Document:

Document

  Exhibit 10.1
Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

																											
	AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT	1. CONTRACT ID CODE	PAGE OF PAGES
1    /  6

	2. AMENDMENT/MODIFICATION NO.
P00004
	3. EFFECTIVE DATE
See Block 16C
	4. REQUISITION/PURCHASE REQ. NO.

	5. PROJECT NO. (If applicable)

	6. ISSUED BY                          CODE	NHLBI	7. ADMINISTERED BY (If other than item 6)                                                     CODE
	NIBIB
	National Institutes of Health
National Heart, Lung, and Blood
Institute
Bethesda, MD 20892-7511
	 National Institutes of Health 
 National Institute of Biomedical 
 Imaging and Bioengineering 
 Bethesda, MD 20892-7511

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

FLUIDIGM CORPORATION:1157584
2 TOWER PLACE SUITE 2000
SOUTH SAN FRANCISCO CA 940801826
	(x)	9A. AMENDMENT OF SOLICITATION NO.
		9B. DATED (SEE ITEM 11)

	x	10A. MODIFICATION OF CONTRACT/ORDER NO.
75N92020C00009

	10B. DATED (SEE ITEM 13)
07/30/2020

	CODE	FACILITY CODE
	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)    See Schedule

	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 date, 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	OTHER (Specify type of modification and authority)
FAR 52.243-1 Changes-Fixed Price (August 1987)

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.)
The purpose of this Modification is to extend the Period of Performance of this contract and to amend "Article B.2 Prices" and to attached the revised Performance Work Statement and deliverable schedule with updated milestones for A2, A3, A4, 7b and 8.

The Period of Performance has changed from July 30, 2020 to September 30, 2021 to July 30, 2021 to December 30, 2021.

All other terms and conditions of this contract remain the same.
Discount Terms: PROMPT PAY

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)
Andrew Quong, CSO
	16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
ROXANE S. BURKETT

	15B. CONTRACTOR/OFFEROR
/s/ Andrew Quong
	Digitally signed by Andrew Quong
                 

	15C. DATE SIGNED

09/28/2021
	1        16B. UNITED STATES OF AMERICA
/s/ Roxane S. Burkett -S 
	Digitally signed by Roxane S. Burkett -S

	16C. DATE SIGNED    

09/29/2021

	(Signature of person authorized to sign)	(Signature of Contracting Officer)

    STANDARD FORM 30 (REV. 11/2016)
Previous edition unusable    Prescribed by GSA FAR (48 CFR) 53.243

Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

									
	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED
75N92020C00009/P00004

	PAGE       OF
    2     /    6

NAME OF OFFEROR OR CONTRACTOR
FLUIDIGM CORPORATION:1157584
																		
	ITEM NO.
(A)
	SUPPLIES/SERVICES
(B)
	QUANTITY
(C)
	UNIT
(D)
	UNIT PRICE
(E)
	AMOUNT
(F)

		Payment:
Approved By, NHLBI Branch A Invoice 
Paid By: NIH Commercial Accounts Br 
2115 East Jefferson St, MSC 8500 
Room 4B-432
Bethesda, MD 20892-8500
Period of Performance: [***]

Change Item 12 to read as follows (amount shown is the obligated amount) : 
				
						
	12	[***]
Obligated Amount:    [***] 
Delivery To: Bldg.31/RM 1C31
Product/Service Code:    Q301
Product/Service Description: MEDICAL- LABORATORY
TESTING

Change Item 13 to read as follows (amount shown is the obligated amount) : 
				[***]
						
	13	[***]
Obligated Amount:    [***] 
Delivery To: Bldg.31/RM 1C31
Product/Service Code:    Q301
Product/Service Description: MEDICAL- LABORATORY
TESTING

Project Data:
151201.2020.300.COVID-19.DIAG.HN81         NIBIB OD OFFICE OF THE DIRECTOR.25235 ALL OTHER NON-FED SERVCS.02/17/2021
Accounting Info: 08039820200DAD.2021.83.8100.EM81000000C.E.C4400.40
6.COVD.25235.61000001.9999.9999.9999
Funded: [***}
				[***]
						
		

                                                                                                                                                                                                                                                                                                                                                                                         
Continued...
				[***]

