Final_Signed_J A_Redacted.pdf

Control No: JA16237

"For Official Use Only”

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 for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014.

2. Requiring Activity: The requiring activity for this action is the U.S Army Center for Environmental Health Research (USACEHR), 568 Doughten Drive, Fort Detrick, MD 21702-5010, Division.

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:

Estimated Total Dollar Value including Options:

4. Contractor Name:

Name of Proposed Contractor(s): Qiagen, Inc., Street Address: 27220 Turnberry Lane, Suite 200 City, State, Zip: Valencia, CA 91355-1005 Phone:

DUNS: 197294564

Cage Code: 01QT0

5. Description of Supplies: The U.S. Army Center for Environmental Health Research (USACEHR) has a requirement for the purchase of Qiagen, Inc., Ingenity Pathway Analysis (IPA). IPA is a web-based software application for the analysis, "For Official Use Only” integration, and interpretation of data derived from ‘omics experiments, such as Ribonucleic Acid (RNA) sequencing, small RNA sequencing, microarrays including microRNA (miRNA) and Single Nucleotide Polymorphism (SNP), metabolomics, proteomics, and small scale experiments that generate gene and chemical lists.

Powerful analysis and search tools uncover the significance of data and identify new targets or candidate biomarkers within the context of biological systems. The requirement is for a base year quantity of three (3) IPA licenses for up to five (5) named users with quantity options for two (2) additional licenses, plus four (4) option years of the same quantity. The IPA web based application from Qiagen Inc. meets the following Minimum Essential Characteristics:

Pathway analysis software.

Must contain Causal Network Analysis for uncovering underlying mechanisms and identifying potential master regulators.

Must contain BioProfiler analysis for understanding diseases, phenotypes, associated genes and compounds, with and without experimental data.

Must integrate with Partek Genomics Suite data mining and statistics software.

Must contain integrated Toxicology and Biomarkers modules and integrated custom pathway design and editing tools.

Must access a knowledge data base of gene and protein ontologies assembled from the scientific literature and curated by subject matter experts.

Must provide pre-constructed “canonical” pathways relevant to metabolism, gene regulation and other biological processes.

Must contain tools specifically for microRNA analysis including Messenger (mRNA) target identification and prediction.

Must provide chemical and pharmacological information on clinical candidates and FDA approved drugs, known targets, effects on gene expression and protein activity, drug metabolism, and drug protein adducts.

Must provide information on compound toxicity and Absorption, Distribution, Metabolism, and Excretion (ADME) information on lethal dose, inhibitory concentration, pharmacokinetic properties, AUC, clearance, and CYP regulation.

Must provide compendia of positive gene expression calls for at least 30 normal tissues, the National Cancer Institute (NCI) 60 panel of cell lines, and other cell lines.

Must provide information on whether proteins of interest are detected in biological fluids including blood, bronchoalveolar lavage fluid, CSF, saliva, and urine

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

"For Official Use Only”

(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: The suggested source for this requirement is Qiagen Inc. (formally known as Ingenuity Systems). Qiagen Inc. is the manufacturer and sole supplier of the IPA web-based software application license. A comparison to other commercially available systems has been conducted and was not compatible with previous data analyzed and collected with IPA. The IPA database is manually curated by PhD scientists and updated regularly to provide high-impact knowledge on a timely basis. Each literature finding represented in the database is reported and substantiated in full-text peer-reviewed scientific articles. The IPA database contains biological interactions between proteins, genes, complexes, cells, tissues, drugs, and diseases.

The ontology modeling process is structured using a class-hierarchy relationship. The IPA database includes FDA approved clinical trial drugs. The IPA software is able to compare functional implications of datasets from multiple platforms to identify common pathways or molecular mechanisms in the experimental model. The IPA software is also able to apply contextual filtering capabilities to identify genes or proteins of interest prior to analysis. The output files are able to be shared with colleagues via email. The networks and pathways displayed in the output files are able to be transformed into publication-quality graphics with color, customized texts and fonts, biological icons, organelles, and custom backgrounds.

USACEHR has historically used IPA for all gene array analysis and use of any other software analyses will cause previous data collected to be obsolete. A significant financial lost and most importantly, the inability for researchers to continue to advance with research projects in the time required would occur without the continued usage of the Qiagen, Inc. IPA web-based software bioinformatics tool.

8. Efforts to obtain Competition: A review of the marketplace for comparable web-based software applications did not uncover any automated systems that can aid in the understanding of biological processes as required by USACEHR. To maintain the accuracy and efficacy of the existing research, the Qiagen, Inc. IPA is required. Qiagen Inc. is the only source available in the marketplace for the IPA web-based software, there are no resellers. No effort will be made to solicit offers from any other potential sources as it is impracticable as there is only one source capable of meeting USACEHR’s requirement. No effective competition is anticipated.

a. Effective competition. There is no reasonable expectation for competition since Qiagen Inc. is the only manufacturer and reseller of the IPA web-based software USACEHR requires for continued research.

b. Subcontracting competition. Not applicable.

"For Official Use Only”

9. Actions to remove or overcome barriers Competition: No barriers exist for this acquisition. Qiagen, Inc. is the sole manufacturer and only source offering the web-based software with the accuracy and efficacy that meets USACEHR’s project needs.

10. Market Survey: Market research was conducted using the Internet, supplier demonstrations, brochures, supply order records, e-mail and telephone communications, and requests for information from peer groups.

11. Interested Sources: To date, no other sources have written to express an interest in the acquisition of the Qiagen, Inc. IPA web-based software. A Notice of Intent to Sole Source will be published on FedBizOpps (FBO) an all responses received will be considered.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number: W81XWH-13-P-0093

Previously competed? Yes

Previous authority for less than Full & Open Competition: Not applicable.

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:

Printed name:

Agency/Position/Title: USACEHR, Deputy Director, Environmental Health Program E-Mail Address:

Date:

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 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:

Printed name:

Agency/Position/Title: USAMRAA, Contracting Officer E-Mail Address:

Date:

13 July 2016

13 July 2016

"For Official Use Only”