DEPARTMENT OF THE ARMY
U.S. ARMY CONTRACTING COMMAND – NEW JERSEYPICATINNY ARSENAL, NEW JERSEY 07806-5000
REPLY TOATTENTION OF
18 April 2020
Army Contracting Command – New Jersey
ACC-NJ, Building 9
Picatinny Arsenal, NJ 07806
SUBJECT: Technical Direction Letter for Medical CRBN Defense Consortium (MCDC), Request forPrototype Proposals (RPP) 19-02, Sub-Objective 19-02 Definitized Ceiling Increase Modification for “SAB
DiversitAb™ Rapid Response Antibody Platform”
REF: Request for Updated Proposal Submitted in Response to RPP-19-02 under OTA W15QKN-16-91002 for Sub-Objective 19-02 Modification, dated 24 March 2020
Advanced Technology International
ATTN: (b) (6), Senior Contracts Manager
315 Sigma Drive
Summerville, SC 29486
Dear (b) (6)The Army Contracting Command – New Jersey (ACC-NJ), in supporting the Joint Project Manager –Medical Countermeasure Systems (JPM-MCS), issued a Request for Proposal Update under MCDC RPP19-02, Sub-Objective 19-02 on 24 March 2020 to Advanced Technology International, for distribution to
SAB Biotherapeutics, Inc. This request would allow SAB to proceed with revisions to current project tasks,
as well as incorporate Coronavirus Disease 2019 (COVID-19) tasks. The Government received the
undefinitized Rough Order of Magnitude (ROM) proposal update on 30 March 2020, and reviewed thecosts and documentation accordingly. Based on the acceptable ROM proposal update, the Government
issued an Undefinitized Project Agreement Modification (UPAM) on 30 March 2020. In order to definitize
the UPAM, the Government received a proposal update on 16 April 2020, and evaluated the costs anddocumentation accordingly. Based on the acceptable update of SAB’s proposal, the Government isincreasing the Project Agreement Ceiling value by (b) (4), from (b) (4)to (b) (4)The Government is also increasing the MCDC CMF Administrative Cost Ceiling increased by (b) (4),from (b) (4)to (b) (4). Please see the below table for additional details.
MCDC1902-007
Current Ceiling
Member Ceiling
MCDC Admin Cost
MCDC Admin Fee
Total

MCDC1902-007
Proposed Increase((b) (4) admin cost rate)

MCDC1902-007
Revised Ceiling(b) (4)(b) (4)(b) (4)(b) (4)Work will be performed in accordance with the SOW, entitled, “Encl 3_MCDC1902-007_SOW_PUL3
SAB_ SS edits 4-15-20” (See Attachment 1). SAB should utilize the not-to-exceed existing obligation
amount of $15,421,972.84 to continue work on the project. More specifically, COVID-19 work shall be
tracked separately using the funding obligated via modification P00063. This Project Agreement is

DEPARTMENT OF THE ARMY
U.S. ARMY CONTRACTING COMMAND – NEW JERSEYPICATINNY ARSENAL, NEW JERSEY 07806-5000
REPLY TOATTENTION OF
05 June 2020
Army Contracting Command – New Jersey
ACC-NJ, Building 9
Picatinny Arsenal, NJ 07806
SUBJECT: Technical Direction Letter for Medical CRBN Defense Consortium (MCDC), Request forPrototype Proposals (RPP) 19-02, Sub-Objective 19-02 Ceiling Increase Modification for “SAB
DiversitAb™ Rapid Response Antibody Platform”
REF: Request for Updated Proposal Submitted in Response to RPP-19-02 under OTA W15QKN-16-91002 for Sub-Objective 19-02 Modification, dated 31 May 2020
Advanced Technology International
ATTN: (b) (6), Sr. Contracts Manager
315 Sigma Drive
Summerville, SC 29486
Dear (b) (6)The Army Contracting Command – New Jersey (ACC-NJ), in supporting the Joint Project Manager –Medical Countermeasure Systems (JPM-MCS), issued a Request for Proposal Update under MCDC RPP19-02, Sub-Objective 19-02 on 31 May 2020 to Advanced Technology International, for distribution to
SAB Biotherapeutics, Inc. (SAB). This request would allow SAB to proceed with revisions to incorporate
additional Stage 4 tasks, in support of the Coronavirus Disease 2019 (COVID-19) pandemic. The
Government received the proposal update on 05 June 2020, and evaluated the costs and documentationaccordingly. Based on the acceptable update of SAB’s proposal, the Government is increasing the Project
Agreement ceiling value by (b) (4)from (b) (4)to (b) (4)The Government isalso increasing the MCDC CMF Administrative Cost Ceiling by (b) (4), from (b) (4)to. Please see the below table for additional details.
(b) (4)
MCDC1902-007
Current Ceiling
Member Ceiling
MCDC Admin Cost
MCDC Admin Fee
Total

MCDC1902-007
Proposed Increase((b) (4) admin cost)

