Request for Proposal 75A50125R00003 Autograft Sparing Devices.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

ASPR-BARDA

See Schedule

ASPR-BARDA CODE 16. ADMINISTERED BYCODE

X

X

339113

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORASPR-BARDA

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

07/07/2025 1400 ET

06/04/2025

RICHARD HALL

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75A50125R00003

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 83 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

See Schedule

15. DELIVER TO

Washington DC 20201 Room 640-G 200 Independence Ave., S.W.

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

ASPR-BARDA

WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

ADMINISTERED BY:

ASPR-BARDA

US DEPT OF HEALTH & HUMAN SERVICES

BIOMEDICAL ADVANCED RESEACH & DEVELOPMENT AUT

200 INDEPENDENCE AVE, S.W.

ROOM 640-G

Washington DC 20201 USA

DELIVER TO:

ASPR-BARDA

US DEPT OF HEALTH & HUMAN SERVICES

Continued ...

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

RICHARD A. HALL

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

BIOMEDICAL ADVANCED RESEACH & DEVEL

200 INDEPENDENCE AVE, S.W; ROOM 640

Washington DC 20201 US

Period of Performance: 09/30/2025 to 09/29/2035

1 CLIN 001 - Initial procurement of FDA approved

Access-Maintenance Agreement products upon notification of requirement purchase for commercially available Autograft Sparing Devices.

2 CLIN 002 - Vender Managed Inventory FDA approved commercial device maintenance fee. Contractor shall ensure Access-Maintenance Agreement products expiry dates, rotation of product through commercial sales, and provide monthly reports to BARDA.

3 CLIN 003 - Emergency Deployment of

Access-Maintenance Agreement products up to a

1000 units per written notification of the

Contracting Officer or designated representative of the current VMI stock being held to be packaged and forwarded to the designated burn/trauma center within the United States and it territories.

Continued ...

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

83 2 of

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 83

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75A50125R00003

4 CLIN 004 - Additional procurement of FDA approved

Access-Maintenance Agreement products upon notification of requirement purchase for commercially available Autograft Sparing Devices up to a maximum of 2000 units.

5 CLIN 005 - Emergency Deployment of

Access-Maintenance Agreement products up to a

2000 units per written notification of the

Contracting Officer or designated representative of the additional VMI stock being procured to be packaged and forwarded to the designated burn/trauma center within the United States and it territories.

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

COMBINED SYNOPSIS / SOLICITATION

FAR 12 COMMERCIAL ITEMS & FAR 15 NEGOTIATION

75A50125R00003

TITLE: Autograft Sparing Device

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; Proposals are being requested.

(ii) The solicitation number is 75A50125R00003 and the solicitation is issued as a request for

Proposal (RFP). This acquisition is for a commercial item and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold.

(iii) This is a competitive combined synopsis/solicitation. Award(s) will be made to the offerors whose

Proposal(s) successfully address each of the identified requirements, and for which the proposed price is determined to be fair and reasonable.

(iv) The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular (FAC) 2025-03 January 17, 2025.

(v) The associated NAICS code 339113 - Surgical Appliance and Supplies Manufacturing and the small business size standard is 800 employees. This requirement has no set-aside restrictions.

(vi) The information in SECTION A - Solicitation/Contract Form, contains important information for any Offeror interested in responding to this solicitation. Any contract resulting from this solicitation will include in its SECTION A - Solicitation/Contract Form, accounting, appropriation and general information applicable to the contract award.

(vii) If your proposal is not received by the Contracting Officer (CO) or his/her designee at the time and place specified, it will be considered late and handled in accordance with the Federal Acquisition Regulation (FAR), FAR 52.215-1 (Instructions to Offerors – Competitive Acquisition), the Health and Human Services Acquisition Regulation (HHSAR)

(viii) Potential Offerors must be registered in the System for Award Management (SAM) prior to submittal of proposal.

(ix) The contract schedule, set forth in SECTIONS B through H, contains contractual information pertinent to this solicitation. It is not an exact representation of the contract document that may be awarded as a result of this solicitation. The contract cost or price and other contractual provisions unique to the Offeror's proposal may be included in the resultant contract.

(x) The contract schedule is intended to provide the Offeror with information to aid in understanding the likely terms and conditions of any resultant contract.

