Exhibit 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

FIRST AMENDMENT TO CLINICAL TRIAL COLLABORATION AGREEMENT

This First Amendment to Clinical Trial Collaboration Agreement (this
“Amendment”) is made and entered into as of June 15, 2014 (the “Amendment
Effective Date”) and amends the Clinical Trial Collaboration Agreement dated
April 18, 2013 (“Agreement”) between ARCA biopharma, Inc., a Delaware
corporation (hereinafter “ARCA”), and Medtronic, Inc., a Delaware corporation
(hereinafter “Medtronic”) (collectively, the “Parties”).

INTRODUCTION

ARCA is currently conducting the Phase 2B Study and has determined that changes
in the terms of the Agreement would improve the progress of the Phase 2B Study.
To that end, the Parties have agreed to modify the Agreement as provided in this
Amendment.

NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants contained herein, and other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, the parties hereby
agree as follows:

ARTICLE I

Terms defined in the Agreement have the same meaning when used in this
Amendment, except to the extent a term is defined differently in this Amendment.

ARTICLE II

Section 5.1 (a) of the Agreement is hereby deleted and replaced in its entirety
with the following:

(a) Medtronic will use its CareLink System and the Medtronic Devices implanted
in patients in the Phase 2B Study to support the collection and analysis of AF
burden data from up to 200 patients enrolled in the Phase 2B Study. [*] The AF
Burden Substudy Protocol will require that the patients in the Phase 2B Study
will either have an existing implanted Medtronic Device, or will have a Reveal
inserted as part of enrollment in the Phase 2B Study; provided, that up to [*]
of the patients in the Phase 2B study may be enrolled without having a Medtronic
Device implanted (“Non-Medtronic Device Patients”). Such non-Medtronic Device
Patients may include patients with no cardiac monitoring device of any kind, as
well as patients implanted with cardiac monitoring devices made by other
manufacturers. The AF Burden Substudy Protocol will also require that all
patients with implanted Medtronic Devices be enrolled in CareLink. Medtronic has
no obligation to provide CRMA Services in connection with Non-Medtronic Device
Patients.

ARTICLE III

Section 5.2 of the Agreement is hereby deleted and replaced in its entirety with
the following:

5.2 The Parties shall agree on an enrollment plan for the Phase 2B Study to
ensure that all patients eligible for the study are actively enrolled, including
those with existing Medtronic Devices and those willing to have a Reveal device
implanted. Eligible patients without a Medtronic Device will be implanted with a
Reveal without unreasonable delay. Medtronic shall ensure that sufficient Reveal
devices and patient monitors are reasonably available to ARCA in order to avoid
unreasonable delay in the enrollment process; provided, that ARCA shall be
responsible for distributing Reveals to the Study sites that require them.
Medtronic shall provide training and technical support for Medtronic Devices,
including training relating to insertion and use of Reveals, to the
investigators. Medtronic will support the reimbursement process for Reveals and
the patient monitors, including insertion and, if necessary, explantation, by
providing information about reimbursement opportunities to investigators. If
reimbursement for the Reveal device and patient monitor is denied for a patient
who receives one during enrollment in the Phase 2B Study after the implanting
physician has made reasonable efforts and cooperated with Medtronic in pursuit
of reimbursement, [*], taken in the order of reimbursement denial, [*]; and b)
only if required up to [*] for the cost of the explant procedure, and up to [*]
for explant physician fees per patient. The Parties agree that the payments made
by Medtronic hereunder: (a) are consistent with the fair market value of the

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applicable services and are inclusive of any and all applicable fees, personnel
costs, overhead and the like; and (b) have not been determined in a manner that
takes into account the volume or value of any referrals or business otherwise
generated between the Parties and any third party. The Parties also agree that
the payments made by Medtronic described in this Section 5.2 constitute the
complete and full compensation owed by Medtronic to ARCA for the work performed
under this Agreement and Medtronic shall not be liable to ARCA or to any third
party for any other payments which may be associated with this Agreement or with
any of the services provided hereunder. ARCA shall provide Medtronic with an
invoice along with accompanying documentation, in a form satisfactory to
Medtronic, of the contracted implant, explant and physician fees for which
payment is sought under this Section 5.2. All fees ARCA seeks for a given
patient shall be included on a single invoice. Medtronic is not required to make
any payment to ARCA for any invoice submitted hereunder until it has had the
required documentation for at least 30 days, and ARCA shall not submit invoices
to Medtronic more often than once every three months.

(a) In addition to the reimbursement process provided for in Section 5.2, ARCA
will have the right, but not the obligation, for the duration of the Study, to
purchase from Medtronic up to [*] of the latest version (available at the time
of purchase) of Reveal devices for use in the Phase 2B study patients, at the
price of [*] per Reveal LINQ System. The price charged in this Agreement is the
confidential information of Medtronic. ARCA may negotiate agreements with
particular Phase 2B study sites, under which any such site may receive Reveal
LINQ Systems purchased and distributed by ARCA. ARCA shall not charge study
patients or sites for any Reveal LINQ Systems so purchased and distributed by
ARCA, and shall obtain the site’s agreement not to seek reimbursement for such
Reveal LINQ Systems. Medtronic’s obligation in Section 5.2, to cover certain
unreimbursed Reveal implant and explant costs for up to [*] Study patients, will
be reduced by 1 patient for each Reveal LINQ System provided pursuant to the
terms of this Section 5.3. In addition, Medtronic shall have no obligation to
provide either reimbursement or reimbursement assistance for any implant or
explant costs associated with any Reveal LINQ System distributed by ARCA
pursuant to this Section 5.2 (a).

