[*] = 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 10.64

User SAP Number:                    

Region:                     

 

CANADIAN ADDENDUM

TO THE CLINICAL TRIAL COLLABORATION AGREEMENT
BETWEEN MEDTRONIC AND ARCA

 

This addendum (“Addendum”) is to the Clinical Trial Collaboration Agreement (the
“Collaboration Agreement”) made and entered into as of April 18, 2013 between
ARCA biopharma, Inc., a Delaware corporation (hereinafter “ARCA”) and Medtronic,
Inc., a Minnesota corporation (hereinafter “Medtronic”), as amended by the
Second Amendment to the Collaboration Agreement entered as of August 28, 2014.
This Addendum is for the purpose of supply and distribution of Medtronic devices
and CareLink services within Canada under the Collaboration Agreement.

 

 

This Addendum is made as of Feb. 4th, 2015 by and between:

 

Medtronic of Canada Ltd., a corporation organized under the laws of Canada
having its principal place of business at 99 Hereford Street, Brampton, Ontario
L6Y 0R3 (“Medtronic Canada”);

 

ARCA; and

 

Medtronic

 

 

WHEREAS, ARCA and Medtronic have entered into the Collaboration Agreement with
respect to GENETIC-AF and the Phase 2B Study;

 

WHEREAS, ARCA wishes to select and activate approximately [*] investigational
sites in the Phase 2B Study, and approximately [*] additional centres will be
added  for the Phase 3 component (as applicable if ARCA carries out the Phase 3
component), for a total of [*] sites, located primarily in the United States and
Canada.

 

WHEREAS, the Parties wish to arrange for the supply and distribution of
Medtronic Reveal devices and Medtronic CareLink services to investigational
sites within Canada under the Collaboration Agreement;

 

WHEREAS, Medtronic Canada is engaged in the business of selling and distributing
Medtronic Devices and CareLink services in Canada;

 

NOW THEREFORE, for good and valuable consideration the Parties agree to
supplement and modify the terms and conditions of the Collaboration Agreement as
follows with respect to investigational sites in Canada:

 

1.Definitions: Except as otherwise defined in this Addendum, all other
capitalized terms shall have the meaning ascribed to them in the Collaboration
Agreement. For the purpose of this Addendum, the following capitalized terms
have the following respective meaning:

 

1.1

“CareLink” or the “CareLink System” means Medtronic’s proprietary remote
monitoring service that provides secure access to data from patients who have
certain Medtronic cardiac medical device implants, including Reveal, that is
currently marketed by Medtronic in Canada under the “Medtronic CareLink”®
trademark.

 

1.2

“De-identify” and “De-identification” mean removal of information that
identifies individuals in a manner that conforms with Canadian Privacy Laws.

 

1.3

“Effective Date” means the date when this Addendum is executed by all Parties;  

 

1.4

“Eligible Patient” means, for the purpose of this Addendum, any patient selected
who (i) meets the criteria for participating in Phase 2B Study, the AF Burden
Substudy, or the Phase 3 Portion, as the case may be, (ii) who has signed the
corresponding REB approved patient informed consent form, and (iii) who has
signed the

 

1

--------------------------------------------------------------------------------

 

Medtronic CareLink network enrolment consent form in accordance with the terms
of use between Medtronic Canada and investigational sites in Canada using
CareLink network services for the commercial use of Medtronic Devices, in a form
substantially similar to Addendum Exhibit B.

 

1.5

“Governmental Authority” means any applicable federal, provincial, local or
other governmental body with jurisdiction over the applicable subject matter.

 

1.6

“Health Canada” means the Therapeutic Products Division of Health Canada.

 

1.7

“Party” means ARCA or Medtronic or Medtronic Canada or either one of them, and
“Parties” mean all of them.

 

1.8

“Privacy Laws” means Canadian federal and provincial legislation and regulations
with respect to the protection of personal information in Canada and in the
relevant province, as applicable, where the Canadian investigational site is
located that is transmitting a study subject’s CareLink Data, including the
federal Personal Information Protection and Electronic Documents Act (Canada),
the British Columbia Freedom of Information and Protection of Privacy Act, the
Alberta Health Information Act, the Ontario Personal Health Information
Protection Act and the Quebec Act respecting the Protection of Personal
Information in the Private Sector.

 

1.9

“Regulatory Authority” means, for purposes of this Addendum when used herein or
in the Collaboration Agreement, any Governmental Authority with jurisdiction
over drug products or medical devices intended for human use in Canada,
including the Therapeutic Products Division of Health Canada.

 

1.10

“Reveal LINQ System” means the Reveal LINQ insertable cardiac monitor, patient
assistant device and MyCareLink™ patient monitor.

 

2.Adherence to Obligations in the Collaboration Agreement. This Addendum is
intended to supplement the Collaboration Agreement with respect to the supply
and distribution of Medtronic Reveal devices and CareLink services to
investigational sites within Canada. For greater clarity, this means that this
addendum does not modify the Collaboration Agreement with respect to the conduct
of the study anywhere outside Canada. This Addendum shall only be read into the
Collaboration Agreement with respect to the conduct of the study within Canada
at Canadian participating sites or dealings with Governmental Authorities in
Canada.

 

3.Product Supply and Distribution.

 

3.1As between the Parties, Medtronic Canada is responsible for the distribution,
shipment and supply of the Reveal LINQ Systems to the investigational sites in
Canada under the Collaboration Agreement. [*], the Reveal LINQ insertable
cardiac monitors and patient assistant devices intended to be distributed to
investigational sites in Canada under the Collaboration Agreement, and Medtronic
Canada shall provide the use of a MyCareLink patient home monitor with each
Reveal LINQ insertable cardiac monitor, [*] per Reveal LINQ System in accordance
with Section 5.2(a) of the Collaboration Agreement, [*]. Medtronic Canada shall
ship such Reveal LINQ Systems to the investigational sites in Canada as directed
from time to time by ARCA.

 

3.2ARCA will issue a purchase order request to Medtronic Canada specifying the
location where Reveal LINQ Systems are to be delivered (“Bill To: ARCA / Ship
to: [specified investigational site(s) in Canada]”) in order to supply and
resupply each investigational site with the number of products needed in Canada.
ARCA will provide Medtronic Canada with the following information that Medtronic
Canada will include as notes in the shipping documents with each product
shipment to help ensure that Reveal devices are used only in the relevant study:
Study Name, Study Coordinator, Room Number of Study Coordinator, Phone Number of
Study Coordinator.

 

Purchase Orders to be sent to:

Medtronic of Canada Customer Service

Tel# [*]

Fax# [*]

[*]

 

With a copy to:

Ms Kathy Schreiber

Marketing Manager of Cardiac Diagnostics and Monitoring

Fax# [*]

[*]

 

2

[*] = 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

 

 

--------------------------------------------------------------------------------

 

 

3.3Medtronic Canada shall ship the requested number of Reveal LINQ Systems to
the designated participating sites in Canada so that the devices are received no
more than 2 working days after Medtronic Canada’s receipt of ARCA’s purchase
order.

 

3.4Upon shipment, Medtronic Canada shall invoice to ARCA directly such Reveal
LINQ Systems ordered by it from time to time under this Addendum, and ARCA shall
pay such invoices to Medtronic Canada directly. Medtronic Canada shall provide
ARCA with an invoice along with accompanying documentation, in a form
satisfactory to ARCA. [*] Unless the Parties agree to use different terms, all
invoices by Medtronic Canada to ARCA shall be addressed to:

 

ARCA biopharma, Inc.,

11080 CirclePoint Rd., Suite 140

Westminster, Colorado 80020

United States

 

to the attention of:  Accounts Payable

Telephone:             [*]

Email:                     [*]

 

3.5Medtronic Canada will pay the shipping costs incurred to deliver the Reveal
LINQ Systems to investigational sites in Canada. Risk of loss of the Reveal LINQ
Systems passes to ARCA upon shipment.

 

3.6Title to the Reveal LINQ insertable cardiac monitor devices and to the
corresponding patient assistant devices shall transfer from Medtronic Canada to
the investigational site at the same time as the transfer of risk of
loss.  There is no title transfer for the CareLink Service, or the MyCareLink
patient home monitors provided as part of a Reveal LINQ System.  Medtronic
Canada retains title to the MyCareLink patient home monitor and patient receives
a license to use them.

 

3.7Payment of the service fees and reimbursable expenses set out in Section 7.2
of this Addendum will be made in Canadian dollars (CAD). Any and all training
services performed and expenses incurred by Medtronic Canada under this Addendum
shall be invoiced to ARCA within a reasonable time after their performance or
being incurred.  ARCA reserves the right not to pay invoices received more than
one year after the date of performance of the corresponding service.

 

3.8Payments under this Addendum will be subject to Goods and Services Tax,
Harmonized Sales Tax and/or Provincial Sales Tax, as applicable.

 

3.9ARCA shall send payments to Medtronic Canada by electronic funds transfer to
the follow address, unless the Parties agree to use a different address for
payment:

 

Name:[*]

Address: [*]

 

[*]

 

Phone: [*]

 

Medtronic of Canada contact for payment questions:

Louise Thurston

[*]

Phone: [*]

 

Medtronic GST #: [*]

 

All payments shall be made by bank transfer to the account number provided by
Medtronic Canada in writing at least thirty (30) days before payment is due. Any
and all costs related to the bank transfer in Canada shall be borne by Medtronic
Canada.  ARCA is not responsible for additional expenses and commissions charged
by the bank(s) of the recipient.

 

3.10ARCA shall provide Medtronic Canada with a complete list of the Canadian
investigational sites and investigators and their addresses, including telephone
numbers, which shall be annexed to this Addendum as Addendum

 

3

[*] = 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 A as the information becomes available.  The Parties will date and
initial the Addendum Exhibit A as it is added to this Addendum, and ARCA may
update Exhibit A from time to time as new sites are added or new information
becomes available.

 

3.11ARCA shall only order from Medtronic Canada such devices for investigational
study sites in Canada that require them for the Phase 2B Study, including the AF
Burden Substudy, or the Phase 3 Study.

 

3.12ARCA’s obligation to pay to Medtronic Canada purchase price or services fees
and expenses due under this Addendum survives termination and expiration of this
Addendum.

 

3.13Each of ARCA and Medtronic Canada shall designate at least one person to act
as the primary contact for the Party for this Addendum and shall direct their
communications relating to this Addendum through that person.  Medtronic Canada
designates Kathy Schreiber, Marketing Manager of Cardiac Diagnostics and
Monitoring, and ARCA designates Laura Emery, Senior Director, Clinical
Operations.  A Party can change its designation by notifying the other party in
writing. To support adequate product supply, ARCA shall provide Medtronic Canada
with a provision/distribution plan per Canadian investigational site
approximately one month prior to study start, and shall provide an updated
version promptly after changes in the enrolment forecast.  Such plans and
forecasts are not binding on ARCA, who is not obligated to purchase the number
of Reveal LINQ Systems forecasted. ARCA will collaborate with Medtronic Canada
and mutually agree on the amount of product to be stocked at individual Canadian
participating sites to minimize product waste and inventory costs.

 

 

4.CRMA Services.

 

4.1As between the Parties, Medtronic Canada shall not be providing CRMA
Services, which shall be performed solely by Medtronic. Medtronic Canada does
not have the ability to provide the collection and analysis services
contemplated by the CRMA Services with respect to study subjects enrolled by
investigational sites in Canada, though Medtronic does have that ability per the
Collaboration Agreement, including with respect to study subjects enrolled by
Canadian investigational sites.

 

4.2[*] Medtronic Canada is not obligated to provide CareLink Services to an
investigational site that does not have a current CareLink Network Services
Agreement in place.

 

4.3If the CareLink Primary User for an Eligible Patient is not the investigator
selected by ARCA prior to the Eligible Patient starting his or her participation
in the study, ARCA shall arrange for the existing CareLink Primary User to
adjust the CareLink settings so that ARCA’s selected investigator becomes the
CareLink Primary User. ARCA acknowledges that Medtronic Canada does not change
CareLink settings for physician users and ARCA’s failure to arrange for the
investigator to be the CareLink Primary User for the Eligible Patient means
Medtronic Canada cannot provide CareLink Services for the study for that
patient.

 

5.Conduct of GENETIC-AF.

 

5.1A new section 2.2(a)(1) is added to the Collaboration Agreement as follows:

 

“(a) ARCA shall conduct GENETIC-AF at no cost to Medtronic Canada. GENETIC-AF
shall be conducted in accordance with the requisite approvals of the FDA and
Health Canada and according to the Protocol, provided that the Protocol may be
revised based on the determination of the Steering Committee as a result of
Regulatory Authority guidance or other factors.”

 

5.2Section 2.2(b) of the Collaboration Agreement is replaced for the purposes of
this Addendum by the following:

 

“(b) The sponsors of GENETIC-AF shall comply with all applicable laws and
regulations governing sponsors of clinical trials and shall be responsible for
complying with agreements with the institutions representing the investigational
sites, and providing appropriate information to and monitoring of the
investigators so that GENETIC-AF is performed by those investigators in
conformance with generally accepted standards of good clinical practice, with
the protocol and with all applicable local, state, provincial and federal laws
and regulations governing the performance of clinical investigations, including,
but not limited to, the United States Food, Drug and Cosmetics Act and the
regulations of the FDA, the Canada Food and Drugs Act and its regulations, and
guidances issued by Health Canada. ARCA shall be responsible for and have the
sole responsibility to conduct all regulatory activities to secure FDA Approval,
and Health Canada authorization, of GENETIC-AF.”

 

 

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

 

 

--------------------------------------------------------------------------------

 

5.3An additional sentence of Section 2.2(c) of the Collaboration Agreement is
added as follows:

 

“Additional support from Medtronic Canada for investigational sites in Canada
requires prior mutual agreement of ARCA and Medtronic Canada.”

 

5.4An additional sentence of Section 2.2(c) of the Collaboration Agreement is
added as follows:

 

“Medtronic Canada shall not be responsible for the payment of any costs relating
to the conduct of GENETIC-AF at Canadian investigational sites, whether direct
or indirect.”

 

5.5A new Section 2.2(d)(1) of the Collaboration Agreement is added as follows:

 

“(d) ARCA shall include in the informed consent and research authorizations
required to be signed by GENETIC-AF participants the appropriate language to
permit the Parties to have access to and utilize the data as provided in this
Agreement, in particular the right to use the De-identified Study Data, the
CareLink Data and the Combined Study Data for research and commercial purposes
pursuant to Sections 3.1, 3.2 and 3.3, respectively, and in compliance with
federal and provincial Privacy Laws applicable in Canada.”

 

6.General; CRMA Committee.

 

6.1Section 4.3(c) of the Collaboration Agreement is amended for the purposes of
this Addendum by adding the following sentence at the end:

 

“In addition, in connection with any such regulatory submissions to Health
Canada regarding the Drug Product, the Parties agree that the CRMA Committee or
ARCA, as the case may be, shall also consult with Medtronic Canada concerning
such filings and coordinate any input from Medtronic Canada in the filings as
necessary or advisable.”

 

6.2If the Parties fail to reach agreement on a matter related to Section 6.1 of
this Addendum (including the substantive elements of Section 4.3(c) of the
Collaboration Agreement, as amended by this Addendum with respect to regulatory
submissions to Health Canada), then any Party may by written notice to the other
Parties invoke the dispute resolution procedure set forth in Article X, unless
otherwise indicated in the Collaboration Agreement.

 

7.Phase 2B Study; CRMA Services.

 

7.1An additional sentence of Section 5.1(a) of the Collaboration Agreement is
added as follows:

 

“The AF Burden Substudy Protocol will also require that all patients be enrolled
in CareLink and have consented prior to their CareLink Data transmission to the
standard CareLink Network Services Agreement consent form reproduced in Addendum
Exhibit B.”

 

7.2A new Section 5.1(b) (1) of the Collaboration Agreement is added, as follows:

 

“(b) The investigator nomination criteria for investigational sites in Canada
will (i) require that all candidates are at an investigational site that has an
active existing CareLink Network Services Agreement in force, and (ii) either
require that all candidates are CareLink users or attempt to determine which
investigators are not CareLink users. Medtronic Canada shall provide training to
investigators on the implantation of the Reveal device prior to performing this
procedure if they are not already trained, at no charge to ARCA. Upon request,
Medtronic Canada will provide documentation to ARCA attesting the training
provided to clinical Investigators on the implantation of the Reveal device. In
the case of investigators that are not CareLink services users, upon prior
written request by ARCA to Medtronic Canada specifying the name(s) and
institution of study personnel to be trained, Medtronic Canada shall provide
additional training services for investigators who are not CareLink users on the
use of the CareLink network,  the MyCareLink patient home monitors or the
CareLink website, and Medtronic Canada shall charge service fees for such
training at Medtronic’s standard rate of [*] plus applicable taxes, and
reimbursement of expenses incurred by Medtronic Canada if training is requested
to be provided on site. If a CareLink trainer must provide the training on site,
all reasonable travel, lodging and meal expenses incurred by the trainer to
deliver such CareLink training shall be reimbursed by ARCA to Medtronic. An
estimate of airfare expenses must be approved in advance by ARCA in writing. All
such expenses shall be duly justified by Medtronic Canada with the corresponding
receipts or invoices in order to be reimbursed.

 

5

[*] = 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

 

 

--------------------------------------------------------------------------------

 

Consistent with Medtronic Canada’s own travel and expense policy:

·

Airfare shall be reimbursed for economy class (coach) fare only.

·

Mileage will be reimbursed at the rate of $ 0.50/ kilometer.

·

Medtronic Canada may not submit gasoline bills in addition to the per kilometer
rate.”

 

7.3An additional paragraph shall be added to Section 5.2 of the Collaboration
Agreement as follows:

 

“Medtronic and ARCA 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, who agree to have a new
device implanted, will be implanted with a Reveal without unreasonable delay.
Medtronic Canada shall ensure that sufficient Reveal devices and MyCareLink
patient monitors are reasonably available to ARCA’s Phase 2B Study
investigational sites in Canada in order to avoid unreasonable delay in the
enrollment process, and Medtronic Canada shall be responsible for distributing
Reveals to the Study sites in Canada that require them based on device orders
from ARCA. Medtronic Canada shall provide training and technical support for
Medtronic Devices, including training relating to insertion and use of Reveals.
Medtronic Canada shall provide training on CareLink services to investigators at
Canadian investigational sites who are not pre-existing CareLink users upon
prior written request by ARCA to Medtronic Canada at its standard service fees
set out in Section 5.1(b) above. [*], given that there are no approved fee codes
in Canada for the reimbursement of the Reveal devices or MyCareLink patient
monitors, and most provinces do not have codes for Reveal insertion or
explantation procedures and related physician fees. As between the Parties, [*]
The Parties agree that Medtronic Canada shall not owe compensation to ARCA for
the work performed by Medtronic Canada under this Agreement and Medtronic Canada
shall not be liable to the other Parties or to any third party for any other
payments which may be associated with the Collaboration Agreement, including
this Addendum, or with any of the services provided hereunder.”

 

7.4An additional sentence shall be added to the end of Section 5.2(b) of the
Collaboration Agreement as follows:

 

“ARCA agrees to engage Medtronic Canada’s CRHF Patient Management Services to
assist ARCA in support of Phase 2B Study and Phase 3 Portion site
identification, as applicable.”

 

7.5As between the Parties, with respect to Section 5.3(e) and Section 5.4 of the
Collaboration Agreement and consistent with Section 4 of this Addendum,
Medtronic shall provide the mutually agreed analysis assistance to ARCA on the
CareLink Data, and the CRMA Services, rather than Medtronic Canada.

 

7.6The following sentence shall be added to Section 5.4 of the Collaboration
Agreement: “Medtronic support for the reimbursement process for Reveal and the
MyCareLink patient monitors shall not apply to Genetic AF Canadian sites.

 

7.7A new Section 5.5(a)(1) of the Collaboration Agreement shall be added as
follow:

 

“(a) ARCA will, through the CRMA Committee, involve Medtronic in all regulatory
communications and actions that implicate Medtronic’s rights and duties under
this Agreement, or that implicate the use of Medtronic Devices, and shall
provide a copy to and involve Medtronic Canada where those regulatory
communications concern a Regulatory Authority as defined under this Addendum.
Medtronic will consult on the regulatory process related to conducting
GENETIC-AF, as reasonably requested by ARCA. The Parties do not believe that an
Investigational Device Exemption (“IDE”) or an Investigational Testing
Authorization under the Food and Drugs Act (Canada) will be necessary in order
to use Reveal in the Phase 2B Study, and the Protocol shall not be amended in a
way that will require use of Reveal in a manner inconsistent with FDA approval
of Reveal, or Health Canada licenses pertaining to the Reveal devices, the
MyCareLink patient home monitor, or the CareLink network system. Medtronic,
however, agrees to file and prosecute any regulatory application or submission
that in Medtronic’s sole judgment is required by any Regulatory Authority in
order for Medtronic to perform the CRMA Services required by this Agreement.”

 

7.8A new Section 5.5(b)(1) of the Collaboration Agreement shall be added as
follows:

 

“(b) ARCA will consult with, and allow participation by Medtronic on a
reasonable basis regarding the content of any submissions to Regulatory
Authorities (as defined in this Addendum) related to the GENETIC-AF trial or any
Drug Product Application to the extent it involves the CRMA Services, Medtronic
Devices, or the Medtronic Field of Use; provided that, as between the Parties,
Medtronic Canada shall file with Health Canada all required Medical Device
Problem Reports (initial and final reports) regarding Medtronic Devices that
arise in the course of conducting Phase 2B Study or the Phase 3 Portion, and
shall file with Health Canada any required notice of field corrective

 

6

[*] = 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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action (“recall”) that affects Medtronic Devices used in the study, should such
a field action occur. ARCA will provide Medtronic with the opportunity to attend
or participate in all substantial contacts, including meetings and conference
calls between ARCA and the FDA, and ARCA and Health Canada, and any other
Regulatory Authority regarding the CRMA Services, Medtronic Devices, or the
Medtronic Field of Use. Medtronic will consult with, and allow participation by
ARCA on a reasonable basis regarding the content of any submissions to the FDA
related to the CRMA Services, and will provide ARCA with the opportunity to
attend or participate in all substantial contacts, including meetings and
conference calls, between Medtronic and the FDA or Health Canada related to the
CRMA Services. Medtronic is responsible for submitting reportable events
relating to Medtronic Devices to the relevant regulatory agencies. At
Medtronic’s request and as further specified in Section 12.7 of the
Collaboration Agreement (as amended for the purposes of this Addendum), ARCA
shall cooperate diligently with Medtronic in the investigation of medical device
complaints, and Medtronic shall determine their reportability under Medtronic’s
regulatory obligations as the device manufacturer. Notwithstanding the
foregoing, each Party shall notify the other Parties of any oral or written
communications to or from the FDA, or to or from Health Canada, on matters
relating to the CRMA Services or the Medtronic Devices used in the study(ies),
and shall provide the other Parties with copies of such communications
reasonably promptly and give the other Party the right to review and participate
in any response to any such communications.”

 

8.Inventions; Confidentiality; Publicity

 

8.1Section 6.1 of the Collaboration Agreement is amended for the purposes of
this Addendum by adding the following sentence at the end of the Section:

 

“For greater certainty, it is understood by the Parties that this joint
ownership means that each Party shall be free to do the following without
consent of the other joint owner(s), but subject to Section 6.2 : (i) utilize
the Joint Inventions as provided in this Agreement, (ii) assign all or any part
of its interest in a Joint Invention to an Affiliate or to a third party, or
(iii) license such Joint Inventions to any third party in their respective
fields of use in accordance with the Collaboration Agreement without having to
account to the other joint owner(s) for profits earned from licensing.”

 

9.Representations, Warranties and Covenants

 

9.1ARCA represents and warrants that all material consents, approvals and
authorizations of all Governmental Authorities and other persons required to be
obtained by ARCA, including any required Clinical Trial Authorization in
connection with the conduct of the GENETIC-AF trial, as applicable, have been
and shall be obtained by ARCA prior to initiating the Phase 2B Study, the AF
Burden Substudy or the Phase 3 Portion at a Canadian investigational site.

 

9.2The following sentence is added to Subsection 7.1(g) of the Collaboration
Agreement:  With respect to Medtronic’s activities with respect to any Canadian
site of Genetic-AF, 7.1(g) shall be read without including the word
“immunizations”.

 

10.Term and Termination

 

10.1This Addendum shall remain in force for the term of the Collaboration
Agreement, and expires upon expiration or earlier termination of the
Collaboration Agreement for any reason, provided that Medtronic Canada may
terminate this Addendum in whole or in part as provided below:

 

(a)

upon at least sixty (60) days written notice to the other Parties after Health
Canada advises any Party, or issues any written decision, pronouncement, or
other communication, including but not limited to letters, emails, website
information, final guidance documents, or final rulemaking, either to the
Parties or to Third Parties, which provides a reasonable basis for concluding
that Health Canada will not allow the GENETIC-AF study to enroll or proceed at
investigational sites in Canada; or

 

(b)

upon at least ten (10) days written notice given within thirty days after an
action, authorized or unauthorized, is taken by the Steering Committee, (e.g. an
amendment that (i) materially expands Medtronic Canada’s obligations hereunder
beyond those Medtronic Canada voluntarily undertakes by entering into this
Addendum, or (ii) causes the proposed use of the Medtronic Devices, the
MyCareLink patient home monitors or the CareLink network services to become
outside the scope of their respective licensed indications in Canada.

 

 

7

[*] = 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

 

 

--------------------------------------------------------------------------------

 

11. Notices. All notices to Medtronic Canada under this Addendum shall be in
writing and shall be deemed given and delivered, as and when provided in Section
11.12 of the Collaboration Agreement, if addressed to:

 

Address:

Medtronic Canada

99 Hereford Street

Brampton, Ontario

L6Y 0R3

Canada

Contact Person:

Ms Kathy Schreiber,
Marketing Manager of Cardiac Diagnostics and Monitoring

Phone:

[*]

Fax:

[*]

Email:

[*]

 

12Reveal Sale and Distribution.

 

12.1Section 12.1 of the Collaboration Agreement shall not apply to the
activities of Medtronic Canada.

 

12.2An additional sentence shall be added to Section 12.2 of the Collaboration
Agreement as follows:

 

“ARCA shall return to Medtronic Canada all Reveal devices unused by Canadian
investigational sites as soon as practicable after the completion of each phase
of the GENETIC-AF study, unless ARCA and Medtronic Canada agree in writing to
maintain the devices at a different location for use in the Phase 3 Portion.
Medtronic Canada shall credit up to two (2) Reveal devices per site provided
that (i) they are returned with at least 90 days remaining prior to their Use
Before Date shown on the Reveal device package, (ii) are in their original
packaging, unopened and undamaged and (iii) the seal of all implantable products
is not damaged or broken.”

 

12.3An additional sentence shall be added to Section 12.7 of the Collaboration
Agreement as follows:

 

“ARCA shall assist and cooperate with Medtronic Canada with respect to
fulfillment of Medtronic Canada’s legal and regulatory obligations applicable to
Reveal devices and Reveal LINQ Systems provided hereunder, such as Health Canada
complaint reporting, complaint investigation, medical device problem reporting,
device tracking pursuant to the provisions of the Food and Drugs Act (Canada)
and its regulations, and carrying out any field corrective actions (recalls)
that may affect Reveal devices and Reveal LINQ Systems sold to ARCA hereunder by
Medtronic Canada and shipped to Canadian investigational sites.  In particular,
in order to meet timelines for reporting to Health Canada, ARCA shall notify
Medtronic Canada as soon as possible, but in any event within 48 hours of
becoming aware of any reported any incident that comes to their attention
involving a device that is sold by Medtronic Canada under this Addendum and
that:

 

(a) is related to a failure of the device or a deterioration in its
effectiveness, or any inadequacy in its labelling or in its the directions for
use; and

 

(b) has led to the death or a serious deterioration in the state of health of a
patient, user or other person, or could do so were it to recur.

Medtronic Canada shall report these to Health Canada as and when required under
the post-market vigilance provisions of the Medical Devices Regulations. ARCA,
as sponsor, and/or ARCA’s clinical investigators shall report them to Research
Ethics Boards / Ethics Committees / Institutional Review Boards or other
recipients if and as required.

 

Medtronic Canada shall maintain complete and accurate records concerning the
post-market traceability of the Medtronic Devices purchased by ARCA. Medtronic
Canada shall maintain records concerning traceability for a minimum period
corresponding to the forecasted lifetime of the Medtronic Devices required to be
so registered. The device tracking system shall record or allow retrieval of
product information as needed to comply with all legal requirements applicable
to Medtronic in Canada, including information on all parties involved in the
product’s chain of distribution and its end user, as well as information on
product performance and safety record.”

 

 

8

[*] = 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

 

 

--------------------------------------------------------------------------------

 

13General Provisions.

 

13.1The Parties are independent contractors, personnel of each Party shall be
employees or agents of such Party and under no circumstances are such personnel
to be considered employees or agents of another Party. Each Party shall have the
sole responsibility for the conduct of its employees or agents, and for the
payment of their entire compensation, including salary, withholding of income
and social security taxes, workers’ compensation, employee and disability
benefits, unemployment insurance and the like.

 

13.2This Addendum may be executed in three (3) or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute
one and the same instrument.

 

13.3Except as expressly and specifically amended herein, all other provisions of
the Collaboration Agreement continue in full force and effect, including as to
the performance of the Collaboration Agreement at Canadian investigational
sites.

 

13.4This Addendum forms part of the Collaboration Agreement and is appended
thereto as its Appendix B.

 

 

 

 

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

 

 

MEDTRONIC:

 

MEDTRONIC, INC.

8200 Coral Sea St NE(MVS23)

Mounds View, MN 55112

United States

Attn:

Email:

Fax:

 

 

ARCA

 

ARCA biopharma, Inc.

11080 CirclePoint Rd, Suite 140

Westminster, Colorado 80020

United States

Attn:

Email:

Fax:

By    /s/ Richard Clark                                                   

 

Print Name    Richard Clark                                          

 

Print Title    Sr. Director                                                 

 

Date     2/4/15                                                                

 

By    /s/ Michael Bristow                                                

 

Print Name   Michael Bristow                                        

 

Print Title    President/CEO                                           

 

Date     2/4/15                                                                

 

 

 

9

[*] = 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

 

 

--------------------------------------------------------------------------------

 

 

MEDTRONIC CANADA:

 

Medtronic of Canada Ltd.

99 Hereford Street

Brampton, Ontario
L6Y 0R3

Canada

Attn: Geneviève Lavertu

 

Sr Director, Legal, Scientific Affairs & Business Development

 

Email : [*]

Fax: [*]

 

 

By:         /s/ Geneviève Lavertu                                         

Geneviève Lavertu

Sr Director, Legal, Scientific Affairs & Business Development

 

Date    February 3, 2015                                                    

 

 

 

10

[*] = 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

 

 

--------------------------------------------------------------------------------

 

 

CANADIAN ADDENDUM EXHIBIT A

 

 

 

Medtronic Canada Initials ____ARCA Initials ____

 

[Note: attach an Excel Spreadsheet here with at least the following information
for each Canadian participating site]

 

Participating Site name:Address:

 

 

 

Clinical Investigator name: Address including telephone number:

 

 

 

 

 

 

 

 

 

11

[*] = 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

 

 

--------------------------------------------------------------------------------

 

 

CANADIAN ADDENDUM EXHIBIT B

 

[Canadian CareLink services standard patient consent form]

 

 

 

INFORMED CONSENT

Collection, Use and Disclosure of Personal Health Information Relating to the
Medtronic CareLink Services and Monitors

 

Client shall obtain and maintain the required consent from all patients enrolled
in the Medtronic CareLink Services.  Said consent shall contain the following
information:

 

Medtronic intends to use the data collected through the Services for the
following purposes:

 

(a)make any and all uses and disclosures of PHI necessary to provide the
Services to Client;

 

(b)use the PHI in its possession for its proper management and administration
and to fulfill any legal responsibilities of Medtronic;

 

(c)disclose the PHI in its possession to a third party for the purpose of
Medtronic’s proper management and administration or to fulfill any legal
responsibilities of Medtronic; provided, however, that the disclosures are
required by law or Medtronic has received from the third party written
assurances that (i) the information will be held confidentially and used or
further disclosed only as required by law or for the purpose for which it was
disclosed to the third party; and (ii) the third party will notify Medtronic of
any instances of which it becomes aware in which the confidentiality of the
information has been breached;

 

(d)perform Data Aggregation for the Health Care Operations of Client;

 

(e)development of systems to enable physicians to deliver better services and to
enhance the performance of medical devices, utilizing only de-identified data;

 

(f)develop tools to improve medical devices, or to enhance the performance of
existing medical devices, utilizing only de-identified data;

 

(g)other research and public health initiatives analogous to those above, using
only de-identified data;

 

(h)patient information collected through the Medtronic CareLink Services may be
transferred and stored outside of Canada, including the United States.

In no case will Medtronic use the data collected through the Services to
identify or contact individuals who provided the data, or provide data to anyone
in a form which would enable them to identify or contact such individuals.

 

 

12

[*] = 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