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Leica Biosystems 1700 Leider Lane, Buffalo Grove, IL 60089 USA 1 800 248-0123

May 23, 2017

Statement of Sole Supplier

Leica Biosystems designs, manufactures and markets automated image analysis systems for use in genetic characterization and protein expression evaluation in a wide range of clinical and research uses. The GSL-120 and the CytoVision system has been specifically designed and optimized to meet the needs of human cytogenetics and FISH-based research applications.

The CytoVision software used in conjunction with our systems and including the GSL-120 was developed by our company's employees "in-house" and, accordingly, is owned 100% by our firm. This includes all improvements and newer versions that we publish from time to time. The software is copyrighted and, accordingly, it cannot be copied without our permission, in whole or in part. Our firm licenses the software ONLY to customers who acquire our CytoVision systems and the use of the software is limited to those CytoVision systems that we sell to the customers.

In addition to copyright rights, the firm also owns several patents on specific functions within the software. Accordingly, no other firm can replicate exactly how our software works in key areas, without risking infringement of these patents.

Leica Biosystems is the OEM and the sole source vendor for the GSL-120 and CytoVision Workstation and Software throughout the United States and Canada. No other vendors are authorized to distribute parts, upgrades, software updates, service, or maintenance for the CytoVision system.

Chris Cruze

Stamp

CytoSystems

2193 West Armand St., Lake Charles, LA 70611 USA

337-540-6162

September 1, 2021

Statement of Sole Supplier

Leica Biosystems designs, manufactures and markets automated image analysis systems for use in genetic characterization and protein expression evaluation in a wide range of clinical and research uses. The GSL-120 and the CytoVision system has been specifically designed and optimized to meet the needs of human cytogenetics and FISH-based research applications.

The CytoVision software used in conjunction with our systems and including the

GSL-120 was developed by our company's employees "in-house" and, accordingly, is owned 100% by our firm. This includes all improvements and newer versions that we publish from time to time. The software is copyrighted and, accordingly, it cannot be copied without our permission, in whole or in part. Our firm licenses the software ONLY to customers who acquire our CytoVision systems and the use of the software is limited to those CytoVision systems that we sell to the customers.

In addition to copyright rights, the firm also owns several patents on specific functions within the software. Accordingly, no other firm can replicate exactly how our software works in key areas, without risking infringement of these patents.

Leica Biosystems is the OEM and the sole source vendor for the GSL-120 and

CytoVision Workstation and Software throughout the United States and Canada.

No other vendors are authorized to distribute parts, upgrades, software updates, service, or maintenance for the CytoVision system.

Chris Cruze

CytoSystems – Owner

Leica-Certified CytoVision Sales Channel

Combined Synopsis/Solicitation

DEPARTMENT OF THE AIR FORCE

81st CONTRACTING SQUADRON (AETC)

Page 1 of 5Page 1 of 5

Requirement Title: Leica Biosystems CytoVision 7.7

Solicitation Number: FA301021QC017

Solicitation Issue Date: Wednesday, 8 September 2021

Response Deadline: Monday, 13 September 2021 no later than 9:00 AM CT

Point(s) of Contact: Raquele B. Darden, Contracting Specialist

Phone: 228-377-1818 | Email: raquele.darden@us.af.mil

General Information

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

2. This solicitation is being issued as a(n) Request For Quotation (RFQ).

3. This solicitation document and incorporated provisions and clauses are those in effect through:

Federal Acquisition Circular 06/10/2021 Defense Federal Acquisition Regulation Public Notice 07/09/2021 Air Force Federal Acquisition Circular 05/21/2021

4. This requirement is being set-aside for: N/A

The North American Industry Size Classification System (NAICS) code associated with this requirement is 334516.

Requirement Information

Description:

The 81st Medical Diagnostic & Therapeutic Squadron requests procurement of Leica BioSystems CytoVision 7.7 Equipment. The Leica BioSystems brand provides the necessary equipment, accessories, and functions needed to complete cytogenetic testing and is required to support our current methodologies (automated karyotyping and FISH testing). This equipment also provides digital, high resolution karyotyping images. Other methodologies (manual karyotyping) require more time to complete, are not authorized under College of American Pathology accreditation, and do not meet high-volume throughput. Keesler Cytogenetic Lab currently operates with the Leica BioSystems Cytovision 7.1 platform which was purchased and installed on 5 December 2011; and this platform operates on Windows 7, which has been phased out by the Keesler Medical Information Systems Team. The new system and subsequent updated versions follow all current College of American Pathology standards and requirements.

