Exhibit 10.1

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

 

1. CONTRACT ID CODE

 

PAGE OF PAGES

 

 

 

 

1

9

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

4. REQUISITION/PURCHASE REQ. NO.

5. PROJECT NO. (If applicable)

P00002

6. ISSUED BY

09/25/2020

OS257167

 

 

 

CODE

ASPR-BARDA

7. ADMINISTERED BY (If other than Item 6)

CODE

ASPR-BARDA

 

 

 

 

 

ASPR-BARDA

200 Independence Ave., S.W.

Room 640-G

AUT

Washington DC 20201

ASPR-BARDA

US DEPT OF HEALTH & HUMAN SERVICES

BIOMEDICAL ADVANCED RESEACH & DEVELOPMENT

 

200 INDEPENDENCE AVE, S.W.

Washington DC 20201

 

 

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

(x)

9A. AMENDMENT OF SOLICITATION NO.

 

 

 

 

 

 

 

 

T2 BIOSYSTEMS, INC. 1512719 Attn: STEPHEN HAGAN

 

 

9B. DATED (SEE ITEM 11)

 

 

 

 

 

 

T2 BIOSYSTEMS, INC.

101 HARTWELL AVE LEXINGTON MA 024213125

 

x

10A. MODIFICATION OF CONTRACT/ORDER NO.

 

75A50119C00053

 

 

 

 

 

 

 

 

 

10B. DATED (SEE ITEM 13)

 

 

CODE

1512719

FACILITY CODE

 

 

09/30/2019

 

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

☐The above numbered solicitation is amended as set forth in Item 14. The hour
and date specified for receipt of Offers

 

☐is extended

☐is not extended

Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended , by one of the following methods:
(a) By completing Items 8 and 15, and returning                         copies
of the amendment; (b) By acknowledging receipt of this amendment on each copy of
the offer submitted ; or (c) By separate letter or electronic communication
which includes a reference to the solicitation and amendment numbers. FAILURE OF
YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF
OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR
OFFER. If by virtue of this amendment you desire to change an offer already
submitted , such change may be made by letter or electronic communication,
provided each letter or electronic communication makes reference to the
solicitation and this amendment, and is received prior to the opening hour and
date specified.

12.  ACCOUNTING AND APPROPRIATION DATA (If required)

 

Net Increase:

$10,495,783.00

 

 

[***] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

 

--------------------------------------------------------------------------------

 

 

2020.1992020.25106

13.  THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE
CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

CHECK ONE

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET
FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

 

 

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH
IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

 

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

X

D. OTHER (Specify type of modification and authority)

 

FAR 52.217-9 Option to Extend the Term of the Contract

 

E. IMPORTANT:

Contractor

☐is not

x is required to sign this document and return

1

 

☐copies to the issuing office.

 

 

 

 

 

14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings,
including solicitation/contract subject matter where feasible.)

Tax ID Number: 20-4827488

DUNS Number: 803126320

The purpose of this modification is to exercise and fully fund Option One (1).In
addition, this modification will modify the following Articles: B.2 Base Period;
B.3 Option Periods; B.4 Estimated Cost-Cost Sharing; B.6 Advance Understandings;
G.3 Key Personnel; F.1 Estimated Period of Performance; and F.2 Deliverables; as
well as update Section J with Attachment #1 - Statement of Work, dated September
12, 2020.

 

The Base period of performance end date remains as October 8, 2020 [UNCHANGED].

 

The Option 1 period of performance will be from [***]

 

Continued ...

Except as provided herein, all terms and conditions of the document referenced
in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force
and effect .

15A.NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

 

 

ALEC BARCLAY

ROSHAWN K. MAJORS

 

 

 

 

15B. CONTRACTOR/OFFEROR

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

16C. DATE SIGNED

 

/S/ ALEC BARCLAY

 

9/25/2020

 

 

 

 

(Signature of person authorized to sign)

 

(Signature of Contracting Officer)

 

 

 

 

Previous edition unusable

 

STANDARD FORM 30 (REV. 11/2016)

 

 

Prescribed by GSA FAR (48 CFR) 53.243

 

[***] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

 

--------------------------------------------------------------------------------

 

 

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

PAGE      OF

75A50119C00053/P00002

2

9

 

NAME OF OFFEROR OR CONTRACTOR

T2 BIOSYSTEMS, INC. 1512719

 

ITEM NO.

SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(A)

(B)

(C)

(D)

(E)

(F)

 

Appr. Yr.: 2020 CAN: 1992020 Object Class: 25106 Period of Performance: [***]

 

 

 

 

 

 

Change Item 2 to read as follows(amount shown is the oblied amount):

 

 

 

 

 

2

Option 1 Period:

[***]

 

 

 

10,495,783.00

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NSN 7540-01-152-8067

 

OPTIONAL FORM 336 (4-86)

 

 

Sponsored by GSA

 

 

FAR (48 CFR) 53.110

 

 

 

[***] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

 

--------------------------------------------------------------------------------

 

 

 

 

Contract No: 75A50119C00053

Modification No: P0002

SPECIAL PROVISIONS

 

 

 

 

 

SUPPLEMENTAL AGREEMENT

 

**RED BOLD font denotes applicable changes

 

Beginning with the effective date of this modification, the Government and the
Contractor mutually agree as follows:

 

Under SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS, ARTICLE B.2 is hereby
modified to reflect the following:

 

B.2 BASE PERIOD

 

 

1.

