S25-104 RFP - Malaria Vaccine Immunogenicity.pdf

P.O. Box B, Frederick, MD 21702-1201 • 301-846-1000

A subsidiary of

RFP No. S25-104 June 3, 2025 - Revision 3

SOLICITATION/RFP NUMBER: S25-

DATE ISSUED: 6/11/2025

ISSUED BY:

Leidos Biomedical Research, Inc.

Research Contracts Department

P.O. Box B

1050 Boyles Street

Frederick, MD 21702

ADDRESS OFFERS TO/FOR INFORMATION REGARDING THIS

SOLICITATION CONTACT:

Cody Wenner/cody.wenner@nih.gov

IMPORTANT:

To be considered for award, offers must be received at the location specified above by 4 PM EST, 7/9/2025. Offers must be clearly identified with the Solicitation/RFP Number listed above.

The cover letter shall acknowledge that your transmission of an offer in response to this Solicitation is valid for a period of 120 days from date of submission.

A. Introduction

This Solicitation is issued by Leidos Biomedical Research, Inc. (Leidos Biomed), a wholly owned subsidiary of Leidos Corporation under its Prime Contract with the National Cancer Institute (NCI/Government) at

Frederick. The provisions and clauses contained herein and attached are influenced by and reflect the relationship of the parties in said Prime Contract, which was awarded and is administered under the provision of the Federal Acquisition Regulation (FAR).

B. Anti-Kickback Act of 1986

The Anti-Kickback Act of 1986 as referenced in FAR 52.203-7 is hereby incorporated into this Solicitation and any subsequent award(s) as a condition of acceptance. If you have reasonable grounds to believe that a violation, as described in paragraph (b) of FAR 52.203-7, may have occurred, you should report this suspected violation to the Leidos Ethics Hotline at (855) 753-4367 or via the internet at www.leidos.ethicspoint.com.

C. Solicitation Package

This Solicitation Package consists of two documents: (i) this one, which is referred to as the Request for

Proposal (RFP) Document and (ii) Subcontractor’s Representations and Certifications.

D. Contract Type

The resulting Subcontract will be a Firm-Fixed-Price contract providing for a price that is not subject to any adjustment on the basis of contractor’s cost experience in performing the contract.

http://www.leidos.ethicspoint.com/

RFP No. S25-104 June 3, 2025 - Revision 3

E. Instructions to Offerors

E.1. General Information

IMPORTANT – ELECTRONIC SUBMISSION:

OFFERS MUST BE SUBMITTED ELECTRONICALLY IN EITHER SEARCHABLE ADOBE ACROBAT, MICROSOFT

WORD, OR MICROSOFT EXCEL FORMATS AS APPLICABLE. SAVED FILES MUST NOT EXCEED 15 MB IN SIZE;

THIS MAY REQUIRE THAT A DOCUMENT BE BROKEN INTO TWO OR MORE SEPARATE FILES.

ALL OFFERS MUST BE RECEIVED BY 4 PM EST, 7/9/2025. OFFERS SHALL BE SUBMITTED TO CODY WENNER

AT CODY.WENNER@NIH.GOV.

All offer submissions must be clearly identified to include the Offeror’s name, Principal Investigator’s name (or Project Manager’s name), and Solicitation/RFP Number.

Late offers will not be considered for award.

E.2. Questions Regarding this Solicitation

IMPORTANT:

ALL QUESTIONS OR REQUESTS FOR CLARIFICATION MUST BE EMAILED TO CODY WENNER AT

CODY.WENNER@NIH.GOV NO LATER THAN 4 PM EST, 6/25/2025.

Questions shall be provided in one concise submission with references to the relevant sections(s) of this

Solicitation. The questions submitted will be compiled with responses into one document that will be incorporated as an amendment to this Solicitation and distributed to all Offerors.

Questions or requests directed to any other individual other than the individual named in this section will not be considered valid, nor will there be a response provided. If deemed necessary or desired by the

Leidos Biomed Subcontracts Administrator, a second round of questions may be solicited.

E.3. Offerors’ Teleconference – RESERVED

E.4. Offeror Site Visit – RESERVED

F. Proposal Instructions to Offeror

To be considered responsive to this Solicitation, the Offeror must provide and/or complete the following requirements:

- Volume 1 – Request for Proposal Document

- Volume 2 – Technical Proposal

- Volume 3 – Price (Cost) Proposal

RFP No. S25-104 June 3, 2025 - Revision 3

- RFP Attachment 3: Worksheet for Review of the Vertebrate Animal Section (VAS)

- Subcontractor’s Representations and Certifications (provided as a separate document with this

Solicitation Package).

- An IRS Form W-9. All Offerors MUST be registered with the System for Award Management (SAM).

Offerors may register with SAM at https://www.sam.gov/SAM/. The address included on the W-

9 MUST match the address registered at SAM, and/or included with Subcontractor’s

Representations and Certifications.

F.1. VOLUME 1 – RFP Document

This Volume shall contain the RFP Document with all items completed as required below and submitted as prescribed in E.1. General Information above and be clearly named Volume 1 – RFP.

Requirements:

• Complete Section J. Certifications

• Complete Section K. Offeror Representatives

• Complete Section L. Offeror Signature

F.2. VOLUME 2 – TECHNICAL PROPOSAL

This Volume shall contain the Technical Proposal Document with all items completed as required below and submitted as prescribed in E.1. General Information above and shall be clearly named Volume 2 –

Technical Proposal.

IMPORTANT:

Technical Proposals shall not include cost or pricing information.

Technical Proposals must include page numbers on all pages, including all appendices and attachments.

