200700153.pdf

Control No: JA‐20‐07‐00153 Contractor: Genedata (USA), Inc.

Genedatata Software License

Version – March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: U. S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD has a requirement for GeneData Software License Renewal.

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Amount: Total estimated cost of the effort $349,711.00, to include a twelve (12) month base period and three (3), twelve (12) month option periods.

Prepared by: Wanda King DSN: 343-2376

Contract Specialist Date: 2 September 2020 Email: wanda.d.king.civ@mail.mil

Contracting Officer: Amanda L. Best DSN: 343-1187 Contracting Officer Date Email: amada.l.best3.civ@mail.mil

Technical: Dr. Rekha G. Panchal DSN: 343-4985 Branch Chief, Therapeutic Discovery

Date: 3 September 2020 Email: rekha.g.panchal.civ@mail.mil

Requirements: Dr. Rekha G. Panchal DSN: 343-7985 Branch Chief, Therapeutic Discovery

Date: 3 September 2020 Email: rekha.g.panchal civ@mail.mil

Reviews: I have reviewed this justification and find it adequate to support sole source.

Program Manager:

Typed Name:

DSN:

PALACIOS.GUSTAVO Digitally signed by

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PALACIOS.GUSTAVO.FABIAN.140

7109267 Date: 2020.09.08 14:31:19 ‐04'00'

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FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole

Source Justification and Approval

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 - 5014.

2. Description of Action: The U. S. Army Medical Research Institute of Infectious Diseases (USAMRIID), 1425 Porter Street, Fort Detrick, MD 21702 - 5711 requests a firm-fixed-price with GeneData (USA), Inc., 1 Cranberry Hill, Suite 403, Lexington, MA 02421-7397.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

(Insert approval authority title) approved an acquisition plan in accordance with DFARS 207.103(d)(i)(B) on (insert date).

The required acquisition plan in accordance with DFARS 207.103(d)(i)(B) is currently awaiting (insert approval authority title) approval.

3. Description of Supplies/Services: USAMRIID has a requirement for the renewal of the Genedata screener software License, Maintenance, and Support, to include the following software components: Screener Core (Analyzer + Database Explorer), Low

Throughput Edition with structure display functionalities for four (4) named users, High Content Extension to Analyzer for four (4) named Users, Cell Population Extension to Analyzer for three (3) named Users, Compound Synergy Extension to Analyzer for three

(3) named users. The renewal of the software will allow for continued data generation from the Opera Imaging instruments to achieve non-biased deformation and strain measurements . The software has been integrated into our imaging systems so that there is seamless transfer of imaging data to the software for statistical analysis to determine potency, cytotoxicity and also provide all curve fitting values and graphs. The Government projects which utilize Genedata Software License begin on 15 September 2020 and ending 14 September 2024 with fiscal year (FY) 2020, funds type of funding Operations and Maintenance Army – 1 Year funds will be used for the base year.

Base Period: _15 Sep 2020_ to 14 Sep 2021 Value: $85,340.00 Option Period 1: _15 Sep 2021 to 14 Sep 2022 Value: $85,340.00 Option Period 2: _15 Sep 2022_ to 14 Sep 2023 Value: $87,900.00 Option Period 3: _15 Sep 2023_ to 14 Sep 2024 Value: $90,537.00

Total: $349,117.00

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented: Less than full and open competition was used by FAR Subpart 13.501(a): Only one source reasonably available (including brand name) for purchase exceeding the simplified acquisition threshold (SAT), and only one source reasonably available.

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization Other:

5. Reason for Authority Cited: GeneData (USA), Inc. is the sole manufacturer and distributor of the software with no authorized resellers in the marketplace, which can be integrated into the Opera Imaging System to meet the Government’s requirement for this software license. Genedata software is the only source compatable with the required Perkin Elmer analytical equipment by the usage of an Opera High-Content Screening System. The software is necessary for analysis of screening assay platforms to provide comparable and accurate data for the existing Opera Imaging System. The platform that integrates data capture, analysis, and reporting across the full biopharma Research and Development process to target complex data allowing focus to provide data integrity, addressing regulatory requirements by achieving optimal time in managing data for real-time investigation of program performance for screening, images, selector, expressionist, biology, bio-process, and profiler to ensure data integrity by eliminating compliance risks of research in using the software produced by Genedata (USA), Inc., which can allow collaborating and sharing information.

For scientific and programmatic consistency, USAMRIID shall complete ongoing multiyear research projects to accept the data from 384 well plate using the analysis by the efforts within the Therapeutic Discovery Branch within USAMRIID. In fulfilling quality analysis of data obtained from the Dose Response studies of molecules using Genedata over seven (7) years with provisions of the specified modules as follow:

1. Screener Core (Analyzer 1 + Database Explorer), Low 2 Throughput Edition without structure display functionalities for four (4) Named Users.

