A02. JA_Final_Redacted.pdf

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JA Control No: JA-22-05-1169

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 U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD, 21702.

2. Requiring Activity: U.S. Army Medical Research Institute of Chemical Defense

(USAMRICD), 8350 Ricketts Point Road, BLDG E2900, Aberdeen Proving Ground, MD 21010

3. Nature of Action:

Commercial Item New Requirement

Non-Commercial Item Follow-on Requirement

Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price*

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

Time & Materials** Cost*

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

* Firm Fixed Price:

**Time & Materials:

* Cost:

Funds: RDT&E Other Funds:

Operations and Maintenance, Army (OMA)

Fiscal Year of Funds: 2022

Estimated Total Dollar Value including Options: $46,690.00

4. Contractor Name:

Name of Proposed: Contractor(s): Simulations Plus, INC Street Address: 42505 10th Street West City, State, Zip: Lancaster, CA 93534 Phone: 661-723-7723

DUNS: 345534338

Cage Code: U02K9

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5. Description of Supplies:

GastroPlus is a mechanistically based simulation software package that simulates intravenous, oral, oral cavity, ocular, inhalation, dermal/subcutaneous, and intramuscular absorption, pharmacokinetics, and pharmacodynamics in animals. We are looking to renew our existing licenses, as well as adding the AIDD module to both of those existing licenses.

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:

This item is manufactured and sold by a single company. USAMRICD needs to renew existing licenses as well as add a new module to the licenses.

8. Efforts to obtain Competition:

As an Army mandatory source, CHESS was searched and this license does not exist. The results from the searches confirmed the software is only available from the manufacturer, Simulations Plus, Incorporated.

9. Actions to remove or overcome barriers competition:

GastroPlus software products were initially purchased by USAMRICD through a competitive process in 2019. USAMRICD has continued use of the same GastroPlus software as it is critical for research continuity. In this application, the use of other software from any other vendors would render the historic dataset virtually useless, preventing USAMRICD from delivering a product to the customer and funding agency. Selecting a different vendor’s software would force USAMRICD to re-establish the pool of data by duplicating two years of research efforts.

The U.S. Army Medical Research Acquisition Activity (USAMRAA) posted an RFI for this requirement on the SAM website that provided interested concerns the opportunity to identify their capability in writing by 13 August 2022. No responses were received in response to the RFI. A Notice of Intent to sole source will be posted to SAM prior to award allowing an additional opportunity for vendors to identify their capability in writing. The notice closed on 04 September 2022 with no responses received.

10. Market Research:

Market research was conducted through the World Wide Web (WWW), CHESS, consulting vendors, collaborators, other laboratories, and reviewing previous purchases. It was determined that no other software can perform the necessary function. This item has previously been purchased for earlier phases of this research, most recently in 2021 under purchase order

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W81XWH21P0170, but also for research with other toxicants since 2019 purchased via credit card.

11. Procurement History and any other facts:

a) Procurement History – Most recently purchased in 2021 under purchase order

W81XWH21P0170 but also purchased for related research in 2019 via credit card.

12. 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: Justin Tressler

Agency/Position/Title: USAMRICD / Laboratory Manager E-Mail Address: Justin.a.tressler.civ@health.mil

13. 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:

Printed name: Erin Maddox

Agency/Position/Title: USAMRAA, Contracting Officer, Contracts Branch 2 E-Mail Address: erin.j.maddox.civ@health.mil

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

Agency/Position/Title: USAMRAA, Contracting Officer, Contracts Branch 2 E-Mail Address: erin.j.maddox.civ@health.mil mailto:Justin.a.tressler.civ@health.mil mailto:erin.j.maddox.civ@health.mil mailto:erin.j.maddox.civ@health.mil

Approval

Based on the foregoing justification, I hereby approve the procurement of on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 or 41 U.S.C. 1903, as implemented by FAR subpart 13.106-1(b)(1) or FAR 13.501(a)(1)(ii), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Agency/Position/Title: USAMRAA, Contracting Officer, Contracts Branch 2 E-Mail Address: erin.j.maddox.civ@health.mil mailto:erin.j.maddox.civ@health.mil