75A50125R00007 Amendment 0001.pdf

(x)

75A50125R00007 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

ASPR-BARDA

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

ASPR-BARDA

07/14/20250001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

07/13/2025

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this amendment is to extend the proposal and to clarify the proposal question due date.

The cutoff date for all questions on this RFP is on July 31, 2025 at 2 p.m. ET. The due date for all proposal submissions is August 27, 2025 at 2 p.m.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

YIFAN YANG

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

Biomedical Advanced Research and Development Authority (BARDA) Request for Proposals (RFP) for

“Enzymatic Debridement Products for Treatments of Deep and Full- Thickness Severe Burn Injuries”

RFP #: 75A50125R00007

Amendment 0001

Issued: 07/14/2025

Questions Due: 7/31/2025

Proposal Responses Due: 08/27/2025

Contracting Officer: Jon Gonzalez Jonathan.Gonzalez@hhs.gov Contract Specialist: Yifan Yang – Yifan.yang@hhs.gov

MedicalCountermeasures.gov mailto:Jonathan.Gonzalez@hhs.gov mailto:Yifan.yang@hhs.gov

NOTE TO OFFERORS

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.

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) Alternate 1, the Health and Human Services Acquisition Regulation (HHSAR)

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

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.

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

The cutoff date for all questions on this RFP is on July 31, 2025 at 2 p.m. ET. All questions shall be submitted via e-mail to Jonathan.Gonzalez@hhs.gov and Yifan.Yang@hhs.gov. The due date for all proposal submissions is August 27, 2025 at 2 p.m. All proposals must be submitted via email to Jonathan.Gonzalez @hhs.gov and Yifan.Yang@hhs.gov. The submission email must include business and technical proposal documents as separate documents.

mailto:Jonathan.Gonzalez@hhs.gov mailto:Jill.Johnson@hhs.gov mailto:Kevin.Dean1@hhs.gov mailto:Kevin.Dean1@hhs.gov mailto:Jill.Johnson@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.

Surgical debridement is the current standard of care for removing dead skin tissue (eschar) from severe burn injuries, the required first step in definitive care. This involves shaving the burn area with bladed instruments and/or use of high-pressure water jets, both of which remove healthy tissue as well as the targeted necrotic tissue. These current debridement methods are labor-intensive, require highly specialized surgical training and resources, and invokes additional risk to the patient due to unavoidable removal of healthy skin. Furthermore, surgical debridement is usually delayed for the first few days after injury to allow for observation and visual assessment of its healing trajectory. This presents additional risks to the patient and potentially prolongs hospital stays. Enzymatic debridement products more selectively remove necrotic burned skin and can be applied in non-surgical settings (e.g. patient bedside) to free up operating room resources, a critical capability for mass casually response. This enables earlier patient care, can reduce resource burden, and potential improves patient outcomes. Such products should be compatible with current procedures to allow easy integration into routine care for ready availability and medical end user familiarity during BCMI’s. This Statement of Objective (SOO) focuses on products which enzymatically debride severe burns to reduce the need for surgical resources for definitive burn care.

Based on this background, the objective of this RFP is to support procurement of an FDA-approved enzymatic debridement product and potentially support development of a next generation product for increased preparedness value. This product must be capable of removing necrotic skin from both partial and full thickness thermal burn wounds in pediatric and adult burn patients. The procurement strategy would involve creating a deployable cache of product (Preparedness Inventory) managed by the vendor and in coordination with their commercial (Planned) inventory. This establishes a vendor-managed inventory (VMI) as a collaborative access-maintenance system of product to maintain ready for emergency deployment (also see Section C- Objectives). To prevent product expiry and waste, the vendor will sell older units from the Preparedness Inventory through their commercial sales mechanism and rotate in newer product. BARDA will pay for this maintenance and the right to access/deploy this cache in the event of a national emergency. Funding will also provide BARDA the option to access an additional, pre-negotiated amount of the vendor’s commercial (Planned) inventory to also deploy for larger emergencies and/or to increase the size of the Preparedness Inventory for increased preparedness. This system allows for national preparedness and response flexibility while limiting waste of unused product by not creating an inventory too large to be rotated into commercial sales when not needed for response. In addition, is critical the USG invest in next generation debridement products that are more cost effective, sustainable, and capable to addressing national health threat needs. Towards those goals, PBS funding would additionally support the development of a more effective, room temperature stable formulation and explore the potential for its use on blast trauma wounds for additional preparedness capability and return on investment.

