Attach J.4 Offeror Checklist.docx

Federal Occupational Health (FOH) Medications, Vaccines, and Medical Supplies (MVMS) procurement solicitation 7571MN26R00052 FOH MVMS Offeror Readiness Checklist Phase One (1): Mandatory Evaluation Criteria (Pass/Fail)- Failure to submit the documents identified in the table below as part of Phase one (1) of the Technical Proposal evaluation will result in the proposal being deemed noncompliant. Such proposals will not receive further evaluation and will be removed from further consideration for award. The Offerors will receive a notification letter via email within three (3) days of noncompliance.

The Offeror must provide clear, verifiable evidence for each of the following "Gate" requirements. Failure to provide any required documentation located on the table below will result in the proposal being removed from further consideration.

1. Regulatory Compliance & Licensure: Provide copies of valid State Board of Pharmacy Wholesale Distributor licenses and DSCSA-compliant transaction tracking systems. Include FDA Establishment Registration confirmation and cGMP compliance documentation.

2. Financial Capability: Provide audited financial statements for the last two (2) fiscal years, demonstrating a Current Ratio between 0.8 and 1.2. Any ratio between 0.8 and 1.2 may be acceptable with a detailed explanation of revenue generation to cover current liabilities (must also submit the Financial Health Justification Form).

3. JIT & Warehouse-less Logistics: Provide a certified statement confirming the ability to ship individual units/parcels with zero Minimum Order Quantities (MOQs) and no minimum dollar values per shipment.

4. Clinical Protocol Alignment: Complete the "Formulary Capability Matrix" showing 100% availability of Unit-Dose or Ready-to-Administer (RTA) formats for all items marked "Critical" in the PWS.

5. Cold-Chain Integrity: Provide validated Standard Operating Procedures (SOPs) and proof of 24/7 temperature data logging capabilities during transit to ensure vaccines remain within CDC-mandated ranges until receipt.

6. Web-Portal Functionality: Provide a video demo or technical manual, proving the system can enforce "Formulary-Only" ordering and support up to 250 unique sub-accounts with customizable approval workflows.

1. Company Registration & Eligibility ☐ Active registration in SAM.gov ☐ Current UEI (Unique Entity Identifier) ☐ Completed FAR and DFARS representations and certifications from SAM.GOV dated within the month the proposal is submitted ☐ Verification of applicable NAICS eligibility (currently identified as primary NAICS 423450; earlier market research also referenced secondary NAICS 424210 codes) ☐ Small business certifications (if applicable):

· SBA 8(a)

· HUBZone

· SDVOSB

· WOSB/EDWOSB

· Small Disadvantaged Business ☐ Good standing certificates (state registrations) ☐ SF1449 Solicitation/Contract/Order for Commercial Products and Commercial Services and SF30 amendments with all applicable fill-ins and signed by individual of firm authorized to bind commitment ☐ Disclosure of Lobbying Activities (The Offeror shall complete the “Disclosure of Lobbying Activities” if there are lobbying activities. If not, the Offeror shall indicate that there are no lobbying activities)

2. Corporate Information Package ☐ Cover letter ☐ Table of Contents ☐ Executive summary ☐ Company profile ☐ Organizational chart ☐ Points of contact ☐ DUNS/UEI and CAGE information ☐ Years in business and ownership structure ☐ Key personnel (Program Manager) resume/qualifications

3. Pharmaceutical & Vaccine Regulatory Compliance ☐ State wholesale drug distributor licenses ☐ State pharmacy licenses (where applicable) ☐ DEA registration(s) ☐ FDA registrations ☐ Drug Supply Chain Security Act (DSCSA) compliance documentation ☐ Vaccine distribution authorizations ☐ Controlled substance handling procedures ☐ Recall management procedures ☐ Adverse event reporting procedures ☐ Cold-chain management Standard Operating Procedures (SOPs) ☐ Formulary Capability Matrix (see the attachments in the solicitation for matrix)

4. Quality Management Documentation ☐ Quality Management System (QMS) ☐ SOPs for pharmaceutical procurement and distribution ☐ Corrective Action/Preventive Action (CAPA) procedures ☐ Product traceability procedures ☐ Inspection and audit reports ☐ Inventory control procedures ☐ Expiration-date management process

5. Technical Capability Narrative Prepare documentation demonstrating ability to:

☐ Supply medications nationwide ☐ Supply vaccines nationwide ☐ Supply medical supplies nationwide ☐ Operate a contractor-managed web ordering portal ☐ Support multiple FOH clinic locations ☐ Process high-volume ordering ☐ Manage emergency orders ☐ Provide order tracking and reporting ☐ Maintain inventory visibility ☐ Support consolidated billing and invoicing

6. IT & Cybersecurity Package ☐ Ordering portal description and demo video (Video must not exceed 35 MB) ☐ User access controls ☐ Incident response plan ☐ System availability metrics

7. Past Performance Package ☐ CPARS references or reports ☐ Federal healthcare contracts ☐ Pharmaceutical distribution contracts ☐ Vaccine distribution contracts ☐ Occupational health support contracts ☐ Commercial healthcare supply contracts ☐ Customer references (must include Past Performance Questionnaire Attachment J.5 completed by a minimum of three (3) references within the past five (5) years) ☐ Contract values and performance periods

8. Distribution & Logistics Documentation ☐ Distribution network map ☐ Warehouse locations ☐ Inventory management capabilities ☐ Shipping procedures ☐ Temperature-controlled shipping capabilities ☐ Emergency fulfillment procedures

9. Pricing Documentation ☐ Discount schedules ☐ GSA/FSS pricing (if applicable) ☐ Price escalation methodology ☐ Rebate structure ☐ Administrative fee structure ☐ Portal maintenance pricing ☐ Pricing Worksheet attachment J.2 (include Base and all options)

10. Financial Responsibility ☐ Audited financial statements (must include prior two (2) fiscal years and must also submit the Financial Health Justification Form found in the solicitation attachments J.6) ☐ A proposed payment schedule for the contract should be included. The payment schedule should be commensurate with the work to be performed for the contract deliverables and advance payments will not be made ☐ Bank references (if requested) ☐ Proof of bonding capability (if requested) ☐ Evidence of working capital

11. Required Policies & Programs ☐ Subcontracting plan (if applicable) ☐ Joint venture documentation (if applicable) ☐ Commitments - The Offeror shall list commitments of key personnel with other clients/contracts and indicate whether these commitments will or will not interfere with the completion of work and services contemplated to be completed under this contract ☐ Organizational Conflict of Interest Disclosure/Mitigation Offerors are required to identify actual and potential organizational conflicts of interest (OCI) related to the services described in the performance work statement for itself, as well as employees, consultants and subcontractors proposed.

☐ 8a program documentation (if applicable)

12. Proposal Volumes All proposals should be separated into the following volumes:

☐ Volume I – Technical Proposal -see pages 71 to 77 of solicitation ☐ Volume II – Business/Pricing Proposal- see pages 77 and 80 of solicitation (pricing must include base and all options) ☐ Volume III – Past Performance- pages 85 and 87 of solicitation (must include Past Performance Questionnaire Attachment J.5 completed by at least three (3) references within the past five (5) years) ☐ Volume IV – Demo of Web Portal – page 72 of solicitation (video must not exceed 35 MB)