There must also be a cover page that lists all appendices and attachments.

Requirements:

The Offeror must provide Technical Proposals that clearly demonstrate the Offeror’s current capabilities to meet each of the various requirements as established in RFP Attachment 1: Statement of Work and in accordance with the guidelines set forth below. Responses shall be focused, succinct, and free of extraneous data or information responding solely to the requirements contained in the RFP Attachment

1: Statement of Work. Additionally, Technical Proposals shall be formatted in such a way to clearly cross-reference the relevant sections in the RFP Document.

Provided below is the outline of specific information to be addressed in the Technical Proposal and for maximum page limitations for each of the required sections.

https://www.sam.gov/SAM/

RFP No. S25-104 June 3, 2025 - Revision 3

F.2.a. Executive Summary (1 page limit)

The summary shall contain the most important elements from sections below but should at a minimum clearly specify the following elements:

• Brief identification and qualifications for this Solicitation of your organization/team, including any lower-tier subcontractors and their roles.

• The purpose and anticipated end result of this Technical Proposal.

• Technical and management approach discriminators.

The summary shall be on separate pages or include a section break before the rest of the Technical

Proposal.

F.2.b. Technical Approach (5 page limit)

Understanding

• Provide your understanding of what needs to be done, the scope of the work, the estimated length of time for the work to be finished, the challenges, and how you are going to address those challenges.

Approach

• Describe a sound technical approach to the proposed work and critical technology challenges required for accomplishing proposed tasks. Describe any unique aspects of the approach, and why you believe it will be the most efficient and effective way of achieving Project objectives. Describe how this approach will meet both Project and overall objectives as described in RFP Attachment

1: Statement of Work.

• Describe the mechanism in place for procuring animals, including approved vendors, lead times for acquisition and quarantine requirements.

• Provide an overview of your animal care program

• This study requires close proximity to the NIH Bethesda campus located in Bethesda, MD to enable VRC researchers to prepare immunogens and transfer to the Subcontractor on the same day as the preparation. Please confirm the location of your facility and also indicate your ability to allow VRC personnel to observe and/or assist with preparation of the immunogens on day of treatments, including what is required in order for VRC to enter appropriate areas of your facility.

F.2.c. Team and Key Personnel (3 page limit)

Introduction

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Introduce your organization and/or team here; give an overview of the capabilities brought to address this effort.

Organization and/or Team

Describe your organization and show chain of command and lines of communication.

Describe each proposed individual’s role, the percentage of their time that is being bid, and a brief description of their qualifications. Fuller experience descriptions may be included in the Appendix.

Personnel

All key personnel shall be clearly indicated. Resume summaries for key personnel shall be included in this section, and full resumes in the Appendix. The percentage of time each key person is proposed should be clearly indicated here. At least one of the key personnel should be the individual(s) tasked with overseeing the execution of the vaccine studies as well as serving as the primary point of contact;

their qualifications should sufficiently demonstrate expertise with small animal models. Evidence of successful past performance should be provided for the individual(s).

F.2.d. Experience and Past Performance (3 page limit)

Describe the teams overall experience with development, processes, and technologies similar to those described in the RFP Attachment 1: Statement of Work. Clearly indicate which organization on your team is providing this experience.

Provide a description of at least three projects successfully performed in the past that indicate the ability to perform on this effort. At least one of these projects should have been performed for an organization other than Leidos Biomed. Clearly indicate who on your team performed, what role was played on each of these projects, and the success criteria that were used to judge the project. Summaries shall be given here, and more complete descriptions may be included in the Appendix.

F.2.e. Project Plan and Project Management Approach (3 page limit)

• Provide a draft Project Plan in MS Excel or PDF format as a separate attachment (no page limit).

This document should contain tasks that demonstrate how objectives described in the RFP

Attachment 1: Statement of Work will be accomplished. The draft Project Plan shall show tasks, dependencies, and milestones, any milestone reviews as requested in RFP Attachment 1:

Statement of Work, as well as any requested Offeror-supplied dates for deliverables. The project plan shall clearly show all three studies and incorporate time needed for sample analysis by the

VRC in between experiments.

• Describe your project management approach and what control mechanisms you can put in place to track progress and ensure project objectives/milestones will be met according to agreed-upon schedules.

RFP No. S25-104 June 3, 2025 - Revision 3

• Provide an initial risk table. This table should include a list of Project risks, an estimation of the severity of the risk (H,M,L), and a risk mitigation approach for that risk.

• Describe management controls to be put in place for lower-tier subcontractor management if lower-tier subcontractors are a part of the proposed team.

• Describe the mechanism you will use to control budget and cost.

F.2.f. Appendix (no page limit)

F.3. VOLUME 3 – COST (OR PRICE) PROPOSAL

This Volume shall contain the Cost (or Price) Proposal Document with all items completed as required below and submitted as prescribed in E.1. General Information above and shall be clearly named Volume

3 – Cost (or Price) Proposal.

Requirements:

Offerors shall submit Cost (or Price) Proposals that provide a budgetary estimate for the project proposed.

The Cost (or Price) Proposal shall include the information required in Sections One and Two below. Budget estimates provided in response to this Solicitation will be used for planning and evaluation purposes. Any requests from Offerors to revise the original budget estimate, as the result of changes requested to the original technical approach during Subcontract negotiations, may be considered but these requests from

Offerors must be accompanied by a detailed explanation of the nature and impact of the change and the need for monetary adjustment.