(b) ARCA agrees to engage Medtronic’s [*] to assist ARCA and ARCA’s CRO (the
Duke Clinical Research Institute (“DCRI”) in the support of Phase 2B study site
identification and activation, and patient identification and enrollment in the
Study, pursuant to the terms attached hereto as Exhibit A-1. The Parties may add
additional services to this Agreement by written amendment, including by adding
an additional Exhibit A, (e.g., Exhibit A-2) that has been signed by both
Parties. The Parties understand and agree that all services provided pursuant to
this Section 5.2 (b) are undertaken at the express direction of ARCA and DCRI,
and by providing such services Medtronic does not assume any obligations or
liabilities of a sponsor of GENETIC-AF. ARCA shall indemnify, defend and hold
harmless Medtronic, its respective trustees, officers, agents and employees
(collectively “Indemnitees”) against any third part claims, actions, suits or
judgments (“Claims”) made or instituted against Indemnitees that are premised on
the claim that by virtue of the services provided pursuant to this section
5.2(b) Medtronic is a sponsor of GENETIC-AF, except to the extent the recovery
in a Claim is caused by Medtronic performing services beyond the scope of the
services for which ARCA retains Medtronic pursuant to this section.

ARTICLE IV

4.1 The following is added to the Agreement as a new Article XII:

ARTICLE XII

REVEAL SALE AND DISTRIBUTION

12.1 Reveal devices provided pursuant to this Agreement will be ordered from
Medtronic by ARCA on behalf of the Genetic-AF study sites in a mutually agreed
manner, shipped by Medtronic to ARCA. Medtronic will pay the shipping costs
incurred to ship to ARCA and risk of loss passes upon shipment. ARCA shall
distribute the Reveal devices to the study sites at its own expense. Medtronic
will provide Reveal devices to ARCA solely for use under Sections 5.2, 5.2(a)
and 5.4 of this Agreement, and ARCA shall only distribute such devices to study
sites that require them for the Genetic-AF study.

12.2 ARCA represents and warrants it will not, and will not allow sites
participating in the Genetic-AF study to use the Reveal devices provided by
Medtronic pursuant to this Agreement for any purpose other than the Genetic-AF
study. ARCA is responsible for the proper care, maintenance, loss, theft or
mysterious disappearance of the Reveal devices provided to ARCA under this
Agreement. ARCA shall return to Medtronic all Reveal devices unused by study
sites as soon as practicable after the completion of the each phase of the
Genetic-AF study, unless the Parties agree in writing to maintain the devices at
a different location for use in the Phase 3 Portion.

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[ * ] = 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

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12.3 ARCA represents and warrants that it will have agreements in place with
study sites that require study sites to use the Reveal devices only for the
purpose of the study, not bill health insurers for the Reveal devices ARCA
purchases from Medtronic, obtain review and approval of the Genetic-AF study
from an ethics committee, and obtain informed consent from study subjects.

12.4 ARCA shall not decompile, reverse engineer, disassemble or otherwise
analyze any portion of the Reveal devices or Reveal LINQ Systems provided by
Medtronic hereunder.

12.5 THE REVEAL DEVICES AND REVEAL LINQ SYSTEMS PROVIDED TO ARCA BY MEDTRONIC
HEREUNDER ARE PROVIDED “AS-IS”, WITHOUT ANY WARRANTY OF ANY KIND, INCLUDING
WITHOUT LIMITATION THE WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR WARRANTY THAT THE USE OF THE MEDTRONIC MATERIALS WILL NOT INFRINGE
ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER RIGHT OF ANY THIRD PARTY.

12.6 ARCA shall indemnify, defend and hold harmless Medtronic, its respective
trustees, officers, agents and employees (collectively “Indemnitees”) against
any third part claims, actions, suits or judgments (“Claims”) made or instituted
against Indemnitees to the extent they are caused by ARCA’s purchase and
distribution of the Reveal devices and Reveal LINQ Systems hereunder, except to
the extent the recovery in a Claim is caused by an act or omission of Medtronic.

12.7 ARCA shall assist and cooperate with Medtronic with respect to fulfillment
of Medtronic’s legal and regulatory obligations applicable to Reveal devices and
Reveal LINQ systems provided hereunder, such as FDA complaint reporting, device
tracking and recall assistance. Upon termination or expiration of this Agreement
or the Genetic-AF study, ARCA shall return all unused Reveal devices and Reveal
LINQ Systems to Medtronic within 30 days of such termination or expiration. ARCA
is not entitled to a credit for such returns.

Article v

MISCELLANEOUS

5.1 This Amendment may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and
the same instrument.

5.2 Except as expressly and specifically amended herein, all other provisions of
the Agreement shall continue in full force and effect.

IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed
by their duly authorized representatives as of the Amendment Effective Date.

 

 

 

MEDTRONIC, INC., a Minnesota corporation

 

 

 

 

Date: July 27, 2014

 

By:

/s/ Richard L. Clark

 

 

 

Name: Richard L. Clark

 

 

 

Title: Senior Director Diagnostics

 

 

 

ARCA BIOPHARMA, INC., a Delaware corporation

 

 

 

 

Date: July 28, 2014

 

By:

/s/ Michael Bristow

 

 

 

Michael Bristow

 

 

 

Chief Executive Officer

 

 

 

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[ * ] = 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

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Exhibit A-1

[*]

 

4

[ * ] = 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