EXHIBIT 10.317

|             |  |                 
|------------ |  | ----------------
|CONFIDENTIAL |  | REDACTED VERSION

[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.

Association Agreement Regarding the Sale and Servicing  of Blood Screening Products

This
Association Agreement Regarding the Sale and Servicing of Blood Screening Products (this "Association Agreement") is made effective as of May 1, 2002, between America's Blood Centers
("ABC"), a charitable and non-profit corporation, having its principal office at 725 15th Street, N.W. Suite
700, Washington, D.C. 20005, and Chiron Corporation, a Delaware corporation ("Chiron") having its offices at 4560 Horton Street, Emeryville, California 94608-2916.

Background

NOW, THEREFORE, in consideration of the foregoing premises and of the mutual covenants of the parties hereinafter contained, the parties hereto hereby
agree as follows:

ARTICLE 1DEFINITIONS



ARTICLE 2PURCHASE OF BLOOD SCREENING ASSAYS



ARTICLE 3PROVISION OF BLOOD SCREENING SYSTEMS; SOFTWARE



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ARTICLE 4SERVICES



ARTICLE 5PRICES, PAYMENTS

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ARTICLE 6CERTAIN AGREEMENTS



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ARTICLE 7REPRESENTATIONS & WARRANTIES; WARRANTY DISCLAIMER; INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE

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ARTICLE 8TERM AND TERMINATION

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ARTICLE 9CONSEQUENCES OF THE TERMINATION OF THE AGREEMENT

ARTICLE 10APPLICABLE LAW



ARTICLE 11DISPUTES

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ARTICLE 12MISCELLANEOUS

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| |  |               |  |                                                                                                                                                                               
| |  | ------------- |  | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |  | If to Chiron: |  | Chiron Corporation
Attention: President, Blood Testing
4560 Horton Street
Emeryville, CA 94608
Telephone: (510) 923-2416
Fax: (510) 655-8556
cc: General Counsel              
| |  | If to ABC:    |  | America's Blood Centers
Attention: Jim MacPherson, Chief Executive Officer
725 15th Street, N.W., Suite 700
Washington, DC 20005
Telephone: (202) 393-5725
Fax: (202) 393-1282



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|      |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
|----- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
|12.10 | Conflict Between Terms and Conditions. In the event of any conflict between the terms and conditions of this Association Agreement and any terms and conditions that may be set forth in a Member
Supplement or on any invoice or purchase order or other similar document, the terms and conditions of this Association Agreement govern.                                                                                                                                                                                                                                                                                                                                                                                         
|12.11 | Compliance with Applicable Law. In performing this Agreement, the parties shall comply with all applicable laws. Nothing in this Agreement shall be construed so as to require the violation
of law, and wherever there is any conflict between any provision of this Agreement and any rule of mandatory law, the latter shall prevail, but in such event, the affected provision of this Agreement shall be ineffective only to the extent necessary
to comply with the applicable law, and the parties hereto undertake to replace the invalid and/or unenforceable provision by a valid and/or enforceable provision, the nature and scope of which will come as close as possible to the contractual
provision to be replaced.
|12.12 | Counterparts. This Association Agreement and any Member Supplement may be executed in two or more counterparts, each of which shall be deemed to be an original and each of which shall
constitute one and the same Agreement.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
|12.13 | Severability. In the event that any provision of this Agreement is found to be invalid or in conflict with any applicable law or regulation, the affected provision of this Agreement shall be
limited or eliminated only to the extent necessary to comply with such law or regulation, and the remainder of this Agreement shall remain in full force and effect, provided that the remainder of this Agreement is consistent with the economic
intentions of the parties as evidenced by this Agreement as a whole.                                                                                                                                                                                                             



|CHIRON CORPORATION |  | AMERICA'S BLOOD CENTERS   
|------------------ |  | --------------------------
|By:                |  | /s/WILLIAM G. GREEN       
|Name:              |  | William G. Green          
|Title:             |  | President of Blood Testing

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|             |  |                 
|------------ |  | ----------------
|CONFIDENTIAL |  | REDACTED VERSION

SCHEDULE A    Definitions



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|------------ |  | ----------------
|CONFIDENTIAL |  | REDACTED VERSION

SCHEDULE B-1    TERMS AND CONDITIONS FOR PURCHASE OF PROCLEIX HIV-1/HCV  BLOOD SCREENING ASSAY

Chiron
will supply the Procleix HIV-1/HCV Blood Screening Assay to the Participating Members on the following terms and conditions:



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ATTACHMENT B-1    Package Insert

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ProcleixHIV-1/HCV Assay

ForIn VitroDiagnostic Use
1000 Test Kit, 5000 Test Kit

|                  |                                            |                                                                                                              
|----------------- | ------------------------------------------ | -------------------------------------------------------------------------------------------------------------
|TABLE OF CONTENTS |                                            |                                                                                                              
|                  | INTENDED USE                               |                                                                                                              
|                  | SUMMARY AND EXPLANATION OF THE TEST        |                                                                                                              
|                  | PRINCIPLES OF THE PROCEDURE                |                                                                                                              
|                  | MATERIALS PROVIDED                         |                                                                                                              
|                  | MATERIALS REQUIRED, SOLD SEPARATELY        |                                                                                                              
|                  | MATERIALS REQUIRED BUT NOT PROVIDED        |                                                                                                              
|                  | REAGENTS                                   |                                                                                                              
|                  | STORAGE INSTRUCTIONS                       |                                                                                                              
|                  | PRECAUTIONS                                |                                                                                                              
|                  | REAGENT PREPARATION                        |                                                                                                              
|                  | SPECIMEN COLLECTION, STORAGE, AND HANDLING |                                                                                                              
|                  | PROCEDURAL NOTES                           |                                                                                                              
|                  | INSTRUCTIONS FOR USE                       |                                                                                                              
|                  |                                            | Target Capture                                                                                               
|                  |                                            | Amplification                                                                                                
|                  |                                            | Hybridization Protection Assay (HPA)                                                                         
|                  |                                            | Procleix HIV-1 and HCV
    Discriminatory Assays                                                             
|                  | QUALITY CONTROL PROCEDURES                 |                                                                                                              
|                  |                                            | Acceptance Criteria for the Procleix
    HIV-1/HCV Assay and Procleix
    HIV-1 and HCV Discriminatory Assays
|                  |                                            |                                                                                                              
|                  | INTERPRETATION OF RESULTS                  |                                                                                                              
|                  | PERFORMANCE CHARACTERISTICS                |                                                                                                              
|                  | PERFORMANCE OF POOLED SAMPLE TESTING       |                                                                                                              
|                  | PERFORMANCE OF INDIVIDUAL DONATION TESTING |                                                                                                              
|                  | LIMITATIONS OF THE PROCEDURE               |                                                                                                              
|                  | CONCLUSIONS                                |                                                                                                              
|                  | BIBLIOGRAPHY                               |                                                                                                              

INTENDED USE

The
Procleix HIV-1/HCV Assay* is a qualitativein vitronucleic acid assay system for the detection of human immunodeficiency
virus type 1 and/or hepatitis C virus RNA in human plasma from donations of whole blood and blood components for transfusion. The assay is intended for use in screening individual donor samples or
pools of human plasma comprised of equal aliquots of not more than 16 individual donations. This assay is intended to be used in conjunction with licensed tests for detecting antibodies to
HIV-1 and HCV.

This
assay may be used as an alternative to licensed HIV-1 p24 antigen tests for screening human plasma from donations of whole blood and blood components.

This
assay is not intended for use as an aid in diagnosis.

*Developed
and manufactured by Gen-Probe Incorporated; distributed by Chiron® Corporation.

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SUMMARY AND EXPLANATION OF THE TEST

Epidemiological studies identified human immunodeficiency virus type 1 (HIV-1) as the etiological agent of acquired immunodeficiency syndrome
(AIDS)1-7 and hepatitis C virus (HCV)8-13 as the etiological agent for most blood-borne non-A, non-B hepatitis (NANBH). Both viruses are
transmitted primarily by
exposure to infected blood or blood products, certain body fluids or tissues, and from mother to fetus or child.

Current
detection of HIV-1 infection in the blood bank setting is based on serologic screening for anti-viral antibodies by enzyme immunoassay (EIA) with
confirmation by supplemental antibody tests such as Western blot or immunofluorescence assays. Although sensitivity of HIV-1 antibody detection has increased in the last few years and
sensitive tests for p24 antigen (p24Ag) have been developed and implemented, a window period between infection and detectable serological markers still exists14,16-17. The screening of
blood with current EIA tests results, on average, in a 22-day seronegative window17. Although addition of the p24Ag test allows earlier detection of HIV-1
infection, implementation of the p24Ag test in the U.S. yielded a very modest number of Ab(-)/Ag(+) donors with no significant reduction in the risk of infection. Several studies suggest that addition
of nucleic acid-based amplification tests would reduce the window period of detection to 6-11 days, preventing more than half of the HIV-1 infections by
blood transfusion14.

Nucleic
Acid Testing (NAT) of whole blood donations has been in place in the United States since early 1999. Stramer et al., have reported the results of testing small pools of 16, 24
and 128 plasma samples15,30 under IND (Investigational New Drug Application) clearances from the FDA. As of November 2001, the major programs (pooled and individual donation
testing) in the U.S. have tested a total of 24.9 million donations for HCV RNA and HIV-1 RNA. A total of 89 donations (1:280,000 screened units) were confirmed to be positive for
HCV RNA and negative in serological testing. Similarly, nine HIV-1 RNA positive, serologically negative donations (1:2,767,000) were identified. During this testing period, two specimens
were reactive for HIV-1 RNA and p24 Ag but nonreactive by HIV antibody testing.

Detection
of HCV is based on serologic screening for anti-viral antibodies with enzyme-linked immunosorbent assays (ELISA) or enzyme immunoassays (EIA) and confirmation with
a Strip Immunoblot Assay (e.g., RIBA® SIA). Even though the development of these tests has significantly reduced the incidence of post transfusion HCV infection in the U.S., risk of
contracting HCV through transfusion still exists14,16-17. Recent studies indicate that nucleic acid-based amplification tests for HCV RNA will allow detection of HCV
infection approximately 59 days earlier than the current antibody-based tests17.

The
Procleix HIV-1/HCV Assay utilizes target amplification nucleic acid probe technology for the detection of HIV-1 and HCV RNA in voluntary blood
donors18. The assay contains reagents which may be used for simultaneous detection of both viruses or individual viruses, HIV-1 and HCV. All three assays incorporate an
Internal Control for monitoring assay performance in each individual specimen.

PRINCIPLES OF THE PROCEDURE

The Procleix HIV-1/HCV Assay involves three main steps which take place in a single tube: sample preparation; HIV-1 and HCV RNA target
amplification by Transcription-Mediated Amplification
(TMA)19; and detection of the amplification products (amplicon) by the Hybridization Protection Assay (HPA)20.

During
sample preparation, RNA is isolated from plasma specimens via the use of target capture. Plasma is treated with a detergent to solubilize the viral envelope, denature proteins and
release viral genomic RNA. Oligonucleotides ("capture oligonucleotides") that are homologous to highly conserved

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regions of HIV-1 and HCV, are hybridized to the HIV-1 or HCV RNA target, if present, in the test specimen. The hybridized target is then captured onto magnetic microparticles
that are separated from plasma in a magnetic field. Wash steps are utilized to remove extraneous plasma components from the reaction tube. Magnetic separation and wash steps are performed with the
Procleix TCS.

