75A50125R00007 Amendment 0002.pdf

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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

07/13/20250002

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 answer vendor questions.

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 .

75A50125R00007 Amendment 0002 2 of 5

Responses to Questions BARDA RFP 75A50125R00007 Amendment 0002 - “Enzymatic Debridement Products for

Treatments of Deep and Full-Thickness Severe Burn Injuries”

1. Is a Proposal Intent Response Form (Attachment 4) required and, if so, by what date/time?

Response:

Not required for proposal submission

2. A Gantt/WBS/Milestones & Deliverables table is mentioned in Section L.4.1.1 Section 3 on pg 59. Where should this be included in the proposal? The SOW? Section 3 of the Technical Proposal?

Response:

It should be included as part of the SOW.

3. Where should the SOW be located? It’s mentioned in both the tech and business proposal sections of the RFP (L.2.4 and L.4.1.1 Section 3). Should it be a separate MS Word document? Does it need its own cover page?

Response:

SOW should be submitted as part of the tech proposal and one copy should be included in the business proposal. It does not need a cover page or a separate document.

4. We are assuming that the data/IP rights for the next generation product (currently in development, pre-award) are negotiable?

Response:

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

5. If an acceptable enzymatic debridement product is on the market and available through a government contract, would BARDA consider purchasing from that contract at the then-current price in lieu CLIN 1 if the quantity of product can be negotiated in advance?

Response:

Offerors should follow the proposal format provided in the solicitation.

6. Will the full text of HHSAR 352.204-75 Supply Chain Risk Assessment During Contract

Performance (Oct 2024) be provided in the contract? The clause is incorrectly stated as 353.204-75.

Response:

Full text of HHSAR 352.204-75 is provided as an attachment in this solicitation amendment.

75A50125R00007 Amendment 0002 3 of 5

7. Will an award be reviewed by the Dept of Government Efficiency (DOGE)? If so, how long would the review take? What are the possible results of such a review?

Response:

Internal reviews will be conducted in accordance with the solicitation.

8. Please provide clarification on this statement on page 61: ” Offeror shall certify and provide proof of freedom to operate such as proof of ownership of, or rights to, Intellectual Property or commercialization rights to but not own the IP per se.” What type of document(s) will satisfy this requirement?

Response:

A statement that certifies or provide proof of freedom to operate such as proof of ownership of, or rights to, Intellectual Property or commercialization rights will suffice.

9. Is the intent to purchase doses of the enzymatic debridement product and pay for management of the inventory, or does BARDA want the cost of the product included in vendor inventory management fees?

Response:

It is important to identify the two separate cost components (unit cost and inventory management costs).

10. What is anticipated frequency of the on-site visits?

Response:

Offeror should plan for at least one a year.

11. What is the anticipated timing/frequency of the 3 emergency drills?

Response:

Offerors should plan for at least three at the first, third and fifth year. Additional trainings may be required as the situation demands.

12. What is the definition of a “dose”?

o Section 5 - 2750 units is referenced:

How many patients does this translate to?

Do we know an average total body surface area (TBSA) for the wound that should be considered?

Do we know an average # of applications or days of treatment that should be considered?

Response:

The product is anticipated to be used as its label indication and the Offeror should define the dose.

13. For Clin 004a Ramp up: Reference to "ability to increase inventory cash by up to 5000 units" o How does this translate to # of patients and assumptions for size of burned area / length of treatment or # of applications?

It is anticipated the product would be used in accordance with its label indication.

75A50125R00007 Amendment 0002 4 of 5

14. Shelf Life Specifications:

o The RFP mentions monitoring and managing shelf life, but does it define a minimum requirement?

o Is there a minimum shelf-life requirement?

Response:

The product is anticipated to be used as its label indication including its approved shelf life.

The VMI management should factor in rotations where steady new procurement replenishes the product from the Preparedness inventory transitioned for commercial use.

15. Delivery Expectations: CLIN 003a references a 24-hour delivery window to any U.S.

destination. Could we clarify the following:

o Who is responsible for transportation?

Response:

Under Emergency Deployment (pg. 13) the Offeror is responsible to package and ship product units via standard shipping methods as set up for the commercial products but directly to burn centers as identified and notified by the USG. The burn centers where the product may be needed would be based on the location of the emergency. For planning purposes, the Offeror should plan for the farthest destination in the US.

The packaging and shipment cost have to be separately itemized in the Cost proposal. As noted on Pg 3 Item 3 (i), there is an alternative possibility that shipment may be handled by SNS. Under that scenario for emergency deployment, the Offeror shall only perform the packaging tasks and not the shipment. The specific instructions would be provided prior to execution.

o Where are the designated burn centers located? [Offeror would be notified upon response requirement is determined] o Are they limited to the mainland, or do they include U.S. territories? [Offeror should plan for the farthest destination in the mainland US and should also plan for US territories and itemize the costs, if different] o Does the 24-hour window include shipping, transportation, and final delivery?

[Covers timing after the Offeror is notified to trigger the emergency response and getting the products out for shipment]

16. What are the expectations regarding notification periods and timelines for securing additional volumes?

Response:

BARDA intends to work collaboratively with the Offeror. Any resulting contract would specify notification periods and timelines.

17. When the contract ends in 10 years, is BARDA planning how they would handle property disposition? Will contractors be required to store existing inventory, dispose, abandon in place, etc.? Is there any guidance on managing shelf life toward the end of the contract?

Response:

If a contract is awarded it may last up to 10 years. Over the course of a contract, property will be dispositioned in accordance with the polices and procedures of the agency, which is often dependent on the given situation.

75A50125R00007 Amendment 0002 5 of 5

18. CLIN008 (Option 5) – Manufacturing Development (including Validation): CLIN008 is currently scheduled to begin in Q3 2027 and includes activities such as integration of changes and testing in the manufacturing process, potential validation of a new U.S.-based facility, and expansion of manufacturing capacity. Given that FDA approval requires a validated commercial manufacturing facility and considering that the establishment of such a facility typically spans approximately five years, this timeline may result in a misalignment with the clinical and regulatory development schedule.

Could BARDA confirm whether earlier initiation of CLIN008 would be acceptable and eligible for funding under the base or option periods, in order to ensure alignment with the overall development and approval timeline?

Offerors can propose and should lay out an overall most feasible product development / procurement plan and timeline is to address all the objectives asked for in the RFP.

19. Subcontractor Commitments in Proposal Submission: Regarding proposal submission requirements:

Is the applicant required to include pre-executed agreements (e.g., Letters of Intent or signed contracts) with major subcontractors involved in the proposed plan? Additionally, are detailed cost quotations from these subcontractors required as part of the initial proposal submission?

Response:

For the purposes of evaluation of a proposal, pre-executed agreements (e.g., Letters of Intent or signed contracts) with major subcontractors and/or detailed cost quotations are strongly encouraged as evidence of the Offeror’s capabilities to execute the goals of the RFP and as evidence of risk mitigation.

20. As I read this, it seems to be limited to enzymatic debridement and it says that the product has to be FDA approved. Am I reading this correctly? Are products in development that show burn (radiation and chemical currently, thermal-TBD) restoration and hair regrowth eligible? The reason I ask is that the product we are developing and testing is effective before eschar presents and therefore no debridement is needed. If this solicitation is not a fit, can you point me to any options I should review?

Proposal submitted in response to this solicitation will be evaluated in accordance with Section M of the RFP.