NSN 7540-01-152-8067    OPTIONAL FORM 336 (4-86)
Sponsored by GSA
FAR (48 CFR) 53.110

Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

									
	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED
75N92020C00009/P00004

	PAGE       OF
    3    /    6

NAME OF OFFEROR OR CONTRACTOR
FLUIDIGM CORPORATION:1157584
																		
	ITEM NO.
(A)
	SUPPLIES/SERVICES
(B)
	QUANTITY
(C)
	UNIT
(D)
	UNIT PRICE
(E)
	AMOUNT
(F)

		Change Item 14 to read as follows (amount shown is the obligated amount) : 				
	14	[***]
Obligated Amount:    [***] 
Delivery To: Bldg.31/RM 1C31
Product/Service Code:    Q301
Product/Service Description: MEDICAL- LABORATORY
TESTING 

Project Data:
151201.2020.300.COVID-19.DIAG.HN81         NIBIB OD OFFICE OF THE DIRECTOR.25235 ALL OTHER NON-FED SERVCS.02/17/2021
Accounting Info: 08039820200DAD.2021.83.8100.EM81000000C.E.C4400.406.COVD.25235.61000001.9999.9999.9999
Funded: [***}

Change Item 17 to read as follows (amount shown is
the obligated amount) :       

				[***]
						
	17	[***]
Obligated Amount:                   [***] 
Delivery To: Bldg.31/RM 1C31
Product/Service Code:    Q301
Product/Service Description: MEDICAL- LABORATORY
TESTING

Project Data:
151201.2020.300.COVID-19.DIAG.HN81         NIBIB OD OFFICE OF THE DIRECTOR.25235 ALL OTHER NON-FED SERVCS.02/17/2021
Accounting Info: 08039820200DAD.2021.83.8100.EM81000000C.E.C4400.406.COVD.25235.61000001.9999.9999.9999
Funded: [***]

Change Item 18 to read as follows (amount shown is the obligated amount) : 
				[***]
						
	18	[***]
Obligated Amount:                   [***] 
Delivery To: Bldg.31/RM 1C31
Product/Service Code:    Q301
Continued ...

				[***]

Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

									
	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED
75N92020C00009/P00004

	PAGE       OF
    4    /    6

NAME OF OFFEROR OR CONTRACTOR
FLUIDIGM CORPORATION:1157584
																		
	ITEM NO.
(A)
	SUPPLIES/SERVICES
(B)
	QUANTITY
(C)
	UNIT
(D)
	UNIT PRICE
(E)
	AMOUNT
(F)

		Product/Service Description: MEDICAL- LABORATORY
TESTING

Project Data:
151201.2020.300.COVID-19.DIAG.HN81         NIBIB OD OFFICE OF THE DIRECTOR.25235 ALL OTHER NON-FED SERVCS.02/17/2021
Accounting Info: 08039820200DAD.2021.83.8100.EM81000000C.E.C4400.406.COVD.25235.61000001.9999.9999.9999
Funded: [***]

				

Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

MODIFICATION OF CONTRACT CONTINUATION PAGE                                        
Contract No. 75N92020C00009
Modification P0004

															
	

BEGINNING WITH THE EFFECTIVE DATE OF THIS MODIFICATION, THE GOVERNMENT AND THE CONTRACTOR MUTUALLY AGREE AS FOLLOWS:

ARTICLE B.2. PRICES shall be amended by updating the milestone dates for A2, A3, A4, 7B and 8:

ARTICLE B.2. PRICES
a.The total Firm Fixed Price (FFP) amount for this contract is $34,016,056.

															
	Prism Line Item	Milestone	Invoice Line Item - description 
	Date	Amount
	9	4	Equipment Procurement, Construction, Initiation of Installation - [***]
	[***]	[***]
	10	5	Equipment Installation - [***]
	[***]	[***]
	11	6	Performance Qualification - [***]
	[***]	[***]
	12	A2	Design Lock - [***]
	[***]	[***]
	13	A3	Clinical Studies - [***]
	[***]	[***]
	14	A4	Submit EUA to FDA - [***]
	[***]	[***]
	15	A5	Clinical Samples - [***]
	[***]	[***]
	16	7a	Full Production Capacity on Line 2 - [***]
	[***]	[***]
	17	7b	Full Production Capacity on Line 3 - [***]
	[***]	[***]
	18	8	Final Report - [***]
	[***]	[***]
	 	Total	$34,016,056

