Questions and Answers.pdf

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Attached to
Foot and Mouth Disease (FMD) Vaccine Antigen Concentrate (VAC)
Solicitation number
12639527R0001
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About this file

This document is a Questions and Answers file for Solicitation 12639527R0001, containing responses to inquiries received by October 9, 2026, at 5:00 PM CT. The solicitation concerns incumbent contract performance for what appears to be foot-and-mouth disease (FMD) vaccine products and services. Four incumbent contracts are currently active: Contract 12639520D0035 awarded to Boehringer Ingelheim Animal Health France ($500,000,000, 07/08/2020-01/07/2036); Contract 12639520D0036 awarded to Biogenesis Bago S.A. ($500,000,000, 07/08/2020-01/07/2038); Contract 12639520D0055 awarded to Biogenesis Bago S.A. ($100,000,000, 09/22/2020-09/21/2038); and Contract 12639521D0047 awarded to Boehringer Ingelheim Animal Health France ($100,000,000, 07/26/2021-07/25/2036). The Government will not disclose an estimated contract value for this new requirement.

Key technical and administrative requirements clarified include: Contractors are responsible for delivery to a designated U.S. airport with the Government serving as importer and handling import duties; Offerors may propose FMD products currently under Centerfor Biologics Evaluation and Research (CVB) review and those expected to undergo CVB review during performance; products using modified seed virus (MSV) with technical attributes still under validation may be proposed with full compliance demonstrated prior to delivery order issuance; Offerors must propose their minimum achievable delivery timeline for rapid conversion and finished vaccine delivery following vaccine bank activation; past performance submissions must include one contract per information sheet with no combining of multiple contracts; and Volume I administrative submissions require a signed SF 1449, applicable FAR provisions, and a one-page cover letter, with no additional certifications or supporting documents required beyond those specified in proposal preparation instructions.

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File Type Posted
Attachment 1 - Statement of Work.pdf PDF
Attachment 3 - Past Performance Information Sheet.pdf PDF
Attachment 2 - Price Schedule.xlsx XLSX spreadsheet
12639527R0001.pdf PDF

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Questions and Answers Solicitation 12639527R0001

Solicitation Questions Received by October 9, 2026, 5:00 PM CT

Question 1: Is this effort considered as a potential new requirement or is there an incumbent contract currently performing these services? If there are incumbent vendor(s), would you be able to provide the contract details (such as: Vendor Name, Contract Number, Award and end dates, total contract value)?

Answer 1: Refer to answer 2.

Question 2: Is this requirement currently performed under the following contract #s: 12639520D0035 and 12639520D0036 and are set to expire on January 7, 2036? Am I missing any other active incumbent contract(s)? If yes, may I ask for the contract number please?

Answer 2: The incumbent contract numbers and details are as follows:

Contract Number 12639520D0035 o Awardee: Boehringer Ingelheim Animal Health France o Period of Performance: 07/08/2020 - 01/07/2036 o Award Amount: $500,000,000.00

Contract Number 12639520D0036 o Awardee: Biogenesis Bago S.A.

o Period of Performance: 07/08/2020 - 01/07/2038 o Award Amount: $500,000,000.00

Contract Number 12639520D0055 o Awardee: Biogenesis Bago S.A.

o Period of Performance: 09/22/2020 - 09/21/2038 o Award Amount: $100,000,000.00

Contract Number 12639521D0047 o Awardee: Boehringer Ingelheim Animal Health France o Period of Performance: 07/26/2021 - 07/25/2036 o Award Amount: $100,000,000.00

Question 3: Is an estimated contract value available for this potential requirement?

Answer 3: The Government will not disclose an estimated contract value for this requirement.

Question 4: Page 1 of the RFP specifies "FOB Destination" as defined in the Clause 52.247-34. Since this is not an official Incoterm it of International Chamber of Commerce for delivery it is not clarified specifically in the Clause who handles international customs clearance, who acts as the Importer of Record (IOR), or who pays foreign customs duties and taxes would take care of import duties. We understand that the Contractor would be responsible for delivering to the designated airport within the USA and the Government would be the importer and take care of import duties, aligning with Incoterm DAP (Delivered at Place). We would like to confirm this is still the case for this RFP.

Answer 4: Correct, the Contractor is responsible for delivering to the designated airport within the USA and the US Government will be the importer and responsible for paying the import duties.

Question 5: FAR 52.222-56, Certification Regarding Trafficking in Persons Compliance Plan. Could you please confirm what specific certification and/or supporting documentation the Offeror is required to include in connection with this provision and when it must be submitted?

Answer 5: The apparent successful Offeror must submit the certification in accordance with paragraph (c) of FAR 52.222‑56, Certification Regarding Trafficking in Persons Compliance Plan, prior to award, if the conditions in paragraph

(b) apply.

Question 6: FAR 52.225-6, Trade Agreements Certificate. Please confirm whether the only information required from the Offeror under this provision is the applicable line-item number(s) and country of origin of the products offered.

Answer 6: Yes. Under FAR 52.225‑6, the only information the Offeror must provide is the line‑item number(s) and country of origin for any end products that are not U.S.-made or designated country end products.

Question 7: FAR 52.240-90, Security Prohibitions and Exclusions Representations and Certifications. Please confirm

Questions and Answers Solicitation 12639527R0001

Solicitation Questions Received by October 9, 2026, 5:00 PM CT whether the Offeror is required to provide any information or certification under paragraphs (c), (d), and (g) of this provision and, if so, what information should be included with the proposal.

Answer 7: The Offeror does not need to provide separate information or certification under paragraphs (c) or (d) with its proposal if, after conducting a reasonable inquiry, it represents compliance with the prohibitions; submission of the offer constitutes the representation. If the Offeror cannot represent compliance with the prohibitions in paragraphs (c) or (d), it must provide the disclosure required by paragraph (g), including the information listed in paragraph (g)(1) for each noncompliant product or service.

Question 8: Volume I – Administrative. Please could you confirm whether, in addition to the signed SF 1449 and the applicable completed FAR provisions, any other certifications, forms, or supporting documents are required to be submitted with the proposal as part of Volume I.

Answer 8: Volume I must also include a one‑page cover letter. No additional certifications, forms, or supporting documents are required beyond those stated in the Proposal Preparation Instructions. Offerors should refer to the amended FAR 52.212‑1, paragraph b., subparagraph a. Volume I – Administrative, for the complete list of required items.

Question 9: Volume III – Past Performance. Please confirm that Offerors are required to submit only the information required in the Past Performance Information Sheets for only two (2) relevant contracts, and that no additional contract references are required or expected. For purposes of our submission, we intend to include two previous contracts as one past performance reference, given their closely related scope and performance, together with our most recent contract. Please confirm whether this approach is acceptable.

Answer 9: Each Past Performance Information Sheet must include only a single contract reference; therefore, multiple contracts may not be combined into one reference.

Question 10: Factor 1 – Technical Capability / CVB status. Factor 1 requires applicable and approved MSV and propagation cell line data to be on file with the CVB, while SOW Section C.1.2 appears to allow the offer of products for which a license or permit has not yet been issued, provided the Contractor is making a good faith effort to obtain it through appropriate CVB submissions. Please confirm whether products currently under the CVB review/approval process may be included in the Offeror's proposed FMD product list.

Answer 10: Yes, products currently under CVB review for license or permit and those that the Offeror expects to submit for CVB review within the period of performance may be included in the Offeror’s proposed FMD product list. CVB review status will be evaluated prior to issuance of a delivery order for each product.

Question 11: Factor 1 – Technical Capability / CVB status. Considering that the solicitation recognizes that vaccine production is a rapidly evolving field. Please confirm whether the Offeror may propose products using MSV for which certain required technical attributes like efficacy or cross protection attributes are still undergoing validation, provided that full compliance can be demonstrated prior to issuance of a delivery order for the applicable product.

Answer 11: Yes, products using MSV for which required technical attributes are still undergoing validation may be proposed, acknowledging that full compliance must be demonstrated prior to issuance of a delivery order for the product.

Question 12: Bank Activation / Delivery Timeline. Upon activation of the vaccine bank, the SOW requires the Contractor to confirm the bank activation request within one working day. Previous antigen bank arrangements contemplated the rapid conversion and delivery of finished vaccine following bank activation, with an initial deadline of no more than 7 days.

Please confirm whether there is a maximum required delivery time following a bank activation request under this solicitation, or whether each Offeror should propose its minimum achievable delivery time and the applicable delivery timeline will be established at the Delivery Order level.

Answer 12: The Offeror should propose its minimum achievable delivery time with expected delivery timeline for rapid conversion and delivery of finished vaccine to a designated destination in the United States following bank activation.

File details come from the government source that posted it. Updated .