Amendment No. 2 to Joint Development and Option Agreement, dated June 21, 2022, by and between The Cleveland Clinic Foundation and BreathTech Corporation

EX-10.10 4 ex_723048.htm EXHIBIT 10.10 ex_723048.htm

Exhibit 10.10

 

 

 

This page needs to be retained with the Agreement at all times.

 

 

 

COMPANY INFORMATION

 

BreathTech Corporation

2028 E. BEN WHITE BLVD. #240-9530

AUSTIN, TX 78741


CONTRACT INFORMATION

 

Contract ID: 4270915  
Master Agreement Number: 4238605  
Dept Reference No.:    
Contract Description: AMENDMENT NO. 2 TO JOINT DEVELPMENT AND OPTION AGREEMENT,  
ADDING ADDITIONAL DISEASE INDICATIONS TO ORIGINAL AGREEMENT  
Institute: Innovations  
Submitting Dept: INNOVATIONS  
Contract Amount:    
     
     
     
Principal Investigator:    
     
Dept Contact: AMANDA WOCHELE  

 

 

 


TERM INFORMATION

 

Effective Date: 6/8/2022  
Expiration Date: 6/7/2024  
Term Type: Fixed  

 


 

LEGAL TEAM INFORMATION

 

Attorney: GERALD SCHAEFER

 

 

Paralegal:

 

 

Contract approved as to form for: 4270915

Attorney: SCHAEFER, GERALD

By: Litchfield, Jo Ann

Date: 6/16/2022 2:33:04 PM

 

 

 

AMENDMENT NO. 2

TO

JOINT DEVELOPMENT AND OPTION AGREEMENT

BETWEEN

THE CLEVELAND CLINIC FOUNDATION

AND

BREATHTECH CORPORATION

 

This Amendment No. 2 to Joint Development and Option Agreement (this "Amendment"), is made and entered into effective as of June l O, 2022 (the "Amendment Date"), by and between The Cleveland Clinic Foundation ("CCF') and BreathTech Corporation, a wholly-owned subsidiary of Astrotech Corporation ("Company", and together with CCF the "Parties", and each, a "Party").

 

ARTICLE I

WHEREAS, CCF and Company are parties to that certain Joint Development and Option Agreement, dated on or around October 20, 2020, and as amended March 23, 2022 (together, the "Original Agreement"); the Parties have an interest in working together to develop a rapid breath test for coronavirus (CV), bloodstream infections/endocarditis, respiratory/FLU A, B, and RSV, staphylococcus aureus carriage, clostridium difficile, and heart disease using COMPANY's mass spectrometry (MS) technology and collection of data related thereto through a clinical study.

 

WHERAS, the Parties desire to further amend the Original Agreement to modify certain provisions thereof; and

 

WHEREAS, capitalized terms used and not defined in this Amendment shall have the respective meanings given them in the Original Agreement.

 

NOW, THEREFORE, in consideration of the premises set forth above and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

l.            Amendments. The Original Agreement is hereby amended by replacing Schedule A with the attached Schedule A.

 

2.           Limited Effect. Except as expressly provided in this Second Amendment, all of the terms and provisions of the Original Agreement are and shall remain in full force and effect. The amendments contained herein shall not be construed as a waiver or amendment of any other provision of the Agreement. On and after the Amendment Date, each reference in the Agreement to "this Agreement," "the Agreement," "hereunder," "hereof," "herein" or words of like import, will mean and be a reference to the Original Agreement, as amended.

 

3.           Governing Law. This Amendment shall be governed by, and construed in accordance with, the laws of the State of Delaware.

 

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4.           Miscellaneous.

 

(a)    This Amendment (together with the Original Agreement, as amended) constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.

 

(b)    This Amendment shall inure to the benefit of and be binding upon each of the Parties and each of their respective successors and permitted assigns.

 

(c)    This Amendment may be executed in any number of counterparts, by different Parties hereto in separate counterparts and by email transmission of a PDF, each of which, when so executed and delivered, shall be deemed to be an original and all of which taken together shall constitute but one and the same agreement.

 

 

 

[SIGNATURE PAGE FOLLOWS]

 

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IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed by their duly authorized representatives as of the date set forth below.

 

 

    The Cleveland Clinic Foundation
     

BREATHTECH CORPORATION

 

THE CLEVELAND CLINIC FOUNDATION

     

By: /s/ Jaime Hinojosa

 

By: /s/ Serpil Erzunum, M.D.

     

Name: Jaime Hinojosa

 

Name: Serpil Erzunum, M.D.

     

Title: CFO

 

Title: Chief Research and Academic Officer

     

Date: June 21 2022

 

Date: June 16, 2022

     

 

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Schedule A

Work Plan

 

Project Description: Development of a rapid breath test for bloodstream infections/endocarditis, respiratory/FLU A, B, and RSV, staphylococcus aureus carriage, clostridium difficile, and heart disease using COMPANY' s mass spectrometry (MS) technology and collection of data related thereto through a clinical study.

 

CCF will:

 

 

1.

Develop a clinical study protocol for obtaining breath samples from patients also being tested for bloodstream infections/endocarditis, respiratory/FLU A, B, and RSV, staphylococcus aureus carriage, clostridium difficile, and heart disease by standard means. Protocol will include, but is not limited to, infection disease sample collection and sample processing protocols meeting all regulatory requirements, and training protocols for personnel, enrollment of patients, collection of patient information, correlation of MS results with standard bloodstream infections/endocarditis, respiratory/FLU A, B, and RSV, staphylococcus aureus carriage, clostridium difficile, and heart disease test results, all meeting IRB criteria for approval.

 

 

2.

Pursuant to a separate clinical trial agreement, manage a clinical trial to carry out the above mentioned protocol for a number of infected and uninfected patients sufficient to conduct the MS analysis and achieve the outcome of developing a library of compounds as described below (number of patients to be determined by statistical analysis).

 

COMPANY will:

 

 

1.

Integrate the COMPANY's MiniMass Spectrometer Technology ("AMMST") into an instrument to detect indicators of bloodstream infections/endocarditis, respiratory/FLU A, B, and RSV, staphylococcus aureus carriage, clostridium difficile, and heart disease infection.

 

 

2.

Provide single use disposable breath capture devices.

 

 

3.

Conduct data analysis and AI required to build the disease detection compound libraries suitable for use with the AMMST.

 

 

Disease Indication

Cleveland Clinic

Invention Disclosure

Publication

Patent

Bloodstream infections/endocardi tis

2022-061

   

Respiratory/FLU A, B, and RSV

2022-060

   

Staphylococcus aureus carriage

2022-059

   

Clostridium difficile (CDIFF)

2018-171

 

US 17/281,324, EP 19797408.2

Heart Disease

14060

Exhaled Acetone and Pentane in Acute Decompensated Heart Failure Correlate with Long Term Disease Free Survival. Tranchito L., et al; Journal of Cardiac Failure, 2017

Aug; 23(8):S3 l

 

Corona Virus

2020-087

   

 

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