MCDC1902-007
Revised Ceiling(b) (4)(b) (4)(b) (4)(b) (4)Work will be performed in accordance with the SOW, entitled, “Encl 3_MCDC1902007_M06_03JUN2020_v8_FINAL_CLEAN” (See Attachment 1). SAB should utilize the not-to-exceed
existing obligation amount of $53,204,934.13 to continue work on the project. More specifically, COVID19 work shall be tracked separately using the funding obligated via modification P00069. This Project
Agreement is anticipated to be incrementally funded. The Government reserves the right to award future
milestones/fund additional months of project tasks. If the Government decides to do so, the MCDC member
will be notified via ATI. The Government’s liability will never exceed the current amount of fundingDEPARTMENT OF THE ARMY
U.S. ARMY CONTRACTING COMMAND – NEW JERSEYPICATINNY ARSENAL, NEW JERSEY 07806-5000
REPLY TOATTENTION OF
23 November 2020
Army Contracting Command – New Jersey
ACC-NJ, Building 9
Picatinny Arsenal, NJ 07806
SUBJECT: Technical Direction Letter for Medical CRBN Defense Consortium (MCDC), Request forPrototype Proposals (RPP) 19-02, Sub-Objective 19-02, Definitization of the Ceiling Increase Modification
for “SAB DiversitAb™ Rapid Response Antibody Platform”
REF: Request for Updated Proposal Submitted in Response to RPP-19-02 under OTA W15QKN-16-91002 for Sub-Objective 19-02 Modification, dated 15 June 2020
Advanced Technology International
ATTN: (b) (6), Sr. Contracts Manager
315 Sigma Drive
Summerville, SC 29486
Dear (b) (6),The Army Contracting Command – New Jersey (ACC-NJ), in supporting the Joint Project Manager –Medical Countermeasure Systems (JPM-MCS), issued a Request for Proposal Update under MCDC RPP19-02, Sub-Objective 19-02 on 15 June 2020 to Advanced Technology International, for distribution to
SAB Biotherapeutics, Inc. This request would allow SAB to proceed with optional Stage 4 manufacturing
tasks, in support of Coronavirus Disease 2019 (COVID-19). The Government received the undefinitized
Rough Order of Magnitude (ROM) proposal update on 18 June 2020, and issued an Undefinitized Project
Agreement (UPA) on 23 June 2020. In order to definitize the UPA, the Government finalized an analysisof the cost proposal on 02 November 2020, which focused on evaluation of the cost components anddocumentation. Based on the acceptable update of SAB’s proposal, the Government is definitizing the
Project Agreement modification. Please see the below table for additional details on the ceiling adjustment.

MCDC1902-007
Current Ceiling
Member Ceiling
MCDC Admin Cost
MCDC Admin Fee
Total

MCDC1902-007
Proposed ALIN 02
Definitization
Adjustment(b) (4) Admin Cost)

MCDC1902-007
Revised Ceiling(b) (4)(b) (4)(b) (4)(b) (4)Work will be performed in accordance with the SOW, entitled, “Encl 3_MCDC1902-007 SOW_PUL_05”(See Attachment 1). SAB should utilize the not-to-exceed existing obligation to continue work on the
project, as detailed in the MCDC OTA Award Tracker. More specifically, COVID-19 work shall be tracked
separately using the funding obligated via modification P00072. This Project Agreement is anticipated to
be incrementally funded. The Government reserves the right to award future milestones/fund additional

