75N95025Q00068

DESCRIPTION OF REQUIREMENT: The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), whose mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Metarrestin is currently in clinical trials to treat pancreatic cancer.  It has proven to be safe in humans and now it is ready to continue to be tested for efficacy and proof of principle in human trials.  The PK study results in mice with the new polymer formulation will help decide the dose to be used in the ongoing human clinical trials). Due to the nature of this compound, we needed a new formulation to be able to carry out the planned PK study currently being proposed.  The formulation is now available and now we can carry out the PK study and compare the results with the previous results using a different formulation.  The results of this PK study will help us choose the proper formulation to be used as we evaluate Metarrestin as a possible clinical candidate for pancreatic cancer.

PERIOD OF PERFORMANCE: 3 Months ARO

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 below:

SPECIFIC REQUIREMENTS: NCATS and/or collaborator will provide Metarrestin formulated as a polymer suspension to Pharmaron.  Pharmaron will carry out the appropriate PK studies to measure the exposure in the various tissues of interest.

LEVEL OF EFFORT:

NCATS will take about 2 hrs to provide the required compound.  Pharmaron will take up up to 1 week to get the data, analyze it and provide a report on the findings.

GOVERNMENT RESPONSIBILITIES:

NCATS will send the compound to Pharmaron.  NCATS scientists will receive and analyze the results and provide feedback to Pharmaron.

DELIVERY OR DELIVERABLES:

Pharmaron will carry out the appropriate studies to generate the data in a reasonable time in the form of a report for the NCATS scientists to analyze.  The timely delivery of results is of essence.

REPORTING REQUIREMENTS:

Pharmaron will provide NCATS scientists with a report on the PK results.  The scientists to send the report to are:  Raul Calvo (raul.calvo@nih.gov) and Juan Marugan (maruganj@mail.nih.gov). The report will provide the results on the exposure of Metarrestin as a polymeric suspension in the various tissues requested and any other information pertinent to the study (i.e. life observations, profile of exposure at the requested times, etc.).

PLEASE VIEW THE ATTACHED STATEMENT OF WORK.

QUOTER TERMS AND CONDITIONS: (to be filled out by the Offeror):

1. Period of Performance OR Delivery Date After Receipt of Order:
2. Shipping Point (F.O.B. OR Destination):
3. Payment Discount Terms; Total Price:
4. Open Market; GSA FSS Contract Number; Other Government Agency (OGA) Contract Number, Government-wide Agency (GWAC) Contract Number; or National Institute of Health (NIH) Blanket Purchase Agreement (BPA) Number:
5. Company Unique Entity ID:
6. Name of Company:
7. Company Address (Including Street Address, City, State, Zip code):
8. Name of Person Authorized to Provide Quote:
9. Telephone Number and Email Address of Person Authorized to Provide Quote:

CONTRACT TYPE:

A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Thresholdis anticipated for any contract resulting from this requirement. The anticipated award date is 12/20/2024.

ADDITIONAL TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

The FAR Clauses are incorporated by reference and are provided in full text at

https://www.acquisition.gov/

1. FAR clause 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services (Sep 2023), applies to this acquisition.
2. FAR Provision 52.212-2 Evaluation—Commercial Items (NOV 2021) is applicable to this solicitation. The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

a. Technical capability of the service offered to meet the Government requirement;

           b. Price; and

          c. Past performance [see FAR 13.106-2(b)(3)].

3. FAR Provision 52.212-3, Offeror Representations and Certifications—Commercial Items

   (NOV 2021), is applicable to this solicitation (Attachment 2).

4. The clause at FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (Nov 2023) applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. The additional contract terms and conditions are as follows.

5. The clause at FAR 52.212-5 Contract Terms and Conditions—Commercial Products and Commercial Services (May 2024) applies to this acquisition and is attached in full text. See Attachment 4 for the FAR clauses the Contractor shall comply with in

this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services.

The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), 

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: 

https://www.acquisition.gov/browse/index/far  https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html 

(End of provision)

In addition, the following FAR provisions are applicable to this solicitation and incorporated by

Reference:

• FAR 52.204-7, System for Award Management (Oct 2018)
• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)
• FAR 52.252-2 Clauses Incorporated By Reference (Feb 1998)
• 52.222-48 Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification. (May 2014)
• HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015)

. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far     https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html 

(End of clause)

The following clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)
• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)
• FAR 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services (Nov 2023)
• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)
• HHSAR 352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

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

The following provisions and clauses apply to this acquisition and are included in full text below

or as attachments to the RFQ. Offerors MUST complete, sign and submit the provision at

52.204-24 and 52.204-26 or 52.212-3 pursuant to FAR 4.2103 Procedures as a separate

document with their quotation.

1. FAR Provision 52.204-24, Representation Regarding Certain Telecommunications and Video

Surveillance Services or Equipment (NOV 2021) – Attachment 5

2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment (Aug 2020)

3. FAR Provision 52.204-26, Covered Telecommunications Equipment or Services-

Representation (OCT 2020) – Attachment 6

4. NIH Invoice and Payment Provisions (Rev. 2/10/2021) – Attachment 7

SPECIAL CONTRACT REQUIREMENTS TO BE INCLUDED ONLY FOR REQUIREMENTS

INVOLVING LIVE VERTEBRATE ANIMALS

The services under this contract involves live vertebrate animals. Quoters must have an active

OLAW Animal Welfare Assurance. In addition, Quoters must include with its quotation:

1. Vertebrate Animal Section (VAS) (see below)

2. Institutional Animal Care and Use Committee (IACUC) project approval. The date of

IACUC approval must not be more than 36 months prior to the anticipated date of

award.