B.1.1. Definitions

Collaborative Access-Maintenance Vendor Managed Inventory (CAM-VMI) - The Contractor and USG agree to build and manage two separate product inventories. One termed ‘Preparedness Inventory’ would maintain a negotiated number of product units procured by the USG directly from the manufacturer. The Preparedness inventory shall serve as a product cache to be used for national security purposes on demand and deployed by the vendor as directed by USG. A second Planned (commercial) inventory shall be maintained by the contractor as part of the routine commercial sales operations. The Contractor shall be responsible for the management and appropriate maintenance of the products in both inventories at a common location and management system. As mutual benefit, the inventory management shall enable reciprocal flow of product units between both inventories by the contractor to support the sales operation. Such reciprocal flow tasks would allow product rotation or allow access for additional units required to meet market demand but replenished within 2 months or as allowed by USG. The USG agrees to pay a fee for the contractor to manage the Preparedness inventory of commercially useable product covering rotation tasks; and the entire product inventory shall be available for emergency deployment when directed by USG.

The Contractor and USG agree to pre-negotiated terms (including price per unit). for priority access to the Planned commercial inventory should the Preparedness inventory not be sufficient to meet the national emergency need. The USG would trigger the option to purchase up to the available Planned (commercial) inventory and/or future supplies and direct them for emergency deployment.

The Contractor and USG agree to periodically revise and expand the size of the Preparedness and Planned (commercial) inventory requiring coordination of procurement for additional units from manufacturer, development of next generation of products etc. The Contractor shall also develop, periodically exercise, and maintain an active plan for deployment of the products from both the inventories to all the burn care centers on demand via their commercial processes and infrastructure (including subcontractors) or in collaboration with the Strategic National Stockpile

(SNS).

Commercial Product - As defined in FAR 2.101.

Food and Drug Administration (FDA) Approval - The Food and Drug Administration (FDA) has determined that a product is safe and effective for its intended use. The Contractor shall provide FDA product validation as part of the technical proposal.

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/PERIOD OF PERFORMANCE

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 with 6 options.

The Base Period and Options consists of Firm Fixed Price and Cost Plus Fixed Fee CLINs to support procurement, maintenance, and emergency deployment of enzymatic debridement products as well as additional product development.

B.2.1. BASE PERIOD and OPTIONs

Anticipated Period of Performance

Structure CLIN Supplies/Services Quantity

Unit Price

Total

09/30/2025- 09/29/2026

FFP CLIN 001

BASE

Initial Procurement of Product to Establish PREPAREDNESS CACHE under VMI Purchase commercially available units

2750.00

09/30/2025- 09/29/2035

FFP CLIN 002

BASE

VMI Maintenance Prevent expiry, rotate through commercial sales, monthly reporting mons.

09/30/2025- 09/29/2035

FFP CLIN 003a

BASE

Emergency Deployment Emergency deployment of Preparedness Cache under VMI to burn centers as directed.

1.00

09/30/2025- 09/29/2035

FFP CLIN 003b

BASE

Emergency Exercises 3 mock deployment exercises by vendor

3.00

09/30/2026- 09/29/2027

FFP CLIN 004a

OPTION 1

Ramp Up Procurement Purchase additional units (up to 5000 units) of available product as required from the commercial /

PLANNED INVENTORY.

up to 5000.00

09/30/2026-

FFP CLIN 004b

OPTION1

Ramp Up VMI Maintenance Additional maintenance support (assumes execution in Year 2 for the remaining POP) mon.

FFP CLIN 005

OPTION 2

Ramp Up Procurement Emergency Deployment Emergency deployment to burn centers as directed

1.00

09/29/2027

CPFF CLIN 006

OPTION 3

Formulation and Development: Room temperature stability of product and changes in mfr process; testing;

excipients

1.00

09/30/2026- 09/29/2028

CPFF CLIN 007

OPTION 4

Clinical Development: Clinical studies to demonstrate superiority of the new formulation (or non-inferiority)

09/30/2027- 09/29/2030

CPFF CLIN 008

OPTION 5

Manufacturing Development (including validation): Integration of changes & testing in mfr. Process; Potential for validation of new US-based facility;

Additional mfr. capacity.

