Exhibit 10.65

 

[*] = 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

CLINICAL RESEARCH AGREEMENT

This Clinical Research Agreement (“Agreement”) is entered into this 5th day of
November, 2013 (“Effective Date”) by and between ARCA biopharma Inc.
(“Sponsor”), a Delaware corporation with offices at 11080 CirclePoint Road,
Suite 140, Westminster, CO 80020, and Duke University (“Duke”), a nonprofit
research, education and healthcare institution with an office at 2400 Pratt
Street, Durham, North Carolina 27705 (individually, a “Party” and collectively,
the “Parties”).

R E C I T A L S

WHEREAS Sponsor wishes to conduct a program of clinical research and development
entitled, “GENETIC-AF – A Genotype-Directed Comparative Effectiveness Trial of
Bucindolol and Metoprolol CR/XL for the Prevention of Symptomatic Recurrent
Atrial Fibrillation in Patients with Heart Failure,”(the “Study”); and,

WHEREAS, Sponsor believes that Duke has the facilities and the personnel with
the requisite skills, experience and knowledge as an Academic Research
Organization to undertake such research as a Coordinating Center for the Study;
and

WHEREAS, Sponsor and Duke enter into this Agreement to set forth the terms and
conditions upon which Sponsor and Duke will conduct the Study; and

WHEREAS, the Study contemplated by this Agreement shall be of mutual interest
and benefit to Sponsor and Duke, and shall further the instructional and
research objectives of Duke in a manner consistent with its status as a
nonprofit research, education and healthcare institution; and

NOW, THEREFORE, in consideration of the foregoing facts and the mutual covenants
set forth herein, the Parties hereto agree as follows:

1.

Scope of Work.

1.1.

Study. The research to be conducted by Duke under this Agreement shall be
conducted as set forth in the scope of work (“Scope of Work”), attached hereto
as Appendix A and incorporated by reference. The Study shall be conducted in
accordance with the Study protocol (the “Protocol”), which Protocol shall fully
detail the clinical research activities and responsibilities to be undertaken;
provided, however, that Duke’s obligation to conduct the Study is expressly
conditioned upon the approval of its Institutional Review Board (“IRB”), as set
forth in Section 14.2 below.  Thereafter, the Protocol may be amended only at
the direction of Sponsor, subject to subsequent approval by the IRB.

1.2.

Transfer of Obligations.  Pursuant to 21 CFR § 312.52, this Agreement, and the
Appendices annexed hereto shall serve as the written description of the
obligations of Sponsor being transferred to Duke under the terms and conditions
hereof.  

1.3.

Principal Investigator.  The Study activities to be conducted by Duke hereunder
shall be under the direction of Jonathan Piccini, MD (“Principal Investigator”)
who is a full time faculty member at Duke University.

1.4.

Participating Investigators and Institutions. The Principal Investigator for the
Study, in collaboration with the Sponsor, shall coordinate the Study at Duke and
at other clinical sites conducting the Study (each site, a “Participating
Institution”) and with the physicians at the Participating Institutions
responsible for administering the Study (“Participating Investigators”). Duke
shall enter into an agreement with each Participating Institution containing
terms consistent with those in this Agreement (“Site Agreement”), which Site
Agreement shall be subject to Sponsor’s prior written consent. Duke shall
exercise all reasonable efforts to ensure that the data generated by the
Participating Institutions shall be coordinated, analyzed and reported in an
efficient and effective manner and in a format fully usable by Sponsor on a
timely basis and in compliance with the Protocol.

1.5.

Supply and Use of the Study Material. Sponsor shall provide Duke with sufficient
amounts of any drug, device, placebo, or comparator drug or device (“Study
Material”) and all other materials to perform the Study on a timely basis.  Duke
agrees that the Study Material shall be used only for the Study. Any unused
Study Material remaining at the end of the Study shall be disposed of in
accordance with Sponsor instructions.  

 

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2.

Inspections and Audits.

