MCM_CSO_W911QY-20-S-C001 AOI A006_Final.docx

U.S. Army Contracting Command – Aberdeen Proving Ground, Joint COVID-19 Response Division (ACC-APG-JCRD) Joint Program Executive Office - Chemical Biological Radiological Nuclear Defense (JPEO-CBRND) Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) Medical Countermeasures (MCM) Commercial Solutions Opening (CSO) Solicitation Number: W911QY-20-S-C001 Area of Interest (AOI) Number A006: Retail Pharmacy Dispensing of Oral Therapeutics Date: 26 July 2021

1. AoI Background:

In December 2019, a novel (new) coronavirus known as SARS-CoV-2 (“the virus”) was first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease COVID-19 that has now spread globally. The Secretary of Health and Human Services (HHS) declared a public health emergency on January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to COVID-19. On March 1, 2020, the President of the United States, pursuant to sections 01 and 301 of the National Emergencies Act (50 U.S.C. 1601 et seq.) and consistent with section 1135 of the Social Security Act (SSA), as amended (42 U.S.C. 1320b-5), proclaimed that the COVID-19 outbreak in the United States constitutes a national emergency.

Under the U.S. Government’s (USG) COVID-19 Response mission, HHS is leading a whole of nation effort with the primary goal to execute on a well-defined portfolio of COVID-19 medical countermeasure (MCM) candidates to maximize availability of safe and effective vaccines, therapeutics and diagnostics as fast as possible for mass distribution. As such, BARDA has a specific need to procure, distribute and ensure access for the American public to orally administered, direct-acting antiviral therapeutic treatment.

2. AoI Objective:

The USG seeks innovative(1) commercial products, technologies, or services that support the retail pharmacy dispensing of USG owned, orally administered, direct-acting antiviral therapeutics to treat outpatients that are under an Emergency Use Authorization (EUA) granted by the Food and Drug Administration (FDA). The pharmacies must reach rural locations and US territories to provide access to the drug to 100% of the US population.

1 “Innovative" means any technology, process, or method, including research and development that is new as of the date of submission of a proposal, or any application that is new as of the date of submission of a proposal of a technology, process, or method existing as of such date.

3. AoI Tasks:

The Solution Brief must address the following tasks:

Task 1 – Obtain the authorized product from authorized distributors

· The Offeror shall establish agreements with the distributors within 15 calendar days of the contract award allowing the product to be shipped to their facilities. Offerors will be able to directly order authorized product from distributors.

· The USG maintains the ability to allocate product to organization / locations.

· Offeror will provide a plan for equitable distribution of the authorized products within their networks and guard against stockpiling within 30 days of contract award.

· The USG has the option to set limits on ordering from distributors and modify those limits as needed.

· The Offeror will store the product under the specified conditions as per manufacturer.

Task 2 – Dispense the authorized product to the American public to ensure that 100% of the population has access.

· The Offeror will ensure patients with prescriptions can fill prescriptions at any site operated by the Offeror within 24 hours. In select locations, access within 24 hours may not be possible. In these cases, the Offeror must propose a solution to ensure the product is delivered to the patient within 48 hours of receiving the prescription.

· The Offeror will provide access to COVID-19 therapeutics that the federal government provides at no cost to the patient or third-party payers.

· The Offeror will comply with all provisions of the FDA letter of authorization for sites dispensing the product authorized under Emergency Use Authorization (EUA).

· The Offeror will accept prescriptions for the authorized product from providers appropriately licensed in their state/territory.

· Before dispensing the COVID-19 therapeutic, the Offeror must provide the most current approved EUA fact sheet (provided by the manufacturer) to each patient, adult caregiver accompanying the patient (if applicable), or other legal representative (if applicable).

Task 3: Data Reporting

· The Offeror shall submit to USG on a weekly basis through designated channels the number of COVID-19 therapeutics that the Offeror:

· Has in stock

· Has dispensed at each location in each state, locality, and territory in an agreed upon format

· The number of treatment courses distributed to residents residing in each zip code

· Additional data elements as defined by USG

· Expenditure of funds. The Offeror will notify the USG when they have expended 75% of funding provided by the contract

· The Offeror will provide information for every location which will receive COVID-19 therapeutic:

· Store’s Organization-assigned ID number

· Location address, telephone, and fax number

· Provide locations where treatment is available and give the USG permission to post on publicly available websites the locations of pharmacies dispensing COVID-19 therapeutics

Task 4- Patient Outreach

· The Offeror will provide information about antiviral therapeutic for patients/customers.

