CSS_Pharmaceutics-Formulation-CMC.pdf

COMBINED SYNOPSIS / SOLICITATION

COMPETITIVE

Solicitation Number: NIH-NINDS-CSS-21-005340

Project Title: Pharmaceutics / Formulation / Chemistry Manufacturing Control Consulting Services

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

The solicitation number is NIH-NINDS-CSS-21-005340 and the solicitation is issued as a request for quote (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5— Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold.

The National Institutes of Health (NIH) intends to make 1-2 awards resulting from this Combined Synopsis/Solicitation (solicitation). However, the NIH reserves the right to make a single award, multiple awards, or no award at all as a result of this Combined Synopsis/Solicitation.

This solicitation and the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-06, dated 06/10/2021.

The associated NAICS code 541990 “All Other Professional, Scientific and Technical Services” has a Size Standard of $16.5 million.

Set Aside Status This acquisition resulting from this solicitation is 100% set aside for small businesses.

STATEMENT OF WORK (SERVICES)

Pharmaceutics / Formulation / Chemistry, Manufacturing Control Consulting Services

Background Information and Objective The NIH is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and lacks effective treatments. In recent decades, there has been an overreliance on opioids for chronic pain despite their poor ability to improve function. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative treatment options for pain are thus critically needed. As part of the mission of the Helping to End Addiction Long-term (HEAL) Initiative, NINDS is working with other NIH Institutes and Centers to encourage the translation of basic research into new non-addictive pain treatments. This Initiative is intended to create a foundation to initiate the optimization and development of pain therapeutics and catalyze the development of partnerships between the academic and industrial sectors so that translational research in pain can flourish as a cooperative, iterative process leading to safe, effective, and non-addictive treatments for pain.

Launched in April 2018, the NIH HEAL Initiative is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. The Initiative advances research to reduce the risks of opioid use and misuse and improve pain management, thereby reducing reliance on opioids.

NINDS is the lead Institute for pain research at NIH and leads the Executive Committee of the NIH Pain Consortium, which includes 23 Institutes and Centers.

The NIH Pain Consortium’s mission includes improving the treatment of a variety of pain conditions.

NINDS will focus efforts in the NIH HEAL Initiative in developing non-addictive pain treatments that may displace the need for opioids, and importantly, serve as effective treatments for acute and chronic pain conditions for which opioids are not effective. This work will be informed by partners from the government, industry, academia, and patients suffering from pain.

The HEAL program will support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate promising small molecule and biologic hits/leads towards clinical trials. The HEAL program will provide neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts.

Purpose/Statement of Need The purpose of this solicitation is to acquire consulting services and technical recommendations in the areas of Pharmaceutics/Formulation/Chemistry Manufacturing Control (CMC). These services will support the NINDS’ HEAL Program and other NIH neuroscience-focused drug discovery and development programs. These services support the NIH HEAL Initiative’s aims to optimize non-addictive Therapies (Small Molecules and Biologics) to treat Pain.

General Requirements Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government, as needed, to perform the Statement of Work (SOW).

The Contractor shall provide this support while serving on NIH HEAL Lead Development Teams. Lead Development Teams (LDT) meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time

The Contractor is expected to provide support services in a collaborative way. Lead Development Teams to which the Contractor is assigned may work on a number of projects in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug (IND) and clinical trial stages.

Specific Requirements The Contractor shall provide consulting support services to the NIH HEAL program as follows:

https://www.nih.gov/heal-initiative https://painconsortium.nih.gov/ https://painconsortium.nih.gov/ https://www.nih.gov/heal-initiative

Pharmaceutics / Formulation / Chemistry Manufacturing Control (CMC) Pharmaceutics / Formulation/ CMC consultants will be expected to provide senior-level Pharmaceutics / Formulation/ CMC expertise and contribute feedback and guidance on projects to the NIH and to LDT members through conference calls and by email. The role of the Pharmaceutics / Formulation/ CMC consultant may include but is not limited to the following responsibilities and tasks:

• Evaluate Pharmaceutics / Formulation / CMC activities for HEAL compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines.

• Identify and assess regulatory risks for compounds under development and provide CMC guidance to HEAL program and LDTs.

• Develop Pharmaceutics / Formulation / CMC strategies which accord with U.S. and international guidelines.

• Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules.

• Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules.

• Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including FDA, European Medicines Agency (EMA) and other national authorities, to support the conduct of clinical trials and marketing applications.

• Provide expertise in activities related to active pharmaceutical ingredient (API) development.

• Recommend dose form selection and API development strategies for HEAL efforts.

• Develop plans to assist HEAL staff in strategically managing chemical manufacturing and control pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies.

• At the request of HEAL staff, accompany NIH staff or visit Contract Research Organizations (CRO) under contract with HEAL, inspect CRO facilities, and discuss appropriateness of CRO proposed methodology. Submit trip reports to HEAL staff.

• Assist HEAL staff in designing investigative chemical manufacturing and controls pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports as needed.

• Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts.

Level of Effort The required level of effort will vary depending on the quantity and complexity of the HEAL projects at any given time. It is anticipated that a minimum of 20 hours of consulting services will be required annually. A Not to Exceed (NTE) amount of up to 780 optional hours shall be exercised if needed, in accordance with FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

Government Furnished Information and Property No Government furnished property will be provided.

Project data will be stored by NINDS. Project related data required for performance of services will be provided to Contractor by NINDS on each occasion that consulting is requested. All data provided to the Contractor must be treated as confidential and not disclosed to any third party.

Key Personnel The Contractor staff providing consulting services for this requirement shall be considered Key Personnel. Key Personnel requirements are as follows:

Key Personnel - General Requirements

• Consultants must have extensive experience in managing, or being a senior leader in, drug discovery projects in the biopharmaceutical industry. Experience with drug discovery for nervous system conditions is preferred.

• Consultants must be able to work in a cross-functional team environment and manage competing priorities.

• Consultants must have strong interpersonal skills, attention to detail, excellent organizational, writing, communication, presentation, and documentation skills, as well as computer and software literacy.

• Consultants must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels.

• Must participate actively in LDT discussions.

• Must possess computer and software literacy.

Key Personnel –Education and Work Experience Requirements

• A PhD in a life or physical science discipline is required.

• A minimum of 15 years of experience in CMC activities.

• Experience in executing and managing drug development tasks, particularly for nervous system conditions.

• A track record of advancing projects into drug development. Measures of success include patents, Investigational New Drug (IND) applications, publications, and drugs brought to market.

• Experience in identifying and anticipating problems early in a project, overcoming technical difficulties, and making strategic decisions that make wise use of limited resources (including terminating projects that appear unlikely to succeed).

• Expertise leading CMC efforts performed by contract research organizations and managing drug project portfolios.

• Experience in small molecule and/or biologic therapeutics for pain relief is preferred.

Key Personnel will be subject to the Health and Human Services Acquisition Regulation (HHSAR) Clause 352.237-75 Key Personnel as follows:

The key personnel specified in the resultant contract are considered to be essential to work performance.

At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

Travel The consultant may be required to travel within the contiguous United States to provide the services described in this statement of work. Travel reimbursement will be provided for such required travel.

All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer and authorized by the Contracting Officer’s Representative prior to being finalized or invoiced.

A Not to Exceed (NTE) amount of $1,500 annually for travel shall be exercised if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

Contracting Officer approved and Contracting Officer’s Representative-authorized travel shall not exceed $1,500.00 annually.

Approximately 8 hours of travel time are anticipated for this requirement. Please note that travel time may not be billed to the Government, in accordance with the Federal Travel Regulation.

Data Rights The National Institute of Neurological Disorders and Stroke shall have unlimited rights to, and ownership of all deliverables provided for this requirement, including reports, analyses, recommendations, and all other deliverables, including those required as a result of modification of the governing contract.

The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, Definitions. FAR clause 52.227-14, Rights in Data-General, shall be incorporated by reference into any contract/order resulting from this solicitation.

Intellectual Property Key personnel who contribute to the creation of new intellectual property will be named as inventors in accordance with U.S. prevailing patent law. Accordingly, consultants must complete negotiations with the principal investigator’s institution regarding assignment of rights and royalty distributions prior to advising on any activities. The key personnel shall provide copies of all existing intellectual property agreements to the NIH COR, for documentation purposes.

