75A50120SO4302021

NOTICE OF INTENT TO SOLE SOURCE This is a NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT (as prescribed in FAR 6.302-1(a)(2). This notice is for informational and planning purposes and does not constitute a solicitation. The NAICS code for this procurement is 32541, Pharmaceutical and Medicine Manufacturing. Period of Performance April 30, 2021-January 31, 2023. 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 Baxter located at Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015-4625. In response to COVID-19 and future pandemic preparedness, the United States Government (USG) has a requirement for Vendor Managed Inventory (VMI) to include rotation, and cold-chain distribution services for the pharmaceutical, Zosyn. The product will be provided as GFP at the start of this Contract and during the performance of this contract if product is distributed and the Government chooses to replenish this quantity. The Contractor shall provide VMI (logistical and supply chain support) for Zosyn, NDC: 0206-8862-02; 4.5 G in 100 mL. VMI services shall operate in 3 Phases. Phase 1: Product Receipt/Inventory; Phase 2: Product Warehousing, Management, and Rotation; Phase 3: Product Distribution Phase 1: Product Receipt/Inventory The Contractor will coordinate receipt of the GFP product into its warehouses within the United States. At a minimum, the Contractor shall have the ability to service all the continental United States while being capable of warehousing the quantities referenced above under proper FDA, cGMP, and manufacturer required conditions. The Contractor must possess an inventory system capable of providing up to date information on all Government owned inventory including quantity and location. The Contractor shall only be required to distribute product to the continental United States, Alaska, Hawaii, and Puerto Rico. Shipment to international and / or other US Territories is not allowed under this contract. Upon receipt of GFP, Contractor shall visually inspect each shipment of GFP for external container or package damage, expired product or product lost in transit, and will provide USG with the inbound documentation within one (1) business day. Contractor shall inventory and validate receiving documentation for product by annotating incoming documentation with the name of the person receiving the product, date, and time of the receipt. Any discrepancies between the incoming (packing list) documentation and the actual product shall be so annotated on the inbound documentation. At a minimum, the Contractor shall ensure that quantities received are accurate and lot numbers match. Upon inspection of the inbound shipment, any damage, shelf-life issues, or missing quantities shall be reported to the Contracting Officer’s Representative (COR) immediately and material suspended by the Contractor pending resolution of the problem. Phase 2: Product Warehousing, Management, & Rotation (CLIN 0001) The Contractor shall provide cold chain storage for Zosyn. The Contractor shall ensure that all material is warehoused in accordance with manufacturer and/or FDA specifications and that the facility is an approved storage facility to perform pharmaceutical warehousing in accordance with Current Good Manufacturing Practices (cGMP) and 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), Drug Enforcement Agency (DEA) and such other Federal, State, or local laws and regulations that may apply. All material shall be warehoused and distributed by a Contractor that has a Drug Distribution Accreditation. In addition, Contractor shall provide certification and proof upon request from the Contracting Officer that the facilities being used to perform under this contract meets all Federal and State Regulatory requirements for the storage of this pharmaceutical product. At the warehouse location(s), Contractor shall have adequate space for storage, staging, receiving, and shipping product. Contractor shall use commercially reasonable efforts to segregate GFP stored in its Distribution Facilities from any commercial inventories of pharmaceutical products owned by Contractor. Contractor shall rotate product with their commercial supply to ensure product does not expire and has no less than six (6) months of dating. The Contractor shall ensure that accurate records and accountability of both inbound and outbound shipment records are auditable and reconcilable to the Government. The Contractor shall maintain an inventory record and location system for the pharmaceutical 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 access to its inventory system which will specify quantities of GFP held in each Distribution Facility. Phase 3: Product Distribution (CLIN 0001) Standard Allocation For Zosyn that is to be provided under an allocation strategy, ASPR shall notify Contractor in writing, every other week, of its intention to allocate GFP to locations (each such period, an “Allocation Period”). Contractor and ASPR shall determine the extent to which any specific allocation request to Contractor of GFP under the Program should be exercised by ASPR pursuant to its priorities and allocations authority. Contractor shall coordinate with ASPR to establish the pace of allocation and distribution of GFP based on various factors to be determined by the parties (including allocation and distribution forecasts that are communicated periodically from ASPR to Contractor). After the ASPR identifies the delivery