Revised_Sole_Source_Justification_Malaria_Redacted.pdf

For Official Use Only

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP)

Malaria Prophylactic Drug Tafenoquine, Brand Name Arakoda

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.

2. Requiring Activity: U.S. Army Medical Materiel Development Activity (USAMMDA), Pharmaceutical Systems Project Management Office (PSPMO), 1430 Veterans Drive Fort Detrick, MD 21702-5009.

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price: X **Time & Materials:

* Cost:

Funds: RDT&E Operations and Maintenance, Army (OMA) Other Funds:

Fiscal Year of Funds: 19 & 20

Estimated Total Dollar Value including Options:

4. Contractor Name:

Name of Proposed Contractor(s): 60 Degrees Pharmaceuticals, LLC

Street Address: 1025 Connecticut Ave NW Suite 1000 City, State, Zip: Washington, DC, 20036-5417 Phone:

DUNS:

Cage Code:

Control No: 19-05-0116

5. Description of Supplies/Services: The PSPMO has an immediate requirement for one commercial lot of ~120,000 tablets (7,500 packages), with three (3) optional Contract Line Item Number (CLINs) to procure up to 3,750 packages per CLIN of a U.S. Food and Drug Administration (FDA) brand name Arakoda Malaria Prophylactic Drug Tafenoquine that offers protection against all stages of all species of the malaria parasite. The estimated total cost is $4,477,500.00 including options.

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name);

OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: Malaria is the number one infectious disease threat to deployed Service Members. Brand name Arakoda Malaria Prophylactic Drug Tafenoquine is the only U.S. Food and Drug Administration (FDA)-approved malaria drug that offers protection against all stages of all species of the malaria parasite. The FDA has granted 60 Degrees Pharmaceuticals LLC (60P) exclusivity for U.S. marketing of Arakoda,100 mg tafenoquine tablets for the prophylaxis of malaria in patients aged 18 years and older. Brand name Arakoda is the only FDA approved drug on the market that will protect Service Members from malaria globally. According to the FDA, no other vendor can develop and market this product until 60 Degrees Pharmaceuticals, LLC’s exclusivity period ends on 20 July 2023, resulting in an unacceptable delay in access to tafenoquine.

8. Efforts to obtain Competition: Two (2), third party distributors were identified as potential providers of the brand name Arakoda Malaria Prophylactic Drug Tafenoquine through a Sought (SS), Request for Information (RFI). The FDA has granted 60 Degrees Pharmaceuticals LLC, exclusive rights to manufacture and market brand name Arakoda Tafenoquine,100 mg tablets for malaria prophylaxis patients aged 18 years and older. 60 Degrees Pharmaceuticals LLC ( ) is designated as a small business. However, in accordance with FAR subpart 5.2, a Sources Sought (SS), Request for Information (RFI) was posted on FedBizOpps (FBO) on 19 April 2019, for thirty (30) days which allowed for the submission of Capability Statements from other potential manufacturers or resellers that could meet the Government’s need for brand name Arakoda. At the close of the RFI two (2) Contractors provided responses: and . The Government Point-of-Contact (POC) sent both Contractors emails requesting their verification that they could provide the required brand name Arakoda Malaria Prophylactic Drug Tafenoquine. , Point-of-Contact (POC) sent an email to the Government POC initially that they “could” provide the required brand name Arakoda Malaria Prophylactic Drug Tafenoquine;

however, in later email request for verification changed the initial response from “could” to “could not” provide the required brand name Arakoda Malaria Prophylactic Drug Tafenoquine. POC sent an initial email to the

Government POC verifying that they “could” provide the required FDA-approved brand name Arakoda Malaria Prophylactic Drug Tafenoquine. The Government POC sent an email to 60 Degrees Pharmaceuticals LLC, POC verifying their exclusive rights to manufacture and market brand name Arakoda. 60 Degrees Pharmaceuticals LLC, POC responded to the Government POC with email indicating they have regulatory exclusivity based on new chemical entity status which runs through 20 July 2023. This necessitated the Government to conduct additional inquiry requesting Contractors POC and verify their claims. The outcome of this inquiry resulted in verification that neither Contractors POC nor could provide the required brand name Arakoda Malaria Prophylactic Drug Tafenoquine.

It was also verified that 60 Degrees Pharmaceuticals LLC, is the only source for the required brand name Arakoda Malaria Prophylactic Drug Tafenoquine.

a. Effective competition. Market research has revealed that there are no available distributors that are able to provide the Malaria Prophylactic Drug Tafenoquine, Brand Name Arakoda products. Therefore, the Government intends to purchase directly from 60 Degrees Pharmaceuticals LLC.

b. Subcontracting competition. Not applicable; as this is a supply-type requirement, the Government does not anticipate subcontracting competition opportunities. In addition, 60 Degrees Pharmaceuticals LLC ( ) is a small business.

9. Actions to remove or overcome barriers Competition: USAMMDA and USAMRAA conduct online research as part of their periodic market research efforts to locate other available sources that are capable of meeting this requirement in the future. Additionally, the Government may post another Request for Information (RFI) for any future procurement to determine if there are additional sources available in the market place that can meet the Government’s need.

10. Market Survey: Market analysis was conducted to identify a U.S. Food and Drug Administration (FDA) approved Tafenoquine weekly malaria prophylaxis drug. While there are other Centers for Disease Control and Prevention (CDC)-recommended drugs for malaria prophylaxis; atovaquone-proguanil (Malarone), doxycycline, mefloquine, and primaquine, none offer protection against all stages of all species of the malaria parasite. 60 Degrees Pharmaceuticals LLC has the exclusive rights to manufacture and market Tafenoquine, brand name Arakoda, 100 mg tablets for malaria prophylaxis in adults.

11. Interested Sources: In accordance with Federal Acquisition Regulation (FAR) 5.201, Sources Sought (SS) / Request for Information (RFI) W81XWH-19-R-0052 posted on 19 April 2019 to FedBizOpps (FBO) announcing the Government’s requirement for thirty days (30), closing on 20 May 2019. Two (2) interested sources purporting to have the ability to provide the required brand name Arakoda Malaria Prophylactic Drug Tafenoquine submitted their responses to the Government to be considered for award. This compelled the Government POC to contact the two (2) Contractor’s ( ) and verify they could indeed provide the required brand name Arakoda Malaria Prophylactic Drug. After several emails and phone calls, both and verified that they “could not” provide required brand name Arakoda Malaria Prophylactic Drug Tafenoquine. No company other than 60 Degrees Pharmaceuticals could provide the required Arakoda malaria prophylactic drug.

12. Procurement History and any other facts: Thorough market research was conducted to include a review of USAMRAA’s contracting writing system, Procurement Desktop-Defense (PD2), the USAMRAA Paperless Acquisition System (UPAS), and the Virtual Contracting Enterprise Paperless Contract File (VCE-PCF). The search results identified no previous Purchase Orders issued for brand name Arakoda Malaria Prophylactic Drug Tafenoquine.

Previous Contract or Purchase Order Number: N/A

Previously competed? N/A

Previous authority for less than Full & Open Competition: N/A

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

Typed Name: Date:

Title: Signature:

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

Title: Signature: _

15. I hereby determine this Brand Name Only Justification to be Legally Sufficient.

Title: Signature:

Approval

Based on the foregoing justification, I hereby approve the procurement of brand name Arakoda Malaria Prophylactic Drug Tafenoquine on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901, as implemented by FAR 13.501(a)(1), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date: Signature: