75A50121R00018 Amendment 1.pdf

(x)

75A50121R00018 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

09/14/20210001

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

08/17/2021

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.)

This amendment extends the proposal due date to Oct 11, 2021 at 4PM Eastern and addresses vendor questions.

Solicitation Article L.2.3 is hereby revised as follows:

Proposals must be submitted in electronic format in order to be accepted. Proposals not submitted in electronic copy will be rejected. Electronic submissions shall be sent via e-mail and shall be received no later than October 11, 2021 4 PM Eastern. No files shall be password protected. Facsimile submissions are not authorized.

Answers to questions and Attachment 8 are attached.

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)

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 .

Skin Allograft RFP Solicitor Questions

Attachment to 75A50121R00018 Amendment 1 1

1. In section G.9, the table for provisional rates is blank. Can you please provide this information?

The provisional rates will be established during negotiations. The following information regarding indirect costs should be submitted as part of the pricing proposal in accordance with Article L.5 of the solicitation: Indicate how the Offeror has computed and applied the Offeror’s indirect costs, including cost breakdowns. Provide a basis for evaluating the reasonableness of proposed rates. Indicate the rates used and provide an appropriate explanation. Where a rate agreement exists, provide a copy.

2. In section 1.2.6, Human Cadaveric Skin Allograft Desirable Attributes, it specifies that skin should be non‐meshed. Would meshed skin, which is ultimately required for patient application, be suitable?

Per our initial market research and assessment, supply of non‐meshed allograft product may be desirable due to the versatility of use at the different centers for grafting and best accommodate the preference of individual surgeons. However, if an offeror can justify the value to the stockpile with meshed skin allograft in their proposal, it would be acceptable. If there are differences in cost between meshed and non‐meshed product, please specify it by comparison.

3. In section 1.2.6, Human Cadaveric Skin Allograft Desirable Attributes, it specifies, “Average Tissue Unit Size of 464 sq cm”. Is a unit comprised of multiple grafts which, when combined, equal an average of 464 sq cm?

A unit signifies an allograft product and will always only be made up of one tissue, irrespective of its size. The suggested unit size of 464 sq cm is a common tissue measurement per unit for skin allograft akin to the exact size of one half square feet, typically offered by many providers. However, if another tissue size can be demonstrated by the offeror to be more favorable to stockpiling via prior market demand and sales data, the offeror is free to propose alternative tissue unit sizes and would be evaluated as part of the proposal submission.

4. In section 1.2.6, Human Cadaveric Skin Allograft Desirable Attributes, it specifies, “Split‐ thickness…between .30 to .45 mm”. Would thicknesses up to 1.0 mm, which are commonly used by burn centers, be suitable for the inventory?

The graft thickness was based on clinical practice and graft take data. Split‐thickness skin grafts classify according to their thickness into thin STSGs (0.15 to 0.3mm), intermediate STSGs (0.3 to 0.45mm), and thick STSGs (0.45 to 0.6mm). However, the skin allograft thickness in the proposal is guidance and if an offeror can demonstrate data for other tissue thickness in their product inventory based on prior market

Attachment to 75A50121R00018 Amendment 1 2 demand and sales data, the offeror is free to propose alternative tissue thickness and it would be evaluated as part of the proposal submission.

5. Will the Offeror maintain ownership/title of the allografts until needed for a mass casualty event?

After product units are accepted into the inventory, the tissue bank can invoice the USG.

Once the invoice is paid, the product title is owned by the USG and contractually maintained by the tissue bank under a vendor‐managed inventory (VMI) as described in a mutually acceptable plan. The tissue bank would have the ability (and responsibility) to rotate the product units for commercial circulation by accessing the inventory and keeping active records. In the event of deployment for use in a mass casualty incident, the tissue bank will be responsible for shipping the specified number of USG products from the VMI. The tissue bank would be able to invoice this expense under a cost‐ reimbursement funding mechanism which would be part of the contract.

6. In Section 1.1.2.1, BARDA recommends teaming and partnership to fully meet the needs of the USG. The Offeror has some concerns that this would require the sharing of competitive intelligence, confidential information, pricing, and costs, which could be considered anticompetitive conduct. Does BARDA plan to support efforts to protect the offerors to encourage "teaming/partnering" per the agreement?

Teaming agreements between two offerors, generally aligned in their needs is a suggested approach for businesses to leverage their core‐competence for efficiency. It has to meet the business objectives of the teaming entities. They are not mandatory under this solicitation. If two or more organizations do decide to combine capabilities to meet the needs of the government for the purpose of this solicitation, the legal protections and sharing of proprietary information are the sole and primary responsibility of the parties entering the agreement. All these matters shall need to be cleared by the parties entering into the teaming agreement and certified as part of the proposal submitted to the USG under this solicitation. Such an arrangement would be in the form of a prime contractor and subcontract. BARDA does not share proprietary information between or among offerors.

7. Section 1.2.6 specifies desirable attributes including "Processed in a AATB Accredited Tissue Bank." We obtain our skin from an AATB accredited OPO and are FDA inspected and licensed. Though we are personal members of AATB our corporation is not. Does this disqualify us?

As specified in the RFP, it is mandatory that Offerors are certified to operate and distribute the product and maintain the accreditation by the American Association of Tissue Banks (AATB) throughout the life of the proposed work. This mandatory criteria for eligibility must be met at the time of proposal receipt as determined by the

Attachment to 75A50121R00018 Amendment 1 3 evaluators and the Contracting Officer in order for any proposals to be considered for further technical review and award.

8. Will you accept proposals for human cadaveric skin allografts that are not cryopreserved but meet all other desirable attributes?

Cryopreserved skin allograft is known to be widely used in burn centers. However, if an offeror has another preservation technique used in the commercial market and has comparable shelf life data, and can be justified to be equivalent based on prior market demand and sales data, the offeror is free to propose alternative temperature storage and it would be evaluated as part of the proposal submission .

9. The “Download All Attachments/Links” on SAM.gov is empty. Is there another instructions document? And is there someplace to download all of the required forms into useable formats?

See Q 10.

10. Page 80 of the solicitation does not provide an active link to the Excel form for

Attachment #8 “Breakdown of Proposed Costs with Excel Spreadsheet” – where can we get that?

The attachment is added as part of the amendment.

11. If we partner with another tissue bank, is there a waiver to protect participating parties from price fixing concerns?

See BARDA RESPONSE to Q 6

12. In section 1.2.6 It was specified that the desired skin graft is a 464 non‐meshed graft, will any other larger sizes be accepted and count towards to total desired cm2? Would any other mesh patter be accepted? The most common we supply is a 2:1 mesh?

See BARDA RESPONSE to Q 2 & 3

13. In section 1.2.6 no widths are specified, do you have a minimum width?

See BARDA RESPONSE to Q 3. The offeror is free to propose any width/configuration of the product to be evaluated in your proposal based on prior market demand and sales data.

14. In section 1.2.6 how did you identify the split thickness homograft between .3 to .45mm?

Attachment to 75A50121R00018 Amendment 1 4

See BARDA RESPONSE to Q 4

15. In section 1.2.6 the RFP noted that a desired attribute was skin with a shelf life over 5 years, our shelf life is 5 years, this is the standard. Is this acceptable?

Five years shelf‐life is a desired attribute, but improvements that exceed 5 years can be evaluated as part of a proposal. If an offeror has another timeframe for shelf‐life used in the commercial market and has comparable data, and can be justified to be beneficial based on prior market demand and sales data, the offeror is free to propose an alternative shelf‐life timeframe and it would be evaluated as part of the proposal submission.

16. Can you confirm that BARDA will pay up front for the initial buy and then pay monthly for storage thereafter for the duration of the contract?

