Change Order No. 2 to Clinical Research Agreement between ARCA biopharma Inc. and Duke University

Summary

ARCA biopharma Inc. and Duke University have agreed to Change Order No. 2, amending their existing Clinical Research Agreement for the GENETIC-AF study. This change order updates the project’s scope and budget, as detailed in an attached fee estimate, but does not alter the study timeline. Payments and invoicing terms remain as previously agreed unless otherwise specified. The amendment is effective upon signature by both parties’ authorized representatives.

EX-10.1 2 abio-ex101_20150331151.htm EX-10.1

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended

Exhibit 10.1

Change Order Form

Change Order No.: 2

Change Order Submission Date:10 March 2015

Sponsor: ARCA biopharma Inc. (“Sponsor”)

Study Drug/Protocol No.: BUC-CLIN-303

Study Title: GENETIC-AF (“Study”)

EPM#: 5969

SPS#: 200267

Sponsor Contact:

[*]

DCRI Contacts:

Project Leader:

[*]

Business Development:

[*]

Sponsor and Duke University (“Duke” or “DCRI”) entered in a Clinical Research Agreement (the “Agreement”), effective 05 November 2013, to conduct the above-referenced Project and Change Order No. 1 was executed November 2014. This Change Order No. 2 serves as an amendment to the Agreement and provides details related to scope changes and associated budget adjustments.

Description of Scope Changes: The budget for this Change Order No. 2 is detailed in Attachment 1: “DCRI Detailed Fees and Pass-through Cost Estimate,” and an explanation of the change is referenced in the column called “Justification for Revised Scope”. Unless otherwise noted, the unit costs remain the same.

Study Timeline

There are no changes to the timeline.

Description of Budget Change Summary:


Type	Contract Value through Change Order No. 1	Change Order No. 2 Value	Revised Total
DCRI Direct Fees	[*]	[*]	[*]
Pass-through Costs	[*]	-	[*]
Total	[*]	[*]	[*]

See attached budget file.

The DCRI will invoice completed units on a monthly basis. All payments remain as agreed upon as in the Agreement unless otherwise stated.

Approval Signature:

Sponsor:

By: /s/ Michael Bristow

Title: President / CEO – ARCA

Date: March 10, 2015

Duke University:

By: /s/ David S. Hill

Title: Assistant Director, Finance – DCRI

Date: March 13, 2015

Attachment 1

DCRI Detailed Fees and Pass-through Cost Estimate

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