Exhibit 10.319

|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.

SALE AND SERVICING AGREEMENT

THIS SALE AND SERVICING AGREEMENT is made effective as of this 1st day of August, 2002 (the "Effective Date"),
between The American National Red Cross, a not-for-profit corporation chartered by an act of Congress, 36 U.S.C. § 30010et
seq., having a principal place of business at 8111 Gatehouse Road, Falls Church, Virginia 22042 ("ARCHQ"), and Chiron
Corporation, a Delaware corporation ("Chiron") having its offices at 4560 Horton Street, Emeryville, California 94608-2916 (the
"Agreement").

Background

WHEREAS, ARCHQ, operating through its Biomedical Services division
("ARC") provides, inter alia, blood services, including the collection of blood from donors, and the screening, packaging and distribution of blood,
blood components and derivatives to those in need of such services;

WHEREAS, ARC currently screens for itself and for other blood banks in the United States, human blood samples for viruses such as Human
Immunodeficiency Virus type-1 ("HIV-1") and Hepatitis C Virus ("HCV") by
performing screening, including without limitation amplified nucleic acid screening, in five (5) of its national testing laboratories located in San Diego, Detroit, St. Louis, Charlotte and
Philadelphia and as further identified onSchedule 1.36(each, an "NTL", and collectively, the
"NTLs");

WHEREAS, Chiron distributes, markets and sells certain blood screening assays and blood screening instruments to conduct nucleic acid
amplification screening to detect the presence of certain viruses in blood, including HIV-1 and HCV; and

WHEREAS, ARC desires to purchase from Chiron and Chiron desires to sell to ARC certain products, instrumentation and services to enable
ARC to perform amplified nucleic acid screening on blood samples and to help ensure that ARC has the ability to further improve the safety of the blood it processes and provides to the public ARC
serves.

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

Capitalized terms used and not otherwise defined in this Agreement shall have the following meanings:



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ARTICLE 2PURCHASE OF BLOOD SCREENING ASSAYS

2.1Supply, Handling and Storage Obligation.During the Term of this Agreement Chiron agrees to supply to ARC,
at the prices specified inSchedule 5.0, the Blood Screening Assays specified onSchedule 2.0to
permit each NTL to conduct screening of blood donations in the Territory. ARC agrees to store and handle all Blood Screening Assays in accordance with the applicable Package Insert. Any Blood
Screening Assays lost or damaged due to failure to comply with such storage and handling instructions will be replaced at ARC's expense.

2.2Purchase Obligation.During the Term of this Agreement, ARC agrees to acquire its requirements of Blood
Screening Assays in the Territory. However, nothing in this Agreement will restrict the right of ARC to evaluate new technologies and products or to perform, in its discretion, any confirmatory and
supplementary nucleic acid screening.

2.3Additional Supplies.All material supplies necessary for the conduct of Pooled Testing using a Blood
Screening Assay on the Blood Screening Systems in compliance with the Regulations are set forth in the applicable Package Insert. All material supplies other than Blood Screening Assays, Blood
Screening Systems, Software and such disposables and calibrators included with the Blood Screening Assays, are identified by Chiron as additional supplies, and may be purchased separately by ARC at
the fees set forth in Paragraph 5 ofSchedule 5.0.

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2.4Packing and Delivery of Blood Screening Assays.Chiron shall ensure that all Blood Screening Assays will
be
suitably packed and transported to ensure safe transport to ARC in accordance with the applicable Specifications and delivered to ARC's designated NTL, and each delivery will be accompanied by a
packing slip indicating the quantity delivered, the Product lot number(s) and the expiration date(s). Blood Screening Assays will be delivered during normal business hours and accompanied by storage
instructions and arrive at the temperatures specified in the applicable Specifications. The Blood Screening Assays will be delivered in kit form, with appropriate distribution between screening tests,
discriminatory tests and related calibrators.

2.5Shipping.Chiron acknowledges that time is of the essence with respect to the delivery of Blood Screening
Assays and the services related thereto. Except as set forth in this Section 2.5, all shipping, handling and risk of loss charges for the Products will be borne entirely by Chiron on shipments
to the NTLs pursuant to a Standing Order or a back order and will be shipped, fully insured, to the designated NTL. All shipping, handling and risk of loss charges for shipping requests other than to
an NTL as requested by ARC, and all incremental shipping, handling and risk of loss charges for Modified Orders or Rush Orders, will be borne by ARC.

2.6Forecasts and Orders.



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2.7IQA Procedures.Chiron and ARC agree to review and approve the existing procedures for quality assurance
testing of Blood Screening Assays received by ARC and/or any of its NTLs ("IQA Procedures"). Chiron and ARC must agree to any modifications to such IQA
Procedures. The IQA Procedures include procedures for testing and notice to Chiron and for implementing the return of Blood Screening Assays for replacement. Chiron agrees to replace, at its sole cost
and expense, Blood Screening Assays which fail the IQA Procedures. If testing by Chiron or its supplier confirms the non-conformity of the Blood Screening Assays, Chiron will bear the
shipping costs associated with replacement. If Chiron's testing provides reasonably acceptable evidence that the Blood Screening Assays do conform to their Specifications, the shipping costs incurred
by Chiron will be reimbursed by ARC. The principal inspection and testing and acceptance point by ARC for Blood Screening Assays under this Agreement will usually be the NTLs. However, the inspection,
testing and acceptance activities may take place at any point, including Chiron's facility, with prior notice to Chiron.

2.8Technical Support.Chiron will provide ARC with technical support to facilitate the operation by ARC of the
Blood Screening Assays on the Blood Screening Systems in accordance with the terms set forth inSchedule 4.0.

2.9Nature of Screening.ARC acknowledges that it has determined, in its sole discretion, to use the Blood
Screening Assays supplied by Chiron to conduct Pooled Testing. If ARC desires to change from Pooled Testing to Single Unit Testing or to any other pool size, ARC and Chiron shall enter into an
amendment to this Agreement reflecting any additional instrumentation, changes to the fees or prices payable underSchedule 5.0of this Agreement
or any other amendments that may be applicable by reason of such change.

2.10Warranty; Limitation of Liability.All Blood Screening Assays supplied by Chiron shall be manufactured in
accordance with the Specifications. All Blood Screening Assays supplied by Chiron shall conform and perform in accordance with the Specifications, provided that ARC is not negligent in its storage,
handling and use of the Blood Screening Assays in accordance with the Specifications provided by Chiron.

ARTICLE 3PROVISION OF BLOOD SCREENING SYSTEMS; SOFTWARE

3.1Blood Screening Systems.



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3.2Software and Documentation.



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ARTICLE 4SERVICES

Installation, training, telephone support, maintenance and other servicing of any of the Products (collectively,
"Services"), shall be provided to ARC by Chiron upon timely payment of the Services Fee in accordance with the terms and conditions set forth in Schedule 4.0attached hereto.

ARTICLE 5FEES, PAYMENTS

5.1Fees.ARC shall pay to Chiron the fees set forth in Schedule 5.0attached hereto for the Products and Services
purchased hereunder.

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5.2Payments.All payments shall be made as set forth in Schedule 5.0. All payments due to Chiron hereunder shall be paid in full by ARC in U.S. Dollars within thirty (30) calendar days of the
applicable invoice date. In the event of late payment, interest shall be charged at the rate of[**], as reported in the Wall
Street Journal on the date such payment was due, until the date of actual payment, such interest to accrue daily and both before and after judgment.

Chiron's
invoices must be submitted to The American National Red Cross, Shared Services Center, Post Office Box 410500, Charlotte, North Carolina 28241-0500. Chiron shall
invoice incremental freight charges relating to Modified Orders and Rush Orders separately.

Each
invoice must contain:



5.3Books & Records; Audit.ARC shall keep reasonably detailed and accurate records and books of account
to enable a determination of the amounts payable by ARC to Chiron for Reportable Results as provided hereunder. Upon thirty (30) days written notice by Chiron, not more frequently than once per
calendar year, Chiron, at its cost (except as otherwise provided below in this Section 5.3) may have such records and books of account relating solely to Reportable Results examined at an ARC
location during reasonable business hours by an independent certified public accountant selected by Chiron for the purpose of verifying the amounts due hereunder and engaged on payment terms
reasonably acceptable to ARC. A copy of any final written report provided by the independent accountant to Chiron shall be given concurrently to ARC. [**]. In all cases, such examination by Chiron shall
not be permitted unless [**]to which the books and records pertain. Where such examination results in a finding that ARC underpaid Chiron [**], ARC shall
reimburse Chiron for its reasonable costs and expenses in conducting such examination. ARC and Chiron shall
promptly rectify underpayments and overpayments by repaying such amounts, together with interest thereon accruing from and, at the rate of [**]as reported in the Wall Street Journal on, the date such
under- or overpayments [**]in the aggregate for such Fiscal Year, until the date of actual payment.

5.4Taxes.Chiron hereby acknowledges that ARC is a not-for-profit, charitable
corporation, exempt from the payment of sales and use taxes and ARC shall have no tax liability on Products unless specifically legislated by a particular state. Chiron is responsible for requesting
and obtaining all tax exemption numbers as required.[**].Notwithstanding the above, if any federal, state, provincial, county
or municipal sales or use tax, excise or similar charge, or other tax assessment (other than that assessed against income), is assessed or charged on the sale of the Blood Screening Assays and Blood
Screening Systems sold to ARC by Chiron pursuant to this Agreement, it shall be paid by ARC.

ARTICLE 6CERTAIN AGREEMENTS

6.1Provision of Facilities by ARC.ARC agrees to make available, at its sole expense and discretion, adequate
facilities (including any necessary facility improvements) and personnel necessary for use of the Products in accordance with all applicable Regulations and Documentation.

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6.2Regulatory Approvals.Chiron will use commercially reasonable efforts, at Chiron's sole expense, to obtain
and maintain any applicable regulatory approval for use of the Products for screening of blood donations in the Territory. Chiron will be solely responsible for compliance with all regulatory
requirements imposed on it in connection with the maintenance of such approvals, including all regulatory reporting requirements. ARC will cooperate with Chiron to support its efforts pursuant to this
Section 6.2, but ARC shall not allocate time, expenses and other resources beyond what ARC deems reasonable in its sole discretion. For clarity of understanding, Chiron has no obligation or
responsibility with respect to regulatory approval or compliance relating to blood donor, blood product or blood recipient management.

6.3Regulatory Compliance.



6.4Quality Assurance



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6.5Corrections, Removals and Recalls of Products



6.6Nonconformities



In
the event the Product that has a Nonconformity is a Blood Screening Assay, Chiron shall immediately replace such Nonconforming Blood Screening Assay and reimburse ARC for the expenses

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associated with shipping such Nonconforming Blood Screening Assay to Chiron, in accordance with Section 2.7 above.

In
the event the Product that has a Nonconformity is a Blood Screening System or Software, Chiron shall repair or replace such Blood Screening System or Software, in accordance with Schedule 4.0attached hereto.



6.7Data.ARC shall provide to Chiron in an agreed format data generated in connection with the use of the Blood
Screening Assays or Blood Screening Systems sufficient to monitor the performance of the Products for quality assurance and to perform their respective regulatory obligations in the Territory
(collectively the "Data"). The Data shall be deemed confidential information of ARC.



6.8Confidentiality.During the Term of this Agreement and [**], absent the consent of the other Party, (i) ARC agrees
to keep in confidence and not to disclose to any Third Party
other than its Affiliates, agents or contractors who need to know in connection with ARC activities under this Agreement, or use for any purpose, except pursuant to, and in order to carry out, the
terms and objectives of this Agreement, any Confidential Information of Chiron, including Confidential Information of Gen-Probe which is disclosed to ARC by or through Chiron; and
(ii) Chiron agrees to keep in confidence and not to disclose to any Third Party other than Gen-Probe and their respective Affiliates, agents or contractors who need to know in
connection with Chiron activities under this Agreement, or use for any purpose, except pursuant to, and in order to carry out, the terms and objectives of this Agreement, any Confidential Information
of ARC. Disclosures of Confidential

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Information to Third Parties authorized hereunder shall be permitted only if the Third Party is bound by confidentiality obligations not less restrictive than those set forth herein.



