Biomedical Advanced Research and Development Authority (BARDA) Rapid Response Partnership Vehicle (RRPV)

Request for Project Proposals (RPP) Solicitation Number: [number]

“Host-Directed Therapeutics for the Prevention of Progression to ARDS”

Issue Date: [date] Questions Due: [date] Responses Due: [date]

In support of:

Biomedical Advanced Research and Development Authority (BARDA) Contracts Management & Acquisition (CMA) 400 7th Street, SW, Washington, DC 20024 MedicalCountermeasures.gov

Solicitation Number: [number]

Executive Summary

1.1 Rapid Response Partnership Vehicle Consortium

The Rapid Response Partnership Vehicle (RRPV) Consortium is an enterprise partnership in collaboration with industry and academia to facilitate research and development activities, in cooperation with the Biomedical Research and Development Authority (BARDA).

The RRPV will help fortify national health security by developing medical countermeasures products prior to and during a pandemic or public health emergency. The RRPV will focus on the acceleration of products and technology development, regulatory approval, commercialization, and sustainment to address pandemic influenza, emerging infectious diseases, and other biological threats. Advanced Technology International (ATI) has been awarded an Other Transaction Agreement (OTA) by BARDA to serve as the Consortium Management Firm (CMF) for the RRPV.

RRPV is openly recruiting members to join a broad and diverse biomedical consortium that includes representatives from all organizations who work within stated technical focus areas; for more information on the RRPV mission, refer to the RRPV website at www.RRPV.org. For entities interested in joining the RRPV Consortium and responding to this solicitation, please at www.rrpv.org/how‐to‐join.

1.2 Background

Acute respiratory distress syndrome (ARDS) is a critical condition that can be incited by viral respiratory infections, including influenza. ARDS is characterized by immune dysregulation that leads to lung damage, making direct- and indirect-acting antivirals ineffective at mitigating the progression to viral-induced ARDS in severely ill patients. Existing challenges in the successful development of drugs to treat or prevent progression to ARDS are in part due to the heterogeneous nature of the condition, including dynamic fluctuations in inflammatory immune markers and differing responses to potential therapeutics amongst patients. There are no FDA-approved drugs for the treatment of ARDS or for the prevention of progression to ARDS in hospitalized patients who have critically severe respiratory illness due to viral infection.

1.3 Purpose

BARDA is requesting project proposals from product developers for the advanced clinical development of host-directed therapeutics for the prevention of progression to ARDS. BARDA has identified a capability gap for treatments for hospitalized patients at risk of developing ARDS due to severe viral respiratory infections, including influenza. The purpose of this project is to support the late-stage development of host-directed therapeutics for the prevention of progression to ARDS in hospitalized patients and to reinforce preparedness and response against future health security threats.

Strategic oversight for the Project Award(s) supported by this RPP will be provided by BARDA.

Administrative Overview

2.1 Request for Project Proposals (RPP)

Each response submitted to this RPP shall contain a Technical Proposal and a Cost Proposal, as well as additional documents described in Section 3 of this request. White papers are not required for this RPP.

2.2 RPP Approach

It is expected that there will be a total of one or more qualified respondents to accomplish the statement of objectives.

Each proposal selected for award under this RPP will be executed as a Project Award under the RRPV by the RPPV CMF and be funded under [RRPV OTA award number]. The same provisions will govern this Base Agreement as the OTA between the U.S. Government (USG) and ATI, unless otherwise noted in the Project Award.

At the time of the submission, Offerors must certify on the cover page of their Proposal that, if selected for award, they will abide by the terms and conditions of the latest version of the RRPV Base Agreement. Base Agreements are typically not executed until Offeror is selected for award.

Offerors are advised to check the RRPV website periodically during the proposal preparation period for any changes to the RRPV Base Agreement terms and conditions.

2.3 Order of Precedence

Each proposal selected for award under this RPP will be executed as a Project Award under the RRPV Base Agreement 75A50123D00005. The same provisions will govern this Base Agreement as the OTA between the U.S. Government (USG) and ATI (“RRPV Base”) unless otherwise noted in the Project Award.

2.4 Period of Performance and Funding

2.3.1 Period of Performance

BARDA estimates the full program Period of Performance to be up to three (3) years from date of award for the completion of a Phase 3 clinical trial, FDA regulatory submissions, and product approval. Specific dates of performance will be negotiated as part of each Offeror’s submission and may extend beyond 3 years. It is anticipated that the primary place of performance will be the performers’ facilities, however this requirement can be negotiated as part of each Performers’ submission.

2.3.2 Funding

The total USG funding amount anticipated to be available for Project Awards is approximately $XM, and the USG anticipates making X (x) award. Award and funding from the Government is contingent upon the availability of federal funds for this program. The funding estimated for this RPP is approximate and subject to realignment.

2.5 Expected Award Date

Offeror should plan on the period of performance beginning on the date of contract award. The Government reserves the right to change the proposed period of performance start date through negotiations via the RRPV CMF and prior to issuing a Project Award.

2.6 Proprietary Information

The RRPV CMF will oversee submission of proposals submitted in response to this RPP. The RRPV CMF shall take the necessary steps to protect all proprietary information and shall not use such proprietary information for purposes other than proposal evaluation and agreement administration. Please mark all Confidential or Proprietary Information as such. An Offeror’s submission of a proposal under this RPP indicates concurrence with the aforementioned CMF responsibilities.

2.7 Mandatory Eligibility Criteria

Offerors submitting proposals will initially be reviewed for compliance with the following minimum eligibility criteria:

a) Offerors must be RRPV members when the proposal is submitted. As mentioned above, prospective Offerors may join the consortium at http://www.rrpv.org/how-to-join.

b) ASPR Security Requirements Attestation Statement (See Attachment 5).

Proposals found to not meet these minimum eligibility criteria as detailed above will be removed from consideration, no further evaluation will be performed, and feedback will not be provided to these Offerors.

2.8 Cost Sharing

Cost sharing is defined as the resources expended by the Project Awardee on the proposed statement of work (SOW). The extent of cost sharing is a consideration in the evaluation of proposals, however, it is not required in order to be eligible to receive an award under this RPP.

If cost sharing is proposed, then the Offeror shall state the amount that is being proposed and whether the cost sharing is a cash contribution or an in‐kind contribution; provide a description of each cost share item proposed; the proposed dollar amount for each cost share item proposed; and the valuation technique used (e.g., vendor quote, historical cost, labor hours and labor rates, number of trips, etc.). Cost sharing is encouraged, if possible, as it leads to stronger leveraging of Government‐contractor collaboration. The Government anticipates up to 30% cost-sharing agreement for this effort.

For more information regarding cost share, please see Attachment 2.

2.9 Intellectual Property and Data Rights

Intellectual Property (IP) rights for RRPV Project Awards will be defined in the terms of a Project Awardee’s Base Agreement. The RRPV CMF reserves the right to assist in the negotiation of IP, royalties, licensing, future development, etc., between the Government and the Project Awardees during the entire award period.

The Offeror shall comply with the terms and conditions defined in the RRPV Base Agreement regarding Data Rights. It is anticipated that anything delivered under this proposed effort would be delivered to the Government with unlimited data rights as defined in the RRPV Base Agreement unless otherwise specified in the proposal and agreed to by the Government. All proposed data rights are subject to Government review and approval. Rights in technical data agreed to by the Government will be incorporated into the Project Award.

The Offeror shall indicate in its Proposal submission its acceptance of the terms and conditions defined in the RRPV Base Agreement regarding intellectual property and data rights.

The Offeror shall complete the table provided in Attachment 3, Statement of Work, for any items to be furnished to the Government with restrictions. An example is provided below. If the Offeror does not assert data rights on any items, a negative response in Attachment 3 is required.

Organization Asserting Restrictions Milestone # Affected

developed exclusively at private expense

Proposals

3.1 Question and Answer Period

Key dates related to this RPP are provided below. Please submit questions to Ms. Kathy Garee (rrpv-contracts@ati.org). Answers will be posted publicly to the RRPV website.

3.2 Proposal General Instructions

Offerors who submit Proposals in response to this RPP must submit by the date on the cover page of this RPP. Proposals received after the time and date specified may not be evaluated.

The Proposal format provided in this RRPV RPP is mandatory and shall reference this RPP number. Offerors are encouraged to contact the Point of Contact (POC) identified herein up until the Proposal submission date/time to clarify requirements.

The Government will evaluate Proposals submitted and will select the Proposal(s) that best meets their current technology priorities using the criteria in Section 5.

All eligible Offerors shall submit Proposals for evaluation according to the criteria set forth in this RPP. Offerors are advised that only ATI, as the RRPV’s CMF, with the approval of the Other Transaction Agreements Officer, is legally authorized to contractually bind or otherwise commit funding for selected Project Awards as result of this RPP.

3.3 Proposal Submission

Proposals shall be submitted by the date and time specified on the cover page to the following website: www.RRPV.HHS.gov

A BDR Portal account is required before a response can be submitted. A BDR account can be requested by contacting ATI at RRPV@ati.org. The account request process is simple but may take several days for approval and access. Upon confirmation of a BDR Portal account, offerors will be able to complete their account registration to be able to submit a proposal.

Failure to propose your submission on time for any reason (e.g., due to late registration in BDR Portal) will result in the submission not being considered for award. Respondents will be provided an automated confirmation of successful submission.

Do not submit any classified information in the Proposal submission.

Offerors shall submit files in Microsoft Word, Microsoft Excel, or Adobe Acrobat (PDF – portable and searchable document format) formats as indicated below. ZIP files and other application formats are not acceptable. All files must be print-capable and without a password required. Filenames shall contain the appropriate filename extension (.docx, .doc, .xlsx, or .pdf). Filenames should not contain special characters. IOS users must ensure the entire filename and path are free of spaces and special characters. The file should not exceed 10 Megabytes of storage space. Movie and sound file attachments, URL Links, or other additional files, will not be accepted.

Once an Offeror has submitted a Proposal, the Government and the RRPV CMF will not discuss evaluation/status until the evaluation results have been provided to the Offerors.

A receipt confirmation will be provided by email. Offerors may submit, or re‐submit, in advance of the deadline. Neither the Government nor the RRPV CMF will make allowances/exceptions for submission problems encountered by the Offeror using system‐to‐system interfaces. If the Offeror fails to submit the full submission prior to the deadline, the submission may not be accepted. It is the Offeror’s responsibility to ensure a timely and complete submission.

3.4 Proposal Preparation Cost

The cost of preparing Proposals in response to this RPP is not considered a direct charge to any resulting award or any other contract.

3.5 Submission Format

Proposals shall reference this RPP number. Each document below (e.g., Technical Proposal, Cost Proposal Narrative, Cost Proposal Format, and Statement of Work) is mandatory and must each be submitted as separate files and shall remain valid for 180 days unless otherwise specified by the Offeror in the proposal. Offerors are encouraged to contact the RRPV CMF with any questions so that all aspects are clearly understood by both parties. The proposal should include the following:

· Technical Proposal submission (30-page limit, unless noted*) – See Attachment 1: One Technical Proposal (.pdf, .doc or .docx). The mandatory template is provided as Attachment 1, and includes mandatory sections for a cover page*, information sheet*, executive summary and minimum eligibility requirements, technical approach, current and pending support, data rights*, and key personnel resumes*.

· Cost Proposal submission (no page limit) – See Attachment 2: One Word (.docx or .doc) or PDF file for Section I: Cost Proposal Narrative is required using the mandatory template. Separately, Section II: Cost Proposal Format is required in Excel (.xlsx) format, with working formulas to the maximum extent practicable.

· Statement of Work/Milestone Payment Schedule (no page limit) – See Attachment 3: One Word (.docx or .doc). The Offeror is required to provide a detailed SOW/Milestone Payment Schedule using the mandatory template provided as Attachment 3.

· Program/Project Management submission (5-page limit) – See Attachment 4: One Word (.docx or .doc) or PDF file. The Offeror is required to provide details on their proposed approach for Program Management and subcontractor management. Submission should include a listing of key personnel (including proposed consultants) who possess the necessary education, training, and experience to successfully perform the work identified in the technical proposal (Note: key personnel resumes to be included in the technical proposal). A summary of related activities must also be provided for key personnel. An organizational chart for the project with affiliations (who will report to whom).

· ASPR Security Requirements Attestation Statement (no page limit) – See Attachment 5. One Word (.docx or .doc) or PDF file. Included with Project Proposals, Offerors must include a statement attesting to their intent and ability to comply with the deliverables and security requirements within the deadline dates stated in Attachment 5.

3.6 Restrictions on Animal and Human Subjects

Project Awardees must comply with restrictions and reporting requirements for the use of animal and human subjects, as addressed in further detail in the RRPV Base Agreement. It is anticipated that the Project Award(s) issued under this RPP will require the following:

· The Project Awardee shall serve as regulatory product sponsor and be responsible for any regulatory submissions to the US Food and Drug Administration (FDA).

· Support and maintain regulatory submissions throughout life of the project.

· The Project Awardee must submit to the Government all regulatory and supporting documentation related to therapeutic development, manufacturing,

· lot releasing, certificates of analysis, analytical development, stability, nonclinical and clinical testing as well as other related documentation.

· The Project Awardee shall cross‐reference any applicable regulatory files, such as Investigational New Drug (IND) applications, Master Files, and Biologics License Applications (BLAs) prior to the conduct of the studies and shall allow cross‐referencing of these documents associated with this effort.

Additional information on the applicable regulatory terms is provided in the RRPV Base Agreement.

These restrictions include mandatory government review and reporting processes that will impact the Offeror’s schedule.

Technical Requirements

4.1 Introduction

The Offeror shall clearly state how it intends to meet and, if possible, exceed the technical requirements. Mere acknowledgement or restatement of the requirements is not acceptable, unless specifically stated otherwise.

4.2 Scope

This project supports advancing the late-stage clinical development of host-directed therapeutics for the prevention of progression to ARDS in hospitalized patients with viral respiratory infection who require supplemental oxygen. The Proposal should include a Phase 3 clinical development plan including dose selection for a host-directed therapeutic product that has supportive Phase 2 data demonstrating efficacy in preventing worsening of severe disease in hospitalized patients with viral respiratory infection. A product that is in an ongoing Phase 3 trial is preferred.

4.3 Performance Objectives

The Offeror will be responsible for the following:

4.3.1 Host-Directed Therapeutics for the Prevention of Progression to ARDS

· Advanced development of host-directed therapeutics for a primary indication of the prevention of progression of severe viral respiratory infection to ARDS through FDA approval.

· The proposed host-directed therapeutic should be able to target a key pathway(s) involved in the progression of severe viral respiratory disease to ARDS.

