D. RFQ_f.pdf

REQUEST FOR QUOTATION

REQUEST NUMBER: 75N95022Q00554

DATE ISSUED: 09/01/2022

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: Chandani Hangilipola, 301-480-7089, chandani.hangilipola@nih.gov

NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE: 325414– Biological Product (except Diagnostic) Manufacturing

SMALL BUSINESS SIZE STANDARD: 1,250 employees

SET-ASIDE STATUS: No set-aside restrictions

Competition Status: This requirement is competitive

DATE QUOTATION DUE:

All responses to this request for quote must be received by 9:00 AM Eastern Standard Time, on September 13, 2022 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 contract specialist cited herein. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this 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 Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which 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. Malaria affects an estimated 250 million people worldwide, particularly in the tropical regions of Sub-Saharan Africa and approximately 650,000 patients die each year. Even while on current therapies, patients remain infectious for a period of time, allowing further mosquito-borne transmission to others. Control of parasite transmission is critical for elimination and eradication of malaria. Torin2 was identified in NCATS as a lead molecule in a new class of antimalarial drugs. As part of a lead optimization program, researchers are using a malaria asexual parasites viability assay to optimize the Torin2 series and advance a drug candidate through pre-clinical development and early clinical development. NCATS requires Malaria Asexual Culture Services.

Background Information:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which 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.

Malaria affects an estimated 250 million people worldwide, particularly in the tropical regions of Sub- Saharan Africa and approximately 650,000 patients die each year. Even while on current therapies, patients remain infectious for a period of time, allowing further mosquito-borne transmission to others.

Control of parasite transmission is critical for elimination and eradication of malaria. Torin2 was identified in NCATS as a lead molecule in a new class of antimalarial drugs.

As part of a lead optimization program, researchers are using a malaria asexual parasites viability assay to optimize the Torin2 series and advance a drug candidate through pre-clinical development and early clinical development.

Monthly, 30 ml asexual parasites at 1% parasitemia and 4% hematocrit are needed for this project. Ring stages must be >90%. The culture has to be maintained at 37 degree under hypoxia conditions (90% N2, 5% CO2, and 5% O2) all the time during the shipment. Additionally, 100 ml complete medium and 1-5 ml human blood are needed for the assay. The cultures will be used in house for viability assays for 72 hour drug sensitivity tests. TDB has developed assay for the drug viability test. The viability assay prefer to >90% ring stage in asexual parasite culture for a successful assay. Additional 1-5 ml of 50% blood and 100 ml complete medium are required for assay dilution. The culture has to be maintained at 37 degree under hypoxia conditions (90% N2, 5% CO2, 5% O2) all the time during the shipment. Delivery is on Tuesday or Friday.

If assay fail because of lower than 90% ring stage provided. The Contractor will provide another 30 ml asexual culture in the following week or two until the drug efficacy assays work. Any additional asexual culture will be provided at no additional cost. If the drug efficacy assays fail because of TDB biology related issues, the Contrcator will not provide additional culture. Therepeutic Developmemntal Branch (TDB) has an option to order 5 additional supply of 30ml of the asexual cultures, blood and medium due to project needs. The contract will be 6 month. TDB will order asexual parasites monthly. TDB may terminate the contract at any time.

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:

All work must be conducted with strict compliance to vendor Standard Operating Procedures (SOP), with all excursions from these SOP immediately reported to TDB and comprehensively noted in the final report. Monthly, 30 ml asexual parasites at 1% parasitemia and 4% hematocrit are needed for this project. Ring stages must be >90%. The culture has to be maintained at 37 degrees under hypoxia conditions (90% N2, 5% CO2, and 5% O2) all the time during the shipment. Additionally, 100 ml complete medium and 1-5 ml human blood are needed for the assay. The cultures will be used in house for viability assays for 72-hour drug sensitivity tests. TDB has developed assay for the drug viability test.

