteins)> Lyophilized, dried or in solution (H2O, Tris Buffer or custom Buffer)> Bulk or aliquoted into tubes or plates> Customized fill & finish> Customized packaging and labeling

puriTy is More Than a nuMber!

puriTiy depends on various paraMeTers. esTablishing The appropriaTe level of oligonucleoTide puriTy for a given assay ensures balance beTween cosT and perforMance.


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The most exhaustive oligonucleotide range from Discovery through Commercialization

More info: http://www.eurogentec.com

Discovery

Oligo grades

ProcessFill & finishDedicated account contact person

Quality ManagementISO 9001 CertificationISO 13485 CertificationFDA 21 CFR Part 820 ComplianceQualification/Validation [Equipment & method]

ControlCleanroom class 100,000 [ISO 8]Cleanroom class 10,000 [ISO 7] on requestTraceabilityCertificate of Analysis [CoA]Batch record [archived for 5 years]Released by QC-authorized person


The most exhaustive oligonucleotide range from Discovery through Commercialization

dedicated Services

Documentation requirements differ

significantly as oligonucleotides progress

from Discovery and feasibility to Validation

and commercialization. eurogentec partners

choose from three progressively detailed levels

of documentation and overall quality assurance

appropriate for each phase of product development and

commercialization.

Discovery

Research

Feasability Commercialization

Pre-Diagnostic Diagnostic

Prototyping Validation

✔✔

✔

--✔

✔

-Partly documented

✔Minimal

✔

✔✔

✔✔✔✔

✔✔

Fully documented✔Full✔

OptionalOptional

✔

---

--

Basic - [TDS]

--



gMp compliant c highly suited for diagnostic kits, lab services (with asrs) and demanding research

ultra-low residual dna content c <1 fg of genomic e. coli dna / Taq unit. Typically < 0.01 fg or 0.002 e. coli genome copies /Taq unit

purity c highly pure (> 98 %) and ultra-low bioburden (≤ 10 cfu/ml). Typically = 0 cfu/ml

sensitivity c amplification of dna templates even at very low concentrations

exceptional reproducibility c gMp process and stringent Qc ensuring lot-to-lot & results reproducibility

full traceability c Quality Management system fully compliant to iso 13 485 Medical device standards and fda’s Quality system regulations

customized fill & finish c cost-effective tailored solution


gMp ultra pure diamond Taq®

Polymerases

these ultra pure Dna polymerases show very good

sensitivity and exceptional reproducibility. as highly

thermostable enzymes, they offer an ideal solution for

Molecular Diagnostic and demanding research pcr

& qpcr. these enzymes have been validated by top

laboratories and several major diagnostic companies.

gMp compliant c highly suited for diagnostic kits, lab services (with asrs) and demanding research

ultra-low residual dna content c <1 fg of genomic e. coli dna / Taq unit. Typically < 0.01 fg or 0.002 e. coli genome copies /Taq unit

purity c highly pure (> 98 %) and ultra-low bioburden (≤ 10 cfu/ml). Typically = 0 cfu/ml

sensitivity c amplification of dna templates even at very low concentrations

exceptional reproducibility c gMp process and stringent Qc ensuring lot-to-lot & results reproducibility

full traceability c Quality Management system fully compliant to iso 13 485 Medical device standards and fda’s Quality system regulations

customized fill & finish c cost-effective tailored solution

generaL BenefiTS


Select with confidence the Taq Polymerase that suits your application

www.eurogentec.com/gmp-taq.html

hot diamond Taq®

hgS diamond Taq®

diamond Taq® +++

+++ +++

+

+++ ++ +++ +++ +++ +++

+++ +++ ++

++ ++ +

+ TAQ-I032-100

TAQ-I010-100

TAQ-I020-100

+++

+

+++

++

PCR qPCR YieldSensitivity Low copy template

SpecificityDifficult template

(GC & AT rich)IP Burden Free Sample

> Shipping on dry ice. > Full traceability from production, storage to shipment of the product. > Tracking number sent to customer the day of the shipment.

Production Storage Order Shipment Shipping Tracking number

IVD Process Yes Yes Yes Yes Yes

Traceability

(shipment at -20 °C) (Sent to customer the day of the shipment)

documentation enzymes are provided with a Technical data sheet &

certificate of analysis. The Qc data are released by a Qc

authorized person and based on review of the complete

batch record.

storage conditions storage at -20 °c is recommended.

eurogentec out licenses

access to the hot diamond

Taq. if you plan to use the hdT

in diagnostic kits or services, you must obtain a license

from eurogentec. please contact eurogentec to

ask about the flexible cost-

effective licensing programs

that we offer.

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Select with confidence the Taq Polymerase that suits your application

> Represents a completely new “HotStart concept”. Neither accomplished through chemical, modification nor a blocking antibody but a proprietary agent.

> Prevents non-specific polymerization. [Preventing primer-dimer formation, increasing

the PCR yield of specific products]

> Needs a short activation time. [100 % activated during the first PCR cycle]

> Compatible with all existing protocols. [from 20 seconds to 15 minutes at 95 °C]

> Customized fill & finish.

> The DiamondTaq® has a very good fidelity and exhibits high performance in

many demanding applications.

For difficult and GC rich

template amplification

High Performance Heat stable > Chemically modified HotStart Taq DNA Polymerases. [Fully inactivated vs Ab modified HotStart]

> Requires a thermal activation of 10 minutes at 95 °C to reach maximal initial activity.[No activity below 74 °C before activation]

> More heat-stable than commonly used Taq DNA Polymerases. [DNA fragments as long as 2 kb can be efficiently amplified]

> Provides efficient amplification of specific products.

> Customized fill & finish.

HotStart Taq HotStart TaqTaq

a Major product

Diamond taq® polymerases are purified from

recombinant escherichia coli bacteria containing the

thermus aquaticus Dna polymerase gene. this

thermophilic eubacterium strain lacks taqi restriction

endonuclease and catalyzes 5’p 3’ synthesis of Dna

with no detectable 3’p 5’ exonuclease activity. the enzyme has 3’ extendase

activity allowing ta cloning.

Diamond Taq® HGS Diamond

Taq®Hot Diamond

Taq®

RPrevents non-specific polymerizationRRecommended for long & difficult templates

RPrevents non-specific

polymerizationRRecommended

for multiplex assays

+ Eurogentec's proprietary modification

+ Chemical modification


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Great experimental results that keep you smiling

free samples can be requested at [email protected]

appearance*c

colorless solution

identity (sds-page) c Mw approx. 95 kda

volume activity c ≥ 5 u/µl

purity (sds-page) c > 98 %

performance test: pcr - l dna* c 0.5 kb fragment positive down to 5 pg

performance test: pcr - 18 s dna* c 0.1 kb fragment positive down to 10 pg

ribonucleases (up to 10 u, 1 h, 37 °c) c not detectable

endonucleases, exonucleases, nicking activity (up to 30 u, 16 h, 65 °c) c not detectable

e.coli residual dna c < 1 fg / Taq unit

bioburden* c ≤ 10 cfu/ml

stability* c 24 months (at -20 °c) from date of manufacture

animal-derived additives* c none

hotstart [hgs diamond Taq®] c no detectable amplification without 95 °c activation

performance test pcr-numb dna [hot diamond Taq®] c 0.3 kb fragment positive down to 10 pg

diaMond TaQ® faMiLY

paraMeTerS SpecificaTionS

* Also for buffer & MgCl2

HGS Diamond Taq® was evaluated for its ability to amplify a PCR template of 0.5 kb (lDNA) for several activation times. PCR products were analyzed by gel electrophoresis.

HGs Diamond taq®

20 sec. 5 min. 10 min.

High quality results obtained using the HGS Diamond Taq® (twice serial dilutions) on ß-actin cDNA performed in singleplex Taqman assay.

0.3

0.2

fluo

resc

ence

(∆R

n)

0.1

0.0

2 4 6 8 10 12 14 16 18 20

CYCLE

22 24 26 36 38 4028 30 32 34

l HGS Diamond Taq® needs at least 5 min. activation time to amplifly DNA fragment

hgS diamond Taq®diamond Taq®

EurogentecIVD-GMP Taq

Competitor GMP Taq

Smart Ladder

1000 100 50 5 1000 100 50 5DNA (pg):

500 bp

Eurogentec (Goldstar ®)RUO Taq

1000 100 50 5

Smart Ladder

Diamond Taq®

Competitor GMP Taq

Diamond Taq® was evaluated against competitor GMP Taq for its ability to amplify different amounts (from 5 to 1000 pg) of a 0.5 kb PCR template (lDNA). PCR products were analyzed by gel electrophoresis.