Target
amplification occurs via TMA, which is a transcription-based nucleic acid amplification method that utilizes two enzymes, MMLV reverse transcriptase and T7 RNA polymerase. The
reverse transcriptase is used to generate a DNA copy (containing a promoter sequence for T7 RNA polymerase) of the target RNA sequence. T7 RNA polymerase produces multiple copies of RNA amplicon from
the DNA copy template. The Procleix HIV-1/HCV Assay utilizes the TMA method to amplify regions of HIV-1 RNA and of HCV RNA.

Detection
is achieved by HPA using single-stranded nucleic acid probes with chemiluminescent labels that are complementary to the amplicon. The labeled nucleic acid probes hybridize
specifically to the amplicon. The Selection Reagent differentiates between hybridized and unhybridized probes by inactivating the label on unhybridized probes. During the detection step, the
chemiluminescent signal produced by the hybridized probe is measured in a luminometer and is reported as Relative Light Units (RLU).

Internal
Control is added to each test specimen, external quality control, or assay calibrator tube via the Target Capture Reagent that contains the Internal Control. The Internal
Control in this reagent controls for specimen processing, amplification and detection steps. Internal Control signal in each tube or assay reaction is discriminated from the HIV-1/HCV
signal by the differential kinetics of light emission from probes with different labels21. Internal Control specific amplicon is detected using a probe with rapid emission of light
(termed flasher signal). Amplicon specific to HIV-1/HCV is detected using probes with relatively slower kinetics of light emission (termed glower signal). The Dual Kinetic Assay (DKA) is a
method used to differentiate between the signals from flasher and glower labels21. When used for the simultaneous detection of HIV-1 and HCV, the Procleix
HIV-1/HCV Assay differentiates between Internal Control and combined HIV-1/HCV signals but does not discriminate between individual HIV-1 and HCV signals.

Specimens
found to be reactive in the Procleix HIV-1/HCV Assay must be run in individual HIV-1 and HCV Discriminatory Assays to determine if they are reactive for
HIV-1, HCV or both.

The
Procleix HIV-1 and HCV Discriminatory Assays utilize the same three main steps as the Procleix HIV-1/HCV Assay (target capture, TMA and HPA); the same assay
procedure is followed with one difference: HIV-1-specific or HCV-specific probe reagents are used in place of the Procleix HIV-1/HCV Assay Probe
Reagent.

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MATERIALS PROVIDED

|Procleix HIV-1/HCV Assay |                                    |                                                  
|------------------------ | ---------------------------------- | -------------------------------------------------
|                         |                                    | 1000 Test Kit P/N 301031
5000 Test Kit P/N 301030
|                         | Internal Control Reagent           |                                                  
|                         | Target Capture Reagent             |                                                  
|                         | Amplification Reagent              |                                                  
|                         | Enzyme Reagent                     |                                                  
|                         | Probe Reagent                      |                                                  
|                         | Selection Reagent                  |                                                  
|                         | Procleix Negative Calibrator       |                                                  
|                         | Procleix HIV-1 Positive Calibrator |                                                  
|                         | Procleix HCV Positive Calibrator   |                                                  

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MATERIALS REQUIRED, SOLD SEPARATELY

|                                                                                              |                                         |             
|--------------------------------------------------------------------------------------------- | --------------------------------------- | ------------
|Procleix HIV-1 and HCV
Discriminatory Probe Reagents                                          |                                         | P/N 301026  
|                                                                                              | HIV-1 Discriminatory Probe Reagent      |             
|                                                                                              | HCV Discriminatory Probe Reagent        |             
|Procleix Assay Fluids                                                                         |                                         | P/N 301027  
|                                                                                              | Wash Solution                           |             
|                                                                                              | Oil                                     |             
|                                                                                              | Buffer for Deactivation Fluid           |             
|Procleix Auto Detect Reagents                                                                 |                                         | P/N 301038  
|                                                                                              | Auto Detect 1                           |             
|                                                                                              | Auto Detect 2                           |             
|Disposables                                                                                   |                                         |             
|(Disposables are single use only, do not reuse.
Use of other disposables is not recommended.) |                                         |             
|                                                                                              | Ten-Tube Units (TTUs)                   |             
|                                                                                              | Ten Tip Cassettes                       |             
|                                                                                              | Sealing Cards                           |             
|Procleix HIV-1/HCV
Proficiency Panel                                                          |                                         | P/N 301034  
|                                                                                              | HIV-1 Positive Panel Members            |             
|                                                                                              | HCV Positive Panel Members              |             
|                                                                                              | HIV-1 and HCV Positive Panel Member     |             
|                                                                                              | Negative Panel Members                  |             
|Procleix HIV-1 and HCV
External Quality Controls                                              |                                         | P/N 301035  
|                                                                                              | HIV-1 Positive External Quality Control |             
|                                                                                              | HCV Positive External Quality Control   |             
|                                                                                              | Negative External Quality Control       |             
|Procleix HIV-1/HCV
Assay Calibrators                                                          |                                         | P/N 301036  
|                                                                                              | HIV-1 Positive Calibrator               |             
|                                                                                              | HCV Positive Calibrator                 |             
|                                                                                              | Negative Calibrator                     |             
|Chiron CPT (Correlated Pipetting Transfer)
Pooling Software(Only required for pooling)        |                                         | P/N 10001970

The
Chiron CPT Pooling Software, used in combination with the TECAN GENESIS RSP, performs sample scanning and pooling operations that combine aliquots from 16 individual samples into a
single Master Pool Tube, which may be used for further testing.

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Equipment

All
equipment is available from Chiron Corporation unless otherwise noted.

Procleix System

P/N 104955 (nominal 115V)
P/N 104954 (nominal 230V)


Dedicated
fixed or adjustable repeat pipettor capable of delivering 400 μL of Target Capture Reagent with a ± 5% accuracy and a
precision of < 5% CV. (Only required for manual sample pipetting method.)

Dedicated
single channel pipettor capable of delivering 500 μl of specimen with a ± 5% accuracy and a precision of
< 5% CV. (only required for manual sample pipetting method.)

MATERIALS REQUIRED BUT NOT PROVIDED

Eppendorf
COMBITIPS repeat pipettor tips (12.5 mL, 5.0 mL, 1.25 mL) or equivalent

Disposable
1000 μL filter tips in rack

Bleach



Sterile,
polypropylene conical tubes with sealing caps

Freestanding
tubes are recommended in two different sizes (5 mL to 10 mL tube and > 30 mL tube). The tubes must be able to accommodate the diameter of an Eppendorf Repeat
pipettor tip

TECAN
GENESIS disposable 1000 μL conductive filter tips

TECAN
100 mL reagent troughs

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REAGENTS

Procleix HIV-1/HCV Assay Kit:

P/N 301031 - 1000 Test Kit

P/N 301030 - 5000 Test Kit

CONTENTS

Number of vials/
Volume per vialReagent Name

1000
Test Kit

5000
Test KitInternal Control ReagentA HEPES buffered solution containing detergent and an RNA transcript.

2 X 5
mL

10 X 5
mLStoreunopened reagentat 15° to 35°C.Target Capture ReagentA HEPES buffered solution containing detergent, capture oligonucleotides and magnetic microparticles.

2 X 280
mL

10 X 280
mLStore at 2° to 8°C. (Do not freeze)Internal Control Reagent must be added to Target Capture Reagent before use in the assay.Amplification ReagentPrimers, dNTPs, NTPs and co-factors in TRIS buffered solution containing PROCLIN 300 as preservative.

3 X 32
mL

15 X 32
mLStoreunopened reagentat 15° to 35°C.Enzyme ReagentMMLV Reverse Transcriptase and T7 RNA Polymerase in HEPES/TRIS buffered solution containing 0.05% sodium azide as preservative.

2 X 18
mL

10 X 18
mLStoreunopened reagentat 15° to 35°C.Probe ReagentChemiluminescent oligonucleotide probes in succinate buffered solution containing detergent.

2 X 75
mL

10 X 75
mLStoreunopened reagentat 15° to 35°C.Selection ReagentBorate buffered solution containing surfactant.

2 X 180
mL

10 X 180
mLStore at 15° to 30°C.Procleix Negative CalibratorDefibrinated normal human plasma, nonreactive for hepatitis B surface antigen (HBsAg),
HIV-1 p24Ag, antibodies to human immunodeficiency virus type 1 (anti-HIV-1) and type 2 (anti-HIV-2), and antibodies to human hepatitis C virus (anti-HCV) when tested by FDA-licensed assays, containing gentamicin and 0.2% sodium azide as
preservatives.Store at 15° to 35°C.

30 X 2
mL

90 X 2
mLLOGO


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Procleix HIV-1 Positive CalibratorInactivated HIV-1 positive plasma in defibrinated normal human plasma, nonreactive for hepatitis B surface antigen (HBsAg), and antibodies to
human hepatitis C virus (anti-HCV) when tested by FDA-licensed assays, containing gentamicin and 0.2% sodium azide as preservatives.
Store at 15° to 35°C.

30 X 2
mL

90 X 2
mLLOGOProcleix HCV Positive CalibratorInactivated HCV positive plasma in defibrinated normal human plasma, nonreactive for hepatitis B surface antigen (HBsAg), and antibodies to
human immunodeficiency virus type 1 (anti-HIV-1) and type 2 (anti-HIV-2), when tested by FDA-licensed assays, containing gentamicin and 0.2% sodium azide as preservatives.
Store at 15° to 35°C.

30 X 2
mL

90 X 2
mLLOGO


STORAGE INSTRUCTIONS

The
Procleix HIV-1/HCV Assay Probe Reagent and the Discriminatory Probe Reagents are light sensitive. Protect these reagents from light during storage and preparation for use.



Wash Solution
Oil
Auto Detect 1
Auto Detect 2
Buffer for Deactivation Fluid




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Internal Control Reagent
Amplification Reagent
Enzyme Reagent
Probe Reagent
Procleix Negative Calibrator
Procleix HIV-1 Positive Calibrator
Procleix HCV Positive Calibrator
Procleix HIV-1 Discriminatory Probe Reagent
Procleix HCV Discriminatory Probe Reagent


Do not use after expiration date.

PRECAUTIONS

ForIn VitroDiagnostic Use.

IN0076 Rev. F

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Procleix Negative Calibrator
Procleix HIV-1 Positive Calibrator
Procleix HCV Positive Calibrator


|Xn. Harmful |  | GRAPHIC R22/R32/S2
S13/S36/S46
|----------- |  | ------------------------------

R22

Harmful if swallowedR32

Contact with acid liberates very toxic gasS2

Keep out of reach of childrenS13

Keep away from food, drink, and animal feeding stuffsS36

Wear suitable protective clothingS46

If swallowed, seek medical advice immediately and show this container or label


REAGENT PREPARATION

This step should be performed prior to beginning Target Capture in an area that is free of template and amplicon.



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SPECIMEN COLLECTION, STORAGE AND HANDLING

NOTE: Handle all specimens as if they are potentially infectious agents.

Take
care to avoid cross-contamination during the sample handling steps. For example, discard used material without passing over open tubes.

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|LOGO
|----





PROCEDURAL NOTES

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INSTRUCTIONS FOR USE:

PROCLEIX HIV-1/HCV ASSAY ON INDIVIDUAL DONOR PLASMA SAMPLES OR ON POOLED PLASMA SAMPLES

All specimens (individual donations or pooled samples) should be run in singlet in the initial Procleix HIV-1/HCV Assay.