6.9Intellectual Property; Inventions.The provision by Chiron to ARC of the Products hereunder includes the
implied license or sublicense under Chiron and Gen-Probe intellectual property to use the Products in the Territory as provided herein. Except for such implied license to the Products, and
except as specifically set forth herein, nothing in this Agreement conveys to either Party any rights or licenses to any intellectual property of the other Party. The Parties do not anticipate that
use of the Products as provided herein will result in new inventions by ARC. However, in the event that any such new invention is made, solely by ARC or persons obligated to assign inventions to ARC,
arising from the use of the Products, ARC will own such invention and ARC grants to Chiron the option to obtain a non-exclusive worldwide license to such invention (with a right to
sublicense for manufacturing purposes only), on commercially reasonable terms to be negotiated by the Parties in good faith. If an invention is made jointly by ARC or persons obligated to assign
inventions to it, and Chiron or persons obligated to assign inventions to it, such invention will be owned jointly by the Parties. All inventions made solely by Chiron or persons obligated to assign
inventions to it will be owned by Chiron.

6.10Upgrades and Enhancements.If any manufacturer releases an Upgrade or Enhancement to any Product, and if
Chiron elects to make such Upgrade or Enhancement available in the Territory, Chiron will provide notice to ARC of the availability of such Upgrade or Enhancement. ARC may, in its discretion, elect to
acquire such Upgrade or Enhancement from Chiron; provided, however, that Chiron reserves the right to discontinue the sale of Products that have been superceded by Upgrades or Enhancements thereof, on [**]. Notwithstanding the availability of a superceding Enhancement, Chiron shall continue to perform the Services on superceded
Products during the initial Term of this Agreement in accordance with Article 4; provided, however, that if the FDA requires the withdrawal of a Product that has been superceded by a Product
Enhancement, the Parties will negotiate in good faith commercially reasonable adjustments to the financial terms of this Agreement. ARC shall be responsible, at ARC expense, for validation of its own
procedures and satisfaction of all regulatory requirements applicable to use by ARC of any Upgrades or Enhancements. The Parties acknowledge that New Products are not to be deemed Upgrades or
Enhancements for the purposes hereof. When commercially available, such New Products will be subject to separate terms and conditions to be negotiated at such time.

6.11Disaster Plan.In order to ensure the provision of Products to ARC during times of disaster, Chiron shall
comply with, and otherwise provide to ARC the benefits of, a disaster preparedness plan satisfying the criteria for such plans as set forth on Schedule 6.11. Chiron shall provide to ARC the final
disaster
preparedness plan[**]of the Effective Date of this Agreement (the "Disaster Preparedness
Plan"). Such Disaster Preparedness Plan may be modified from time to time by Chiron in its reasonable discretion, provided that such modifications do not diminish Chiron's
obligations to ARC thereunder. Any such modifications that diminish such obligations will require the prior written consent of ARC (which shall not be unreasonably withheld or delayed).

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6.12Inventory Levels.Chiron shall, at no cost to ARC, assist each NTL monthly in managing its inventory, as
well as actual Product usage versus the Product Requirement Forecasts.

6.13Technical and Operational Reviews.From time to time, Chiron shall conduct technical and operational
reviews with ARC of the Products and other Services provided by Chiron, as well as Agreement performance, at each Party's respective expense. The Parties shall mutually agree upon the scheduling and
locations of such reviews.

6.14Future Products.The Parties may agree to enter into other mutually beneficial contractual relationships
including without limitation, participation in feasibility studies, clinical trials, studies and collaborations, focusing in areas of automation and new screening markers, of mutual interest and
benefit to the Parties. Some specific projects include without limitation, the automated instrument system feasibility study and clinical trials.

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

7.1Chiron Representations & Warranties.Chiron hereby represents, warrants and covenants to ARC that:



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7.2ARC Representations & Warranties.ARC hereby represents, warrants and covenants that:



7.3Limitation of Warranty.Chiron is not the manufacturer of the Blood Screening Assays or the Blood Screening
Systems provided to ARC under this Agreement. EXCEPT AS EXPRESSLY PROVIDED ELSEWHERE IN THIS AGREEMENT, CHIRON MAKES NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING WITHOUT
LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

7.4Pass-Through of Warranty.With no further act required by ARC, Chiron agrees to pass through to
ARC the benefit of the manufacturer's warranties with respect to the Products to the extent it is legally permitted to do so by the applicable manufacturers.

7.5Indemnity by Chiron.Chiron agrees to protect, defend, indemnify and hold harmless ARC, the NTLs and all ARC
units, including without limitation, all ARC chapters and other operating units, and their respective officers, directors, governors, employees, Affiliates, assigns, successors, and agents
(collectively, the "ARC Indemnitees") and agrees to hold them harmless from and against all Damages arising from a breach by Chiron of this Agreement or
from the negligence or willful misconduct of any of the Chiron Indemnitees in the performance of Chiron's obligations under this Agreement, including without limitation:



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provided, thatin all of the above cases Chiron's indemnification responsibilities to ARC Indemnitees shall be reduced to the extent that any of such
Damages claimed by any ARC Indemnitee results from the willful misconduct, negligence or omission of ARC or any ARC Indemnitee or ARC's breach of its representations, warranties, covenants or other
agreements and obligations provided in this Agreement.

7.6Indemnity by ARC.ARC agrees to protect, defend, indemnify and hold harmless Chiron and its Affiliates, and
their respective officers, directors, employees, assigns, successors, contractors, subcontractors, suppliers and agents (collectively, the "Chiron
Indemnitees") and agrees to hold them harmless from and against all Damages arising from the breach of the representations and warranties made by ARC in this Agreement or from
the negligence or willful misconduct of any of the ARC Indemnities in the performance of ARC's obligations under this Agreement, including without limitation:



provided, thatin all of the above cases ARC's indemnification responsibilities will be reduced to the extent that any of such Damages claimed by any
Chiron Indemnitee results from the willful misconduct, negligence or omission of Chiron or any Chiron Indemnitee or Chiron's breach of its representations, warranties, covenants or other agreements
and obligations provided in this Agreement.

7.7IP Infringement Indemnity.



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7.8Indemnification Procedures.Any ARC Indemnitee or Chiron Indemnitee claiming indemnification (the
"Indemnitee") shall notify the Party from which indemnification is claimed (the "Indemnifying Party") in
writing promptly upon becoming aware of any claim to which such indemnification may apply. Failure to provide such notice shall constitute a waiver of the Indemnifying Party's indemnity obligations
hereunder if, and only to the extent that, the Indemnifying Party is materially damaged thereby. The Indemnifying Party shall have the right to assume and control the defense of the claim at its own
expense. If the right to assume and have sole control of the defense is exercised, the Indemnitee shall have the right to participate in, but not to control, such defense at its own expense. If the
Indemnifying Party does not assume the defense of the claim, the Indemnitee may defend the claim at the Indemnifying Party's expense. The Indemnitee will not settle or compromise the claim without the
prior written consent of the Indemnifying Party, and the Indemnifying Party will not settle or compromise the claim in any manner which would have an adverse effect of the Indemnitee without the
consent of Indemnitee, which consent, in each case, will not be unreasonably withheld. The Indemnitee shall reasonably cooperate with the Indemnifying Party and will make available to the Indemnifying
Party all pertinent information under the control of the Indemnitee.

7.9Exclusion of Consequential Damages; Limitation of Liability.Unless recovery for such damages is otherwise
expressly provided for in this Agreement, neither Party shall be liable with respect to the subject matter of this Agreement under breach of contract, negligence, strict liability or any other cause
of action for any consequential, incidental or indirect loss or damage (whether arising directly or indirectly from a breach of this Agreement), including loss of profit or for any cost of procurement
of substitute goods, technology or services, except to the extent of liability to Third Parties for bodily injury or death as to which Chiron is obligated to indemnify ARC under Section 7.5.
Notwithstanding any provision herein to the contrary, in no event shall Chiron nor any Affiliate thereof be liable to ARC with respect to the subject matter of this Agreement under breach of contract,
negligence, strict liability or any other cause of action in an aggregate that exceeds the total amount paid by ARC to Chiron hereunder, except to the extent of liability to Third Parties for bodily
injury or death as to which Chiron is obligated to indemnify ARC under Section 7.5.

7.10Insurance.Chiron and ARC agree to maintain insurance as follows:



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ARTICLE 8TERM AND TERMINATION

8.1Term.This Agreement shall be effective as of the Effective Date and shall continue until the [**](the "Term"), unless terminated earlier in accordance with this Agreement.
The obligations under this Agreement shall terminate and expire without any further action by the Parties upon the expiration of the Term unless, no less than six (6) months before the
expiration of this Agreement, the Parties mutually agree in writing to extend this Agreement.

8.2Termination.This Agreement may be terminated by written notice to the other Party at any time during the
Term of this Agreement, which termination shall be effective when such termination notice is received in accordance with Article 13, as follows:



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8.3[**]

ARTICLE 9FORCE MAJEURE; DELAY

9.1Force Majeure.Neither Party shall be liable for any failure or delay in performing any of its obligations
under this Agreement to the extent that such failure or delay is due to any cause beyond the affected Party's reasonable control, including without limitation war, terrorism, riot, insurrection or
other civil commotion, any strike, lockout or other labor dispute, any governmental or court order, decree or regulation, any fire, flood, epidemic, earthquake, unusually severe weather condition or
other act of God, or any freight embargo or public utility failure (a "Force Majeure Event").



9.2[**].

9.3Exclusivity of Article.Except as expressly provided herein, the rights and remedies of the Parties provided
in Article 8 and Article 9 shall not be exclusive and are in addition to any other rights and remedies provided by law or under this Agreement. Except as expressly provided in this
Agreement, neither Party shall be restricted from seeking and/or recovering any types of Damages to which such Party may be entitled at law or in equity or under this Agreement.

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ARTICLE 10CONSEQUENCES OF THE TERMINATION OF THIS AGREEMENT

10.1Payment Obligations Unaffected.The termination of this Agreement for any reason whatsoever shall not
affect any Party's obligations to perform those obligations due and already accrued prior to such termination. In the event that termination occurs at a time prior to ARC having made full payment that
is due and owing for any Products, the Parties agree that Chiron shall have all applicable ownership rights to such Products until such payment has been made in full to Chiron.

10.2Transition.If the Term of this Agreement expires, upon such expiration and for a period of no more than [**]thereafter,
Chiron shall continue to make available to ARC for purchase, at prices not to exceed [**]of the then current prices for such quantity of Products under this Agreement, such quantity of Products and
Services as
ARC deems necessary for its use in the Blood Screening Field to facilitate an orderly transition to the replacement service provider.

In
the event of a termination of this Agreement by ARC for any reason, Chiron shall cooperate with ARC in the transfer of Chiron's obligations hereunder to a replacement service
provider. After receiving notice of such termination and except as otherwise directed by ARC, Chiron shall continue to make available to ARC for purchase, at prices not to exceed [**]of the then
current prices for such quantity of Products under this Agreement, such quantity of Products and Services as
ARC deems necessary for its use in the Blood Screening Field to facilitate an orderly transition to the replacement service provider during the time period required for such transition, not to exceed [**].

During
any such transition following expiration or termination by ARC, ARC's purchase obligations with respect to the quantity of such Products and/or Services shall be reduced to the
extent ARC deems necessary to transition to the replacement service provider.

10.3Survival of Certain Provisions.In addition, notwithstanding anything herein to the contrary, the following
provisions of this Agreement shall survive termination of this Agreement: Sections 3.1(d), 3.2(f)(vii), 5.3, 6.4(d), 6.5(a), 6.7, 6.8, 7.3, 7.4 7.5, 7.6, 7.7, 7.8, 7.9, and 7.10 and Articles 10, 11,
12 and 13.[**].

10.4Return of Confidential Information.Upon termination of this Agreement for any reason whatsoever, the
Parties shall immediately return to the other all confidential information in documentary or printed form and any copies or extracts thereof and shall thereafter cease to use such information but
without prejudice to the then surviving confidentiality obligations provided for in Section 6.8 hereof.

10.5No Other Payment.No indemnity or compensation in any form whatsoever shall be paid by either Party to the
other in connection with a termination in accordance with the terms hereof (subject to any liability that may exist in respect of any material breach prior to such termination).

ARTICLE 11APPLICABLE LAW

This Agreement shall be governed by and construed in accordance with the laws of the State of California, without giving effect to any conflict of law rules and
regulations.

ARTICLE 12DISPUTES

12.1 To
the extent that there are disputes with respect to performance under this Agreement, such disputes (other than non-payment) are not cause for Chiron to
stop performance under this Agreement, but will be resolved in due course to the extent possible in accordance with this Article.

12.2 The
Parties to this Agreement will attempt to resolve any problem or dispute arising out of, or related to, this Agreement through good faith consultation in the
ordinary course of business.

