JA-18-115_Brand_Name_Illumina_6.8.2018.pdf

Control No: JA-18-115

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP)

1. Contracting Activity: The Contracting Activity responsible for this action is the United States Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014.

2. Requiring Activity: The requiring activity is the Armed Forces Medical Examiner System (AFMES).

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price:

**Time & Materials:

* Cost:

Funds: RDT&E Operations and Maintenance, Army (OMA) Other Funds:

Fiscal Year of Funds: To Be Determined, will be provided on Call Order

Estimated Total Dollar Value including Options: $5.5M Ceiling

4. Contractor Name:

Contractor(s): Illumina, Inc.

Address: 5200 Illumina Way City, State, Zip: San Diego, CA 92122 Phone: 1-833-837-6436

DUNS: 033305264

Cage Code: 1WCS2

5. Description of Supplies/Services: This requirement is for a new Blanket Purchase Agreement (BPA) for over sixty line item kits, reagents, and consumable supplies and materials related to Illumina’s NextSeq and MiSeq equipment systems. The minimum essential characteristics are as follows:

ForenSeq DNA Signature Prep Kit (384 rxns) Illumina# TG-450-1001

MiSeq FGx Reagent Kit (600 cycles) Illumina # TG-143-1001

MiSeq Reagent Kit v3 (150 cycles) Illumina # MS-102-3001

MiSeq Reagent Kit v3 (600 cycles) Illumina # MS-102-3003

Nextera XT DNA Sample Preparation Kit, 96 samples Illumina # FC-131-1096

Nextera XT Index Kit (96 indices, 384 samples) Illumina # FC-131-1002

PhiX Control v3 Illumina

# FC-110-3001

MiSeq Reagent Kit v2 - 300 cycle Illumina # MS-102-2002

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b) (1) (i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization);

OR

(b) FAR 13.106-1(b) (1) (ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a) (1) (i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a) (1) (ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: FAR 13.500(a) authorizes the use of simplified procedures under 41 U.S.C. 1901 for the acquisition of commercial supplies and services in amounts greater than the simplified acquisition threshold but not exceeding $7 million. Illumina is the manufacturer of customized consumable kits and reagents that complement and are compatible with their equipment. The only authorized licensed distributor of Illumina reagents and supply kits is Verogen, Inc. These supplies and equipment may only be obtained direct from the manufacturer and or Verogen, Inc.

Ilumina is the only source that can meet the Government’s requirement for reagents and supply kits for the NextSeq and MiSeq Systems. By prior acquisition, AFMES acquired Illumina MiSeq equipment. Collectively, the instrumentation consists of sequencing analyzers to include proprietary software to support Armed Forces DNA Identification Laboratory’s (AFDIL) ancient remains DNA identification mission and future expansion to other Illumina platforms (NextSeq). AFMES has an ongoing need to acquire additional equipment to facilitate increased output and to ensure backup instrumentation in the event of primary analyzer equipment failure. The Illumina proprietary consumable kits and reagents are compatible only with Illumina proprietary systems.

For scientific and programmatic consistency, AFMES must complete ongoing multiple year research projects under OTSG/MEDCOM Policy 15-042 using the NextSeq and MiSeq Systems with their respective proprietary reagents and consumables. In order to maintain data integrity, future supplies must conform to the standardization requirements of previously validated data that is part of existing research protocols. The established standardized baseline of these reagents is integral to maintaining the International Organization for Standardization (ISO) Accreditation. In-process projects have used these reagents to maintain a validated data set, therefore, to maintain scientific continuity it is imperative that the end-user continue to use Illumina proprietary brand name reagents, supply kits, and consumables.

Moreover, AFMES has expended considerable time and funds to establish its existing bioinformatics data stream based on the data generated by the existing MiSeq platform. Data output from other commercially available sequencing analyzers that are not compatible would require additional labor to redevelop, incorporate, and standardize new protocols. The time required to undertake such an effort would adversely affect AFMES’s ability to report data in real-time to healthcare providers and endanger its ability to fulfill the mission and funding stakeholders. Products must be compatible for use with the Illumina NextSeq and MiSeq DNA Sequencing systems, otherwise, epidemiological and public health performance standards mandated under OTSG/MEDCOM Policy 15-042 cannot be fulfilled.