Diamond taq® compared to competitor gMp taq

l Diamond Taq® performance is similar or higher than competitor GMP Taq


Great experimental results that keep you smiling


CYCLE

Hot Diamond Taq® was evaluated using from 20 secondes to 10 minutes as activation time for its ability to amplify 1 and 5 pg of lDNA. PCR products were analyzed by gel electrophoresis.

l Hot Diamond Taq® needs very short activation time [20 sec. are sufficient]

Hot Diamond Taq® (HDT) & Diamond Taq® (DT) were evaluated against HotStart competitors (C1, 2 & 4 – Chemical modification; C3 - Antibody) for their ability to amplify difficult and GC rich templates. PCR products were analyzed by gel electrophoresis.

Hot Diamond taq® compared to hotstart competitors

HDT C1 C2 C3 C4 DTDT

Performance test on difficult template: gDNA NUMB (306b)

DTC4C3C1 C2HDT

Performance test on GC rich template: SCO3449 (152b) – 72 % GC

l Hot Diamond Taq® is highly suitable for difficult and GC rich template amplifications

activation time

hot diamond Taq®

0.3

0.2

fluo

resc

ence

(dR

n)

0.1

0.0

2 4 6 8 10 12 14 16 18 20 22 24 26 36 38 4028 30 32 34

diamond Taq® family [5 u/µl]

R Mgcl2 solution: 25 mM Mgcl

2.

R enzyme storage buffer: 20 mM Tris-hcl, 1 mM dTT, 0.1 mM edTa, 0.1 M Kcl, 0.5 % (v/v)

nonidet p40, 0.5 % (v/v) Tween 20, 50 % (v/v)

glycerol and stabilizer, ph 8.0 (19 °c).

R 10x reaction buffer:

750 mM Tris-hcl, 200 mM (nh4)2so

4, 0.1 %

(v/v) Tween 20 and stabilizer, ph 8.8 (at 19 °c).

except hgs diamond Taq®

150 mM Tris-hcl, 500 mM Kci and stabilizer, ph 8.5 (at 19 °c).

High quality results obtained using the Hot Diamond Taq® (twice serial dilutions) on ß-actin cDNA performed in singleplex Taqman assay.

20


Confidentiality Agreements

We treat all details including oligonucleotide sequences, probe formats,

manufacturing specifications, product formulations and business plans

with utmost confidentiality.

client consultation

We encourage regular face-to-face meetings or online teleconferences

to ensure clear understanding of manufacturing requirements and

specifications. in addition, our technical experts are available for

consultation on all aspects of manufacturing and regulatory compliance.

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Partnering with Eurogentec… a Dedicated Process

contact

For EU: [email protected] US : [email protected]

We consider each customer with utmost respect. Our specialists are available to you throughout the entire evolution of your project.


Supplier Questionnaires and audits

We encourage site visits and formal audits of our

facilities. please discuss submission of supplier/

Vendor questionnaires or arrangements for on-

site facility audits with your iVD representative.

Quotations

Quotations are typically short-term guarantees

of pricing based on product descriptions,

manufacturing specifications, shipping and

delivery information.

pilot Studies for evaluation and

validation

evaluation and validation projects are key

components of the vendor evaluation process

and we work closely with you to provide these

services.

Partnering with Eurogentec… a Dedicated Process

Supply or purchase agreements

supply or purchase agreements typically guarantee

pricing for one or more years, can include discounted

pricing based on annualized usage forecasts, can

incorporate our partners’ detailed and comprehensive

customized manufacturing specifications and may

contain additional client terms and conditions.

dedicated account contact person

a dedicated account contact person acts as your

advocate in the production plant, monitors all aspects

of the production process and will provide you with

frequent real-time updates during each production

run. clients are also provided a confidential email

address that goes directly to the account contact

person to ensure a rapid response to all inquiries.