(xi) The cutoff date for all questions on this Request for Proposal (RFP) is June 16, 2025 at 2:00 PM ET. All questions shall be submitted via e-mail to richard.hall@hhs.gov. The due date for all proposal submissions is July 7, 2025 at 2:00 PM ET. All proposals must be submitted via email to richard.hall@hhs.gov and kevin.dean1@hhs.gov. The submission email must include business and technical proposal documents as separate documents.

mailto:richard.hall@hhs.gov mailto:richard.hall@hhs.gov mailto:kevin.dean1@hhs.gov

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

Treatment and care for burn injuries is both resource and labor intensive. The national capacity is typically limited and presents a significant limitation to when a sudden surge capacity is required in a burn mass casualty incident (BMCI). A BMCI in a geographic area could overwhelm a regional existing capacity and present to substantial resource constraints. To mitigate this challenge, BARDA has collaboratively worked with the burn care community to identify areas of improvement in the delivery of this care. This collaboration has identified numerous area which BARDA has systematically addressed over the years. The two major areas where enhanced treatment options could provide a meaningful difference are in the initial care and triage of patients, and secondly, in the long-term treatment and recovery steps of burn care. The focus of this RFP is to address the long-term treatment and recovery steps of burn care.

Autografting is the current standard of care for long term treatment and recovery of deep partial and full thickness burn injuries. This involves removing healthy skin from an uninjured area of the patient’s body and affixing it on top of the burn wound. The autografting procedure is labor-intensive, requires training, is time consuming and invokes additional risk to the patient due to the operative procedures at multiple sites. Discussions with the professional burn community and market research data indicates that products that reduce the amounts of autograft needed to provide wound closure (autograft-sparing) can provide an advantage for rapid and effective care of severe burn injuries. Such products also have the potential to reduce the morbidity of the donor sites. Such products should be compatible with current procedures to allow easy integration so they could be also used during a mass casualty scenario involving significantly high numbers of burn patients. Additionally, such products that have indications for full thickness skin defects due to traumatic injury would be advantageous to address additional injuries resulting from an MCI. This Statement of Objective (SOO) focuses on products which could contribute to autograft-sparing in burn and trauma patients and potentially accelerate the healing process while leading to better outcomes.

Based on this background, the objective of this RFP is to support procurement of an approved autograft sparing device. The technology must be capable of treating both full thickness thermal burn wounds as well as full thickness skin defects resulting from trauma. Procurement strategies would include use of an Access-Maintenance Vendor Managed Inventory (AM-VMI) contract covering the period of performance.

Via this Access-Maintenance VMI, the Offeror will maintain a cache of product determined by the shelf life and sales volume. This cache will be maintained by the Offeror monthly to ensure all product is within expiry and report total inventory numbers to BARDA. In return, BARDA will pay for this monthly maintenance cost and the right to access/procure this VMI cache in the event of a national emergency.

The negotiated terms include the price per unit as well as the size of the product inventory. This system allows for maximum national preparedness while limiting waste of unused product by only procuring the product if it is needed to respond to a mass casualty incident.

B.1.1. Definitions

Access-Maintenance Vendor Managed Inventory (AM-VMI) – The Contractor and U.S. Government (USG) agree the USG shall pay a fee for the contractor to hold, and maintain in reserve, a negotiated level of commercially useable product for its intended purpose in delivery of care; and the entire product inventory shall be available for purchase by USG. The Contractor and USG also agree to a pre-negotiated price for procurement on demand of the products in the inventory, to mutual terms for periodically expanding the size of the inventory, and for the contractor to deploy the procured product via their commercial processes and infrastructure or in collaboration with the Strategic National Stockpile

(SNS).

Commercial Product – As defined in FAR 2.101.

Food and Drug Administration (FDA) Approved - The FDA approval of a medical product (e.g., drug, device or biologic) means the product’s safety and effectiveness have been reviewed by the FDA and the product’s known and potential benefits outweigh the known and potential risks. If the FDA grants an approval, it means the agency has determined the product is safe and effective for its intended use.

Government Furnished Property (GFP) - All property owned or leased by the Government. Government property includes both Government-furnished property and contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property.

Government property does not include intellectual property and software. The Government shall not own any property under this contract.

B.2. PRICES / COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. It is anticipated that the final contract will consist of a base period of performance of up to ten (10) years.

The Base Period consists of five Firm Fixed Price CLINs to support procurement, maintenance, and emergency deployment of autograft sparing devices. This requirement has no proposed or required options at this time.