A. Pass/Fail Criteria: Proposed host-directed therapeutic(s) must meet the following minimum criteria to be considered for award:

a. Data demonstrating a robust therapeutic mechanism of action that is applicable to the resolution of severe disease due to influenza infection.

b. Demonstrated preclinical and/or clinical efficacy against severe disease due to viral respiratory infection.

c. Relevance to viral respiratory infection, including influenza, through intended enrollment of appropriate patients.

d. Rationale behind dose selection for a Phase 3 study.

e. Feedback and concurrence from FDA on the study design of a proposed or current Phase 3 study.

B. Preferred Criteria: Proposed host-directed therapeutic(s) that also meet the following preferred criteria will be given preferential consideration:

a. Current use in an ongoing, adequate and well-controlled Phase 3 clinical trial.

C. Out of Scope: *The following are out of scope and will not be considered:

a. Candidate host-directed therapeutics lacking supportive Phase 2 data.

b. Proposals for preclinical, Phase 1, or Phase 2 studies.

c. Direct-acting or indirect-acting antivirals.

d. Nucleic acid-based products.

* Proposals found to be out of scope as detailed above will be removed from consideration, no further evaluation will be performed, and feedback will not be provided to these Offerors.

4.3.2 Project Tasks

A. Regulatory Strategy and Clinical Development Plan Awardee shall develop and implement a regulatory strategy and a clinical development plan for obtaining FDA approval, using aggressive risk management, and taking advantage of any regulatory flexibilities. The regulatory strategy and clinical development plan should be focused on achieving FDA approval.

B. Clinical Trials Awardee shall conduct a Phase 3 clinical trial(s) for the prevention of progression to ARDS for those hospitalized with a viral respiratory infection, following Good Clinical Practice (GCP) guidelines to support product registration and approval by the FDA.

C. Regulatory Interactions

· Awardee shall serve as regulatory product sponsor and be responsible for all regulatory submissions to the FDA and continue to support and maintain regulatory submissions throughout the life of the project including BLA/NDA submission if the clinical study(ies) is successful.

· Awardee shall submit to the Government all regulatory and supporting documentation related to candidate therapeutic development, manufacturing, lot releasing, certificates of analysis, analytical development, stability, nonclinical and clinical testing, as well as other related documentation.

· Awardee shall cross-reference any applicable regulatory files, such as INDs, Master Files and New Drug Applications (NDAs) prior to the conduct of the studies and shall allow cross-referencing of these documents associated with this effort. All clinical studies should be approved in accordance with industry standards, and HHS Office of Human Research Protection (OHRP) respectively.

D. Project Management It is anticipated that the project agreement holder (PAH) will be required to submit a number of documents to capture the progression of the project, post-award. Requirements may include, but are not limited to the following:

a. Reporting Awardee shall deliver monthly technical and financial reports and progress reports, to including a master schedule. Annual reports shall also be provided. At the end of the effort, the Awardee shall provide a detailed clinical study report, and a final technical and business report.

b. Meetings

· Awardee shall schedule regular, recurring progress meetings with the Government. The meeting agenda shall be submitted to the Government at least 3 business days in advance of the meeting. The meeting minutes shall be submitted to the Government no later than 3 business days following the meeting.

· Awardee shall include the Government in all FDA meetings and submit all ‘read-ahead’ packages at least 3 business days in advance of the FDA meeting.

· Awardee shall provide to the Government records of all communications with the FDA no later than 3 business days after communications occur.

c. Logistics Objectives Awardee shall be responsible for (sub)contracting or executing all intellectual property, materiel, and sample shipments and maintenance of all associated records and permits.

4.3.3 Performance Requirements

Submission and maintenance of nonclinical and clinical documentation for regulatory filings (pre-IND/IND) that support a regulatory strategy to achieve FDA approval.

4.3.4 Deliverables

Over the course of this project, Awardee is required to provide the deliverables in Attachment 3 Section 4.0 of this RPP.

NOTE: Technical data deliverables described herein shall be delivered to the Government with unlimited data rights.

4.3.5 Special Requirements

Selection/Evaluation

5.1 Compliance Screening

The RRPV CMF will conduct a preliminary screening of submitted Proposals to ensure compliance with the RPP requirements. As part of the preliminary screening process, Proposals that do not meet the requirements of the RPP may be eliminated from the competition or additional information may be requested by the RRPV CMF. The Government reserves the right to request additional information or eliminate proposals that do not meet these requirements from further consideration.

5.2 Proposal Evaluation Process

Following the preliminary screening, the Government sponsor will perform source selection using the evaluation factors detailed below. The Government will conduct an evaluation of all qualified Proposals.

Qualified Proposals will be evaluated by a panel of subject matter experts (SMEs) who will make recommendations to a Source Selection Authority.

This process may involve the use of contractors as SME consultants or reviewers. Where appropriate, the USG will employ non‐disclosure agreements to protect information contained in the RPP as outlined in Section 2.9. An Offeror’s submission of a Proposal under this RPP indicates concurrence with the aforementioned use of contractors and SMEs.

Evaluation of proposals will be based on an independent, comprehensive review and assessment of the work proposed against stated source selection criteria and evaluation factors. The Government will evaluate each proposal against the evaluation factors detailed below and assign adjectival ratings to the non‐cost/price factor(s) as discussed below. The Offeror shall clearly state how it intends to meet and, if possible, exceed the RPP requirements. Mere acknowledgement or restatement of a RPP requirement is not acceptable, unless specifically stated otherwise.

