75N95023Q00584

Post Date/ Solicitation Issue Date

August 2, 2023 12:00 pm

Closing Response Date

August 4, 2023 3:00 pm

Proposed Award Date

August 16, 2023 12:00 pm

Project Title

Custom Synthesis of Nine (9) Antisense Oligonucleotides (ASOs) for Liver Tox Study

Contracting Office

National Center for Advancing Translational Sciences (NCATS)

Small Business Size Standard

1,250 Employees

FPDS Classification Code

Q301 - Medical- Laboratory Testing

Estimated Period of Performance

1 - 2 weeks after award

Competition Status

Non-Competitive

Single-Sole Source Determination

This vendor has provided NCATS with custom synthesis services for other projects, including Antisense Oligonucleotides (ASOs) for the initial testing as well as control ASOs in the past under Order #75N95023P00420 and #75N95022P00402. Therefore, it is a continuation of the scientific progress we already started with Integrated DNA Technologies, Inc. and we need continuity in the scientific research and consistency of data/results.

Background/Description of Requirement

The National Center for Advancing Translation Sciences (NCATS) requires services for the manufacture of nine (9) antisense oligonucleotides (ASOs) commercially. These ASOs are the necessary starting material to be used to evaluate if a platform based on liver toxicity can be used for the rapid and reliable prediction of hepatotoxicity associated with administering ASOs. The antisense oligonucleotides will be used for research and require high sequence specificity and purity.

There are over 7,000 different rare diseases that affect 350 million globally and about 35 million people in the U.S. Sadly, about half of these rare diseases have onset in childhood, and the vast majority (~95%) have no FDA-approved treatment. Most rare diseases have a known single gene cause, making them potentially amenable to oligonucleotide therapeutics like ASOs. ASOs are short strands of modified RNA and DNA that bind to target RNA and can act by modulating splicing, inhibiting translation, or inducing mRNA degradation. ASOs are increasingly being deployed as individualized medicines as they are rapidly customizable, relatively easy to deliver, and inexpensive to manufacture. Although there is a growing number of clinical examples and safety data for ASOs, there is a need to reduce the cost and development timelines to test these therapies in more patients with rapidly progressing life-threatening diseases faster without compromising safety.

Antisense oligonucleotides comprise 16 to 20 nucleotide bases, often with chemical modifications of the phosphate backbone. It is thought that the sequence and backbone chemistry of the ASOs determines whether administering a particular ASO molecule will lead to liver toxicity. However, there is currently no means to test in vitro whether a particular ASO will be associated with liver toxicity. This gap in early testing means that the evaluation of an ASO's effect on the liver requires animal testing that is expensive and time-consuming. Animal testing also has relatively low throughput, limiting the scope of therapy development pipelines.

This requirement aims to generate proof-of-concept data for evaluating the ability of the 3D Liver Microtissue platform developed in animals to predict the hepatoxicity of individual ASOs. If successful, this will represent a new means to screen ASOs for this type of toxicity that is cheaper, faster, and has high throughput.

The contractor shall synthesize and deliver nine (9) antisense oligonucleotides as a test case for treating rare diseases. This approach potentially represents a new means to treat rare diseases, as it can also be adapted to target other human genes.

Scope of Work:

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:

The contractor shall synthesize and deliver nine (9) antisense oligonucleotides (ASOs). The ASOs shall be customized according to sequences specified by the National Center for Advancing Translational Sciences (NCATS). The ASOs shall be synthesized, purified using standard desalting methods, and normalized to the required quantity and concentration. The standard desalting material will be shipped dry in 2 ml tubes.

Quantity: Each ASO 36 mg final concentration standard desalting

Government Responsibilities:

Providing ASO sequences to the contractor.

Data Rights:

All ASOs and data are the sole property of the government. The contractor has no right to do any analysis with the ASOs and sequences received from NCATS.

Note: The contractor shall not distribute or sell these ASOs. They shall be delivered at the end of the synthesis process at the direction of NCATS.

Confidentiality of Information:

All the information related to the ASOs will be kept confidential.

Quoter Terms and Conditions (To be completed 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:
4. NIH BPA Number
5. DUNS No:
6. Name of Company:
7. 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 Threshold is anticipated for any contract resulting from this requirement. The anticipated award date is August 16, 2023.

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. 1. 1. 1. The provisions of FAR Clause 52.212-1 Instructions to Offerors—Commercial Items (Mar 2023) is applicable to this solicitation.
         2. The provisions of FAR Clause 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:
            1. 1. 1. 1. Technical capability of the service offered to meet the Government requirement;
                     2. Price; and
                     3. Past performance [see FAR 13.106-2(b)(3)].
         3. The provisions of FAR Clause 52.212-3, Offeror Representations and Certifications—Commercial Items (Dec 2022), is applicable to this solicitation.
         4. The provisions of FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items (Dec 2022) with Addenda: Stop Work Order, FAR Clause 52.242-15 (Aug 1989) is applicable to this solicitation.
         5. The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Jun 2023) is applicable to this solicitation:

52.204-27 Prohibition on a ByteDance Covered Application (Jun 2023)

52.219-28 Post Award Small Business Program Rerepresentation (Mar 2023)

52.222-3 Convict Labor (Jun 2003)

52.222-19 Child Labor-Cooperation With Authorities and Remedies (Dec 2022)

52.222-21 Prohibition of Segregated Facilities (Apr 2015)

52.222-26 Equal Opportunity (Sep 2016)

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

52.222-50 Combating Trafficking in Persons (Nov 2021)

52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020)

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

52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Oct 2018)

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

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

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

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

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

The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) is applicable.

The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provision at 52.204-24 and 52.204-26 and submit completed copies as a separate document with their quotation.

1. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
3. FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
4. NIH Invoice and Payment Provisions (3/20/2023)

Period of Performance/Delivery Date:  1-2 weeks after 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.