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12.3 If
the Parties are unable to resolve the problem or dispute within thirty (30) days, either Party may initiate and submit a matter through the dispute resolution
procedure set forth in Section 12.4 below. No Party may institute litigation until the dispute resolution procedure has been completed unless, and to the extent that, doing so is necessary to
avoid irreparable harm.

12.4Dispute Resolution Procedure.If any problem or dispute arising out of or related to this Agreement is not
resolved by the Parties in the above described manner, the Parties hereby agree to resolve such dispute by arbitration conducted in accordance with the Commercial Arbitration Rules of the American
Arbitration Association. The place of arbitration shall be Arlington, Virginia. The arbitration panel shall consist of three arbitrators, one arbitrator appointed by each of the Parties, and the third
arbitrator appointed by the two appointed arbitrators (the "Panel"). The Panel may, at its discretion, provide for discovery by the Parties not to
exceed a period of sixty (60) days from the date of filing of the notice of arbitration. The Panel shall render its decision within ninety (90) days from the date of filing the notice of
arbitration and may, at its discretion, award costs and expenses but shall not have the right to award punitive damages. The decision of the Panel shall be final and binding on the Parties, and shall
be enforceable in any court of competent jurisdiction.

12.5 The
prevailing Party shall be entitled to recover all costs and expenses, including reasonable attorney's fees, incurred because of any legal action arising in relation
to this Agreement.

ARTICLE 13MISCELLANEOUS

13.1National Testing Laboratories.The full names and addresses of the NTLs participating in this Agreement are
set forth inSchedule 1.36, which may be modified from time to time as determined by ARC. Any change to the number or location of NTLs shall be
provided in writing by ARC to Chiron at least ninety (90) days in advance of such change, wherever possible. If, after the Effective Date, [**], the Per Reportable Result Fee will be modified in
accordance with Paragraph 2.2 of Schedule 5.0.

13.2Equal Employment Opportunity.Neither ARC nor Chiron will discriminate, in terms and conditions of
employment, against employees or applicants because of age, race, color, religion, sex, national origin, qualified disability or any other basis protected by applicable state or local law. ARC and
Chiron agree to abide by all federal, state and local employment and labor law notice posting requirements.

13.3Assignment.This Agreement shall not be directly or indirectly assigned or otherwise transferred by the
Parties, nor, except as expressly provided hereunder, may any right or obligations of either of the Parties hereunder be assigned or transferred (whether voluntarily, by operation of law or otherwise)
without the prior written consent of the other Party. Either Party may assign and transfer to an Affiliate, or any Third Party acquiring all or substantially all of the business assets or liabilities
necessary to transact business, as contemplated hereunder, provided that (i) the assigning Party provides written notice of such assignment at least forty-five (45) days
prior to its intended effectiveness and (ii) the assignee provides to the non-assigning Party adequate assurances of its intent to perform under this Agreement. This Agreement shall
inure to the benefit of and be binding upon the Parties hereto and their respective successors and permitted assigns.

13.4Subcontracting.Chiron's obligations under this contract may not be subcontracted without the prior written
consent of ARC. Any attempt to subcontract without such consent will be null and void and of no effect.

Chiron
must require that all subcontractors approved by ARC be bound by the terms of this Agreement and to assume toward Chiron all obligations and responsibilities which Chiron assumes
toward ARC. Chiron must make available to each approved subcontractor, prior to the execution of any subcontract agreement, a copy of this Agreement to which the subcontractor will be bound. For
purposes of any subcontracts entered into pursuant to this Section 13.4, the term "Chiron" as used in this Agreement, will include any and all ARC-approved subcontractors.

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Each subcontract agreement must preserve and protect the rights of ARC with respect to the goods or services provided by Chiron. The subcontractor must enter into similar agreements with
all sub-subcontractors. ARC retains the unrestricted right to review all subcontract agreements, or other documents pertaining to the retention of any subcontractor at any tier, for
performance under this Agreement, prior to the execution of such subcontract or other agreement. Upon ARC approval, each subcontract agreement shall be assigned by Chiron to ARC; provided, however
that assignment shall only be effective in the event Chiron terminates a subcontracting agreement with a subcontractor and ARC accepts such assignment by notifying the subcontractor in writing. Chiron
must expressly provide for such assignment in all of its subcontract agreements.

Chiron
must require each ARC-approved subcontractor, if any, to procure and maintain insurance of the types and amounts required of Chiron in favor of ARC. In addition, the
subcontractors must assume indemnification responsibilities identical to those provisions agreed to by Chiron and contained in this Agreement, in favor of ARC.

Chiron
agrees to include in all subcontracts entered into under this Agreement a provision to the effect that ARC and its authorized representatives will, until [**]after final payment under the subcontract,
or for any shorter period specified by law for particular records, have access
to and the right to examine any books, documents, papers, or other records of the subcontractor relating to the subcontract.

Nothing
in this Agreement will be deemed to entitle subcontractors, materialmen, or lower-tier subcontractors rights as Third Party beneficiaries of this Agreement between
ARC and Chiron. Notwithstanding any statement to the contrary, Chiron will at all times be responsible for all acts and/or omissions of its subcontractors.

13.5Notices.Any Notice or request required or permitted to be given in connection with this Agreement shall be
deemed to have been sufficiently given if sent by (i) pre-paid registered or certified mail, return receipt requested, or (ii) hand-delivered by a nationally
recognized courier, to the address set forth below or to such other address as may have been notified in writing.

|If to Chiron:                                       |  | Chiron Corporation
Attention: President, Blood Testing
4560 Horton Street
Emeryville, California 94608
Phone:                     
|--------------------------------------------------- |  | ----------------------------------------------------------------------------------------------------------------------------------
|With a copy to:                                     |  | General Counsel                                                                                                                   
|If to ARC:                                          |  | American National Red Cross
Attention: Vice President, NTRL
13504 South Point Boulevard
Charlotte, North Carolina 28273
Phone:[**]
|With a copy to:
(which shall not
constitute notice) |  | The American National Red Cross
Attention: Office of the General Counsel
430 17th Street
Washington, DC 20006-5307
Phone:[**]     

A
notice, consent, approval or other communication takes effect from the time it is received unless a later time is specified in it, and receipt shall be deemed to occur as follows:



25

---



13.6Entire Agreement.This Agreement constitutes the entire agreement between the Parties in respect of the
subject matter hereof. This Agreement cancels and supersedes any and all pre-existing agreements, either oral or in writing between the Parties, including without limitation the Agreement,
effective as of July 1, 2000 by and among Chiron, ARC and Gen-Probe, as amended by that certain Letter Amendment,
dated April 25, 2001, by that certain Second Letter Amendment, dated April 24, 2002, and by that certain Third Letter Agreement, effective as of August 1, 2002 (all of which when
taken together shall be referred to as the"July 2000 Agreement"), which are terminated in their entirety and shall be of no further force or
effect. There are not and shall not be any oral statements, representations, warranties, undertakings or agreements between the Parties other than as provided by this Agreement and any mutually
accepted written amendments or letter agreements attached hereto. This Agreement may not be amended, altered or modified except by a written document executed by all of the Parties hereto.

13.7[RESERVED]

13.8Order of Precedence; Conflict Between Terms and Conditions.In the event of a conflict between the terms of
this Agreement and any other document related hereto, the terms of this Agreement shall govern. Unless otherwise explicitly stated in this Agreement, in the event of any conflict between the terms of
this Agreement and the terms of any of the Schedules or Exhibits hereto, or the terms and conditions of this Agreement and any terms and conditions that may be set forth in any order, invoice, verbal
agreement or otherwise, the terms and conditions of this Agreement shall control and govern any interpretative efforts.

13.9Interpretation.This Agreement shall be construed as if both Parties drafted it jointly, and shall not be
construed against either Party as principal drafter.

13.11No Waiver.The failure on the part of either Party hereto to exercise or enforce any right conferred upon
it by this Agreement shall not be a waiver of any such right nor shall any single or partial exercise of any right or power hereunder or further exercise thereof operate so as to bar the later
exercise or enforcement thereof.

13.12Nature of Relationship; Independent Contractor.Nothing herein contained shall be deemed to be or
construed as constituting either Party the agent or partner of the other Party. The relationship between ARC and Chiron shall be that of an independent contractor. No Party shall have the right, title
or authority to enter into any contract, agreement or commitment on behalf of the other or to bind the other Party in any manner whatsoever.

13.13Compliance with Applicable Law.In performing this Agreement, the Parties shall comply with all applicable
laws and Regulations. 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, the remainder
of this Agreement shall remain in full force and effect, 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, taking into account the economic intentions and business purposes of the Parties.

13.14Publicity.Neither Party shall permit or generate any publicity, advertising or promotion concerning this
Agreement without the prior written consent of the other Party. Each Party recognizes that the name, logo and marks of the other Party represent valuable assets of that Party and that substantial
recognition and goodwill are associated with such assets. Each Party hereby agrees that

26

---

neither it nor any of its Affiliates shall use the other Party's name, logo or marks without the prior written authorization from such other Party.

Each
of the Parties acknowledges that a violation of this Section 13.14 would cause irreparable harm to the other Party for which no adequate remedy at law exists and each Party
therefore agrees that, in addition to any other remedies available, and notwithstanding any other provision of this Agreement, the aggrieved Party shall be entitled to injunctive relief to enforce the
terms of this Section 13.14. To the extent allowed by law, the prevailing Party shall be entitled to recover all costs and expenses, including reasonable attorneys' fees, incurred because of
any legal action arising in relation to this Section 13.14.

13.15Disclosure of Agreements and Terms.Subject to mutual agreement as to form and substance, each of the
Parties may issue a press release disclosing the existence of this Agreement. Each Party may disclose any of the terms of this Agreement to any Affiliate; provided that the recipient of such
disclosure is obligated to confidentiality terms no less restrictive than those contained in Section 6.8. Each Party may disclose any information contained in or regarding this Agreement to the
extent required in its respective reasonable judgment by applicable law, regulation or order of any court or governmental agency. Further, each Party may determine in its respective discretion to file
this Agreement under the Securities and Exchange Act of 1934, even if that filing may result in this Agreement becoming available to the public generally. The filing Party shall seek confidential
treatment for at least the essential financial terms hereof in connection with any such filing, subject to applicable law and regulation, and shall notify the other Party in advance of any such filing
and consider such suggestions as the other Party may make as to the terms herein as to which the filing party should seek confidential treatment.

13.16Counterparts.This Agreement 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.

[Remainder of page intentionally left blank]

[Signature pages follow.]

27

---

IN
WITNESS WHEREOF, the Parties hereto, through their authorized representatives, have set their hands as of the date first above written, whereby they evidence their intent to be
legally bound to this Sale and Servicing Agreement.

|CHIRON CORPORATION |                   | THE AMERICAN NATIONAL RED CROSS
|------------------ | ----------------- | -------------------------------
|By:                | /s/JACK GOLDSTEIN |                                
|Name:              |                   | Jack Goldstein                 
|Title:             |                   | President, Chiron Blood Testing
|                   |                   |                                
|                   |                   |                                
|                   |                   |                                

28

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Schedule 1.10

BLOOD SCREENING SYSTEMS

[attached]

