Notice of Intent to Use Other than Full and Open Competition

Clarification - Per the changes in bold below, this edit to the Notice of Intent hereby clarifies that the Government intends to award a sole source contract to Ridgeback Biotherapeutics LP.  All references in the below Notice of Intent are bolded to reflect this change.  This edit to the Notice of Intent does not change any of the dates that are contained in the Notice of Intent.

NOTICE OF INTENT

Solicitation Number:

75A50120C00009

Notice Type:

Special Notice

Synopsis:

Added: February 12, 2020

 Notice of Intent to Use Other than Full and Open Competition

 Action Code: Notice of Intent to Sole Source

 Agency: Department of Health and Human Services

 Office: Office of the Secretary, Assistant Secretary for Preparedness and Response (ASPR), Division of Contracts Management and Acquisition (DCMA) on behalf of the Office of Biomedical Advanced Research and Development Authority (BARDA).

Location: Department of Health and Human Services, Office of the Assistant Secretary for Preparedness & Response (ASPR).

Address:  200 C Street, O’Neill House Office Building, Washington, District of Columbia 20515 United States.

The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Division of Contract Management & Acquisition (DCMA), and Office of the Biomedical Advanced Research and Development Authority (BARDA), intends to use other than full and open competition to award a sole source contract to Ridgeback Biotherapeutics LP for the development of mAb114 for treatment of Ebolavirus Disease (EVD) based under the authority of 41 United States Code (U.S.C.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1. Only One Responsible Source and No Other Supplies or Services will satisfy Agency Requirements.

This notice of intent to award a sole source contract will be posted for fifteen (15) calendar days to verify that no other sources can meet this requirement given only one responsible source and no other supplies or services will satisfy the Government requirements.  This fifteen (15) calendar day notice shall expire on 27 February 2020 at 11:59 PM Eastern Standard Time.  

If no credible responses to the intent to sole source are received by the Government, a contract to Ridgeback Biotherapeutics LP for the development of mAb114 for Ebola will be forwarded to Ridgeback Biotherapeutics LP.  Following the award of the contract to Ridgeback Biotherapeutics LP for the development of mAb114 for EVD, the Government will amend the intent to sole source by posting the redacted Justification and Approval (J&A) for 30 days.  The proposed contract action will support services for which the Government intends to solicit and negotiate with only one source under the authority of the Federal Acquisition Regulation (FAR) 6.302-1 entitled “Only one responsible source and no other supplies or services will satisfy agency requirements.”  This notice of intent is not a request for competitive proposals.

Interested individuals may identify their interest and capability to respond to the requirement by submitting in writing their name, address, telephone number, email, and a statement regarding capability to provide the specified efforts above.  Responses shall be limited to ten (10) pages or less, including all attachments.  Interested parties will be considered only if they respond to this notice with clear and convincing evidence that competition would be advantageous to the Government, would not be cost or time prohibitive, and that they can meet the requirement for the development of mAb114 for Ebola.  All capability statements, proposals, or quotes received prior to 27 February 2020 at 11:59 PM Eastern Standard Time will be considered by the Government.  The Government will not be responsible for any costs incurred by responding to this notice.  The Government will notify parties of the outcome of any capability statement, proposals, or quotes submitted in response.  A determination by the Government not to compete this proposed contract modification based upon responses to this notice is solely within the discretion of the Government.  Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

Anticipated Award Date and Period of Performance:
The Government anticipates the award of a contract to Ridgeback Biotherapeutics LP in FY2020 for a base CLIN plus four Option CLINs that, if all are exercised, will have up to three years of additional potential performance to March 31, 2023.  The base CLIN and the Option CLINs will be for the development of mAb114 for EVD.

Performance Schedule:
The performance schedule of the base CLIN plus Option CLINs that, if all are exercised, will have up to three years of additional potential performance to March 31, 2023 for the development of mAb114 for EVD will be established during contract negotiations.

Contract type:
The Government proposes the award of a contract to Ridgeback Biotherapeutics LP in FY2020 for a Total Estimated Cost Plus Fixed Fee base CLIN plus four Total Estimated Cost Plus Fixed Fee Option CLINs that, if all are exercised, will have up to a three years of additional potential performance to 31 March 2023.  The base CLIN and the Option CLINs will be for the development of mAb114 for EVD.

Estimated award amount:
The total dollar value for the base CLIN funding for the contract is $10,907,600.00.  The total dollar value of the Option CLINs for the continued development of mAb114 for EVD will be $139,793,901.00.  The total base plus option(s) estimated contract value is up to $150,701,501.00.

Background:

As of January 16, 2020, the ongoing Ebola outbreak in North Kivu and Ituri provinces in the Democratic Republic of the Congo (DRC) has killed 2,236 people out of 3,288 total cases.  The Pamoja Tulinde Maisha (PALM) randomized, controlled trial (RCT) conducted during the current outbreak evaluated efficacy of mAb114, EB3 (Regeneron Pharmaceuticals) and remdesivir (Gilead) relative to a ZMapp (Mapp Biopharmaceutical) control arm.  The study was closed early due to the EB3 arm meeting predefined early termination criteria.  Subsequent analysis of the final study data has shown that both mAb114 and EB3 were superior to the ZMapp control arm and that there is no significant difference in mortality between the mAb114 and EB3 arms.  Remdesivir failed to show superiority to ZMapp.  As such, use of ZMapp and remdesivir has been discontinued within the current response.

In order to ensure continued advancement of the mAb114 program, BARDA is seeking to support all scope required to advance mAb114 to Biologics License Application (BLA) submission during or before July 2020.  It is anticipated that this scope of work will include manufacturing that, in addition to allowing for completion of CMC requirements, will augment the existing USG supply of mAb114.

The National Institute of Allergy and Infectious Diseases’s (NIAID) Vaccine Research Center (VRC) transferred non-exclusive rights to mAb114 to Ridgeback Biotherapeutics LP and a second company.  As such, there are only two companies with rights to advance mAb114 to FDA approval.  Ridgeback Biotherapeutics LP has completed manufacturing of mAb114, has reviewed all proposed components of the BLA with the US Food and Drug Administration, has coordinated pre-approval inspections and has a defined path to approval which, cumulatively, places them in position to fulfill the aforementioned USG requirement to advance mAb114 to BLA submission during or before July 2020.  To the best of the Government’s knowledge, the second company with non-exclusive rights to develop mAb114 has not completed similar work that would make them a second source for fulfillment of this requirement.

Furthermore, NIAID/VRC is no longer manufacturing mAb114.  Consequently, Ridgeback Biotherapeutics LP, by virtue of having completed technology transfer to a commercial manufacturing facility, is the only source for additional manufacturing of mAb114 consistent with the temporal requirements for replenishment of the limited USG stockpile.

The USG will make the justification for other than full and open competition (JOFOC) publicly available within fourteen (14) calendar days after a resulting award, as required by FAR 6.303-1.

Contracting Office Address:

Office of the Assistant Secretary for Preparedness & Response (ASPR)

Department of Health and Human Services
200 C Street

O’Neill House Office Building
Washington, District of Columbia 20515
United States

Place of Performance:

Ridgeback Biotherapeutics LP

3162 Commodore Plaza, Ste. 3E

Coconut Grove, FL  33133-5815

Primary Point of Contact:

Ethan J. Mueller

Contracting Officer

Ethan.Mueller@HHS.Gov