The evaluation factors and evaluation criteria are described below.

For each evaluated proposal, the non‐cost/price factors will each be assigned one of the following adjectival merit ratings:

· Excellent

· Good

· Fair

· Poor

· Unacceptable

Once an Offeror has submitted a Proposal, the Government and the RRPV CMF will not discuss evaluation/status until the evaluation results have been provided to the Offerors.

5.3 Evaluation Factors

The Government will evaluate the information provided in each Offeror’s Proposal to determine which Proposal(s) provide(s) the best value to the Government. Such a determination will be based on the following criteria:

Factor 1 ‐ Technical Approach: This factor evaluates the relevancy, thoroughness, completeness, and feasibility of the proposed approach in relation to the following subfactors:

a. General Technical Approach including ability of proposal to meet all requirements as outlined in Section 4 of this RPP.

b. Clinical and Regulatory Approach including an adequate justification for the size and power of the phase 3 clinical study

c. Clear Evidence and Data supporting the mechanism of action for the prevention of progression to ARDS in those with viral respiratory disease

Factor 2 ‐ Relevant Corporate and Capabilities Experience: This factor evaluates the offeror’s demonstrated corporate experience and capabilities experience as well as the technical and program management experience of the proposed team to perform the proposed work. The Government may also consider information in Contractor Performance Assessment Reporting System (CPARS), and the Federal Awardee Performance and Integrity Information System (FAPIIS) or similar systems.

Factor 3 ‐ Program Management Approach: This factor evaluates the quality, thoroughness, completeness and feasibility of the proposed Program Management approach in relation to the following subfactors:

a. Key Personnel & Personnel Management

b. Contract/Subcontract Management

Factor 4 ‐ Cost/Price (See Section 5.4 below) Non-Cost/Price Evaluation factors are listed in descending order of importance. Non-Cost/Price factors are more important than Cost/Price, collectively and individually.

5.4 Cost/Price Evaluation

The Cost Proposal will receive a narrative rating to determine whether costs are realistic, reasonable, and complete.

If a proposal is selected for award, the RRPV CMF will evaluate the estimated cost proposed by the Offeror for performing all requirements outlined in this RPP. Evaluation will include analysis of the proposed cost together with all supporting information. The RRPV CMF will request additional information or clarification as necessary. The RRPV CMF will assess the reasonableness and completeness of the cost estimates and then provide a formal assessment to the Government. The Government will review this assessment and make the final determination that the project value is fair and reasonable, subject to final Government negotiations.

Proposals will be evaluated using the understanding of cost realism, reasonableness and completeness as outlined below:

a) Realism. Proposals will be evaluated to determine if Costs are realistic for the work to be performed, reflect a clear understanding of the requirements, and are consistent with the various elements of the Offeror's schedule proposal.

Estimates are “realistic” when they are neither excessive nor insufficient for the effort to be accomplished. Estimates must also be realistic for each phase of the proposed project when compared to the total proposed cost.

The RRPV CMF will make a determination by directly comparing proposed costs with comparable current and historical data, evaluator experience, available estimates, etc. Proposed estimates will be compared with the corresponding technical proposals for consistency.

b) Reasonableness. The Offeror’s cost proposal will be evaluated to determine if it is reasonable. For a price to be reasonable, it must represent a price to the Government that a prudent person would pay in the conduct of competitive business. Normally, price reasonableness is established through cost and price analysis.

To be considered reasonable, the Offeror’s cost estimate should be developed from applicable historic cost data. The Offeror should show that sound, rational judgment was used in deriving and applying cost methodologies. Appropriate narrative explanation and justification should be provided for critical cost elements. The overall estimate should be presented in a coherent, organized and systematic manner.

Costs provided shall be clearly attributable to activities or materials as described by the Offeror. Costs should be broken down in the Cost Proposal Format. An optional template is located on the Members-Only RRPV website.

c) Completeness. The RRPV CMF will evaluate whether the proposal clearly and thoroughly documents the rationale supporting the proposed cost and is compliant with the requirements of the solicitation.

The proposal should clearly and thoroughly document the cost/price information supporting the proposed cost in sufficient detail and depth. The RRPV CMF will evaluate whether the Offeror’s cost proposal is complete with respect to the work proposed. The RRPV CMF will consider substantiation of proposed cost (i.e., supporting data and estimating rationale) for all elements.

Rate and pricing information is required to properly perform the cost analysis of the proposal. If the Offeror is unwilling to provide this information in a timely manner, its proposal will be lacking information that is required to properly evaluate the proposal, and the proposal may not be selected for award.

5.5 Best Value

The Government will conduct the source selection based on the evaluation criteria and ratings listed above. The Government does not guarantee a minimum or maximum number of awards resulting from this solicitation. If an award is made, the overall award decision will be based upon a Best Value determination by considering and comparing factors in addition to cost or price. Funding recommendations depend on various factors and programmatic relevance. Based on the evaluation of the Technical Approach, Relevant Corporate and Capabilities Experience, Project Management Approach and Cost/Price, the Government reserves the right to negotiate and request changes to any or all parts of the SOW. Offerors will have the opportunity to concur with the requested changes, propose further changes and revise cost proposals, as necessary.