29

---

American Red Cross  National Genome Testing Laboratory  8810 Rehco Road Suite E  San Diego, CA 92121

|            |  |              |  |                     |  |            |  |      |  |            |  |      |  | 2/28/2002 |  |      |  |     
|----------- |  | ------------ |  | ------------------- |  | ---------- |  | ---- |  | ---------- |  | ---- |  | --------- |  | ---- |  | ----
|
|
|Tecan       |  | Assay        |  | 4355                |  |            |  | 7546 |  | 1/1/2000   |  |      |  |           |  | $   |  |     
|Monitor     |  | Assay        |  | 1780R-M08CR-70      |  |            |  | 7547 |  | 1/1/2000   |  |      |  |           |  |      |  |     
|Keyboard    |  | Assay        |  | 12743-967-1977      |  |            |  | 7548 |  | 1/1/2000   |  | [**] |  | [**]      |  | [**] |  | [**]
|CPU         |  | Assay        |  | 1EQ4V               |  |            |  | 7549 |  | 1/1/2000   |  |      |  |           |  |      |  |     
|Mouse       |  | Assay        |  | 3831166-20000       |  |            |  | 7550 |  | 1/1/2000   |  |      |  |           |  |      |  |     
|            |  |              |  |                     |  |            |  |      |  |            |  |      |  |           |  |      |  |     
|Vortex      |  | Pre-amp      |  | 1377                |  |            |  | 7555 |  | 1/1/2000   |  |      |  | [**]      |  | $    |  |     
|Vortex      |  | Pre-amp      |  | 1288                |  |            |  | 7556 |  | 1/1/2000   |  |      |  | [**]      |  | $    |  |     
|Vortex      |  | Post-amp     |  | 1376                |  |            |  | 7562 |  | 1/1/2000   |  |      |  | [**]      |  | $    |  |     
|Vortex      |  | Post-amp     |  | 1294                |  |            |  | 7563 |  | 1/1/2000   |  |      |  | [**]      |  | $    |  |     
|TCS         |  | Rev B.       |  | 473                 |  |            |  | 7557 |  | 4/1/2000   |  |      |  | [**]      |  | $    |  |     
|Vacuum Pump |  | N/A          |  | KK031469            |  |            |  | 7558 |  | 3/1/2000   |  |      |  |           |  |      |  |     
|TCS         |  | Rev B.       |  | 449                 |  |            |  | 7559 |  | 4/1/2000   |  |      |  | [**]      |  | $    |  |     
|Vacuum Pump |  | N/A          |  | KK061238            |  |            |  | 7560 |  | 3/1/2000   |  |      |  |           |  |      |  |     
|Waterbath   |  | 60 Pre-amp   |  | 699061300           |  | 601071154  |  | 7529 |  | 11/2/2001  |  |      |  | [**]      |  | $    |  |     
|Waterbath   |  | 60 Pre-amp   |  | 699061331           |  | 601061293  |  | 7579 |  | 10/31/2001 |  |      |  | [**]      |  | $    |  |     
|Waterbath   |  | 41.5 Pre-amp |  | 699061041           |  | 601052149  |  | 7530 |  | 10/31/2001 |  |      |  | [**]      |  | $    |  |     
|Waterbath   |  | 41.5 Pre-amp |  | 699061313           |  | 600101193  |  | 7561 |  | 8/14/2001  |  |      |  | [**]      |  | $    |  |     
|Waterbath   |  | 60 Post-amp  |  | 699061040           |  | 699061329  |  | 7554 |  | 3/12/2001  |  |      |  | [**]      |  | $    |  |     
|Waterbath   |  | 60 Post-amp  |  | 699061045           |  | 699081311  |  | 1393 |  | 9/15/2000  |  |      |  | [**]      |  | $    |  |     
|            |  |              |  |                     |  |            |  |      |  |            |  |      |  |           |  |      |  |     
|HC+         |  | Luminometer  |  | 400264              |  | 400233     |  | 7533 |  | 3/15/2001  |  |      |  |           |  |      |  |     
|Monitor     |  | Luminometer  |  | 7753TPOMV299        |  |            |  | 7534 |  | 3/15/2001  |  |      |  |           |  |      |  |     
|Keyboard    |  | Luminometer  |  | 37172-99K-3090      |  |            |  | 7536 |  | 3/15/2001  |  |      |  |           |  |      |  |     
|CPU         |  | Luminometer  |  | GANRW               |  |            |  | 7535 |  | 3/15/2001  |  | [**] |  | 11        |  | [**] |  | [**]
|Mouse       |  | Luminometer  |  | 63618-OEM-4449786-5 |  |            |  | 7537 |  | 3/15/2001  |  |      |  |           |  |      |  |     
|Printer     |  | Luminometer  |  | MX99S1L1DY          |  | CN07P1Q16J |  | 7538 |  | 4/17/2001  |  |      |  |           |  |      |  |     
|UPS         |  | Luminometer  |  | D02238537           |  |            |  | 7539 |  | 4/17/2001  |  |      |  |           |  |      |  |     
|            |  |              |  |                     |  |            |  |      |  |            |  |      |  |           |  |      |  |     
|HC+         |  | Luminometer  |  | 400263              |  | 400412     |  | 7531 |  | 11/2/2001  |  |      |  |           |  |      |  |     
|Monitor     |  | Luminometer  |  | 7753TPOQK099        |  |            |  | 6540 |  | 11/2/2001  |  |      |  |           |  |      |  |     
|Keyboard    |  | Luminometer  |  | 37172-99K-3123      |  |            |  | 7541 |  | 11/2/2001  |  |      |  |           |  |      |  |     
|CPU         |  | Luminometer  |  | 7TDVE               |  | 7RH5901    |  | 7542 |  | 11/2/2001  |  | [**] |  | 4         |  | [**] |  | [**]
|Mouse       |  | Luminometer  |  | 63618-OEM-0905932-7 |  |            |  | 7543 |  | 11/2/2001  |  |      |  |           |  |      |  |     
|Printer     |  | Luminometer  |  | MY95V161FB          |  | CN07P1Q1CR |  | 7544 |  | 3/26/2001  |  |      |  |           |  |      |  |     
|UPS         |  | Luminometer  |  | D02238542           |  |            |  | 7545 |  | 3/26/2001  |  |      |  |           |  |      |  |     
|            |  |              |  |                     |  |            |  |      |  |            |  |      |  |           |  |      |  |     
|HC+         |  | Luminometer  |  |                     |  | 40034      |  |      |  | 5/1/2002   |  |      |  |           |  |      |  |     
|Monitor     |  | Luminometer  |  |                     |  |            |  |      |  |            |  |      |  |           |  |      |  |     
|Keyboard    |  | Luminometer  |  |                     |  |            |  |      |  |            |  |      |  |           |  |      |  |     
|CPU         |  | Luminometer  |  |                     |  |            |  |      |  |            |  | [**] |  | -2        |  | [**] |  | [**]
|Mouse       |  | Luminometer  |  |                     |  |            |  |      |  |            |  |      |  |           |  |      |  |     
|Printer     |  | Luminometer  |  |                     |  |            |  |      |  |            |  |      |  |           |  |      |  |     
|UPS         |  | Luminometer  |  |                     |  |            |  |      |  |            |  |      |  |           |  |      |  |     
|            |  |              |  |                     |  |            |  |      |  |            |  |      |  |           |  |      |  |     
|            |  |              |  |                     |  |            |  |      |  |            |  | [**] |  |           |  | [**] |  | [**]

29a

---

ARC NGTL SAN DIEGOMAIN LAB  National Genome Testing Laboratory  8885 Rehco Road  San Diego, Ca 92121

|            |  |              |  |                         |  |      |  |            |  |              |  | 2/28/2002 |  |      |  |     
|----------- |  | ------------ |  | ----------------------- |  | ---- |  | ---------- |  | ------------ |  | --------- |  | ---- |  | ----
|
|Tecan       |  | Pooling      |  | 2816                    |  | 7564 |  |            |  |              |  |           |  |      |  | [**]
|Monitor     |  | Pooling      |  | 84779JFCMT68            |  | 7565 |  |            |  | Already sold |  |           |  |      |  |     
|Keyboard    |  | Pooling      |  | 127438641038            |  | 7566 |  |            |  |              |  |           |  |      |  |     
|CPU         |  | Pooling      |  | F1XWV                   |  | 7567 |  |            |  |              |  |           |  |      |  |     
|            |  |              |  |                         |  |      |  |            |  |              |  |           |  |      |  |     
|Tecan       |  | Pooling      |  | 2805                    |  | 7568 |  |            |  |              |  |           |  |      |  | [**]
|Monitor     |  | Pooling      |  | 84779C309797            |  | 7569 |  |            |  | Already sold |  |           |  |      |  |     
|Keyboard    |  | Pooling      |  | 127107A3010820          |  | 7570 |  |            |  |              |  |           |  |      |  |     
|CPU         |  | Pooling      |  | C9SQK                   |  | 7571 |  |            |  |              |  |           |  |      |  |     
|            |  |              |  |                         |  |      |  |            |  |              |  |           |  |      |  |     
|Tecan       |  | Pooling      |  | 2807                    |  | 7572 |  |            |  |              |  |           |  |      |  | [**]
|Monitor     |  | Pooling      |  | 84779C306P97            |  | 7573 |  |            |  | Already sold |  |           |  |      |  |     
|Keyboard    |  | Pooling      |  | 127107621942            |  | 7574 |  |            |  |              |  |           |  |      |  |     
|CPU         |  | Pooling      |  | C9SQR                   |  | 7575 |  |            |  |              |  |           |  |      |  |     
|            |  |              |  |                         |  |      |  |            |  |              |  |           |  |      |  |     
|Tecan       |  | Assay        |  | 3046                    |  | 7501 |  | 12/1/1998  |  |              |  |           |  |      |  | [**]
|Monitor     |  | Assay        |  | 84766ACU2358            |  | 7502 |  | 12/1/1998  |  |              |  |           |  |      |  |     
|Keyboard    |  | Assay        |  | 1274385K2152            |  | 7503 |  | 12/1/1998  |  | [**]         |  | [**]      |  | [**] |  |     
|CPU         |  | Assay        |  | ERV66                   |  | 7504 |  | 12/1/1998  |  |              |  |           |  |      |  |     
|Mouse       |  | Assay        |  | 3524511-00000           |  | 7505 |  | 12/1/1998  |  |              |  |           |  |      |  |     
|            |  |              |  |                         |  |      |  |            |  |              |  |           |  |      |  |     
|Tecan       |  | Assay        |  | 3107                    |  | 7506 |  | 12/1/1998  |  |              |  |           |  |      |  | [**]
|Monitor     |  | Assay        |  | 84766ACU2X58            |  | 7507 |  | 12/1/1998  |  |              |  |           |  |      |  |     
|Keyboard    |  | Assay        |  | 1271081G1402            |  | 7508 |  | 12/1/1998  |  | [**]         |  | [**]      |  | [**] |  |     
|CPU         |  | Assay        |  | DMJJXK                  |  | 7509 |  | 12/1/1998  |  |              |  |           |  |      |  |     
|Mouse       |  | Assay        |  | 1767894-50000           |  | 7510 |  | 12/1/1998  |  |              |  |           |  |      |  |     
|            |  |              |  |                         |  |      |  |            |  |              |  |           |  |      |  |     
|Vortex      |  | Pre-amp      |  | 1221                    |  | 7511 |  | 3/1/2000   |  |              |  | [**]      |  |      |  |     
|Vortex      |  | Pre-amp      |  | 1293                    |  | N/A  |  | 10/31/2001 |  |              |  | [**]      |  |      |  |     
|Vortex      |  | Post-amp     |  | 1227                    |  | 1408 |  | 11/28/2000 |  |              |  | [**]      |  |      |  |     
|Vortex      |  | Post-amp     |  | 1383                    |  | 1407 |  | 3/1/2000   |  |              |  | [**]      |  |      |  |     
|TCS         |  | Rev. B       |  | 509                     |  | 7515 |  | 4/1/2000   |  |              |  |           |  |      |  |     
|Vacuum Pump |  | N/A          |  | KK091208                |  | 7516 |  | 4/1/2000   |  |              |  | [**]      |  |      |  |     
|TCS         |  | Rev. B       |  | 511                     |  | 7517 |  | 4/1/2000   |  |              |  |           |  |      |  |     
|Vacuum Pump |  | N/A          |  | KK091210                |  | 7518 |  | 4/1/2000   |  |              |  | [**]      |  |      |  |     
|TCS         |  | Rev. B       |  | 513                     |  | 7519 |  | 4/1/2000   |  |              |  |           |  |      |  |     
|Vacuum Pump |  | N/A          |  | KK071282                |  | 4526 |  | 5/1/2000   |  |              |  | [**]      |  |      |  |     
|TCS         |  | Rev. B       |  | 448                     |  | 7513 |  | 11/7/2000  |  |              |  |           |  |      |  |     
|Vacuum Pump |  | N/A          |  | KK091211                |  | 7514 |  | 4/1/2000   |  |              |  | [**]      |  |      |  |     
|Waterbath   |  | 60 Pre-amp   |  | 698100304               |  | 573  |  | 7/15/2000  |  |              |  | [**]      |  |      |  |     
|Waterbath   |  | 60 Pre-amp   |  | 698041215               |  | 576  |  | 7/15/2000  |  |              |  | [**]      |  |      |  |     
|Waterbath   |  | 41.5 Pre-amp |  | 698041204               |  | 574  |  | 7/15/2000  |  |              |  | [**]      |  |      |  |     
|Waterbath   |  | 41.5 Pre-amp |  | 698091022               |  | 575  |  | 7/15/2000  |  |              |  | [**]      |  |      |  |     
|Waterbath   |  | 60 Post-amp  |  | 698030823               |  | 1399 |  | 10/4/2001  |  |              |  | [**]      |  |      |  |     
|Waterbath   |  | 60 Post-amp  |  | 698060293               |  | 7584 |  | 6/5/2001   |  |              |  | [**]      |  |      |  |     
|Waterbath   |  |              |  | 699050807               |  | 573  |  | 7/15/2000  |  |              |  | [**]      |  |      |  |     
|Waterbath   |  |              |  | 699050811               |  | 576  |  | 7/15/2000  |  |              |  | [**]      |  |      |  |     
|Waterbath   |  |              |  | 699050816               |  | 574  |  | 7/15/2000  |  |              |  | [**]      |  |      |  |     
|Waterbath   |  |              |  | 699050810               |  | 1399 |  | 10/4/2001  |  |              |  | [**]      |  |      |  |     
|Waterbath   |  |              |  | 699050814               |  | 7584 |  | 6/5/2001   |  |              |  | [**]      |  |      |  |     
|Waterbath   |  |              |  | 699060080               |  | 575  |  | 7/15/2000  |  |              |  | [**]      |  |      |  |     
|Waterbath   |  |              |  | 601061292               |  | 1399 |  | 10/4/2001  |  |              |  | [**]      |  |      |  |     
|Waterbath   |  |              |  | 699081310               |  | 7588 |  | 12/18/2001 |  |              |  | [**]      |  |      |  |     
|            |  |              |  |                         |  |      |  |            |  |              |  |           |  |      |  |     
|HC+         |  | Luminometer  |  | 400274                  |  | 1392 |  | 8/23/2000  |  |              |  |           |  |      |  | [**]
|Monitor     |  | Luminometer  |  | 84779A49D1A8            |  | 7520 |  |            |  |              |  |           |  |      |  |     
|Keyboard    |  | Luminometer  |  | 3862A246                |  | 7552 |  |            |  |              |  |           |  |      |  |     
|CPU         |  | Luminometer  |  | HRPWC                   |  | 7551 |  | 3/6/2001   |  | [**]         |  | [**]      |  | [**] |  |     
|Mouse       |  | Luminometer  |  | 52463-OEM-1376272-00000 |  | 7522 |  |            |  |              |  |           |  |      |  |     
|Printer     |  | Luminometer  |  | SG87S1N2PP              |  | 7582 |  | 4/1701     |  |              |  |           |  |      |  |     
|UPS         |  | Luminometer  |  | D02238595               |  | 7527 |  |            |  |              |  |           |  |      |  |     
|            |  |              |  |                         |  |      |  |            |  |              |  |           |  |      |  |     
|HC+         |  | Luminometer  |  | 400408                  |  | 1403 |  | 1/10/2001  |  |              |  |           |  |      |  | [**]
|Monitor     |  | Luminometer  |  | MY73253695              |  | 1409 |  |            |  |              |  |           |  |      |  |     
|Keyboard    |  | Luminometer  |  | M971069221              |  | 7524 |  | 6/1/2000   |  | [**]         |  | [**]      |  | [**] |  |     
|CPU         |  | Luminometer  |  | US81102668              |  | 1410 |  |            |  |              |  |           |  |      |  |     
|Mouse       |  | Luminometer  |  | LZB75220471             |  | 7525 |  |            |  |              |  |           |  |      |  |     
|Printer     |  | Luminometer  |  | SG87V1N15D              |  | 7528 |  | 2/15/2001  |  |              |  |           |  |      |  |     
|            |  |              |  |                         |  |      |  |            |  |              |  |           |  |      |  |     
|HC+         |  | Luminometer  |  | 400280                  |  | 1382 |  | 3/15/2001  |  |              |  |           |  |      |  | [**]
|Monitor     |  | Luminometer  |  | MY07753T4663203820HZ    |  | 1404 |  |            |  |              |  |           |  |      |  |     
|Keyboard    |  | Luminometer  |  | 37172036C166            |  | 1405 |  |            |  | [**]         |  | [**]      |  | [**] |  |     
|CPU         |  | Luminometer  |  | 4WFIM                   |  | 1402 |  | 1/8/2001   |  |              |  |           |  |      |  |     
|Mouse       |  | Luminometer  |  | 63618-OEM-3612216-8     |  | 1406 |  |            |  |              |  |           |  |      |  |     
|            |  |              |  |                         |  |      |  |            |  |              |  |           |  |      |  |     
|            |  |              |  |                         |  |      |  |            |  | [**]         |  |           |  | [**] |  | [**]