Section 508 Compliance Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies’ electronic and information technology (EIT) is accessible to people with disabilities. The FAR Final Rule on Section 508 (EIT Accessibility) can be found at https://www.section508.gov/manage/laws-and-policies. To provide services/support for this requirement, the Contractor must agree in writing to comply with the requirements of Section 508 or cite a justifiable reason for an exception.

Non-Personal Services Statement Contractors performing services for this requirement will be controlled, directed, and supervised at all times by management personnel of the Contractor, if applicable. Actions of the Contractor may not be interpreted or implemented in any manner that results in any Contractor or Contractor’s agent creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR).

Confidentiality of Information Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. Confidential Information or records shall not be disclosed by the Contractor without written authorization from the Contracting Officer. Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information as related to this requirement, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

Collaboration Requirements https://www.section508.gov/manage/laws-and-policies

It is required that all contractors involved with the NIH community work collaboratively with federal staff and other contractors towards the NIH mission and other affected organizations and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer, and the creation and sharing of documentation when required.

Period of Performance The required period of performance is a one-year base period, which shall start and end as specified in the contract/order, immediately followed by two (2), subsequent, one-year option periods.

Place of Performance The primary place of performance shall be Contractor worksite. Conference calls and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities or facilities of principal investigators, on an as-needed basis.

Contract Type Labor-Hour Contract with Options to Extend the Term of the Contract and Options for Increased Quantity.

Invoicing shall be in accordance with FAR Clause 52.212-4(g) and Attachment #3 – Invoice Submission Instructions. Payment of invoices shall be made via Electronic Funds Transfer (EFT).

INSTUCTIONS TO OFFERORS:

The provision at FAR 52.212-1, Instructions to Offerors – Commercial Items, applies to this solicitation.

The following instructions are included as an addendum.

Phase One Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. Technical evaluation of responses to this solicitation shall take place in two phases.

During Phase One, responses shall be evaluated against the criteria for Technical Factor 1: Personnel Qualifications, and for conformance to the solicitation. Therefore, Offeror responses shall contain only the information required per the Phase One Response Requirements below.

Phase One Written Response Requirements:

Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as related 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, including the Statement of Work requirements.

Technical Requirements:

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

The response shall include resumes of proposed key personnel, consultants, and any subcontractors, as well as a letter of commitment from proposed key personnel who are not employed by Offeror. The response should also clearly identify whether proposed key personnel is or will be an employee of the Offeror. Finally, Offeror must address how it will ensure compliance with FAR Clause 52.219-14, Limitations on Subcontracting, if the proposed key personnel is not an employee of the Offeror.

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

Business Requirements:

Offeror shall complete Attachment #1 – Price Template. Offeror is to fill out only the highlighted cells;

all other cells will then auto-populate. Offeror shall include in its response its completed Price Template in Excel format (do not convert to PDF). The price template shall not be combined or embedded with other materials.

The Government anticipates annual funding in the estimated amount of 20 labor hours of consulting services and has included an annual not to exceed amount of 780 optional hours (for a total annual ceiling of 800 hours). In addition, the Government will reimburse the Contractor up to $1,500.00 in travel-related expenses that are necessary for performance of this requirement. These funds shall be provided only after it is determined there is a need for travel. Furthermore, all travel requests require advance approval by the Government. In recognition of these facts, Offeror shall include the following statement in its offer:

“It is anticipated that the Government will fund an estimated amount of 20 hours and that a maximum of up to 780 additional hours may be funded and exercised in any increment during each contract period. It is also understood that a travel amount not-to-exceed $1,500.00 may be funded and exercised during each contract period and may only be used with advance approval.” Any billable travel expenses must follow the Federal Travel Regulation (FTR).”

If the Offeror proposes the involvement of any additional staff besides Key Personnel, it must clearly articulate how their role will be fulfilled and why it believes additional personnel are necessary. The Offeror must also specify how work time of additional staff will be charged (e.g. direct hourly rate or included within overhead cost). Finally, if Offer includes any Other Direct Costs (ODCs) besides travel in its Price Template, the Offeror must include its rationale for the other ODCs in the Offeror’s Price Narrative.

Salary Rate Limitation:

Offerors 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 an Offeror 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 Offeror.

This does not preclude the Offeror 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 proposed subcontractors as well as consultants.

Link to Executive Schedule Rates of Pay: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2021/EX.pdf. (Rates are effective January 1 of each calendar year unless otherwise noted.)

Note to Offerors: Proposed rates must adhere to the current Fiscal Year Executive Level II Salary Rate.

All costs associated with any contract/award resulting from this solicitation shall fully comply with the current Fiscal Year Executive Level II Salary rates.

Offeror shall certify that its quoted labor rates comply with the Department of Health and Human Services Acquisition Regulation (HHSAR) Clause 352.231-70 Salary Rate Limitation, by completing Attachment #2 – Representations and Certification.

Offerors must also include the following in its response:

1) Company’s Full Name and Address

2) Dun & Bradstreet Number (DUNS), Commercial and Government Entity (CAGE) Code, and

Taxpayer Identification Number (TIN)

3) Name, Telephone Number, and Email Address of Person Authorized to Provide Quote

Past Performance:

Offeror’s response shall identify 1-2 existing contract awards from 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.

Offeror shall include the following information in its 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

Phase One Response Format:

Offeror’s response 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 https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2021/EX.pdf

(iii) Representations and Certifications

(iv) Completed Price Template

Please note that, to be considered for award, Offeror must be actively registered in the System for Award Management (SAM), accessible at www.sam.gov, at the time of offer submission.

RESPONSES/OFFERS DUE: Responses including all required materials specified above must be submitted by 11:59 PM Eastern Time on August 6, 2021 and must reference solicitation number NIH- NINDS-CSS-210-005340. Responses must be submitted via email to: Marlene Milgram, Contract Specialist, at marlene.milgram@nih.gov Fax responses will not be accepted.

All timely and responsive offers that fully comply with these solicitation instructions and are submitted by responsible Offerors will be evaluated by the Technical Evaluation Panel (TEP). Late submissions shall be treated in accordance with FAR Provision 52.212-1(f). Faxed responses will not be accepted.

Only the highest-rated Offerors from Phase One will be given the opportunity to submit materials for Phase Two (described below). Offerors who advance to Phase Two will also be required to give oral presentations to the Contracting Officer, Contract Specialist, and members of the TEP. The format for these presentations is described in the following section.

Phase Two All Offerors that have advanced to Phase Two will be given the opportunity to clarify, discuss, or revise aspects of their Phase One response (including Technical Factor 1, Price, and Past Performance).

Additionally, they will be evaluated according to the criteria for the following factors:

• Technical Factor 2: Understanding the Project and Technical Approach, and

• Technical Factor 3: Communication and Oral Presentation Skills.

Please note that all presentations will take place via virtual conferences. The Contract Specialist will provide eligible Offerors with the information necessary to join the conferences, including, if applicable, the virtual meeting link, password, and/or call-in number.

Oral Presentation Requirements:

It is strongly recommended that the proposed Key Personnel conduct or participate in the Offeror’s presentation. Offeror shall discuss its response to Phase One and present its response to Technical Factor 2: Understanding the Project and Technical Approach during the oral presentation, which will include, at a minimum:

• Background discussion of the work contemplated under this project

• Personnel qualifications and specific areas of expertise relevant to the SOW

• Proposed technical approach for fulfilling the requirements described in the SOW, including how the key personnel would characterize their role and responsibilities

• Anticipated problems and constraints anticipated in performing the work and potential plans and solutions for resolving them

• If applicable, examples of how the Offeror has effectively trained other project staff or clients in their discipline.

Phase Two Written Response Requirements:

Phase Two responses must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to all evaluation factors:

http://www.sam.gov/ mailto:marlene.milgram@nih.gov

• Technical Factor 1: Personnel Qualifications;

• Technical Factor 2: Understanding the Project and Technical Approach;

• Technical Factor 3: Communication and Oral Presentation Skills;

• Price; and

• Past Performance.

Phase Two responses will be evaluated according to the evaluation criteria identified in this solicitation as well as the SOW requirements.

Offeror’s written response shall be no more than fifteen (15) 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) Technical Approach Narrative (no more than two pages)

(vi) Price Narrative, if applicable

(vii) 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

(v) Electronic Copy of Oral Presentation materials, if applicable

Offerors who are invited to participate in Phase Two will be notified by email of due date and time for submission of the Phase Two written response.

EVALUTION CRITERIA:

The Government will award a contract(s)/order(s) resulting from this requirement on the basis of best value, technical factors, price, and past performance considered. Technical factors together shall be considered significantly more important than price and past performance. All technical evaluation factors are detailed below.