09/30/2027- 09/29/2035

CPFF CLIN 009

OPTION 6

Regulatory Tasks for FDA Approval:

Regulatory activities for new sBLA filing for FDA approval

1.00

09/30/2029- 09/29/2035

FFP CLIN 010

OPTION 7

Procurement of New Formulated Product: Expanding procurement of new formulated product; preparedness inventory.

Up to 5000.00

09/30/2027- 09/29/2030

CPFF CLIN 011

OPTION 8

Expanded Indications for Use in Trauma:

Studies (clinical/non-clinical) for expanding indications for use in blast trauma (concomitant or standalone traumatic injuries along with burns)

Total Cost

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.

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) Collaborative access and maintenance of two inventories: Contractor and U.S. Government (USG) Governs establishment of a collaborative model with two inventories- ‘Preparedness Inventory’ and ‘Planned (commercial) Inventory’ and their management by the vendor.

Priority Access: The Contractor and USG agree to pre-negotiated terms (including price per unit) for priority access to the Planned commercial inventory Procurement for surge response capacity & emergency deployment: The Contractor and USG agree to periodically revise and expand the size of the Preparedness and Planned (commercial) inventory requiring coordination of procurement for additional units from manufacturer, development of next generation of products etc. The Contractor shall also develop, periodically exercise, and maintain an active plan for deployment of the products from both the inventories to all the burn care centers on demand via their commercial processes and infrastructure (including subcontractors) or in collaboration with the Strategic National Stockpile (SNS).

a. 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.

b. Security

A security plan will be required as part of the contract. Please include an initial security plan with your proposal.

c. 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.

d. Overtime Compensation

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

e. Sharing of contract deliverables within United States Government (USG)

In an effort to build a robust medical countermeasure pipeline through increased collaboration, the Government may share technical deliverables with Government entities responsible for Medical Countermeasure Development. In accordance with recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review, agreements established in the Integrated Portfolio Advisory Committee (PAC) Charter, and agreements between BARDA and the Department of Defense, the National Institutes of Health, the Centers for Disease Control, and the Food and Drug Administration, BARDA may share technical deliverables and test results created in the performance of this Contract with colleagues within the Integrated Portfolio.

This advance understanding does not authorize the Government to share financial information outside of the United States Government. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data – General, regarding the government’s rights to deliverables submitted during performance as well as the government’s rights to data contained within those deliverables.

f. Rights in Data

The contract will incorporate the FAR Clause 52.227-14, Rights in Data—General. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data--General, regarding the government’s rights to deliverables submitted during performance as well as the government’s rights to data contained within those deliverables.

g. Invoice Submission during end of Fiscal Year

The government will not accept invoices for processing from Sep 6th through Oct 5th because of end of year fiscal requirements. Any invoices received from September 6th through October 5th will be canceled and returned to the Contractor for resubmission beginning on October 6th.

B.4 ORGANIZATIONAL CONFLICT OF INTEREST

a. 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.

b. 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.

c. 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

While BARDA can support all activities in support of FDA regulatory filings, we cannot pay the fees requires for those filings. In other words, funds should no ever go from one USG agency (BARDA) to another (FDA).

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 time and surgical burden to remove (debride) necrotic skin from partial and full thickness burns as the critical, first treatment step in definitive care. Reducing the time to eschar removal in a more selective way than the current standard of care by surgery 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 that enzymatically remove necrotic tissue (eschar) from partial and full thickness burns in both children and adults. Such enzymatic debridement products can significantly reduce the surgical time and resource burden required to treat severe burns to reduce patient morbidity and mortality.

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

1. Enzymatic debridement product is approved for use in the US by the FDA for removal of necrotic skin from both partial and full thickness thermal burns in both adults and pediatrics.

2. Product has the potential to function in non-surgical suites settings (e.g., patient bedside) to achieve complete debridement as per approved indication to enable the next step in burn care.

3. Offeror has the infrastructure to support management of product rotation across multiple caches via a vendor-managed inventory (VMI) and commercial sales to prevent expiry and waste. The Offeror also has the capability for product distribution to end users (such as burn centers) and in an emergency response distribution.

