CSS_BD consultant.pdf

Solicitation No. 75N95020Q00024

Title: Business Development consultants for the National Institute on Drug Abuse (NIDA)

Step Up for Substance Use Disorder (SUD): Drug target initiative for scientists Engaged in Fundamental Research.

i. 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 separate written solicitation will not be issued.

ii. The solicitation number is 75N95020Q00024 and the solicitation is issued as a Request for Quotation (RFQ) on an unrestricted basis, as a full and open requirement.

iii. 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. A time and materials type of purchase order is contemplated for this requirement.

iv. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-04 / 01/15/20

v. The North American Industry Classification System (NAICS) code for this procurement is 541690 - Other Scientific and Technical Consulting Services with size standard of $16.5 million.

vi. Project Requirements:

Please see the attached Statement of Work for further details regarding project requirements.

vii. Deliverables and Reporting requirements:

Monthly Reports - The Contractor shall provide the Contracting Officer’s Representative (COR) and Contracting Officer (CO) a report of all tasks and subtasks completed during the month.

Final Report - The Contractor shall provide the Contracting Officer’s Representative (COR) and Contracting Officer (CO) a final report of all tasks and subtasks completed, outcomes of each, timelines within which they were accomplished, any challenges encountered and how they were resolved, lessons learned, and a summary of customer feedback, where applicable. The final report may be a compilation or summary of those details.

The Contractor shall prepare and submit a final report that includes all tasks/activities for the duration of the Contract. The Contractor shall submit a draft final report within four (4) weeks prior to the contract end period, in a format approved by the COR. The COR will have ten (10) business days to provide the Contractor any comments/edits. The contractor shall revise and submit the final document within three (3) business days of receipt of comments.

Publications and Publicity: Contractor shall not, nor is required to, publish any articles of data as a result of fulfilling this requirement.

Confidentiality of Information: All electronic data files and storage for these files which correspond to the project are to be considered confidential and property of the Government and the Contractor may not release, disclose, disseminate, or publish this information to anyone other than the Government.

Contracting Officer’s Representative:

The Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract and will be specified at time of award.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Government may unilaterally change the COR designation at any time throughout the performance period of this contract.

The following provisions and clauses are incorporated by reference:

viii. The provision at FAR Clause 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment is applicable to this solicitation. Offerors MUST include a completed copy of this provision with their offer, OR provide a copy of the valid certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror’s cover sheet.

ix. The provision at FAR Clause 52.212-1 Instructions to Offerors—Commercial Items is applicable to this solicitation.

x. The provision at FAR clause 52.212-2, Evaluation – Commercial Items, applies to this acquisition. The following is provided as an addendum to clause 52.212-2:

http://www.sam.gov/

Selection of an offeror for contract award will be based on an evaluation of proposals against the technical factors and price. Although technical factors are of paramount consideration in the award of the contract, price and past performance are also important to the overall contract award decision. All evaluation factors other than price, when combined, are significantly more important than price. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government.

Technical evaluation will be based on the following:

1. Technical Approach

For proposal purposes, a combination of following experience is likely to result in excellent performance as a business development consultant.

• Over 10 years’ experience leading business development efforts in biopharmaceutical industry, preferably, in the area of substance use disorders and/or nervous system conditions as demonstrated by holding a senior level position.

• 15 years’ participation in business development tasks in small molecules and biologics drug discovery and development teams in the area of substance use disorder research and/or nervous system conditions.

• Preparation and submission of businesses due diligence, including competitor analysis, market opportunity analysis, and risk mitigation strategies.

• 3+ years providing business development consulting to small companies and academics for small molecules and biologics drug discovery and development programs.

• PhD degree in biological sciences or translational sciences and/or Master of Business Administration (MBA) and at least 15+ years business development experience in small molecules and biologics drug discovery and development programs in the pharmaceutical industry.

OR

MS degree in biological sciences or translational sciences and/or business administration with more than 20 years business development experience in business development of small molecules and biologics drug discovery and development programs in the pharmaceutical industry. [MS degree + 6 years’ work experience can be equated to a PhD with limited post-doctoral experience].

NOTE: The Contract’s proposal must include detailed resume(s).

Technical proposals will be evaluated using a numerical rating in accordance with the following scale:

Factor 1: Key Personnel Professional Experience in business development for biologics and small molecules drug discovery and development projects in the area of SUD or/and nervous system conditions (40 points)

Key personnel proposed shall be evaluated for length and breadth of demonstrated leadership experience in providing business development advise for biologics and small molecules drug discovery and development projects in the area of SUD or/and nervous system conditions.

Leadership experience in executing target due diligence and competitor analysis using public and private drug development databases such as Citeline Pipeline, Thomson Reuters’ Integrity, FDA Orange Book, USPTO, and Clinical Trials.gov for biologics and small molecules drug discovery and development projects, particularly for SUD or/and nervous system conditions, shall be evaluated. Business development experience across the entire drug discovery and development process from discovery to clinical trials shall be evaluated.

Key personnel professional experience shall also be evaluated for identifying and anticipating business development problems early in a project, overcoming business development difficulties, and making strategic decisions that make wise use of limited resources.

