SOLICITATION NOTICE
68 -- Synthesis of Custom Drug KD025
- Notice Date
- 11/9/2018
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 5601 Fishers Lane, 3rd Floor MSC 9822, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- NIAID-RFQ-19-1933409
- Archive Date
- 12/9/2018
- Point of Contact
- LAWRENCE A. BLAND JR., Phone: 2406695113
- E-Mail Address
-
blandl@mail.nih.gov
(blandl@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This notice is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and Solicitation for Commercial Items," as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. Submit offers on NIAID-RFQ-19-1933409. This solicitation is a request for quotes (RFQ). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-100, dated 8/22/18. The associated North American Industry Classification System (NAICS) code for this procurement is 541715 with a business size standard of 1000. The National Institute of Allergy and Infectious Diseases (NIAID) seeks to purchase synthesis of the custom drug KD025 (1.1kg and 500mg). Synthesis needs to be pharmaceutical grade purity, >99% pure. To be considered for award, offerors must meet the following criteria for the synthesis of the custom drug KD025. This drug will be used in the labs Non_Human Primate NHP study. This drug is needed to observe NHP immune response to HIV infection. This is a custom drug. It must be synthesized for the lab. The vendor must have the chemical and engineering knowledge to synthesize this custom drug. The vendor must meet the labs scale-up needs all while providing the starting material for the Good Manufacturing Practice (GMP) production. The vendor must provide 1.1kg and 500mg of the custom material, KD25 using the methanesulfonate salt. The mission at the Vaccine research Center (VRC) is to determine the immune correlates of protection against emerging infectious diseases. One of the specific aims of the lab is to understand processes that determine the course of human diseases in which the immune system plays a central role in their pathogenesis and outcome. The work in HIV infection in part involves analysis of the clonal composition of CD8 T cells that respond to HIV and the interaction with HIV quasispecies. Escape from adaptive T cell immunity through viral epitope mutation is a major obstacle to the development of vaccines that aim to elicit cellular immunity. The lab is investigating the molecular determinants of this phenomenon at the level of the T cell receptor-epitope contact interface and defining structural motifs that govern the pace and pattern of epitope escape. The practical consequences of findings suggest that vaccine strategies should elicit responding T cells that are qualitatively superior, in terms of clonotypic composition, to those elicited in natural infection. Period of Performance: Within 60 days of receipt of purchase order. Delivery date must be stipulated within quote/proposal. Delivery: FOB Point shall be Destination Bethesda, MD. Delivery location is 40 Convent Drive, Room 3615B, Bethesda, Md., 20892. The successful offeror shall coordinate delivery arrangements with the customer prior to shipment. The Loading Dock hours are as follows: 8:00 am to 4:30 pm Eastern, Monday through Friday except for federal holidays. All equipment delivered shall contain a Packing Slip (with serial numbers when applicable)." Discussions: The Government intends to award without discussions but reserves the right to conduct discussions should it be in the Government's best interest. The award will be based on the following; price, capability to meet the requirements, delivery/installation, and the best value to the government. The following FAR provisions apply to this acquisition: FAR 52.212-1 Instructions to Offerors Commercial Items (Aug 2018) FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (Aug 2018) Offerors must complete annual representations and certifications on-line at http://www.sam.gov in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items The following contract clauses apply to this acquisition: FAR 52.212-4 Contract Terms and Conditions Commercial Items (Jan 2017) FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (Aug 2018) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) Quoter must include the following provision in their quote and check the appropriate response. 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. (Nov 2015) (a) Definitions. "Inverted domestic corporation" and "subsidiary" have the meaning given in the clause of this contract entitled Prohibition on Contracting with Inverted Domestic Corporations (52.209-10). (b) Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4. (c) Representation. By submission of its offer, the offeror represents that- (check one) ____ (1) It is not an inverted domestic corporation: and ____ (2) It is not a subsidiary of an inverted domestic corporation By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov). Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov/far/loadmainre.html or, upon request, either by telephone or fax. This is an open-market combined synopsis/solicitation for synthesis of custom drug KD025 (1.1kg and 500mg) as defined herein. The government intends to award a purchase order because of this combined synopsis/solicitation that will include the terms and conditions set forth herein. All quotes shall include: price(s) (unit price, extended price, total price); documentation demonstrating offerors is either the manufacturer or authorized distributor/reseller of the product(s); confirmation of required delivery timeframe; point of contact: name, phone number & email; DUNS #; and Cage Code. Each response must clearly indicate the capability of the offeror to meet all specifications and requirements. The Government may evaluate only those quotes that fully meet the requirements as outlined above and respond to the solicitation instructions and requirements. Failure to furnish a full and complete quote as instructed may result in the Offeror's response being considered non-responsive and will therefore be eliminated from further consideration and award. If an offeror proposes an OPEN MARKET item, NIAID will only consider those which are clearly identified on the quote as Open Market. All or part of the successful offeror's quote may be incorporated in any contract resulting from this solicitation. The successful offeror's quote may be incorporated by reference. To facilitate the award process all quotes should include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" (Quoter shall list exception(s) and rationale for the exception(s).) Offers may be e-mailed to blandl@mail.nih.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/NIAID-RFQ-19-1933409/listing.html)
- Place of Performance
- Address: 40 Convent Drive, Rm 3615B, Bethesda, Maryland, 20814, United States
- Zip Code: 20814
- Zip Code: 20814
- Record
- SN05149178-W 20181111/181109230633-cf06a35431206789b860421c443582f8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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