5.6 Evaluation Results

Following the evaluation of the Proposals, the Source Selection Authority may:

0. Select the proposal (or some portion of the proposal) for award;

0. Place the proposal in the Basket if funding currently is unavailable; or

0. Reject the proposal (will not be considered for award and will not be placed in the Basket)

The Government does not guarantee a minimum or maximum number of awards resulting from this solicitation.

5.7 Basket Provision

The electronic “Basket” is an innovative acquisition tool. Proposals rated as Fair through Excellent, but not immediately selected for award, will be placed in the Basket for 2 years and eligible for award during that time. Proposals rated as Unacceptable will not be placed in the Basket and will not be eligible for future award. If awarding from the Basket, the Government reserves the right to award whichever proposal best meets its needs.

5.8 Points of Contact

Questions related to this RPP should be directed to Ms. Kathy Garee (rrpv‐contracts@ati.org).

All technical questions must be submitted by [date and time] to allow for Government response. The Government will respond to questions at its discretion. All questions and responses will be posted to the RRPV Solicitation webpage (https://www.rrpv.org/opportunities/).

Once an Offeror has submitted a Proposal, the Government and the RRPV CMF will not discuss evaluation/status until the evaluation results have been provided to the Offerors.

Attachment 1 – Technical Proposal Template

General Instructions The Technical Proposal must address the technical requirements described in the RPP in sufficient detail to permit evaluation from a technical perspective in accordance with the evaluation factors set forth in the RPP. The Technical Proposal shall be single‐spaced, single‐sided, and 8.5 x 11 inches, and 12‐point font. Smaller type may be used in figures and tables but must be clearly legible. Margins on all sides (top, bottom, left, and right) should be at least 1 inch. Offerors are strongly encouraged to use pictures and graphics to succinctly represent proposed ideas, organization, etc.

The Technical Proposal shall be limited to 30 pages (unless otherwise noted below). Pages in excess of this limitation may not be considered. Offerors are advised that the number of pages should be commensurate with the degree of complexity of the proposed effort. It is expected, and encouraged, that less complex, less expensive proposals will be significantly less than 30 pages in length.

To ensure Technical Proposals receive proper consideration, the Technical Proposal format shown below is mandatory. If there are any items which are not applicable to a specific proposal, include the section topic in the proposal with a short explanation as to why it is not applicable.

1. Cover Page*

2. RRPV Member Organization Information Sheet*

3. Executive Summary & Minimum Eligibility Criteria

4. Technical Approach

5. Current & Pending Support

6. Data Rights*

7. Resumes of Key Personnel* (each not to exceed 3 pages)

*Excluded from page limitation

1. Technical Proposal Cover Page

[Name of Offeror] [Address of Offeror]

[RPP Number]

[Proposal Title]

[Offeror] certifies that, if selected for award, the Offeror will abide by the terms and conditions of the RRPV Base Agreement.

[Offeror] certifies that this Proposal is valid for 180 days from the close of the applicable RPP, unless otherwise stated.

[As detailed in Section 2.6 of the Request for Project Proposals, Offerors are to include a proprietary data disclosure statement/legend if proprietary data is included.

Sample:

This Proposal includes data that shall not be disclosed outside the RRPV Consortium Management Firm and the Government. It shall not be duplicated, used, or disclosed, in whole or in part, for any purpose other than proposal evaluation and agreement administration. The data subject to this restriction is (clearly identify) and contained on pages (insert page numbers).]

2. Member Information Sheet If an item is not applicable, then that section should be listed as “not applicable.”

OFFEROR NAME:

ALL PLACES OF PERFORMANCE:

TITLE OF PROPOSED EFFORT:

UEI # (if applicable):

CAGE CODE (if applicable):

SMALL BUSINESS (YES/NO):

CONFLICT OF INTEREST (YES/NO):

TOTAL COST OF PROPOSAL:

PROPOSED PERIOD OF PERFORMANCE IN MONTHS:

PREFERRED PAYMENT METHOD (FFP, CPFF, Cost Reimbursable (CR), CR/COST SHARE):

REQUESTED USE OF GOVERNMENT RESOURCES, PROPERTY, LABS, ETC. (YES/NO):

PROPOSED USE OF ANIMAL SUBJECTS (YES/NO):

PROPOSED USE OF HUMAN SUBJECT (YES/NO):

PROPOSED USE OF HUMAN SPECIMEN MATERIAL (YES/NO):

PROPOSED USE OF HUMAN FETAL TISSUE (YES/NO):

PROPOSED USE OF LIVE VERTABRATE ANIMALS (YES/NO):

PROPOSED USE OF SELECT BIOLOGICAL AGENTS OR TOXINS (YES/NO):

CONTRACT/NEGOTIATION CONTACT (NAME, ADDRESS, PHONE, EMAIL):

TECHNICAL/PRINCIPAL INVESTIGATOR CONTACT (NAME, ADDRESS, PHONE, EMAIL):

COGNIZANT RATE AUDIT AGENCY OFFICE (IF KNOWN, INCLUDE POC, ADDRESS, PHONE #, E‐MAIL):

3. Executive Summary & Minimum Eligibility Requirements [The Executive Summary allows Offerors to present briefly and concisely present the important aspects of their proposals to evaluators. The summary should present an organized progression of the work to be accomplished, without the technical details, such that the reader can grasp the core concepts of the proposed project.]