Finally, key personnel professional experience shall be evaluated for efforts involving commercial forecasts and valuation of new products, and in assessment of licensing and acquisitions of new drug products relevant to biologics and small molecule drug discovery development, especially for SUD and/or nervous system indications.

Factor 2: Key Personnel Education & Qualifications (40 points)

Key personnel proposed shall be evaluated for conformance to the key personnel qualifications identified in the statement of work as well as for additional education and certifications related to the statement of work requirements. Advanced education and board certifications, as well as other evidence of advanced expertise applicable to business development plans for drug discovery and development shall be evaluated.

Factor 3: Key Personnel Collaborative Team Experience (20 points)

Key personnel proposed shall be evaluated for length and breadth of experience collaborating with multi- disciplinary teams, especially teams with members from outside organizations and members at various management levels. Experiences such as team leadership, consulting, or service on strategic and advisory boards shall be evaluated.

2. Price and Options

The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

3. Past Performance

Offeror's past performance information will be evaluated subsequent to the technical evaluation. However, this evaluation will not be conducted on any offeror whose proposal is determined to be technically unacceptable.

The evaluation will be based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.

The government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance.

The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers relevant information.

When assessing performance risks, the Government will focus on the past performance of the offeror as it relates to all acquisition requirements, such as the offeror's record of performing according to specifications, including standards of good workmanship; the offeror's record of controlling and forecasting costs; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror's business-like concern for the interest of the customer.

The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance.

The lack of a relevant performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror.

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 outlined in this Statement of Work. References shall include the following information:

• Name of Organization

• Brief Description of Contractor's Responsibilities

• Point of Contact Name, Title, and Telephone Number

Past Performance will be evaluated for demonstrated performance of the offeror on current and past contracts relevant to the current requirement as well as customer satisfaction in reference to the following:

• Interpersonal skills

• Attention to detail

• Computer and software literacy, Writing, Communication, and Presentation

Skills

xi. The provision at FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition.

xii. The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

xiii. The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items, applies to this acquisition. See attachment.

xiv. The provision of FAR Clause 52.216-31, Time-and-Materials/Labor Hour Proposal Requirements – Commercial item Acquisition, applies to this acquisition.

xv. The provision of FAR Clause 52.216-7, Allowable Cost and Payment, applies to this acquisition with conjunction with FAR Clause 52.232-7, Payments under Time-and- Materials and Labor-Hour Contracts, but only to the portion of the contract that provides for reimbursement of materials at actual cost.

xvi. The provision of FAR Clause 52.227-14, Rights in Data – General, applies to this acquisition.

xvii. The provision of HHSAR Clause 352.231-70, Salary Rate Limitation, applies to this acquisition.

xviii. The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices:

FAR Clause 52.217-8 Option to Extend Services.

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 15 days.

FAR Clause 52.217-9, Option to Extend the Term of the Contract.

a. The Government may extend the term of this contract by written notice to the Contractor prior to contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 5 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 3 years.

KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this 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 (including, when applicable, Human Subjects Testing requirements). 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.

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

TBD

PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (December 2013) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually following the anniversary date of contract award, if options are exercised.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted fourteen days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov

DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

PRIVACY ACT, HHSAR 352.224-70 (December 2015) This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term "system of records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C.

552a(i)). The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in CFR 45 part 5b and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract work statement: (a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance.

Confidentiality and Nondisclosure of Information - Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government http://www.cpars.gov/ http://www.cpars.gov/ records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

Each employee, including subcontractors, having access to non-public Department information under this acquisition shall complete the "Commitment to Protect Non- Public Information - Contractor Employee Agreement" located at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf . A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer/COR prior to performing any work under this acquisition.

Contractor Non-Disclosure Agreement (NDA) - Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

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

xx. Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to the government requirements stated in this solicitation. The Offeror's technical approach shall indicate compliance with the Scope of Work, and describe an essential understanding of the requirements involved in accomplishing the work. Please also include with your technical proposal sufficient information (including contract numbers, if applicable) to demonstrate performance of a contract with similar requirements to those outlined in the Scope of Work.

The total number of pages, (combination of technical approach and price quote) must not exceed 25 pages in length, excluding resumes. The Contractor shall submit its quote electronically.

The price quote must include the labor categories, an estimate of the number of hours https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the ceiling price, as a Time and Materials type of purchase order is contemplated for this requirement.

Basic cost and price information in the Offeror’s proposal must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required services.

Offerors MUST include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer, OR provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror’s cover sheet.

In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received no later than February 25th, 2020, 05:00 PM EST. Late responses will not be accepted. All responses must reference solicitation number 75N95020Q00024. Responses must be submitted electronically to polina.klimenkova@nih.gov and andrew.hotaling@nih.gov. For information regarding this solicitation, please contact Polina Klimenkova by email at polina.klimenkova@nih.gov or by phone at 301-443-6677.

mailto:polina.klimenkova@nih.gov mailto:polina.klimenkova@nih.gov mailto:andrew.hotaling@nih.gov mailto:andrew.hotaling@nih.gov mailto:polina.klimenkova@nih.gov mailto:polina.klimenkova@nih.gov