B.2.1. BASE PERIOD

Base Period Firm Fixed Price CLINs

Estimated Period of Performance

CLIN Description of Supplies/Services Quantity Unit Price

Total ($)

09/30/2025 to 09/29/2035

CLIN 001

Initial procurement of FDA approved Access-Maintenance Agreement products up to a maximum of 1000 units for commercially available Autograft Sparing Devices.

Up to 1000

09/30/2025 to 09/29/2035

CLIN 002

Vender Managed Inventory FDA approved commercial device maintenance fee.

Contractor shall ensure Access- Maintenance Agreement products expiry dates, rotation of product through commercial sales, and provide monthly reports to BARDA.

120 months

09/30/2025 to 09/29/2035

CLIN 003

Emergency Deployment of Access- Maintenance Agreement products up to a 1000 units per written notification of the Contracting Officer or designated representative of the current VMI stock being held to be packaged and forwarded to the designated burn/trauma center within the United States and it territories.

1.00

09/30/2025 to 09/29/2035

CLIN 004

Additional procurement of FDA approved Access-Maintenance Agreement products upon notification of requirement purchase for commercially available Autograft Sparing Devices up to a maximum of 2000 units.

Up to 2000

09/30/2025 to 09/29/2035

CLIN 005

Emergency Deployment of Access- Maintenance Agreement products up to a 2000 units per written notification of the Contracting Officer or designated representative of the additional VMI

1.00 stock being procured to be packaged and forwarded to the designated burn/trauma center within the United States and it territories.

TOTAL COST

B.2.2. PBS Contract Authority: 42 USC 247d-6b(c) and (g), the Project BioShield Act of 2004.

B.2.3. Multi-Year Contract: Multi-year Project BioShield (PBS) contract means a contract for the purchase of supplies or services for more than one, but not more than ten, program years. A multi-year contract may provide that performance under the contract during the option periods and subsequent years of the contract is contingent upon the appropriation of funds, and (if it does so provide) may provide for a cancellation payment to be made to the contractor if appropriations are not made. The key distinguishing difference between multi-year contracts and multiple year contracts is that multi-year contracts, defined in the statutes cited at 17.101, buy more than one year’s requirement (of a product or service) without establishing and having to exercise an option for each program year after the first.

B.2.4. Type of Contract: The Contracting Officer has determined this to be a Firm-Fixed Priced (FFP) Contract.

B.3. ADVANCE UNDERSTANDINGS

The final contract may contain advance understandings between the Government and the Offeror.

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost will be included in this Section if the Contracting Officer has granted his/her approval prior to contract award.

B.3.1. BARDA shall designate in each request for delivery, the specific delivery date, shipping company information, driver information (may or may not be required), quantity and inventory information.

Additional requirements may be required by the receiving location. This information shall be provided in an authorization and approval memorandum by the Contracting Officer or designated representative.

B.3.2. The Contractor shall provide a Quality Agreement to BARDA within sixty-days of the awarded contract for review and approval. This Quality Agreement shall outline the responsibilities of both the Contractor and BARDA for product shipping, receiving, and storage. These documents shall be bilaterally signed once approved by both parties. This Quality Agreement will be a deliverable on the contract and will not supersede the terms and conditions of the overarching contract.

B.3.3. The Contractor shall notify the Government of changes to the recommended product delivery system. The Government shall have the right to adjust the total products available for procurement within the AM-VMI based upon technological or manufacturing advancements and the Governments requirements.

Rights In Data

No data rights are required or anticipated.

Travel

No travel is anticipated for this award at this time.

Person-in-Plant

With seven (7) days advance notice to the Contractor in writing from the Contracting Officer, the Government may place a man-in-plant in the Contractor’s or Subcontractor’s facility, who shall be subject to the Contractor’s or Subcontractor’s policies and procedures regarding security and facility access at all times while in the Contractor’s or Subcontractor’s facility. The Government’s representative shall be provided reasonable access, during normal business hours, of the production areas being utilized in performance on the Contract. As determined by federal law, no Government representative shall publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any information coming to him in the course of employment or official duties, while stationed in a contractor or subcontractor plant.

An article substantially similar to this Person-in-Plant article shall be incorporated into any subcontract for experimental or manufacturing work.

Security

A security plan will be submitted for approval within 90 days of award. See Section J.

Subcontracts

Prior written consent from the Contracting Officer in the form of Contracting Officer Authorization (COA) is required for any subcontract that:

• Is of the cost-reimbursement type; or

• Is of the fixed price type and exceeds $250,000 or 5% of the contract, whichever is less.