D i s c o v e r E u r o g e n t e c E x p e r t i s e &

*

Europe

Tel.: +32 4 372 74 00

Fax: +32 4 372 75 00

[email protected]

5, Rue Bois Saint-Jean - 4102 Seraing - Belgium - EU

North America

Tel.: +1-510-896-1350

Fax: +1 510-791-9573

[email protected]

34801 Campus Drive - Fremont, CA 94555 - USA

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* for production & sales of iVD oligonucleotides

Trademark Labels and License statementsDiamond Taq® products and Hot Diamond Taq® products are

registered trademarks of Eurogentec S.A. and are covered by

international pending patent application (PCT/EP2008/067435). Hot

Diamond Taq® products are sold exclusively for research use only

by the purchaser and may not be used for clinical or diagnostic

purposes, resold, distributed or re-packaged without the prior

written consent of Eurogentec S.A. It may be necessary to obtain

a separate license for certain patented applications in which the

Hot Diamond Taq® products are used. • Roche Enzyme Products

Conveying Polymerase Patent Rights Purchase of this product

includes an immunity from suit under patents specified in the product

insert to use only the amount purchased for the purchaser’s own

internal research. No other patent rights are conveyed expressly,

by implication, or by estoppel. Further information on purchasing

licenses may be obtained by contacting the Dierctor of Licensing,

Applied Biosystems, 850 Lincoln Centre Drive, Foster City, California

94404, USA. • Chemically-Modified Hot-Start Polymerase

Reagents and Kits Purchase of this product includes an immunity

from suit under patents specified in the product insert to use only

the amount purchased for the purchaser’s own internal research.

No other patent rights are conveyed expressly, by implication,

or by estoppel. Further information on purchasing licenses may

be obtained by contacting the Dierctor of Licensing, Applied

Biosystems, 850 Lincoln Centre Drive, Foster City, California 94404,

USA. • Licensed dsDNA-Binding Dye Research Kits Purchase

of this product includes an immunity from suit under patents

specified in the product insert to use only the amount purchased

for the purchaser’s own internal research. No other patent rights

are conveyed expressly, by implication, or by estoppel. Further

information on purchasing licenses may be obtained by contacting

the Dierctor of Licensing, Applied Biosystems, 850 Lincoln Centre

Drive, Foster City, California 94404, USA. • Custom Molecular

Beacon Probes The use of Custom Molecular Beacon Probes

employs the following patent rights licensed to Eurogentec S.A. from

The Public Health Research Institute of the City of New York: (a) the

claims of U.S. Patent Application Serial No. 08/439,819; (b) the claims

of U.S. Patent Application Serial No. 08/990,176; and (c) all patent

application claims and all patent claims, U.S. and foreign, that cover

improvements in the foregoing claimed probes, kits and assays and

whose subjects are inventions and discoveries that are made by the

Public Health Research Institute of New York. The use of Custom

Molecular Beacon Probes is limited to the field of use comprising the

internal use by an end user of a product solely in assays of the end

user (or in applications of the end user’s customer, if the end user is

performing contract research) in scientific research and development.

• LNA® oligonucleotides are registered trademark of Exiqon A/S

and produced under license from Exiqon A/S for research use only. Not

for resale or for therapeutic use or use in humans. • Probes Use of

this product is covered by one or more of the following US patents

and corresponding patent claims outside the US: 5,538,848, 5,723,591,

5,876,930, 6,030,787, 6,258,569 and 5,804,375 (claims 1-12 only). The

purchase of this product includes a limited, non-transferable immunity

from suit under the foregoing patent claims for using only this amount

of product for the purchaser’s own internal research. Except under

separate license rights available from Applied Biosysterns, no right

under any other patent claim, or to perform commercial services of any

kind, including without limitation reporting the results of purchaser’s

activities for a fee or other commercial consideration, or to sublicense,

repackage with other products, or resell in any form, is conveyed

expressly, by implication, or by estoppel. This product is for research

use only. Diagnostic uses under Roche patents require a separate

license from Roche. Further information on purchasing licenses may

be obtained from the Director of Licensing, Applied Biosystems, 850

Lincoln Centre Drive, Foster City, California 94404, USA.

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