months of project tasks. If the Government decides to do so, the MCDC member will be notified via ATI.
The Government’s liability will never exceed the current amount of funding obligated under the Project
Agreement. The Project Agreement Holder shall notify ATI when they are approaching 75% of current
funding obligated in incurred costs by written notice.
The prime contractor is considered a small business, nontraditional defense contractor, or nonprofit research
institution and determined to be providing a significant contribution. The affirmation of business status
certifications submitted as part of the proposal are hereby incorporated into the agreement. The contractor
shall notify the MCDC CMF of any deviation from the final proposed affirmation of business status
certifications that would affect the contributions of the small business, nontraditional defense contractor, or
nonprofit research institution as proposed.
In accordance with 10.U.S.C. 2371b(f), and upon a determination that the prototype project for thistransaction has been successfully completed, this competitively awarded prototype OTA may result in theaward of a follow-on production contract or transaction without the use of competitive procedures.
In addition, ATI is advised of the implementation guidance for Section § 889(a)(1)(B) of the John S.
McCain National Defense Authorization Act (NDAA) for Fiscal Year 2019 (Pub. L. 115–232), which
prohibits executive agencies from entering into, extending, or renewing a contract with an entity that uses
any equipment, system, or service that uses covered telecommunications equipment or services as a
substantial or essential component of any system, or as critical technology as part of any system. While theinterim rule and Defense Pricing and Contracting (DPC) implementation memorandum are directed to
FAR-based contracts, the § 889(a)(1)(B) prohibition went into effect August 13, 2020, and applies to Other
Transactions (OTs) for Prototype Projects under § 2371b of title 10, United States Code (U.S.C.). Any OT
for Prototype Project agreement on or after August 13, 2020 must contain an article for the Prohibition on
the Use of Certain Telecommunications and Video Surveillance Services or Equipment that requires theofferor to represent if it uses any equipment, system, or service that uses covered telecommunications
equipment or services.
ATI must receive § 889(a)(1)(B) Certification from the MCDC member prior to executing any new projectagreements or modification to an existing project agreement. A copy of the certification should be provided
to the undersigned.
Points of Contact:
Agreements Specialist:(b) (6)E-mail:(b) (6)Phone: (b) (6)Agreements Officer:(b) (6)E-mail:(b) (6)Phone: (b) (6)DEPARTMENT OF THE ARMY
U.S. ARMY CONTRACTING COMMAND – NEW JERSEYPICATINNY ARSENAL, NEW JERSEY 07806-5000
REPLY TOATTENTION OF
09 December 2020
Army Contracting Command – New Jersey
ACC-NJ, Building 9
Picatinny Arsenal, NJ 07806
SUBJECT: Technical Direction Letter for Medical CRBN Defense Consortium (MCDC), Request forPrototype Proposals (RPP) 19-02, Sub-Objective 19-02 Ceiling Increase Modification for “SAB
DiversitAb™ Rapid Response Antibody Platform”
REF: Request for Updated Proposal Submitted in Response to RPP-19-02 under OTA W15QKN-16-91002 for Sub-Objective 19-02 Modification, dated 01 December 2020
Advanced Technology International
ATTN: (b) (6), Sr. Contracts Manager
315 Sigma Drive
Summerville, SC 29486
Dear (b) (6),The Army Contracting Command – New Jersey (ACC-NJ), in supporting the Joint Project Manager –Medical Countermeasure Systems (JPM-MCS), issued a Request for Proposal Update under MCDC RPP19-02, Sub-Objective 19-02 on 01 December 2020 to Advanced Technology International, for distribution
to SAB Biotherapeutics, Inc. (SAB). This request would allow SAB to proceed with revisions to increase
manufacturing runs and enhance scope for pre-clinical and clinical development of the Stage 4 tasks. The
Government received the proposal update on 01 December 2020, and evaluated the costs anddocumentation accordingly. Based on the acceptable update of SAB’s proposal, the Government isincreasing the Project Agreement ceiling value by (b) (4)from (b) (4)to. The Government is also increasing the MCDC CMF Administrative Cost Ceiling by(b) (4), from (b) (4)to(b) (4). The ceiling will be updated appropriately via a future(b) (4)prime modification. Please see the below table for additional details.
MCDC1902-007
Current Ceiling
Member Ceiling
MCDC Admin Cost
MCDC Admin Fee
Total

MCDC1902-007
Proposed Increase

MCDC1902-007
Revised Ceiling(b) (4)(b) (4)(b) (4)(b) (4)Work will be performed in accordance with the SOW, entitled, “Encl 1_MCDC1902-007 SOW_PUL06
07DEC20” (See Attachment 1). SAB should utilize the not-to-exceed existing obligation amounts within
their agreement to continue work on the project. More specifically, COVID-19 work shall be tracked
separately, as indicated in the MCDC OTA Award Tracker. This Project Agreement is anticipated to be
incrementally funded. The Government reserves the right to award future milestones/fund additional
months of project tasks. If the Government decides to do so, the MCDC member will be notified via ATI.
The Government’s liability will never exceed the current amount of funding obligated under the ProjectAttachment A
Statement of WorkForSAB DiversitAb™ Rapid Response Antibody Platform
RPP #: RPP-19-02
Sub-Objective Area: (TRE/PRE-19-02): Development and Testing (b) (4)Medical Countermeasure (MCM) (b) (4)Consortium Member: SAB Biotherapeutics, Inc.
Title of Proposal: SAB DiversitAb™ Rapid Response Antibody Platform
Requiring Activity: Joint Program Executive Office for Chemical, Biological, Radiological andNuclear Defense (JPEO-CBRND)- Enabling Biotechnologies (EB)
1.0

INTRODUCTION, SCOPE, AND OBJECTIVES

1.1

Introduction

The recent acceleration in the evolution of biotechnology has significantly altered the biologicaland chemical weapons threat landscape. The advent of modern synthetic biology and its associatedtools and methods has significantly reduced financial and educational barriers to the modificationand design of biological organisms and toxins. In response to this changing threat environment,
the US Department of Defense (DoD) through the Joint Program Executive Office for Chemical,
Biological, Radiological and Nuclear Defense (JPEO-CBRND) has established a new office forEnabling Biotechnologies (JPEO-EB), to integrate platform Medical Countermeasures (MCM)
development technologies (b) (4)SAB Biotherapeutics will support the JPEO-EB program in developing a rapid response Antibody(Ab)(b) (4)The proposed projectwill support the development of a MCM production capability (b) (4)to enable
Food and Drug Administration (FDA) concurrence with MCM use prior to full FDA licensure inan emergency scenario. (b) (4)allows SAB to meet DoD
requirements (b) (4)