The Contracting Officer shall request appropriate supporting documentation in order to review and determine authorization, pursuant with FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, the Contractor shall provide a copy of the signed, executed subcontract and consulting agreement to the Contracting Officer within ten (10) calendar days.

Note: Consulting services are treated as subcontracts and subject to the ‘consent to subcontract’ provisions set forth in this Section. In accordance with Health and Human Services Acquisition Regulation 352.231-70 Salary Rate Limitation - (a) The Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding was obligated.

(b) For purposes of the salary rate limitation, the terms “direct salary,” “salary,” and “institutional base salary,” have the same meaning and are collectively referred to as “direct salary,” in this clause. An individual's direct salary is the annual compensation that the Contractor pays for an individual's direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative costs). The salary rate limitation does not restrict the salary that an organization may pay an individual working under a Department of Health and Human Services contract or order; it merely limits the portion of that salary that may be paid with contract funds. This applies to subcontractors and consultants.

Overtime Compensation

No overtime (premium) compensation is authorized under the subject contract.

Invoice Submission during end of Fiscal Year

The government will not accept invoices for processing from September 15th through first week in October for processing because of end of year fiscal requirements. Any invoices received from September 15th through the first week in October, will be processed when financial systems are available.

B.4 ORGANIZATIONAL CONFLICT OF INTEREST

General: For the purpose of this provision/clause, “consultant” is defined as a company, firm, LLC, sole proprietor, joint venture member, independent contractor, subcontractor, affiliate, or similar entity that is not an employee of the Contractor.

Disclosure: The Contractor shall report contacts with consultants who are paid to furnish advice, information, direction, or assistance to the Contractor or any subcontractor in support of the preparation or submission of the Contractor’s business or technical proposal. The report shall include the following information:

a. The name, title, and contact information for the consultant, including the name and contact information for his/her company/firm/etc.

b. The name, title, and contact information for a Contractor point of contact, including the name and contact information for the prime contractor if the consulting services were received by a subcontractor.

c. The nature of the consulting services received.

Resolution: The responsible Contracting Officer will review the Contractor’s disclosure to determine whether an actual or appearance of a conflict of interest exists based on the information disclosed by the Contractor and/or from other sources. The framework for the Contracting Officer’s review will be FAR Subpart 9.5, Organizational and Consultant Conflicts of Interest. If an actual or appearance of a conflict of interest exists, the Contracting officer will take action which may include, but is not limited to, requesting a mitigation plan from the Contractor.

B.5. PROVISIONS TO APPLICABLE COSTS

This section prohibits or restricts the use of contract funds which includes the following items (costs unallowable unless otherwise approved by the Contracting Officer):

a) Acquisition, by purchase or lease, of any interest in real property.

b) Rearrangement or alteration of facilities.

c) Purchase of lease of any item of general-purpose office furniture or office equipment regardless of dollar value.

d) Accountable Government Property.

e) Overtime

f) General scientific meetings/conferences.

g) Travel costs including foreign travel.

h) Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements).

i) Costs to be paid for the performance of a fixed-price subcontract that exceeds $250,000.00;

j) Refreshments and Meal Expenditures.

k) Promotional Items

l) Printing

SECTION C – DESCRIPTION / SPECIFICATIONS / WORK STATEMENT

C.1. STATEMENT OF OBJECTIVES

BACKGROUND and PURPOSE

Treatment and care for burn injuries is labor intensive and influenced by the unique properties of each case with complicating factors including patient age, pre-existing health conditions, burn wound size, depth, and location. The challenges of providing definitive burn care are heightened when delivering treatment after a mass casualty event in a resource strained environment. The anticipated high number of injured in a mass casualty incident especially in a geographical area would pose significant limitations on the ability to provide conventional standards of care for victims. To mitigate some of these challenges BARDA has collaboratively worked with the burn care community to identify areas to improve the delivery of care and treatment procedures. Two major areas where enhanced medical countermeasures (MCM) can provide a meaningful difference are in the triage of initial care and in a definitive burn care setting.

A large burn mass casualty incident could quickly overwhelm the US healthcare infrastructure. Severe burn injuries (especially, >10% TBSA) typically require highly specialized care for effective delivery of resource-intensive therapies including surgeries. Nationally, this capability is critically limited at multiple levels and would challenge timely access and treatment of those injured even in a relatively small incident. This makes it imperative to leverage technology that reduces the amount of donor skin required for full thickness and large deep partial thickness burns. Reducing the required amount of donor skin for delivery of definitive care has the potential to greatly improve the patient’s quality of life while reducing hospital length of stay and the need for reconstructive surgery.