As described above, the evaluation of offers will proceed in two phases: Phase One and Phase Two.

Phase One will be scored out of 50 possible points for Technical Factor 1. Phase Two will be scored out of 100 possible points for Technical Factors 1, 2, and 3. Price and past performance will be considered during both Phases One and Two of the evaluation process but will not be point-scored.

Please note that during Phase Two of the evaluation process, the Government may revise any Offeror’s Phase One score for Technical Factor 1 and/or revise its evaluation of the Offeror’s price and past performance if merited by the Offeror’s oral presentation and Phase Two response.

The Contract Specialist and Contracting Officer will review offers for conformance to these solicitation instructions. The Government’s Technical Evaluation Panel (TEP) will evaluate all offers based on the technical criteria described below.

Phase One

During Phase One, the TEP will evaluate the qualifications of proposed key personnel to determine capability of performing the consulting services described in this solicitation. The TEP will base its evaluation on Technical Factor 1: Personnel Qualifications and its sub-factors, which are described below in Table A. An overall score will be given for Technical Factor 1; sub-factors will not be individually scored.

Table A Technical Factor 1: Personnel Qualifications – Total Possible Points: 50 Qualifications of proposed personnel will be evaluated to determine to what extent the personnel are capable of performing the work outlined in the SOW. This includes documented experience with drug discovery and development programs in the area of pharmaceutics/formulation/CMC;

executive-level competence; educational background; and training.

The availability of proposed personnel and their designated responsibility in the project will also be evaluated, including letter(s) of commitment from proposed key personnel.

Resumes of proposed key personnel, consultants, and any subcontractors will be evaluated for appropriateness of credentials, training, qualifications, experience, and competence to carry out this requirement. Basic credentials will be evaluated in the following areas, designated as sub-factors of Technical Factor 1:

Sub-factor 1: Professional Experience and Expertise in Drug Discovery and Development

Professional experience of proposed personnel shall be evaluated for length and breadth of demonstrated leadership experience in drug discovery and development projects related to the consulting services described in the SOW, including hands-on leadership and management experience in Phase 1 in-house and outsourced trials, particularly for nervous system and pain conditions. Broad experience across the entire drug discovery and development process from discovery to clinical trials shall be considered favorably.

Professional experience of proposed personnel shall also be evaluated for experience in managing or leading drug discovery projects in biopharmaceutical industry, as well as publications, patents, and work on drugs brought to market. In addition, experience showing the use of expertise to identify or anticipate problems early on, overcome technical or regulatory difficulties, distill complex situations, or demonstrate strong risk-assessment ability to make wise use of limited resources, shall be considered favorably.

Professional experience of proposed personnel shall be further evaluated for experience involving cross-functional team efforts in drug development, as well as indications of strong interpersonal and organizational skills.

Sub-factor 2: Educational Degrees and Certification Educational degrees and certifications of proposed personnel shall be evaluated for conformance to the required qualifications identified in the SOW; additional degrees and certifications related to the SOW requirements will also be evaluated. Advanced degrees and board certifications and other evidence of advanced training applicable to pharmaceutics/formulation/CMC shall be considered favorable.

Sub-factor 3: Collaborative Team Experience Qualifications of proposed personnel shall be evaluated for length and breadth of experience collaborating with multi-disciplinary teams, especially teams with members from external organizations and members at various management levels. Experience such as team leadership, consulting, or service on strategic and advisory boards shall be considered favorably.

In addition, the Government will, in accordance with FAR 52.217-5 Evaluation of Options, evaluate the proposed total price by adding the proposed prices for all options to the proposed price for the base requirement. The Government may determine that a quote is unacceptable if the option prices are significantly unbalanced. Evaluation of options does not obligate the Government to exercise any option.

The non-technical factors of Price and Past Performance are described in more detail in Table B:

Table B Proposed Price The price quotation in the Price Template (Attachment #1) must include an hourly rate as well as extended pricing for the full level of effort for the base year and option years 1 and 2. A travel option amount NTE $1,500 should be included for the base and each option year. A summary of the whole contract price, including if options are exercised, must also be included.