29b

---

ARC Charlotte NAT Laboratory  13500-A South Point Blvd.  Charlotte, NC 28274-6759

|                    |  |             |  |            |  |      |  |           |  |  |  |              |  | 2/28/2002 |  |      |  |     
|------------------- |  | ----------- |  | ---------- |  | ---- |  | --------- |  |  |  | ------------ |  | --------- |  | ---- |  | ----
|
|Tecan (Pooling)     |  | Pooling     |  | 5616       |  | 422  |  | 12/6/2000 |  |  |  |              |  |           |  |      |  | [**]
|Tecan (Pooling)     |  | Pooling     |  | 2808       |  | N/A  |  | 12/6/2000 |  |  |  |              |  |           |  |      |  | [**]
|Tecan (Pooling)     |  | Pooling     |  | 3058       |  | N/A  |  | 3/30/2001 |  |  |  | Already sold |  |           |  |      |  | [**]
|Dell CPUTecan CPT  |  | Pooling     |  | 9ZLH301    |  | 420  |  | 12/6/2000 |  |  |  |              |  |           |  |      |  |     
|Dell CPUTecan CPT  |  | Pooling     |  | C9SQX      |  | N/A  |  | 1/9/2001  |  |  |  |              |  |           |  |      |  |     
|Dell CPUTecan CPT  |  | Pooling     |  | C9SPS      |  | N/A  |  | 3/30/2001 |  |  |  |              |  |           |  |      |  |     
|                    |  |             |  |            |  |      |  |           |  |  |  |              |  |           |  |      |  |     
|Tecan (Assay)       |  | Assay       |  | 5581       |  | 475  |  | 12/5/2000 |  |  |  | [**]         |  | [**]      |  | [**] |  | [**]
|Dell CPUTecan CPAS |  | Assay       |  | 1CFM201    |  | 472  |  | 12/5/2000 |  |  |  |              |  |           |  |      |  |     
|                    |  |             |  |            |  |      |  |           |  |  |  |              |  |           |  |      |  |     
|Tecan (Assay)       |  | Assay       |  | 5582       |  | 423  |  | 12/5/2000 |  |  |  | [**]         |  | [**]      |  | [**] |  | [**]
|Dell CPUTecan CPAS |  | Assay       |  | 4GBC101    |  | 477  |  | 12/5/2000 |  |  |  |              |  |           |  |      |  |     
|                    |  |             |  |            |  |      |  |           |  |  |  |              |  |           |  |      |  |     
|Vortexer            |  |             |  | 2241       |  | 471  |  | 12/5/2000 |  |  |  |              |  | [**]      |  |     |  |     
|Vortexer            |  |             |  | 2289       |  | 407  |  | 12/5/2000 |  |  |  |              |  | [**]      |  |     |  |     
|Vortexer            |  |             |  | 2219       |  | 412  |  | 12/4/2000 |  |  |  |              |  | [**]      |  |     |  |     
|Vortexer            |  |             |  | 2224       |  | 413  |  | 12/4/2000 |  |  |  |              |  | [**]      |  |     |  |     
|TCS                 |  | PreAmp      |  | 581B       |  | 402  |  | 2/22/2001 |  |  |  |              |  | [**]      |  |     |  |     
|Vacuum Pump         |  | PreAmp      |  | EE091527   |  | 405  |  | 7/12/2001 |  |  |  |              |  |           |  |      |  |     
|TCS                 |  | PreAmp      |  | 585B       |  | 404  |  | 2/22/2001 |  |  |  |              |  | [**]      |  |     |  |     
|Vacuum Pump         |  | PreAmp      |  | EE091525   |  | 6081 |  | 7/12/2001 |  |  |  |              |  |           |  |      |  |     
|Waterbath           |  |             |  | 600071224  |  | 410  |  | 12/4/2000 |  |  |  |              |  | [**]      |  |     |  |     
|Waterbath           |  |             |  | 600071227  |  | 464  |  | 12/4/2000 |  |  |  |              |  | [**]      |  |     |  |     
|Waterbath           |  |             |  | 600071226  |  | 416  |  | 12/5/2000 |  |  |  |              |  | [**]      |  |     |  |     
|Waterbath           |  |             |  | 600071221  |  | 414  |  | 12/5/2000 |  |  |  |              |  | [**]      |  |     |  |     
|Waterbath           |  |             |  | 600071225  |  | 417  |  | 12/5/2000 |  |  |  |              |  | [**]      |  |     |  |     
|Waterbath           |  |             |  | 600071223  |  | 415  |  | 12/5/2000 |  |  |  |              |  | [**]      |  |     |  |     
|                    |  |             |  |            |  |      |  |           |  |  |  |              |  |           |  |      |  |     
|HC+                 |  | Luminometer |  | 400265     |  | 6027 |  | 2/22/2001 |  |  |  | [**]         |  | [**]      |  | [**] |  | [**]
|Printer (930C)      |  |             |  | MY02E160DG |  | 427  |  | 12/5/2000 |  |  |  |              |  |           |  |      |  |     
|CPU                 |  | Luminometer |  | JSWB201    |  | 408  |  | 12/4/2000 |  |  |  |              |  |           |  |      |  |     
|                    |  |             |  |            |  |      |  |           |  |  |  |              |  |           |  |     |  | [**]
|HC+                 |  | Luminometer |  | 400249     |  | 6022 |  | 3/15/2002 |  |  |  | [**]         |  | [**]      |  | [**] |  |     
|Printer (930C)      |  |             |  | CN07P1Q1C1 |  | 6926 |  | 3/15/2002 |  |  |  |              |  |           |  |      |  |     
|CPU                 |  | Luminometer |  | 8TWB201    |  | 6023 |  | 3/15/2002 |  |  |  |              |  |           |  |      |  |     
|                    |  |             |  |            |  |      |  |           |  |  |  |              |  |           |  |      |  |     
|                    |  |             |  |            |  |      |  |           |  |  |  |              |  |           |  |     |  | [**]
|HC+                 |  | Luminometer |  | 400402     |  | 6082 |  | 7/12/2001 |  |  |  | [**]         |  | [**]      |  | [**] |  |     
|Printer (930C)      |  |             |  | MY02E160DM |  | 424  |  | 12/5/2000 |  |  |  |              |  |           |  |      |  |     
|CPU                 |  | Luminometer |  | 9SWB201    |  | 467  |  | 12/5/2000 |  |  |  |              |  |           |  |      |  |     
|                    |  |             |  |            |  |      |  |           |  |  |  |              |  |           |  |      |  |     
|                    |  |             |  |            |  |      |  |           |  |  |  | [**]         |  |           |  | [**] |  | [**]