F.3.a. Section One – Cost (or Price) Proposal

The Cost (or Price) Proposal shall contain sufficient information to allow Leidos Biomed to perform an analysis of the proposed cost (or price) of the work proposed. This information shall include the amounts of the basic elements of the proposed cost (or price) including, but not limited to, labor hour rates, travel, materials, and lower-tier subcontracts.

In preparing your Cost (or Price) Proposal, the following shall be considered:

▪ FAR 52.215-17 Waiver of Facilities Capital Cost of Money is incorporated in this Solicitation;

therefore, Facilities Capital Cost of Money is an unallowable cost under any resulting Subcontract.

▪ As prescribed in HHSAR 331.101.70 Salary rate limitation, in response to this Solicitation/Request for Proposal, the Offeror cannot use any resulting Subcontract 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 is obligated.

▪ Offeror is to prepare their Cost (or Price) Proposal using RFP Attachment 2: Cost (or Price)

Template and submit with Offer in Microsoft Excel format.

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▪ Costs shall be broken out by task.

▪ A milestone payment schedule shall be provided, if applicable. Milestones shall be identified by number, title and description. Provide amount of milestone and if applicable, include unit of measure, quantity and unit price.

▪ Offerors shall provide substantive detail regarding the cost (or price) proposed to enable reviewers to objectively determine the reasonableness. Failure to provide a level of detail to facilitate this determination may result in the offer being considered nonresponsive.

F.3.b. Section Two – Cost (or Price) Justification and Documentation

In this section, provide justifications and explanations of all proposed costs. This INCLUDES explanation of the processes by which extended costs were derived and a basis for why the proposed costs should be considered reasonable. The supporting information to be provided includes, but is not limited to:

▪ Labor costs: Provide labor categories and a description of the position’s planned role on the project. If the proposed positions have not been filled or are to be named or hired, provide description of anticipated position and estimated labor category and rate.

▪ Demonstration of the reasonableness of any proposed lower-tier subcontractor costs, including demonstration that the proposed rates/costs are in keeping with those normally charged for the work to be performed.

G. Proposal Evaluation Criteria

G.1. Basis for Award

Leidos Biomed intends to award a Subcontract(s) resulting from this Solicitation to the responsible organization(s) whose offer(s) conforming to this Solicitation will be of the best value to Leidos Biomed, price and other factors considered. Although technical factors are of paramount consideration in the award of a Subcontract, cost and/or price is also important to the overall award decision.

G.2. Potential Award Without Discussions

Leidos Biomed reserves the right to award a Subcontract without discussions if the Leidos Biomed

Subcontracts Administrator determines that the initial offer(s) are fair and reasonable and that discussions are not necessary. Therefore, the Offeror’s initial offer should contain the Offeror’s best terms from a price and technical standpoint. However, Leidos Biomed reserves the right to conduct discussions if later determined by the Leidos Biomed Subcontracts Administrator to be necessary. Leidos Biomed may reject any or all offers; accept other than the lowest priced offer; and waive informalities and minor irregularities in offers received.

The assessment of the offers received in response to this Solicitation will be carefully considered against the needs of Leidos Biomed and the Government. This assessment is not intended to be a solely

RFP No. S25-104 June 3, 2025 - Revision 3 mechanical or mathematical analysis of an offer, but rather the product of both objective and subjective measurements and judgments of the source selection officials after consideration of the relevant information.

H. Proposal Evaluation Factors

Evaluation of the offers submitted will be considered against the following evaluation factors.

General Evaluation Criteria

H.1. Technical Approach (25%)

▪ The Offeror demonstrates good understanding of the scope, objectives, and challenges of this project.

▪ The proposed approach is capable of meeting project objectives as stated in the RFP Attachment

1: Statement of Work.

▪ The solution proposed is within the scope of the effort.

▪ Process for procuring animals is in place including approved vendors; lead times for acquisition and quarantine are reasonable.

▪ Animal care program details are provided and sufficient

▪ Subcontractor is willing to facilitate VRC personnel to observe and/or assist with preparation of the immunogens on day of treatments.

H.2. Team and Key Personnel (20%)

▪ Project Organization covers all skills needed to execute this project.

▪ Key Personnel have demonstrated experience in the technical evaluation factors given above that are applicable to their role.

▪ Evidence has been provided that Key Personnel have performed successfully in the past in the role proposed.

▪ Key Personnel are bid at a level of effort commensurate with their proposed role.

H.3. Experience and Past Performance (25%)

▪ The Offeror has demonstrated experience in the technologies and procedures required to execute this project.

▪ Past performance examples are for projects of similar size, scope, and technical objectives.

▪ Evidence of successful performance on these projects has been provided.

RFP No. S25-104 June 3, 2025 - Revision 3

H.4. Project Plan and Project Management (20%)

▪ Project plan and schedule are reasonable given the tasks proposed.

▪ Mechanism by which budget and costs are controlled has been described.

▪ Project risks have been identified and risk mitigation strategies proposed as applicable.

▪ Lower-tier subcontractor roles, if proposed, are defined, and management controls are adequate.

H.5. Cost (or Price) Reasonableness (10%)

▪ Costs (or prices) proposed are commensurate with the technical tasks bid.

I. RFP Attachments

The following are considered attachments to this RFP Document:

Attachment No. Document Description

1 Statement of Work

2 Cost (or Price) Template

3 Vertebrate Animal Section (VAS) Worksheet

The following is provided as a separate document in this Solicitation Package:

Subcontractor’s Representations and Certifications

J. Certifications

J.1. Organizational Conflicts of Interest (OCI)

This certification is required to ensure OCIs do not exist for the anticipated performance of the

Subcontract or that any potential OCI is identified, neutralized or mitigated when:

Offeror hereby certifies that Offeror’s performance of its obligations under any Subcontract that may be issued as a result of this Solicitation will not be biased because of its financial, contractual, organizational or other interests which relate to the proposed work; Offeror will be able to render impartial, technically sound, and objective assistance or advice; and Offeror will not obtain any unfair competitive advantage over other parties by virtue of its performance of the proposed

Subcontract.