1.2

Scope

SAB, as part of this prototype project, will develop (b) (4)antibody-based MCMs for biological andchemical threats, (b) (4)to meet the DoD’s requirement (b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)the Project Agreement language willsupersede and control the relationship of the parties.
1.3

Objective

SAB will undertake all activities required to (b) (4)technology to provide the US Department of Defense (b) (4)medical countermeasure
antibodies against threats of interest. (b) (4)2(b) (4)(b) (4)(b) (4)This is a prototype project because the contractor will develop physical models of (b) (4)to evaluate the technical feasibility of (b) (4)The system shall deliver DP (b) (4)In accordance with 10.U.S.C.§ 2371b(f), and upon a determination that the prototype project forthis transaction has been successfully completed, this competitively awarded prototype OTA may
result in the award of a follow-on production contract or transaction without the use of competitive
procedures. (b) (4)2.0

APPLICABLE REFERENCES

3

N/A
3.0

REQUIREMENTS

The numbers preceding the following tasks are equivalent to the associated Work Breakdown
Structure (WBS) reference.
1.0 (b) (4)1.1 Program Management(b) (4)

1.1.1

JPEO-EB Project Management(b) (4)

1.1.2

Internal Program Management(b) (4)

1.1.3

Collaborator/Contractor Management(b) (4)

1.1.4 Advisor/Consultant Management(b) (4)

1.2 Regulatory and Quality
1.2.1

Cooperative Evaluation with JPEO-EB and ONE-RAQA(b) (4)

1.2.2

Regulatory
1.2.2.1 (b) (4)4(b) (4)1.2.2.2 (b) (4)1.2.2.3 (b) (4)1.2.2.4 (b) (4)1.2.3 Quality
1.2.3.1 (b) (4)1.2.3.2 (b) (4)1.2.3.3 (b) (4)1.3 Upstream Manufacturing(b) (4)5

(b) (4)(b) (4)

1.4 Downstream Manufacturing(b) (4)6

(b) (4)

1.5 (b) (4) Development (b) (4)(b) (4)2.0 (b) (4)2.1 Program Management(b) (4)7

2.1.1

JPEO-EB Project Management(b) (4)2.1.2

Internal Program Management(b) (4)

2.1.3

Collaborator/Contractor Management(b) (4)2.1.4 Advisor/Consultant Management(b) (4)

2.2 Regulatory and Quality
2.2.1 (b) (4)2.2.2 Regulatory
2.2.2.1 (b) (4)2.2.2.1.1(b) (4)2.2.2.1.2(b) (4)2.2.2.1.3(b) (4)2.2.2.1.4(b) (4)8

(b) (4)2.2.3

Quality
2.2.3.1 (b) (4)2.2.3.2 (b) (4)2.2.3.3 (b) (4)2.3 Upstream Manufacturing
The awardee shall produce (b) (4)sufficient to demonstrate the ability to execute activities (b) (4)2.3.1 (b) (4)9,2.3.2 (b) (4)2.3.3 (b) (4)2.3.4 (b) (4)2.3.5 (b) (4)2.4 Downstream Manufacturing(b) (4)2.4.1 (b) (4)2.4.2 (b) (4)2.4.3 (b) (4)10(b) (4)2.4.4 (b) (4)2.4.5 (b) (4)2.4.6 (b) (4)2.5 (b) (4)2.5.1 (b) (4)2.5.2 (b) (4)2.5.3 (b) (4)2.6 (b) (4)2.6.1 (b) (4)11(b) (4)2.6.2 (b) (4)3.0 (b) (4)3.1 Program Management(b) (4)3.1.1 (b) (4)3.1.2Internal Program Management(b) (4)

3.1.3

Collaborator/Contractor Management(b) (4)3.1.4

Advisor/Consultant Management(b) (4)

3.2 Regulatory and Quality
3.2.1 (b) (4)3.2.2

Regulatory(b) (4)12

(b) (4)13(b) (4)3.2.3

Quality(b) (4)

3.3 Upstream Manufacturing(b) (4)14

(b) (4)3.4 Downstream Manufacturing(b) (4)3.4.1 (b) (4)3.4.2 (b) (4)3.4.3 (b) (4)15

3.4.4 (b) (4)3.4.5 (b) (4)3.5 Non-Clinical(b) (4)3.5.1 (b) (4)3.5.2 (b) (4)3.5.3 (b) (4)3.5.4 (b) (4)3.6 Clinical3.6.1 (b) (4)16(b) (4)3.6.2 (b) (4)3.6.3 (b) (4)4.0 (b) (4)4.1 Program Management(b) (4)4.1.1 (b) (4)4.1.2 (b) (4)4.1.3 (b) (4)4.1.4 (b) (4)17(b) (4)4.2 Regulatory and Quality
4.2.1 (b) (4)4.2.2 Regulatory(b) (4)18