BARDA does not intend to include FAR Part 52.232‐12 Advance Payments in the award.

During contract negotiations the proposed price may include the ‘cost‐of‐goods’ component and the ‘VMI maintenance cost’ (which includes storage) combined to comprise a complete price per unit. How the vendor invoices can be discussed during contract negotiations.

17. What does Vendor Managed Inventory mean to BARDA?

A vendor managed inventory (VMI) is an inventory of USG owned product managed by the vendor, who (mostly, though not always) has supplied the product to the USG. A VMI is managed according to a contractually agreed upon plan containing tasks for maintenance, rotation, quality, security, reporting, logistical, and business agreements executed by the USG and vendor over the course of the contract. It is expected that the offeror/contractor or vendor is managing the routine commercial operations on the sale of the product such that when orders for the specific SKU that may also be in the BARDA VMI, the unexpired products from the VMI are shipped and rotated out with newly manufactured products. This ensures that VMI products are not wasted and products are rotated using a well‐managed first‐in, first‐out inventory management system.

Demonstration of such a VMI capability is part of the evaluation in the proposal review.

18. Can you confirm that we must hold inventory par levels to cover the 12.7M cm² and rotate inventory? Considering GAAP rules, we may need to have designated freezers for BARDA if you purchase up front.

As described in response to Q17, VMI requires the vendor (offeror) to hold the agreed upon inventory negotiated under the contract. Please note that the 12.7M cm² is the total product the USG plans to procure to meet a USG requirement. The overall goal of this solicitation is to build a stockpile of the required product that meets a national

Attachment to 75A50121R00018 Amendment 1 5 security objective. It is expected that the capacity and capabilities of different offerors will vary in order to fulfill quantities of this requirement. As part of this procurement process, the USG will evaluate proposals from various offeror’s to determine the best value for the USG to achieve the requirement of the product amount and sustainable VMI inventory to build national preparedness.

19. What is your potential concept for operations? Understanding this will help us understand what quantity you need day 1 as well as the optional buys.

Please see response to Q 18. If a contract is successfully negotiated with an offeror, it is incumbent on them to maintain the predetermined negotiated amount of product inventory under VMI (see response to QN 17). In addition, if there is an emergency and the USG decides to deploy the product from the VMI, the contractor would ship the product to the specified locations using the funds set aside under a specific line item (or CLIN) in the contract for “deployment”.

20. Just confirming, that we need to quote for storage of 12.7M cm² of burn skin or do we also quote for an addition 12.7M cm² storage (option 2) and again for an additional storage 12.7M cm² (option 3)?

The Offeror shall provide a quote for both the base period and all option periods.

21. Can you provide the G9 provisional rates?

See Q 1

22. What happens to the skin after our contract period if it is not used in an emergency situation?

As part of the contract negotiations the USG will work with the Offeror on potential approaches or plans that might include absorbing the VMI into a commercial supply‐ chain or to transferred the VMI to a new USG contract with the same or different entity.

The USG is committed to working with the contractors to find an amicable way to transition inventory without causing market disruptions for example, using either of the two approaches or other novel methods as negotiated in the contract.

23. What are the specific data, reports and presentations you are looking for based on chart

F4?

The reports/deliverables in Section F.4 are post award contract deliverables and will be established as part of the contract negotiations.

24. How long after submittal will your decision be made?

Attachment to 75A50121R00018 Amendment 1 6

This award is intended to be completed within a few months in FY 22.

25. Tissue donors need familial consent for international distribution, is it required that donors used to satisfy this proposal are consented for use outside of the United States?

The products under VMI are largely for use within United States although they should be available for international requests should they be made. The USG will follow all rules and regulations governing tissue donation. Please provide any local laws and customs observed by your organization, association, or business that dictate the proper use and distribution of your product that the USG will have to consider in order to evaluate any proposal received. Please include citations and references.