Offeror hereby certifies that the circumstances as to why it cannot make the foregoing “No OCI

Representation” certification are fully disclosed in the attached pages (Offeror to provide as a separate document in advance of full proposal) and reflect:

RFP No. S25-104 June 3, 2025 - Revision 3

- The category of conflict (organizational, contractual and/or financial);

- The company, agency, organization in which you have a past, present, or currently planned interest or activity (financial, contractual, organizational, or otherwise);

- A brief description of the relationship, period of relationship and the extent of relationship (e.g., value of financial interest of work; percent of total holdings, total work, etc.).

Offerors who have a real or potential conflict of interest must notify Leidos Biomed in writing and provide a mitigation plan addressing the conflict at least 2 weeks prior to the submittal due date for offers.

If this direction is not followed, Offeror will be disqualified from the competition.

J.2. Place of Performance (FAR 52.215-6)

In performance of any Subcontract resulting from this Solicitation, the Offeror certifies that it:

Does not intend to use one or more plants or facilities located at a different location from the

Offeror’s primary performance address as proposed in this RFP Document.

Intends to use one or more plants or facilities located at a different location from the Offeror’s primary performance address as proposed in this RFP Document, and provides the following information for the other plants or facilities where work will be performed below:

RFP No. S25-104 June 3, 2025 - Revision 3

Place of Performance Street Address, City, State, County, Zip Code

Name and Address of Owner/Operator of Plant/Facility if Other than Offeror/Respondent

J.3. FAR 52.215-22 Limitations on Pass-Through Charges

Select one:

The proposal excludes excessive passthroughs.

The offeror/subcontractor intends to subcontract to a lower-tier subcontractor more than 70 percent of the total cost of work to be performed under its subcontract, the offeror/subcontractor has identified in their proposal, (i) The amount of the subcontractor’s indirect costs and profit/fee applicable to the work to be performed by the lower-tier subcontractor(s); and (ii) A description of the added value provided by the subcontractor as related to the work to be performed by the lower-tier subcontractor(s).

The offeror/subcontractor shall complete the following representation and certification providing the percentage of effort that would be conducted by your employee personnel during the execution of the

Statement of Work as provided herein including any optional tasks/periods, if applicable.

By submission of this signed offer, Insert Organization Name hereby certifies that:

% of the effort expended in the execution of the Statement of Work as provided by Leidos Biomed in Solicitation/RFP Number will be conducted by employees of this organization.

J.4. FAR 52.215-23 Limitations on Pass-Through Charges

Select one:

The offeror/subcontractor does not certify

The offeror subcontractor does certify

Required reporting of performance of work by the offeror/subcontractor. The offeror/subcontractor shall notify the cognizant LBR Subcontract Administrator in writing if:

The offeror/subcontractor changes the amount of lower-tier subcontractor effort after award such that it exceeds 70 percent of the total cost of the work to be performed under its subcontract. The

RFP No. S25-104 June 3, 2025 - Revision 3 notification shall identify the revised cost of the subcontract effort and shall include verification that the subcontractor will provide added value as related to the work to be performed by the lower-tier subcontractor(s).

J.5. Utilization of Small Business Concerns

In accordance with the terms of its Prime Contract, under which a resulting Subcontract will be issued, Leidos Biomed is committed to maximizing small business subcontracting opportunities to the greatest extent practicable.

Any lower-tier subcontractor effort shall be detailed in the Offeror’s Technical Proposal.

Small Business Subcontracting Plan (FAR 52.219-9)

Select One:

Not applicable, the offeror/subcontractor is a small business.

Not applicable, the offeror/subcontractor is other than a small business and the award is not expected to exceed the threshold specified in FAR 19.702(a) at date of subcontract award.

Not applicable, the offeror/subcontractor is other than a small business and the award will be performed entirely outside of the United States and its outlying areas.

OR

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If the offeror/subcontractor selects this option, both boxes must be checked:

Not applicable at time of award, the offeror/subcontractor is other than a small business and certifies that they do not anticipate any subcontracting opportunities.

Should subcontract opportunities exist in the future the offeror/subcontractor will comply with the requirements in FAR 52.219-9.

OR

Applicable, the offeror/subcontractor is other than a small business and is providing a small business subcontracting plan in accordance with FAR 52.219-9. The Leidos Biomed

Subcontracting Plan template can be found at:

https://frederick.cancer.gov/sites/default/files/2025-

05/LBR%20Subcontracting%20Plan%20Template.pdf

J.6. Certificate of Minimum Labor Category Requirements

In order to be considered for a Time and Materials, Labor Hour or Level-of-Effort type subcontract, the

Offeror must agree to maintain minimum labor qualification standards and requirements.

Select one:

Offeror/Subcontractor is exempt because the proposal being submitted is for other than Time and Materials, Labor Hour or Fixed Price Level-of-Effort.

The Offeror/Subcontractor certifies that it does and will conduct and maintain records of all employees’ background verifications (employment education, licensing and professional certifications) performing under the anticipated Subcontract resulting from this Solicitation and such documented verifications will be provided to Leidos Biomed immediately upon request.

The Offeror/Subcontractor certifies that it does not and will not conduct and maintain records of all employees’ background verifications (employment education, licensing and professional certifications) performing under the anticipated Subcontract resulting from this Solicitation.