Per CLIA requirements (42 CFR 493), the Procleix HIV-1 and HCV External Quality Controls or equivalent must be run every time a Procleix assay is performed.
Procleix HIV-1/HCV Assay Calibrators and Discriminatory Probe Reagents are to be used with the corresponding master lot of the Procleix HIV-1/HCV Assays. The operator must
check to ensure that the Procleix HIV-1/HCV Assay Calibrators and Discriminatory Probe Reagents are used with the corresponding master lot of kit reagents as indicated on the master lot
sheet enclosed with each shipment of Procleix HIV-1/HCV Assay Calibrators and Discriminatory Probe Reagents.

To
run the Procleix HIV-1/HCV Assay for the detection of HIV-1 and HCV RNA, follow the steps below for Target Capture, Amplification and Hybridization Protection Assay. To run
the Procleix HIV-1/HCV Assay for discrimination between HIV-1 and HCV RNA, see Section D, below, prior to proceeding.

Note:
Continuous Process Flow:

All
process steps described below are intended to be completed in a continuous flow with a minimal, if any, delay between steps.



IN0076 Rev. F

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QUALITY CONTROL PROCEDURES:

PROCLEIX HIV-1/HCV ASSAY ON INDIVIDUAL DONOR PLASMA SAMPLES OR ON POOLED PLASMA SAMPLES

Run Validity Criteria





IN0076 Rev. F

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|Negative Calibrator          |  | Internal Control
Relative Light Units
|---------------------------- |  | -------------------------------------
|1                            |  | 124,000                              
|2                            |  | 126,000                              
|3                            |  | 125,000                              
|                             |  |                                      
|Total Internal Control RLU = |  | 375,000                              



|Negative Calibrator |  | Analyte
Relative Light Units
|------------------- |  | ----------------------------
|1                   |  | 14,000                      
|2                   |  | 16,000                      
|3                   |  | 15,000                      
|                    |  |                             
|Total Analyte RLU = |  | 45,000                      



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HIV-1 Positive Calibrator

Analyte
Relative Light Units1

690,0002

700,0003

710,000Total Analyte RLU =

2,100,000




HCV Positive Calibrator Acceptance Criteria

Individual HCV Positive Calibrator Analyte values must be less than or equal to 900,000 RLU and greater than or equal to 200,000 RLU. If one of the HCV Positive
Calibrator values is outside these limits, the HCV Positive Calibrator mean (HCV PCx) will be recalculated based upon the two acceptable HCV Positive Calibrator values. The run is invalid
and must be repeated if two or more of the three HCV Positive Calibrator Analyte values are outside these limits. IC values may not exceed 475,000 RLU.



HCV Positive Calibrator

Analyte
Relative Light Units1

350,0002

360,0003

340,000Total Analyte RLU =

1,050,000




Calculation of the Internal Control Cutoff Value

Internal
Control Cutoff Value = 0.5 X [NCx (Internal Control)]

Using
values given in the Negative Calibrator example above:

Internal
Control Cutoff Value = 0.5 X (125,000)

Internal
Control Cutoff Value = 62,500 RLU

Calculation of the HIV-1/HCV Analyte Cutoff Value

Analyte
Cutoff Value = NCx (Analyte) + [0.02 X HIV-1 PCx
(Analyte)]+ [0.04 X HCV PCx (Analyte)]

Using
values given in the Negative Calibrator and Positive Calibrator examples above:

Analyte
Cutoff Value = 15,000 + (0.02 X 700,000) + (0.04 X 350,000)

Analyte
Cutoff Value = 43,000 RLU

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Summary of Acceptance Criteria for Procleix HIV-1/ HCV Assay

|Acceptance Criteria:      |  |                              
|------------------------- |  | -----------------------------
|Negative Calibrator       |  |                              
|Analyte                   |  | > 0 and < 40,000 RLU         
|Internal Control          |  | > 75,000 and < 300,000 RLU   
|HIV-1 Positive Calibrator |  |                              
|Analyte                   |  | > 300,000 and < 1,800,000 RLU
|Internal Control          |  | < 475,000 RLU                
|HCV Positive Calibrator   |  |                              
|Analyte                   |  | > 200,000 and < 900,000 RLU  
|Internal Control          |  | < 475,000 RLU                

Summary of Cutoff Calculations for Procleix HIV-1/HCV Assay

|Analyte Cutoff =                                                  |  | NC Analyte Mean RLU                 
|----------------------------------------------------------------- |  | ------------------------------------
|                                                                  |  | + 0.02 X (HIV-1 PC Analyte Mean RLU)
|                                                                  |  | + 0.04 X (HCV PC Analyte Mean RLU)  
|Internal Control Cutoff = 0.5 X (Negative Calibrator IC Mean RLU)



|Negative Calibrator          |  | Internal Control Relative Light Units
|---------------------------- |  | -------------------------------------
|1                            |  | 124,000                              
|2                            |  | 126,000                              
|3                            |  | 125,000                              
|                             |  |                                      
|Total Internal Control RLU = |  | 375,000                              



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|Negative Calibrator |  | Analyte
Relative Light Units
|------------------- |  | ----------------------------
|1                   |  | 12,000                      
|2                   |  | 11,000                      
|3                   |  | 13,000                      
|                    |  |                             
|Total Analyte RLU = |  | 36,000                      



HIV-1 Positive Calibrator

Analyte
Relative Light Units1

690,0002

700,0003

710,000Total Analyte RLU =

2,100,000




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Summary of Acceptance Criteria for the Procleix HIV-1 Discriminatory Assay

|Acceptance Criteria:      |  |                              
|------------------------- |  | -----------------------------
|Negative Calibrator       |  |                              
|Analyte                   |  | > 0 and < 40,000 RLU         
|Internal Control          |  | > 75,000 and < 300,000 RLU   
|HIV-1 Positive Calibrator |  |                              
|Analyte                   |  | > 300,000 and < 1,800,000 RLU
|Internal Control          |  | < 475,000 RLU                
|HCV Positive Calibrator*  |  |                              
|Analyte                   |  | > 0 and < 40,000 RLU         
|Internal Control          |  | < 75,000 and < 300,000 RLU   

---

Summary of Cutoff Calculations for the Procleix HIV-1 Discriminatory Assay

|Analyte Cutoff =                                                  | NC Analyte Mean RLU + 0.04 X (HIV-1 PC Analyte Mean RLU)
|----------------------------------------------------------------- | --------------------------------------------------------
|Internal Control Cutoff = 0.5 X (Negative Calibrator IC Mean RLU)



|Negative Calibrator |  | Internal Control
Relative Light Units
|------------------- |  | -------------------------------------
|1                   |  | 124,000                              
|2                   |  | 126,000                              
|3                   |  | 125,000                              
|                    |  |                                      
|Total Analyte RLU = |  | 375,000                              



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|Negative Calibrator |  | Analyte
Relative Light Units
|------------------- |  | ----------------------------
|1                   |  | 20,000                      
|2                   |  | 22,000                      
|3                   |  | 18,000                      
|                    |  |                             
|Total Analyte RLU = |  | 60,000                      



In the HCV Discriminatory Assay, each individual HIV-1 Positive Calibrator must have Analyte values less than or equal to 40,000 RLU and greater than or equal to 0
RLU. Each HIV-1 Positive Calibrator must also have IC values greater than or equal to 75,000 RLU and less than or equal to 300,000 RLU. The run is invalid and must be repeated if two or
more of the three calibrator values have IC values or Analyte values that are outside of these limits.



Individual HCV Positive Calibrator value must be less than or equal to 2,700,000 RLU and greater than or equal to 400,000 RLU. If one of the HCV Positive Calibrator values is
outside these limits, the HCV Positive Calibrator mean (HCV PCx) will be recalculated based upon the two acceptable HCV Positive Calibrator values. The run is invalid and must be repeated
if two or more of the three HCV Positive Calibrator values are outside these limits. IC values may not exceed 475,000 RLU.



HCV Positive Calibrator

Analyte
Relative Light Units1

900,0002

1,000,0003

1,100,000Total Analyte RLU =

3,000,000




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Summary of Acceptance Criteria for the Procleix HCV Discriminatory Assay

|Acceptance Criteria:       |  |                              
|-------------------------- |  | -----------------------------
|Negative Calibrator        |  |                              
|Analyte                    |  | > 0 and < 40,000 RLU         
|Internal Control           |  | > 75,000 and < 300,000 RLU   
|HIV-1 Positive Calibrator* |  |                              
|Analyte                    |  | > 0 and < 40,000 RLU         
|Internal Control           |  | > 75,000 and < 300,000 RLU   
|HCV Positive Calibrator    |  |                              
|Analyte                    |  | > 400,000 and < 2,700,000 RLU
|Internal Control           |  | < 475,000 RLU                

---

Summary of Cutoff Calculations for the Procleix HCV Discriminatory Assay

|Analyte Cutoff =          |  | NC Analyte Mean RLU                    
|------------------------- |  | ---------------------------------------
|                          |  | + 0.04 X (HCV PC Analyte Mean RLU)     
|Internal Control Cutoff = |  | 0.5 X (Negative Calibrator IC Mean RLU)

INTERPRETATION OF RESULTS

All calculations described above are performed by the Procleix System Software.Two cutoffs are determined for each assay: one for the Analyte signal
(glower signal) termed the Analyte Cutoff and one for the Internal Control signal (flasher signal) termed the Internal Control Cutoff. The calculation of these cutoffs is shown above. For each sample,
an Analyte signal RLU value and Internal Control signal RLU value is determined. Analyte signal RLU divided by the Analyte Cutoff is abbreviated as the Analyte Signal/Cutoff (S/CO) on the report.

For
a sample with Analyte signal less than the Analyte Cutoff (i.e., Analyte S/CO < 1), the Internal Control (IC) signal must be greater than or equal to the Internal Control Cutoff (IC
Cutoff) for the result to be valid. In this case the Internal Control result will be reported asValidand the sample is reported as NonReactive. For a
sample with the Analyte signal less than the Analyte Cutoff (i.e., Analyte S/CO < 1) and the Internal Control
signal less than the Internal Control Cutoff, the Internal Control Result will be reported asInvalidand the sample result is reported as Invalid. For all
samples, the Internal Control signal may not exceed 475,000 RLU. The sample will automatically be reported as Invalidwith the Procleix System Software.

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Summary of Sample Validity:

|Sample
Interpretation |  | Internal Control
Result |  |                                                        
|--------------------- |  | ----------------------- |  | -------------------------------------------------------
|Nonreactive           |  | Valid                   |  | Analyte S/CO < 1 and IC> IC Cutoff and IC <
475,000 RLU
|Reactive              |  | (Not used)              |  | Analyte S/CO > 1and IC< 475,000 RLU                    



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PERFORMANCE CHARACTERISTICS

REPRODUCIBILITY

Procleix
HIV-1/HCV Assay reproducibility was determined at three blood testing laboratories. The reproducibility study evaluated both automated pipetting using TECAN GENESIS RSP, and
manual pipetting of the specimen and Target Capture Reagent (TCR) into the reaction tube. The reproducibility of the HIV-1/HCV Assay was assessed with a seven member reproducibility panel;
16 individual specimens were pipetted with the Chiron CPT Pooling Software to create each of the seven panel members (each panel member is a 16 member pool). Each pool contained from zero to three
HIV-1 and/or HCV RNA positive specimens with the remaining specimens in the pool being HIV-1 and HCV RNA negative (Table I).

For
determination of the reproducibility of the Procleix HIV-1 Discriminatory Assay and the Procleix HCV Discriminatory Assay, nine panel members were tested as individual specimens and
not in a pool. Eight of these panel members were HIV-1 and/or HCV RNA positive, and one was HIV-1 and HCV RNA negative (Tables IIa, IIb).

