EX-10 10 ttoo-ex10_65.htm EX-10.65 EX-10

Exhibit 10.65

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

 

1. CONTRACT ID CODE

 

PAGE OF PAGES

 

1

7

2. AMENDMENT/MODIFICATION NO.

P00012

 

3. EFFECTIVE DATE

See Block 16C

4. REQUISITION/PURCHASE REQ. NO.

5. PROJECT NO. (If applicable)

6. ISSUED BY

CODE

ASPR-BARDA

7. ADMINISTERED BY (If other than Item 6)

CODE

ASPR-BARDA

 

 

 

 

 

 

 

 

 

ASPR-BARDA

 

ASPR-BARDA

 

 

 

200 Independence Ave., S.W.

Room 640-G

Washington DC 20201

 

US DEPT OF HEALTH & HUMAN SERVICES

 

 

 

BIOMEDICAL ADVANCED RESEACH & DEVELOPMENT AUT

 

 

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 : MICHAEL GIBBS

 

 

9B. DATED (SEE ITEM 11)

T2 BIOSYSTEMS, INC.

101 HARTWE

 

 

 

 

 

101 HARTWELL AVE

 

 

LEXINGTON MA 02421

 

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)

 

 

 

2022.1992022.25106

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).

 

 

X

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

FAR Part 43.103(a) - Bilateral Modification

 

 

 

D. OTHER (Specify type of modification and authority)

 

 

E. IMPORTANT:

Contractor

is not

☒ 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

UEI:

QVYNQM9WLJG3

The purpose of this no-cost modification is to extend the period of performance for CLIN Option Period 3, from 09/30/2022 - 03/31/2023 to 09/30/2022 - 08/31/2023. See Block 14 Continuation Sheet.

 

OTA:

N

Appr. Yr.:

2022

CAN:

1992022

Object Class:

25106

Period of Performance:

04/01/2022 to 03/31/2025

 

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)

 

Roger Smith SVP Science R&D

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

 

RICHARD A. HALL

15B. CONTRACTOR/OFFEROR

Roger Smith Digitally signed

(Signature of person authorized to sign) Date: 2023.03.16

15C. DATE SIGNED

by Roger Smith 08:35:36 -04'00'

16B. UNITED STATES OF AMERICA

Richard A. Hall -S Digitally signed

Date: 2023.03.20

(Signature of Contracting Officer)

16C. DATE SIGNED

by Richard A. Hall -S 10:20:21 -04'00'

 

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.

Exhibit 10.65

 

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

75A50119C00053/P00012

PAGE OF

2

7

NAME OF OFFEROR OR CONTRACTOR

T2 BIOSYSTEMS, INC. 1512719

ITEM NO.

(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

 

Change Item 11 to read as follows (amount shown is the obligated amount):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11

ASPR-22-02198- Option 3 funds to T2 Biosystems under

Contract Number 75A50119C00053 Obligated Amount: $0.00

 

 

 

0.00

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.

Exhibit 10.65

 

Contract No.

75A50119C00053

Modification No. P00012

Continuation Sheet Block 14

 

 

**Yellow Highlights denotes applicable changes

 

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

 

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS,

 

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

 

B.3. COST REIMBURSEMENT OPTIONS

 

I.
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.

 

II.
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.

 

III.
Unless the government exercises its option pursuant to the option clause contained in ARTICLE 1.2, the contract consists only of the Base Work segment specified in the Statement of Work as defined in SECTION C and F, for the price set forth in ARTICLE B.2 of the contract.

 

IV.
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.

 

[***] = 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.

Page 3 of 7

Exhibit 10.65

V.
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

 

 

09/14/2020 -

10/15/2021

Option 1 Period: Optimize the T2 Biothreat Panel to meet requirements on the T2Dx device.

Design, build, and optimize

T2Nxt subsystems, and integrate those subsystems into

 

 

 

$10,495,783

 

 

 

$3,925,669

 

 

 

$14,421,452

 

 

 

a working device.