Page 5 of 7  

Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

MODIFICATION OF CONTRACT CONTINUATION PAGE                                        
Contract No. 75N92020C00009
Modification P0004

															
	

ARTICLE C.1. STATEMENT OF OBJECTIVES shall be amended and read as follows:
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Objectives, dated July 27, 2020 and the Performance Work Statement (PWS) dated January 19, 2021, set forth in SECTION J – List of Attachments, attached hereto and made a part of this Contract. Work to be performed shall be consistent with the application and preliminary work file submitted by the Contractor and subsequent documentation submitted during the application review process and the discussions between the parties that have taken place between date of application submission through contract award.
ARTICLE C.2. REPORTING REQUIREMENTS shall be amended and read as follows:
All reports required herein shall be submitted in electronic format only. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."
The following reporting requirements shall be submitted electronically to the Contracting Officer and Contracting Officer’s Representative in accordance with the due dates specified below: 
									
	Item No.	Reporting Requirements	Due Date
	1	Bi-weekly Production Status Report – to include the following:
•current plant production capacity and output on a per-week basis, 
•a breakdown of capacity and output on a per-line/per week basis, 
•a description of any issues/problems encountered with plans for 
solution/mitigation (e.g., delays in meeting deliverables, supply chain issues, 
design/validation issues, etc.)
•sales reporting to include the name and kind of organization, as well as the number of IFCs sold to that organization during the reporting period.  Sales reports may be submitted in every other bi-weekly report (i.e. monthly).

	[***]

	2	Final Report  - Summary of salient results of the entire contract period, including number of lines built, production capacity over time, production output over time, and a summary of the sales reports. It shall include evidence of sustained production at capacity levels or higher assuming demand has not decreased.	[***]

Page 6 of 7  

Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

MODIFICATION OF CONTRACT CONTINUATION PAGE                                        
Contract No. 75N92020C00009
Modification P0004

															
	

ARTICLE F.1. PERIOD OF PERFORMANCE shall be amended and read as follows:
The period of performance of the contract is [***].

ARTICLE F.2. DELIVERIES shall be amended and read as follows:
Satisfactory performance shall be deemed to occur upon performance of the work described in the Statement of Objectives Article in SECTION C of this Contract and upon notice and acceptance by the Contracting Officer, or the duly authorized representative, in accordance with the stated deliverables schedule  as listed in the Performance Work Statement (PWS) dated January 19, 2021 (See Attachment 2).
The deliverables or documentation shall be submitted to the Contracting Officer and designated Contracting Officer Representative (COR) by email.

SECTION J  - LIST OF ATTACHMENTS shall be amended and read as follows:

1.Performance Work Statement dated January 19, 2021
Appendix 1: Cost-Price Quote

All other terms and conditions of the contract remain the same.
Page 7 of 7  

Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

RADx #6114
Fluidigm Corporation
Letter Contract number: 75N92020C00009

Performance Work Statement 
			
	PWS Title:  Rapid Acceleration of Diagnostics (RADx) Program: Tech Project # 6114 Fluidigm – Advanta Dx SARS-CoV-2 RT-PCR Assay for Saliva

1.0 Background
Fluidigm has developed a diagnostic molecular test for the qualitative detection of SARS-CoV-2 in saliva specimens under FDA Emergency Use Authorization (EUA). The AdvantaTM Dx SARS-CoV-2 RT-PCR Assay is a qPCR-based test that, by taking advantage of Fluidigm’s proprietary microfluidics technology and JunoTM and BiomarkTM HD systems, enables high throughput and scalable testing of saliva samples from patients suspected of COVID-19 (coronavirus) infection. Featuring extraction-free sample processing, a modular workflow and large batch-sample size, the Advanta Dx SARS-CoV-2 RT-PCR Assay aims to meet the RADx goal of enhance laboratory SARS-CoV-2 testing capacity.

Fluidigm’s BioMark HD microfluidics platform addresses the massive demand for SARS-CoV-2PCR testing- combining speed, minimal cost, and massive throughput unparalleled in the industry. Further advantages include flexibility to rapidly integrate new mutational markers or increase panel size to include additional infectious agents. This platform works with all clinical sample types.

Our solution leverages AdvantaTM Dx SARS-CoV-2 RT-PCR Assay submitted for an EUA, and two assays under development that can change the landscape for detection. This assay allows for up to 6000 samples per day on a single system. Additional assays address different needs in testing, throughput, specificity and sensitivity. 

Our technology offers significant advantages overcoming many supply chain barriers and provides a robust platform for scale up of testing for SARS-CoV-2.

Fluidigm has been able to detect both N1 and N2 SARS-CoV-2 targets across all samples provided by Washington University, including the lowest dilution (10 cp/ul). Highlights from that work are the detection of:
•10 copies in the reaction using 4 ul of saliva sample
•1.x copies in the reaction using 1 ul of saliva sample
•Across all dilution buffer and RNase inhibitor conditions
Of the amplification chemistries tested, optimum results were obtained from the FLDM 1-Step
RT-PCR Master Mix, 2.5 hour 1-step RT-PCR protocol.

2.0 Objectives
The baseline technology provided in Fluidigm’s EUA filing allows for performing 6000 tests per day on each Biomark HD system and Fluidigm currently has the ability to manufacture approximately 50,000 tests per day.  The rate limiting component is the Integrated Fluidic Circuit (IFC), which is the microfluidic chip that is required for running the assay.  The two types of IFCs described herein are the 192.24 IFC which is used in the current AdvantaTM Dx SARS-CoV-2 RT-PCR Assay under EUA, and a cartridge-based solution IFC which is the basis for a simplified workflow. Each 192.24 IFC has the capacity to run 192 tests and each cartridge-based solution IFC has the capacity to run 96 tests. This project has 
Page 1

Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

RADx #6114
Fluidigm Corporation
Letter Contract number: 75N92020C00009

two major deliverables: 1) to increase manufacturing capacity of IFCs and to develop and 2) to manufacture a cartridge-based solution that will simplify the workflow and increase the likelihood of sales and deployment of the COVID tests to a broader customer base. 

The cartridge-based solution incorporates two independent reactions necessary to process the sample into the same chip to simplify the overall workflow. Compared to the 192.24 IFC approach, each individual sample in the cartridge-based solution increases the number of reaction chambers in the microfluidic chip. Thus, the overall sample capacity of the chip is reduced as there is more chemistry being performed on chip. As a result, switching to the production of the cartridge will result in a simplified workflow but lower volume of tests because it has half the sample capacity of the 192.24 IFC. Furthermore, the cartridge IFC will require more time for both manufacturing and quality control compared to the 192.24 IFC. While the expected initial production capacity is expected to be lower than the established 192.24 IFC production capacity, Fluidigm historically demonstrated that on average, IFC yield can be expected to increase from pilot phase to maturity (3 quarter) by approximately 20%.
The cartridge-based solution requires the redevelopment of the assay to include the use of extracted RNA from nasal pharyngeal (NP) samples as input. The addition of RNA extraction to the assay workflow is a departure from the EUA for the Advanta Dx SARS-CoV-2 assay. Therefore, the full development of the cartridge-based assay will require a new clinical study and new EUA submission. This cartridge-based assay complements the Advanta Dx SARS-CoV2 assay by providing an NP-based test in addition to the saliva-based test already on market.
The limiting factor to Fluidigm provided testing is the manufacture of the IFCs.  This is because the Advanta Dx SARS-CoV2 assay does not require extraction, and only nano-liters of reagents are used for each PCR reaction.  Scale up for IFC production will occur in Fluidigm’s Singapore facility by first maximizing production in the existing manufacturing line which will increase production capacity to 12,000 IFCs per month from the current 7,000 per month.  Simultaneously, Fluidigm will add two additional manufacturing lines to the Singapore facility which will ultimately provide manufacturing capacity of 36,000 IFCs per month. The investment into the capital equipment to construct additional manufacturing lines and expand the production of the IFCs can be leveraged to produce the cartridge-based solution. The cartridge-based solution requires a new process and molds but uses the existing equipment.
3.0 Scope
Fluidigm will deploy the Advanta Dx SARS-CoV2 assay, a complete testing solution using a saliva based, extraction free, viral detection assay for broad distribution. Fluidigm will also develop an NP extracted RNA based viral detection assay. This section describes the scope of work for RADx 6114.
Currently Fluidigm has the capability to deliver testing capacity of approximately 50,000 tests/day. The cartridge-based solution will deliver testing capacity of up to 115,200 tests/day by Q3 2021. 
The Contractor shall accomplish the following milestones in the stages outlined below:
•Stage 1: Test Verification
◦Deliver 1plex tests to Verification Core at Emory University
◦Provide final report from the Verification Core

Page 2

Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

RADx #6114
Fluidigm Corporation
Letter Contract number: 75N92020C00009

•Stage 2: Scale Up
◦Increase production capacity of Line 1 with 24/7 operation
•Stage 3: Scale Up and Facility Construction
◦Increase production capacity of Line 1 to full scale
◦Begin construction of facility to build two additional production lines
•Stage 4: Quality Systems, Equipment and Performance Qualification 
◦Expansion of Quality Control (QC) systems
◦Equipment procurement, delivery, and initiation of installation
•Stage 5: Achieve Full Production Capacity
◦Capital equipment installed, qualified, and validated for two additional production lines
◦Demonstrate full IFC production capacity on all three production lines 
▪192.24 IFC production on Line 1 (see Stage 2 Scale Up)
▪192.24 IFC production on Line 2
▪Cartridge IFC production on Line 3

The Contractor shall accomplish the following milestones which have been defined by subtasks
•Stage A1: Multi-plex design finalized 
◦Determine final design for barcoding solution and the requirements for the clinical study
•Stage A2: Cartridge-based solution design finalized 
◦Determine final design for the cartridge-based solution and the requirements for the clinical study
•Stage A3 - A5: Clinical/FDA studies and EUA Submission 
◦Complete clinical studies required for EUA Submission 
◦Submission of EUA for cartridge-based solution
◦Purchase of clinical samples if applicable
    
4.0 Tasks
Tasks to be completed by the Contractor are divided into three main objectives:
1) Maximizing throughput on the existing manufacturing line to 12k IFCs per month 
2) Addition of two manufacturing lines in the Singapore facility 
3) Simplifying the workflow of the current RT-PCR assay by developing the cartridge-based solution.
Progress on the tasks will be included in the project workstream tracker. Updates will be provided to the COR and RADx program personnel in the weekly meetings.
5.0 Deliverables
Deliverables for the PWS include deliverables outlined in the final Statement of Objectives, and reports which shall be paired with the agreed upon Payment Schedule.

Page 3

Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

RADx #6114
Fluidigm Corporation
Letter Contract number: 75N92020C00009

The list of milestones and deliverables for the PWS is available in Appendix 1: Cost-Price Quote.

6.0 Quality Assurance

The Contractor shall ensure that all deliverables are reviewed and edited to ensure that documents are free of typographical, grammatical, and technical errors. The Contracting Officer Representative (COR), shall have final authority over the format, style, editing, and content of all deliverables. Further, the contractor will be responsible for ensuring that final documents incorporate all comments, modifications, and editing recommended by the COR.

7.0 Quality Assurance Surveillance Plan (QASP)
The QASP is attached as Appendix 2. Additional quality assurance processes are included in the attached file: Fluidigm Corporate Quality Manual.
8.0 Period of Performance
The period of performance is as follows:
						
	Base Period	[***]

9.0 Appendices 
Appendix 1: Cost-Price Quote
Appendix 2: QASP  
10.0 Additional Documents
Fluidigm Corporate Quality Manual
Page 4

Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.

												
	RADx Proposal Modifications: 6

	Date
	Milestone
	Deliverable
	Amount
	[***]	[***]	[***]	[***]

	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
	[***]	[***]	[***]	[***]
			Total	$34,016,056lyra-ex101_82.htm

Exhibit 10.1

 

Transition Agreement

This Transition Agreement (“Agreement”) is made by and between Don Elsey (“Executive”) and Lyra Therapeutics, Inc., a Delaware corporation (the “Company”) (collectively referred to as the “Parties” or individually referred to as a “Party”) as of September 12, 2021 (the “Agreement Date”), effective as of the Effective Date (as defined below).