The
reproducibility panels were tested by a total of six operators (two at each site) with three different Clinical Lots over at least 18 nonconsecutive days. Inter- and intra-assay variability and
inter-lot variability were determined. Mean S/CO, standard deviation (SD) and coefficient of variation (%CV) results are shown for panel members and for the Negative, HIV-1
Positive and HCV Positive Calibrators. Since no significant difference in assay reproducibility was observed between automated
pipetting and manual pipetting, results for the two methods are combined in the Tables below (Tables I, IIa, IIb). Also, since HCV RNA positive and HIV-1 RNA positive samples containing 90
copies/mL or greater gave high (saturated) signals in all three assays, results on multiple panel members are combined.

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Table I. Reproducibility of the Procleix HIV-1/HCV Assay

|            |  |   |  |               |  |     |  |        |  |       |  | Intra-Assay |  | Inter-Assay |  | Inter-Lot
|----------- |  | - |  | ------------- |  | --- |  | ------ |  | ----- |  | ----------- |  | ----------- |  | ---------
|
|
|Nonreactive |  | 1 |  | 0             |  | 320 |  | 100.00 |  | 0.23  |  | 0.054       |  | 23.5        |  | 0.034    
|HIV-1       |  | 3 |  | 190, 620, 720 |  | 965 |  | 99.90  |  | 18.75 |  | 1.864       |  | 9.9         |  | 1.191    
|HIV-1/HCV   |  | 2 |  | 620,720/90    |  | 641 |  | 100.00 |  | 27.42 |  | 2.374       |  | 8.7         |  | 1.840    
|HCV         |  | 1 |  | 190           |  | 321 |  | 100.00 |  | 8.70  |  | 1.074       |  | 12.3        |  | 0.615    

|                          |  |     |  |     |  |        |  | Intra-Assay |  | Inter-Assay |  | Inter-Lot
|------------------------- |  | --- |  | --- |  | ------ |  | ----------- |  | ----------- |  | ---------
|
|
|Negative Calibrator       |  | 323 |  | N/A |  | 10363  |  | 2023        |  | 19.5        |  | 1740     
|HIV-1 Positive Calibrator |  | 324 |  | N/A |  | 858644 |  | 34660       |  | 4.0         |  | 55020    
|HCV Positive Calibrator   |  | 316 |  | N/A |  | 398939 |  | 17511       |  | 4.4         |  | 15926    

---

N
= Number of panel members combined for this analysis.

Table IIa. Reproducibility of the Procleix HIV-1 Discriminatory Assay (excludes 10 false positive results)

|            |  |   |  |                |  |      |  |        |  |       |  | Intra-Assay |  | Inter-Assay |  | Inter-Lot
|----------- |  | - |  | -------------- |  | ---- |  | ------ |  | ----- |  | ----------- |  | ----------- |  | ---------
|
|
|Nonreactive |  | 1 |  | 0              |  | 322  |  | 100.00 |  | 0.19  |  | 0.050       |  | 26.3        |  | 0.029    
|HIV-1       |  | 4 |  | 150, 500,      |  | 1289 |  | 100.00 |  | 19.69 |  | 2.391       |  | 12.1        |  | 1.114    
|            |  |   |  | 1500, 10000    |  |      |  |        |  |       |  |             |  |             |  |          
|HIV-1/HCV   |  | 1 |  | 500/500        |  | 318  |  | 100.00 |  | 19.44 |  | 1.225       |  | 6.3         |  | 1.373    
|HCV         |  | 3 |  | 150, 500, 1500 |  | 955  |  | 100.00 |  | 0.18  |  | 0.054       |  | 29.7        |  | 0.038    

|                          |  |     |  |     |  |        |  | Intra-Assay |  | Inter-Assay |  | Inter-Lot
|------------------------- |  | --- |  | --- |  | ------ |  | ----------- |  | ----------- |  | ---------
|
|
|Negative Calibrator       |  | 323 |  | N/A |  | 8900   |  | 2121        |  | 23.8        |  | 1824     
|HIV-1 Positive Calibrator |  | 320 |  | N/A |  | 894464 |  | 57091       |  | 6.4         |  | 63756    
|HCV Positive Calibrator   |  | 322 |  | N/A |  | 8686   |  | 2381        |  | 27.4        |  | 1572     

---

N
= Number of panel members combined for this analysis.

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Table IIb. Reproducibility of the Procleix HCV Discriminatory Assay (excludes 3 false positive results)

|            |  |   |  |                |  |      |  |        |  |       |  | Intra-Assay |  | Inter-Assay |  | Inter-Lot
|----------- |  | - |  | -------------- |  | ---- |  | ------ |  | ----- |  | ----------- |  | ----------- |  | ---------
|
|
|Nonreactive |  | 1 |  | 0              |  | 323  |  | 100.00 |  | 0.13  |  | 0.051       |  | 39.0        |  | 0.031    
|HIV-1       |  | 4 |  | 150, 500,      |  | 1288 |  | 100.00 |  | 0.13  |  | 0.073       |  | 55.0        |  | 0.042    
|            |  |   |  | 1500, 10000    |  |      |  |        |  |       |  |             |  |             |  |          
|HIV-1/HCV   |  | 1 |  | 500/500        |  | 323  |  | 100.00 |  | 21.32 |  | 1.965       |  | 9.2         |  | 1.000    
|HCV         |  | 3 |  | 150, 500, 1500 |  | 966  |  | 99.90  |  | 21.48 |  | 1.884       |  | 8.8         |  | 1.211    

|                          |  |     |  |     |  |         |  | Intra-Assay |  | Inter-Assay |  | Inter-Lot
|------------------------- |  | --- |  | --- |  | ------- |  | ----------- |  | ----------- |  | ---------
|
|
|Negative Calibrator       |  | 320 |  | N/A |  | 8132    |  | 2861        |  | 35.2        |  | 1893     
|HIV-1 Positive Calibrator |  | 321 |  | N/A |  | 7937    |  | 3089        |  | 38.9        |  | 2240     
|HCV Positive Calibrator   |  | 323 |  | N/A |  | 1243692 |  | 57818       |  | 4.6         |  | 92720    

---

N
= Number of panel members combined for this analysis.

PERFORMANCE OF POOLED SAMPLE TESTING

Specificity of the Procleix HIV-1/HCV Assay

The
HIV-1/HCV Assay was used to screen plasma pools comprised of 16 donor specimens and individual donor specimens (IDS). These specimens were tested at eight volunteer blood donor sites
using three Clinical Lots of reagents. This population derived from approximately 103 geographically diverse blood donor sites in the continental US and five others which were US military blood donor
sites located in Hawaii (one), Japan (two), Germany (one), and Guam (one). Pools or individual specimens with S/CO<1.0 are considered Nonreactive (NR). Individual specimens that are
Reactive (R) by the HIV-1/HCV Assay and Reactive by either the HIV-1 or HCV Discriminatory Assay or both are termed Reactive-Discriminated. Individual specimens that are
reactive by the HIV-1/HCV Assay but Nonreactive by both the HIV-1 or HCV Discriminatory Assays are termed Reactive-Non-Discriminated. A
non-discriminated specimen which tested again as HIV-1/HCV Reactive was termed Repeatedly Reactive-Non-Discriminated. A non-discriminated
specimen which tested again as HIV-1/HCV Assay Nonreactive was considered Nonreactive for HIV-1 and HCV RNA.

At
the time the study was performed there was no recognized standard for establishing the presence or absence of HIV-1 RNA or HCV RNA in blood. Specificity was based on testing of blood
donations from random volunteer blood donors. For the purpose of specificity calculations, specimens testing seroreactive for anti-HIV-1 and anti-HCV antibody (Ab)
or HIV p24 antigen (Ag) were eliminated from the analysis.

In
the pooling specificity study, 11,978 pools (191,648 donor specimens) were tested (Table III and Table IV). Specificity of pool testing relative to serology testing was 99.67% (11,625/11,663).
Specificity was defined as number of pools containing all serology and Procleix HIV-1/HCV Assay nonreactive specimens (True negative, TN) divided by the sum of TN and False positive pools.
False positive pools were defined as pools Reactive by the HIV-1/HCV Assay and that contained all specimens nonreactive by serology.

There
were 175 (1.46%) pools initially reactive by the HIV-1/HCV Assay. All 16 individual donor specimens from each reactive pool were tested. There were 33 pools containing all
Nonreactive

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individual donor specimens. One hundred and sixty-six individual donor specimens derived from the remaining 142 pools were Reactive in the HIV-1/HCV Assay. No significant
differences among sites or Clinical Lots were observed.

Of
the 166 HIV-1/HCV Assay reactive individual donor specimens, 138 (83.1%) were Reactive in the HCV Discriminatory Assay, 13 (7.8%) were Reactive in the HIV-1 Discriminatory
Assay and 15 (9.0%) were Nonreactive in both discriminatory tests. The 15 Reactive-Non-Discriminated specimens were seronegative for HIV and HCV and were Nonreactive when
retested in the HIV-1/HCV Assay. The adjusted reactive rate after removal of reactive pools containing true positive samples was 0.31% (37/11,841).

A
total of 49,054 specimens (total of pooled and individual donor specimens) were run in the HIV-1/HCV Assay during these specificity studies and 185 (0.38%) specimens tested as initially
invalid due to an Internal Control failure. All 185 specimens giving initially invalid results gave valid repeat testing results in the HIV-1/HCV Assay.

Table III. Procleix HIV-1/HCV Assay Reactivity in Volunteer Blood Donors

|                                        |  | Procleix HIV-1/HCV Assay
Plasma Pool of 16
|--------------------------------------- |  | ------------------------------------------
|Samples Tested*                         |  | 11,978                                    
|Initial Reactive                        |  | 175                                       
|Initial Reactive Rate                   |  | 1.46%                                     
|Adjusted Reactive Rate                  |  | 0.31%                                     
|Combined Mean S/CO on Negative Analytes |  | 0.21 ± 0.10                               

---

*Combined
data across all sites and Clinical Lots.

No
significant differences among Clinical Lots of reagents were observed for either the Negative population Analyte mean S/CO or mean Internal Control S/CO in the negative population distribution.

Results
of deconvolution of all 16 member pools are shown in Table IV. In these pivotal specificity studies (pooled and individual donation testing), no specimen was identified as a yield specimen
based on the HIV-1/HCV Assay reactivity, HIV-1 and/or HCV Discriminatory Assay reactivity, reactivity by Alternative NAT and lack of HCV or HIV-1 antibody
reactivity. The finding of no HIV-1 or HCV RNA yield donors in 226,205 specimens is consistent with published yields15. Rates of specimens testing reactive for both HCV RNA
and HCV antibody in volunteer donors was 1 in 1,508 donors and rates of specimens testing reactive for both HIV-1 RNA and HIV-1 antibody was 1 in 14,138 donors.

