HOLOGIC (GENPROBE) SS CONTRACT.PDF

Office of Procurement Services
GOODS AND SERVICES
SOLE SOURCE FORM
This form Is to be used when an agency believes an acquisition is a sole source and the acquisition dollar amount Is above

$5,000. The Chief Procurement Officer can approve purchases up to $100,000. Board of Supervisors approval is required if
the acquisition is over $100,000. This form must be submitted for approval to: Office of Procurement Services | 320 W.

Lincoln | Phoenix, AZ 85003, Fax number: 602.258.1573. The signed form must be retained in the purchasing file.

DEPARTMENT NAME
Public Health Laboratory

DEPARTMENT RX#

Department Contact
Stephanie Kreis

Contact Phone Number
+1 (602) 506-6997

PROPOSED CONTRACT VENDOR

NEED IDENTIFIED Date: August,30 2020

Company: Hologic (GenProbe) REQUESTED DELIVERY
Address: 10210 Genetic Center Drive Date: August 30,2023
City, State: San Diego, CA QUOTED PRICE: 1,500,000
Zip/Postal Code: }92121
Phone: (800) 523-5001 Accounting String:
Fax: (855) 885-5456
Contact Name: [Jennifer Shenfeld
Material / Service Information
Is this a Technology Procurement? QYes @No

Needs Statement:
Describe in detail the material or service to be procured and
how only it meets your needs.

FDA approved test kits for rapid Identification of Mycobacterium species from culture,
The Aptima Combo°2 Assay is a target amplification nucleic acid probe test that
detects Chlamydia trachomatis and Nelsserla gonorrhoeae .While the Aptima HIV-1
Quant Dx assay, (Real-time TMA) technology, detects HIV viral load assay with a dual
claim for both diagnosis and treatment.

Features/Requirements:

Identify the major features/capabilitles that are required, What
unique design/performance feature(s) make this material or
vendor the only one that can meet your requirements? Provide
a brief explanation as to why only these features or this vendor
can meet your requirements. Identify the manufacturer/model
or your existing equipment, service or system if applicable.

Rapid Identification of Mycobacterium tuberculosis complex and other common
Mycobacterium species.The Aptima Combo®2 Assay is a target amplification nucleic
acid probe test that utilizes target capture for the in vitro qualitative detection and
differentiation of ribosomal RNA(TRNA) from Chlamydia trachomatis (CT) and/or
Neisseria gonorrhoeae (GC) Chlamydia trachomatis (CT) and Nelsserla gonorrhoeae
(GC) infections While theAptima HIV-1 Quant Dx assay technology, Is the first HIV viral
load assay with a dual claim for both diagnosis and treatment monitoring.

Competing Brands/Vendors Investigated:

Did you consider other materials or vendors with similar
capabllitles? Indicate specific competitor's brands/models or
vendors that were Investigated and describe why they do not
meet your requirements, You need to state that - to the best of
your knowledge - these are the only companies making this
material, equipment or providing this service. List sales
representatives and their phone numbers so the Procurement
Officer can contact them to verify that other materials,
equipment or services do not meet your requirements.

1.To my knowledge Hologic Is the only company that offers an FDA approved rapid
culture based Identification system for Mycobacterium tuberculosis complex and other
common Mycobacterium species.

2.The Aptima Combo 2 Assay combines the technologies of target capture, TMA, and
DKA. First generation NAATs for CT and GC have technological issues that have limited
their performance. These issues include cumbersome specimen processing and
specimen inhibition that can yield false negative results While the Aptima HIV-1 Quant
Dx assay Is an in vitro nucleic acid amplification test for the detection and quantitation
of human immunodeficiency virus type 1 (HIV-1) RNA groups M, N, and O on the fully
automated Panther™ system, It is intended for use as an ald In the diagnosis of HIV-1
Infection, as a confirmation of HIV-1 Infection, and as an ald In clinical management.

THIS PROCURMENT JS A SOLE SOURCE BECAUSE (attach additional page if needed):

1.These test kits are used for rapid identification of Mycobacterium species from culture, Currently, GenProbe/Hologic is the only company that offers a
FDA approved nucleic acid based culture identification system capable of identifying Mycobacterium tuberculosis complex, M. kansasil, M. gordanae, M.
avium complex, M. avium and M. intracellulare. This laboratory has been using these probes for several years now and already has the equipment and
instrumentation need for testing.

