Redacted_J&A_Redacted_FINAL.PDF

DEPARTMENT OF THE ARMY

US ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY

820 CHANDLER STREET

FORT DETRICK MD 21701-5014

Control No: JA-18-230

Justification and Approval for Other Than Full and Open Competition

Program/Equipment: Ultra-Small Volume Adenosine, Lidocaine and Mg2+ (ALM) Fluid Resuscitation for Uncontrolled Hemorrhage.

Authority: 10 U.S.C2304(c)(l) as implemented by FAR 6.302-1-0nly One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Prepared by:

Contracting Officer:

Technical Representative:

Requirements Representative:

Control No: JA-18-230

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Manager/Project Manager/COR

Signature:

Legal Counsel

Typed Name

DSN:

Date: ---------

J&A, Other Than Full and Open Competition

FOR OFFICIAL USE ONLY

Justification and Approval for Other- Than Full and Open Competition

1. Contracting Activity:

This is a Justification and Approval for Other Than Full and Open Competition (J&A) for the United States Special Operations Command (USSOCOM) conducted by the U.S. Army Medical Research Acquisition Activity (USAMRAA).

2. Description of Action:

Approval is requested to modify current contract W81XWH-16-C-0143 with James Cook Uhiversity to continue a follow-on effort for the research, development, testing and evaluation required to establish safety and toxicology data in a large animal model and initial safety and efficacy data in an injured human using patients presented to an Urban, Level-I Trauma Center.

This requirement is a cost type contract. The anticipated cost of this modification is for a 24 month period of performance.

funds will be used to support this requirement.

3. Description of Supplies/Services:

This contract modification specifically allows for the continued development of a highly specialized pharmaceutical therapy. This modification will continue the study of small-volume resuscitation therapy utilizing that offers the healthcare provider a small-volume, intravenously infusible fluid that improves cardiac function and hemodynamics in a hemorrhaging patient compared to current available treatments. Hemorrhage is responsible for up to 50% of trauma deaths on the battlefield and 30% to 40% of deaths in the civilian population with one-third to one-half occurring in the prehospital period. The continued development of a small-volume fluid that can offer cardiac and hemodynamic stability while a patient is being transported to definitive care would revolutionize prolonged field care in combat situations as well as in the civilian realm.

This follow-on effort has two aims focused on preparing the government to formally discuss a clinical and regulatory pathway with the Food & Drug Administration (FDA) for approval of this novel therapy. The first aim includes utilizing data produced in the current contract, which indicated efficacy in both a small and large animal model. This efficacy data will be used to study the safety and toxicology of efficacious dosing in the large animal model in preparation to move to pre-clinical human trials. The second aim utilizes the data obtained in the current contract and data obtained in the first aim to conduct initial safety and efficacy research in injured humans to demonstrate both safety of ALM in this patient population as well as a clear clinical benefit based on a range of parameters including: survival, amount of blood product administered, and time of return to hemodynamic normalcy.

4. Authority Cited:

J&A, Other Than Full and Open Competition

The statutory authority permitting other than full and open competition is 10 U.S.C. 2304 (c) (1), as implemented by 6.302-1-0nly One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. Reason for Authority Cited:

If this continued development were awarded as a riew requirement through foll and open competition, it would likely cause a substantial duplication of costs which equates to approximately $3,500,000 and 36 months of time to bring the research to a similar maturity level. A new contractor would likely have to repeat the research already conducted by James Cook University under this current contract, in addition to any previous research conducted.

Additionally the government would likely bare the cost of procuring testing and evaluation equipment previously paid for in the current and previous contracts which equates to an additional $270,000. Full and open competition would likely create unacceptable delays in the follow-on development as James Cook University already has agreements in place for the production of the pharmaceutical compounds required to perform this development as well as significant experience with the trauma models outlined in this effort. Additionally, James Cook University already has an agreement in place from a level-I trauma center to support the initial human safety and efficacy aim for this effort. Any award to another contractor would likely cause unacceptable delays of more than 12 months due to the above considerations.

For the reasons stated above, James Cook University is the only responsible source and no other supplier or services will satisfy the agency requirements.