8. Efforts to obtain Competition: The required reagent consumables and supply kits are unique to Illumina, Inc. Illumina retains intellectual rights on their NextSeq and MiSeq DNA Sequencing equipment, along with the corresponding reagents and consumables that are uniquely compatible to their manufactured equipment. There have been changes in the market and other licensed authorized distributors of Illumina supplies and equipment have become available. Therefore, it is the intent of the Government to issue a Request for Quotes to the Federal Business Opportunities website on a Brand Name Only basis, which will allow competition of manufacturer and authorized distributors. AFMES will also continue to reevaluate mission requirements and products that meet those needs in future actions.

a. Effective competition. A mission requirement for AFMES to maintain and ensure the consistency and scientific merit of research results by eliminating potential variables that may occur by modification of the source of supply kits and consumables. As a result, AFMES requires same source consistency and cannot substitute another source of supply. The Government seeks to contract on a brand name only basis and competition will be available between the manufacturer and authorized distributors.

b. Subcontracting competition. The reagents and consumables being procured are proprietary and therefore are no anticipated subcontracting opportunities for this requirement.

9. Actions to remove or overcome barriers Competition: The Government will continue to survey the market place to determine if there are any other sources capable of providing the specified customized reagents and consumables required for future research. However, for the current projects at AFMES, variability in supplies for existing equipment is not possible for the reasons cited under paragraph 7 above. Using any other brand or substitute for consumables would compromise the validity and integrity of future tests. Validation of new products requires significant man-hours and efforts by the scientists. Validation and research may last 9 to 12 months during which time the normal daily operation of forensic identification will be adversely impacted. Therefore, it is unlikely that there will be any meaningful actions to increase competition.

10. Market Survey: Market research was performed using the internet, supplier demonstrations, brochures, supply order records, email and phone communications, as well as requests for information from peer groups. Although there are multiple suppliers of reagents, the reagents compatible with the NextSeq and MiSeq DNA Sequencing systems are only available from Illumina and Verogen (an authorized distributor) can provide. This is consistent with information provided by the Illumina sales team which indicated that they do not license their technology and only permit resale through Verogen, Inc.

Additionally a Request for Information (RFI) was posted on the Federal Business Opportunities website on 1 July 2017 requesting information from alternative commercial suppliers with the capability of providing equal product along with sufficient technical data to document equivalency to Illumina brand name products.

No responses were received.

11. Interested Sources: A RFI for Brand Name Only Illumina products was posted for 30 days on the Federal Business Opportunities website to afford the public an opportunity to respond with a Capability Statement. No sources other than Illumina responded in writing to express an interest in this requirement. Since that time, Illumina’s authorized distributor has provided its authorized distributor letter dated

13 March 2018 to the Contract Specialist.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number:

W81XWH-12-D-0051 dated 17 September 2012 issued to Illumina W81XWH-18-A-0001 dated 1 November 2017 issued to Illumina

Previously competed?

No. The previous BPA awarded in 17 September 2012 and 01 November 2017 were awarded as a sole source, as Illumina was the only distributor of the corresponding reagents and consumables that are uniquely compatible to their manufactured equipment. However, Illumina has recently entered an agreement with an authorized distributor, which will allow the brand name only reagents and consumables to be competed amongst the manufacturer and distributors.

Previous authority for less than Full & Open Competition: FAR 13.501(a) (1) (i)

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

Submitted by Signature:

Digitally signed by

LALANI.SHAIROS LALANI.SHAIROSE.A.106034

E.A.1060346573 Date: 2018.04.23 09:18:15 -04'00'

Printed name: Shairose A. Lalani Agency/Position/Title: DNA Program Specialist; DHA-AFMES E-Mail Address: shairose.a.lalani.civ@mail.mil Date: 17 April 2018 mailto:shairose.a.lalani.civ@mail.mil

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price/ cost to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

Contracting Officer Signature:

BROWN.JENNIFE Digitally signed by

BROWN.JENNIFER.K.1288358598

R.K.1288358598 Date: 2018.06.01 15:12:02 -04'00'

Printed name: Jennifer K. Brown Agency/Position/Title: Contracting Officer, USAMRAA, Materiel 1 E-Mail Address: jennifer.k.brown38.civ@mail.mil Date: 30 April 2018 mailto:jennifer.k.brown38.civ@mail.mil

15. I hereby determine this SSJ to be Legally Sufficient.

Signature:

Typed Name: CPT, JA Scott Luu Title: Attorney-Advisor, USAMRAA Date:

Approval

Based on the foregoing justification, I hereby approve the BPA for Illumina’s NextSeq and MiSeq equipment consumables and reagent supplies on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901, as implemented by FAR subpart 13.501(a)(1)(ii), and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature:

Typed Name: Christopher E. Sherman Title: Special Advocate for Competition, USAMRAA Date: