MCM CSO AoI W911QY-20-S-C001-A001 COVID-19 Vaccine Fill Finish.pdf

U.S. Army Contracting Command – Aberdeen Proving Ground, Natick Division (ACC-APG-Natick) 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-SS-C001

Area of Interest (AOI) Number A001: COVID-19 Fill and Finish Manufacturing Capacity

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 President’s Operation Warp Speed 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 candidates to maximize probability of having safe and effective diagnostics, therapeutics and vaccines as fast as possible for mass distribution. As such, BARDA has a specific need to identify US domestic aseptic fill and finish manufacturing capacity for critical vaccines and therapeutics in response to the COVID-19 pandemic to ensure uninterrupted supply throughout the COVID-19 campaign. BARDA needs to identify these US domestic aseptic fill and finish manufacturing capacities because BARDA-sponsored product developers and manufacturers may not have timely access to this capacity for COVID-19 response.

2. AoI Objective:

The government seeks to reserve domestic aseptic fill and finish manufacturing capacity for critical vaccines and therapeutics in response to the COVID-19 pandemic to ensure uninterrupted supply throughout the COVID-19 campaign between August 2020 and July 2021. The reserved capacity must include the currently unallocated production slots at the specific Contract Manufacturing Organization (CMO) facilities that could be secured for future government use. Included in the “capacity” are the costs associated with facilities and equipment usage for a given production slot, labor, materials as well as support services necessary to fill, label, package, and release a standard batch fill. For efficiency and in order to minimize risk, it is preferred that these services are provided in-house. The reservation must exclude the performance of any work in the reserved capacity without the explicit, written approval from the government during the reservation period. The offeror must be responsible for management of all activities to meet the goals of the contract, including holding routine meetings with BARDA, and completion of meeting minutes. On a monthly basis, the offeror(s) must provide a monthly report that includes capacity availability and utilization, as well as any issues that impact the operational availability of the reserved capacity.

3. AoI Tasks:

Task 1 – Aseptic Fill and Fill Manufacturing Capacity Reservation:

The offeror must identify domestic aseptic fill and finish manufacturing capacity for critical vaccines and therapeutics in response to the COVID-19 pandemic to ensure uninterrupted supply throughout the COVID-19 campaign to be reserved for the exclusive use of the government for the duration of the period of performance. Where possible, it is preferred that Fill and finish activities be completed at the same manufacturing site. The capacity must include currently open production slots on a commercial filling line utilizing a multi-dose vial size (2R, 6R, 10R, etc.), inspection, labeling and packaging, as well as the support services required to release each lot. The maximum batch size in liters, anticipated batch vial yield for 10R vial size, batches per month and doses/month (10 dose vial) should be presented in the proposal.

The offeror should outline the capabilities for each filling line (filling technology, vial size range, throughput, nitrogen overlay, etc.) including current qualified vial sizes. The offeror(s) must maintain the reserved capacity in a state of readiness to perform current good manufacturing practices (cGMP) manufacturing activities, approved by the government, under separate task orders/contracts/agreements for the entirety of the period of performance. The reservation must exclude the performance of any work in the reserved capacity without the explicit, written approval from the government during the reservation period.

Task 2 – Program Management Activities:

The offeror must establish the new capacity in compliance with Food and Drug Administration (FDA) current good manufacturing practices (cGMP) regulations, and Biosafety Level standards if applicable.

The offeror must be responsible for management of all activities, subcontractors, etc. to meet the goals of the contract, including holding routine meetings with BARDA, and completion of meeting minutes. On a monthly basis, the offeror(s) must provide a monthly report that includes capacity availability and utilization, as well as any issues that impact the operational availability of the reserved capacity.

Task 3 – Surge Capacity Evaluation:

The offeror must identify non-construction, aseptic fill and finish manufacturing surge capacity capabilities with existing manufacturing equipment. If possible, the offeror must develop a plan to increase manufacturing capacity through short lead-time equipment purchase (change parts, test equipment, etc.), temporary staffing increases, and /or moving of existing customer production to facilitate additional open capacity from August 2020 and July 2021. The offeror must reserve the surge capacity, in alignment with Objective Task 1 above, for the exclusive use of the government for the duration of the period of performance.

4. 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 proposal 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 government 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).

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

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

g. The government intends to issue Firm Fixed Price FAR Part 12 type contract(s).

5. AoI Solution Brief Submission Requirements:

Solution Briefs must not exceed five (5) 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. Solution Briefs must be submitted no later than 1200 on 3 July, 2020. 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 President’s Operation Warp Speed Mission CSO the government does not intend to enter into CSO Phase 2 procedures but reserves the right to do so 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 5 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 manufacture products used to combat the current COVID-19 pandemic, as well as address future pandemics or medical emergencies. Describe the unique aspects of your technology and the proposed work as it relates to the 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 date 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. ROM.

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

Proposals must include separate technical and price volumes. All submission 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.

If 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 anticipates that proposals will be required to be submitted within seven (7) days after receipt of the request for proposal but reserves the right to define the specific due date and time that may be less or more than seven (7) days based on the urgency of the requirement. 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) COVID-19 Fill and Finish Manufacturing Capacity AoI A001” to the POCs listed in the POC section of this AoI. Due the urgent nature surrounding the President’s Operation Warp Speed Mission the government may execute awards against this AoI at any time after the receipt of proposals.

Proposals must include the following:

a. The technical volume that includes a detailed work plan indicating how each aspect of the objectives 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 assumptions utilized to develop the reservation plan and associated costs. 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 and all technical assumptions made in determining the scope of the reservation cost including (i.e. technology transfer, formulation, in-house vs out sourced, etc.). Information must be provided that demonstrates an understanding and management of important events or tasks. The technical volume must include a list of suggested deliverables and deliverable dates.

b. The price volume must contain sufficient information to allow the government to perform a basic analysis of the proposed cost or price of the work. 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.

7. Points of contact:

Contracting Officer: Sean Auld, sean.g.auld.civ@mail.mil Procurement Analyst: Maria Dunton, maria.c.dunton.civ@mail.mil.

8. 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.