(b) (4)4.2.3 Quality(b) (4)

4.3 Upstream Manufacturing(b) (4)4.3.1 (b) (4)4.3.2 (b) (4)4.3.3 (b) (4)4.3.4 (b) (4)19(b) (4)4.4 Downstream Manufacturing(b) (4)4.4.1 (b) (4)4.4.2 (b) (4)4.4.3 (b) (4)4.4.4 (b) (4)4.4.5 (b) (4)204.5 (b) (4)4.5.1 (b) (4)4.5.2 (b) (4)4.6 Non-Clinical(b) (4)4.6.1 (b) (4)4.6.2 (b) (4)4.6.3 (b) (4)4.6.4 (b) (4)4.6.5 (b) (4)Go/No-Go (Optional Trial Task):
4.7 Clinical4.7.1 (b) (4)4.7.2 (b) (4)21

(b) (4)4.7.3 (b) (4)4.0

DELIVERABLES(b) (4)1.1(b) (4)1.2(b) (4)(b) (4)2.1(b) (4)2.2(b) (4)2.3(b) (4)(b) (4)3.1(b) (4)3.2(b) (4)3.3(b) (4)

3.4
3.5
3.6
3.7
3.8
3.9

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)22

(b) (4)4.1(b) (4)

4.2
4.3
4.4
4.5
4.6
4.7

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)4.8
4.9(b) (4)(b) (4)(b) (4)(b) (4)23

(b) (4)(b) (4)24

(b) (4)(b) (4)25

(b) (4)(b) (4)26(b) (4)(b) (4)(b) (4)31

(b) (4)(b) (4)33

(b) (4)(b) (4)34

(b) (4)11.0

AOR AND ALTERNATE AOR CONTACT INFORMATION:

AOR
NAME: (b) (6)
MAILING ADDRESS: JPEO-EB
EMAIL: (b) (6)
PHONE: (b) (6)Alternate AOR
NAME: (b) (6)
MAILING ADDRESS: JPEO-EB
EMAIL: (b) (6)
PHONE: (b) (6)35Attachment A
Statement of WorkForSAB DiversitAb™ Rapid Response Antibody Platform
RPP #: RPP-19-02
Sub-Objective Area: (TRE/PRE-19-02): Development and Testing (b) (4)Medical Countermeasure (MCM)(b) (4)

Consortium Member: SAB Biotherapeutics, Inc.
Title of Proposal: SAB DiversitAb™ Rapid Response Antibody Platform
Requiring Activity: Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear
Defense (JPEO-CBRND)- Enabling Biotechnologies (EB)
1.0

INTRODUCTION, SCOPE, AND OBJECTIVES

1.1

Introduction

The recent acceleration in the evolution of biotechnology has significantly altered the biological and chemical
weapons threat landscape. The advent of modern synthetic biology and its associated tools and methods has
significantly reduced financial and educational barriers to the modification and design of biological organisms
and toxins. In response to this changing threat environment, the US Department of Defense (DoD) through the
Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)
has established a new office for Enabling Biotechnologies (JPEO-EB), to integrate platform Medical
Countermeasures (MCM) development technologies (b) (4)SAB Biotherapeutics will support the JPEO-EB program in developing a rapid response Antibody (Ab) (b) (4)The proposed project will support the developmentof a MCM production capability (b) (4)to enable Food and Drug Administration (FDA) concurrence with MCM use prior to full FDA licensure
in an emergency scenario. (b) (4)allows SAB to meet DoD
requirements (b) (4)

1.2

Scope

SAB, as part of this prototype project, will develop a (b) (4)antibody-based MCMs for biological and chemical threats, (b) (4)to meet the DoD’s requirement (b) (4)(b) (4)

(b) (4)(b) (4)(b) (4)the Project Agreement language will supersede and control the
relationship of the parties.
1.3

Objective

SAB will undertake all activities required to (b) (4)technology to provide the US Department of Defense (b) (4)medical countermeasure antibodies against threats of interest. (b) (4)2(b) (4)(b) (4)This is a prototype project because the contractor will develop physical models of (b) (4)to evaluate the technical feasibility of (b) (4)The system shalldeliver DP(b) (4)

In accordance with 10.U.S.C.§ 2371b(f), and upon a determination that the prototype project for this transaction
has been successfully completed, this competitively awarded prototype OTA may result in the award of a followon production contract or transaction without the use of competitive procedures. (b) (4)2.0

APPLICABLE REFERENCES

N/A
3.0

REQUIREMENTS

3

The numbers preceding the following tasks are equivalent to the associated Work Breakdown Structure (WBS)
reference.
1.0 (b) (4)1.1 Program Management(b) (4)