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Table IV. Deconvoluted Pooling Results

|                                               |  | N (%)         |   | Sero-RR* |  |  |  | 
|---------------------------------------------- |  | ------------- | - | -------- |  |  |  | 
|Total pools tested                             |  | 11,978 (100.0 | ) | N/A      |  |  |  | 
|HIV-1/HCV Assay Nonreactive pools              |  | 11,803 (98.54 | ) | N/A      |  |  |  | 
|HIV-1/HCV Assay Reactive pools                 |  | 175 (1.46     | ) | N/A      |  |  |  | 
|Pools with all HIV-1/HCV Assay Nonreactive IDS |  | 33 (18.9      | ) | N/A      |  |  |  | 
|Pools with > 1 HIV-1/HCV Assay Reactive IDS    |  | 142 (81.1     | ) | N/A      |  |  |  | 
|HIV-1/HCV Assay Reactive IDS                   |  | 166 (100.0    | ) | 120      |  |  |  | 
|HIV-1 and HCV Discriminatory Reactive IDS      |  | 0 (0.0        | ) | 0        |  |  |  | 
|HIV-1 Discriminatory Reactive IDS              |  | 13 (7.8       | ) | 13       |  |  |  | 
|HCV Discriminatory Reactive IDS                |  | 138 (83.1     | ) | 131      |  |  |  | 
|HIV-1 and HCV Discriminatory Nonreactive IDS   |  | 15 (9.0       | ) | 0        |  |  |  | 
|Repeat HIV-1/HCV Assay Nonreactive IDS         |  | 15 (100.0     | ) | 0        |  |  |  | 
|Repeat HIV-1/HCV Assay Reactive IDS            |  | 0 (0.0        | ) | 0        |  |  |  | 

---

*EIA
repeatedly reactive, supplemental serology positive or indeterminate.

IDS
= Individual Donor Specimen.

Specificity of the Procleix HIV-1 and HCV Discriminatory Assays

In
the HIV-1 and HCV Discriminatory Assays specificity study, the HIV-1 Discriminatory and HCV Discriminatory assays were run only on individual donor specimens which had
previously tested as Nonreactive by the HIV-1/HCV assay. The initial reactive rates for the HIV-1 Discriminatory and HCV Discriminatory Assays were 0.24% (6/2508) and 0.29%
(7/2443), respectively. In this study initially reactive specimens were not retested.

Comparison with Serology

Results
generated from the pooled and individual donation testing specificity studies allow comparison of the HIV-1/HCV Assay with serology reactivity (Table V). Sixteen of 17
HIV-1 seroreactive, Western blot positive specimens were also Procleix HIV-1/HCV Assay Reactive (Table V). The one discordant specimen was Nonreactive when tested as a pool by
the Procleix HIV-1/HCV Assay but was Reactive by the Procleix HIV-1/HCV Assay when tested as an individual donor specimen. All of the HIV seroreactive specimens which were
Indeterminate or negative by Western Blot (91.7% of total HIV seroreactive specimens) were Nonreactive by the Procleix HIV-1/HCV Assay. Overall agreement between the Procleix
HIV-1/HCV Assay and Western blot was 100% (226/226) if testing at an individual donor level is compared.

77.3%
(150/194) of HCV seroreactive, Chiron RIBA HCV 3.0 (RIBA) Positive specimens were Reactive by the HIV-1/HCV Assay. 3.3% (2/60) of HCV seroreactive, RIBA Indeterminate specimens were
reactive by the Procleix HIV-1/HCV Assay. All 163 RIBA Negative specimens were also Nonreactive by the Procleix HIV-1/HCV Assay. Overall agreement between the Procleix
HIV-1/HCV Assay and RIBA was 89.0% (371/417). These data are consistent with previous reports that about 20% of HCV seropositives will have undetectable HCV RNA27 and
estimates that approximately 20% of HCV seropositive individuals may have resolved infection28.

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Table V. Comparison of Serologic and Procleix HIV-1/HCV Assay Reactives from the Specificity Studies

|             |  |     |  | Procleix HIV-1/HCV |   
|------------ |  | --- |  | ------------------ | --
|
|HIV Ab RR    |  | POS |  | 16 (7.0            | %)
|Western Blot |  | IND |  | 0 (0               | %)
|(N = 228)    |  | NEG |  | 0 (0               | %)
|             |  | N/A |  | 0 (0               | %)
|HCV Ab RR    |  | POS |  | 150 (35.8          | %)
|RIBA         |  | IND |  | 2 (0.5             | %)
|(N = 419)    |  | NEG |  | 0 (0.0             | %)
|             |  | N/A |  | 1 (0.2             | %)

---

*Sample
contained < 50 copies/mL of HIV-1 RNA and was Procleix HIV-1/HCV negative in pool testing but reactive in individual sample testing.

Non-Specificity Studies

When
tested with the Procleix HIV-1/HCV Assay, no cross-reactivity or interference was observed for naturally occurring icteric, hemolyzed or lipemic specimens or plasma containing the
following substances: serum albumin (up to 225 g/L), hemoglobin (up to 5000 mg/L), billirubin (up to 200 mg/L) and lipids (up to 2,752 mg/dL).

No
cross-reactivity or interference was observed in specimens from patients with autoimmune diseases or with liver diseases not caused by HCV infection. Autoimmune conditions included rheumatoid
arthritis (n = 10), rheumatoid factor (n = 10), antinuclear antibody (n = 10), multiple sclerosis (n = 10), lupus (n = 10) and multiple myeloma (n =
9). Also tested were flu vaccinees (n = 10), hepatitis B vaccinees (n = 10), elevated IgM (n = 6), elevated IgG (n = 11), alcoholic liver cirrhosis
(n = 10) and elevated ALT (n = 10).

No
cross-reactivity or interference was observed in bacterially contaminated plasmas or in plasmas infected with other blood borne pathogens, including herpes simplex virus-1 (n =
10), herpes simplex virus-2 (n = 1), CMV (n = 10), EBV (n = 10), hepatitis A virus (n = 10), HTLV-I (n = 10), HTLV-II (n =
10), hepatitis B virus (n = 10), HIV-2 (n = 10), rubella (n = 10) and parvovirus B-19 (n = 10).

CLINICAL SENSITIVITY

Testing of Whole Blood Donor Specimens

A
total of 24,764,889 donations were screened as part of pooled sample testing since early 199930. As of November 2001, eighty-eight Procleix HCV yield cases (1:281,419) and seven
HIV-1 yield cases (1:3,537,841) were identified across the ten Procleix pooled testing sites. Yield cases were confirmed to be positive for either HIV-1 or HCV RNA, but
negative in serology testing.

Two
of the nine HIV-1 yield cases were reactive for HIV-1 RNA and p24 Ag but Nonreactive by HIV antibody testing (Table VI).

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Table VI. Summary of Procleix Assay Yield Cases

|Pooled Sample Testing     
|--------------------------
|Number of Donations Tested
|Procleix HCV
Yield Cases  
|Procleix HIV-1            
|Yield Cases               

Testing of Specimens from HIV-1 and/or HCV Infected Individuals

A
total of 2014 specimens positive by commercial HIV-1 RNA and HCV RNA assays (sensitivity >100 copies/mL) were obtained from four commercial vendors. Three
Clinical Lots were used for all testing. These specimens were classified as HIV-1 RNA positives (n = 867), HCV RNA positives (n = 967) and both HIV-1 and HCV RNA
(coinfected) positives (n = 180) based on alternate nucleic acid testing (Table VII). These specimens were also classified by disease category as described below and as shown in Table
VIII. These positive samples were tested undiluted (neat) with the Procleix HIV-1/HCV Assay, HIV-1 Discriminatory Assay and the HCV Discriminatory Assay, and tested diluted
1:16 with the Procleix HIV-1/HCV Assay. All dilutions were made with processed human serum that was negative for HIV-1 RNA and antibody/antigen, and HCV RNA and antibody.

During
the study, specimens known to contain <100 copies/mL of viral RNA were excluded from this analysis and therefore the sensitivity presented herein is for samples with viral RNA
concentrations equal to or greater than 100 copies/mL, or of unknown viral concentration.

The
sensitivity for the Procleix HIV-1/HCV and HIV-1 Discriminatory Assays for undiluted (neat) HIV-1 positive samples was 99.9% (95% CI: 99.4-100%) and
100% (95% CI: 99.6-100%), respectively. The sensitivity for the Procleix HIV-1/HCV Assay for diluted (1:16) HIV-1 positive samples was 99.0% (95% CI:
98.0-99.5%).

The
sensitivity for both the Procleix HIV-1/HCV Assay and the HCV Discriminatory Assay for undiluted (neat) HCV positive samples was 99.6% (95% CI: 98.9-99.9%). The sensitivity
for the Procleix HIV-1/HCV Assay for diluted (1:16) HCV positives was 99.6% (95% CI: 98.9-99.9).

The
sensitivity for the Procleix HIV-1/HCV Assay, HIV-1 Discriminatory Assay and HCV Discriminatory Assay for undiluted HIV-1/HCV coinfected specimens was 100% (95%
CI: 98.0-100%), 100% (95% CI: 97.9-100%) and 100% (95% CI: 92.6-100%), respectively. The sensitivity for the Procleix HIV-1/HCV Assay for
HIV-1/HCV coinfected specimens was 98.9% (95% CI: 96.0-99.9) when tested at 1:16 dilution.

The
overall clinical sensitivity for the Procleix HIV-1/HCV Assay, which takes into account all samples (RNA concentrations > 100 copies/mL or unknown viral
concentration) tested, is 99.8% (95% CI: 99.4-99.9), that for the HIV-1 Discriminatory Assay is 100% (95% CI: 99.6-100%), and that for the HCV Discriminatory Assay
is 99.6% (95% CI: 99.0-99.9%).

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Table VII. The Sensitivity of the Procleix HIV-1/HCV, HIV-1 and HCV Discriminatory Assays for HIV-1 and HCV Positive Specimens with RNA
Concentrations > 100 Copies/mL or Unknown

|HIV-1/HCV Assay | 
|--------------- | 
|
|
|
|All             | 
|HIV Only        | 
|HCV Only        | 
|HIV & HCV       | 

|HIV-1 Discriminatory Assay | 
|-------------------------- | 
|
|
|
|All                        | 
|HIV Only                   | 
|HIV & HCV                  | 

|HIV Discriminatory Assay | 
|------------------------ | 
|
|
|
|All                      | 
|HCV Only                 | 
|HIV & HCV                | 

---

C.
I. = Confidence interval.

The
data from the above study were further analyzed according to the disease stages of the patients from whom the specimens were obtained as shown in Table VIII. A total of 296 samples were from AIDS
patients (as defined by AIDS-indicative conditions and/or a CD4 count of <200/mm3), 338 from asymptomatic patients (asymptomatic, persistent generalized
lymphadenopathy, or acute HIV infection), 168 from symptomatic but non-AIDS patients (not AIDS and not asymptomatic) and 240 from individuals with unknown HIV disease
state29. Most of these patients were on HIV anti-viral medication. The sensitivity for HIV detection with the Procleix HIV-1/HCV Assay ranged from 99.6 to 100%
for neat specimens and from 96.4 to 100% for 1:16 diluted specimens. The sensitivity for the HIV-1 Discriminatory Assay was 100%. All HIV-1 p24 Ag reactive specimens were also
reactive with the Procleix HIV-1/HCV Assay when tested as undiluted (neat) or as 1:16 diluted samples, and with HIV-1 Discriminatory Assay when tested as neat samples. This was
also true of all specimens excluded from the study due to low viral RNA concentrations (<100 copies/mL).

Similarly,
the specimens from HCV infected patients were segregated as shown in Table IX. A total of 887 specimens were from volunteer blood donors whose donations were HCV reactive with
PCR-based NAT, 53 specimens were from patients with chronic HCV infection that was first identified by blood donation screening and 75 specimens were not categorized by the vendor other
than being HCV NAT or antibody positive. The sensitivity for HCV testing with the Procleix HIV-1/HCV Assay ranged from 99.5 to 100% (95% CI: 98.9-99.9%) with neat samples and
97.3 to 100% (95% CI: 93.3-100%) with 1:16 diluted samples. The sensitivity for HCV Discriminatory Assay ranged from 99.5 to 100% (95% CI: 95.2-100%) for neat samples.