Optimize the T2AMR Panel to detect targets

 

 

 

 

 

 

Option 2A Continue

 

 

 

 

 

 

 

2A

 

 

 

 

0003

 

 

 

 

09/30/2021-

03/31/2022

T2Biothreat verification testing and initiate validation testing. Produce a functioning Beta instrument. Complete initial optimization studies and demonstrate required sensitivity with a manual process. Initiate T2Resistance Panel verification and clinical

validation studies

 

 

 

 

$6,357,371

 

 

 

 

$2,087,418

 

 

 

 

$8,444,789

 

 

 

 

2B

 

 

 

 

0004

 

 

 

04/01/2022-

09/30/2022

Option 2B Continue T2Biothreat verification testing and initiate validation testing. Produce a functioning Beta instrument.

Complete initial optimization studies and demonstrate

required sensitivity with a

 

 

 

 

$4,389,160

 

 

 

 

$2,960,502

 

 

 

 

$7,349,662

 

 

 

manual process.

 

 

 

 

[***] = 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.

Page 4 of 7

Exhibit 10.65

 

 

 

Option 3 Period: Complete validation testing of the

T2Biothreat panel on the T2Dx

 

 

 

 

 

 

instrument under BSL-3 and

prepare and submit a 510(k)

 

 

 

 

 

 

application to the FDA for the T2Biothreat panel for use on the T2Dx instrument. The

contractor will also complete

 

 

 

 

 

 

verification and validation

testing and prepare and submit a 510(k) application to the FDA

 

 

 

 

3

 

0005

09/30/2022 -

08/31/2023

for the T2Resistance Panel for use on the T2Dx instrument. In AIM 1, the contractor will

complete contrived sample

 

$3,690,810

 

$3,332,064

 

$7,022,874

 

 

 

verification studies of the

 

 

 

 

 

 

T2Biothreat panel, prepare a

510(k) application and submit

 

 

 

 

 

 

to FDA for clearance. In AIM 6,

 

 

 

 

 

 

the contractor will complete

verification and validation

 

 

 

 

 

 

testing of the T2Resistance panel and prepare a 510(k)

application and submit to FDA

 

 

 

 

 

 

for clearance.

 

 

 

 

[***] = 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.

Page 5 of 7

Exhibit 10.65

 

 

 

 

 

 

 

 

4

 

 

 

 

 

 

 

0006

 

 

 

 

 

 

 

[***]-

[***]

Option 4 Period: [***]

 

 

 

 

 

 

 

$[***]

 

 

 

 

 

 

 

$[***]

 

 

 

 

 

 

 

$[***]

 

 

 

 

 

 

 

 

 

5

 

 

 

 

 

 

 

 

 

0007

 

 

 

 

 

 

 

 

[***]-

[***]

Option 5 Period: [***]

 

 

 

 

 

 

 

 

 

$[***]

 

 

 

 

 

 

 

 

 

$[***]

 

 

 

 

 

 

 

 

 

$[***]

 

 

 

 

 

 

 

6

 

 

 

 

 

 

 

0008

 

 

 

 

 

 

 

[***]-

[***]

Option 6 Period: [***]

 

 

 

 

 

 

 

$[***]

 

 

 

 

 

 

 

$[***]

 

 

 

 

 

 

 

$[***]

 

[***] = 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.

Page 6 of 7

Exhibit 10.65

 

 

 

 

 

 

 

 

 

Optional Services

 

 

 

0009

 

 

TBD-TBD as

Exercised

Option 7 Period: [***]

 

 

 

$[***]

 

 

 

$[***]

 

 

 

$[***]

 

 

TOTALS

Only option years

$[***]

$[***]

$[***]

 

 

TOTALS

Base+ options

$62,024,574

$[***]

$[***]

 

End of Changes for Modification P00012.

[***] = 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.

Page 7 of 7