2.1

Regulatory Inspections. Authorized representatives of Sponsor may, upon
reasonable advance notice, and representatives of the U.S. Food and Drug
Administration (the “FDA”) or any other international health agency having
regulatory authority over the subject matter of the Study may, at reasonable
times, examine and inspect the facilities being used to conduct the Study,
including the Participating Institutions, and review all records, procedures and
other materials (including Case Report Forms and patient medical records to the
extent allowed by the informed consent document or other legal disclosure
authorization) related to the Study, and have access to the Principal
Investigator and the Participating Investigators to discuss the Study.  If a
Participating Institution is found deficient in any manner by Sponsor or Duke
and reasonable efforts to correct the deficiency are ineffectual, Duke shall
either terminate that Institution’s continued participation in the Study or take
such corrective actions as may be agreed between Sponsor and Duke.  It is
further agreed that if Duke is notified that the Study is to be the subject of
an audit, Duke shall promptly inform Sponsor.  If a formal response to any audit
is required, Duke shall provide Sponsor with the reasonable opportunity to
review and comment upon Duke’s proposed response and shall provide Sponsor with
a copy of Duke’s final response.  

2.2.

Compliance Audits.  Sponsor has the right to conduct on-site Study compliance
audits of Duke and Participating Institutions monitored by Duke at mutually
agreed upon times.  Audits shall be at no additional cost to Sponsor provided
such audits are at mutually agreed intervals and do not significantly alter
Duke's ability to meet any deadlines delineated in this Agreement.  Sponsor may
only request records or documents that are within the scope of the documents
Duke or the Participating Institution is required to maintain pursuant to the
Protocol, all applicable regulatory requirements and under the obligations of
this Agreement.

3.

Debarment and Financial Disclosures.  

3.1

Duke hereby certifies that neither it nor the Principal Investigator have been
debarred under Article 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.
§335a(a) or (b), or disqualified as described in 21 C.F.R. §812.119.  In the
event that Duke becomes debarred, Duke agrees to notify Sponsor
immediately.  Duke hereby certifies that it has not and shall not use in any
capacity related to the Study the services of any individual, corporation,
partnership, or association which has been debarred under Article 306 of the
Federal Food, Drug and Cosmetic Act, 21 U.S.C. §335a(a) or (b), or disqualified
as described in 21 C.F.R. §812.119.  In the event that Duke becomes aware of or
receives notice of the debarment or disqualification of any individual,
corporation, partnership, or association providing services to Duke which relate
to the research conducted under this Agreement, Duke agrees to notify Sponsor
immediately.

3.2

Financial Disclosure and Statement of Investigator.  Prior to the commencement
of the Study at any particular Participating Institution, the Participating
Investigators at such Participating Institution shall have completed, signed,
and delivered to Sponsor a Statement of Investigator, Form FDA-1572, as
described in 21 C.F.R. §312.53.

4.

Payment.

4.1.

Amount.  Sponsor shall compensate Duke according to the Budget and Payment
Schedule attached hereto as Appendix B and incorporated herein by reference.  

4.2.

Payee. Any payment due from Sponsor set forth in Appendix B shall be tendered in
the form of a check payable to Duke University at one of the following
addresses:

Duke University Accounts Receivable Lockbox

P.O. Box 602651

Charlotte, NC  28260-2651

Where a physical address is required, checks should be mailed to:

Wells Fargo Lockbox

Duke University Accounts Receivable

Lockbox 602651

1525 West WT Harris Blvd – 2C2

Charlotte, NC  28262

Duke University’s Tax ID Number is 56-0532129.

 

[*] = 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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4.3.

Delays.  In the event of Force Majeure (as defined in Section 21 herein) or a
modification to the Protocol pursuant to Section 1.1 hereof, the Parties agree
to revise the Budget and Payment Schedule as necessary to reflect cost increases
or decreases resulting from said event.

4.4.

Pass Through Expenses. Any expenses listed as a pass through cost in the Budget
or Payment Schedule shall be reimbursed at actual cost plus a six-percent (6%)
pass through cost.

4.5.