During
this clinical study, in which a total of 1014 HCV RNA-positive samples were tested, two of these samples were consistently reactive when tested at 1:16 dilution, but nonreactive
when tested neat.

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In
the same study, 13 sero-positive samples with low copy numbers of HIV or HCV (or both) were non-reactive when tested at 1:16 dilution, and reactive when tested neat.

In
summary, it appears that the disease stages for HIV-1 or HCV infected individuals did not significantly affect the sensitivity for the Procleix Assays, although some low copy number HCV
antibody positive specimens (2/967) were non-reactive when tested neat but reactive when tested at 1:16 dilution.

The
clinical sensitivity claims of the assay are still met with the inclusion of these specimens.

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Table VIII. Sensitivity of the Procleix HIV-1/HCV and HIV-1 Discriminatory Assays for HIV-1 Positive Specimens from Individuals at Various
Disease States*

|                |  | Procleix HIV-1/HCV Assay |  | HIV-1 Discriminatory |  | HIV-1 Antibody |  | HIV-1 p24 Ag
|--------------- |  | ------------------------ |  | -------------------- |  | -------------- |  | ------------
|
|
|AIDS            |  | 295                      |  | 295                  |  | 100.0          |  | 296         
|Symptomatic**   |  | 168                      |  | 168                  |  | 100.0          |  | 167         
|Asymptomatic*** |  | 338                      |  | 338                  |  | 100.0          |  | 338         
|Unknown         |  | 240                      |  | 239                  |  | 99.6           |  | 240         
|                |  |                          |  |                      |  |                |  |             
|Total           |  | 1041                     |  | 1040                 |  | 99.9           |  | 1041        

---

N = Number        R = Reactive

Table IX. Sensitivity of the Procleix HIV-1/HCV and HCV Discriminatory Assays for HCV Positive Specimens From Individuals at Various Disease States*

|                 |  | Procleix HIV-1/HCV Assay |  | HIV Discriminatory Assay |  | HIV Antibody
|---------------- |  | ------------------------ |  | ------------------------ |  | ------------
|
|
|First Time Blood |  | 887                      |  | 883                      |  | 99.5        
|Chronic HCV      |  | 53                       |  | 53                       |  | 100         
|Unknown          |  | 75                       |  | 75                       |  | 100         
|                 |  |                          |  |                          |  |             
|Total            |  | 1015                     |  | 1011                     |  | 99.6        

---

N = Number        R = Reactive

Sensitivity for Pooled Samples

The clinical sensitivity of the Procleix HIV-1/HCV Assay with pooled samples was determined by testing 102 sixteen-member pools composed of one
HIV-1 or HCV positive sample and 15 negative samples, and 102 sixteen-member pools composed of two HIV-1 and/or HCV positive samples and 14 negative samples. The viral load of
the HIV-1 positive samples used to make the pools ranged from 1060 copies/mL to 10,018,200 copies/mL with a median of 27,490 copies/mL. The viral load of the HCV positive samples used to
make the pools ranged from 1660 copies/mL to 20,200,000 copies/mL with a median of 327,000 copies/mL. All 204 (100%; 95% CI: 98.2-100%) pools containing at least one HIV-1
and/or HCV RNA positive specimen were reactive with the HIV-1/HCV Assay.

Prospective Study of Individuals at High Risk for HIV-1 and HCV Infection

Specimens from 539 individuals at high risk for infection with HIV-1 and/or HCV were tested as undiluted (neat) samples with the Procleix
HIV-1/HCV, HIV-1 Discriminatory and HCV Discriminatory Assays. These samples were also tested at 1:16 dilution with the Procleix HIV-1/HCV Assay. Results

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are shown in Table X. 72.5% (391/539) had IV drug use (IVDU) as one of their risk factors. Risk factors other than IVDU included having unprotected sex, men having sex with men, occupational
exposure, having sex with positive partner, and having transfusion of blood or blood products. Sensitivity was determined by comparing the Procleix Assays with an HIV-1 or HCV
PCR-based assay that has a claimed analytical sensitivity of 3100 copies viral RNA /mL.

Both
the Procleix HIV-1/HCV Assay and HIV-1 Discriminatory Assay detected all 23 samples, either undiluted or 1:16 diluted, that were tested reactive for
HIV-1 with the PCR NAT test. Of these 23 HIV-1 reactive specimens, 11 were also reactive with the HCV Discriminatory Assay and are considered samples from individuals
coinfected with HIV-1 and HCV.

There
was one confirmed HIV-1 yield case that appeared to be in the window period. This specimen was reactive with the Procleix HIV-1/HCV and HIV-1
Discriminatory Assays as an undiluted sample, and with the Procleix HIV-1/HCV Assay as a 1:16 diluted sample. The specimen was HIV antibody seronegative, HIV p24 Ag positive and was
positive with an alternate HIV-1 nucleic acid test (NAT).

There
were 268 HCV antibody and/or alternate HCV NAT positive specimens among the 520 high-risk specimens that were tested with Procleix HIV-1/HCV and HCV
Discriminatory Assays. When tested as undiluted (neat) samples, 266 of the 268 positive specimens (99.3%, 95% CI: 97.3-99.9%) were reactive with both the Procleix HIV-1/HCV and
HCV Discriminatory Assays. When tested as diluted samples, 254 of 259 (98.1%, 95% CI: 95.6-99.4%) were reactive with the Procleix HIV-1/HCV Assay. There were 44 HCV
seropositive specimens that were nonreactive in all Procleix Assays. Of the 44, 37 were tested
by an alternate HCV NAT and 34 were found to be NAT negative (considered Procleix TN for sensitivity calculations), two were equivocal, and one was positive (Procleix FN). This study resulted in three
confirmed HCV yield cases that were considered true positives for the Procleix assay. These specimens were HCV antibody negative; two of which were alternate HCV NAT positive and one was QNS for
alternate NAT. All three subjects later seroconverted.

Table X. Clinical Sensitivity of the Procleix HIV-1/HCV Assay in a High Risk Population

|       |  |         |  |     |  |     |  |   |  |     |  |   |  | Sensitivity
|------ |  | ------- |  | --- |  | --- |  | - |  | --- |  | - |  | -----------
|
|
|HIV-1* |  | Neat    |  | 530 |  | 23  |  | 0 |  | 507 |  | 0 |  | 100        
|       |  | Diluted |  | 520 |  | 23  |  | 0 |  | 497 |  | 0 |  | 100        
|HCV**  |  | Neat    |  | 520 |  | 266 |  | 3 |  | 249 |  | 2 |  | 99.3       
|       |  | Diluted |  | 508 |  | 254 |  | 2 |  | 247 |  | 5 |  | 98.1       

---

Analytical Sensitivity

To determine the analytical sensitivity of the Procleix HIV-1/HCV Assay and HIV-1 and HCV Discriminatory Assays for detection of
HIV-1 and HCV viral RNA, HIV-1 panel members were prepared by serial dilution of negative human plasma spiked with HIV-1 (type B isolate) tissue culture
supernatant. HCV panel members were made by serial dilution of a patient plasma specimen containing HCV (subtype 1a). The RNA levels in viral stocks used to make the HIV-1 panel and high
titer HCV plasma used to make the HCV panel were value assigned using an in-house quantitative HIV-1 assay calibrated to the VQA standard obtained from Dr. James Bremer
(Rush-Presbyterian

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Hospital, Chicago, IL) or quantitative HCV assay compared to HCV RNA WHO standard. (1 WHO IU/mL is equivalent to 2.7 copies/mL).

The
panel members were tested with ten clinical lots of reagents and the test results are presented in Table XI. The Procleix HIV-1/HCV Assay and HIV-1 and HCV
Discriminatory Assays achieved 100% detection for panel members containing 300 copies/mL, and > 99% detection for those members containing 100 copies/mL of HIV-1 or HCV RNA. The lower
bound of 95% CI for both HIV-1 and HCV at 100 and 300 copies/mL for all assays exceeded 95%, which is consistent with a claimed analytical sensitivity of 100 copies RNA/mL. The Procleix
HIV-1/HCV and Discriminatory Assays were able to detect 30 copies/mL of HIV-1 or HCV RNA at a frequency greater than 90%, with the lower bound of 95% CI ranging from 90% to
97.3%.

Table XI. Detection of HIV-1 B RNA and HCV 1a RNA in Analytical Sensitivity Panels

|    |  | Procleix HIV-1/HCV Assay |  | HIV-1 Discriminatory Assay
|--- |  | ------------------------ |  | --------------------------
|
|
|
|300 |  | 716/716                  |  | 100                       
|100 |  | 719/719                  |  | 100                       
|30  |  | 707/720                  |  | 98.2                      
|10  |  | 573/718                  |  | 79.8                      
|3   |  | 297/718                  |  | 41.4                      
|1   |  | 112/717                  |  | 15.6                      

|    |  | Procleix HIV-1/HCV Assay |  | HIV Discriminatory Assay
|--- |  | ------------------------ |  | ------------------------
|
|
|
|300 |  | 718/718                  |  | 100                     
|100 |  | 720/720                  |  | 100                     
|30  |  | 669/718                  |  | 93.2                    
|10  |  | 470/719                  |  | 65.4                    
|3   |  | 231/718                  |  | 32.2                    
|1   |  | 70/716                   |  | 9.8                     

---

CBER HIV-1 RNA Panel

Panel A (5 members) and Panel B (8 members) were tested in duplicate with 5 Clinical Lots using both the HIV-1/HCV Assay and the HIV-1
Discriminatory Assay. Results for both Panel A and B are shown in Table XII. For Panel A, testing with the HIV-1/HCV Assay showed reproducible detection of HIV-1 RNA at copy
levels ranging from 250,000 to 100 copies/mL; the panel member at 0 copies/mL was non-reactive. Results for Panel B demonstrated reproducible detection of HIV-1 RNA at copy
levels ranging from 250,000 to 50 copies/mL and non-reactive results with both negative panel members (B4 and B8). Similar results were obtained with the Discriminatory Assays.

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CBER HCV RNA Panel

This panel consisted of 10 panel members with copy levels ranging from 100,000 to 0 copies/mL. This panel was tested in duplicate with 5 Clinical Lots using both
the HIV-1/HCV and HCV Discriminatory Assays. Results are shown in Table XII. Reproducible detection of HCV was obtained down to 50 copies/mL with both assays.

Table XII. Detection of HIV-1 RNA and HCV RNA in CBER panel members

|                                |  | Panel members tested and positivity rates |  
|------------------------------- |  | ----------------------------------------- | -
|
|CBER HIV-1 RNA Panel(copies/mL) |  | 250,00                                    |  
|HIV-1/HCV Assay*                |  | 100                                       | %
|HIV-1 Discriminatory Assay**    |  | 100                                       | %

|                              |  | Panel members tested and positivity rates |  
|----------------------------- |  | ----------------------------------------- | -
|
|CBER HCV RNA Panel(copies/mL) |  | 1,000                                     |  
|HIV-1/HCV Assay*              |  | 100                                       | %
|HCV Discriminatory Assay**    |  | 100                                       | %

---

* n=10; ** n=6

WHO International Standard for HIV-1

The WHO International Standard for HIV-1 RNA (NIBSC code 97/656) with a concentration of 100,000 IU/mL was serially diluted and tested with the
HIV-1/HCV Assay and the HIV-1 Discriminatory Assay. The results obtained are shown in Table XIII.