1.1.1

JPEO-EB Project Management(b) (4)

1.1.2

Internal Program Management(b) (4)

1.1.3

Collaborator/Contractor Management(b) (4)1.1.4

Advisor/Consultant Management(b) (4)

1.2 Regulatory and Quality
1.2.1

Cooperative Evaluation with JPEO-EB and ONE-RAQA(b) (4)1.2.2 Regulatory
1.2.2.1 (b) (4)1.2.2.2 (b) (4)1.2.2.3 (b) (4)4(b) (4)1.2.2.4 (b) (4)1.2.3

Quality
1.2.3.1 (b) (4)1.2.3.2 (b) (4)1.2.3.3 (b) (4)1.3 Upstream Manufacturing(b) (4)(b) (4)5

(b) (4)1.4 Downstream Manufacturing(b) (4)

1.5 (b) (4) Development (b) (4)(b) (4)6

(b) (4)2.0 (b) (4)2.1 Program Management(b) (4)2.1.1 JPEO-EB Project Management(b) (4)2.1.2

Internal Program Management(b) (4)

2.1.3

Collaborator/Contractor Management(b) (4)2.1.4

Advisor/Consultant Management(b) (4)

2.2 Regulatory and Quality
2.2.1 (b) (4)2.2.2

Regulatory
2.2.2.1 (b) (4)7(b) (4)2.2.2.1.1(b) (4)2.2.2.1.2(b) (4)2.2.2.1.3(b) (4)2.2.2.1.4(b) (4)(b) (4)2.2.3 Quality
2.2.3.1 (b) (4)2.2.3.2 (b) (4)2.2.3.3 (b) (4)8(b) (4)2.3 Upstream Manufacturing
The awardee shall produce (b) (4)demonstrate the ability to execute activities (b) (4)sufficient to2.3.1 (b) (4)2.3.2 (b) (4)2.3.3 (b) (4)2.3.4 (b) (4)2.3.5 (b) (4)2.4 Downstream Manufacturing(b) (4)2.4.1 (b) (4)9(b) (4)2.4.2 (b) (4)2.4.3 (b) (4)2.4.4 (b) (4)2.4.5 (b) (4)2.4.6 (b) (4)2.5 (b) (4)2.5.1 (b) (4)2.5.2 (b) (4)2.5.3 (b) (4)102.6 (b) (4)2.6.1 (b) (4)2.6.2 (b) (4)3.0 (b) (4)3.1 Program Management(b) (4)3.1.1 (b) (4)3.1.2Internal Program Management(b) (4)

3.1.3

Collaborator/Contractor Management(b) (4)3.1.4

Advisor/Consultant Management(b) (4)

3.2 Regulatory and Quality
3.2.1 (b) (4)3.2.2

Regulatory(b) (4)11

(b) (4)(b) (4)(b) (4)12

(b) (4)3.2.3 Quality(b) (4)

3.3 Upstream Manufacturing(b) (4)13

(b) (4)3.4 Downstream Manufacturing(b) (4)3.4.1 (b) (4)3.4.2 (b) (4)3.4.3 (b) (4)3.4.4 (b) (4)3.4.5 (b) (4)14(b) (4)3.5 Non-Clinical(b) (4)3.5.1 (b) (4)3.5.2 (b) (4)3.5.3 (b) (4)3.5.4 (b) (4)3.6 Clinical3.6.1 (b) (4)3.6.2 (b) (4)3.6.3 (b) (4)15(b) (4)4.0 (b) (4)4.1 Program Management(b) (4)4.1.1 (b) (4)4.1.2 (b) (4)4.1.3 (b) (4)4.1.4 (b) (4)4.2 Regulatory and Quality
4.2.1 (b) (4)4.2.2

Regulatory(b) (4)16

(b) (4)(b) (4)4.2.3 Quality
4.2.3.1 (b) (4)4.2.3.2 (b) (4)4.2.3.3 (b) (4)4.3 Upstream Manufacturing(b) (4)4.3.1 (b) (4)4.3.2 (b) (4)17(b) (4)4.3.3 (b) (4)4.3.4 (b) (4)4.4 Downstream Manufacturing(b) (4)4.4.1 (b) (4)4.4.2 (b) (4)4.4.3 (b) (4)4.4.4 (b) (4)18

4.4.5 (b) (4)4.5 (b) (4)4.5.1 (b) (4)4.5.2 (b) (4)4.6 Non-Clinical(b) (4)4.6.1 (b) (4)4.6.2 (b) (4)4.6.3 (b) (4)4.6.4 (b) (4)4.6.5 (b) (4)4.7 (b) (4)194.7.1 (b) (4)4.7.2 (b) (4)4.7.3 (b) (4)4.7.4 (b) (4)(b) (4)