For the Government, the total estimated cost of the base period of this
contract, excluding fee, is $5,978,993.  For the Contractor, the total estimated
cost of the base period of this contract, excluding fee, is $[***]

 

 

2.

The Contractor shall maintain records of all contract costs and such records
shall be subject to FAR 52.215-2 (Oct 2010), Audit and Records – Negotiation and
incorporated by reference into the contract in SECTION I.

 

 

3.

The amount currently obligated will cover base performance of the contract
through October 8, 2020.

 

CLIN

Period of Performance

Supplies/Services

BARDA Estimated Not To Exceed

T2 Estimated Not to Exceed

Overall Total Estimated Not to Exceed

0001

Base Period 9/9/2019

through

10/8/2020

[***]

$5,978,993

$[***]

$[***]

 

ARTICLE B.3 OPTION PERIODS - the table included in this Article is hereby
modified to reflect the following:

 

B.3 COST REIMBURSMENT OPTIONS

 

 

a.

The contract includes optional, cost reimbursement CLINs 0002 through 0007.  The
Government may exercise Option Periods in accordance with FAR 52.217-9 Option to
Extend the Term of the Contract (March 2000), as set forth in Section I of the
contract.  

 

 

b.

The contract includes optional services, cost reimbursement CLIN 0008.  The
Government may exercise Option Services in accordance with FAR 52.217-8 Option
to Extend Services, as set forth in Section I of the contract.  

 

 

[***] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

 

--------------------------------------------------------------------------------

 

 

 

 

Contract No: 75A50119C00053

Modification No: P0002

SPECIAL PROVISIONS

 

 

 

 

 

 

c.

Unless the government exercises its option pursuant to the option clause
contained in ARTICLE I.2, the contract consists only of the Base Work segment
specified in the Statement of Work as defined in SECTONS C and F, for the price
set forth in ARTICLE B.2 of the contract.

 

 

d.

The Government may modify the contract unilaterally and require the contractor
to provide supplies and services for Option Periods listed below, in accordance
with FAR 52.217-9.

 

 

e.

If the Government decides to exercise an option(s), the Government will provide
the Contractor a preliminary written notice of its intent as referenced in the
clause.  Specific information regarding the time frame for this notice is set
forth in the OPTION CLAUSE Article in SECTION G of this contract. The estimated
cost of the contract will be increased as set forth below:

 

Option

CLIN

Period of Performance

Supplies/Services

BARDA Estimated Not to Exceed

T2 Estimated Not to Exceed

Overall Total Estimated Not to Exceed

1

0002

[***]

Option 1 Period:

[***]

$10,495,783

$[***]

$[***]

2

0003

[***]

Option 2 Period:

[***]

$[***]

$[***]

$[***]

3

0004

[***]

Option 3 Period:

 

[***]

$[***]

$[***]

$[***]

4

0005

[***]

Option 4 Period:

 

[***]

$[***]

$[***]

$[***]

5

0006

[***]

Option 5 Period:

 

[***]

$[***]

$[***]

$[***]

6

007

[***]

Option 6 Period:

$[***]

$[***]

$[***]

Optional Services

0008

[***]

[***]

$[***]

$[***]

$[***]

 

 

TOTALS

Only option years

$[***]

$[***]

$[***]

 

 

TOTALS

Base + options

$68,952,025

$[***]

$[***]

 

 

[***] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

 

--------------------------------------------------------------------------------

 

 

 

 

Contract No: 75A50119C00053

Modification No: P0002

SPECIAL PROVISIONS

 

 

 

 

 

ARTICLE B.4 ESTIMATED COST-COST SHARING is hereby modified as follows:  

B.4 ESTIMATED COST - COST SHARING

 

This is a cost-sharing contract. The overall estimated total cost sharing for
performance under this contract is $[***] (Base plus Options for both BARDA and
T2).  For further provisions regarding the specific cost-sharing arrangement,
see the ADVANCE UNDERSTANDINGS, Article in SECTION B of the Contract.B.6.
ADVANCE UNDERSTANDINGS, subparagraph (i), number (2) is hereby modified to
reflect the following:

 

B.6 ADVANCE UNDERSTANDINGS

 

 

i.

Cost Sharing

 

2.

The Government shall provide monies in an amount not to exceed the values set
forth Article B.2 and B.3.  The Contractor's share is estimated using the values
set forth in Article B2. and B.3.

 

All other contract terms under Section B remains unchanged.

 

Under SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT, Statement of Work
is hereby modified to reflect Attachment # 1 dated September 12, 2020 in Section
J of this contract.

 

All other contract terms under Section C remains unchanged.

 

Under SECTION SECTION F – DELIVERIES OR PERFORMANCE, ARTICLES G.3 KEY PERSONNEL
is hereby modified to reflect the following:

 

F.1 ESTIMATED PERIOD OF PERFORMANCE

 

The estimated period of performance for this contract shall be consistent with
the dates set forth in the Base Period in Section B.2. If the Government
exercises the Options Period(s) and/or Option Services, pursuant to the Option
Clause in Section I.3 of the contract, the period of performance shall be
increased as shown in the table in Section B.3.

 

F. 2 DELIVERABLES

 

Successful performance of the final contract shall be deemed to occur upon
completion of performance of the work set forth in the Statement of Work dated
September 12, 2020, set forth in Section J - List of Attachments of this
contract and upon delivery and acceptance, as required by the Statement of Work,
by the COR, of each of the deliverables described in Section C, Section F, and
Section J.

 

 

[***] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

 

--------------------------------------------------------------------------------

 

 

 

 

Contract No: 75A50119C00053

Modification No: P0002

SPECIAL PROVISIONS

 

 

 

 

 

All other contract terms under Section F remains unchanged.

 

Under SECTION G – CONTRACT ADMINISTRATION DATA, ARTICLE G.3 KEY PERSONNEL is
hereby modified to reflect the following:

 

G.3 KEY PERSONNEL

 

Pursuant to the Key Personnel clause incorporated in Section I of this contract,
the following individuals are considered to be essential to the work being
performed hereunder:

 

Name

Title

Alec Barclay

Principal Investigator, Chief Operations Officer

Catherine Hogan

Director, Program Management

 

The key personnel specified in this contract are considered to be essential to
work performance. At least 30 days prior to diverting any of the specified
individuals to other programs or contracts (or as soon as possible, if an
individual must be replaced, for example, as a result of leaving the employ of
the Contractor), the Contractor shall notify the Contracting Officer and shall
submit comprehensive justification for the diversion or replacement request
(including proposed substitutions for key personnel) and qualifications of the
individual proposed as a substitute to permit evaluation by the Government of
the impact on performance under this contract. The Contractor shall not divert
or otherwise replace any key personnel without the written consent of the
Contracting Officer. The Government may modify the contract to add or delete key
personnel at the request of the contractor or Government. At a minimum, the key
personnel should include the project manager, principal investigator, radiation
biologist, quality control manager, quality assurance director, regulatory lead,
and manufacturing lead.

 

All other contract terms under Section G remains unchanged.

 

Under SECTION J LIST OF ATTACHMENTS is hereby modified to reflect the following:

 

 

1.

STATEMENT OF WORK

 

Statement of Work, dated September 12, 2020, 28 pages

 

All other contract terms under Section J remains unchanged.

 

 

[***] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

 

--------------------------------------------------------------------------------

 

 

 

 

Contract No: 75A50119C00053

Modification No: P0002

SPECIAL PROVISIONS

 

 

 

 

 

CONTRACTOR’S STATEMENT OF RELEASE

 

In consideration of the modification(s) agreed to herein as complete and
equitable adjustments of any sort are NOT due from Contractor's revision of
Section J, Attachment 1 – Statement of Work, dated September 12, 2020.  The
Contractor hereby releases the Government from any and all liability under the
contract for further equitable adjustments attributable to such facts or
circumstances as a result of this action.

 

All other contract terms remain unchanged.

 

 

END OF MODIFICATION P00002

 

 

 

 

 

[***] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

 

--------------------------------------------------------------------------------

 

 

 

 

Contract No: 75A50119C00053

Modification No: P0002

SPECIAL PROVISIONS

 

 

 

 

 

 

ATTACHMENT 1

Biomedical Advanced Research and Development Authority (BARDA) Broad Agency
Announcement (BAA)

(Solicitation   #BAA-18-100-SOL-00003)

Advanced Research and Development of Chemical, Biological, Radiological, and
Nuclear Medical Countermeasures

RAPID, HIGH-THROUGHPUT, MULTIPLEXED DETECTION OF BIOTHREAT SPECIES ID AND
RESISTANCE GENES USING T2MR

Topic Area of Interest No. [7.2.4 & 7.3.3] Statement of Work DATED July 22, 2019
(Diagnostics/Devices Product Development)

 

STATEMENT OF WORK

 

BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY (BARDA) BROAD AGENCY
ANNOUNCEMENT (BAA) BAA-18-100-SOL-00003

 

ADVANCED RESEARCH AND DEVELOPMENT OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND
NUCLEAR MEDICAL COUNTERMEASURES

 

RAPID, HIGH-THROUGHPUT, MULTIPLEXED DETECTION OF BIOTHREAT SPECIES ID AND
RESISTANCE GENES USING T2MR

AREA OF INTEREST NUMBERS 7.2.4 AND 7.3.3 CONTRACTUAL STATEMENT OF WORK

 

[***]

 

 

 

 

 

 

 

 

 

 

[***] = Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.