J.7. Health and Human Services Acquisition Regulation – 352.231-70 Salary Rate Limitation

The Offeror/Subcontractor Certifies or Does not Certify that the “direct salary” as defined in

352.231-70 and as proposed in response to this RFP/solicitation is compliant with 352.231-70.

https://frederick.cancer.gov/sites/default/files/2025-05/LBR%20Subcontracting%20Plan%20Template.pdf https://frederick.cancer.gov/sites/default/files/2025-05/LBR%20Subcontracting%20Plan%20Template.pdf

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J.8. Office of Laboratory Animal Welfare (OLAW) Certification

Select One:

Offeror is exempt as the solicitation and the contemplated subcontract does not involve animals.

Offeror is not exempt as the solicitation and the contemplated subcontract does involve animals.

Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Any award made using Public Health Service funding for the use of laboratory animals must comply with Public Health Service Policy.

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) establishes several requirements for research activities involving animals. Before award may be made to an Offeror, the Offeror shall file, with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC).

Note: OLAW Assurance is required regardless of location animal work is performed (i.e., if Offeror proposes a lower-tier subcontractor to perform the animal work, Assurance is still required [this scenario would require an Inter-institutional type of Assurance]).

In accordance with the PHS Policy, Offerors must establish an Institutional Animal Care & Use Committee (IACUC), qualified through the experience and expertise of its members, to oversee the institution's animal program, facilities, and procedures. Offerors are required to provide verification of IACUC approval prior to release of a subcontract involving live vertebrate animals. No award involving the use of animals shall be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal activities has been provided to Leidos Biomed. Prior to award, Leidos Biomed will notify Offeror(s) selected for projects that involve live vertebrate animals that an Assurance and verification of IACUC approval are required. Leidos Biomed will request that OLAW negotiate an acceptable Assurance with those Offeror(s) and request verification of IACUC approval. For further information contact OLAW, at NIH, 6700B Rockledge Drive, Suite 2500, MSC 6910, Bethesda, MD 20892 (E-mail: olawoad@mail.nih.gov; Phone: 301-496-7163). The PHS Policy is available on the internet at:

https://olaw.nih.gov/policies-laws/phs-policy.htm.

mailto:olawoad@mail.nih.gov https://olaw.nih.gov/policies-laws/phs-policy.htm

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If animal work is being conducted at multiple organizations, please provide the below Assurance details for all organizations.

Link to Animal Welfare Assurance guidance and sample assurance:

https://olaw.nih.gov/guidance/obtaining-an-assurance.htm

Select One:

Offeror’s organization has an approved Assurance by the Office of Laboratory Animal Welfare (OLAW); our Assurance number is . The Assurance expiration date is: .

Offeror’s organization does not have an approved Assurance by the Office of Laboratory Animal Welfare (OLAW).

J.9. Protection of Human Subjects – Federal Wide Assurance (FWA)

Select One:

Offeror is exempt as the solicitation and the contemplated subcontract does not involve human subjects.

Offeror is not exempt as the solicitation and the contemplated subcontract does involve human subjects.

Offeror agrees that the rights and welfare of human subjects involved in research under this potential Subcontract shall be protected in accordance with 45 CFR part 46 and with the Offeror’s current Federal Wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Offeror further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

Offeror shall bear full responsibility for the performance of all work and services involving the use of human subjects under any Subcontract resulting from this Solicitation and shall ensure that work is conducted in a proper manner and as safely as is feasible.

Offerors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Offeror’s FWA via designation as agents of the institution or via individual investigator agreements see OHRP website at: https://www.hhs.gov/ohrp/

Select One:

Our organization has an approved Federal Wide Assurance on file with the Office of Human Research Protections, Department of Health and Human Services; our FWA number is .

The FWA expiration date is: .

Our organization does not have an approved Federal Wide Assurance with the Office of Human Research Protections.

https://olaw.nih.gov/guidance/obtaining-an-assurance.htm https://www.hhs.gov/ohrp/

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J.10. Restrictions on Use of Human Subjects

Select One:

Offeror is exempt as the solicitation and the contemplated subcontract does not involve human subjects or projects related to human subjects requiring the Offeror to obtain local Institutional Review Board (IRB) approval.

Offeror is not exempt as the solicitation and the contemplated subcontract does involve human subjects or projects related to human subjects requiring the Offeror to obtain local Institutional Review Board (IRB) approval.

Pursuant to 45 CFR part 46, Protection of Human Research Subjects, the Offeror shall not expend funds under any Subcontract resulting from this Solicitation for research involving human subjects or engage in any human subjects’ research activity prior to Leidos Biomedical’s receipt of a certification that the research has been reviewed and approved by the Institutional Review Board (IRB) registered with the Office for Human Research Protections (OHRP). This restriction applies to all collaborating sites, whether domestic or foreign, and subcontractors at all tiers. The Offeror must ensure compliance by their collaborators and lower-tier subcontractors.

Select One:

Offeror certifies the research will be reviewed and approved by the IRB registered with OHRP.

IRB Number: _____________________________________

[Insert IRB Number Above.]

Offeror does not certify that research will be reviewed and approved by the IRB registered with

OHRP.

