INTENT TO SOLE SOURCE TOPRX.pdf

INTENT TO SOLE SOURCE TO TOPRX FOR LENTOCILIN

The Oklahoma City Area Indian Health Center intends to award a non-competitive, sole source contract to proposed contractor TopRX. authority cited FAR Part 5.406(a) - Only one source is capable of providing the required Lentocilin, to address the shortages of Bicillin L-A (penicillin G benzathine injectable suspension) in the United States.

This product is the only available treatment option for congenital Syphilis patients and those at high risk of contracting it. An ample supply is needed throughout the Indian Health Services to ensure prompt treatment and to support ongoing mission critical deployments aimed at combating Syphilis outbreaks across Indian Country in the United States.

This notice of intent to award a sole source contract is not a request for competitive proposals.

There will be no solicitation available for competitive quotes. Any response to this notice must show clear and convincing evidence, that competition would be advantageous to the Government. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Provide response to: Forrest.Ward@ihs.gov. Last day to provide affirmation written response is August 15, 2025 at 4:00pm CST.

A determination by the Government not to compete the proposed procurement base upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for determining whether to conduct a competitive procurement in the future. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation (s).

mailto:Forrest.Ward@ihs.gov

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

Acquisition Title:

Agency:

Acquisition Year (FY):

Author and Title:

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s):

Street Address:

City, State, Zip:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is $

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.

National Supply Service Center / Lentocilin

Sharla Van Winkle, COR

2025/2026

IHS

TopRx

2950 Brother Blvd Ste 102

Memphis, TN 38133

211,200

To address the shortages of Bicillin® L-A (penicillin G benzathine injectable suspension) in the United States, Mark Cuban Cost Plus Drug Company, PBC (“MCCPDC”) is coordinating with the U.S. Food and Drug Administration (FDA) and TopRx to temporarily import Lentocilin© (Benzathine Benzylpenicillin Tetrahydrate) Powder and diluent for suspension for injection, 1,200,000 units into the United States. Benzathine benzylpenicillin is another name for P i illi G b hi Thi d i h l il bl i f i l S hili i d h hi h i k f

211,200

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

Explain why the intended contractor is the only responsible source who can provide the required supplies or s ervices.

Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or servic es will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays.

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2) If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5) Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

Other (See FAR Subpart 6.3 for additional authority) Provide the authority and citation to the applicable section of FAR 6.3.

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

TopRx, working through MCCPDC has obtained special approval from the FDA to import this product temporarily while the reference product, Bicilin, remains on hold for production. There are no other known sources that have a biosimilar product that is approved for the treatment of Syphilis and it is unknown when the FDA will authorize production of Bicillin to resume. This product is the only available treatment option for congenital Syphilis patients and those at high risk of contracting it. An ample supply is needed throughout the Indian l h i d i i i i i l d l i d b i hili b k

None Taken, there is no other identified company that has obtained approved from the FDA to import or utilize an alternative product. This J&A will be posted on SAM.gov.

6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones f or the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start -up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quant ity or performance period.

7. Actions to Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart

5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. You may state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to compete it to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

8. Market Research:

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If ac tion is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

9. Procurement History:

Purchase order or contract number:

Was action competed? Yes No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

Not Applicable

None Taken. Competition will be sought if and when production of Bicillin resumes in the US and there are alternative sources. To date, TopRX. is the only offerer that can source this product.

The nature of this requirement necessitated a streamlined market research process. Current research was based on non-availability of the primary product, Bicillin. Other government agencies were tapped and all normal procurement avenues exhausted before identifying that TopRX along with MCCPDC had obtained FDA approval to utilize the alternate, Lentocilin temporarily while Bicillin production remains on hold. There is currently no other FDA-approved product currently available within the US with the indication of Syphilis treatment.

This product was not competed due to it only being available from one source via a special authorization from the FDA.

10.Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;

describe actions taken to remedy the situation.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this J&A is accurate and complete.

Program Manager

Name:

Position Title:

Email address:

Phone:

Program Manager Supervisor (or one level above Program Manager)

Name:

Position Title:

Email address:

Signature:

Date:

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

Name: Phone:

Signature: Date:

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date:

CAPT Weston Thompson weston.thompson@ihs.gov

NSSC Pharmacy Support Branch Supervisor

405-951-3996

Andrea Klimo andrea.klimo@ihs.gov

Deputy Director

405-951-3996

918-342-6509

Drugs are tested and approved by the FDA.

Andrea Klimo Digitally signed by Andrea Klimo Date: 2025.08.07 14:53:46 -05'00'

CAPT Weston Thompson

Sean L. Long

Weston D.

Thompson -S

Digitally signed by Weston D.

Thompson -S Date: 2025.08.07 15:05:31 -05'00'

Sean L. Long -S Digitally signed by Sean L. Long - S Date: 2025.08.08 06:15:50 -05'00'

The estimated price for 2025-2026 requirement is $15 per dose. Quantity: 14,080 = $211,200.00. Past pricing history for similar product is $210 per dose. Based on a comparison of past history pricing from VA GWAC's contract pricing, the pricing provided by PBC is hereby determined fair and reasonable.

14. Legal Review:

All J&As greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million (value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Phone:

Signature: Date:

All J&As greater than $68 million must have a review from the Office of Small & Disadvantaged Business Utilization (OSDBU) prior to sending it to the Department. The OSDBU at their discretion may review any J&A.

16. Office of Small and Disadvantaged Business Utilization Review: (Required for contracts exceeding $68 million (value calculated including all options)):

Concur: Non-Concur:

Name: Phone:

Signature: Date:

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million (value calculated including all options)):

Name: Phone:

Signature: Date:

18. Department Competition Advocate (Required for contracts exceeding $68 million (value calculated including all options)):

Concur: Non-Concur:

Name: Phone:

Signature: Date:

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/services being procured:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:

Name: Phone:

Signature: Date: