Inactive
Notice ID:75A50121R00041
Notice of Award of Definitized Letter contract 1/12/2022 Letter Contract 8-6-2021 NOTICE OF INTENT TO SOLE SOURCE This is a NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT. The statutory authority fo...
Notice of Award of Definitized Letter contract 1/12/2022 Letter Contract 8-6-2021 NOTICE OF INTENT TO SOLE SOURCE This is a NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT. The statutory authority for this sole source procurement is prescribed in FAR 6.302-3(a)(2)(i). This notice is for informational and planning purposes and does not constitute a solicitation. The NAICS code for this procurement is 325412, Pharmaceutical and Medicine Manufacturing. Period of Performance, from Date of Award through 14 September 2024, including option quantities. The Office of the Assistant Secretary for Preparedness and Response (ASPR), Division of Strategic National Stockpile (DSNS) intends to award a sole source Firm Fixed Price contract to Elusys located at Elusys Therapeutics, Inc. 4 Century Drive, Suite 260 Parsippany NJ 07054 In response to COVID-19 and future pandemic preparedness, the United States Government (USG) has a requirement for Manufacture of and Vendor Managed Inventory (VMI) to include rotation, and cold-chain distribution services for the FDA approved Anthrax Antitoxin pharmaceutical, Anthim (obiltoxaximab) Injection. The product will be provided as GFP at the start of this Contract and during the performance of this contract as product is manufactured and distributed and the Government chooses to replenish this quantity. The Contractor shall manufacture and provide VMI (logistical and supply chain support) for USG Food and Drug Administration (FDA) approved anthrax antitoxin Final Drug Product (FDP) Anthim (obiltoxaximab) 600mg/6mL for Injection (NDC: 69604-204-01) and Bulk Drug Substance (BDS) for conversion to FDP per the Statement of Work: TASKS TO BE PERFORMED Task 1: Manufacture and deliver to the SNS Anthim (obiltoxaximab) 600mg/6ml for Injection (NDC: 69604-204-01) Finished Drug Product (FDP), FDA approved anthrax antitoxins. The Anthim (obiltoxaximab) 600mg/6ml for Injection shall be tested and characterized, and documentation establishing compliance with cGMP requirements shall be provided. The finished product shall be delivered in a controlled and validated way, and documentation establishing compliance with cGMP requirements shall be provided. This will immediately allow for the replenishment of existing inventories of antitoxins and sustain the current preparedness level. Delivery of this product will be to a USG provided location(s) at time of award and is FOB Destination. Task 2: Manufacture and deliver Bulk Drug Substance (BDS) required for the manufacturing of the FDP. Given the time required to manufacture the BDS, BDS must be manufactured well in advance of conversion into the FDP so Task 4, VMI services, for BDS and FDP allows the manufacturing of FDP to occur in a much shorter time-frame. Task 3 (Option): Vendor shall convert BDS procured under Task 2 into FDP. Task 4: Provide Vendor Manage Inventory services of BDS and FDP for the SNS until such time the Government exercises the option to convert BDS to FDP and/or the Government directs the vendor to deliver FDP. Vendor shall manage product in accordance with all FDA rules and regulations. The finished product shall be managed in a controlled and validated way, and documentation establishing compliance with cGMP requirements shall be provided. The Contractor shall ensure that all material is warehoused in accordance with manufacturer and/or FDA specifications in an approved storage facility to perform pharmaceutical warehousing in accordance with Current Good Manufacturing Practices (cGMP) and that meets all Federal and State Government regulatory requirements. Contractor shall be responsible to ensure that all products are stored in compliance with all applicable regulations as administered by the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), and such other Federal, State, or local laws and regulations that may apply. In addition, Contractor shall provide certification and proof upon request from the Contracting Officer that the facility being used to perform this contract does indeed meet all Federal and State Regulatory requirements for the storage of this product. At the warehouse location, Contractor shall have adequate space for storage, staging, and shipping product. Contractor shall use commercially reasonable efforts to segregate GFP stored in its Distribution Facilities from any non-SNS inventories of products owned by Contractor. The Contractor shall ensure that accurate records and accountability of outbound shipment records are auditable and reconcilable to the Government. The Contractor shall maintain an inventory record and location system for the products. All documentation related to the inventory quantities of product shall be retained by the Contractor and made available to the USG upon request. Contractor shall provide ASPR with reporting from its inventory system which will specify quantities of GFP held in each Distribution Facility. Task 5 (Option): Delivery of FDP executed under Task 3. The finished product shall be delivered in a controlled and validated way, and documentation establishing compliance with cGMP requirements shall be provided. This notice of intent is NOT a request for competitive proposals. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. All responses must be received by July 30, 2021 at 2:00 PM Eastern Standard Time. All responses must be in writing and can be sent via email to ixm9@cdc.gov reference 75A50121R00041 in the subject line. No phone calls will be accepted. CHANGE: Updated to make correction to posting and removed the following language "This notice is posted per the exception authorized in FAR 5.203(a)." in addition, change posting date to August 2, 2021.
