Amendment No. 2 to Clinical Research Agreement between Artivion, Inc. and Duke University for PROACT Xa Trial
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Summary
This amendment updates the clinical research agreement between Artivion, Inc. (formerly CryoLife, Inc.) and Duke University for the PROACT Xa clinical trial. It reflects the sponsor's name change, revises the study timeline, and replaces the previous budget with a new detailed cost estimate. The amendment clarifies that Duke will invoice monthly for completed work, with no additional upfront payment required for the increased budget. All other terms remain unchanged unless specified. The amendment is effective as of January 20, 2022, upon approval by both parties.
EX-10.13(B) 5 aort-20221231xexx1013b.htm EX-10.13(B) Document
Exhibit 10.13(b)
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. | 2 | ||||
Amendment Submission Date: | January 20, 2022 | ||||
Sponsor: | Artivion, Inc. (formerly CryoLife, Inc.) | ||||
Study Title: | PROACT Xa - Prospective Randomized On-X Anticoagulation Clinical Trial | ||||
Sponsor Contact: | Brittanny Boyer, Director, Aortic Repair Technologies | ||||
DCRI Contacts: | Alma Chavez, Project Leader Clinical Operations Dawn Goodwin, Sr. Grants and Proposals Analyst, 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. 2 serves as an amendment to the Agreement and provides details related to the scope changes and associated budget adjustments.
Name Change: Sponsor has changed its name effective January 18, 2022, and shall henceforth be known as Artivion, Inc. for purposes of the Study and the Agreement.
Description of Scope Changes: The budget for this Amendment is detailed in Attachment 1: “DCRI Detailed Fees and Pass-through Cost Estimate.” Attachment 1 to this Amendment No. 2 hereby replaces the budget table included in Amendment No 1 titled “Start-Up Agreement 7th Extension thru Full Study Budget 11/1/2020” in its entirety.
Changes to Study Timeline: This Amendment to the Agreement includes an
]. The treatment/follow-up period was decreased to offset the additional months of enrollment.
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7156-CRYL-01-Amendment No. 2 to the CRA
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Current Study Timeline in the Agreement:
| Study Timeline (Amendment No. 1) | ||||||||
| General Study Milestones | Number of Months | Date | ||||||
Planning/Startup | ||||||||
| Enrollment | ||||||||
| Treatment/Follow-up | ||||||||
| Last CRF In-house/Database Lock | ||||||||
Close Out/Archival/Stat Report | ||||||||
| Final Reporting | ||||||||
| TOTAL PROJECT DURATION: | ||||||||
Revised Study Timeline:
| Revised Study Timeline (Amendment No. 2) | ||||||||
| General Study Milestones | Number of Months | Date | ||||||
| Planning/Startup | ||||||||
| Enrollment | ||||||||
| Treatment/Follow-up | ||||||||
| Last CRF In-house/Database Lock | ||||||||
| Close Out/Archival/Stat Report | ||||||||
| Final Reporting | ||||||||
| TOTAL PROJECT DURATION: | ||||||||
Description of Budget Change Summary:
| Original SUA Through Amendment No. 1 | Amendment No. 2 | Revised Contract Value | |||||||||
| DCRI Direct Fees | |||||||||||
| Pass-through Costs | |||||||||||
| Total | |||||||||||
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 DCRI will invoice completed units on a monthly basis. All payments remain as agreed upon as in the Agreement unless otherwise stated.
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. 2.
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7156-CRYL-01-Amendment No. 2 to the CRA
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Approval Signatures:
Artivion, Inc.: By: ______________________________ Title:______________________________ Date:______________________________ | Duke University: By: ____________________________ Title: ___________________________ Date:___________________________ | ||||
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7156-CRYL-01-Amendment No. 2 to the CRA
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Attachment 1: “DCRI Detailed Fees and Pass-through Cost Estimate.”
[Omitted]
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7156-CRYL-01-Amendment No. 2 to the CRA
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