29c

---

ARC Philadelphia  700 Spring Garden Street  Philadelphia, PA 19123-3594

|Equipment      |  | Description
/Location |  | Serial
Number            |  | Asset
Tag |  | Install
Date |  | List Price   |  | 2/28/2002
Age in Months |  | FMV  |  | Service
|-------------- |  | --------------------- |  | ------------------------ |  | --------- |  | ------------ |  | ------------ |  | ----------------------- |  | ---- |  | -------
|Tecan          |  | Pooling               |  | 2437                     |  | N/A       |  | 3/21/2001    |  |              |  |                         |  |      |  | [**]   
|CPU            |  | Pooling               |  | C9SN3                    |  | N/A       |  | 3/21/2001    |  | Already sold |  |                         |  |      |  |        
|Moniter        |  | Pooling               |  | 84779C30CV97             |  | N/A       |  | 3/21/2001    |  |              |  |                         |  |      |  |        
|Keyboard       |  | Pooling               |  | 127107A3010868           |  | N/A       |  | 3/21/2001    |  |              |  |                         |  |      |  |        
|               |  |                       |  |                          |  |           |  |              |  |              |  |                         |  |      |  |        
|Tecan          |  | Pooling               |  | 2812                     |  | N/A       |  | 3/22/2001    |  |              |  |                         |  |      |  | [**]   
|CPU            |  | Pooling               |  | C9SQJ                    |  | N/A       |  | 3/22/2001    |  | Already sold |  |                         |  |      |  |        
|Moniter        |  | Pooling               |  | 66746J1TMG87             |  | N/A       |  | 3/22/2001    |  |              |  |                         |  |      |  |        
|Keyboard       |  | Pooling               |  | 127107A3010894           |  | N/A       |  | 3/22/2001    |  |              |  |                         |  |      |  |        
|               |  |                       |  |                          |  |           |  |              |  |              |  |                         |  |      |  |        
|Tecan          |  | Assay                 |  | 5585                     |  | 6074      |  | 3/21/2001    |  |              |  |                         |  |      |  | [**]   
|CPU            |  | Assay                 |  | DPFFF01                  |  | 6076      |  | 3/21/2001    |  |              |  |                         |  |      |  |        
|Monitor        |  | Assay                 |  | MX-0819ET-47801-12E-HOER |  | 6075      |  | 3/21/2001    |  | [**]         |  | [**]                    |  | [**] |  |        
|Keyboard       |  | Assay                 |  | TH-0463CD-37171-0B3-1518 |  | 6077      |  | 3/21/2001    |  |              |  |                         |  |      |  |        
|Mouse          |  | Assay                 |  | 63618-OEM-4863052-4      |  | N/A       |  | 3/21/2001    |  |              |  |                         |  |      |  |        
|               |  |                       |  |                          |  |           |  |              |  |              |  |                         |  |      |  |        
|Tecan          |  | Assay                 |  | 5587                     |  | 6072      |  | 3/21/2001    |  |              |  |                         |  |      |  | [**]   
|CPU            |  | Assay                 |  | FB5N30B                  |  | 6059      |  | 3/21/2001    |  |              |  |                         |  |      |  |        
|Moniter        |  | Assay                 |  | MY-07753T-46632-04T-21JT |  | 6060      |  | 3/21/2001    |  | [**]         |  | [**]                    |  | [**] |  |        
|Keyboard       |  | Assay                 |  | TH-0463CD-37172-05N-2065 |  | 6073      |  | 3/21/2001    |  |              |  |                         |  |      |  |        
|Mouse          |  | Assay                 |  | 63618-OEM-2170263-0      |  | N/A       |  | 3/21/2001    |  |              |  |                         |  |      |  |        
|               |  |                       |  |                          |  |           |  |              |  |              |  |                         |  |      |  |        
|Tecan          |  | Pooling               |  | 2858                     |  |           |  | 3/21/2001    |  |              |  |                         |  |      |  | [**]   
|CPU            |  | Pooling               |  |                          |  |           |  | 3/21/2001    |  | Already sold |  |                         |  |      |  |        
|Moniter        |  | Pooling               |  |                          |  |           |  | 3/21/2001    |  |              |  |                         |  |      |  |        
|Keyboard       |  | Pooling               |  |                          |  |           |  | 3/21/2001    |  |              |  |                         |  |      |  |        
|               |  |                       |  |                          |  |           |  |              |  |              |  |                         |  |      |  |        
|Tecan          |  | Pooling               |  | 2817                     |  |           |  | 7/1/2001     |  |              |  |                         |  |      |  | [**]   
|CPU            |  | Pooling               |  |                          |  |           |  | 7/1/2001     |  | Already sold |  |                         |  |      |  |        
|Moniter        |  | Pooling               |  |                          |  |           |  | 7/1/2001     |  |              |  |                         |  |      |  |        
|Keyboard       |  | Pooling               |  |                          |  |           |  | 7/1/2001     |  |              |  |                         |  |      |  |        
|               |  |                       |  |                          |  |           |  |              |  |              |  |                         |  |      |  |        
|TCS            |  | Rev. B                |  | 656B                     |  | 6055      |  | 3/20/2001    |  |              |  | [**]                    |  |     |  |        
|Vacuum Pump    |  | N/A                   |  | EE121013                 |  | 6058      |  | 3/20/2001    |  |              |  |                         |  |      |  |        
|Waterbath      |  | 41.5/Pre-amp          |  | 600081456                |  | 6049      |  | 3/20/2001    |  |              |  | [**]                    |  |     |  |        
|Waterbath      |  | 41.5/Pre-amp          |  | 600071052                |  | 6047      |  | 3/20/2001    |  |              |  | [**]                    |  |     |  |        
|Waterbath      |  | 60/Pre-amp            |  | 600081452                |  | 6048      |  | 3/19/2001    |  |              |  | [**]                    |  |     |  |        
|Waterbath      |  | 60/Pre-amp            |  | 600081095                |  | 6051      |  | 3/20/2001    |  |              |  | [**]                    |  |     |  |        
|Waterbath      |  | 60/Post-amp           |  | 600091557                |  | 6030      |  | 3/20/2001    |  |              |  | [**]                    |  |     |  |        
|Waterbath      |  | 60/Pre-amp            |  | 600071053                |  | 6029      |  | 3/20/2001    |  |              |  | [**]                    |  |     |  |        
|               |  |                       |  |                          |  |           |  |              |  |              |  |                         |  |      |  |        
|HC+            |  | Luminometer           |  | 400277                   |  | 6036      |  | 5/13/2002    |  |              |  |                         |  |      |  | [**]   
|CPU            |  | Luminometer           |  | 1QH5901                  |  | 6033      |  | 5/13/2002    |  |              |  |                         |  |      |  |        
|Moniter        |  | Luminometer           |  | MX-06204T-47605-0CC-B774 |  | 6035      |  | 5/13/2002    |  |              |  |                         |  |      |  |        
|Keyboard       |  | Luminometer           |  | TH-0463CD-37171-08A-9956 |  | 6034      |  | 5/13/2002    |  | [**]         |  | [**]                    |  | [**] |  |        
|Printer (930C) |  | Luminometer           |  | CN07P1Q1CM               |  | 6042      |  | 5/13/2002    |  |              |  |                         |  |      |  |        
|UPS            |  | Luminometer           |  | F02654817                |  | 6071      |  | 5/13/2002    |  |              |  |                         |  |      |  |        
|Mouse          |  | Luminometer           |  | 63618-OEM-2380852-3      |  | N/A       |  | 5/13/2002    |  |              |  |                         |  |      |  |        
|               |  |                       |  |                          |  |           |  |              |  |              |  |                         |  |      |  |        
|HC+            |  | Luminometer           |  | 400116                   |  | 6043      |  | 5/20/2002    |  |              |  |                         |  |      |  | [**]   
|CPU            |  | Luminometer           |  | 2SH5901                  |  | 6052      |  | 5/20/2002    |  |              |  |                         |  |      |  |        
|Moniter        |  | Luminometer           |  | MX-06204T-47605-0CC-B7J8 |  | 6040      |  | 5/20/2002    |  |              |  |                         |  |      |  |        
|Keyboard       |  | Luminometer           |  | TH-0463CD-37171-08A-9982 |  | 6053      |  | 5/20/2002    |  | [**]         |  | [**]                    |  | [**] |  |        
|Mouse          |  | Luminometer           |  | 63618-OEM-2381167-3      |  | N/A       |  | 5/20/2002    |  |              |  |                         |  |      |  |        
|UPS            |  | Luminometer           |  | F02654773                |  | 6070      |  | 5/20/2002    |  |              |  |                         |  |      |  |        
|Printer (930C) |  | Luminometer           |  | CN07P1Q1CW               |  | 6044      |  | 5/20/2002    |  |              |  |                         |  |      |  |        
|               |  |                       |  |                          |  |           |  |              |  |              |  |                         |  |      |  |        
|HC+            |  | Luminometer           |  | 400403                   |  | 6041      |  | 6/17/2002    |  |              |  |                         |  |      |  | [**]   
|CPU            |  | Luminometer           |  | 4TH5901                  |  | 6039      |  | 6/17/2002    |  |              |  |                         |  |      |  |        
|Moniter        |  | Luminometer           |  | MX-06204T-47605-0CC-B77D |  | 6038      |  | 6/17/2002    |  |              |  |                         |  |      |  |        
|Keyboard       |  | Luminometer           |  | Th-0463CD-37171-08A-9997 |  | 6037      |  | 6/17/2002    |  | [**]         |  | [**]                    |  | [**] |  |        
|Mouse          |  | Luminometer           |  | 63616-OEM-2380762-3      |  | N/A       |  | 6/17/2002    |  |              |  |                         |  |      |  |        
|Printer (930C) |  | Luminometer           |  | MY09E172HY               |  | 6045      |  | 6/17/2002    |  |              |  |                         |  |      |  |        
|               |  |                       |  |                          |  |           |  |              |  |              |  |                         |  |      |  |        
|               |  |                       |  |                          |  |           |  |              |  | [**]         |  |                         |  | [**] |  | [**]   

29d

---

|                   |  |                  |  |        |  | s/n                   |  |      |  | Service  |  |     
|------------------ |  | ---------------- |  | ------ |  | --------------------- |  | ---- |  | -------- |  | ----
|American Red Cross |  | ARCSan Diego    |  | 10-124 |  | Genesis 200ID W/O ARM |  | 3085 |  | Scanning |  | [**]
|American Red Cross |  | ARCSan Diego    |  | 10-124 |  | Genesis 200ID W/O ARM |  | 3086 |  | Scanning |  | [**]
|American Red Cross |  | ARCSan Diego    |  | 10-124 |  | Genesis 200ID W/O ARM |  | 5982 |  | Scanning |  | [**]
|American Red Cross |  | ARCPhiladelphia |  | 10-124 |  | Genesis 200ID W/O ARM |  | 4287 |  | Scanning |  | [**]
|American Red Cross |  | ARCDetroit      |  | 10-124 |  | Genesis 200ID W/O ARM |  | 5981 |  | Scanning |  | [**]
|American Red Cross |  | ARCDetroit      |  | 10-124 |  | Genesis 200ID W/O ARM |  | 4673 |  | Scanning |  | [**]
|American Red Cross |  | ARCPhiladelphia |  | 10-124 |  | Genesis 200ID W/O ARM |  | 4672 |  | Scanning |  | [**]
|American Red Cross |  | ARCDetroit      |  | 10-124 |  | Genesis 200ID W/O ARM |  | 4671 |  | Scanning |  | [**]
|American Red Cross |  | ARCCharlotte    |  | 10-124 |  | Genesis 200ID W/O ARM |  | 5558 |  | Scanning |  | [**]
|American Red Cross |  | ARCSt. Louis    |  | 10-124 |  | Genesis 200ID W/O ARM |  | 5559 |  | Scanning |  | [**]
|American Red Cross |  | ARCCharlotte    |  | 10-124 |  | Genesis 200ID W/O ARM |  | 5560 |  | Scanning |  | [**]
|American Red Cross |  | ARCSt. Louis    |  | 10-124 |  | Genesis 200ID W/O ARM |  | 5571 |  | Scanning |  | [**]
|                   |  |                  |  |        |  |                       |  |      |  |          |  | [**]

29e

---

American Red CrossSt. Louis NTL Equipment List4050 Lindell Blvd.