WHO International Standard for HCV

The WHO International Standard for HCV RNA (96/790) with a concentration of 100,000 international units (IU)/mL was serially diluted and tested with the
HIV-1/HCV Assay and the HCV Discriminatory Assay. The results obtained are shown in Table XIII.

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Table XIII. Testing of International Standards for HIV-1 RNA (NIBSC code 97/656) and HCV RNA (NIBSC 96/790)

|                             |  | Concentrations tested and positivity rates
|---------------------------- |  | ------------------------------------------
|WHO HIV-1 (97/656)           |  | 300
IU/mL                                 
|HIV-1/HCV Assay*             |  | 100%                                      
|HIV-1 Discriminatory Assay** |  | 100%                                      

|                           |  | Concentrations tested and positivity rates
|-------------------------- |  | ------------------------------------------
|WHO HCV (96/790)           |  | 110
IU/mL                                 
|HIV-1/HCV Assay*           |  | 100%                                      
|HCV Discriminatory Assay** |  | 100%                                      

---

*
n=40; ** n=30

Reactivity in Seroconverting Donors

Commercially available seroconversion panels collected from plasmapheresis donors were tested with the Procleix HIV-1/HCV Assay (neat and 1:16
diluted), HIV-1 Discriminatory (neat only) and HCV Discriminatory (neat only) Assays. Ten seroconversion panels for HIV-1 and ten panels for HCV were tested with one Clinical
Lot. The test results were compared with those of the Ortho HCV 3.0 ELISA test or the Abbott Anti-HCV 2.0 test for HCV seroconversion panels, or with those of Abbott
HIV-1/-2 antibody and Abbott or Coulter HIV-1 p24 antigen test for HIV-1 seroconversion panels. The Procleix HIV-1/HCV Assay was able to
detect the infection with median values of 12 and 7 days earlier than the Abbott HIV-1/-2 antibody and HIV-1 p24 Ag assays, respectively, when specimens were
tested neat (Table XIV). The Procleix HIV-1/HCV Assay was able to detect the infection with median values of 10 and 3 days earlier than the Abbott HIV-1/-2
antibody and HIV-1 p24 Ag tests, respectively, when specimens were tested at a 1:16 dilution. The HIV-1 Discriminatory Assay was able to detect infection with median values of
12 and 6 days earlier than the Abbott HIV-1/-2 antibody and HIV-1 p24 Ag tests, respectively, when specimens were tested neat. Reduction of the window period
was observed in 9 of 10 panels when the Procleix HIV-1/HCV and HIV-1 Discriminatory Assays were used as compared to the use of the Abbott HIV Ab test alone. When compared to
the HIV-1 p24 Ag assay, the Procleix HIV-1/HCV Assay detected the infection earlier in 8 of 10 panels and at the same time as HIV-1 p24 Ag in the other two panels.
In all cases, HIV-1 p24 Ag reactive specimens were reactive with the Procleix HIV-1/HCV Assay and the HIV-1 Discriminatory Assay.

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Table XIV. Testing for HIV-1 RNA with the Procleix HIV-1/HCV and HIV-1 Discriminatory Assays on HIV-1 Seroconversion Panels

|          |  | Days Earlier Detection Than HIV Antibody |  | Days Earlier Detection Than HIV-1 p24 Ag
|--------- |  | ---------------------------------------- |  | ----------------------------------------
|
|
|
|
|BCP 6240  |  | 12                                       |  | 7                                       
|BCP 6248  |  | 14                                       |  | 11                                      
|PRB923*   |  | 12                                       |  | 17                                      
|PRB926**  |  | 27                                       |  | 25                                      
|PRB929*** |  | 11                                       |  | 11                                      
|PRB932^   |  | 0                                        |  | 0                                       
|PRB943    |  | 9                                        |  | 9                                       
|PRB945**  |  | 13                                       |  | 10                                      
|PRB946^^  |  | 11                                       |  | 7                                       
|PRB950**  |  | 28                                       |  | 10                                      
|          |  |                                          |  |                                         
|Median    |  | 12                                       |  | 10                                      

---

The
Procleix HIV-1/HCV and HCV Discriminatory Assays were able to detect infection with a median value of 25 days earlier than the HCV antibody tests (Table
XV) when tested diluted or undiluted. Reduction of the seroconversion window period by the Procleix HIV-1/HCV and HCV Discriminatory Assays was observed in 10 of 10 panels compared
to the HCV antibody test.

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Table XV. Testing for HCV RNA with the Procleix HIV-1/HCV and HCV Discriminatory Assays on HCV Seroconversion Panels

Days Earlier Detection Than HCV AntibodyHCV DiscriminatoryPanel ID

HIV-1/HCVNeat

1/16

NeatBCP 6213

26

26

26BCP 6225

39

33

39BCP 6226*

39

39

39BCP 6228*

31

31

31BCP 9045*

41

41

41PHV904*

14

14

14PHV907*

21

21

21PHV908*

19

19

19PHV914*

24

24

24PHV916*

23

23

23Median

25

25

25


---

*HIV-1/HCV
Assay reactive in first bleed of seroconversion panel vs. Ortho HCV 3.0.

Subtype Detectability

Since there are no recognized international standards for HCV or HIV-1 other than HCV subtype 1a and HIV-1 subtype B, multiple specimens
and isolates (59 different HIV-1 and 53 different HCV specimens) were tested to determine detectability of these viral subtypes31. HIV-1 specimens of subtypes A,
B, C, D, E, F, and G were quantified for HIV-1 RNA concentrations using commercial quantitative HIV-1 RNA assays or an in-house developed quantitative test, the
latter using the same technology as the Procleix assays. HIV-1 subtypes N and O were quantified with an in-house quantitative HIV-1 RNA test. Specimens were diluted
into negative human plasma to target viral concentrations of 300 or 100 copies/mL and diluted specimens were tested in the HIV-1/HCV and HIV-1 Discriminatory Assays. All
HIV-1 subtypes were reactive with both the Procleix HIV-1/HCV and HIV-1 Discriminatory Assays at 300 and 100 copies/mL (Table XVI).

HCV
specimens of subtypes 1, 2, 3, 4, 5 and 6 were quantified for HCV RNA using commercially available quantitative HCV RNA assays. Specimens were diluted into negative human plasma to
target viral concentrations of 300 or 100 copies/mL and diluted specimens were tested with the HIV-1/HCV and HCV Discriminatory Assays. All HCV subtypes were reactive by the
HIV-1/HCV and HCV Discriminatory Assays at 300 and 100 copies/mL, except one HCV subtype 2 specimen which was reactive at 300 copies/mL, but nonreactive at 100 copies/mL (Table XVI).

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Table XVI. HIV-1 and HCV Subtype Detectability

Specimen

Subtype

Copies/mL

HIV-1/HCV
Reactive/Total

HIV-1 Discriminatory
Reactive/TotalHIV

A*

300
100

11/11
9/9

11/11
9/9B

300
100

10/10
10/10

11/11
11/11C

300
100

9/9
9/9

9/9
9/9D

300
100

6/6
6/6

6/6
6/6E

300
100

8/8
8/8

8/8
8/8F

300
100

5/5
5/5

5/5
5/5G

300
100

3/3
3/3

3/3
3/3N

300
100

1/1
1/1

1/1
1/1O

300
100

6/6
6/6

6/6
6/6


Specimen

Subtype

Copies/mL

HIV-1/HCV
Reactive/Total

HIV Discriminatory
Reactive/TotalHCV

1

300
100

10/10
10/10

10/10
10/102

300
100

13/13
12/13

13/13
13/133

300
100

11/11
11/11

11/11
11/114

300
100

10/10
10/10

11/11
11/115

300
100

4/4
4/4

4/4
4/46

300
100

4/4
5/5

4/4
5/5


---

*
Two samples were quantified at < 1000 copies/mL and were reactive when tested undiluted and at 1:3 dilution.

PERFORMANCE OF INDIVIDUAL DONATION TESTING

Clinical Sensitivity

The clinical sensitivity of the HIV-1/HCV Assay, HIV-1 Discriminatory and HCV Discriminatory Assays were evaluated by testing clinical
samples without dilution (neat). The HIV-1/HCV Assay was used to test a total of 867 confirmed HIV positive, 967 HCV positive and 180 HIV and HCV positive samples. As summarized in Table
VII, the overall sensitivity based on this study was 99.8% (95% CI: 99.4-99.9). Specifically, the sensitivity for HIV positive samples was 99.9% (95% CI: 99.4-100.0) while

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that for HCV positive samples and HIV and HCV positive samples was 99.6% (95% CI: 98.9-99.9) and 100% (95% CI: 98.0-100.0), respectively.Three HCV
positive samples tested non-reactive as undiluted samples, but reactive at 1:16 dilution. However, one of the three showed a viral load lower than the Limit of Detection for the Procleix
HIV-1/HCV Assay as determined by an alternate nucleic acid test. The other two consistently tested reactive at 1:16 dilution but non-reactive with the undiluted sample and the
nature of this discordance is under investigation.

The
sensitivity for the discriminatory assays was evaluated as well. As shown in Table VII, the sensitivity for the HIV-1 Discriminatory Assay was 100% (95% CI:
99.6-100.0) for HIV positive samples and 100% (95% CI: 97.9-100.0) for HIV and HCV positive samples. The HCV Discriminatory Assay showed a sensitivity of 99.6% (95% CI:
98.9-99.9) for HCV positive samples and 100% (95% CI: 92.6-100.0) for HIV and HCV positive samples.

The
data in the aforementioned studies were re-analyzed according to the disease stages and the results are presented in Tables VIII (for HIV/AIDS) and IX (for HCV). Overall,
the assays showed similar sensitivity for samples from various disease stages.

Seroconversion Panel Testing

When a limited number of HIV-1 seroconversion panel members were tested as undiluted (neat), an average of two days earlier detection was observed as
compared to 1:16 dilution (Table XIV). No difference was observed between the HIV-1/HCV Assay and HIV-1 Discriminatory Assay. Both assays were more sensitive for detecting
window period samples as compared to the HIV-1 p24 Antigen assay.

For
HCV seroconversion panels, no differences were observed between the Procleix HIV-1/HCV Assay and the HCV Discriminatory Assay when testing was performed on undiluted
samples or 1:16 diluted samples (Table XV). Both assays were able to detect HCV infection on average 25 days earlier than the antibody test.

Clinical Specificity

The clinical specificity for individual donation testing was determined for the HIV-1/HCV assay by testing individual donor specimens that were never
pooled (Table XVII). Seventy-one of 34,557 (0.21%) individual donor specimens were initially reactive in the Procleix HIV-1/HCV assay. Twenty-one of these 71
specimens were also reactive in the HCV Discriminatory Assay and were seropositive for HCV. Three of the 71 were reactive in the HIV-1 Discriminatory Assay and seropositive for
HIV-1/HIV-2. Forty-five specimens were nonreactive by both the HCV and HIV-1 Discriminatory Assays and HCV and HIV-1/HIV-2
antibody assays yielding an adjusted (false) reactive rate of 0.13% (45/34,533). One specimen had incomplete assay results and could not be discriminated. One specimen was Procleix HCV Discriminated,
HCV EIA repeatedly Reactive with no RIBA available. Seventeen samples with Nonreactive Procleix assay results had incomplete serologic results and were excluded from the specificity calculations,
yielding a specificity in individually tested donor samples of 99.87% (34,229/34,274).