Payment of Invoices. Duke shall invoice Sponsor on a monthly basis for
activities set forth in the applicable Budget. Sponsor shall be responsible for
paying invoices within thirty (30) calendar days of receipt.  Sponsor shall
notify Duke of any disputed invoices within twenty (20) calendar days of
receiving such invoice and shall pay any undisputed amounts as set forth above.
Provided that Sponsor pays undisputed amounts as set forth above, Duke shall
continue to conduct research during which time the Parties shall use best
efforts to resolve the disputed amount. In the event that the Parties cannot
resolve the disputed amount within twenty (20) calendar days of Duke receiving
the invoice dispute notice from Sponsor, the dispute shall be submitted to
arbitration in accord with Section 19 herein, with each party paying its own
legal fees.  Both Parties agree to continue good faith efforts to resolve the
dispute prior to such stoppage of work

5.

Modifications and Amendments.

This Agreement may be amended from time to time upon the written agreement of
the Parties.  The Parties agree to exert good faith efforts to incorporate any
revisions required by law, FDA or other international health authorities. Any
changes to a Scope of Work or Budget and/or Payment Schedule shall be
incorporated into this Agreement by means of a written amendment.  Duke shall be
under no obligation to commence work on any change to the Scope of Work until
such amendment is executed.

6.

Data.

Clinical Data. All clinical data, including case report forms and other relevant
information generated during the Study shall be owned by Sponsor, and shall be
promptly and fully disclosed to Sponsor and shall be freely usable by
Sponsor.  Sponsor shall ensure that Duke receives data transfers and/or a final
data set of any Study data developed and/or maintained by Sponsor or any third
party in privity of contract with Sponsor, including but not limited to a
pharmacy and/or randomization vendor, as required for Duke to fulfill its
obligations and exercise its rights pursuant to this Agreement.  Duke shall be
free to maintain copies of all such materials and to use the results of the
research for its own non-commercial teaching, research, education, clinical, and
publication purposes only, subject to Section 8 (“Confidential Information”) and
Section 9 (“Publication”) below, which rights shall not be transferable and
shall be limited to non-commercial uses. If Duke’s activities in the Study are
terminated prior to the end of the Study (other than for material breach under
Section 16.2), Sponsor shall ensure that Duke receives a copy of the closed,
locked, clinical database for the Study for its use, but limited to the scope of
use permitted herein, prior to the unblinding of the data.

Regulatory Filings. Any and all findings obtained as a result of the Study shall
be communicated to Sponsor which shall be free to incorporate such findings in
any regulatory filing concerning the Study Material.  Duke and Principal
Investigator(s) understand and agree that they shall have no ownership, license
or access rights in, or to, such regulatory filings, nor shall they acquire any
interest whatsoever in the Study Material as a result of performing the Study.

7.

Inventions.

7.1

Prior Inventions. It is recognized and understood that certain existing
inventions and technologies are the separate property of Sponsor or Duke and are
not affected by this Agreement, and neither Party shall have any claims to or
rights in such prior, separate inventions and technologies, or improvements
thereto, except only to the extent required for the conduct of the Study.

7.2

Title. Inventorship of new inventions, developments, or discoveries arising out
of the Study (hereinafter “Invention”) shall be determined in accordance with
U.S. patent law or by mutual agreement if the invention is not patentable. All
rights, title and interest in and to any Invention that is not a Sponsor
Invention, as defined below, shall be based upon inventorship with Sponsor
holding sole title to any Invention made solely by Sponsor personnel, Duke
holding sole title to any Invention made solely by Duke personnel, and the
Parties holding joint title to any Invention made jointly by their personnel
during the conduct of the Study, subject to the assignment and option provisions
below. Duke shall promptly disclose to Sponsor in writing on a confidential
basis any Invention made solely by Duke personnel or jointly with

 

[*] = 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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Sponsor personnel. Sponsor shall promptly disclose to Duke on a confidential
basis any Invention jointly made by Sponsor personnel together with Duke
personnel.

7.3

Sponsor Inventions. All of Duke’s rights, title and interest in and to any
Invention arising out of the Study and representing a reduction to practice of
Sponsor’s documented prior conception (which documented prior conception
includes the Protocol) or directly related to the Study Material shall be
assigned to Sponsor (“Sponsor Invention”).  Sponsor shall reimburse Duke or
Principal Investigator(s) for any reasonable expenses incurred at Sponsor’s
request to secure title or legal protection for any such Sponsor Invention, and
Duke shall cooperate, at Sponsor’s request, in any actions (including the
execution of formal documents of assignment by Duke or any personnel assigned to
the Study) required for such assignment.

7.4

Grant of Option.  Duke hereby grants Sponsor, without option fee other than the
consideration of the Study sponsored herein and the reimbursement of all patent
expenses related to the Invention incurred by Duke prior to and during the
option period, an option to acquire an exclusive, worldwide, royalty‑bearing
license to Duke’s rights to any Invention other than a Sponsor Invention, which
option shall extend for ninety (90) days after Sponsor’s receipt of an Invention
disclosure. If Sponsor notifies Duke in writing of its exercise of the option
within the option period, then the Parties will have sixty (60) days after such
notice to negotiate in good faith a license agreement on commercially reasonable
terms. If Sponsor does not exercise this option, or notifies Duke that it will
not exercise this option, or if the Parties fail to sign a license agreement
within said sixty (60) day negotiation period, then Sponsor shall no longer have
any claim or interest in Duke’s rights in the subject Invention, except that if
the Parties are unable to reach agreement on licensing terms then for a period
of one year after the negotiation period, Duke will not offer to license the
Duke Invention to a third party on terms more favorable to the licensee than
those last offered to Sponsor without first giving Sponsor thirty (30) days to
accept such terms.  

7.5

Reserved Rights. Duke shall reserve the right to use any Invention assigned or
licensed by Duke to Sponsor for Duke’s own non-commercial research, educational,
clinical and publication purposes, which rights shall not be transferable and
shall be limited to non-commercial uses.

8.

Confidential Information.

8.1

Confidential Information. “Confidential Information” shall mean all information
provided by one Party to the other and relating to the Study or the Study
Material. If such transmittal occurs orally, the transmitting Party shall
promptly reduce such transmittal to writing, mark and identify it as
confidential, and provide such record to the other Party within thirty (30) days
after the date of disclosure.  Specifically excepted from Confidential
Information is all information that: (a) was previously known by the receiving
Party; (b) is publicly disclosed except by breach of this Agreement either prior
to or subsequent to the receiving Party’s receipt of such information; (c) is
rightfully received by the receiving Party from a third party without an express
obligation of confidence; or (d) is independently developed by personnel of the
receiving Party without use of or reliance upon the Confidential Information of
the other Party.

8.2

Nondisclosure and Non-Use. Subject to the provisions of the section headed
“Publications” hereunder (Section 9), the receiving Party shall (a) not disclose
Confidential Information of the Disclosing Party to any third party without
prior written authorization from the Disclosing Party, (b) restrict disclosure
to its own personnel who have a need to know such Confidential Information for
purposes of the conduct of the Study or in furtherance of its rights or
obligations hereunder, (c) use such Confidential Information only as necessary
to conduct of the Study or in furtherance of its rights or obligations
hereunder.  This provision shall remain in effect for five (5) years following
the termination of the Study.

8.3

Patient Information. Each Party shall be provided with patient information as
allowed by law and the patient informed consent and authorization documents and
shall maintain the confidentiality of all such patient information, unless
specifically required to disclose such information by law.  

8.4

Legally Required Disclosure. Nothing set forth herein shall operate to prohibit
or prevent a Party from disclosing Confidential Information pursuant to any
judicial or government request, requirement or order, provided that the
disclosing Party takes reasonable steps to provide the other Party with
sufficient prior notice in order to allow the other Party to contest such
request, requirement or order.

8.5

Publicity.  ARCA may disclose this Agreement and its terms at its discretion and
as may be required by applicable law or regulations, subject to providing Duke
with a reasonable opportunity to review and comment upon such disclosure; and
further provided, that ARCA agrees to seek confidential treatment of any
Confidential Information, consistent with

 

[*] = 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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applicable law.  After the initial public disclosure, either party may publicize
information related to the Study or the Agreement, to the extent that such
information is no longer confidential.

9.

Publication.  

Sponsor recognizes the importance of communicating medical research and
scientific data and its obligations to patients enrolled in the Study, and
therefore encourages publication of such material in reputable scientific
journals and at professional and/or academic seminars or conferences, in accord
with the terms of this Agreement. The Steering Committee of the Study shall
oversee the formation of a Publications Committee to review and approve analyses
that may result in peer-reviewed manuscripts disclosing and/or analyzing
clinical data generated from the Study (“Trial Results”) in scientific or
academic journals by the Principal or Participating Investigators, Participating
Institutions including Duke, or the Sponsor.  The Publications Committee will be
comprised of the Principal Investigator, the Chair and the Co-Chair of the
Steering Committee, and an ARCA representative, which initially shall be the
ARCA CEO (Dr. Michael Bristow).  The Committee Chair will be selected by the
Steering Committee. The Publications Committee will act as an independent body
of scientific and medical experts, and shall consider each analysis with due
regard for the scientific merit of the proposed publication with the aim of
promoting the dissemination of scientific and medical knowledge. Decisions of
the Publication Committee shall be by majority vote.  There shall be no
restrictions on the topics or analytical approaches used in developing
manuscripts, other than those imposed by the Publication Committee.  

In addition to submission of any analysis to the Publications Committee for
approval, any proposed publication resulting from an analysis approved by the
Publication Committee shall also be submitted to Sponsor for its review and
comment at least thirty (30) calendar days prior to submission for
publication.  If Sponsor determines that the proposed publication contains
patentable subject matter which requires protection, Sponsor may require the
delay of publication for an additional period of time not to exceed sixty (60)
calendar days for the purpose of filing patent applications. Duke shall ensure
that Sponsor will be acknowledged on any publication authorized by the
Publications Committee for its sponsorship of the Study in accordance with
customary scientific principles of publication, and shall give Sponsor and/or
Sponsor’s personnel appropriate credit for any direct contribution made by
them.  Sponsor shall register the Study with www.clinicaltrials.gov, or an
equivalent registry, and all Publications shall be consistent with usual
academic standards in a manner compliant with the Uniform Requirements for
Manuscripts Submitted to Biomedical Journals guidelines of the International
Committee of Medical Journal Editors (http://www.icmje.org).

Notwithstanding the foregoing, Sponsor shall be permitted to coordinate or
undertake other publications of Trial Results in forums other than peer-reviewed
manuscripts published in academic or scientific journals, without prior
authorization from the Publications Committee, including but not limited to
presentations or posters at medical conferences, industry conferences, or in
industry or marketing publications or other business-related disclosures.

10.

Use of Name.

No Party shall use the name, trademarks, logos, physical likeness or other
symbol of any other Party, or its employees, for any marketing, advertising or
public relations purposes without the prior written consent of the affected
Party.  Notwithstanding anything herein to the contrary, Duke shall have the
right to post Sponsor’s name, the Study name, and the Study period, on Duke’s
publically accessible lists of research conducted at Duke and as may be required
in submissions to funding agencies.

11.

Medical Care Costs.

Sponsor shall be responsible for payment of the actual and reasonable medical
expenses incurred in diagnosing and treating any injury, illness, or adverse
reaction of a Study subject that results from the administration or use of the
Study Material in accordance with the Protocol or the proper performance of any
Protocol procedure, and which does not arise from any of the causes attributable
to Duke or Principal Investigator set forth in Section 12.2 hereof.

12.

Indemnification.

12.1

Indemnification by Sponsor.  Sponsor agrees to indemnify, hold harmless and
defend Duke, its trustees, officers, employees, and agents from and against any
and all claims, suits, losses, damages, costs, fees, expenses (including
attorneys’ fees), and other liabilities asserted by third parties, both
government and non-government, resulting from or arising out of the Study
conducted pursuant to this Agreement (the “Liabilities”).  Notwithstanding the
forgoing, Sponsor

 

[*] = 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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shall not be liable to Duke to the extent the Liabilities result from (i) Duke’s
failure to obtain the prior approval of an IRB in accordance with the IRB’s
approved procedures; (ii) Duke’s failure to follow the Protocol in any material
respect or to comply with federal, state, local or international health
authority law or regulation in connection with the Study; or (iii) Duke’s
negligence or willful misconduct in connection with the Study or its breach of
the material terms of this Agreement.

12.2

Indemnification by Duke.  Duke agrees to indemnify, hold harmless and defend
Sponsor, its directors, officers, employees, and agents from and against the
Liabilities, to the extent the Liabilities result from (i) Duke’s failure to
obtain the prior approval of the IRB in accordance with the IRB’s approved
procedures; (ii) Duke’s failure to follow the Protocol in any material respect
or to comply with federal, state, local or international health authority law or
regulation in connection with the Study; or (iii)  Duke’s negligence or willful
misconduct in connection with the Study or its breach of the material terms of
this Agreement.  Notwithstanding the forgoing, Duke shall not be liable to
Sponsor under this indemnity to the extent that such Liabilities result from
Sponsor’s negligence, or willful misconduct, or its breach of the material terms
of this Agreement.

12.3

Indemnification Process.  A Party seeking indemnification hereunder shall give
notice to the other Party promptly upon receipt of written notice of the
potential claim.  The Party seeking indemnification shall permit the
indemnifying party to assume the defense and/or disposition of any such claim or
related litigation, provided that counsel is reasonably acceptable to the Party
seeking indemnification.  The Party seeking indemnification shall cooperate with
the indemnifying Party in all reasonable respects with respect to the defense of
any such claim, with the out-of-pocket costs of the Party seeking
indemnification to be reimbursed by the indemnifying Party.

12.4

Indemnification for Participating Institutions and Participating
Investigators.  Sponsor agrees to enter into an indemnification agreement with
each Participating Institution and Participating Investigator for liabilities
arising from the Study, in a form to be agreed-on between Sponsor and each such
party.

12.5

Disclaimer of Warranty.  Duke and Sponsor understand and agree that the conduct
of the Study is experimental in nature and that no warranty, either expressed or
implied, is made regarding the results of any research conducted under this
Agreement. Neither party shall be liable for incidental or consequential damages
under this Agreement, other than each party’s obligation to indemnify the other
party for Liabilities pursuant to this Article 12.

13.

Insurance.  

The Parties hereto warrant that they shall maintain during the term hereof
policies of liability insurance with minimum coverage as follows:

13.1

As to Sponsor: Sponsor represents that, as of the Effective Date, it carries
Products and Completed Operations Liability Insurance with limits not less than
one million dollars ($1,000,000) per occurrence combined single limit and one
million dollars ($1,000,000) annual aggregate.  Sponsor shall, no later than the
date of enrollment of the first patient in the Study, increase such coverage
under its Products and Completed Operations Liability Insurance to limits not
less than five million dollars ($5,000,000) per occurrence combined single limit
and five million dollars ($5,000,000) annual aggregate.  If such insurance or
program of self-insurance is written on a claim-made form, coverage shall
survive for a period of not less than three (3) years following locking of the
clinical database for the Study. Sponsor agrees to furnish to Duke a certificate
of insurance or evidence of self-insurance acceptable to Duke indicating the
required coverage, including a certificate indicating the required increase in
coverage when the Study begins enrollment.

13.2

As to Duke: Duke represents that it carries Comprehensive Form General and
Professional Liability Insurance with limits of not less than three million
dollars ($3,000,000) per occurrence combined single limit and ten million
dollars ($10,000,000) annual aggregate. If such insurance or program of
self-insurance is written on a claim-made form, coverage shall survive for a
period of not less than three (3) years following termination of this Agreement.
Coverage shall provide for a retroactive date of placement coinciding with or
prior to the Effective Date. Duke agrees to furnish to Sponsor a certificate of
insurance or evidence of self-insurance acceptable to Sponsor indicating the
required coverage.

14.

Compliance.  

14.1

The Study shall be conducted in compliance with all applicable federal, state,
local, international health authority and institutional laws, regulations and
guidelines, including, without limitation, all good clinical practice
requirements as promulgated by the FDA, the Health Insurance Portability and
Accountability Act (“HIPAA”) of 1996 and all

 

[*] = 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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requirements imposed by legally constituted IRBs. Sponsor agrees to collect, use
and disclose information with respect to the Study subject only in accordance
with the informed consents and legal disclosure authorizations obtained from
such Study subject as part of the Study, unless otherwise required by law.

14.2

Duke shall apply for approval to conduct the Study with Duke’s IRB. Sponsor and
Duke shall cooperate with each other in preparing and filing the Study protocol,
informed consent form, and other information with the IRB, including any
modifications thereof, prior to use by Duke or any Participating Institution.