|                        |  |                     |  |                      |  |      |  |            |  |              |  | 2/28/02 |  |         |  |     
|----------------------- |  | ------------------- |  | -------------------- |  | ---- |  | ---------- |  | ------------ |  | ------- |  | ------- |  | ----
|
|Tecan                   |  | Pooling             |  | 2815                 |  | 326  |  | 4/1/2001   |  |              |  |         |  |         |  | [**]
|CPU                     |  | Pooling             |  | DCM                  |  | 325  |  | 4/1/2001   |  | Already sold |  |         |  |         |  |     
|Moniter                 |  | Pooling             |  | E770p                |  | 324  |  | 4/1/2001   |  |              |  |         |  |         |  |     
|Keyboard                |  | Pooling             |  | N/A                  |  | N/A  |  | 4/1/2001   |  |              |  |         |  |         |  |     
|                        |  |                     |  |                      |  |      |  |            |  |              |  |         |  |         |  |     
|Tecan                   |  | Pooling             |  | 2253                 |  | 328  |  | 4/1/2001   |  |              |  |         |  |         |  | [**]
|CPU                     |  | Pooling             |  | DCM                  |  | 327  |  | 4/1/2001   |  | Already sold |  |         |  |         |  |     
|Moniter                 |  | Pooling             |  | 66746J6CMU18         |  | N/A  |  | 4/1/2001   |  |              |  |         |  |         |  |     
|Keyboard                |  | Pooling             |  | N/A                  |  | N/A  |  | 4/1/2001   |  |              |  |         |  |         |  |     
|                        |  |                     |  |                      |  |      |  |            |  |              |  |         |  |         |  |     
|Tecan (ARC property)    |  | Pooling             |  | 2809                 |  | 610  |  | 12/12/2000 |  |              |  |         |  |         |  | [**]
|CPU (ARC property)      |  | Pooling             |  | DCM                  |  | 616  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Monitor (ARC property)  |  | Pooling             |  | D1028L               |  | 615  |  | 12/12/2000 |  | Already sold |  |         |  |         |  |     
|Keyboard (ARC property) |  | Pooling             |  | SK-1000REW           |  | 617  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Mouse (ARC property)    |  | Pooling             |  | M-S34                |  | NA   |  | 12/12/2000 |  |              |  |         |  |         |  |     
|                        |  |                     |  |                      |  |      |  |            |  |              |  |         |  |         |  |     
|Tecan                   |  | Pooling             |  | 5617                 |  | 611  |  | 12/12/2000 |  |              |  |         |  |         |  | [**]
|CPU                     |  | Pooling             |  | DCM                  |  | 613  |  | 12/12/2000 |  | Already sold |  |         |  |         |  |     
|Monitor                 |  | Pooling             |  | E770p                |  | 612  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Keyboard                |  | Pooling             |  | RT7D5JTW             |  | 614  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|                        |  |                     |  |                      |  |      |  |            |  |              |  |         |  |         |  |     
|Mouse                   |  | Assay               |  | 5586                 |  | NA   |  | 12/12/2000 |  |              |  |         |  |         |  | [**]
|CPU                     |  | Assay               |  | DCM                  |  | 602  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Monitor                 |  | Assay               |  | E770p                |  | 601  |  | 12/12/2000 |  | [**]         |  | [**]    |  | [**]    |  |     
|Keyboard                |  | Assay               |  | RT705JTW             |  | 603  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Mouse                   |  | Assay               |  | 3882A611             |  | NA   |  | 12/12/2000 |  |              |  |         |  |         |  |     
|                        |  |                     |  |                      |  |      |  |            |  |              |  |         |  |         |  |     
|Tecan                   |  | Assay               |  | 5584                 |  | 609  |  | 12/12/2000 |  |              |  |         |  |         |  | [**]
|CPU                     |  | Assay               |  | DCM                  |  | 606  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Monitor                 |  | Assay               |  | E770p                |  | 607  |  | 12/12/2000 |  | [**]         |  | [**]    |  | [**]    |  |     
|Keyboard                |  | Assay               |  | RT705JTW             |  | 608  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Mouse                   |  | Assay               |  | 388A611              |  | NA   |  | 12/12/2000 |  |              |  |         |  |         |  |     
|                        |  |                     |  |                      |  |      |  |            |  |              |  |         |  |         |  |     
|Vortex                  |  | Pre-amp             |  | 945057               |  | 599  |  | 12/12/2000 |  |              |  | [**]    |  |        |  |     
|Vortex                  |  | Pre-amp             |  | 945057               |  | 605  |  | 12/12/2000 |  |              |  | [**]    |  |        |  |     
|Vortex                  |  | Post-amp            |  | 945057               |  | 593  |  | 12/12/2000 |  |              |  | [**]    |  |        |  |     
|Vortex                  |  | Post-amp            |  | 945057               |  | 586  |  | 12/12/2000 |  |              |  | [**]    |  |        |  |     
|                        |  | BACK UP??           |  |                      |  |      |  |            |  | [**]         |  |        |  |        
|TCS                     |  | Rev. B              |  | Rev B                |  | 658  |  | 12/12/2000 |  |              |  | [**]    |  |        |  |     
|Vacuum Pump             |  | N/A                 |  | 2585B                |  | 655  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|TCS                     |  | Rev. B              |  | Rev B                |  | 657  |  | 12/12/2000 |  |              |  |         |  |        |  |     
|Vacuum Pump             |  | N/A                 |  | 2585B-55             |  | 656  |  | 12/12/2000 |  |              |  | [**]    |  |         |  |     
|Waterbath               |  | Room Temp           |  | Circulating Bath 260 |  | 597  |  | 12/12/2000 |  |              |  | [**]    |  |        |  |     
|Waterbath               |  | 41.5 Pre-amp        |  | Circulating Bath 260 |  | 598  |  | 12/12/2000 |  |              |  | [**]    |  |        |  |     
|Waterbath               |  | 60 Pre-amp          |  | Circulating Bath 260 |  | 600  |  | 12/12/2000 |  |              |  | [**]    |  |        |  |     
|Waterbath               |  | 60 Pre-amp          |  | Circulating Bath 260 |  | 596  |  | 12/12/2000 |  |              |  | [**]    |  |        |  |     
|Waterbath               |  | 41.5 Pre-amp        |  | Circulating Bath 260 |  | 595  |  | 12/12/2000 |  |              |  | [**]    |  |        |  |     
|Waterbath 60.0          |  | Post-amp/ 60.0      |  | Circulating Bath 260 |  | 585  |  | 12/12/2000 |  |              |  | [**]    |  |        |  |     
|Waterbath 60.0          |  | Post-amp/60.0       |  | Circulating Bath 260 |  | 592  |  | 12/12/2000 |  |              |  | [**]    |  | #VALUE! |  |     
|                        |  |                     |  |                      |  |      |  |            |  |              |  |         |  |         |  |     
|HC+                     |  | Luminometer         |  | 400288               |  | 581  |  | 12/12/2000 |  |              |  |         |  |         |  | [**]
|CPU                     |  | Luminometer         |  | DCM                  |  | 583  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Monitor                 |  | Luminometer         |  | M570                 |  | 584  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Keyboard                |  | Luminometer         |  | RT705JTW             |  | 582  |  | 12/12/2000 |  | [**]         |  | [**]    |  | [**]    |  |     
|Mouse                   |  | Luminometer         |  | 3882A611             |  | N/A  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Printer                 |  | Luminometer         |  | C6427A               |  | 587  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|                        |  |                     |  |                      |  |      |  |            |  |              |  |         |  |         |  |     
|Leader HC+              |  | Luminometer         |  | 400298               |  | 667  |  | 3/1/2001   |  |              |  |         |  |         |  | [**]
|CPU                     |  | Luminometer         |  | DCM                  |  | 590  |  | 3/1/2001   |  |              |  |         |  |         |  |     
|Monitor                 |  | Luminometer         |  | M570                 |  | 589  |  | 3/1/2001   |  | [**]         |  | [**]    |  | [**]    |  |     
|Keyboard                |  | Luminometer         |  | RT705JTW             |  | 594  |  | 3/1/2001   |  |              |  |         |  |         |  |     
|Mouse                   |  | Luminometer         |  | 3882A611             |  | N/A  |  | 3/1/2001   |  |              |  |         |  |         |  |     
|Printer HP DJ 930C      |  | Luminometer/HP 930C |  | C6427A               |  | 6211 |  | 3/1/2001   |  |              |  |         |  |         |  |     
|                        |  |                     |  |                      |  |      |  |            |  |              |  |         |  |         |  |     
|HC+                     |  | Luminometer         |  | 400405               |  | N/A  |  | 12/12/2000 |  |              |  |         |  |         |  | [**]
|CPU                     |  | Luminometer         |  | DCM                  |  | 660  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Monitor                 |  | Luminometer         |  | M570                 |  | 661  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Keyboard                |  | Luminometer         |  | RT705JTW             |  | 662  |  | 12/12/2000 |  | [**]         |  | [**]    |  | [**]    |  |     
|Mouse                   |  | Luminometer         |  | 3882A611             |  | NA   |  | 12/12/2000 |  |              |  |         |  |         |  |     
|Printer                 |  | Luminometer/HP 930C |  | C6427A               |  | 663  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|UPS                     |  | Luminometer         |  | SM3414               |  | 664  |  | 12/12/2000 |  |              |  |         |  |         |  |     
|                        |  |                     |  |                      |  |      |  |            |  |              |  |         |  |         |  |     
|                        |  |                     |  |                      |  |      |  |            |  | [**]         |  |         |  | [**]    |  | [**]

29f

---

ARC Detroit NTL

|               |  |             |  |            |  |          |  |            |  |              |  | 2/28/2002 |  |      |  |     
|-------------- |  | ----------- |  | ---------- |  | -------- |  | ---------- |  | ------------ |  | --------- |  | ---- |  | ----
|
|Tecan          |  | Pooling     |  | 2810       |  | Customer |  | 3/10/2000  |  |              |  |           |  |      |  | [**]
|Tecan          |  | Pooling     |  | 4535       |  | Customer |  | 3/11/2000  |  |              |  |           |  |      |  | [**]
|               |  |             |  |            |  |          |  |            |  | Already sold |  |           |  |      |  |     
|Tecan          |  | Pooling     |  | 4536       |  | Customer |  | 3/12/2000  |  |              |  |           |  |      |  | [**]
|Tecan          |  | Pooling     |  | 2806       |  | Customer |  | 3/13/2000  |  |              |  |           |  |      |  | [**]
|               |  |             |  |            |  |          |  |            |  |              |  |           |  |      |  |     
|CPU            |  | Pooling     |  | GATX2      |  | Customer |  | 3/10/2000  |  |              |  |           |  |      |  |     
|CPU            |  | Pooling     |  | CK9FA      |  | Customer |  | 3/11/2000  |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  | Already sold |  |           |  |      |  |     
|CPU            |  | Pooling     |  | GTVXY      |  | Customer |  | 3/12/2000  |  |              |  |           |  |      |  |     
|CPU            |  | Pooling     |  | GE2GM      |  | Customer |  | 3/13/2000  |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  |              |  |           |  |      |  |     
|Tecan          |  | Assay       |  | 4394       |  | 5011     |  | 3/6/2000   |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  | [**]         |  | [**]      |  | [**] |  | [**]
|CPU            |  | Assay       |  | IEQ4Y      |  | 5013     |  | 3/6/2000   |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  |              |  |           |  |      |  |     
|Tecan          |  | Assay       |  | 4459       |  | 5021     |  | 3/7/2000   |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  | [**]         |  | [**]      |  | [**] |  | [**]
|CPU            |  | Assay       |  | 256DX      |  | 5017     |  | 3/7/2000   |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  |              |  |           |  |      |  |     
|Tecan          |  | Assay       |  | 4693       |  | 5016     |  | 3/7/2000   |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  | [**]         |  | [**]      |  | [**] |  | [**]
|CPU            |  | Assay       |  | 256DM      |  | 5023     |  | 3/7/2000   |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  |              |  |           |  |      |  |     
|Vortexer       |  |             |  | 1203       |  | 5084     |  | 7/19/2001  |  |              |  | [**]      |  |      |  |     
|Vortexer       |  |             |  | 2307       |  | N/A      |  | 12/12/2001 |  |              |  | [**]      |  |      |  |     
|Vortexer       |  |             |  | 2420       |  | 5097     |  | 8/15/2001  |  |              |  | [**]      |  |      |  |     
|Vortexer       |  |             |  | 2437       |  | 5098     |  | 8/15/2001  |  |              |  | [**]      |  |      |  |     
|Vortexer       |  |             |  | 2444       |  | 5101     |  | 9/10/2001  |  |              |  | [**]      |  |      |  |     
|Vortexer       |  |             |  | 2462       |  | 5096     |  | 8/15/2001  |  |              |  | [**]      |  |      |  |     
|Vortexer       |  |             |  | 2466       |  | 1414     |  | 8/28/2001  |  |              |  | [**]      |  |      |  |     
|Vortexer       |  |             |  | 2468       |  | 1413     |  | 8/28/2001  |  |              |  | [**]      |  |      |  |     
|TCS            |  | Rev. B      |  | 508B       |  | 5066     |  | 3/7/2000   |  |              |  | [**]      |  |      |  |     
|TCS            |  | Rev. B      |  | 506B       |  | 5064     |  | 3/9/2000   |  |              |  | [**]      |  |      |  |     
|TCS            |  | Rev. B      |  | S414       |  | 5080     |  | 3/23/2001  |  |              |  | [**]      |  |      |  |     
|TCS            |  | Rev. B      |  | S419       |  | 5082     |  | 6/20/2001  |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 600081457  |  | 5083     |  | 6/5/2001   |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 600081510  |  | 5078     |  | 2/22/2001  |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 600081515  |  | 5079     |  | 2/22/2001  |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 600121463  |  | 5107     |  | 10/11/2001 |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 601032118  |  | 5104     |  | 9/24/2001  |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 601041891  |  |          |  | 11/15/2001 |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 601041893  |  | 5110     |  | 10/29/2001 |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 601041896  |  | 5105     |  | 10/9/2001  |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 601061296  |  | 5106     |  | 10/11/2001 |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 601061315  |  |          |  | 11/15/2001 |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 601061316  |  | 5108     |  | 10/11/2001 |  |              |  | [**]      |  |      |  |     
|Waterbath      |  |             |  | 601061317  |  | 5109     |  | 10/11/2001 |  |              |  | [**]      |  |      |  |     
|               |  |             |  |            |  |          |  |            |  |              |  |           |  |      |  |     
|HC+            |  | Luminometer |  | 400283     |  | 1390     |  | 1/8/2002   |  |              |  |           |  |      |  | [**]
|Printer (930C) |  |             |  | MY20E160DO |  | 5042     |  | 11/9/2000  |  | [**]         |  | [**]      |  | [**] |  |     
|CPU            |  | Luminometer |  | B1I0T      |  | 5027     |  | 3/10/2000  |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  |              |  |           |  |      |  |     
|HC+            |  | Luminometer |  | 400260     |  | 1388     |  | 9/14/2000  |  |              |  |           |  |      |  | [**]
|Printer (930C) |  |             |  | MY09E172KH |  | 5081     |  | 3/28/2001  |  | [**]         |  | [**]      |  | [**] |  |     
|CPU            |  | Luminometer |  | B1IOR      |  | 5033     |  | 3/10/2000  |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  |              |  |           |  |      |  |     
|HC+            |  | Luminometer |  | 400029     |  | 1389     |  | 6/12/2000  |  |              |  |           |  |      |  | [**]
|Printer (930C) |  |             |  | MY09E172DO |  | 6079     |  | 4/24/2001  |  | [**]         |  | [**]      |  | [**] |  |     
|CPU            |  | Luminometer |  | B1I0J      |  | 5039     |  | 3/11/2000  |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  |              |  |           |  |      |  |     
|HC+            |  | Luminometer |  | 400404     |  | N/A      |  | 8/14/2001  |  |              |  |           |  |      |  | [**]
|Printer (930C) |  |             |  | MY09E173MC |  | 6080     |  | 4/24/2001  |  | [**]         |  | [**]      |  | [**] |  |     
|CPU            |  | Luminometer |  | B1IOP      |  | 5045     |  | 3/11/2000  |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  |              |  |           |  |      |  |     
|               |  |             |  |            |  |          |  |            |  | [**]         |  |           |  | [**] |  | [**]