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Table XVII. Procleix HIV-1/HCV Assay Reactivity in Volunteer Blood Donors

Procleix HIV-1/HCV Assay
Individual DonationSamples Tested*

34,557Initial Reactive

71Initial Reactive Rate

0.21%Adjusted Reactive Rate

0.13%Combined Mean S/CO on Negative Analytes

0.17 ± 0.07


---

*
Combined data across all sites and Clinical Lots.

This
specificity study was conducted primarily in three military sites. The military donor population may differ from the civilian donor population. However, when
sub-analyses were conducted across donor age groups, gender and race, comparable clinical specificity was observed across all categories ranging from 99.7% to 100% (all 95% confidence
intervals overlapped). These sub-analyses included evaluation of 5,743 females; 1,102 donors over the age of 50; and at least 2,900 donors in each of the race categories of
Black/Non-Hispanic, White/Hispanic, and White/Non-Hispanic. These results suggest that the specificity of the Procleix HIV-1/HCV Assay with individual donations is
not affected by race, age or gender.

Table XVIII. Summary of Procleix Assay Yield Under IND Testing

Individual Donation TestingNumber of Donations Tested

103,357Procleix HCV
Yield Case

1
(1:103,357)Procleix HIV-1
Yield Case

0


A
total of 103,357 individual donations were screened under IND from April 2000 to November 2001 (Table XVIII). One Procleix HCV yield case (1:103,357) was identified
across the three Procleix individual donation test sites. The yield case was confirmed to be positive for HCV RNA, but negative in serology testing. No HIV-1 yield cases were identified
with individual donation testing.

LIMITATIONS OF THE PROCEDURE



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CONCLUSIONS

Overall specificity for the Procleix HIV-1/HCV Assay (16-member pools, single donors), HIV-1 Discriminatory Assay (single
donors) and HCV Discriminatory Assay (single donors) is shown in Table XIX. Sensitivity for the Procleix HIV-1/HCV Assay (based on known HIV-1 and HCV RNA positives run neat
and diluted 1:16), HIV-1 Discriminatory Assay (based on known HIV-1 RNA positives run neat), and HCV Discriminatory Assay (based on known HCV RNA positives run neat) are also
shown in Table XIX.

Table XIX. Overview

Specificity (95% C.I.)

Sensitivity (95% C.I.)Procleix HIV-1/HCV

16-member Pool

99.67% (99.55-99.77%)

99.3% (98.8-99.6%)*Individual donation

99.87% (99.83-99.91%)

99.8% (99.4-99.9%)HIV-1 Discriminatory

Individual donation

99.76% (99.48-99.91%)

100%
(99.6-100%)HCV Discriminatory

Individual donation

99.71% (99.41-99.88%)

99.6% (99.0-99.9%)


---

C.I.
= Confidence intervals.

BIBLIOGRAPHY

IN0076 Rev. F

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IN0076 Rev. F

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Gen-Probe
U.S. LICENSE 1592

IN0076
Rev. F
2002-02

Developed and manufactured by:Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121
(858) 410-8000

Distributed in U.S. by:Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
Telephone (In U.S.): (800) CHIRON-8
(510) 655-8730

Distributed in rest of world by:Chiron Ireland, Limited
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Dublin 24, Ireland

Chiron Blood Testing Technical Support:(North America)
Telephone: (800) 452-6877
FAX: (800) 462-3938

(Europe,
Middle East, Latin America, Africa)
Telephone: +33 (4) 78 37 99 04
FAX: +33 (4) 78 37 99 04

IN0076 Rev. F

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(Asia/Pacific)
Telephone: +61 (4) 1044 5810
FAX: +61 (2) 9974 5411

Chiron,
RIBA and Procleix are trademarks of Chiron Corporation; TECAN, GENESIS (stylized), and RSP are trademarks of Tecan AG; eppendorf (stylized) and COMBITIPS are trademarks of Eppendorf-
Netheler-Hinz GmbH; PROCLIN (stylized) is a trademark of Rohm and Haas Company.

This
product and its intended use are covered by one or more of the following: U.S. patent no. 5,030,557; 5,185,439; 5,283,174; 5,399,491; 5,437,990; 5,480,784; 5,585,481; 5,612,200; 5,639,604;
5,656,207; 5,656,744; 5,658,737; 5,696,251; 5,714,596; 5,750,338; 5,756,011; 5,756,709; 5,766,890; 5,827,656; 5,840,873; 5,863,719; 5,888,779; 5,948,899; 5,955,261; 6,004,745; 6,031,091; 6,074,816;
6,090,591; 6,110,678; 6,245,519; 6,252,059; 6,280,952; and international counterparts.

©
2000, 2001, 2002 Gen-Probe Incorporated

IN0076 Rev. F

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|             |  |                 
|------------ |  | ----------------
|CONFIDENTIAL |  | REDACTED VERSION

SCHEDULE C    TERMS AND CONDITIONS FOR USE OF BLOOD SCREENING SYSTEMS

Chiron
will make available Blood Screening Systems to ABC on the following terms and conditions:

53

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|             |  |                 
|------------ |  | ----------------
|CONFIDENTIAL |  | REDACTED VERSION

SCHEDULE D    BLOOD SCREENING SYSTEMS AND SOFTWARE  SERVICE & SUPPORT



56

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Priority

Response*Priority 1:

Instrument not operating and alternate or back-up equipment not available; tests cannot be performed

 Immediate telephone support
 Support Technician on site ASAP but no later than next morning
 Resolution within 24 hours (may be temporary workaround)Priority 2:

Instrument operational but testing process (processing time) is affected

 Telephone support within 2 hours
 Support Technician on site within 24 hours
 Resolution within 48 hoursPriority 3:

Instrument is operational; no impact on testing process

 Telephone support next business day
 Work commenced within 24 hours
 Resolution within 1 week


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|             |  |                 
|------------ |  | ----------------
|CONFIDENTIAL |  | REDACTED VERSION

SCHEDULE E    PRICES

POOLED TESTING

|                                                   |  |      |  | Aggregate Participating Members Reportable Results
For Prior Calendar Year2
|-------------------------------------------------- |  | ---- |  | ---------------------------------------------------------------------------
|
|
|                                                   |  |      |  | Per Reportable Result                                                      
|Individual Participating Member
Reportable Results |  | A    |  | B                                                                          
|P1                                                 |  | [**] |  | [**]                                                                       
|P2                                                 |  | [**] |  | [**]                                                                       
|P3                                                 |  | [**] |  | [**]                                                                       
|P4                                                 |  | [**] |  | [**]                                                                       
|P5                                                 |  | [**] |  | [**]                                                                       
|P6                                                 |  | [**] |  | [**]                                                                       

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60

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POOLED TESTING

|                                                   |  |      |  | Aggregate Participating Members Reportable Results
For Prior Calendar Year4
|-------------------------------------------------- |  | ---- |  | ---------------------------------------------------------------------------
|
|
|                                                   |  |      |  | Per Reportable Result                                                      
|Individual Participating Member
Reportable Results |  | A    |  | B                                                                          
|P1                                                 |  | [**] |  | [**]                                                                       
|P2                                                 |  | [**] |  | [**]                                                                       
|P3                                                 |  | [**] |  | [**]                                                                       
|P4                                                 |  | [**] |  | [**]                                                                       
|P5                                                 |  | [**] |  | [**]                                                                       
|P6                                                 |  | [**] |  | [**]                                                                       

POOLED TESTING

|                                                   |  |      |  | Aggregate Participating Members Reportable Results
For Prior Calendar Year4
|-------------------------------------------------- |  | ---- |  | ---------------------------------------------------------------------------
|
|
|                                                   |  |      |  | Per Reportable Result                                                      
|Individual Participating Member
Reportable Results |  | A    |  | B                                                                          
|P1                                                 |  | [**] |  | [**]                                                                       
|P2                                                 |  | [**] |  | [**]                                                                       
|P3                                                 |  | [**] |  | [**]                                                                       
|P4                                                 |  | [**] |  | [**]                                                                       
|P5                                                 |  | [**] |  | [**]                                                                       
|P6                                                 |  | [**] |  | [**]                                                                       

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Single Donor Testing

|                                                   |  |      |  | Aggregate Participating Members Reportable Results
For Prior Calendar Year4
|-------------------------------------------------- |  | ---- |  | ---------------------------------------------------------------------------
|
|
|Individual Participating Member
Reportable Results |  | A    |  | B                                                                          
|S0                                                 |  | [**] |  | [**]                                                                       
|S1                                                 |  | [**] |  | [**]                                                                       
|S2                                                 |  | [**] |  | [**]                                                                       
|S3                                                 |  | [**] |  | [**]                                                                       
|S4                                                 |  | [**] |  | [**]                                                                       
|S5                                                 |  | [**] |  | [**]                                                                       
|S6                                                 |  | [**] |  | [**]                                                                       
|S7                                                 |  | [**] |  | [**]                                                                       

On
or prior to the 5th of each month, each Participating Member shall provide Chiron with a report showing the Reportable Results and Reagent Utilization Factor for the
prior month for each of its Testing Centers. On or prior to the 15th of each month, Chiron shall prepare and deliver an invoice to each Participating Member based on such report,
calculating the Blood Screening Assay Fee by multiplying the Reportable Results by the applicable Per Result Fee, determined in accordance with the then current Product Requirements Forecast. If a
Participating Member's report is not timely received by Chiron, Chiron will prepare the invoice substituting one-twelfth of the then current Product Requirements Forecast and the parties
shall "true-up" payments made to the actual Reportable Results achieved on a calendar quarter basis, rectifying any under- or over-payment on the next subsequent invoice,
without application of interest. Each Participating Member shall make payment on invoices in accordance with Section 5.3 of the Association Agreement, except where modified by the applicable
Member Supplement.



Blood Screening System Components

Unit Price

Monthly Lease
Payment5Pooling TECAN6

[**]

$Assay TECAN7

[**]

$Procleix System8

[**]

$


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62

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Blood Screening System Components

Price/Year/Unit

Monthly
Installment
PaymentPooling TECAN9

[**]

$Assay TECAN10

[**]

$Procleix System11

[**]

$


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63

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64

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EXHIBIT 10.317

|             |  |                 
|------------ |  | ----------------
|CONFIDENTIAL |  | REDACTED VERSION

[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.

MEMBER SUPPLEMENT

This Member Supplement (this "Member Supplement"), dated as
of                        (the "Effective Date"), is by and between Chiron Corporation, a Delaware
corporation ("Chiron"), and                        ("ABC Member").

RECITALS

AGREEMENT

NOW,
THEREFORE, in consideration of the foregoing and the mutual covenants and agreements herein contained, and for other good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the parties hereto agree as follows:

1

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TESTING

|                                                   |  |      |  | Aggregate Participating Members Reportable Results
For Prior Calendar Year2
|-------------------------------------------------- |  | ---- |  | ---------------------------------------------------------------------------
|
|
|                                                   |  |      |  | Per Reportable Result                                                      
|Individual Participating Member
Reportable Results |  | A    |  | B                                                                          
|[**]                                               |  | [**] |  | [**]                                                                       

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Software

Price/Year

Number of
Testing Centers

Extended License
FeeNAT Tracker3

$
[**]



$


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3

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[SIGNATURE
PAGE FOLLOWS]

4

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IN
WITNESS WHEREOF, the parties hereto, acting through their duly authorized officers, have executed this Agreement as of the date first set forth above.

| |  |                    |  | 
| |  | ------------------ |  | 
| |  | CHIRON CORPORATION
| |  | By:                |  | 
| |  | ABC MEMBER        
| |  | By:                |  | 

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EXHIBITS

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