2. This assay , Aptima Combo 2 Assay is designed to detect the presence of CT and GC in the following specimens: endocervical and male urethral swab
specimens, vaginal swab specimens, PreservCyt Solution liquid Pap specimens, and in female and male urine specimens, This laboratory has been using
these assay for several years now and already has the equipment and instrumentation need for testing.

3.The Aptima HIV-1 Quant Dx assay is designed to be used as an aid in the diagnosis of HIV-1 infection, including acute or primary infection. Presence of
HIV-1 RNA in the plasma or serum of patients without antibodies to HIV-1 is indicative of acute or primary HIV-1 infection.The Aptima HIV-1 Quant Dx
assay Is also used as a supplemental test for specimens that have repeat reactive results with approved HIV immunoassays, If the specimen is reactive in
the Aptima HIV-1 Quant Dx assay, HIV-1 infection is confirmed,

SEARCH

MC1-349-A states: Any request by a Using Agency that a Procurement be restricted to one potential Contractor shall be accompanied by
jan explanation as to why no other would be suitable or acceptable to meet the need. The Using Agency requesting sole source
Procurement shall provide written evidence to support a sole source determination. A requirement for a particular proprietary item does
not alone justify a sole source Procurement if there is more than one potential Respondent for that item.

Asearch was conducted consisting of: (check all that apply) RESULTS

Market research [7] Public notice given, list no alternatives were identified

[J Other vendors contacted [J Other or alternatives were deemed acceptable
because (explain below):

Describe the search from above in detail:

Search on the FDA website on nucleic acid based tests for identification of Mycobacterium tuberculosis complex, M. gordonae, M, avium complex, M.
avium, M, intracellulare, M. kansasii Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC)

https://www.fda.gov/medical-devices/vitro-diagnostics/nucleic-acid-based-tests

PRICE ¥ \- .)

The estimated cost of this Procurement is: —erssteek— 17 Y> $100k eekivesS

MC1-347 States: The Chief Procurement Officer may make the determination that the sole source method set forth in Bo S
MC1-349 shall be used if a Commodity or Service Is available from only one vendor, and the purchase is estimated to Cost G ? youa\,
ho more than $100,000, Pe

Price has been fairly and reasonably established by: [J Comparison to public sector contract pricing
oO Comparison to previous comparable purchases Discount off published catalog pricing
from a different vendor [] Market survey

[J Independent estimate (1 Other, explain:

Describe methodology and results (attach any written supporting data, e.g., survey or market analysis):

See quote/agreement from Hologic

CONFLICT OF INTEREST STATEMENT

The submitting department agrees that there is no real or potential conflict of interest in recommending this material or
service as a sole source procurement.

NOTE: If a real or potential conflict exists, contact the Procurement Officer listed on your Requisition,

CERTIFICATIONS

I certify:

1) | recognize that the Maricopa County Procurement Code requires the use of competitive solicitations unless
exempted by law. | have reviewed the information and materials relevant to this procurement of goods and services,
and am requesting approval of an exception to the competitive process for the reasons described;

2) the price to be paid to the proposed sole source vendor is fair, reasonable, and provides the best value to Maricopa
County; and ,

3) this request for an exception to the competitive solicitation process is not the result of inadequate advance planning
or for purposes of securing the services of a preferred vendor.

Agency Head or Appointing Authority Signature (Required)

Max Porter Max Porter petiaipetnnmrne,, FD. |. 202.0
Printed Name Signature Date

Office of Procurement Services
IX] Approved. Please send a Requisition to OPS to process.
[1 Not Approved. Reasoning:

y, 4 Diten-Kevin Tyne, o-Marcopa County,

(fiz - ou=Office of Procurement Services,
Kevin Tyne, Director OPS ine 20n0Dn ear Or July 1, 2020
Printed Name Signature Date

HOLOGIC’

MT te seers Quote

June 29, 2020

MARICOPA COUNTY PUBLIC HEALTH LAB

Attn: Irma Guzman

Procurement Officer

1645 E ROOSEVELT

phoenix, AZ 85006 USA

Account #: 158889

Dear Irma Guzman,

Thank you for your interest in Hologic's line of products. We are pleased to quote the following pricing and annual commitment.
APTIMA Products