29g

---

Sale and Servicing Agreement  Blood Screening Systems  Summary for Schedule 1.10

|Laboratory                |       | FMV  |      | Service
|------------------------- | ----- | ---- | ---- | -------
|San Diego8810 Rehco West |       | [**] |      | [**]   
|San Diego8885 Rehco Road |       | [**] |      | [**]   
|Charlotte                 |       | [**] |      | [**]   
|Philadelphia              |       | [**] |      | [**]   
|Scanning Tecans           |       |      |      | [**]   
|St. Louis                 |       | [**] |      | [**]   
|Detroit                   |       | [**] |      | [**]   
|                          | Total |      | [**] |        
|Discount[**]              |       | [**] |      | [**]   
|Total                     |       | [**] |      |        

29h

---



Schedule 1.36        NTLs

30

---

Schedule 2.0        BLOOD SCREENING ASSAYS

[Package
Insert for Nos. 1 & 2 attached as Exhibit A]

31

---



Schedule 4.0

BLOOD SCREENING SYSTEMS AND SOFTWARE
SERVICE & SUPPORT

1.Maintenance & Troubleshooting.



2.Technical Support and Service.



32

---



33

---



|Priority    |                                                                                                          | Response*
|----------- | -------------------------------------------------------------------------------------------------------- | ---------
|Priority 1: | Instrument not operating and alternate or back-up equipment not available; screening cannot be performed |          
|            |                                                                                                          |          
|            |                                                                                                          |          
|Priority 2: | Instrument operational but screening process (processing time) is affected                               |          
|            |                                                                                                          |          
|Priority 3: | Instrument is operational; no impact on screening process                                                |          
|            |                                                                                                          |          

---



34

---



3.Warranty; Limitation of Liability.



35

---





Schedule 5.0        FEES

1.Fees



|POOLED TESTING                                   
|-------------------------------------------------
|Product Requirements Forecast for ARC Fiscal Year
|[**]                                             
|Per Reportable Result                            
|A                                                
|[**]                                             



36

---



Blood Screening Systems

Total Purchase Price[**]

[**]




|Illustration A     
|-------------------
|
|Pooling TECAN(2)   
|Assay TECAN(3)     
|Procleix System(4)



|Blood Screening Systems |  | Annual Fee |  
|----------------------- |  | ---------- | -
|[Per Schedule 1.10]     |  | [**](5     | )

---



37

---



|Illustration B     
|-------------------
|
|Pooling TECAN(6)   
|Assay TECAN(7)     
|Procleix System(8)



|Initial License Fee Per NTL
|---------------------------
|[**]                       

---

|Annual NAT Tracker License Fee(9)                  
|---------------------------------------------------
|(Product Requirements Forecast for ARC Fiscal Year)
|[**]                                               
|[**]                                               

2.Adjustments to Fees.



38

---



---

|Reportable Results for ARC Fiscal Year
|--------------------------------------
|[**]                                  
|[**]                                  



3.[**].

4.Effect of Change in Nature of Screening.If the ARC elects to move from Pooled Testing to Single Unit
Testing, or from Single Unit Testing to Pooled Testing, pursuant to Section 2.9 of the Agreement, (i) the Per Reportable Result Fees set forth on the Assay Pricing Chart shall be
adjusted and (ii) the Target RUF will be recalculated.

5.Additional Supplies.The following additional supplies are available from Chiron at the prices set forth
below. The fees for such additional supplies may be increased[**]by Chiron in the event of, and in the amount of, any price
increases by the manufacturers of such additional supplies.

|External Run Controls (30 sets)  |  | [**]
|-------------------------------- |  | ----
|Ten-Tube Units (TTUs) (1000)     |  | [**]
|Ten-Tube Cassettes (TTCs) (1000) |  | [**]
|Proficiency Panels (9 sets)      |  | [**]

39

---



Schedule 6.11        Disaster Preparedness Plan Criteria

Introduction

To help ensure a continued supply of Products and Services in the event of a Force Majeure Event (also sometimes referred to herein as a "crisis") Chiron assures
immediate response to ARC's situation for Products and Services. Of crucial importance is the ability to develop a communication link between ARC and Chiron.

Communication Link

ARC will communicate with Chiron Technical Support personnel in accordance with Paragraph 2.6 of Schedule 4.0. In the event of a
crisis, ARC shall immediately notify Chiron Technical Support personnel, describing the nature of such crisis.
Chiron Technical Support personnel will immediately notify all appropriate Corporate Customer Service personnel. This step will trigger the Chiron Response System.

If
ARC's phone lines should be inoperative, one of the following alternative methods of communication will be utilized: e.g. cellular phone, law enforcement communication network, U.S.
government/military networks, ham radio, or citizen band (CB) radio.

In
situations where advance warning is available, Chiron encourages ARC and Chiron field sales personnel to call Corporate Customer Service in advance to preplan anticipated needs.

Corporate
Customer Service/Distribution Management staff members will immediately enter into disaster sites as "Crisis Assessment Manager," when appropriate.

Corporate
Customer Service will immediately contact all affected Chiron Division's local and district sales management personnel who will provide on-site disaster assistance.

Depending
on the severity of the situation, Chiron's respective district manager or area director may designate the local representative or other Chiron personnel as a local coordinator.

The
primary responsibility of the local field sales representative is to facilitate communications and/or to personally assist, as situation requires, getting product to Chiron's
customer(s).

Chiron
Technical Support personnel will be available in accordance with Paragraph 2.6 ofSchedule 4.0to respond to
emergency situations. During Normal Support Hours, ARC may bypass Chiron Technical Support personnel to speak directly with Chiron Corporate Customer Service by calling direct to
1-            -            -            .

Corporate
Customer Service will proactively call ARC and each NTL affected by a Force Majeure Event (or in advance, when prior warning is known) to assess the immediate situation, and
the needs and requirements of ARC and each NTL.

ARC
and each NTL affected by a crisis will be assigned by Chiron a specific customer service representative during the duration of the crisis. Chiron's responsibility will include the
initiation of ongoing daily (or more often, as necessary) contacts with ARC and each NTL affected by a crisis.

Delivery of Products and Services

Special handling and premium transportation charges will be absorbed by Chiron on initial and subsequent shipments during a crisis. If a crisis requires a
restricted allocation of the Products, the ARC will receive the same percentage of Products of the total available for shipment that it receives under normal shipping circumstances.

40

---

Corporate
Customer Service will expedite emergency orders to the primary Chiron shipping location or from an alternative shipping point, if necessary. All Chiron distribution centers and
public warehouses will be available 24 hours a day, 7 days a week to make emergency shipments.

The
Chiron transportation staff will arrange for carriers to deliver to ARC all Products and Services. Chiron fleet tractors, trailers and drivers will be utilized as required.

Chiron
will contact local, county and state law enforcement officials, as necessary, to escort delivery vehicles carrying Chiron emergency medical supplies into a crisis (disaster) area.

Corporate
Customer Service will follow up on each segment of Chiron's service arrangements and commitments to the point of delivery to help assure ARC's total customer satisfaction.

Corporate
Customer Service will arrange for and position quantities of Products in a secured area of each NTL as emergency backup inventory, when necessary.

Backup Inventory

Chiron will arrange for additional field backup inventory and will continually monitor and replenish inventories, including all alternative ship locations. To
help bridge the product availability gap in the event Chiron's primary manufacturing facility is damaged or destroyed, Chiron is investigating the creation of finished goods stockpiles in
off-site distribution center(s). Because of the limited shelf life of certain Products, Chiron will investigate the feasibility of maintaining a rotating stock of such Products at these
distribution center(s) to provide an additional safety stock of Products should there be an interruption in Chiron's manufacturing capability or transportation.

Chiron
Customer Service/Logistics Personnel will fly into the disaster site to assist in coordination of ARC's recovery and product delivery plans when appropriate.

Manufacturing Capabilities

To the extent that Chiron's back-up manufacturing facility for Certain Products is located outside of the Territory, and in the event Chiron's
facility in the Territory is damaged or destroyed, Chiron would petition the U.S. FDA to allow shipment of foreign manufactured products into the U.S. and take such other steps in Chiron's reasonable
business judgment to implement a plan to provide such shipment.

Chiron
will continue to investigate the feasibility of maintaining a strategic reserve of Products outside of the location of its primary manufacturing facility.

Additional Safeguards

Chiron's manufacturing and distribution site has and will continue to have full-time safety, emergency and security staff who are collectively
responsible for people and property protection. Chiron's site-wide comprehensive emergency preparedness plan covers chemical spills, fires, major injury events, etc.

The
site(s) has and will continue to be located in a jurisdiction served by a trained, full-time fire department, which provides coverage 24 hours a day, 7 days
a week. In addition, Chiron has an extremely close and somewhat unique relationship with community emergency responder agencies. These agencies are trained at Chiron's facilities and each has an
in-depth knowledge of Chiron's business.

Buildings
will be protected by monitored automatic fire suppression systems. Smoke detection systems are installed in HVAC air handling systems, which are also monitored. Hazardous
materials storage is and will continue to be well maintained in all areas of the operation.

41

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All
non-office areas will be patrolled by trained security force members after normal business hours and on weekends and during holiday periods once every three hours, at a
minimum. High-risk areas, such as Chiron's distribution center, are patrolled on an hourly basis.

Chiron
shall take great pride in its overall safety/fire prevention program. All operations, distribution and laboratory areas are and will continue to be formally inspected from a
safety/fire prevention perspective on a monthly basis. Daily housekeeping and general safety reviews are and will continue to be part of a fully engaged management team's responsibilities. In
addition, Chiron's operations are and will continue to be inspected by external organizations, including but not limited to Chiron's fire insurance company and the local fire department on a regular
basis.

42

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Exhibit A

Procleix
HIV-1/HCV Package Insert
[attached]

43

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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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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.

IN0076 Rev. F

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|LOGO
|----





PROCEDURAL NOTES

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IN0076 Rev. F

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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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IN0076 Rev. F

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IN0076 Rev. F

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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                      



IN0076 Rev. F

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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

IN0076 Rev. F

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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
United Drug House
Belgard Road, Tallaght
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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Exhibit B        "True-Up" Calculation Example

[attached]

44

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Exhibit B

"True-Up" Calculation Example

[**CONFIDENTIAL TREATMENT REQUESTED**]

1

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