· The Offeror will provide information on product availability on public-facing resources (e.g., website, apps, etc.) as identified by the USG.

· The Offeror will gain USG approval for all public-facing documents.

4. AoI Deliverables: A full list of deliverables will be included in any resulting Request for Full Proposal (RFFP) as Attachment 1, Antiviral Deliverables Table, and will be applicable to any resultant award. The Government reserves the right to modify or supplement the Deliverables Table. Technical data deliverables described therein that are funded exclusively by the USG shall be delivered to the USG with a minimum of Government Purpose Rights as described in DFARS 252-227-7013.

5. AoI Constraints:

a. Offeror(s) selected to receive an award will be required to be registered in the System for Award Maintenance (sam.gov). It is critical offerors are registered in the System for Award Management (SAM), https://www.sam.gov/. Companies will be ineligible for an award if not registered in SAM at the time your response to the RFFP is submitted. Additionally, verify that you are registered to receive contracts (not just grants) and that your address matches your proposal and SAM.

b. When registering in SAM.gov, be sure to select ‘YES’ to the question ‘Do you wish to bid on contracts?’ in order to be able to compete for CSO. If you are only registered to compete for grants, you may be ineligible for award.

c. The USG is working to move expeditiously to execute contract(s), therefore it is extremely important that all companies double check your CAGE codes and DUNS numbers to ensure they are accurate. If they are not accurate at the time of submission, you may be ineligible for award.

d. If applicable under Food and Drug Administration (FDA or USFDA) guidance addressing the current public health emergency, offerors will be required to comply with the Drug Supply Chain Security Act (DSCSA), which pertains to item level serialization. The DSCSA requires wholesale distributors and third-party logistics providers to report licensure and other information annually to the FDA.

e. The USG reserves the right to request clarifying information or not to request clarifying information after receipt and evaluation of proposals.

f. The USG reserves the right to enter into discussions or not to enter into discussions.

g. The USG intends to issue either an Other Transaction Agreement (OTA) or Firm-Fixed-Price FAR Part 12 type contract, as a result of this AoI.

6. AoI Solution Brief Submission Requirements:

Solution briefs must address all of the tasks identified in paragraph 3 above and shall not exceed ten (10) single-sided written pages using 12-point font or, alternatively, Solution briefs may take the form of briefing slides which should not exceed fifteen (15) slides. Any tables and figures submitted cannot exceed 8-1/2 X 11-inch on printed paper to be counted as one page. Font size for tables and figures shall be no smaller than 8-point. Solution Briefs must be submitted no later than 5:00 PM EDT on 3 August 2021. The government reserves the right to or not to evaluate Solution Briefs received after the submission deadline. All submissions must be sent to the points of contact (POC) listed in the POC section of this AoI. Due the urgent nature surrounding the U.S. Government’s COVID-19 Response Mission, the government does not intend to enter into CSO Phase 2 procedures but reserves the right to based on the evaluation results.

Solution Briefs must include the following:

a. Company Name, Title, Date, Point of Contact Name, E-Mail Address, Phone, and Address. Specifically identify the AoI for which the Solution Brief is submitted.

b. Executive Summary: Provide an executive summary of the technology. (This is included in the 10 written pages limit).

c. Technology Concept: Show and/or describe how your proposed solution or potential new capabilities fulfill innovative, commercial products, commercial technologies and services or adaptations/modifications of existing commercial product technologies and services to this AoI. Describe the unique aspects of your technology and the proposed work as it relates to this AoI. Identify whether the effort includes the pilot or demonstration of existing commercial technology (identified as commercially ready and viable technology), or the development of technology for potential defense application. If development or adaptation is proposed, identify a suggested path to mature the technology. Identify aspects of your proposal, to include data and software, which may be considered proprietary.

d. Price: Provide a rough order of magnitude price for the proposed solution and include desired payment terms.

