NOI-to-Sole-Source_W81XWH-22-R-0083_POLYSERP-Snake-Antivenom(2).docx

NOTICE NO.: W81XWH-22-R-0083

POLYSERP™, a Non-FDA Approved Polyvalent F(ab')2 Immunoglobulin Fragments (Equine) Snake Antivenom

NOTICE OF INTENT TO SOLE SOURCE

NOTICE NO.: W81XWH-22-R-0083

ISSUE DATE: 04 August 2022

1.0 TITLE: POLYSERP™, a Non-FDA Approved Polyvalent F(ab')2 Immunoglobulin Fragments (Equine) Snake Antivenom

2.0 AGENCY: United States Army Medical Research and Development Command (USAMRDC), Fort Detrick, MD

3.0 OFFICE: US Army Medical Materiel Development Activity (USAMMDA) Force Health Protection (FHP) Directorate, Fort Detrick, MD

4.0 CONTRACTING OFFICE: United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD

5.0 DESCRIPTION: The proposed contract action is for supplies for which the Government intends to solicit and negotiate with only one source. USAMRAA intends to issue a sole source contract under the authority of FAR 13.106(b)(1) – Soliciting from a single source for purchases not exceeding the simplified acquisition threshold and only one source is reasonably available, on or about 19 August 2022 to CRO, LLC, 516 E. Spruce St., Missoula, MT 59802 under NAICS 325414 Biological Product (except Diagnostics) Manufacturing.

FHP has a requirement for: one (1) shipment of Polyvalent F(ab’)2 Immunoglobulin Fragments (Equine), Snake Antivenom for multiple African nations that shall include:

5.1 Eighteen (18) boxes of freeze-dried snake antivenom POLYSERP™ PAN-AFRICA (POLYSERP-P™), each box shall contain six (6) vials of lyophilized powder and a package insert. The product shall be supplied with the maximum shelf life possible consistent with current production technology and stability data.

5.2 Six (6) boxes of freeze-dried snake antivenom POLYSERP™ MENA (POLYSERP-M™), each box shall contain six (6) vials of lyophilized powder and a package insert. The product shall be supplied with the maximum shelf life possible consistent with current production technology and stability data.

5.3 The shipment will include a Certificate of Analysis (CoA) for supplied POLYSERP-P™ and POLYSERP-M™ antivenom that ensures that the product has meet the desired quality standard, the lot number(s) of the product, together with a statement by the manufacturer that the antivenom has passed the applicable safety and sterility tests and the names of regulatory bodies where products are registered, and date of original registration.

5.4 Product Adverse Events and Recalls: The vendor shall comply with all applicable laws, regulations and requirements regarding product safety. The terms used surrounding adverse experiences shall have the meanings set forth in the International Conference on Harmonization (ICH) of Technical Requirements of Pharmaceuticals for Human Use E2A. The manufacturer shall promptly inform USAMMDA FHP of serious issues (actual or alleged) regarding product safety and shall provide them with information sufficient to consider such issues. USAMMDA FHP shall promptly notify the supplier of serious adverse events involving supplier's products of which they become aware.

If any circumstance or event may require or make reasonably appropriate any recall or withdrawal of product or any field alert regarding the product, the vendor shall immediately notify USAMMDA FHP at usarmy.detrick.medcom-usammda.mbx.force-health-protection@mail.mil. When a recall, withdrawal or field alert is required or appropriate, the vendor shall take all appropriate actions and shall bear all associated expenses until expiry date is passed for the provided product.

5.5 The vendor shall submit the following documentation with the shipment:

5.6 Packaging, Storage, and Transportation: The product shall conform to international standards for product packaging and labelling. The vendor shall ensure all provided product is stored under all recommended storage conditions prior and during shipment until the product has been received and accepted at the delivery address. The vendor shall provide shipping support and documentation support for the importation of the products and ensure shipment is cleared through U.S. Customs and Border Protection (CBP). If the shipment is received at the delivery site without customs stamps indicating clearance the vendor’s customs broker shall ensure clearance. The cost of such packaging, packing, and all temperature monitoring devices must be included in the offered price. Shipping shall be completed through DHL International Air Priority.

5.7 Delivery Date: The anticipated period of performance of this contract is twelve (12) calendar months. Base year will start upon purchase of the product. The delivery preparation lead-time for the shipment and presentation after receipt of order including time to make administrative arrangements, including documentation, packing, and shipment shall not exceed 30 calendar days.

5.8 Delivery Address: BLDG E-1733 KUWAIT ST. Ft. Bragg, NC. 28310

6.0 DISCLAIMER: This notice of intent is for information purposes only. Interested contractors may identify their interest and bona fide capability to fulfill the requirement. All sources eligible to provide these products must respond in writing. Responses must be supported with clear and convincing evidence to clearly be able to provide products outlined above. A request for documentation will not be considered as an affirmative response. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. If no responses are received within fifteen (15) calendar days, 19 August 2022, after publication of this notice, to the effect that comparable supplies and services are available, and that it is more advantageous to the Government than obtaining these supplies through a sole-source contract, then a sole source contract award will be made.

This notice shall not be construed as a solicitation or as an obligation on the part of the USAMRDC, or collaborative Department of Defense (DoD) activities. This notice is not a Request for Proposal or Invitation for Bid, nor does it restrict the Government to an ultimate acquisition approach. This notice is for information and planning purposes only and is not to be construed as a commitment by the Government. Neither unsolicited proposals nor any other kind of offers will be considered in response to this notice. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this notice or any follow-up information requests. All information received in response to this notice or any follow-up information request that is marked ‘Proprietary’, or includes any other confidentiality marking, will be handled accordingly. Responses to the notice will not be returned. Questions concerning the composition and requirements for a future request for proposal will not be entertained. NO PHONE CALLS PLEASE.

7.0 SUBMISSION CONTACT INFORMATION:

Interested entities shall forward submissions electronically to Toloria DuVall at toloria.s.duvall.civ@mail.mil and David Payne at david.t.payne10.civ@mail.mil no later than 10:00 AM ET on 19 August 2022. Telephonic communication will not be considered as submission nor receive response.

The Government appreciates responses from all capable and qualified sources.

8.0 ADDITIONAL DISCLAIMER AND IMPORTANT NOTES: The purpose of this notice is to make the vendor community aware of the Government’s intent to sole source. The Government is not obliged to award a contract or otherwise pay for the information provided in the responses received. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its responses are complete and sufficiently detailed to allow the Government to determine the organization's solution and qualifications to perform the work. Responders are advised that the Government is under no obligation to acknowledge receipt of the information received, or to provide feedback to respondents regarding any information submitted.

9.0 CONFIDENTIALITY: All ‘Proprietary’, ‘Classified’, ‘Confidential’, or ‘Sensitive’ information shall be marked as such, and will be treated accordingly. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

(End of NOI W81XWH-22-R-0083)