OBJECTIVE

For building national burn care preparedness under the conditions described above, BARDA intends to procure FDA approved products which can reduce the amount of autograft required to provide definitive coverage for any traumatic injuries or for full and deep partial thickness burn injuries. Such autograft sparing technologies significantly reduce the amount of donor skin required to treat full thickness burns and other full thickness skin defects in trauma to reduce patient morbidity and mortality.

To build national preparedness and address the unmet needs identified in both burn and trauma care, products shall meet both the capabilities (as also cited in Section M.3 Mandatory Criteria):

(1) FDA approved to treat full-thickness thermal burn wounds and full-thickness skin defects resulting from other traumatic injuries, in both adults and pediatrics.

(2) Demonstrated evidence in clinical use for autograft sparing, as in reduction in the amount of donor skin required for definitive care treatment.

As an FDA approved product, it is expected the product use case settings would include both burn and trauma centers. Information on the integration of the products in these routine healthcare settings would be important towards the indicated purpose to build national preparedness and availability for use and trained physicians.

Under this RFP, BARDA plans to establish an access-maintenance vendor-managed inventory (VMI) system. In this system, the Offeror is required to maintain as part of the normal (commercial) operations a pre-specified (negotiated) inventory stock of devices which are accessible on demand. In the event of a mass casualty incident and upon notification by the U.S. Government (USG), the stock shall be available in its entirety for immediate procurement and deployment to identified burn and trauma centers within 24 hours.

SCOPE

This RFP focuses on access-maintenance VMI procurement of an FDA-approved autograft-sparing product. Critical attributes of the device shall include the capability to reduce the amount of donor skin required to treat full thickness wounds from burns and trauma in children and adults. The following areas of work are considered within the overall scope of this RFP:

a) VMI management and product shipment.

b) Operational regulatory and (QSR) quality management infrastructure.

c) Capability for manufacturing at commercial scale to support both initial and additional procurements.

d) Reporting on the market penetration and integration in health care.

To meet the scope outlined above, Offeror shall address the objectives outlined in the following six sections following the guidelines provided in Section L (INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS). Note that objective 6 is required the Base Period. Proposals will be evaluated per criteria on the Offeror’s ability to meet these objectives as described below for the base period:

1) Initial procurement of FDA approved Access-Maintenance Vendor Managed Inventory products for commercially available Autograft Sparing Devices. (CLIN 001)

The vendor would maintain a cache of ready for use product units as part of the commercial inventory management. The product units are part of the vendor’s commercial operation inventory management.

The inventory is actively managed under first in- first out principle to ensure the newly manufactured product unit remains in the inventory. If a mass casualty occurs or other emergency at the USG discretion, the vendor may be notified of USG’s intent to procure a part or the entire cache of the devices in the inventory. The size of the initial cache would be subject to negotiations up to a maximum of 1000 unit devices. At any point during the duration of the contract, the USG may notify the Offeror of an intent to procure up to 1000 units from the Access-Maintenance VMI. At that time, the Offeror shall provide all necessary documentation for quality assurance and acceptance of the product by the USG. In the case of a commercial product, only what is consistent with customary commercial practice under FAR 12.301(a) will be required (e.g., Certificate of Conformance).

The Offeror shall include commercial sales data to demonstrate the capability to manufacture and store a surplus inventory of a minimum of 1000 unit devices. The Offeror shall also provide data supporting their manufacturing capacity.

2) Vendor Managed Inventory FDA approved commercial device maintenance fee. Contractor shall ensure Access-Maintenance Vendor Managed Inventory product expiry dates, rotation of product through commercial sales, and provide monthly reports to BARDA. (CLIN 002)

The Offeror shall maintain a cache of devices available for emergency deployment purposes. The stock in this inventory shall be rotated as part of routine sales using the principle of “First Expiry, First Out”. The final number of units in the inventory would be subject to finalization as part of the negotiation but should address capability to maintain a minimum of 1000 devices up to a total ramp up of 3000 devices. Ideally, with increased sales and growth in the market share over time, USG anticipates the Offeror would be able to increase the size of the cache by an additional 2000 devices (to a total of 3000 devices maintained under VMI). Each unit shall have at least 3 months of shelf-life as part of the access-maintenance VMI.