Place of Delivery/Performance/Acceptance/FOB Point:

Keesler Medical Center, Delivery On Or Before 30 September 2021, FOB Destination

Line Item Description Quantity Unit Unit Price Extended Price

0001 CYTOVISION WORKSTATION 3 EA

0002 KARYOTYPING SOFTWARE UPGRADE 3 EA

0003 KAROTYPING AND FISH UPGRADE 2 EA

0004 110VAC CONFIGURATION 4 EA

0005 CYTOVISION V7.7 CONFIGURATION 4 EA

0006 FISH WORKSTATION 1 EA

0007 ZEIS AXIO 91029 DAPI 1 EA

0008 ZEIS AXIO 91029 ORANGE 1 EA

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0009 ZEIS AXIO 91029 GREEN 1 EA

0010 ZEIS AXIO 91029 AQUA 1 EA

0011 ZEIS AXIO 91029 GREEN ORANGE 1 EA

0012 ZEIS AXIO 91029 DAPI ORANGE GREEN 1 EA

0013 CYTOVISION WORKGROUP SERVER 1 EA

0014 CYTOVISION CASEBASE 1 EA

0015 WORKGROUP DATA STORAGE 1 EA

0016 REMOVABLE ARCHIVE 1 EA

0017 INSTALLATION AND TRAINING 2 EA

0018 SHIPPING AND FREIGHT 1 EA

Instructions to Offerors

FAR provision 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition. As prescribed in FAR 12.301(b)(1), the following addendum is provided for this solicitation and hereby amends any language therein:

- Quoted amounts need to be net prices without tax

- The Government reserves the right to award on an "All or None" basis

- Provide Quote Expiration Date, Best Delivery Date, and any Discount Terms

- Quotes, attachments, and all other correspondence as listed in this solicitation must be emailed to both points of contact (POCs)

- All questions are to be submitted in writing by 13 September 2021 @ 12:00 PM CT

- Quotes are required to be valid until 15 October 2021

Evaluation Criteria

FAR Provision 52.212-2, Evaluation -- Commercial Items, applies to this acquisition. As prescribed in FAR 12.301(c), the following addendum is provided for this solicitation and hereby amends any language therein:

Price & Technical Acceptability

Clauses and Provisions

FAR provision 52.212-3, Offeror Representations and Certifications -- Commercial Items with alternate I applies to this acquisition;

the offeror verifies by submission of their offer that the representation and certifications posted at FAR 52.212-3 have been entered or updated electronically via the System for Award Management (SAM) Web site located at http://www.sam.gov/portal in the last 12 months, and are current, accurate, complete, and applicable to this solicitation. Alternatively, if the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) of this provision and include a completed copy with its offer.

FAR clause 52.212-4, Contract Terms and Conditions -- Commercial Items applies to this acquisition.

FAR clause 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders -- Commercial Items applies to this acquisition; the following checked clauses are hereby included by reference:

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52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards ✖

52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment ✖

52.222-19, Child Labor--Cooperation with Authorities and Remedies✖

52.222-21, Prohibition of Segregated Facilities ✖

52.222-26, Equal Opportunity ✖

52.222-36, Equal Opportunity for Workers with Disabilities ✖ 52.222-50, Combating Trafficking Persons✖

52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving ✖

52.225-13, Restrictions on Certain Foreign Purchases✖

52.232-33, Payment by Electronic Funds Transfer--System for Award Management✖

The provisions and clauses listed below have been determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices. The following provisions and clauses are hereby included by reference:

No additional clauses or provisions will be added to this requirement (by reference) for the purposes of this solicitation. However, additional applicable and/or required clauses may be added to the purchase order as required by the Federal Acquisition Regulation, Defense Federal Acquisition Regulation Supplement, and the Air Force Federal Acquisition Regulation Supplement.

The following provisions and clauses are hereby included by full text:

252.232-7006 Wife Area WorkFlow Instructions

As prescribed in 232.7004(b), use the following clause:

WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)

(a) Definitions. As used in this clause-

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization.

Document type means the type of payment request or receiving report available for creation in Wide Area WorkFlow

(WAWF).

Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system.

Payment request and receiving report are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall-

(1) Have a designated electronic business point of contact in the System for Award Management at https:// www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the Web Based Training link on the WAWF home page at https://wawf.eb.mil/

(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items-

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

Invoice Stand-Alone

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2-in-1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

N/A

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial item financing, submit a commercial item financing request.

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

(f) [Note: The Contractor may use a WAWF combo document type to create some combinations of invoice and receiving report in one step.]

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

Field Name in WAWF || Data to be entered in WAWF

Pay Official DoDAAC || F67100

Issue By DoDAAC || FA3010

Admin DoDAAC || FA3010

Inspect By DoDAAC || FM3010

Ship To Code || FM3010

Ship From Code ||

Mark For Code ||

Service Approver (DoDAAC) ||

Service Acceptor (DoDAAC) ||

Accept at Other DoDAAC ||

LPO DoDAAC ||

DCAA Auditor DoDAAC ||

Other DoDAAC(s) ||

(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

raquele.darden@us.af.mil john_andre.mabida@us.af.mil

(2) Contact the WAWF HelpDesk at 866-618-5988, if assistance is needed.

(End of clause)

Attachments

Attachment 1 - Single Source Justification Attachment 2 - Sole Manufacturer Letter (Leica BioSystems) Attachment 3 - Sole Source Letter (CytoSystems)

Funds Available

Funds Not Currently Available

Single Source Justification (Simplified Acquisition)

Controlled Unclassified Information (CUI) Controlled Unclassified Information (CUI)

April 2021 Controlled Unclassified Information (CUI) Page 1 of 2April 2021 Controlled Unclassified Information (CUI) Page 1 of 2

Section A: General Contract Information

Is this a Bridge Action as defined in the AF Bridge Action Reduction Plan? Yes No

Contracting Activity: 81 CONS/PKB

Project/Program Name: Leica BioSystems CytoVision 7.7

Purchase Request / Local ID Number: FM301002720802, FM301002720812, FM301002720826, FM301002720833, FM301002720861, FM301002720864, FM301002720866, FM301002720868, FM301002720870, FM301002720872, FM301002720874, FM301002720876, FM301002720897, FM301002720901, FM301002720903, FM301002720906, FM301002720908, FM301002720910

Estimated Contract Cost (including Options): $108,291.22

Section B: Description of the Supplies/Services Required

81 MDTS requests procurement of Leica BioSystems CytoVision 7.7 Equipment. The Leica BioSystems brand provides the necessary equipment, accessories, and functions needed to complete cytogenetic testing and is required to support our current methodologies (automated karyotyping and FISH testing). This equipment also provides digital, high resolution karyotyping images. Other methodologies (manual karyotyping) require more time to complete, are not authorized under College of American Pathology accreditation, and do not meet high-volume throughput. Keesler Cytogenetic Lab currently operates with the Leica BioSystems Cytovision 7.1 platform which was purchased and installed on 5 December 2011; and this platform operates on Windows 7, which has been phased out by the Keesler Medical Information Systems Team. The new system and subsequent updated versions follow all current College of American Pathology standards and requirements.

- Must provide capability to automate karyotyping and FISH (Fluorescence Insitu Hybridization) testing

- Must provide high-resolution karyotyping images

- Must be able to capture different probe signals as well as analyze FISH MC2 hybridization data

- Platform must be compatible with hardware installed in cytogenetics lab (computers, microscopes, cameras, etc.)

- Must be capable of accessing previous archived data electronically

Section C: Justification for Soliciting from a Single Source or Brand Name

Leica BioSystems is the only vendor that can provide the necessary equipment, accessories, and functions needed to complete cytogenetic testing (see Single Source Justification). Leica BioSystems CytoVision 7.7 platform is compatible with the current methodologies (automated karyotyping and FISH testing).

Leica BioSystems is the sole manufacturer of the CytoVision 7.7. CytoSystems is the sole distributor for Leica BioSystems.

Section D: Efforts to Obtain Competition

In order to find vendors that could provide an alternative product, market research via internet search, AbilityOne, and GSA was conducted. There were no vendors found in these databases. A Sources Sought was posted on Beta SAM and received zero responses. Leica BioSystems was contacted and asked if there were any authorized distributors/resellers; in response, they submitted a sole source letter.

Section E: Steps to Preclude Future Single Source or Brand Name Awards

81 MDTS/SGQX will continue to monitor the market for any other viable products/sources that may become available for future procurements of cytogenetic testing equipment.

Single Source Justification (Simplified Acquisition)

Controlled Unclassified Information (CUI) Controlled Unclassified Information (CUI)

April 2021 Controlled Unclassified Information (CUI) Page 2 of 2April 2021 Controlled Unclassified Information (CUI) Page 2 of 2

Section F: Contracting Officer's Determination

I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available.

Date

09/07/2021

Typed Name and Rank/Grade of Contracting Officer JOHN ANDRE N. MABIDA, SSgt, USAF Contracting Officer, 81st Contracting Squadron

Signature of Contracting Officer Digitally signed by MABIDA.JOHN

ANDRE.NACAR.1539257370

Date: 2021.09.07 13:58:00 -05'00'