75N95023Q00421

Submitted by whipple on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Development of Cap-Dependent Endonuclease Inhibitors for Bunyaviruses
Contracting Office
National Institute on Drug Abuse (NIDA)

Contact Points

Primary Contract Specialist

Sarah
Adan
sarah.adan@nih.gov
NAICS Code Number
325413
In Vitro Diagnostic Substance Manufacturing
Small Business Size Standard
1,250 employees
FPDS Classification Code
6550 - In Vitro Diagnostic Substances, Reagents, Test Kits And Sets
Estimated Period of Performance
N/A
Delivery of Goods
Within 4-6 weeks After Receipt of Order
Set-Aside Status
Not Set Aside
Competition Status
Non-Competitive
Vendor Name
MedChemExpress LLC
Vendor Address
1 Deer Park Dr, Suite Q,
Monmouth Junction, NJ 08852
Single-Sole Source Determination
Because of the urgency of this requirement, only one source will be solicited. If the required delivery date is not met, this will delay NCATS’ efforts to identify a CEN inhibitor to treat RVFV. Based on market research, it is estimated that it will take at least 12 weeks for another contractor to take up this task and the cost will be more than double of the estimated price.
Background/Description of Requirement

Title: Development of Cap-Dependent Endonuclease Inhibitors for Bunyaviruses

DATE ISSUED: June 22, 2023

ISSUED BY CONTRACTING OFFICE:  Department of Health and Human Services, National
Institutes of Health, National Institute on Drug Abuse (NIDA), Office of Acquisition (OA)

FOR INFORMATION CONTACT:  Sarah Adan, 301-480-5422, sarah.adan@nih.gov

NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE:  325413 - In Vitro Diagnostic Substance Manufacturing

CLASSIFICATION CODE:  6550 - In Vitro Diagnostic Substances, Reagents, Test Kits And Sets

SMALL BUSINESS SIZE STANDARD: 1,250 employees

COMPETITION STATUS:  This requirement is non-competitive.

Date Quotation Due: All responses to this request for quote must be received by 5:00 PM Eastern Time on July 2, 2023 and must reference the request number cited above. Responses must be submitted electronically to the contact person cited above.  Fax responses will not be accepted. 

IMPORTANT: This is a request for quotations. If you are unable to quote, please so indicate in a reply email to the point of contact cited herein.  This request does not commit the Government to pay any costs incurred in the preparation of the submission of a quotation or to contract for supplies or service. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotation must be completed by the quoter.


Description of Requirement:
The Antiviral Pandemic Program (APP) at the National Center for Advancing Translational Sciences (NCATS) aims to develop small molecule cap-dependent endonuclease inhibitors for bunyaviruses. Early studies found baloxavir acid, an FDA approved cap-dependent endonuclease inhibitor acid containing a divalent metal chelating pharmacophore, showed antiviral activity for certain bunyaviruses. 7 baloxavir analogs were designed which needs to be synthesized by the Contractor to test their antiviral activities against a variety of bunyaviruses including the La Crosse Encephalitis Virus (LACV) and the Rift Valley Fever Virus (RVFV).  

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 deliver the compounds described below:

Specific Requirements: 
1)    Custom synthesis of 7 compounds; 
2)    Provide 1H NMR and LCMS characterization to prove the required purity (>95%); and
3)    Each compound amount >10 mg.

Delivery or Deliverables:
All PDF files of 1H NMR and LCMS characterizations need to be sent to the APP scientist (Dr. Jiankang Jiang) via email, jiankangj@nih.gov, when the 7 compounds are ready for shipment. The contractor shall provide the compounds within 4-6 weeks after receipt of order. 

Quote 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 (if applicable)
5.    SAM Unique Identity ID
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 July 19, 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.    The provisions of FAR Clause 52.212-1 Instructions to Offerors-Commercial Products and Commercial Services (Nov 2021) is applicable to this solicitation. 
2.    The provisions of FAR Clause 52.212.2 Evaluation—Commercial Products and Commercial Services (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 product offered to meet the Government requirement;
b.    Price; and 
c.    Past performance [see FAR 13.106-2(b)(3)].
3.    The provisions of FAR Clause 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (Dec 2022) is applicable to this solicitation. 
4.    The provisions of FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (Dec 2022) with Addenda: Stop Work Order, FAR Clause 52.242-15 (August 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:
52.204-27 Prohibition on a ByteDance Covered Application (Jun 2023)
52.219-28 Post Award Small Business Program Rerepresentation (Sep 2021) (15 U.S.C. 632(a)(2)). May require contractor completion.
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)
52.225-1 Buy American-Supplies (Oct 2022)
52.225-13 Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury)
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 following provisions and clauses apply to this acquisition. Offerors MUST complete the provision at 52.204-24 and 52.204-26 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 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
3. Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services (Dec 2022), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.
4. NIH Invoice and Payment Instructions 

All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.


DELIVERY DATE:  Within 4-6 weeks after award. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive Rockville, MD 20850 (ATTN: Jiankang Jiang).  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.
 

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.