7. Phase I Solution Brief Basis of Evaluation – Additional Evaluation Criteria:

In addition to the evaluation criteria listed in the CSO W911WY-20-S-C001 paragraph 3.2.2, the technology at the time of submission must demonstrate the following, as documented in the solution brief:

· Provide a map of all retail pharmacy locations within the continental United States and estimate the percentage of Americans that are within a 1) 10-mile radius and 2) 20-minute drive time of locations. Submissions that cannot demonstrate that pharmacy locations are within a 10-mile radius or a 20-minute drive time from at least 40% of the US population will not be considered responsive.

· Discuss significant geographic gaps in location accessibility and solutions to provide access patients that are outside the 1) 10-mile radius and 2) 20-minute drive time. Offerors that have the ability to provide all Americans access to the therapeutic within 48 hours (e.g., by delivery) will be rated highly.

· Provide a plan to ensure equitable access to all Americans using your retail locations

· Explain the ability to adapt to changes in the pandemic and provide access to pharmaceuticals in multiple areas experiencing a potential surge in COVID-19 and allocate resources as needed. Offerors that can provide surge capabilities will be prioritized over those that cannot.

· Provide data sharing plan that ensures timely and accurate information on drug being dispensed on a weekly basis

· Provide a single firm-fixed price per prescription filled to dispense at least 500,000 oral drugs provided by the USG over 3-6 months at geographically dispersed locations. Contracts may have options to dispense additional drugs as needed by the USG.

8. AoI Request for Commercial Solutions Proposal (CSP) Submission Requirements:

Proposals must include separate technical and price volumes. All submissions are limited to 10 pages (12- point font) per volume not including the cover page and table of contents. Pages after the 10th page will be discarded and not evaluated. Based on the government’s market research and previous efforts the government anticipates selecting multiple offerors to submit proposals as a result of solution brief evaluations. The government reserves the right to request proposals from “all, some, or none” of the offerors who submitted solution briefs based on the evaluation and individual merits.

9. Points of contact:

Contracting/Agreement Officers: Christopher L. Johnston; christopher.l.johnston20.civ@mail.mil Branch Chief: Keith L. Mcpherson; keith.l.mcpherson2.civ@mail.mil Procurement Analyst: TBD

10. General Note:

This AoI does not commit the government to pay the costs associated with your proposal preparation or transmission. The Contracting Officer is the only individual who can legally commit the government to the expenditure of public funds on any resultant contract.

If a/an offeror(s) receives a request to submit a proposal from the government, proposals must be submitted no later than the date and time identified in the request for proposal. The government reserves the right to or not to evaluate proposals received after the submission deadline. All proposal submissions must be sent via e-mail, with subject line stating “(Insert Company Name) “Retail Pharmacy Dispensing of Oral Therapeutics AoI #A006” to the POCs listed in the POC section of this AoI. Due the urgent nature surrounding the U.S. Government’s COVID-19 Response Mission, the government may execute awards against this AoI at any time after the receipt of proposals.

Proposals must include the following:

a. A technical volume that includes a detailed work plan indicating how each aspect of the objectives, tasks and deliverables are to be accomplished. CSP’s technical volumes must be in as much detail as considered necessary to fully explain the proposed technical approach or method including all technical assumptions. The technical volume must reflect a clear understanding of the nature of the work being undertaken. The technical volume must include information on how the project will be organized, staffed, and managed, including a monthly breakdown of capacity available. Information must be provided that demonstrates an understanding and management of important events or tasks. The technical volume must include a list of any other suggested deliverables and deliverable dates.

b. A price volume that includes sufficient information to allow the government to perform an analysis of the proposed cost or price of the work, to include all related pricing assumptions. The government reserves the right to request any other price data or supporting cost information the government deems necessary to determine the total overall price is fair and reasonable. This can include but is not limited to commercial price catalog(s), previous commercial sales receipts, and/or other proprietary information to help the government determine reasonableness and future budgetary cost estimates. If a price proposal includes a time and materials contract line item, the proposal must include labor categories and corresponding number of direct labor hours; fixed hourly rates that include wages, overhead, general and administrative expenses, and profit; and actual costs for materials.

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