4. Provide an explicit statement of acknowledgement understanding the definition and concur to negotiate entering into the agreement as defined under the Collaborative Access-Maintenance Vendor Managed Inventory (CAM-VMI) in Section B.1.1 Definitions. The final negotiated agreement would be part of the Advanced Understanding statements of the potential contract.

As an FDA approved product, it is expected that the product will be used in all intended settings such as within US burn centers. Information on the integration of the products into these routine healthcare settings would be important towards the indicated goal to build national preparedness and availability for use by trained physicians.

Under this RFP, BARDA plans to establish a collaborative access-maintenance vendor-managed inventory (VMI) system. In this system, the Offeror is required to maintain a pre-specified, Preparedness Inventory of product units which are accessible on demand for emergency deployment. The Preparedness Inventory is maintained in conjunction with routine Planned Inventory established by the vendor as part of the normal (commercial) operations.

In the event of a need (such as a mass casualty) upon notification by the U.S. Government (USG), the Preparedness Inventory shall be deployed as directed within pre-specified time using the established distribution system by the vendor. Additional MCMs from the Planned inventory shall be available to USG for deployment under pre-negotiated terms.

SCOPE

This RFP focuses on procurement of an FDA-approved enzymatic debridement product for a collaborative access-maintenance VMI described above. Critical attributes of the product shall include the capability to selectively remove necrotic burned skin in non-surgical settings to reduce the time and need for surgical debridement. Additionally, advanced development such as room temperature formulation/dose-sparing / additional indications of the FDA approved product is also within the scope of work. The following areas of work are considered within the overall scope of this RFP:

a) VMI management and product deployment (distribution).

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

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

d) Advanced development and FDA approval of next generation product

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). Proposals will be evaluated per criteria under Section M.4 on the Offeror’s ability to meet objectives described below:

[Base] Initial Procurement and VMI Establishment (CLIN 1) [Base] Vendor Managed Inventory (VMI) Maintenance (CLIN 2) [Base] Emergency Deployment/Exercises (CLIN 3a, CLIN 3b) [Option 1] Ramp Up Procurement/VMI Maintenance (CLIN 4a, CLIN 4b) [Option 2] Ramp Up Procurement Emergency Deployment (CLIN 5) [Option 3] Formulation and Development (CLIN 6) [Option 4] Clinical Development (CLIN 7) [Option 5] Manufacturing Development (CLIN 8) [Option 6] Regulatory Tasks (CLIN 9) [Option 7] Procurement of New Formulation (CLIN 10) [Option 8] Expanded Indications for Use in Trauma (CLIN 11) [Base & Options] Project Management & Quality Assurance Objectives (All CLINs)

1) Initial Procurement and VMI Establishment (CLIN 1) Upon procurement by the BARDA, the vendor shall create a Preparedness Inventory. The intended goal is for the products to be ready for immediate deployment in an emergency to burn centers per USG request and direction. If a mass casualty or other emergency occurs per the determination of the USG, the vendor shall be notified of USG’s instruction to deploy part or all the Preparedness Inventory. The size of this product cache would be subject to negotiations but would be a minimum of 2750 units. As part of normal operations, products in the Preparedness Inventory will be rotated out into the vendor’s Planned Inventory established for commercial sales and replaced with newer product received from manufacturer. This will establish a Collaborative Access-Maintenance Vendor-Managed Inventory (VMI). The routine commercial Planned Inventory shall be large enough to support rotation of Preparedness Inventory to prevent product expiry and at any time have a shelf-life of transfer for commercial use. The Offeror shall include commercial sales data to demonstrate the capability. as part of the VMI process.

2) Vendor Managed Inventory (VMI) Maintenance (CLIN 2)

As part of the VMI program, the Offeror shall establish and maintain the Preparedness Inventory cache primarily ready for emergency deployment purposes. The Preparedness Inventory is maintained in conjunction with routine Planned Inventory established by the vendor as part of the normal (commercial) operations. The size shall support the stock rotation from the preparedness cache to routine sales using the principle of “First Expiry, First Out”. While the number of units in the inventory would be subject to finalization as part of the negotiation the Offeror shall address capability to maintain a minimum of 2750 units. Ideally, with increased sales and growth in the market share over time, USG anticipates the Offeror would be able to support rotation and increase the size of the cache by an additional 5000 product units (to a total of 7750 units maintained under VMI). The vendor shall be responsible for all the supply chain operations (communications with the product manufacturer for delivery of the product for the Planned Inventory and the initial Preparedness Inventory. The Preparedness Inventory shall be procured at-cost.

Information on the availability of resources for inventory maintenance / management activities, systems for monitoring will be required to demonstrate the capability. The Offeror shall include data demonstrating tracking and shuffling inventory, and the ability to ensure a minimum shelf-life for all products in the VMI. Systems for regular reporting (such as monthly or as deemed appropriate) have to be demonstrated. The Offeror shall specify how the process is organized and managed with Standard Operating Procedures (SOPs) and Quality systems. The Offeror shall provide all necessary documentation for quality assurance and acceptance of the product by the

USG.

3) Emergency Deployment and Exercise (CLIN 3a, and CLIN 3b)

i) CLIN 3a: At any point during the duration of the contract, the USG may notify the Offeror of to deploy product units under the Preparedness Inventory. The offeror will be required to prepare a specified number of units for emergency deployment within 24 hours of notification. The Offeror shall package and ship product units via standard shipping methods as set up for the commercial products but directly to burn 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.

ii) CLIN 3b: At least three times during the duration of the contract, USG and Offeror shall synchronize a mock-deployment exercises to ensure the procedures and personnel are trained to react to an emergency deployment. Any deficiencies identified shall be documented and rectified.

4) Ramp Up Procurement (CLIN 4a and CLIN 4b)

i) CLIN 4a: Towards the original goals for national preparedness, USG may consider the need to increase in the size of the Preparedness Inventory cache for a more robust direct response to a larger burn emergency. An anticipated increase in the size of the cache for access and maintenance and available for procurement could be up to 5000 units (or as negotiated) to be delivered within an agreed upon timeframe. If the commercial plans are not sustainable for the larger cache, the Offeror shall provide the shortest ramp up plan to deliver the additional devices and timeframe required.

ii) CLIN4b: Akin to the VMI maintenance (CLIN 2) the ramp up to an increased size of this increased Preparedness Inventory and the resultant additional costs (if any) shall be described by the Offeror. The offeror shall provide all necessary documentation for quality assurance and acceptance of the product by the USG. The Offeror shall specify how the process is organized for the maintenance and management (rotation) of the larger inventory with SOPs and Quality systems. The Offeror shall provide all necessary documentation for quality assurance and acceptance of the product by the USG.

5) Ramp Up Emergency Deployment (CLIN 5)

Akin to CLIN 3a, procurement of additional units in CLIN 4 may result in additional costs for deployment of the larger number of units in an emergency within 24 hours of notification. The offeror shall package and ship device units via standard commercial shipping methods directly to burn 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) Formulation and Development (CLIN 6)

Funding will support development of a next generation enzymatic debridement product formulation with increased preparedness value. This potentially includes room temperature stability for more cost-effective shipping and storage as well as increased effectiveness for dose-sparing. Studies will enable successful application of the new formulation as an Investigational New Drug (IND) with the FDA to enable entry into clinical studies. These efforts could include stability and non-clinical comparability testing as well as necessary changes to the manufacturing process. Offeror shall provide strong proof-of-concept data on a candidate product to justify funding towards final formulation and IND acceptance. This data shall demonstrate superior qualities vs the currently licensed, commercial product. The Offeror shall include all study plans remaining to execute towards that goal as supported by formal FDA feedback.

7) Clinical Development (CLIN 7)

Funding will support clinical development of a next generation enzymatic debridement product formulation with increased preparedness value. This involves completion of a pivotal human study to demonstrate the equivalence (non-inferiority) or superiority of the next generation product compared to the current product on the commercial market. Data from this completed study will enable application for FDA approval to towards market entry and integration in U.S.

routine burn care. Offeror shall provide a clinical design and strategy for achieving FDA approval.

8) Manufacturing Development (including validation) (CLIN 8)

Successful clinical development and anticipated FDA approval will require changes in manufacturing process to enable product production at commercial scale and to support future procurements. This would include process validation with priority in a US-based facility for increased national security/availability. Offeror shall provide a list of required manufacturing studies and processes to achieve a domestic based manufacturing line and describe its target commercial and surge production capacity.

9) Regulatory Tasks for FDA Approval (CLIN 9)

Funding will support execution of the Offeror’s described regulatory path towards FDA approval of the new formulation (next generation) enzymatic debridement product. Offeror shall provide formal FDA feedback to support this described regulatory pathway as well as a budget for anticipated data requests from the FDA during the product review period (RFIs, additional data analyses, data audits, etc.).

10) Procurement of New Formulated Product (CLIN 10)

Successful development, approval, and integration of a more effective/room temperature stable product would increase the product’s preparedness value in the intended Collaborative Access- Maintenance Vendor-Managed Inventory (VMI). The USG would support procurement of up to 5000 product units for placement into the Offeror’s VMI infrastructure. As with CLINs 1,2, and 4a above, the vendor shall be responsible for all the supply chain operations (communications with the product manufacturer for delivery of the product for the Planned Inventory and the initial Preparedness Inventory. The Preparedness Inventory shall be procured at-cost.

Information on the availability of resources for inventory maintenance / management activities, systems for monitoring will be required to demonstrate the capability. The Offeror shall include data demonstrating tracking and shuffling inventory, and the ability to ensure a minimum shelf-life for all products in the VMI. Systems for regular reporting (such as monthly or as deemed appropriate) have to be demonstrated. The Offeror shall specify how the process is organized and managed with Standard Operating Procedures (SOPs) and Quality systems. The Offeror shall provide all necessary documentation for quality assurance and acceptance of the product by the

USG.

11) Expanded Indications for Use in Trauma (CLIN 11)

Medical treatment from blast injuries can require debridement of skin wounds from other insults besides and in combination with thermal burns (e.g shrapnel). Treatment still requires effective, selective, non-surgical removal of only necrotic tissue to enable continued care. To this end, this CLIN intends to support the exploration of a next generation debridement product for improved treatment of blast skin injuries from non-burn insults. The development of one product that addresses the medical need for enzymatic skin debridement regardless of blast injury type would maximize the preparedness value to the USG for future procurements. The support this goal, the Offeror shall propose proof-of-concept studies (non-clinical and/or clinic) to test the product’s effectiveness for debriding blast-derived necrotic skin. This product shall be the same formulation developed/procured under CLINs 6-10 to this demonstrate its multi-use, multi-threat preparedness capability. Proposed study designs should be supported by FDA feedback that would support a long-term plan towards FDA approval for these expanded indications for blast trauma treatment.

12) Project Management Objectives (Applicable to all CLINs)

The Offeror is directed towards details provided in the section on Reporting Requirements. All work under this 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 collaborative access-maintenance) to deploy within 24 hours notification from the Government.

i) Monthly maintenance costs must be tracked and invoiced at the negotiated frequency accordingly.

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

iii) 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.

iv) The Offeror shall provide a security plan that includes physical and information technology (IT) security associated with all aspects of process, storage, and inventory of the assets when under the Offeror’s direct control.

The offeror shall track and provide all key personnel, report changes which affect work under all active CLINs especially, collaborative access-maintenance under VMI, activities to be performed by all proposed subcontractors. Offeror shall monitor key personnel role and impending or proposed changes and roles within the project.

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) CO/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 METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, all deliverable items to be furnished to the Government under this contract (including invoices) shall be made as described in SECTION F.3.

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Contracting Officer or the Contracting Officer’s Representative. Acceptance of a commercial product will be consistent with customary commercial practice under FAR 12.301(a):

Center for the Biomedical Advanced Research and Development Authority Administration for Strategic Preparedness & Response 400 7th Street SW Washington, D.C. 20024

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duty authorized representative 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)

FAR 52.246-5 Inspection of Services – Cost Reimbursement (April 1984)

FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984)

FAR 52.246-16, Responsibility for Supplies (April 1984)

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.

E.4 – NONCONFORMING SUPPLIES OR SERVICES

FAR 46.407 Nonconforming Supplies or Services

(a)The contracting officer should reject supplies or services not conforming in all respects to contract requirements…