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K. Offeror Representatives

K.1. Offeror Authorized Representative

The following individual is the designated representative of the Offeror; this will be the Official authorized to obligate your organization and sign the resulting Subcontract:

Name

Title

Organization

Address Line 1

Address Line 2

City, State, and ZIP Code

Phone

Email

K.2. Offeror Key Personnel

The following individual(s) are considered to be essential to the work being performed hereunder, and shall not be re-assigned, removed or substituted without the concurrence of the Leidos Biomed

Subcontracts Administrator:

Name Title Email Address

K.3. Offeror Invoice Representative

The following individual is the designated representative to submit invoices:

Name

Title

Organization

Address Line 1

Address Line 2

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City, State, and ZIP Code

Phone

Email

K.3.a. Offeror Invoice Remittance Address

Organization

Address Line 1

Address Line 2

City, State, and ZIP Code

K.4. Offeror Regulatory Affairs Representative, if applicable

The following individual is the designated representative handling all matters pertaining to Regulatory

Affairs:

Name

Title

Organization

Address Line 1

Address Line 2

City, State, and ZIP Code

Phone

Email

L. Offer Signature

By signing of this document, I hereby affirm that I am duly authorized on behalf of my organization to submit this offer and all information including Subcontractor’s Representations and Certifications submitted to be accurate and complete.

By:

Title:

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RFP No. S25-104 June 3, 2025 - Revision 3

Attachment 1: Statement of Work

A. Background

The Dale and Betty Bumpers Vaccine Research Center (VRC) of the National Institute of Allergy and

Infectious Diseases (NIAID), at the National Institutes of Health, was established to facilitate research in vaccine development. The VRC is dedicated to improving global human health through the rigorous pursuit of effective vaccines and treatments for human diseases. One of the key components of the VRC’s mission involves the rapid advancement of promising candidates from the laboratory to the clinic. The

Vaccine Clinical Materials Program (VCMP) operated by Leidos Biomedical Research Inc. (Leidos Biomed) serves the VRC needs by providing support for preclinical, proof-of-concept and/or vaccine efficacy studies in animal models.

Malaria kills ~0.6 million people annually, mostly children < 5 years old. While WHO has approved two malaria vaccines, which are designed to prevent parasites from invading human hepatocytes, in the last 3-4 years, there is much room to improve, e.g., the vaccine efficacy is usually <50% in highly endemic areas, requires 4 immunizations. In this study, we propose to design a better RH5-based vaccine by a structure-based approach.

B. Scope of Work

Independently, and not as an agent of the Government, the Subcontractor shall furnish the necessary management oversight and personnel for the performance of laboratory animal support services. The

Subcontractor will be responsible for providing husbandry and technical support services required for the proper care, use and humane treatment of laboratory animals in their respective contract facility.

The Subcontractor will be responsible for overseeing experimental activities described below. The

Subcontractor will be responsible for veterinary medical services, treatments/medications, investigator interaction, training and support of facility and research staff, and protocol review.

Study scope:

• Animal model: 8-14-week-old, female, either Wistar or Sprague-Dawley rats Rat

• Animal Quantity:

o Study 1; 3 animals/group, 20 groups, n=60 o Study 2; 8 animals/group, 6 groups, n=48 o Study 3; 8 animals/group, 6 groups, n=48

• Study type: Vaccine administration

• Biosafety level (BSL): BSL1

• Experimental procedures/outputs: blood draw, vaccine administration, weight, clinical observations, and euthanasia

RFP No. S25-104 June 3, 2025 - Revision 3

C. Project Objectives and Requirements

1. Participate in task order kick-off teleconference

a. Within 1 week of task order award, the Subcontractor will participate in a kick-off teleconference along with the Leidos Biomed Technical Project Manager (TPM) and VRC investigator or their designee. The Subcontractor will be responsible for supplying a study schedule prior to the kick-off. The purpose of the kick-off will be to discuss final study design, statement of work, schedule, deliverables and reporting requirements. The kick-off will be coordinated by the Leidos Biomed TPM and will be held at a time that is mutually agreeable to Leidos Biomed, VRC and the Subcontractor.

2. Procure and house sufficient number of rats to support 3 studies consisting of 156 rats from an approved supplier.

a. Note, animals will be required to be placed under the Subcontractor Animal Study

Protocol (ASP). An approved ASP will be provided by the Subcontractor to Leidos Biomed.

b. Total study duration will vary with study:

i. Experiment 1-2: ~45 days; Pre-immune blood up to 3 days prior to Day 0, Day

42 terminal blood collection

ii. Experiment 3: ~70 days; Pre-immune blood up to 3 days prior to Day 0, Day 70 terminal blood collection. Based on results from Exp 2, potential for not performing 3rd immunization (Day 56). In such a case, the immunization and bleed days will be the same as Experiment 1 and 2.

iii. Subcontractor should assume approximately 3-5 weeks between each experiment, to allow for time to transfer sera to VRC, analysis of samples, and to finalize study designs based on results.

c. Subcontractor should ensure robust healthy animals prior to the study start.

3. Execute technical procedures according to study schemas and schedules (Tables 1, 2, 3):

a. Animal health shall be monitored in accordance with Subcontractor SOPs and IACUC protocol

b. Animals shall be immunized with vaccine material via IM route according to Subcontractor approved SOP

i. VRC scientists will provide the vaccine material to be injected by the

Subcontractor.

ii. AddaS03 will be provided by the Subcontractor and mixed with the provided vaccine material based on dilution instructions provided by the VRC; up to 50 uL

RFP No. S25-104 June 3, 2025 - Revision 3 of AddaS03 is anticipated per dose and will be mixed 1:1 (v/v) with vaccine supplied by VRC

c. Blood collections will be performed according to Subcontractor approved SOPs.

i. At least 200ul of serum is to be collected per animal per timepoint during the in-life portion of the study.

ii. Terminal bleed (Max serum) will be collected at indicated Days of study.

d. Physical measurements: body temperature and weight at each dose and before terminal bleed as follows:

i. Body temperature: prior to first dose, on day of dosing (~4 hours post dose), 24 and 48 hours post-dose, and prior to terminal bleed

ii. Weight: prior to first dose, daily for six days following each dose, and prior to terminal bleed

e. Euthanasia according to Subcontractor approved SOP

i. Terminal blood collections (Max serum) will occur as indicated.

ii. No other tissues will be required at euthanasia.

4. One (1) VRC scientist will be permitted to observe and/or assist with preparation of the immunogens on day of treatments. The Subcontractor will coordinate with the VRC scientist to enable access to appropriate areas of the Subcontractor facility.

RFP No. S25-104 June 3, 2025 - Revision 3

Table 1: Study Schema, Experiment 1

Group

Serum

Collection

(Day -3)

Vaccine (Day 0)a Vaccine (Day 28)a Terminal Serum

Collection (Day 42) Animal #

1 200ul RH5 Candidate 1 RH5 Candidate 1 Max 3

2 200ul RH5 Candidate 2 RH5 Candidate 2 Max 3

3 200ul RH5 Candidate 3 RH5 Candidate 3 Max 3

4 200ul RH5 Candidate 4 RH5 Candidate 4 Max 3

5 200ul RH5 Candidate 5 RH5 Candidate 5 Max 3

6 200ul RH5 Candidate 6 RH5 Candidate 6 Max 3

7 200ul RH5 Candidate 7 RH5 Candidate 7 Max 3

8 200ul RH5 Candidate 8 RH5 Candidate 8 Max 3

9 200ul RH5 Candidate 9 RH5 Candidate 9 Max 3

10 200ul RH5 Candidate 10 RH5 Candidate 10 Max 3

11 200ul RH5 Candidate 11 RH5 Candidate 11 Max 3

12 200ul RH5 Candidate 12 RH5 Candidate 12 Max 3

13 200ul RH5 Candidate 12 RH5 Candidate 12 Max 3

14 200ul RH5 Candidate 14 RH5 Candidate 14 Max 3

15 200ul RH5 Candidate 15 RH5 Candidate 15 Max 3

16 200ul RH5 Candidate 16 RH5 Candidate 16 Max 3

17 200ul RH5 Candidate 17 RH5 Candidate 17 Max 3

18 200ul RH5 Candidate 18 RH5 Candidate 18 Max 3

19 200ul RH5 Candidate 19 RH5 Candidate 19 Max 3

20 200ul RH5 Candidate 20 RH5 Candidate 20 Max 3 a Vaccines administer by IM route; dose TBD; each dose will include AddaS03 adjuvant

RFP No. S25-104 June 3, 2025 - Revision 3

Table 2: Study Schema, Experiment 2

Group

Serum

Collection

(Day -3)

Vaccine (Day 0)ab Vaccine (Day 28)ab Terminal Serum

Collection (Day 42) Animal #

1 200ul RH5 Candidate TBD RH5 Candidate TBD Max 8

2 200ul RH5 Candidate TBD RH5 Candidate TBD Max 8

3 200ul RH5 Candidate TBD RH5 Candidate TBD Max 8

4 200ul RH5 Candidate TBD RH5 Candidate TBD Max 8

5 200ul RH5 Candidate TBD RH5 Candidate TBD Max 8

6 200ul RH5 Candidate TBD RH5 Candidate TBD Max 8 a RH5 Candidate vaccines determined from Exp 1 b Vaccines administer by IM route; dose TBD; each dose will include AddaS03 adjuvant

RFP No. S25-104 June 3, 2025 - Revision 3

Table 3: Study Schema, Experiment 3

Group

Serum

Collection

(Day -3)

Vaccine

(Day 0)ab

Vaccine

(Day 28)ab

Vaccine

(Day 56)abc

Terminal Serum

Collection (Day 70) Animal #

200ul RH5

Candidate

TBD

RH5

Candidate

TBD

RH5

Candidate

TBD

Max 8

200ul RH5

Candidate

TBD

RH5

Candidate

TBD

RH5

Candidate

TBD

Max 8

200ul RH5

Candidate

TBD

RH5

Candidate

TBD

RH5

Candidate

TBD

Max 8

200ul RH5

Candidate

TBD

RH5

Candidate

TBD

RH5

Candidate

TBD

Max 8

200ul RH5

Candidate

TBD

RH5

Candidate

TBD

RH5

Candidate

TBD

Max 8

200ul RH5

Candidate

TBD

RH5

Candidate

TBD

RH5

Candidate

TBD

Max 8 a RH5 Candidate vaccines determined from Exp 2 b Vaccines administer by IM route; dose TBD c 3rd immunization to be determined

RFP No. S25-104 June 3, 2025 - Revision 3

D. Conformance and Compliance

1. The study does not require compliance with Good Laboratory Practices; however, the

Subcontractor should utilize SOPs and best practices for documenting laboratory procedures.

2. The Subcontractor’s Animal Care and Use Program must have the following credentials:

a) Office of Laboratory Animal Welfare, Animal Welfare Assurance numbers

b) Association for Assessment and Accreditation of Laboratory Animal Care International file number (AAALAC).