6. Efforts to Obtain Competition:

A Request For Information (RFI) was posted on the Federal Business Opportunities (FedBizOpps) website on 02 August 2018 with a closing date of 07 August 2018. A response was received from Cherokee Nation Technology Solutions, LLC and Kapili Services, LLC as a result of the RFI. Each of these responses were reviewed by USSOCOM and it was determined that each of these companies were not capable of providing the requested research. As a result of this, a notice of intent (NOI) to sole-source to James Cook University was posted on FedBizOpps on 09 August 2018 with a closing date of24 August 2018. This NOI was posted for 15 days in accordance with FAR 5.203(a). The synopsis included a statement, which allowed any and all responsible sources to submit a bid, proposal, or quotation for consideration. The Government received no offers/responses against this announcement.

A. Based on the results of the RFI and NOI, there is no expected competition.

B. Sub-contractor competition. The Government has promoted competition through subcontracting opportunities by the inclusion of FAR 52.219-8 Utilization of Small Business Concerns and FAR 52.244-2 Subcontracts under the current contract.

7. Actions to Increase Competition:

J&A, Other Than Full and Open Competition

As noted in paragraph 6 above, an RFI and NOI were-posted to FedBizOpps in an effort to increase competition. However, no additional sources were found that could meet the government's requirement. Given the research that has already been conducted by James Cook University and the fact that no additional sources have been found that can meet the government's requirement, it is not anticipated that this requirement will be competed in the future. James Cook University is the only entity that can provide the research needed to fulfill this requirement.

8. Market Research:

Per paragraphs 6 and 7 above, an RFI and NOI were published on FedBizOpps. As a result of the RFI, only two responses were received and both were deemed incapable of providing the requested research. The NOI resulted in no responses received. During the Broad Agency Announcement competitive process for the original award, market research was conducted as part of the literature review and an external scientific review was conducted on all proposals received. Market research indicated that James Cook University's proposal and subsequent award was a novel approach to this requirement. Additional market research was conducted into professional and scientific journals which indicate that James Cook University remains the sole researcher pursuing this approach for treating uncontrolled hemorrhage. Based on this market research, no other company can provide the research needed to fulfill this requirement.

9. Interested Sources:

To date, only two sources have written to express an interest in this requirement. However, after review of the provided capability statements, the submitting companies were determined to be incapable of performing this research.

10. Other Facts: Discuss any other facts supporting the use of other than full and open competition, such as the following:

a. Procurement history.

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

WSlXWH-15-1-002: A New Ultra-Small Volume Fluid for Far-Forward, Noncompressible Hemorrhage and Traumatic Brain Injury. Period of Performance: 01 November 2014- 31 October 2015.

W81XWH-16-C-0143: Optimization of Ultra-Small Volume ALM Fluid Resuscitation and 72 Hour Stabilization Drip for Uncontrolled Hemorrhage and TBI. Period of Performance:

26 Sep 2016-25 December 2018.

(2) Competitive status of these actions.

J&A, Other Than Full and Open Competition

Contract W81XWH--15-1-0002 originated from-USSOCOM MRMC Broad Agency Announcement, W81XWH-USS0COM-BAA-l3-1 and Contract W81XWH-16-C-0143 originated from USSOCOM MRMC Broad Agency Announcement, W81XWH-16-R-S0Cl.

(3) Authority previously cited if less than full and open competition was used.

FAR 35.016 (a:) Broad Agency Announcement authority for acquisition of basic and applied research were utilized as the competitive basis on previous awards.

(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.

Not applicable.

(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.

Not applicable.

(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.

Not applicable.

b. Other facts.

None.

J&A, Other Than Full and Open Competition

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.

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.

J&A, Other Than Full and Open Competition

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis.for determination: FAR 15.4-Contract Pricing procedures will be used to determine the price to be fair and reasonable. In accordance with FAR 15.403, Certified Cost or Pricing Data will be required for this modification.

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

15. Legal Sufficiency Review:

Based on the information provided in this document, I hereby determine this justification for other than full and open competition to be legally sufficient.

Typed Name: ______________ _ Date: ---------

Title: ----------

Approval

Command Advocate for Competition

Based on the foregoing justification, I hereby approve the procurement of Ultra-Small Volume Adenosine, Lidocaine and Mg2+ (ALM) Fluid Resuscitation for Uncontrolled Hemorrhage on an other than full and open competition basis pursuant to the authority of 10 U.S.C 2304(c)(l) as implemented by FAR 6.302-1-0nly One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.