The viability assay prefers to >90% ring stage in asexual parasite culture for a successful assay.

Additional 1-5 ml of 50% blood and 100 ml complete medium are required for assay dilution. The culture has to be maintained at 37 degrees under hypoxia conditions (90% N2, 5% CO2, 5% O2) all the time during the shipment. Delivery is on Tuesday or Friday.

If assay fails because of lower than 90% ring stage provided. The Contractor will provide another 30 ml asexual culture in the following week or two until the drug efficacy assays work. Any additional asexual culture will be provided at no additional cost. If the drug efficacy assays fail because of TDB biology related issues, The Contractor will not provide additional culture. TDB has an option to order 5 additional supply of 30ml of the asexual cultures, blood and medium due to project needs. The contract will be 6 months. TDB will order asexual parasites monthly. TDB may terminate the contract at any time.

• All work must be conducted with strict compliance to vendor Standard Operating Procedures (SOP), with all excursions from these SOP immediately reported to TDB and comprehensively noted in the final report.

DELIVERY OR DELIVERABLES:

Asexual parasites, blood and complete medium will be delivered Monthly. Asexual delivery is intended to be normal business days and on Tuesday or Friday of the month unless otherwise specified. The Subcontractor may suggest an alternative due date for any or all deliverables in their offer. The final schedule will be agreed to by TDB based on the Subcontractor’s proposed cost and proposed delivery schedule.

The following deliverables shall be developed in this project. The Offeror’s proposed Project Plan should clearly contain all tasks and milestones required to produce these deliverables.

All deliverables shall be developed according to constraints lists in the “Conformance and Compliance” section above where applicable.

Deliverable: Asexual stage parasites.

Description and Acceptance Criteria: The culture must be prepared at 1% parasitemia and 4% hematocrit. Ring stages must be >90%. It has to be maintained at 37 degree under hypoxia conditions (90% N2, 5% CO2, 5% O2) all the time during the shipment. Ring stages has to be more than 90%.

Deliverable: complete medium.

Description and Acceptance Criteria: the same batch of complete medium used for parasite culture are required. At least 100 ml of complete medium is required for asexual culture.

Deliverable: 50% human blood.

Description and Acceptance Criteria: 50% human blood is required for asexual culture and viability assay. The human blood must be less than 3 weeks after withdrawing and must be able to maintain asexual parasite culture.

General Acceptance Criteria

• In addition to specific acceptance criteria listed above, general quality measures, as set forth below, will be applied to each deliverable received from the Subcontractor under this Statement of Work.

• Accuracy – Deliverables shall be accurate in presentation, technical content, and adherence to accepted elements of style.

• Clarity – Deliverables shall be clear and concise. Any/all diagrams shall be easy to understand and be relevant to the supporting narrative.

REPORTING REQUIREMENTS:

Monthly Analytical Report The contractor shall document the analyses for each monthly delivery in a report due with each delivery. It is expected that this report will include, but not be limited to:

• Document the percentage of ring stages for asexual culture.

• Document the percentage of hematocrite of the culture.

• Document the age of the blood (time since the blood was drawn) and the time since the parasites were thawed.

Final Report Contractor shall submit a Final Report within 30 days of subcontract completion and shall include the following:

• Subcontractor Name and Address

• Name of Person Submitting the Report

• Subcontract Number

• Report Date

• Period Covered by the Report

• A comprehensive Summary of Work performed during reporting period

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. UEI:

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 Purchase Order award not exceeding the Simplified Acquisition Threshold is anticipated for any contract resulting from this requirement. The anticipated award date is 9/15/2022.

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. 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:

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. 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 (JAN 2022) is applicable to this solicitation. See attachment.

http://www.acquisition.gov/ https://www.acquisition.gov/

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)

Period of Performance: The anticipated period of performance is a 6-month service after receipt of award. Data will be sent to NCATS 30 days after receiving the compounds. 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.