[Additionally, this section must address how the Offeror currently satisfies each aspect of the following minimum eligibility requirements:]

1. Offerors must be RRPV members when the proposal is submitted. As mentioned above, prospective Offerors may join the consortium at www.rrpv.org/how‐to‐join.

2. Demonstrated successful history of developing, cGMP manufacturing, release testing, and conduct of clinical trials for therapeutics and/or vaccines.

3. ASPR Security Requirements Attestation Statement (See Attachment 5).

4. Technical Approach [Provide sufficient technical detail and analysis to support the technical solution being proposed for the project. Clearly identify the core of the intended approach. It is not effective simply to address a variety of possible solutions to the technology problems. Include citation to each Deliverable identified in the Statement of Work throughout the Technical Approach (e.g. (1.1)). Provide the following information:]

1. Background: [Describe the problem that the proposal is addressing.]

2. Approach: [Describe your approach to solving the problem, broken out by Phase as outlined in Section 4.2 (Solution Requirements) of the RPP. Include relevant background data about your approach. Include the current status of your approach.]

3. Objectives: [Specify the objectives of the proposed effort.]

4. Past Experience: [Describe relative corporate and capabilities past experience, as well as the technical and management experience of the proposed team, to perform the proposed work. Past experience should be recent, relevant and similar in size and scope to offeror’s proposed effort.]

5. Technical Strategy: [Describe the proposed methodology, including development and manufacturing approach, in sufficient detail to show a clear course of action.]

6. Clinical Trial: [If a clinical trial is proposed as part of Technical Strategy, then include the following information as part of the technical approach. Clinical trials should be described in adequate detail to assess conformance with FDA regulations, guidance, and the requirements related to development and testing of biologics. This will include compliance with applicable portions of Title 21 of the US Code of Federal Regulations (CFR) including Title 21 CFR Parts 11, 50, 54, 56, the Health Insurance Portability and Accountability Act (HIPPA) of 1996 (Pub.L. 104‐ 191, 110 Stat. 1936, enacted August 21, 1996), and International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practices (GCPs) (ICH Guidelines for Good Clinical Practice (E6), Published May 9, 1997).]

· Clinical Trial History: [If the proposed clinical trial/testing was initiated using other funding prior to this application, explain the history and background of the clinical trial/testing and declare the source of prior funding. Specifically identify the portions of the study that will be supported with funds from this award.]

· On‐Going Effort: [If the proposed clinical trial/testing involves continuation or assumption of an ongoing effort then state the transition plan proposed (e.g., transfer of FDA Sponsorship). In the case of ongoing clinical trials, append or provide reference to previous FDA‐regulated studies. Offeror must justify carefully any changes proposed to ongoing FDA‐regulated protocols and provide specific rationale for alterations (e.g., FDA feedback, change in clinical resources or study sites, etc.)]

· FDA Interactions: [Describe plan to meet all regulatory sponsor responsibilities under ICH parts E6, E2A, E8, and 21 Code Federal Regulation parts 312, 11, 50, 54, 56 including regulatory writing and submissions support for clinical efforts, safety reporting, pharmacovigilance, clinical monitoring, data management, regulatory writing and submissions, etc.]

· Test Materials:

· Describe the clinical intervention, medical drug, biologic, device or human exposure model to be tested and the projected outcomes or measures.

· Document the availability and accessibility of the drug/compound, device, or other materials needed for the proposed research.

· Describe the production/manufacturing plan for the test materials proposed.

· Study Design/Clinical Protocol:

· Provide a description of the purpose and objectives of the study with detailed specific aims and/or study questions/ hypotheses to include the following details as applicable to the proposed work.

· Describe the type of study to be performed (e.g., prospective, randomized, controlled) and outline the proposed methodology in sufficient detail to show a clear course of action.

· Describe potential challenges and alternative strategies where appropriate. Define the study variables, outline why they were chosen, and describe how they will be measured. Include a description of appropriate controls and the endpoints to be tested.

· Describe the study population, criteria for inclusion/exclusion, and the methods that will be used for recruitment/accrual of human subjects and/or samples (e.g., convenience, simple random, stratified random).

· Describe the human subject‐to‐group assignment process (e.g., randomization, block randomization, stratified randomization, age‐matched controls, alternating group, or other procedures), if applicable. Explain the specific actions to accomplish the group assignment (e.g., computer assignment, use of table of random numbers).

