2063418 - J and A _Redacted.pdf

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Justification & Approval/Justification for Other than Full and Open Competition Sole Source over the Simplified Acquisition Threshold

“Source Selection Information – see FAR 2.101 and 3.104”

Project Title: Acquisition of Adjuplex adjuvant for use with vaccines against infectious diseases

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. DHHS/National Institutes of Health (NIH)/National Institute of Allergy & Infectious Diseases (NIAID)/Acquisitions Management Operations Branch (AMOB)

b. Sponsoring organization. Vaccinee Research Center (VRC)

c. Project Officer Information:

• Project Officer Name.

• Mailing address.

Bethesda, MD 20

• E-mail address.

• Telephone num

d. Contract Specialist:

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

Acquisition of a specific type of adjuvant for use with vaccines against infectious diseases is required, specifically the Adjuplex-adjuvant from the company Advanced Bioadjuvants, LLC. The VRC has used the Know How, information and technical assistance provided by Advanced BioAdjuvants LLC (ABA) to manufacture in the original license from an earlier acquisition dating to 2019 to produce and develop the Adjuplex adjuvant, which was used to manufacture clinical grade (cGMP) Adjuplex for use in VRC’s HIV, influenza, and other viral vaccine trials. The Know How, unpublished company-owned information, technical assistance and documents required for regulatory approval about production are only available from ABA.

This is a follow-on requirement to an acquisition from 2019 (which had options extending to 2021) that used this product for research/studies, clinical trials, etc. Thus, we must continue using this same vendor and same product in order to maintain consistency and progress to later or more advanced stages of the trials and studies.

Program’s trials/experiments have passed the preclinical stage and these Adjuplex adjuvants are being manufactured for use in clinical trials. Program has conducted preclinical GLP toxicology studies with this Adjuplex adjuvant and these reports are being submitted to the

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FDA. A new adjuvant, even if it was as effective as Adjuplex in the preclinical trials, cannot be substituted at this stage.

b. Project background.

The mission of the VRC, NIAID is to develop vaccines to protect against infectious diseases that are public health threats. Our research includes developing novel vaccines and using different methods to optimize their effectiveness. An adjuvant is a substance that is formulated as part of a vaccine to enhance its ability to induce protection against infection. As one component of our research, the VRC, NIAID, NIH has been investigating the use of novel adjuvants in our vaccine development program for HIV, influenza and other viral vaccines, and has found the Adjuplex brand of adjuvant from Advanced BioAdjuvants LLC (ABA) to be superior to other adjuvants.

3. Description of the supplies or services required to meet the agency’s needs

(including the estimated value).

a. Project title. Acquisition of Adjuplex adjuvant for use with vaccines against infectious diseases

b. Project description.

Adjuplex from Advanced BioAdjuvants is required. Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) X Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

• Type of action.

New requirement X Follow-on to: PO#7SN93019P00810 Other (specify): ______________________

• Proposed contract/order type:

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________

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Other (specify): ___________ Completion Form Term form

• Acquisition identification number. ABMIS 2927438

c. Total estimated dollar value is

d. Description of the supplies or services to be purchased:

Continued access to ABA’s patents, proprietary process/Know

How to use Adjuplex for manufacture of current Good Manufacturing Process (cGMP) grade material and additional research grade material.

This includes the following:

• Ability to use Adjuplex for clinical evaluation of this material with vaccines/immunogens designed to prevent human infectious diseases

• Right to provide either cGMP or research grade Adjuplex to collaborators and other outside parties for evaluating human vaccine candidates for infectious diseases in Phase 1 and Phase 2 clinical studies

• Continued use of the Master batch record containing sufficient detail for the VRC, NIAID to make Adjuplex

• Expanded scope to allow the VRC to distribute research grade material, as available, to other parties

• Continued use of process information and assistance for manufacture of clinical grade material by the VRC, NIAID’s Vaccine Clinical Materials Program

4. Identification of the statutory authority permitting other than full and open competition.

X This acquisition is conducted under the authority of 41 USC 3304(a)(1) and FAR Part 6.302-1 – Only one responsible source.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Advanced BioAdjuvants LLC 5321 South 162nd Avenue Omaha, NE 68135

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b. Nature of the acquisition and proposed unique qualifications of the contractor(s)

The Adjuplex adjuvant is proprietary to ABA. They hold a patent and do not license it to other resellers. Only one source, Advanced BioAdjuvants LLC, is capable of providing the Know How required because the Adjuplex adjuvant product is unique, highly specialized, and proprietary to this company and only this company sells/licenses this product.