Past Performance The Contractor shall provide at least two (2) past performance references with knowledge of the contractor’s relevant skills and experience related to the requirements. References shall include the following information:

1) Name of Organization to Which Contractor Provided Services

2) Brief Description of Contractor’s Responsibilities

3) Point of Contact Name, Title, Telephone Number, and Email Address

Past Performance shall be evaluated for relevance to the current requirement. Examples of relevant past performance that demonstrate customer satisfaction in the following areas shall be considered favorable:

1) Interpersonal skills

2) Attention to detail

3) Computer and software literacy

Phase Two During Phase Two, Offerors whose responses received the highest ratings in Phase One will be given an opportunity to deliver oral presentations to the TEP. These presentations will be delivered in accordance with the instructions outlined in this solicitation.

The TEP will use these presentations to evaluate each Offeror’s proposed technical approach as well as the quality of its oral communication/presentation skills, in accordance with Technical Factor 2:

Understanding the Project and Technical Approach and Technical Factor 3: Communication and Oral Presentation Skills, respectively. Evaluation criteria for Technical Factors 2 and 3 are described in Table C:

Table C

Technical Factor 1: Personnel Qualifications – Total Possible Points: 50 Please see Table A (above).

Technical Factor 2: Understanding the Project and Technical Approach – Total Possible Points: 25 The Government will evaluate the Offeror’s proposed technical approach and comprehensive understanding of the project’s goals, objectives, and specific requirements as described in the SOW, including their interrelation and complexity. The technical approach will also be evaluated for soundness, practicality, and feasibility for accomplishing these requirements.

This evaluation will include an assessment of the thoroughness of the Offeror’s background discussion of the work contemplated under this project. It will also include an evaluation of the Offeror’s discussion of anticipated problems and constraints likely to be encountered in performing the work and potential plans and solutions for resolving them. Finally, the Government will evaluate all examples of the Offeror having effectively trained other project staff or clients in their discipline.

Technical Factor 3: Communication and Oral Presentation Skills – Total Possible Points: 25 The Government will evaluate the effectiveness of Offeror’s interpersonal, written, and verbal communication skills as well as demonstration of its ability to successfully communicate with groups.

Due to the frequency and importance of the Lead Development Teams (LDTs) meetings, the Contractor must be capable of making positive and meaningful contributions to group discussions.

Since some members of the LDTs may lack drug discovery and development experience; the Offeror’s oral presentation must also establish that it is capable of sharing its knowledge with fellow team members in a manner that is both informative and collegial. These qualities will be evaluated based upon the Offeror’s demonstrated ability to communicate its technical approach during its oral presentation, address any questions raised by the TEP members, and provide an overview of Key Personnel’s specific areas of expertise and experience

Total Possible Points: 100

Important:

The Government may elect to discuss or obtain additional information and/or request revisions from one or more offerors at any point during the evaluation and source selection process, in accordance with FAR Part 13 procedures. The Government also reserves the right to evaluate responses and award a purchase order without discussions as well as the right to make no award at all.

APPLICABLE CLAUSES AND PROVISIONS:

The following Federal Acquisition Regulations (FAR) clauses and provisions shall apply to this solicitation and the resulting contract/order and are included herein by reference:

1. FAR Provision 52.212-1 Instructions to Offerors- Commercial Items (Jun 2020).

2. FAR Clause 52.212-4 Contract Terms and Conditions – Commercial Items (Oct 2018), Alternate I.

3. FAR Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes of

Executive Orders-Commercial Items (Jan 2021).

4. The Contractor shall comply with the FAR provisions in this paragraph that the Contracting

Officer has indicated as being incorporated by reference in the contract, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

- 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (JAN 2017)

- 52.204-7, System for Award Management (Oct 2018)

- 52.204-16, Commercial and Government Entity Code Reporting (AUG 2020)

- 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations-

Representation (NOV 2015)

- 52.216-31, Time-and-Materials/Labor-Hour Proposal Requirements-Commercial Item

Acquisition (FEB 2007)

5. The Contractor shall comply with the FAR clauses in this paragraph that the Contracting Officer has indicated as being incorporated by reference in the contract, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

- 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)

- 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018)

- 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004)

- 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020)

- 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun

2020)

- 52.204-13, System for Award Management Maintenance. (Oct 2018)

- 52.204-14, Service Contract Reporting Requirements (Oct 2016)

- 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)

- 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment (Jun 2020)

- 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct

2018)

- 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020)

- 52.219-8, Utilization of Small Business Concerns (Oct 2018)

- 52.219-13, Notice of Set-Aside of Orders (Mar 2020)

- 52.219-14, Limitations on Subcontracting (Mar 2020)

- 52.219-28, Post Award Small Business Program Representation (Nov 2020)

- 52.222-3, Convict Labor (Jun 2003)

- 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2020)

- 52.222-21, Prohibition of Segregated Facilities (Apr 2015)

- 52.222-26, Equal Opportunity (Sept 2016)

- 52.222-35, Equal Opportunity for Veterans (Jun 2020)

- 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020)

- 52.222-37, Employment Reports on Veterans (Jun 2020)

- 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec

2010)

- 52.222-50, Combating Trafficking in Persons (Oct 2020)

- 52.222-54, Employment Eligibility Verification (Oct 2015)

- 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun

2020)

- 52.224-3, Privacy Training (Jan 2017)

- 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021)

- 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct

2018)

- 52.239-1, Privacy or Security Safeguards (Aug 1996)

- 52.222-41, Service Contract Labor Standards (Aug 2018)

- 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014)

- 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price

Adjustment (Multiple Year and Option Contracts) (Aug 2018)

- 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020)

- 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017)

- 52.242-15, Stop-Work Order (AUG 1989)

6. FAR Clause 52.216-31, Time-and-Materials/Labor-Hour Proposal Requirements-Commercial Item Acquisition (Feb 2007) applies to this acquisition and states as follows:

(a) The Government contemplates award of a Time-and-Materials or Labor-Hour contract resulting from this solicitation.

(b) The offeror must specify fixed hourly rates in its offer that include wages, overhead, general and administrative expenses, and profit. The offeror must specify whether the fixed hourly rate for each labor category applies to labor performed by-

(1) The offeror;

(2) Subcontractors; and/or

(3) Divisions, subsidiaries, or affiliates of the offeror under common control.

7. FAR Clause 52.217-5, Evaluation of Options (July 1990) applies to this acquisition and states as follows:

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

8. FAR Clause 52.217-7, Option for Increased Quantity – Separately Priced Line Item (Mar 1989) applies to this acquisition and states as follows:

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within three (3) days. Delivery of added items shall continue at the same rate that like items as are called for under the contract, unless the parties otherwise agree.

9. FAR Clause 52.217-8, Option to Extend Services (Nov 1999) applies to this acquisition and states as follows:

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 3 days.

10. FAR Clause 52.217-9: Option to Extend the Term of the Contract (Mar 2000) applies to this acquisition and states as follows:

(a) The Government may extend the term of this contract by written notice to the Contractor within the contract period of performance; provided that the Government gives the Contractor a https://www.acquisition.gov/far/17.206#FAR_17_206 preliminary written notice of its intent to extend at least three (3) days before the contract expires.

The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed three (3) years.

11. The Defense Priorities and Allocations System is not applicable to this acquisition.

12. The Contractor shall comply with the following Health and Human Services Acquisition Regulations (HHSAR) that the Contracting Officer has indicated as being incorporated by reference in the contract:

HHSAR Clause 352.231-70, Salary Rate Limitation (December 18, 2015)

(a) The Contractor shall not use contract 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 was obligated.

(b) For purposes of the salary rate limitation, the terms “direct salary,” “salary,” and “institutional base salary,” have the same meaning and are collectively referred to as “direct salary,” in this clause. An individual's direct salary is the annual compensation that the Contractor pays for an individual's direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative costs). The salary rate limitation does not restrict the salary that an organization may pay an individual working under a Department of Health and Human Services contract or order; it merely limits the portion of that salary that may be paid with contract funds.

(c) The salary rate limitation also applies to individuals under subcontracts.

(d) If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act used to fund this contract.

(e) See the salaries and wages pay tables on the Office of Personnel Management website for Federal Executive Schedule salary levels.

(End of clause)

Note: The Salary Rate Limitation for these consulting services is at the Executive Level II Rate.

Refer to the following webpage for Executive Schedule rates of pay:

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2021/EX.pdf

HHSAR Clause 352.203-70, Anti-Lobbying (December 18, 2015)

Pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for:

(a) Publicity or propaganda purposes;

(b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or…