Term: 36 Months

Annual Test

Product Test Price
Volume
APTIMA Combo2 CT/GC 42,000 $ 7.25
Collection Devices 42,000 see kits below
HIV Quant CPR $ 45.00
The committed volume above may be comprised of any of the following kit types or sizes:
Product Number Product Description Kit Size Price/Kit
c/s 303094 Kit, AC2 250 TEST (PANTHER) 250 $ 1,812.50
ct/6c 302923 Kit, AC2 100 TEST (PANTHER) 100 $ 725.00
Collection Device 301040 Kit, APTIMA COMBO 2 Urine Spec Coll 50 $ 62.50
Collection Device 301041 Kit, APTIMA COMBO 2 Swab Spec Coll 50 $s 62.50
Collection Device PRD-03546 Aptima Multitest Swab Collection 50 $ 62.50
Additional tests that will be available to you include:
Product Number Product Description Kit Size Price/Reportable
PRD-03565-CPR APTIMA HIV Quant Assay, Cost Per Reportable 100 $45.00
Non-Committed items available to you at the prices listed below include the following:
Product Number Product Description Kit Size Price
102800 ACCUPROBE Culture Identification Reagent Kit 20 $ 75.00
102845 ACCUPROBE MYCOBACTERIUM AVIUM Complex Culture Identification Test 20 $ 235.00
102850 ACCUPROBE MYCOBACTERIUM GORDONAE Culture Identification Test 20 $ 235.00
102855 ACCUPROBE MYCOBACTERIUM KANSASII Culture Identification Test 20 $ 235.00
102860 ACCUPROBE MYCOBACTERIUM TUBERCULOSIS Complex Culture Identification Test 20 $ 235.00
201791 Detection Reagent Kit $ 26.00
301154C Kit, APTIMA LPT-IVD Sales BOM 100 $ 120.00
105575 APTIMA Urine Collection Tubes 100 $ 120.00
303096 Run Kit, PANTHER 5000 No Charge
CLO040 Caps, TCR/SEL.(CLO038) DIAG. No Charge
CLOO41 Caps, AMP/P.R.S.(CLO045)DIAG. No Charge
105668 Kit, Penetrable Caps $ 100.00
303085 Lbld, Advanced Cleaning Solution, 255 mL No Charge
501604 Spare Caps, PP, 60mL, TCR APTIMA 2x50 No Charge
501616 Spare Caps,30mL tube (501213)Diagnostics No Charge
301110 APTIMA CT/GC Cntrls Kit (1 tray) IVD. No Charge
PRD-03566 HIV VIRAL LOAD ASSAY CALIBRATOR, APTIMA, US IVD No Charge
PRD-03567 HIV VIRAL LOAD ASSAY CONTROLS, APTIMA, US IVD No Charge
503762 Specimen Aliquot Tubes (SAT) 100 No Charge
504415 Transport Tube Cap 100 No Charge
PRD-03503 Aptima Specimen diluent $s 260.00
PRD-03654 Aptima Specimen Diluent Kit $ 300.00
PRD-03455 Panther Run Kit for Real Time Assays 5000 No Charge

The following instrumentation is provided:

Product Number Instrumentation Units Unit Price
303095 PANTHER 1 $0
103100 Inst, Leader 50 EE $0

Total Instrumentation Price 2 $0

One (1) Panther Instrument System (SN 2090001269) is already on site.

This document is provided for quoting purposes only. To take advantage of this pricing, Customer and Hologic must enter into a signed agreement. Payment terms: 30

days. Shipping charges to be paid by Customer. This offer is valid for 90 days from the date hereof.

If you should need further assistance, do not hesitate to call me personally at (480) 243-0920.

Sincerely,

STEPHEN VEIT

Hologic Account Executive

HOLOGIC’
INNA 3

June 2, 2020
To Whom It May Concern:

This letter is to verify that Hologic, Inc. (“Hologic”) is the sole source of the instrument system, assay
kits, and associated kits and reagents listed below.