The Adjuplex adjuvant is the only product that will meet the government’s needs for the following reasons:

• This is a continuation of the acquisition that purchased Adjuplex adjuvants for research and clinical trials in 2019, with options extending to 2021.

These research studies and trials have been successful so far, so the VRC wishes to continue using this product that have proven effective and is required in further studies and trials.

• Timing of the initiation of the studies is critical to the mission of the VRC.

The timing of GMP production and release of the adjuvant, which depends on continued access to the information and technical expertise is required to test the VRC’s HIV fusion protein/trimer vaccine candidate in a clinical study that is planned for Q2, 2021 and no other product can meet our timeline. The IND application relying on data with Adjuplex is in the final stages of preparation for submission to the FDA.

• Access – no existing adjuvants that are effective at boosting an immune response with the VRC’s proteins meet the VRC’s requirements (are freely available for all of VRC’s cGMP manufacture and release by the VRC for use in a clinical trial scheduled for Q2, 2021, are available for advanced development by the VRC and can subsequently be made available to a vaccine developer. The public health goal of the VRC is to perform initial testing of vaccines, then out-license them for wider distribution. It is therefore imperative that the adjuvant be available for commercial use by our partners. Adjuplex is the only adjuvant that boosts the immune response that allows all of these activities to occur within the timeframe needed.

• Functionality – this is the only adjuvant that improves the response to the VRC’s HIV vaccine candidates. Clinical trials are planned to start in Q2, 2021, and cGMP material is planned to be released in Q2 2021.

• Manufacturing - Manufacture of this adjuvant is close to being completed at the Vaccine Research Center’s production facility. Development of the methods took approximately 6 months before meeting standards to transfer for cGMP production. Manufacture at the VRC is critical for allowing the VRC to maintain control over timing, quality and inventory of the final product.

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6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

This shall be a sole source acquisition because only one vendor owns the patent to the required adjuvants.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable based on comparison to similar equipment.

The price is determined to be fair and reasonable based examination of the prices in the previous acquisition for this same product and based on a comparison with the prices of other adjuvants on the market. Please see the acquisition file for more details regarding price reasonableness determination.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Several market research techniques were used to identify other possible sources, including review of acquisitions on similar items, queries of internet information sources, contact of knowledgeable individuals in the government and in industry, and review of catalogs and product literature. The results of this research indicated there is only one manufacturer/source for this specific product that would retain compatibility with existing systems.

A Notice of Intent to Sole Source was posted on SAM.gov under NIAID_NOI21_2063418. This posting notice closed on August 2, 2021 at 5:00 PM without any responses.

9. Any other facts supporting the use of other than full and open competition.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest in the proposed acquisition.

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11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

It is the policy of NIAID to promote the use of competitive procedures whenever and wherever possible. In an effort to remove or overcome barriers to competition in the future, the market will be scanned frequently for new companies and products that could satisfy the Government’s requirement. The staff meets regularly with products manufacturers and vendors and attends manufacturer and industry training to keep current on technology. Vendor and trade magazines are scanned for new, open technologies that can satisfy future infrastructure requirements. The agency will continually re-evaluate the products currently being used and will research for the manufacturers and products that will be in the Government’s best interest as best value for future replacement products at the agency’s site and at sites the agency supports. The current situation requires a sole source justification to satisfy requirements. Since there is a continual re-evaluation to products currently being used by the agency for the present requirement, if/when alternatives become available, they will be evaluated for use.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date Requestor Certification

Project Officer

Project Officer’s Immediate Supervisor

Head of the Sponsoring Program Office

13. Contracting Officer & Requestor Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date Contracting Officer