75N95023Q00591

Post Date/ Solicitation Issue Date

August 16, 2023 12:00 pm

Closing Response Date

August 21, 2023 3:00 pm

Proposed Award Date

August 31, 2023 12:00 pm

Project Title

Custom ACVR1 HEK293/BRE-Luc Stable Cell Lines

Contracting Office

National Center for Advancing Translational Sciences (NCATS)

Small Business Size Standard

1000 Employees

FPDS Classification Code

Q301 - Medical- Laboratory Testing

Delivery of Goods

8 weeks after receipt of order

Competition Status

Non-Competitive

Single-Sole Source Determination

Non-Competitive (Single-sole Source (Including brand-name)) Determination:
This notice of proposed acquisition is posted as an intent to award a purchase order on a non-competitive basis to Codex BioSolutions Inc, 401 Professional Dr, STE 160, Gaithersburg, MD, 20879 Phone: 301-538-8802

The Non-Competitive (Single-sole Source (Including brand-name)) Determination is based upon the market research conducted. Specifically, only one source is capable of providing the supplies or services required pursuant to FAR 13.106-1(b)(1)(i), only one source is reasonably available.

Background/Description of Requirement

Description of Requirement:

The National Center for Advancing Translational Sciences (NCATS) requires Custom ACVR1 HEK293/BRE-Luc stable cell lines.

Background Information and Objective:

The National Center for Advancing Translational Sciences (NCATS) focuses on getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions that can be used by all translational researchers.

Within NCATS, the Therapeutic Development Brand (TDB) works to encourage and speed the development of new treatments for diseases with high-unmet medical needs. This acquisition will specifically address the need for therapeutic options for a rare disease known as Fibrodysplasia Ossificans Progressiva (FOP) that arises from gain of function mutations in the Activin Receptor Type 1 protein (ACVR1) gene. ACVR1 encodes for bone morphogenetic protein (BMP) type I receptor ALK2, which is involved in the growth and development of bones. In FOP, muscle or connective is abnormally replaced with bone, thereby severely affecting movement, quality of life and leading to reduced life expectancy.

There are no effective or approved therapeutics for preventing or mitigating the pathophysiology of FOP. While some inhibitors of ALK2 receptor kinase (ATP-sensitive) are currently being tested in clinical trials, those drugs are not completely selective for ALK2 and thus have off-target affects, which is not ideal as a long-term therapeutic option. Non-ATP-competitive inhibitors of ALK2 may exhibit high selectivity for ALK2 or mutant forms of ALK2 commonly found in FOP. Those novel inhibitors of ALK2 may have fewer off-target effects and could potentially serve as new lead compounds for therapeutic development. To this end, TDB Biology would like to procure a custom reporter cell line of human origin (HEK293 cells) that stably expresses wild-type ACVR1 proteins or other known ACVR1 mutants commonly found in FOP. Codex BioSolutions specializes in cell-based assays and has substantial experience in generating stable cell lines such as the hERG potassium channel cell line for high-throughput screening. In order to perform a high-throughput small molecule screen in a cellular model of gain-of-function mutations in ACVR1, we would like to procure stable HEK293 cell lines with BMP-responsive element (BRE)-Luciferase reporter overexpressing wildtype AVCR1, or AVCR1 mutations such as ACVR1-R206H, ACVR1-T283I, and ACVR1-R206H-T283I.

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:

Codex BioSolutions will generate and deliver four custom HEK293/BRE-Luc stable cell lines overexpressing wild-type ACVR1 or ACVR1-mutations. The four lines shall be:

1. ACVR1-WT

2. ACVR1-R206H

3. ACVR1-T283I

4. ACVR1-R206H-T283I

Delivery or Deliverables:

Codex BioSolutions will generate and deliver four custom HEK293/BRE-Luc stable cell lines overexpressing wild-type ACVR1 or ACVR1-mutations. Contractor will have 8 weeks to complete the project. Should the project require more time, contractor must inform TDB and provide a new timeline. The contractor has 5-10 business days to deliver the final cells/vials from date of completion.

Reporting Requirements:

Codex will send email updates to NCATS every 4 weeks, or sooner if there are any technical difficulties encountered. Codex will provide a final report consisting stable cell line generation validation, as well as any cell performance data, due upon delivery of cells.

See Attachment 1 – Statement of Work.

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. 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. 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 08/31/2023

 

ADDITIONAL TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

 

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 this/these address(es): www.acquisition.gov

(End of provision)

FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)

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 this/these address(es): www.acquisition.gov

 

(End of clause)

 

The FAR provisions and 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 (NOV 2021) 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 (NOV 2021), is applicable to this solicitation.
         4. The provisions of FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items (NOV 2021) 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 (JUNE 2023) is applicable to this solicitation.  See attachment.  

In addition, the following FAR provisions and clauses 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 (December 18, 2015)

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 pursuant to FAR 4.2103 Procedures and submit a completed copy 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 (Aug 2020)
3. FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
4. NIH Invoice and Payment Provisions (Rev. 2/10/2021)

Date of Delivery: The anticipated date of delivery is within 8 weeks after receipt of order. 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.