Leukine-ASPR-2019-00406

See J & A attached..

Awarded Vendors: Partner Therapeutics, Inc.. Contract Award Dollar Amount: $54,999,800.00. Contract Award Date: 2019-09-16.

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 Office of the Assistant Secretary for Preparedness and Response (ASPR), Division of Strategic National Stockpile (DSNS), intends to award a sole source contract to Partner Therapeutics, 19 Muzzey Street, Lexington, MA 02421 for the acquisition of Cytokines (GM-CSF) Colony Stimulating Factor (Leukine) for mitigation of Neutropenia arising from exposure to ionizing radiation.

The statutory authority for this sole source acquisition is 10 U.S.C 2304(c) (1) in accordance with FAR Part 6.302-1- only one responsible source and no other supplies or services will satisfy the agency requirement. The NAICS code for this procurement is 325412, Pharmaceutical Preparation Manufacturing. The period of performance for this procurement is 12 months.

The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads the nation in preventing, preparing for, responding to, and recovering from the adverse health effects of emergencies and disasters by supporting our communities' ability to withstand adversity, strengthening our health and response systems, and enhancing national health security.

The Division of Strategic National Stockpile (DSNS) is responsible for stockpiling and deploying pharmaceuticals and medical supplies needed during a public health response. During a public health emergency, federal supplies of medications used to treat or prevent illness may need to be distributed and dispensed to people throughout the country.

Neutropenia, the decrease in neutrophils, is expected to be a significant health issue following a radiologic event. It is anticipated that the medical management of neutropenia following a mass casualty event will best be served by employing medical practices already in use for oncological and other medical treatments. The Food and Drug Administration (FDA) has approved PEGylated-G-CSF (Leukine), for treating individuals receiving myelosuppressive levels of ionizing radiation or the acute radiation syndrome (ARS) indication.

The purpose of this requirement is to sustain access up to 34,000 treatment courses of Leukine through the purchase of product, vendor managed inventory (VMI), and/or reverse vendor managed inventory (rVMI).

The following technical specifications are necessary to fulfill our requirements:

1. The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the USG, to meet the requirements of this requirement.
2. The product shall be a PEGylated-G-CSF cytokine.
3. The product shall meet regulatory requirements for use in a mass casualty radiological event through an FDA approved indication for treatment of patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome.

4. Product shall have 90% of Shelf-Life remaining at time of delivery (not applicable to VMI deployment).

5. VMI structure shall include the following:
a. Storage facility shall be cGMP compliant.
b. Government shall have 24/7/365 access.
c. Contractor shall have 24/7/365 deployment operations and capability.
d. Contractor shall be able to deliver product to a DSNS identified location within 12 hours of notification.
e. Contractor shall allow the Government to pick up and transport product upon request.
f. Contractor shall monitor and maintain specified inventory levels and product shelf life.
g. Contractor shall include a plan to provide the USG with an accurate inventory of the product as well as Contractor storage location(s) should the USG have an immediate need for the product to be released from VMI in an emergency situation.
h. Contractor shall participate in simulated deployment exercises.
i. Contractor shall plan to provide access to the product as needed by the USG and the Quality Agreement with the ASPR/SNS shall align with the USG's specific product use during a mass casualty event. In order to meet the above objectives, the Contractor shall have evidence that the labeling, storage, distribution and transport programs are secure and controlled.

j. Licensing: The contractor shall possess - prior to acceptance of the proposed facility - and thereafter maintain current Federal, state, and/or local jurisdiction licenses for the holding and distribution of pharmaceuticals as required by the state and local jurisdictions where the facility is located. In the event that the local jurisdiction does not require licensing for the holding and distribution of pharmaceuticals, the contractor shall meet and maintain whatever specific legal requirements do exist and provide acceptable documentation in this regard to the Government on demand. At a minimum, the contractor shall have registered for the storage and distribution of pharmaceuticals with the FDA.
As a result of this Notice of Intent, no competitive solicitation will be posted on FedBizOpps. We will issue only one solicitation to Partner Therapeutics. However, all responsible sources that believe they can meet these requirements may submit their capabilities/qualifications statement.

All capabilities/qualification statements must be received NO LATER THAN April 5, 2019 at 2:00PM EST and sent to Kimberly Golden via email ONLY at IXM9@cdc.gov with the solicitation number #ASPR 2019-00406 referenced in the subject line. TELEPHONE CALLS WILL NOT BE ACCEPTED.
A determination by the Government not to compete this proposed action will be based on responses to this notice and are solely within the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

Place of Performance:

Partner Therapeutics
19 Muzzey Street
Lexington, MA 02421

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