First Amendment to Clinical Research Agreement, dated October 10, 2019, by and between CryoLife, Inc. and Duke University
Exhibit 10.23(a)
CERTAIN INFORMATION HAS BEEN OMITTED OR REDACTED FROM VERSION OF THIS EXHIBIT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION BECAUSE IT BOTH (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED
Amendment Form
| Amendment No. |
| 1 |
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| Amendment Submission Date: |
| November 17, 2020 |
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| Sponsor: |
| CryoLife, Inc. |
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| Study Title: |
| Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT Xa) |
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| Sponsor Contact: |
| Brittanny Boyer, Associate Director, New Technology, Clinical Research |
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| DCRI Contacts: |
| Alma Chavez, Project Leader Clinical Operations Dawn Goodwin, Grants and Proposals Analyst III, Grants and Proposals Services |
CryoLife, Inc. (“Sponsor”) and Duke University (“Duke” or “DCRI”) entered into a Clinical Research Agreement (the “Agreement”), effective October 10, 2019, to conduct the PROACT Xa - Prospective Randomized On-X Anticoagulation Clinical Trial. This Amendment No. 1 serves as an amendment to the Agreement and provides details related to the scope changes and associated budget adjustments.
Description of Scope Changes: The budget for this Amendment is detailed in Attachment 1: “DCRI Detailed Fees and Pass-through Cost Estimate” (the “Amended Budget”). Attachment 1 to this Amendment No. 1 hereby replaces the budget table titled “Star-Up Agreement 7th Extension thru Full Study Budget 10/8/2019” in its entirety.
Changes to Study Timeline: This Amendment to the Agreement includes [ ]as shown in the revised study timeline table below:
Original Study Timeline in the Agreement:
| Study Timeline (Clinical Research Agreement) | ||
| General Study Milestones | Number of Months | Date |
| Planning/Startup |
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| Enrollment |
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| Treatment/Follow-up |
| [OMITTED] |
| Last CRF In-house/Database Lock |
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| Close Out/Archival/Stat Report |
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| Final Reporting |
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| TOTAL PROJECT DURATION: |
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Revised Study Timeline:
| Study Timeline (Amendment to the Clinical Research Agreement) | ||
| General Study Milestones | Number of Months | Date |
| Planning/Startup |
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| Enrollment |
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| Treatment/Follow-up |
| [OMITTED] |
| Last CRF In-house/Database Lock |
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| Close Out/Archival/Stat Report |
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| Final Reporting |
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| TOTAL PROJECT DURATION: |
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Description of Budget Change Summary:
| | Original SUA Through Clinical Research Full Budget | Amendment No. 1 to the Clinical Research Agreement | Revised Contract Value |
| DCRI Direct Fees |
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| Pass-through Costs |
| [OMITTED] |
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| Total |
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Description of Scope Changes: The DCRI budget for Amendment is detailed in Attachment I: “DCRI Detailed Fees and Pass-through Cost Estimate in the “Scope Change Justification” column.
The budget includes a correction of $12,509.16 for a credit that was erroneously included in the Start-Up Agreement (SUA).
DCRI will invoice completed units on a monthly basis pursuant to the terms of the Agreement, provided, however, no additional upfront payment shall be required with respect to the budget increases reflected in this Amendment No. 1.
Approval Signatures:
| CryoLife, Inc.:
By: __/s/ Pat Mackin___________________
Title: __President and CEO_________________
Date:_December 4, 2020_____________________________ | Duke University:
By: __/s/ Aimee Turner________________
Title: __Chief Financial Officer, DCRI____
Date:_Dec. 8, 2020__________________________ |
Attachment 1: “DCRI Detailed Fees and Pass-through Cost Estimate.”
[OMITTED]
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