RFQ.docx

Exhibit 11

COMBINED SYNOPSIS / SOLICITATION COMPETITIVE

Solicitation Number: 75N95025Q00058

TITLE: Assay Development Consultant Support Services

Introductory Statement

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

The Government reserves the right to make one award, multiple awards, or no awards as a result of this solicitation.

Solicitation Number and Authority

The solicitation number is 75N95025Q00058 and the solicitation is issued as a Request for Quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the FAR Part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Items and is expected not to exceed the simplified acquisition threshold.

Applicable Federal Acquisition Circular

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-04, dated August 7, 2025.

NAICS Code and Small Business Standard

The associated NAICS code is 541690 (Other Scientific and Technical Consulting Services) and the small business size standard is $19 million.

This acquisition is set aside for any small business concerns.

Anticipated Contract Type

The Government intends to award a Labor-Hour Purchase Order with Options for Increased Quantity.

Description of Requirement

Statement of Need and Purpose: The NIH is seeking executive (senior scientific)-level, industry-experienced drug discovery and development consultants with expertise in Pharmaceutics / Formulation/CMC to provide technical guidance to the following programs:

· Pharmaceutics / Formulation / CMC consulting to support the NIH Blueprint Neurotherapeutics [BPN] program.

· Pharmaceutics / Formulation / CMC consulting to support the NIH Help End Addiction Longterm [HEAL] program.

· Pharmaceutics / Formulation / CMC consulting to support the NIH Biologics program.

· Other NIH neuroscience-focused drug discovery and development programs Please refer to Attachment #1 - Statement of Work (SOW) for complete details and specifications.

Period and Place of Performance

Period of Performance: The anticipated period of performance is a one-year base period from the effective date of award as follows:

Estimated Base Period: September 20, 2025 – September 19, 2026

Place of Performance: The primary place of performance shall be the Contractor site. Conference calls and email shall be the primary mode of communication.

Applicability of FAR clause 52.212-1

The provision at FAR 52.212-1, Instructions to Offerors – Commercial Items (Mar 2023), applies to this acquisition. The following instructions are included as an addendum.

Evaluation Criteria

As described in Attachment #5 – Evaluation Criteria, all quotes from responsible Quoters will be evaluated by a Technical Evaluation Panel according to the technical evaluation factors.

Responses to this solicitation must include clear and convincing evidence of the Quoter’s capability of fulfilling the requirement as it relates to the following evaluation factors:

· Technical Factor 1: Personnel Qualifications;

· Price; and

· Past Performance.

Responses will be evaluated in accordance with the evaluation criteria identified in this solicitation as well as the SOW requirements.

Technical Requirements:

Responses must include clear and convincing evidence of the Quoter’s capability of fulfilling the requirement as it relates to Technical Factor 1: Personnel Qualifications.

These responses shall include resumes of proposed key personnel, consultants, and any subcontractors, as well as a letter of commitment from proposed key personnel. These responses should also clearly identify whether proposed personnel will be or are an employee of the Quoter. Please note that all proposed key personnel must be employed by the Quoter no later than the start of the contract’s period of performance.

Please note, however, that while resumes of all proposed key personnel are required, they are NOT, by themselves, sufficient. Quoters MUST also submit a separate narrative demonstrating how proposed Key Personnel satisfy the Personnel Qualifications evaluation criteria. Please carefully examine the evaluation criteria prior to writing this narrative.

Business Requirements:

Quoters are required to complete Attachment #4 – Price Template. Quoters are only to fill in the highlighted cells (including the proposed labor rate and the number of consultants being proposed); all other cells will then auto-populate. Quoters must submit the completed pricing template in Excel (do not convert to PDF) as a separate attachment and shall not combine or embed the pricing template with other materials.

Quoters will note that the Government anticipates annual funding for an estimated 20 labor hours per-consultant and has included an annual not to exceed amount of 780 optional hours (for a total annual ceiling of 800 hours per-consultant). It should also be noted that the Government may reimburse the successful Quoter(s) for up to $1,500 in annual travel-related expenses, per-consultant, that are necessary for performance of this requirement. These funds shall be provided only after it is determined there is a need for travel. Additionally, all travel requests require advance approval by the Government.