Under this CLIN, the Offeror shall provide information on the availability of resources for inventory maintenance / management activities. The Offeror shall include data demonstrating the approved shelf-life of the device, tracking and shuffling inventory and the ability to ensure a minimum shelf-life for all products in the access-maintenance VMI. The Offeror shall specify how the process is organized and managed with Standard Operating Procedures (SOPs).

3) Emergency Deployment of Access-Maintenance Vendor Managed Inventory products up to 1000 units per written notification of the Contracting Officer or designated representative of the current VMI stock being held to be packaged and forwarded to the designated burn/trauma center within the United States and its territories. (CLIN 003)

If the USG procures up to 1000 units from the Access-Maintenance VMI, the offeror will be required to prepare the specified number of units for emergency deployment within 24 hours of notification.

i) Notification to release product(s) under this Contract shall be provided in writing to the Contractor by the Contracting Officer.

ii) The Offeror shall package and ship device units via standard commercial shipping methods directly to burn and trauma centers as identified by the USG. The Offeror’s deployment plan shall also include an alternative shipment method whereby devices are deployed directly by ASPR/SNS to burn and trauma centers.

iii) At least three times during the duration of the contract, USG and Offeror shall synchronize a mock-deployment exercise to ensure the procedures and personnel are trained to react to an emergency deployment. Any deficiencies identified shall be documented and rectified.

4) Additional procurement of FDA approved Access-Maintenance Agreement products for commercially available Autograft Sparing Devices (up to a maximum of 2000 units).(CLIN 004)

Towards the original goals for national preparedness, USG may consider the need to increase in the size of the cache to be held as part of inventory available for procurement. An anticipated increase in the size of the cache would be up to 2000 devices (or as negotiated) for access and maintenance and available for procurement to be delivered within an agreed upon timeframe. If the commercial market cannot sustain maintenance of the larger cache, the Offeror shall provide the shortest ramp up plan to manufacture and deliver the additional devices and timeframe required. At any point during the duration of the contract, the USG may notify the Offeror of an intent to procure from these additional units. At that time, the Offeror shall provide all necessary documentation for quality assurance and acceptance of the product by the USG. In the case of a commercial product, only what is consistent with customary commercial practice under FAR 12.301(a) will be required (e.g., Certificate of Conformance).

5) Emergency Deployment of Access-Maintenance Agreement products up to a 2000 units per written notification of the Contracting Officer or designated representative of the additional VMI stock being procured to be packaged and forwarded to the designated burn/trauma center within the United States and its territories.(CLIN 005)

Upon purchase of additional devices in CLIN 004 above, the offeror will be required to prepare a specified number of units for emergency deployment within 24 hours of notification.

i) Notification to release product(s) under this Contract shall be provided in writing to the Contractor by the Contracting Officer.

ii) The offeror shall package and ship device units via standard commercial shipping methods directly to burn and trauma centers as identified by the USG. An option for an alternative shipment method as directed by ASPR/SNS shall be part of the deployment plan.

6) Project Management Objectives (CLINs 001 - 005)

The Offeror is directed towards details provided in the section on Reporting Requirements. The work here is intended to be performed in the Base period. Hence, all SOW activities generated for the duration of the contract shall have a Project Management and Risk Mitigation section covering objectives in this

CLIN.

(i) The Offeror shall provide a monthly inventory spreadsheet detailing the product available (under access-maintenance) to procure and deploy within 24 hours notification from the Government.

(ii) AM-VMI costs must be tracked and invoiced at the negotiated frequency.

(iii) The Offeror shall participate in regular meetings at the negotiated frequency to coordinate and oversee the contracting effort.

(iv) The Offeror shall provide a list of individuals to serve as primary and secondary points of contact who will be available 24 hours a day, seven days a week, for the purpose of a public health emergency notification.

(v) The Offeror shall provide a security plan that includes physical and information technology (IT) security associated with all aspects of manufacture of product, process, storage, and inventory of the critical assets such as devices or components when under the Offeror’s direct control.

C.2. REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

Performance of the contract will be monitored by the Contracting Officer (CO)/Contracting Officer’s Representative (COR) on a regular basis. The Contracting Officer will be responsible for inspection and acceptance of deliverables and services. Monitoring of the contract will be based on periodic reporting by the Offeror.

C.3. MEETINGS / SITE VISITS

The Contractor and BARDA/CMA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the CO/COR. Such meetings may include, but are not limited to, a kickoff meeting to be held at a location determined by the COR, status update meetings and/or teleconferences, site visits to the Contractor’s and/or subcontractor’s facilities, and meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and contractual aspects of the program. The Contractor shall provide data, reports, and presentations to USG personnel and USG-contracted subject matter experts as required by the CO/COR facilitating review of activities.