3. The Subcontractor’s standards for all animal care (acquisition, breeding, and experimental protocols), biosafety, and personnel occupational health and safety will conform to all Federal, State and local regulations including but not limited to the following:

a) Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, updated 2015.

b) The Guide for the Care and Use of Laboratory Animals, Eighth Edition (revised 2011 version)

c) Biosafety in Microbiological and Biomedical Laboratories, Fifth Edition (DHHS 2009).

d) Occupational Health and Safety in the Care and Use of Research Animals (NRC 1997)

Continuous high-quality animal care shall be provided as set forth in the applicable animal welfare regulations, and Federal, state and local standards and regulations. Animals must be maintained under carefully controlled conditions to minimize research variables and allow the accurate interpretation of laboratory results. Consequently, it is essential that animal colonies be properly maintained to avoid any situation or condition such as undue stress, diseases, animal identification problems, animal escapes, etc., that might adversely affect ongoing research.

E. Deliverables

The following table contains a list of deliverables with notation of due dates. All days identified are intended to be normal business days unless otherwise specified. The Subcontractor may suggest an alternative due date for any or all deliverables in their offer.

E.1. Deliverable Summary and Due Dates

Item No. Deliverable Due Date

1 Task Order Kickoff with Study

Schedule Within 1 week of task order award

RFP No. S25-104 June 3, 2025 - Revision 3

Item No. Deliverable Due Date

2 IACUC-approved animal study protocol

At least 2 weeks prior to animal receipt

3 Weights and body temperature Within 2 weeks after final euthanasia

4 Final QC’d Data from weights and body temperature

Within 4 weeks after experiment completion

Serum samples frozen at -80oC. Pre-infection serum will be shipped on dry ice to VRC.

Within 1 week following the terminal bleed. Both pre-study and terminal serum samples will be shipped together for each experiment.

Subcontractor will provide email notification to VRC investigator at least 24 hours prior to shipment.

6 Unexpected results or findings As needed

Monthly Report (one report)

10th day of the month following the month in which work was completed

8 Final Report (one report) 6 weeks after study completion

E.2. Deliverable Descriptions and Acceptance Criteria

E.2.a. Descriptions and Specific Acceptance Criteria

The following deliverables shall be developed in this project. The Offeror’s proposed

Project Plan should clearly contain all tasks and milestones required to produce these deliverables.

All deliverables shall be developed according to constraints lists in the “Conformance and

Compliance” section above where applicable.

Where indicated below, electronic communications of deliverables/reports will be sent to the following individuals:

• Leidos Biomed TPM: Chris Case (chris.case@nih.gov)

• VRC investigator: Kazutoyo Miura (kmiura@niaid.nih.gov)

• VRC Animal Program Coordinator: JP Todd (jptodd@mail.nih.gov) mailto:chris.case@nih.gov mailto:kmiura@niaid.nih.gov mailto:jptodd@mail.nih.gov

RFP No. S25-104 June 3, 2025 - Revision 3

1. Deliverable: Task Order Kickoff with Study Schedule

Description and Acceptance Criteria: Within 1 week of Subcontract award, a study kick-off will be held and include the Subcontractor Study Director, VRC investigator or their designees, and Leidos Biomed TPM. Included with the kick-off will be a single study schedule provided by the Subcontractor that covers all planned experiments under this task order, including pertinent dates outlined in the biosampling tables above. The kick-off will be coordinated by the Leidos

Biomed TPM and will be held at a time that is mutually agreeable to Leidos

Biomed, VRC and the Subcontractor.

2. Deliverable: IACUC-approved animal study protocol

Description and Acceptance Criteria: Subcontract will furnish the IACUC approval letter relevant for the current study.

3. Deliverable: Daily data from weight measurements and clinical observations

Description and Acceptance Criteria: Summary data will be provided in Excel or other spreadsheet format to the VRC investigator, VRC Animal Program

Coordinator and Leidos Biomed TPM.

4. Deliverable: QC’d Data from weight measurements, and clinical observations.

Description and Acceptance Criteria: Final QC’d data will be provided in Excel or other spreadsheet format to the VRC investigator, VRC Animal Program

Coordinator and Leidos Biomed TPM.

5. Deliverable: Serum samples

Description and Acceptance Criteria: Samples will be prepared according to

Subcontractor SOPs, appropriate stored (less than or equal to -20C) and shipped to VRC for analysis. Timing and frequency of shipments will be discussed and agreed upon.

a) Pre-study and terminal serum will be delivered to the VRC Investigator (listed above):

9000 Rockville Pike Building 40 Bethesda, MD 20892

6. Deliverable: Unexpected results or findings

Description and Acceptance Criteria: Any unexpected results or findings should be conveyed via an immediate telephone call to the VRC investigator with an

RFP No. S25-104 June 3, 2025 - Revision 3 email follow up to the VRC investigator, VRC Animal Program Coordinator and

Leidos Biomed TPM. Such instances should include, but not be limited to, unexpected deaths or observed illness in animals.

7. Deliverable: Monthly Report

Description and Acceptance Criteria: Subcontractor shall submit progress reports describing the technical progress made during the period in relation to the funds expended. Monthly reports shall include details regarding dates in which animals are acquired, completion of in-life period, shipments to VRC, and any additional details requested in the ‘Reporting Requirements’ section.

8. Deliverable: Final Report

Description and Acceptance Criteria: This report should be sent to the Leidos

Biomed TPM, VRC Investigator, and VRC Animal Program Coordinator. The VRC and Leidos Biomed will have 10 business days to provide comments/edits to

Subcontractor in a single, compiled document to be supplied by Leidos Biomed.

If no edits are requested, the report will be considered accepted and final. Any comments/edits requested by VRC/Leidos Biomed will be incorporated into the final report by Subcontractor within 10 business days of receipt of compiled comments/edits from Leidos Biomed.

The final report should contain the following information:

• Summary of study including methods, results, and conclusions

a. Included as attachments should be animal forms, material receipt forms, sample processing forms and other study related documents generated during execution of the experiments

• Total number of animals…