2. High Content Extension to Analyzer, for four (4) Named Users.

3. Cell Population Extension to Analyzer, for three (3) Named Users.

4. Compound Synergy Extension to Analyzer, for three (3) Named Users.

The software being procured under this requirement shall be Genedata and all of associated modules to be compatible with the Perkin Elmer Opera Instrument for the use of past and present comparison of research. The use of any other vendor would negate the previous protocols, resulting in a loss of time, effort, and will be costly to the

Government of a replacement software not suitable to be operable and critical to the research and possibly push research back several years.

6. Efforts to Obtain Competition: Market research was conducted on May 2020 on the internet, there were no other comparable software available to continue the research already in place. A Special Notice of Intent to Sole Source was published IAW FAR

5.201 with www.beta.SAM.gov (W81XWH-20-Q-0178) on 20 August 2020 and closed on 01 September 2020. Only Genedata (USA), Inc. could provide the required software;

there were no known sources received or able to meet the requirement.

7. Actions to Increase Competition: The Government will continue to survey the marketplace to see if there are any other companies that are capable of providing the required software required for future research. New projects or analytical equipment may allow for competition among companies capable of meeting the customer’s requirement.

8. Market Research: Market research, conducted June/July 2020 performed using the internet and it has been determined there are no authorized re-sellers of the software nor are any other vendors capable to sync the software for the capability to run with the specialized Perkin Elmer Opera Instrument and provides only option of a streamlined approach to sustain mission requirements. Genedata software license can only be obtained direct from Genedata (USA), Inc. which operates as both the manufacturer and distributor of their product.

9. Interested Sources: To date, no other sources have written to express interest in meeting the acquisition.

10. Other Facts:

a. Procurement History:

(1) Contract numbers and dates of the last several contracts for these same requirements:

a. W81XWH-19-P-0079 15 September 2019 through 14 September2020

b. W81XWH-18-P-0088 15 September 2018 through 14 September2019

c. W81XWH-16-P-0288 15 September 2016 through 14 September2018

d. W81XWH-15-P-0402 01 October 2015 through 21 July 2016

(2) The competitive status of these actions:

a. W81XWH-19-P-0079 Sole Source

b. W81XWH-18-P-0088 Sole Source

c. W81XWH-16-P-0288 Sole Source

d. W81XWH-15-P-0402 Competitive

(3) Authority previously cited if less than full and open competition was used: IAW FAR 13.501(a)(1)(a) Only one source reasonably available (including brand name).

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results:

The Government will continue to survey the market place to see if there are any other companies that are capable of providing the required software required for future research. New projects or analytical equipment may allow for competition among companies capable of meeting the customer’s requirement.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources:

During FY 16, the requirement was competed on the open market to determine if there were other contractors in the marketplace not available on the internet. Additionally, the software has been optimized in meeting protocols for the past few years as a sole source manufacturer and publisher. The continuity of this research is essential to remain in fulfilment of meeting the needs of the researchers achieving operational excellence and can be easily tailored on the need for all research projects.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys: Not Applicable

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes:

Only GeneData (USA), Inc. can meet the Government’s requirements for the renewal of the software license. This is the only contractor that can provide the most continuous upgrades in the support of compatibility with the Perkin Elmer Opera Instrument.

PANCHAL.R Digitally signed by PANCHAL.REKHA.G.

X EKHA.G.126 1267180233

7180233

Date: 2020.09.03 14:17:25 ‐04'00'

11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Date:

Title: Branch Chief, Therapeutic Discovery Signature:

Digitally signed by

PANCHAL.REKHA.G.12

KHA.G.12671 67180233

Date: 2020.09.03

80233 14:17:04 ‐04'00'

12. Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Title: Branch Chief, Therapeutic Discovery Signature:

PANCHAL.RE

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. On the basis with an IGE and price analysis will be used to determine to be fair and reasonable to the Government. IAW FAR 15.403-1(b)(3) requesting cost and pricing data is prohibited for a commercial item.

This determination will be made using the following: price analysis cost analysis IGCE audit: other:

Price Analysis of historical contracts to be used to determine fair and reasonable price.

Title: Contracting Officer Signature:

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Title: Contracting Officer Signature:

BEST.AMANDA.

Digitally signed by

BEST.AMANDA.LEE.13696308

LEE.1369630896 Date: 2020.09.09 06:26:31 ‐04'00'

BEST.AMANDA Digitally signed by

BEST.AMANDA.LEE.13696

X96

.LEE.13696308 30896

Date: 2020.09.09 06:26:09 ‐04'00'