Vertebrate Animals Section (VAS). The VAS should be no more than two (2) pages and must

address the following criteria:

1. Description of Procedures. Provide a concise description of the proposed procedures

to be used that involve vertebrate animals in the work outlined in the Statement of

Work. Identify the species, strains, ages, sex and total number of animals by species

to be used in the proposed work.

2. Justifications. Provide justification that the species are appropriate for the proposed

research. Explain why the research goals cannot be accomplished using an

alternative model (e.g., computational, human, invertebrate, in vitro).

3. Minimization of Pain and Distress. Describe the interventions including analgesia,

anesthesia, sedation, palliative care and humane endpoints to minimize discomfort,

distress, pain and injury.

4. Euthanasia. State whether the method of euthanasia is consistent with the

recommendations of the American Veterinary Medical Association (AVMA)

Guidelines for the Euthanasia of Animals. If not, describe the method and provide a

scientific justification.

For more discussion regarding the VAS, see NIH Guide Notice NOT-OD-16-006 at:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html.

The VAS Worksheet is provided as an attachment to this solicitation to assist in the

preparation of the VAS.

Animal Welfare. All research involving live, vertebrate animals shall be conducted in

accordance with the Public Health Service Policy on Humane Care and Use of Laboratory

Animals (PHS Policy). The PHS Policy can be accessed at:

http://grants1.nih.gov/grants/olaw/references/phspol.htm. In addition, the research involving live

vertebrate animals shall be conducted in accordance with the description set forth in the

Vertebrate Animal Section (VAS) of the Contractor’s quotation.

The provision at HHSAR 352.270-5a, Notice to Offerors of Requirement for Compliance

with the Public Health Service Policy on Humane Care and Use of Laboratory

Animals (December 18, 2015).

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS

Policy) establishes a number of requirements for research activities involving animals.

Before awarding a contract to an offeror, the organization shall file, with the Office of

Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal

Welfare Assurance (Assurance) which commits the organization to comply with the

provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and

Use of Laboratory Animals (National Academy Press, Washington, DC). In accordance

with the PHS Policy, offerors must establish an Institutional Animal Care and Use

Committee (IACUC), qualified through the experience and expertise of its members, to

oversee the institution’s animal program, facilities, and procedures. Offerors must

provide verification of IACUC approval prior to receiving an award involving live

vertebrate animals. No award involving the use of animals shall be made unless OLAW

approves the Assurance and verification of IACUC approval for the proposed animal

activities has been provided to the Contracting Officer. Prior to award, the Contracting

Officer will notify Contractor(s) selected for projects involving live vertebrate animals of

the Assurance and verification of IACUC approval requirement. The Contracting Officer

will request that OLAW negotiate an acceptable Assurance with those Contractor(s) and

request verification of IACUC approval. For further information, contact OLAW at NIH,

6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892-7982

(E-mail: olaw@od.nih.gov; Phone: 301-496-7163).

(End of provision)

The clause at HHSAR 352.270-5b, Care of Live Vertebrate Animals (December 18, 2015).

a. Before undertaking performance of any contract involving animal-related activities

where the species is regulated by the United Sates Department of Agriculture

(USDA), the Contractor shall register with the Secretary of Agriculture of the United

States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The

Contractor shall furnish evidence of the registration to the Contracting Officer.

b. The Contractor shall acquire vertebrate animals used in research from a dealer

licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR sections

2.1-2.11, or from a source that is exempt from licensing under those sections.

c. The Contractor agrees that the care, use, and intended use of any live vertebrate

animals in the performance of this contract shall conform with the Public Health

Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy),

the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use

of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent

laws and regulations of the United States Department of Agriculture (see 7 U.S.C.

2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between

standards, the more stringent standard shall govern.

d. If at any time during performance of this contract, the Contracting Officer determines,

in consultation with the Office of Laboratory Animal Welfare (OLAW), National

Institutes of Health (NIH), that the Contractor is not in compliance with any of the

requirements and standards stated in paragraphs (a) through (c) above, the

Contracting Officer may immediately suspend, in whole or in part, work and further

payments under this contract until the Contractor corrects the noncompliance. Notice

of the suspension may be communicated by telephone and confirmed in writing. If

the Contractor fails to complete corrective action within the period of time designated

in the Contracting Officer’s written notice of suspension, the Contracting Officer may,

in consultation with OLAW, NIH, terminate this contract in whole or in part, and the

Contractor’s name may be removed from the list of those contractors with Animal

Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed

dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS),

USDA, for the region in which its research facility is located. The location of the appropriate

APHIS Regional Office, as well as information concerning this program may be obtained by

contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737

(E-mail: ace@aphis.usda.gov; website:

http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).

(End of clause)

Attachment 8 - VAS Worksheet

PERIOD OF PERFORMANCE:

The anticipated period of performance shall be 4-8  weeks from date of purchase order award.

Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive,

Rockville, MD 20852. A firm fixed price type order is anticipated to be awarded as a result of

this RFQ.

SUMMARY STATEMENT:

Responses to this notice must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The response shall include: the unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision.  Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.

ATTACHMENTS

• Statement of Work (SOW)
• FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
• FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
• Addendum to FAR 52.212-4 (Nov, 2023)  Terms and Conditions – Commercial Items
• FAR 52.212-5, Contract Terms and Conditions—Commercial Products and Commercial Services (May 2024)
• Invoice Instructions with and without IPP