W81XWH-20-C-0137 JA ETEC Redacted_Redacted.pdf

Control No:

Contractor: Scandinavian Biopharma Holding AB

Program/Equipment: ETEC Vaccine

Version – September 2018 FOR OFFICIAL USE ONLY

Through extensive market research, Scandinavian Biopharma was identified for its advanced development of a multivalent ETEC vaccine for adult traveler indication. There is currently no such vaccine on the market; prevention is achieved through sanitation and hygiene and treatment is through antibiotic administration. Passive immune supplements consisting of bovine colostrum antibodies against ETEC are available but must be taken prior to every meal or other food/drink consumption to be effective. These limitations have created a gap in Warfighter infectious disease prevention and market research has determined Etvax, the vaccine under development by Scandinavian Biopharma, possesses the following characteristics which, taken together, address the requirements to fill that gap and provide the highest technology readiness level of any other product under development:

1) The vaccine has been shown to be safe in humans (adults and children). The first generation of the vaccine has shown to be 60-80% effective against diarrhea caused by ETEC.

2) The second generation vaccine improves the multivalent composition of the first generation vaccine, with five antigenic components (up to 90% ETEC strain coverage) and the addition of an adjuvant.

3) The vaccine has shown stability for 5 years.

4) The vaccine is administered in 2 oral doses.

Moreover, Scandinavian Biopharma has achieved clinical progress which contributes to a TRL6 technology readiness level. They have completed a Phase I/II clinical trial with their first generation vaccine under a U.S. Investigational New Drug (IND) using an adult traveler population exposed to ETEC under natural transmission conditions. Using second generation Etvax, they have already demonstrated safety and significant immunogenicity in adults and have completed the active portion of a Phase IIb study using adult Finnish travelers to a high transmission area. Scandinavian Biopharma will unblind the data from this study and perform final analyses of safety and efficacy in August 2019. This clinical progression, ownership of patented and proprietary information, status as a Sponsor of U.S. INDs, and partnerships with scalable manufacturing organizations supports the authority cited herein for a Scandinavian Biopharma sole source award. Competing this requirement would not result in a different outcome, as market research demonstrates, as every other potential solution is years behind Etvax in development, technology readiness, and efficacy. A sole source would save an estimated $14.2 million and two years.

The only other viable alternatives available to the Government are:

1) Current standard of care (sanitation and hygiene for prevention and antibiotics for treatment). The effectiveness of sanitation and hygiene is negatively impacted by poor compliance and uncontrolled sources of food and drink, such as local vendors. Treatment is effective for limiting duration of symptoms but cannot prevent disease incidence. The insufficiency of these measures is indicated by the Infectious Disease Threat Prioritization Panel ranking bacterial diarrhea as the number one infectious disease threat to the Warfighter in 2019.

2) Passive immunity supplements such as Travelan. While this is a commercial off the shelf product, it must be taken prior to every food or drink consumption and each dose confers only a few hours of protection. This is not a sustainable or reliable alternative and falls severely short of the validated requirement threshold for 1 year duration of protection.

Market research was conducted to survey new and emerging technologies to satisfy the requirements. The findings concluded that similar products are either lacking in maturity (no clinical studies performed, no commercial partner) and/or do not satisfy the requirements (poor efficacy, short duration of protection). Scandinavian Biopharma is the only provider currently in Phase IIb trials and capable of moving into pivotal clinical studies within two years, significantly accelerating a capability to the Warfighter. If approved by the FDA, Etvax is expected to satisfy all requirements thresholds, at a minimum, within reasonable cost and schedule.

6. Efforts to Obtain Competition:

The Contracting Officer shall publish the Notice of Intent to Sole Source in accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302- 1(d)and any responses received shall be considered.

a. Effective Competition: Because this is a sole source action, effective competition is not applicable as there is only one responsible source and no other supplies or services will satisfy agency requirements.

b. Subcontracting Competition: Subcontracting competition will be achieved by requiring the contract to provide evidence of market research and competition when seeking out subcontractors to work on the contract.

7. Actions to Increase Competition: A Request for Information (RFI) was issued on 10 October 2019 via FedBizOps (FBO) to supplement the existing market research and encourage other potential providers to self-identify and/or clarify their capability and progress toward satisfying requirements prior to proceeding with this acquisition. No responses were received as there is no other treatment available in the marketplace at the TRL 6 level. The PM will continue to assess market intelligence through the development phase to ensure any opportunity for competition of an equal or greater capability is identified prior to proceeding with a production decision.

8. Market Research:

The ETEC vaccine market research report was completed in July 2019. The market research identified four candidates being developed by industry for ETEC prevention and two additional candidates in clinical development by government or academic researchers. Both of the two laboratory-based candidates are assessed at TRL 5/6 and neither has a commercial partner. One of the candidates is a commercial-off-the-shelf product; however, it is sold as a supplement and its passive immunity mechanism of

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.

Typed Name: Date:

Title: Product Manager Signature:

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.

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

As a part of this basis, certified cost or pricing data:

☒ will be required.

☐ will not be required and the following exception applies (FAR 15.403):

☐ Prices that will be agreed upon are based on adequate price competition.

☐ Prices that will be agreed upon are based on prices set by law or regulation.

☐ A commercial item is being acquired.

☐ A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

☐ The contract action is a modification to a contract or subcontract for commercial item(s).

☐ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

Typed Name:

Title: Contracting Officer

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

Title: Contracting Officer

Approval Based on the foregoing justification, I hereby approve the procurement of advanced development to deliver an ETEC vaccine for the prevention of traveler’s diarrhea for the estimated amount of on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements, subject to availability of funds, and provided that the services or property herein described have otherwise been authorized for acquisition.

Title: Special Advocate for Competition