Instrument System
Cat. #303095 Panther® System

Assay Kits for Use on the Instrument System

Cat. #303094 Aptima Combo 2° Assay Kit — Panther System (250 test kit) and Cat. #302923
Aptima Combo 2 Assay Kit — Panther System (100 test kit) for the detection of Chlamydia
trachomatis and Neisseria gonorrhoeae

Cat. #303585 Aptima HPV Assay Kit — Panther System (250 test kit) and Cat. #303570 Aptima
HPV Assay Kit — Panther System (100 test kit) for the detection of human papillomavirus (HPV)

Cat. #303537 Aptima Trichomonas vaginalis Assay Kit — Panther System (250 test kit) and Cat.
#303536 Aptima Trichomonas vaginalis Assay Kit — Panther System (100 test kit) for the detection
of T. vaginalis

Cat. #PRD-04037-D Aptima Zika Virus Assay, Kit — Panther System (1000 test kit)*

Cat. #PRD-03565 Aptima HIV-1 Quant Assay, Kit — Panther System (100 test kit)

Cat. #PRD-03705 Aptima HCV Quant Assay, Kit —- Panther System (100 test kit)

Cat. #PRD-03568 Aptima HSV 1 & 2 Assay, Kit — Panther System (100 test kit)

Cat. #PRD-03868 Aptima HBV Quant Assay, Kit — Panther System (100 test kit)

Cat. #PRD-03919 Aptima Mycoplasma genitalium Assay, Kit, Panther System (100 test kit)
Cat. #PRD-05186 Aptima BV Assay, Kit — Panther System (100 test kit)

Cat. #PRD-05189 Aptima CV/TV Assay Kit — Panther System (100 test kit)

Cat. #PRD-06419 Aptima SARS-CoV-2 Assay Kit—Panther System (250 test kit)**

The Aptima assays have been validated for use with the Panther system. The firmware in the
Panther system is necessary for running the Aptima assays and is unique to Hologic. Hologic is the
sole source of this firmware.

10210 Genetic Center Drive, San Diego, CA 92121

HOLOGIC’
11 ED

Kits and Reagents Associated with the Assay Kits

The following kits and reagents were developed and qualified to be used with the Aptima assays
and may include proprietary technology. Hologic is the sole source of these kits and reagents.

Cat. #301040 Aptima Urine Specimen Collection Kit for Male and Female Urine Specimens
Cat. #301041 Aptima Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens
Cat. #PRD-03546 Aptima Multi-test Swab Specimen Collection Kit

Cat. #301154C Aptima Specimen Transfer Kit

Cat. #301048 Aptima Auto Detection Reagent Kit

Cat. #301110 Aptima Controls Kit

Cat. #303001 Aptima Assay Fluids Kit

Cat. #303000 Aptima Auto Detect Kit

Cat. #303096 Panther System Run Kit

Cat. #303085 Advanced Cleaning Solution

Cat. #303099 Panther System Start-Up kit

Cat. #PRD-03455 Panther Run Kit for Real Time Assays (for real time assays only)

Cat. #PRD-06420 Aptima SARS-CoV-2 Assay Controls

Cat. #PRD-03836 Universal Panel A

Cat. #PRD-06506 Aptima SARS-CoV-2 Assay Panel C

Hologic does not sell through dealers or distributors in the U.S. All sales are made directly to end users.

U.S. patents covering the Panther system and associated assay kits, reagents, and consumables can be
found at https://www.hologic.com/IP.

If you have any questions or require additional information, please call Hologic Customer
Service at 1.800.442.9892.

Sincerely, F f
Jax =
Keith Gantner
Senior Vice President, Commercial, Diagnostics Solutions

*The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the
use of the Aptima Zika Virus Assay on the Panther System for the in vitro qualitative detection of RNA from Zika virus
in human serum and plasma specimens. This EVA will terminate when the Secretary of Health and Human Services’
declaration terminates unless the FDA revokes the EUA sooner. The Customer acknowledges and agrees that the Aptima
Zika Virus Assay is only available for sale and use while the EUA is in effect. Hologic reserves the right to discontinue the
Aptima Zika Virus Assay product at any time.

** The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use
of the Aptima SARS CoV-2 assay on the Panther System by authorized laboratories for the detection of nucleic acid from
SARS-CoV-2 virus only and not for any other viruses or pathogens. The Aptima SARS CoV-2 assay is only authorized for the
duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic
tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner. The Aptima SARS CoV-2 assay has not been FDA cleared or approved.
The Customer acknowledges and agrees that the Aptima SARS CoV-2 assay is only available for sale and use while the
EUA is in effect. Hologic reserves the right to discontinue the Aptima SARS CoV-2 assay product at any time.

Gen-Probe Sales & Service, Inc. is a subsidiary of Hologic, Inc.

10210 Genetic Center Drive, San Diego, CA 92121