WHEREAS, the Parties have previously entered into an Employment Agreement, dated as of April 27, 2020 (the “Employment Agreement”) and an Employee Non-Disclosure, Non-Competition, Non-Solicitation and Inventions Agreement, dated as of July 31, 2019 (the “Confidentiality Agreement”);

WHEREAS, the Parties desire to set forth the terms and conditions of Executive’s transition from employment with the Company;

NOW, THEREFORE, in consideration of the mutual promises made herein, the Company and Executive hereby agree as follows:

1.Continued Employment.

(a)Transition Period.  From the Effective Date through October 6, 2021 (the “Initial Transition Period”), Executive shall remain employed by the Company on a full-time basis, provided that upon the appointment of Executive’s successor as the Company’s Chief Financial Officer, Executive’s status as the Company’s Chief Financial Officer and as an officer of the Company shall cease and executive hereby resigns from all such offices.  From October 7, 2021 through December 31, 2021 (the “Part-Time Transition Period” and together with the Initial Transition Period, the “Transition Period”), Executive shall remain employed by the Company on a part-time basis and shall devote 50% (reduced to 25% following December 9, 2021) of Executive’s full business time and attention to Company duties.  During the Transition Period, Executive will perform such duties as may be specified from time to time by the Company’s Chief Executive Officer.

(b)Compensation.

(i)Salary and Benefits Continuation.  During the Transition Period, Executive shall continue to be paid Executive’s base salary at the rate in effect as of the Effective Date, less applicable withholdings, provided that such base salary shall be prorated based on Executive’s level of part-time employment during the Part-Time Transition Period.  In addition, during the Transition Period, Executive will continue to be eligible to participate in the Company’s employee benefit plans made available to similarly situated employees of the Company on the terms and conditions set forth in such employee benefit plans, provided, however, that Executive will not be eligible to receive an annual performance bonus for the Company’s 2021 fiscal year.

(ii)Options.  Exhibit A to this Agreement sets forth each option to purchase shares of common stock of the Company (collectively, the “Options”) held by Executive as of the Agreement Date and the extent to which each Option was vested and unexercised as of the Agreement Date.  The Parties acknowledge and agree that each 

 

 

Option shall remain eligible to vest with respect to the number of shares shown under the heading “Shares Eligible to Vest During the Transition Period” set forth on Exhibit A in accordance with the original vesting schedule of the Option based on Executive’s continued services during the Transition Period. 

(iii)2021 Bonus. Provided that Executive remains continuously employed by the Company through the end of the Transition Period, as described in Section 1(a) above, Executive will be eligible to receive an annual bonus of up to forty percent (40%) of his actual base salary earned during the Company’s 2021 fiscal year (the “2021 Bonus”). The actual amount of the 2021 Bonus earned shall be based on the Company’s achievement of its performance objectives, as determined by the Board. Executive’s 2021 Bonus, if earned, will be paid as soon as administratively practicable after the end of the 2021 fiscal year, and in any event no later than March 15, 2022. For the avoidance of doubt, Executive shall not be entitled to receive any annual bonus with respect to the 2021 fiscal year other than as specifically set forth in this Section 1(b)(iii). 

2.Separation Date; Final Payments.

(a)Separation Date.  Executive acknowledges and agrees that Executive’s status as an employee of the Company shall end effective as of December 31, 2021 (the “Separation Date”).  Notwithstanding anything herein to the contrary, Executive’s employment with the Company during the Transition Period remains at-will.  

(b)Final Payments.  As soon as administratively practicable on or after the Separation Date, the Company will pay Executive all compensation, wages, commissions, bonuses and/or benefits to which Executive may be entitled, including Executive’s annual base salary earned through the Separation Date, any accrued and unused vacation earned through the Separation Date and reimbursement for any reimbursable expenses incurred by Executive as of the Separation Date.

3.Consulting Services.

(a)From January 1, 2022 through June 30, 2022 (the “Consulting Period”), Executive shall be available to provide transition consulting services relating to Executive’s area of work experience and expertise as reasonably requested by the Company (the “Consulting Services”) in exchange for a consulting fee of $500 per hour of Consulting Services performed.  Either Party may terminate the Consulting Services at any time in its discretion by written notice to the other Party.

(b)In addition to the hourly consulting fee stated above and in consideration of Executive’s provision of the Consulting Services, the Parties acknowledge and agree that (i) each Option shall remain eligible to vest with respect to the number of shares shown under the heading “Shares Eligible to Vest During Consulting Period” set forth on Exhibit A in accordance with the original vesting schedule of the Option based on Executive’s continued services during the Consulting Period; (ii) the portion of each Option that is neither denoted as “Shares Eligible to Vest During Transition Period” nor “Shares Eligible to Vesting During Consulting Period” on Exhibit A will be forfeited and terminated for no consideration as of the Effective Date; and (iii) 

 

 

 

each Option that is unvested as of the termination of Executive’s service with the Company will thereupon be forfeited and terminated for no consideration and each Option that is vested as of the termination of Executive’s service with the Company will remain outstanding and exercisable following such termination for the period set forth in the agreement governing the Option.  Executive further acknowledges and agrees that each Option that is an “incentive stock option” within the meaning of Section 422 of the Internal Revenue Code will cease to qualify as an incentive stock option upon the expiration of three months from the Separation Date.

(c)Executive and the Company acknowledge and agree that, during the Consulting Period, Executive shall be an independent contractor.  During the Consulting Period and thereafter, Executive shall not be an agent or employee of the Company and shall not be authorized to act on behalf of the Company.  As an independent contractor, Executive understands and agrees that, while performing the Consulting Services, (i) Executive shall not be eligible to participate in or accrue benefits under any Company benefit plan for which status as an employee of the Company is a condition of such participation or accrual, and (ii) to the extent that Executive is deemed eligible to participate, as an employee, in any Company benefit plan, Executive hereby waives Executive’s participation.

4.Restrictive Covenants; Non-Disparagement; Return of Property.

(a)Executive’s covenants under the Confidentiality Agreement are hereby incorporated by reference into this Agreement. Notwithstanding anything to the contrary in the Confidentiality Agreement, in consideration of the promises herein, Executive agrees that the post-termination obligations under the heading “Exclusive Commitment” in the Confidentiality Agreement shall apply following the Separation Date, provided that the section under the heading “Consideration” in the Confidentiality Agreement shall be deemed deleted and of no further force or effect. Executive affirms Executive’s commitment to remain in compliance with the Confidentiality Agreement while Executive is providing the Consulting Services, it being understood that the period during which Executive performs Consulting Services shall be deemed a period of Executive’s continued employment for purposes of determining Executive’s obligations under the Confidentiality Agreement relative to the provision of the Consulting Services, provided that this sentence shall not be deemed to extend the covenants set forth under the headings “Exclusive Commitment”, “General Non-Solicitation” and “Non-solicitation of Employees” in the Confidentiality Agreement.  Executive acknowledges and agrees that Executive’s obligations under the Confidentiality Agreement, as modified herein, shall remain in full force and effect following the Separation Date in accordance with the terms thereof.

(b)Executive agrees that Executive shall not publicly disparage, criticize or defame the Company or its directors, officers, products, services, technology or business.  The Company agrees that it will instruct the current members of its board of directors and its current executive officers not to publicly disparage, criticize or defame Executive.  Nothing in this Section 4(b) will prohibit disclosure of information that is required to be disclosed to enforce the terms of this Agreement or to comply with applicable law or order of a court or other regulatory body of competent jurisdiction.

(c)Within five days following the Separation Date or upon the Company’s earlier request, Executive shall return to the Company all files, memoranda, records, and other 

 

 

 

documents, and any other physical or personal property which are the property of the Company and which Executive had in Executive’s possession, custody or control.

5.Severability. In the event that any provision or any portion of any provision hereof or any surviving agreement made a part hereof becomes or is declared by a court of competent jurisdiction or arbitrator to be illegal, unenforceable, or void, this Agreement shall continue in full force and effect without said provision or portion of provision.

6.No Oral Modification.  This Agreement may only be amended in a writing signed by Executive and the Chief Executive Officer of the Company.

7.Governing Law.  This Agreement shall be governed, construed, interpreted and enforced in accordance with its express terms, and otherwise in accordance with the substantive laws of the Commonwealth of Massachusetts, without reference to the principles of conflicts of law of the Commonwealth of Massachusetts or any other jurisdiction that would result in the application of the substantive laws of any jurisdiction other than the Commonwealth of Massachusetts, and where applicable, the laws of the United States.  The venue for any action, suit or other legal proceeding arising under or relating to any provision of this Agreement shall be in Suffolk County, Commonwealth of Massachusetts, and the Company and Executive each consent to the jurisdiction of such a court.  The Parties waive any and all rights to a trial by jury with respect to any action arising hereunder.

8.Effective Date.  Executive has seven business days after Executive signs this Agreement to revoke it by delivering written notice to the Chief Executive Officer of the Company, and this Agreement will automatically become effective upon expiration of such seven business day period (the “Effective Date”), so long as it has been signed by the Parties and has not been revoked by Executive before that date.

9.Trade Secrets; Whistleblower Protections.  In accordance with 18 U.S.C. §1833, notwithstanding anything to the contrary in this Agreement, the Confidentiality Agreement or any other agreement between Executive and the Company or any of its subsidiaries (together, the “Subject Documents”): (a) Executive will not be in breach of any Subject Document, and shall not be held criminally or civilly liable under any federal or state trade secret law (i) for the disclosure of a trade secret that is made in confidence to a federal, state, or local government official or to an attorney solely for the purpose of reporting or investigating a suspected violation of law, or (ii) for the disclosure of a trade secret that is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal; and (b) if Executive files a lawsuit for retaliation by the Company for reporting a suspected violation of law, Executive may disclose the trade secret to Executive’s attorney, and may use the trade secret information in the court proceeding, if Executive files any document containing the trade secret under seal, and does not disclose the trade secret, except pursuant to court order.  Furthermore, the Parties agree that nothing in the Subject Documents prohibits Executive from reporting possible violations of federal law or regulation to any governmental agency or entity in accordance with the provisions of and rules promulgated under any whistleblower protection provisions of state or federal law or regulation or releases or restrains Executive’s right to receive an award for information provided to any such government agencies or entities.

 

 

 

10.Miscellaneous.  Executive acknowledges that the payment and arrangements herein shall constitute the full and complete satisfaction of any and all amounts properly due and owing to Executive as a result of Executive’s employment with the Company and the termination thereof.  This Agreement represents the entire agreement of the Parties regarding the termination of Executive’ employment and supersedes in their entirety any prior agreements, whether written or oral, regarding such subject matter, including the Employment Agreement, provided for the avoidance of doubt, that the Executive’s obligations under the Confidentiality Agreement shall survive and the agreements governing the Options shall continue in effect.  In addition, for the avoidance of doubt, Executive acknowledges and agrees that nothing in this Agreement shall trigger Good Reason to resign Executive’s employment under the Employment Agreement.  

[signature page follows]

 

 

 

 

IN WITNESS WHEREOF, the Parties have executed this Agreement on the respective dates set forth below.

 

	
Dated: September 12, 2021
	
/s/ Don Elsey

	
 
	
R. Don Elsey

	
 
	
 
	
 

	
 
	
 
	
 

	
 
	
LYRA THERAPEUTICS, INC.

	
 
	
 
	
 

	
Dated: September 12, 2021
	
By:
	
/s/ Maria Palasis

	
 
	
Name:
	
Maria Palasis, Ph.D.

	
 
	
Title:
	
President and Chief Executive Officer

 

 

 

US-DOCS\126315998.5

 

 

Exhibit A

Options

 

	
Grant Date
	
Exercise Price
	
Vested Shares*
	
Shares Eligible to

Vest During

Transition

Period**
	
Shares Eligible to

Vest During

Consulting Period

***

	
July 29, 2019
	
$4.49
	
38,949
	
6,232
	
9,348

	
April 30, 2020
	
$16.00
	
6,878
	
1,719
	
2,580

	
February 8, 2021
	
$10.63
	
6,562
	
2,813
	
5,625

 

*Represents the number of shares of the Company’s common stock as to which the Option was vested and unexercised, as of the Agreement Date.

**Represents the number of shares of the Company’s common stock as to which the Option will be eligible to vest during the Transition Period, subject to Executive’s continued service through the applicable vesting date.

***Represents the number of shares of the Company’s common stock as to which the Option will be eligible to vest during the Consulting Period, subject to Executive’s continued service through the applicable vesting date.

 

US-DOCS\126315998.5

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