If the Quoter proposes the involvement of any additional staff besides the Key Personnel, it must clearly articulate their role and why it believes additional personnel are necessary to fulfill the requirement. The Quoter must also specify how this time will be charged (e.g. direct hourly rate or included within overhead). Finally, the Quoter is required to document its rationale for any proposed Other Direct Costs (ODCs) besides travel as well as the total amount. If any of these conditions are applicable, the Quoter shall add rows for the additional costs to the Price Template and include a Price Narrative in its response.

Salary Rate Limitation:

Quoters are advised that no NIH funds may be used to pay the direct annual salary of an individual through any contract awarded as a result of this solicitation at a rate in excess of the Executive Schedule, Level II* (direct salary is exclusive of Overhead, Fringe Benefits and General and Administrative expenses, also referred to as "indirect cost" or "facilities and administrative (F&A) costs"). Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the Quoter pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the Quoter.

This does not preclude Quoters from absorbing that portion of an employee's annual salary (plus the dollar amount for fringe benefits and associated indirect costs) that exceeds a rate of the Executive Schedule, Level II*. The Executive Schedule, Level II* annual salary rate limitation also applies to individuals proposed under subcontracts as well as consultants.

LINK TO EXECUTIVE SCHEDULE RATES OF PAY:

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/ (For current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.)

Past Performance:

Quoter shall identify 1-2 awards with the Federal Government and/or commercial customers that demonstrate recent and relevant past performance. Relevant is defined as work similar in complexity and magnitude to the work described in the SOW.

Quoter shall include the following information in their past performance examples:

· Project title

· Description of the project

· Contract number

· Contract amount

· Government Agency/Organization

· Point of contact name, address, and phone number

· Contract and, if applicable, task order number

· Current status, e.g., completed and/or if in progress, start and estimated completion dates

· SOW paragraphs that the reference applies to

· Key personnel (please highlight those individuals who worked on the relevant project(s) and are also being proposed for this effort.)

· A brief narrative of why you deem the reference to be relevant to this effort

Response:

Quoter responses shall be no more than ten (10) single-sided pages in length. This page limit includes the following:

(i) Cover Page, if applicable

(ii) Executive Summary, if applicable

(iii) Table of Contents, if applicable

(iv) Key Personnel Narrative (no more than two pages)

(v) Price Narrative, if applicable

(vi) Past Performance Examples

This page limit does NOT include:

(i) Key Personnel Resume(s)

(ii) Letter(s) of Commitment

(iii) Representations and Certifications

(iv) Completed Price Template

Additional Required Information:

In addition to the previously discussed requirements, Quoters must include the following in their response:

1) Company’s Full Name and Address

2) Unique Entity ID (UEI)

3) Name, Telephone Number, and Email Address of Person Authorized to Provide Quote Please note that, to be considered for award, Quoters must also be actively registered in the System for Award Management (SAM), accessible at www.sam.gov, at the time of quote submission.

QUOTES DUE: To be considered for Phase One evaluation, Quoter must submit all required materials by 12:00 PM Eastern Time on August 22, 2025 and reference solicitation number 75N95025Q00058. Responses must be submitted electronically to Polina Klimenkova, Contracting Officer, at polina.klimenkova@nih.gov

Applicability of FAR clause 52.212-4

The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items (Dec 2022), Alternate I (NOV 2021) apply to this acquisition and is incorporated by reference.

Applicability of FAR clause 52.212-5

The clause at 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (MAY 2022) applies to this acquisition.

FAR 52.212-5 is included in full text at Attachment #2 - Additional Terms and Conditions.

Applicability of HHSAR clause 352.224-71

The clause at HHSAR 352.224-71 Confidential Information (DEC 2015), applies to this acquisition and is incorporated by reference.

Applicability of Defense Priorities and Allocations System (DPAS)

The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

RFQ Attachments

Attachment #1 – Statement of Work (SOW) Attachment #2 – Additional Terms and Conditions Attachment #3 – Invoice Instruction Attachment #4 – Price Template Attachment #5 – Evaluation Criteria