The purpose of the kickoff meeting will be to orient the Contractor to HHS/BARDA and review contract requirements. This meeting usually occurs within a month after contract award. Monthly status update meetings/teleconferences will be held. The schedule for these meetings will be established by the CO and COR.

Periodic site visits shall occur on an ad hoc basis.

Within thirty (30) calendar days of an FDA audit of Contractor or subcontractor facilities, the Contractor shall provide copies of the audit findings, final report, and a plan for addressing areas of nonconformance to FDA regulations and guidance for GLP, GMP or GCP guidelines as identified in the final audit report.

Other U.S. Government Audits

The USG reserves the right to conduct an audit of the Contractor with 48 hours advance notice. The USG reserves the right to accompany the Contractor on routine and for-cause site-visits/audits of subcontractor(s). At the discretion of the USG and independent of testing conducted by the Contractor, BARDA reserves the right to conduct site visits/audits and collect samples of product held by the Contractor and subcontractor(s).

Pre-award site visits may be made with short notice. Contractors are expected to guarantee the availability of key staff or other staff determined by the Government as essential for purposes of this site visit.

SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. PACKAGING OF PRODUCT

Packaging shall be consistent with the FDA-approved labeling and packaging for this product at the time of manufacture.

D.2. MARKING

Marking of product and shipping packages shall be in accordance with FDA-approved labeling direction to be provided at the time of manufacture.

D.3. DISTRIBUTION AND DEPLOYMENT/SHIPPING SERVICES

Shipping/deployment of products shall be in accordance with written authorization by the CO for each shipment. The USG may request a number of units to be delivered to the location of the emergency as requested by the CO in the Notification of Release of Product for each shipment.

All Products shall be labeled and packaged in accordance with GCP (Good Clinical Practices) and/or cGMP (Current Good Manufacturing Practices) as appropriate. Products shall be packed to ensure compliance with known product stability requirements that maintain satisfactory product temperatures during transit and arrival at destination. Products shall be packed to ensure maintenance of FDA recommended temperature during transit and safe arrival at destination

Concurrence on planned shipment protocols shall be obtained from HHS prior to transport.

D.3.1. SPECIFIC SHIPPING SERVICES

The USG may issue a Notification of Release of Product for shipment for a requested number of doses to be delivered to a location as requested by the Contracting Officer or by an authorized representative designated by the CO.

The Contractor shall perform the following activities for distribution. Following the completion of packaging the product into cartons and master cartons, the master cartons shall be palletized in a pattern suitable for storage and eventual shipment. The pallet pattern shall be standardized for each product type such that the quantity shall be uniform across all full pallets in a lot. The master cartons on the full pallets and partial pallets, if one exists, shall be securely stretch wrapped to the pallet itself in order to prevent damage in transit.

If required, at the time of shipping, a temperature recorder (preferably a TempTale or a functionally equivalent product) shall be placed on each pallet. The temperature recorder shall have alarm limits set based on the established temperature parameters, and they shall be activated when the pallets are placed on the trucks that have been pre-cooled to their target temperature prior to loading. The Contractor is required to maintain records that document the date of delivery receipt, and that the product was properly maintained within the recommended cold chain temperatures during Contractor’s transit of Product until receipt of Product by the USG or its designee. After loading, numbered seals shall be affixed to the cargo doors and the numbers entered on the bill of lading.

The Contractor shall be responsible for delivering USG-owned product in a condition fit for its intended use to shorten the recovery time.

D.3.2. PACKAGE PRODUCT FOR PICKUP BY THE USG

The CO may request the Contractor to transfer product to the USG for pick up at the Contractor’s VMI facility(s). The Contractor shall perform the following activities to prepare the product for pickup by the USG. Following the completion of packaging the product into cartons and master cartons, the master cartons shall be palletized in a pattern suitable for storage and eventual shipment. The pallet pattern shall be standardized for each product type such that the quantity shall be uniform across all full pallets in a lot.

The master cartons on the full pallets and partial pallets, if one exists, shall be securely stretch wrapped to the pallet itself in order to prevent damage in transit.

If required, a temperature recorder (preferably a TempTale or a functionally equivalent product) shall be placed on each pallet. The temperature recorder shall have alarm limits set based on the established temperature parameters, and they shall be activated when the pallets are placed on the trucks that have been pre-cooled to their target temperature prior to loading. The USG will be responsible for all shipping costs and handling all shipping/logistics.

