75N95020Q00289

Post Date/ Solicitation Issue Date

August 31, 2020 12:00 pm

Closing Response Date

September 4, 2020 3:00 pm

Proposed Award Date

September 11, 2020 12:00 pm

Project Title

Analysis of APX2039 in Rabbit Plasma, CSF and Brain Tissue Samples

Contracting Office

National Center for Advancing Translational Sciences (NCATS)

Small Business Size Standard

$16.5 million

FPDS Classification Code

Q301

Estimated Period of Performance

3 months

Competition Status

Non-Competitive

Single-Sole Source Determination

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

Date Quotation Due: All responses to this request for quote must be received by 3:00 PM Eastern Standard Time, on September 4, 2020 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 National Center for Advancing Translation Sciences (NCATS) is collaborating with Amplyx Pharmaceuticals to develop APX2039 as a potential drug candidate for the treatment of cryptococcal meningitis (CM).  To test pharmacologic effects of APX2039, a rabbit model of CM is used.  After oral treatment of APX2039 at different dose levels, plasma, CSF and brain tissues were collected from rabbits for drug concentration measurement.  Drug concentration data determined from this task order will be used to correlate with the efficacy data observed in rabbits.  Since these samples were collected from infected rabbits, not all bioanalytical labs could be able to handle these samples.  Amplyx has been working with Duke Proteomics & Metabolomics Core Facility to develop the bioanalytical method for APX2039.  This method was used in the previous pilot study in rabbits.  Thus, it will be more efficient to use the same method to measure APX2039 drug concentrations in rabbit plasma, CSF and tissue homogenates.    

The objective of this study is to determine APX2039 concentrations in plasma, CSF and brain tissue samples collected from an efficacy study in rabbits infected with cryptococcal meningitis (CM).  Data generated from this study will be used to assess in vivo pharmacokinetic and pharmacodynamic correlation.  

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 bioanalytical lab will determine APX2039 concentrations in plasma, CSF and brain tissues collected from the rabbit efficacy study for a total of 363 samples: 

The drug concentrations will be determined with a verified LC-MS/MS method with standard curves and quality control (QC) samples for each biologic matrix.  When applicable, mean and standard of drug concentrations will be calculated.   

Government Responsibility:

NCATS will review the bioanalytical method developed for the sample analysis.  NCATS will also review the drug concentration data determined by the lab and help on the data interpretation.  

Delivery or Deliverables:

1. Bioanalytical methods used for sample analysis
2. Drug concentration data for 363 samples
3. Calculate mean and SD of concentrations when applicable
4. Bioanalytical Report 

Reporting Requirements:

1. Progress update
2. Bioanalytical Report which includes the methodology and drug concentration data  

Data Rights:

NCATS owns the right of results generated from this study.   

Publications and Publicity:

NCATS will be responsible for all publications on the data generated from this study. 

Confidentiality of Information:

No data can be disclosed without the permission from NCATS. 

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 September 11, 2020.

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. The provisions of FAR Clause 52.212-1 Instructions to Offerors—Commercial Items (OCT 2018) is applicable to this solicitation.
   2. The provisions of FAR Clause 52.212.2 Evaluation—Commercial Items (Oct 2014) 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. Technical capability of the item 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 2019), is applicable to this solicitation.
   4. The provisions of FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items (OCT 2018) 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 (Aug 2020) is applicable to this solicitation:
      52.222-3 Convict Labor (Jun 2003)
      52.222-19 Child Labor-Cooperation With Authorities and Remedies (Jan 2020)
      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 (Jan 2019)
      52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020)
      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 (Jul 2016),

52.204-18 Commercial and Government Entity Code Maintenance (Jul 2016). 

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 separate documents with their quotation.

1. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)
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 (Dec 2019)
4. NIH Invoice and Payment Provisions (2/2014)

DELIVERY DATE:  3 months 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.