4.8 Clinical4.8.1 (b) (4)4.8.2 (b) (4)4.8.3 (b) (4)4.9 (b) (4)4.9.1 (b) (4)20(b) (4)4.9.2 (b) (4)4.9.3 (b) (4)4.0

DELIVERABLES(b) (4)1.1(b) (4)1.2(b) (4)(b) (4)2.1(b) (4)2.2(b) (4)212.3(b) (4)(b) (4)3.1(b) (4)3.2(b) (4)3.3(b) (4)

3.4
3.5
3.6
3.7
3.8
3.9

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)4.1(b) (4)

4.2
4.3
4.4
4.5
4.6
4.7

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)

4.8
4.9
4.10
4.11

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)

4.12
4.13
4.14
4.15

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)

22

4.16
4.17
4.18
4.19
4.20
4.21
4.22
4.23
4.24
4.25
4.26
4.27

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)23

(b) (4)(b) (4)(b) (4)24

(b) (4)(b) (4)(b) (4)25

(b) (4)(b) (4)(b) (4)26

(b) (4)28(b) (4)(b) (4(b) (4)(b) (4(b) (4)32

(b) (4)(b) (4)(b) (4)34

(b) (4)(b) (4)(b) (4)35

(b) (4)36Attachment A
Statement of WorkForSAB DiversitAb™ Rapid Response Antibody Platform
RPP #: RPP-19-02
Sub-Objective Area: (TRE/PRE-19-02): Development and Testing (b) (4)Medical Countermeasure (MCM)(b) (4)

Consortium Member: SAB Biotherapeutics, Inc.
Title of Proposal: SAB DiversitAb™ Rapid Response Antibody Platform
Requiring Activity: Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear
Defense (JPEO-CBRND) - Enabling Biotechnologies (EB)
1.0

INTRODUCTION, SCOPE, AND OBJECTIVES

1.1

Introduction

The recent acceleration in the evolution of biotechnology has significantly altered the biological and chemical
weapons threat landscape. The advent of modern synthetic biology and its associated tools and methods has
significantly reduced financial and educational barriers to the modification and design of biological organisms
and toxins. In response to this changing threat environment, the US Department of Defense (DoD) through the
Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)
has established a new office for Enabling Biotechnologies (JPEO-EB), to integrate platform Medical
Countermeasures (MCM) development technologies (b) (4)SAB Biotherapeutics will support the JPEO-EB program in developing a rapid response Antibody (Ab) (b) (4)The proposed project will support the developmentof a MCM production capability (b) (4)to enable Food and Drug Administration (FDA) concurrence with MCM use prior to full FDA licensure
in an emergency scenario. (b) (4)allows SAB to meet DoD
requirements (b) (4)

1.2

Scope

SAB, as part of this prototype project, will develop a (b) (4)antibody-based MCMs for biological and chemical threats, (b) (4)to meet the DoD’s requirement (b) (4)(b) (4)

(b) (4)(b) (4)(b) (4)the Project Agreement language will supersede and control the
relationship of the parties.
1.3

Objective

SAB will undertake all activities required to (b) (4)technology to provide the US Department of Defense (b) (4)medical countermeasure antibodies against threats of interest. (b) (4)2(b) (4)(b) (4)This is a prototype project because the contractor will develop physical models of (b) (4)to evaluate the technical feasibility of (b) (4)The system shalldeliver DP(b) (4)

In accordance with 10.U.S.C.§ 2371b(f), and upon a determination that the prototype project for this transaction
has been successfully completed, this competitively awarded prototype OTA may result in the award of a followon production contract or transaction without the use of competitive procedures. (b) (4)2.0

APPLICABLE REFERENCES

N/A
3.0

REQUIREMENTS

3

The numbers preceding the following tasks are equivalent to the associated Work Breakdown Structure (WBS)
reference.
1.0(b) (4)1.1 Program Management(b) (4)

1.1.1

JPEO-EB Project Management(b) (4)

1.1.2

Internal Program Management(b) (4)

1.1.3

Collaborator/Contractor Management(b) (4)1.1.4

Advisor/Consultant Management(b) (4)

1.2 Regulatory and Quality
1.2.1

Cooperative Evaluation with JPEO-EB and ONE-RAQA(b) (4)1.2.2 Regulatory
1.2.2.1 (b) (4)1.2.2.2 (b) (4)1.2.2.3 (b) (4)4(b) (4)1.2.2.4 (b) (4)1.2.3

Quality
1.2.3.1 (b) (4)1.2.3.2 (b) (4)1.2.3.3 (b) (4)1.3 Upstream Manufacturing(b) (4)5

(b) (4)1.4 Downstream Manufacturing(b) (4)(b) (4)

1.5 (b) (4) Development (b) (4)(b) (4)6

(b) (4)2.0 (b) (4)2.1 Program Management(b) (4)2.1.1 JPEO-EB Project Management(b) (4)2.1.2

Internal Program Management(b) (4)

2.1.3

Collaborator/Contractor Management(b) (4)2.1.4

Advisor/Consultant Management(b) (4)