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

Inspection and acceptance of the product, services, and documentation (Certificate of Conformance) shall be shared via email with Contracting Officer or the designated Contracting Officer’s Representative prior to product acceptance. Acceptance of a commercial product will be consistent with customary commercial practice under FAR 12.301(a).

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the designated COR within 30-days of receipt.

E.2. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

This contract incorporates the following clauses by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR 52.246-2, Inspection of Supplies – Fixed-price (August 1996) (CLINs 001 – 005) FAR 52.246-4 Inspection of Services-Fixed-Price (Aug 1996) (CLIN 002) FAR 52.246-16, Responsibility for Supplies (April 1984) (CLINs 001 – 005)

E.3. INSPECTION, ACCEPTANCE AND CONTRACT MONITORING

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Contracting Officer or designated COR consistent with customary commercial practice under FAR 12.301(a).

At the discretion of the Government and independent of activities conducted by the Contractor, with 48-hours’ notice to the Contractor, the Government reserves the right to conduct site visits and inspections related to this Contract on an as needed basis during normal business hours, including collection of product samples and intermediates held at the location of the Contractor, or its subcontractor. The Contractor shall coordinate these visits and shall have the opportunity to accompany the Government on any such visits.

Under time-sensitive or critical situations, the Government reserves the right to suspend the 48-hour notice to the Contractor. The areas included under the site visit could include, but are not limited to:

security, regulatory and quality systems, manufacturing processes and cGMP/GLP/GCP compliance related to activities funded under this Contract.

If the Government, Contractor, or other party identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the Government for review and acceptance:

• If issues are identified during the audit, the Contractor shall submit a report to the CO and COR within five business days detailing the finding and corrective action(s) of the audit.

• COR and CO will review the report and provide a response to the Contractor within ten business days.

• Once corrective action is completed, the Contractor will provide a final report to the CO and COR.

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The base period of performance of this contract is anticipated for a maximum of 120-months from the date of award.

F.2. DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in SECTION C of this RFP and upon delivery and acceptance of the items described in SECTION F.3 by the Contracting Officer or designated COR.

F.2.1. Place and method of delivery for Product purchased will be determined at the time of procurement or as determined necessary to respond to an emergency scenario. Refer to SECTIONS F.2.2, F.2.3, and F.2.4. for place and method of delivery requirements for those Items.

F.2.3. When distribution and shipping of product is ordered, delivery of the product and other deliverables shall be in accordance with FAR 52.247-34 entitled F.O.B. DESTINATION.

F.2.4. When product preparation for pick-up by the USG is ordered, delivery of drug product and other deliverables shall be in accordance with FAR 52.247-30 entitled F.O.B. ORIGIN, CONTRACTOR’s

FACILITY.

F.2.5. Place of Delivery: The Product shall be delivered as requested by the CO or authorized representative prior to time of delivery.

F.2.7. Manufacturers product stability requirements shall be maintained during shipping. If the Product is determined to be out of compliance, (if determined) will not be accepted or off-loaded from the Contractor’s own or subcontracted conveyance but will be immediately returned to Contractor by the same transport used for delivery, at the Contractor’s cost. The Contractor shall be responsible for replacing the product that is not with compliance, at no additional cost to the Government.

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.3.1. Submission of Contract Deliverables

Documents shall be delivered electronically via email to the Contracting Officer (CO), Richard.Hall@hhs.gov and the Contracting Officer Representative (COR), (to be determined). No hard copies will be accepted.

F.3.2. Reporting Requirements

In addition to those reports required by other terms of this RFP, the Contractor shall submit to the CO and the COR technical progress reports as identified in any potential resultant contract. These reports shall be subject to the technical inspection and requests for clarification by the COR, and approval by the CO/COR. These reports shall be brief, factual, and prepared in accordance with the following format:

A. Monthly Inventory Report

This report shall include a table of the available products within the Access-Maintenance VMI during each reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

The Contractor shall submit a Monthly Inventory Report on or before the 15th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor's name, address, telephone number, fax number, and e-mail address;

and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

The inventory report shall contain the following information:

a. Device/Unit SKU

b. Device/unit description/identifier (e.g., device/unit name, component name, etc.)

c. Quantity

d. Expiration date

Contracting Officer’s Approvals – This section shall include a table indicating each Contracting Officer Approval (COA) request, its…