locations to receive GFP during any Allocation Period, Contractor will contact those locations to confirm shipment location, shipment dates and other delivery requirements. Contractor shall contact the applicable location to ensure they can accept delivery of such product and that they have the necessary licenses and schedules to receive this product. To the extent a location declines any amount of Zosyn allotted to it by ASPR, Contractor shall notify ASPR, which shall determine the disposition of such GFP for the next Allocation Period. Contractor shall have no responsibility or liability for any such declination decisions made by delivery locations. Any decisions, notifications or instructions issued by ASPR under this Contract shall be communicated to Contractor only by those individuals designated, CO & COR. Contractor shall ship the designated amount of Zosyn to specific delivery locations identified by ASPR, subject to the following: ASPR will provide sufficient and timely information to Contractor within the Allocation Period regarding the allocated quantities of Zosyn to be shipped to delivery location as well as any additional information needed to fulfill this request. Each allocation of Zosyn to a delivery location shall be no less than one full case: and In the event that the delivery location does not have required licenses, Contractor shall not be required to ship to such location. Following receipt and confirmation of items listed above, Contractor shall deliver the specified quantities of Zosyn to any such delivery location(s) located within the continental United States within five (5) business days. Contractor shall not be required to deliver within five (5) business days should the delivery location be unable or unwilling to accept the delivery within that time. Expedited (Emergency) Allocation For expedited needs to distribute GFP outside an Allocation Period cycle (an “Emergency Allocation”), the authorized representatives of ASPR shall notify Contractor of the request, which shall consist of (i) the quantity of GFP requested by ASPR to be allocated to the delivery location(s), and (ii) the delivery location(s) designated to receive such GFP. Upon receipt of an Emergency Allocation request, Contractor shall notify ASPR of the time frame anticipated for delivery to the designated delivery location(s). Deliveries of any GFP pursuant to an Emergency Allocation freight costs. Task 2: Freight & Transportation Freight & Transportation The Contractor shall, at the direction of the SNS, distribute products to all points of care as directed and will bill in accordance SOW. All shipments shall be made using traceable means under F.O.B. Origin, Freight Allowed. For each shipment, Contractor shall provide the following information to the COR within 24 hours after delivery: a) Delivery/order number b) NDC/Product # c) Product Name d) Qty Shipped e) Number of Containers/Pallets f) Date Shipped g) Estimated Arrival date/time h) Carrier Name i) Tracking Number(s) j) Proof of Delivery Outside packing label for each shipping container pallet, case or box must contain the following minimum data elements: Shipper’s address Ship to address Mark for data or Transportation Control Number (TCN) Delivery/Order Number Number of Boxes/Cases Shipped; 1 of 4, 2 of 4, 3 of 4, 4 of 4, etc. Shipping Label Fixed to outer box(es) may contain additional wording as determined by the Contracting Officer’s Representative, such as “PANDEMIC COVID PROGRAM”. At a minimum the inside packing slip must contain the following information: Customer name Ship to address NDC Product Name NDC Unit of Issue Qty Shipped Delivery/Order number Transportation Control Number or Customer Requisition Number Under FOB Destination procedures, any in-transit damages as well as any loss of material or damages of product while in storage at the Contractor’s facilities is the responsibility of the Contractor. Contractor shall at all times handle, maintain, transport, deliver and/or otherwise manage and distribute the Zosyn in its possession in accordance with the applicable handling and storage requirements (as set forth in the special handling and storage requirements of the Product Information sheet provided by the manufacturer of Zosyn). In the event the Contractor has not handled, maintained, stored, transported, delivered and/or otherwise managed GFP in accordance with this paragraph, Contractor shall notify ASPR within 24 hours of knowledge of such incident and provide a GFP Handling Issue Report and shall destroy such GFP in accordance with all applicable laws, ordinances, regulations, and rules at no cost to the Government within three (3) business days of becoming aware of such incident. Within 72 hours after providing such notice of loss or damage to the Contracting Officer, the contractor shall reimburse SNS for the lost or damaged GFP at SNS’s original acquisition cost or replacement product. To the extent possible, Contractor shall ship shortest dated product first. 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. Interested parties who believe they possess the capabilities to satisfy this requirement should submit a capability demonstrating their abilities to meet this requirement. All responses must be received by April 26, 2021 at 2:00 PM Eastern Standard Time. All responses must be in writing and can be sent via email to [email protected] reference 75A50120SO4302021 in the subject line. No phone calls will be accepted.