2.2 Regulatory and Quality
2.2.1 (b) (4)2.2.2

Regulatory
2.2.2.1 (b) (4)7(b) (4)2.2.2.1.1(b) (4)2.2.2.1.2(b) (4)2.2.2.1.3(b) (4)2.2.2.1.4(b) (4)(b) (4)2.2.3 Quality
2.2.3.1 (b) (4)2.2.3.2 (b) (4)2.2.3.3 (b) (4)8(b) (4)2.3 Upstream Manufacturing
The awardee shall produce (b) (4)demonstrate the ability to execute activities (b) (4), sufficient to2.3.1 (b) (4)2.3.2 (b) (4)2.3.3 (b) (4)2.3.4 (b) (4)2.3.5 (b) (4)2.4 Downstream Manufacturing(b) (4)2.4.1 (b) (4)9(b) (4)2.4.2 (b) (4)2.4.3 (b) (4)2.4.4 (b) (4)2.4.5 (b) (4)2.4.6 (b) (4)2.5 (b) (4)2.5.1 (b) (4)2.5.2 (b) (4)2.5.3 (b) (4)102.6 (b) (4)2.6.1 (b) (4)2.6.2 (b) (4)3.0 (b) (4)3.1 Program Management(b) (4)3.1.1 (b) (4)3.1.2Internal Program Management(b) (4)

3.1.3

Collaborator/Contractor Management(b) (4)3.1.4

Advisor/Consultant Management(b) (4)

3.2 Regulatory and Quality
3.2.1 (b) (4)3.2.2

Regulatory(b) (4)11

(b) (4)(b) (4)(b) (4)12

(b) (4)3.2.3 Quality(b) (4)(b) (4)

3.3 Upstream Manufacturing(b) (4)13

(b) (4)3.4 Downstream Manufacturing(b) (4)3.4.1 (b) (4)3.4.2 (b) (4)3.4.3 (b) (4)3.4.4 (b) (4)3.4.5 (b) (4)14(b) (4)3.5 Non-Clinical(b) (4)3.5.1 (b) (4)3.5.2 (b) (4)3.5.3 (b) (4)3.5.4 (b) (4)3.6 Clinical3.6.1 (b) (4)3.6.2 (b) (4)3.6.3 (b) (4)15(b) (4)4.0 (b) (4)4.1 Program Management(b) (4)4.1.1 (b) (4)4.1.2 (b) (4)4.1.3 (b) (4)4.1.4 (b) (4)4.2 Regulatory and Quality
4.2.1 (b) (4)4.2.2

Regulatory(b) (4)16

(b) (4)(b) (4)4.2.3 Quality
4.2.3.1 (b) (4)4.2.3.2 (b) (4)4.2.3.3 (b) (4)4.3 Upstream Manufacturing(b) (4)4.3.1 (b) (4)4.3.2 (b) (4)17(b) (4)4.3.3 (b) (4)4.3.4 (b) (4)4.4 Downstream Manufacturing(b) (4)4.4.1 (b) (4)4.4.2 (b) (4)4.4.3 (b) (4)4.4.4 (b) (4)18

4.4.5 (b) (4)4.5 (b) (4)4.5.1 (b) (4)4.5.2 (b) (4)4.6 Non-Clinical(b) (4)4.6.1 (b) (4)4.6.2 (b) (4)4.6.3 (b) (4)4.6.4 (b) (4)4.6.5 (b) (4)4.7 (b) (4)194.7.1 (b) (4)4.7.2 (b) (4)4.7.3 (b) (4)4.7.4 (b) (4)(b) (4)

4.8 Clinical4.8.1 (b) (4)4.8.2 (b) (4)4.8.3 (b) (4)4.9 (b) (4)4.9.1 (b) (4)20(b) (4)4.9.2 (b) (4)4.9.3 (b) (4)4.0

DELIVERABLES(b) (4)1.1(b) (4)1.2(b) (4)(b) (4)2.1(b) (4)2.2(b) (4)2.3(b) (4)(b) (4)213.1(b) (4)3.2(b) (4)3.3(b) (4)

3.4
3.5
3.6
3.7
3.8
3.9

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)4.1(b) (4)

4.2
4.3
4.4
4.5
4.6
4.7

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)

4.8
4.9
4.10
4.11

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)

4.12
4.13
4.14
4.15

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)

4.16
4.17
4.18
4.19

(b) (4)(b) (4)(b) (4)(b) (4)224.20(b) (4)4.21(b) (4)4.22(b) (4)(b) (4)(b) (4)(b) (4)23

(b) (4)(b) (4)(b) (4)24

(b) (4)(b) (4)(b) (4)25

(b) (4)(b) (4)(b) (4)26

(b) (4)(b) (4)(b) (4)27

(b) (4)29(b) (4)(b) (4)(b) (433

(b) (4)(b) (4(b) (434

(b) (4)(b) (4)(b) (4)36

(b) (4)(b) (4)37