J&A_Redacted.pdf

NMLC LOG #18-10011

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity:

The Justification and Approval (J&A) is executed by the Naval Medical Logistics Command (NMLC), 693 Neiman Street, Fort Detrick, MD 21702, on behalf of the requesting agency: Naval Medical Research Center (NMRC), Rockville, MD.

2. Description of the Action Being approved:

Approval is being sought for the award of a single contract to CAMRIS International (located at 3 Bethesda Metro Center in Bethesda, MD 2081) on a sole source basis for the conduct of research activities associated with the development of E140. E140 is a novel pre-erythrocytic and erythrocytic vaccine candidate for P. falciparum. The period of performance is anticipated to be 48 months.

3. Description of the Supplies or Services Required to Meet the Agency's Needs:

The aim of this study is to develop a P. falciparum vaccine lead candidate, E140, a novel pre-erythrocytic and erythrocytic vaccine candidate.

This procurement requires research support expertise to review and provide guidance on the planning and conduct of the development of the PfE140 vaccine and antigen discovery projects. The PfE140 vaccine work will focus first on the systematic evaluation of several vaccine platforms and regimens to optimize the PfE140 vaccine efficacy. This extensive phase of the project will be followed by a series of studies aiming to increase the vaccine efficacy by combining PfE140 with PfCSP antigen. Finally, studies will be done to evaluate PfE140 cross-protection against one or more heterologous (different from the vaccine strain, such as Pf7G8) challenge parasite strains. This comprehensive approach will ensure the prioritization of the most efficacious PfE140 subunit vaccine establishing a path forward into Investigational New Drug (IND) filing and Phase 1 clinical trials. The work will also involve the generation of human monoclonal antibodies (Hu mAb) and continuation of the malaria antigen discovery project (to identify and characterize additional malaria antigens). The Malaria Department requires the technical and research support expertise for existing funded PfE140 vaccine development, Hu mAb generation, and malaria antigen discovery projects and to develop and apply for new grants to support malaria antigen discovery and vaccine development.

The contract is anticipated to include a base 12 month period of performance and three 12-month option periods.

The type of funds being utilized for this requirement is FY 2018 Navy Research, Development, Test and Evaluation (RDT&E).

The total estimated value of this contract is $2,500,000.00.

4. Statutory Authority Permitting Other than Full and Open Competition:

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1) (as implemented by FAR 6.302-1) only one responsible source and no other supplies or services will satisfy agency requirements.

5. Rationale Justifying Use of Cited Statutory Authority:

The subject requirement provides for the continuance of previous research conducted under task order W911QY-11-D-0063-0002. The work conducted under this task order was titled “Malaria Antigen Discovery” (MAD) and researchers were led by Dr. Joao Aguiar (a CAMRIS employee). Under this task order, the team led by Dr. Joao Aguiar, identified a novel highly protective mouse malaria pre-erythrocytic (PE) antigen, E140, which induced up to 100% sterile protection in outbred and inbred mice, alone or in combination with other antigens, which persisted for at least three months. The E140 protection levels are exceptionally high and unprecedented in malaria pre-clinical research.

The research to be conducted under this requirement is a continuation of the research that was conducted under task order W911QY-11-D-0063-0002. Dr. Aguiar has a patent pending for Novel Antigen for use in Malaria. The further development of the PfE140 vaccine and antigen discovery projects are impossible without building upon the Novel Antigen for use in Malaria (patent pending), which is vital to the ongoing-pre-clinical development of PfE140 vaccine. The use of any other source would cause substantial delays and disruption to the ongoing pre-clinical development of PfE140 vaccine.

Given the extensive knowledge of Dr. Joao Aguiar, coupled with the groundbreaking discovery of the Novel Antigen for use in Malaria (patent pending), which is vital to the ongoing-pre-clinical development of PfE140 vaccine, CAMRIS is the only source that possesses the intimate knowledge required to utilize the patent pending discovery and continue to provide research studies and expertise in support of the ongoing pre-clinical development of PfE140 vaccine.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable:

A sources sought notice to solicit capable sources was synopsized on the Federal Business Opportunities (FBO) website on 14 December 2017; no capability statements were received. In addition, a notice of intent to sole source was synopsized on the FBO website on 20 December 2017; no capability statements were received. Currently, CAMRIS, utilizing Dr. Joao Aguiar and his patent pending research, is the only source known to meet the Government’s need; therefore, no other sources are being solicited.

7. Determination of Fair and Reasonable Cost:

The Contracting Officer will perform a cost and price analysis in order to determine whether the anticipated quotes received by the Government for the services covered by this J&A will be within fair market value and reasonable.

8. Actions to Remove Barriers to Future Competition:

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the type of services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.

9. Contracting Point of Contact:

The point of contact at NMLC is Cheryl Vendemia, 301-619-6004 or by email at cheryl.r.vendemia.civ@mail.mil.

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TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein are complete and accurate to the best of my knowledge and belief.

TECHNICAL/REQUIREMENTS COGNIZANCE

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have determined this Justification is legally sufficient.

CONTRACTING OFFICER CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief. To the extent that the J&A/LSJ value is between $150K and $650K, the Contracting Officer’s signature below also represents approval of the J&A/LSJ.

COMPETITION ADVOCATE REVIEW

To the extent that the J&A/LSJ value is between $650K and $12.5M, the Competition Advocate’s signature below also represents approval of the J&A/LSJ