· Statistical Plan and Data Analysis: [Describe the data collection plan, statistical model, and data analysis plan with respect to the study objectives. Specify the approximate number of human subjects to be enrolled or number of human samples to be studied. If multiple study sites are involved, state the approximate number to be enrolled or samples collected at each site. Include a complete power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study. If a subpopulation of a sample population will be used for analysis, complete a statistical analysis to ensure appropriate power can be achieved within the subpopulation study.]

· Technical Risks: [Identify and describe potential problem areas in the proposed approach and alternative methods and approaches that will be employed to mitigate any risks that are identified.]

· Ethical Issues: [Include a clear and detailed description of the potential ethical issues raised by the proposed study and provide a detailed plan for how the ethical issues will be addressed.]

· Training/Proficiency Requirements: [Determination to ensure that personnel have appropriate training/competency.]

7. Anticipated Outcomes: [Provide a description of the anticipated outcomes from the proposed work.]

8. Technical Maturity and Commercialization Strategy: [Provide a description and justification of the maturity of the proposed technology, anticipated regulatory pathway and commercialization plans. Include high‐level information about Intellectual Property/Data Rights Assertions. Describe the planned indication for the product label, if appropriate, and include an outline of the development plan required to support that indication. The application should describe a transition plan (including potential funding and resources) showing how the product will progress to the next clinical trial phase and/or delivery to the market after the successful completion of this award.]

9. Organizational Conflict of Interest: [An Organizational Conflict of Interest can occur when an individual or an entity is unable, or potentially unable, to provide impartial advice or service to the Government or separate entity because of other business activities or relationships. Disclose any potential conflict of interest pertaining to this opportunity. If none, state as such.]

10. Key Personnel: [Identify the proposed management and technical personnel for the project using a summary table in the below format. Principal Investigator must be identified].

Name (Principal Investigator)

Name

Name

[Address the qualifications, capabilities, and experience of the proposed personnel who will be assigned to carry out the project. Ensure resumes of key personnel are provided in the “Resumes of Key Personnel” section. Resumes are excluded from page count limit]

11. Schedule: [Identify key technical, schedule, and cost risks, their potential impact and mitigation.]

12. Offeror Resources: [Identify any key facilities, equipment and other resources proposed for the effort. Identified facilities, equipment and resources should be available and relevant for the technical solution being proposed.]

13. Government Resources: [Identify any key Government facilities, Government equipment, Government property, etc. that your organization requests to use for the effort.]

14. Proposed Cost Share: [If applicable, this section provides technical evaluators with information on any additional cost share proposed by the Offeror. If proposing cost share, identify deliverables that are associated with cost shared resources as well as the technical benefit resulting from this resource.]

15. Cost Realism: [This section provides technical evaluators with high‐level cost data in order for them to determine if the costs proposed are realistic as compared to the scope of work proposed. This information must be consistent with the Cost Proposal. The information must be provided in this section of the Technical Proposal. Include the following table as a summary of the costs by cost element.]

Cost Realism Form EXAMPLE This form is to be completed by Offeror and evaluated by Technical Evaluators. Items in italics are provided as examples only. Offeror must complete table with the applicable information. Add or delete columns to match optional tasks.

Labor Hours

7,500

Sub B ‐ $25,000; 250 hours of Testing – each task

Travel

$20,000 2 trips for 2 people for 2 days to Washington, DC from Charleston, for program meetings – each task

5,000 hours of lab assistant – each task

5. Current & Pending Support Current Award Number:

Title:

Funding Agency/Requiring Activity:

Dates of Funding:

Total Direct Costs:

Role: (i.e., Principal Investigator, Co‐Investigator, etc.)

Brief summary of the scope of work:

Award Number:

Title:

Funding Agency/Requiring Activity:

Dates of Funding:

Total Direct Costs:

Role: (i.e., Principal Investigator, Co‐Investigator, etc.)

Brief summary of the scope of work:

[Add additional fields, if needed, to report all current support]

Pending Title of Proposal:

Funding Agency/Requiring Activity:

Estimated Dates of Funding:

Proposed Total Direct Costs:

Role: (i.e., Principal Investigator, Co‐Investigator, etc.)

Brief summary of the scope of work:

Title of Proposal:

Funding Agency/Requiring Activity:

Estimated Dates of Funding:

Proposed Total Direct Costs:

Role: (i.e., Principal Investigator, Co‐Investigator, etc.)

Brief summary of the scope of work:

[Add additional fields, if needed, to report all current support]

6. Resumes of Key Personnel Include the resumes of key personnel from the Offeror’s organization, as well as subcontractors or consultants, who will work on this project if selected (each resume not to exceed 3 pages). The Principal Investigator must be identified.

Attachment 2 – Cost Proposal Template

General Instructions The objective of the Cost Proposal is to provide sufficient cost information to substantiate that the proposed cost is realistic, reasonable and complete for the proposed work. The Cost Proposal should provide enough information to ensure that a complete and fair evaluation of the reasonableness and realism of cost or price can be conducted and reflect the best estimate of the costs for the project. The Cost Proposal must be consistent with information provided in the Technical Proposal (i.e., costs, cost share, dates, etc.).