14.3

Sponsor shall promptly report to Duke and Principal Investigator any
information, including data and safety monitoring findings or information
contained in site monitoring reports, which could directly affect the safety of
past or current Study subjects or influence the conduct of the Study.  In each
case, the Principal Investigator and Duke shall be free to communicate these
findings to each Study subject and the IRB.  Duke will (and will require all
Participating Institutions to) promptly, in accordance with applicable laws and
regulations and in accordance with the Protocol, advise the Sponsor of any
adverse reactions or side effects relating to the Study Material occurring
during the conduct of the Study or that become known to it.  

14.4

Duke shall use reasonable efforts to ensure the integrity of all Study data and
promptly report to Sponsor any suspected “research misconduct” arising in
connection with the Study, as that term is defined pursuant to 42 C.F.R.
§93.103.

15.

Term.  

Term. The term of this Agreement shall commence as of the Effective Date and
terminate upon completion of the Scope of Work under this Agreement, unless
terminated sooner in accordance with the terms herein.  

16.

Termination.

16.1

Termination. This Agreement hereto may be terminated for any reason by Sponsor
upon ninety (90) days prior written notice to Duke. Notwithstanding the
foregoing, this Agreement may be terminated immediately by written notice, in
the following circumstances:

(a)

Authorization and approval to perform the Study in the United States is
withdrawn by the FDA on a permanent or temporary basis;

(b)

Animal, human or toxicological test results, in the reasonable determination of
Sponsor, support immediate termination of the Study;

(c)

The emergence of adverse events with a compound administered in the Study is of
such magnitude or significance that, in the reasonable determination of Sponsor
or a Data Safety Monitoring Board, supports immediate termination of the Study;

(d)

If, for any reason the Principal Investigator is unable to continue to in that
role and a successor acceptable to Sponsor is not available; or

(e)

A material event adversely affecting Sponsor’s ability to finance the Study.

16.2

Termination for Breach. This Agreement may be terminated by either Party upon
the occurrence of any material breach or default by the other Party, provided
that the breaching or defaulting party shall be given not less than thirty (30)
days prior written notice and the opportunity to cure the breach or default
during such period.

16.3

Wind-Down Plan Upon Termination.  Both Duke and Sponsor recognize that early
termination of this Agreement requires both discussion and coordination between
the Parties to ensure patient safety, continuity of treatment, if appropriate,
and compliance with all applicable regulations.  Upon early termination of this
Agreement, the Parties shall cooperate to provide for an orderly cessation of
the Study.  Each Party further agrees to take no action or forego taking action
if such action or forbearance would in any manner jeopardize patient safety or
the utility, quality or integrity of the Study or violate or cause the other
Party to violate any applicable laws.  In addition, Duke shall conduct such
activities as are reasonably necessary in connection with the orderly wind-down
of the Study or the transfer of Duke’s responsibilities to Sponsor or its
designee.  Based upon Sponsor’s written instructions regarding the scope of
activities to be conducted by Duke in connection with termination of the Study,
to be delivered to Duke as soon as possible after notice of termination is
received, Duke shall submit to Sponsor a wind-down, close out, or transfer plan
to accomplish the tasks or research identified by Sponsor’s written instructions
together with a budget, both to be mutually agreed on in writing (“Plan”).

 

[*] = 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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16.4

Handling Data Upon Termination. The Parties agree that the transfer of the Study
data and outstanding reports are critically important to both Parties.  The Plan
shall include the procedures and responsibilities of each Party including but
not limited to the orderly collection of all patient data outstanding at
participating sites, data analysis and entry of such data into the Study
database, and any manuscript resulting therefrom.

16.5

Compensation Upon Termination. Upon early termination of this Agreement other
than for material breach or default by Duke, Sponsor shall promptly compensate
Duke for all work and research performed under this Agreement up to the
effective date of termination, and reimburse Duke for any non-cancelable
commitments and all activities in connection with the orderly wind-down and
close out of the Study pursuant to the Plan.  In the event of early termination
hereunder and a Plan agreed-to by the Parties, Sponsor shall compensate Duke for
the processing of any outstanding data collected, analyzed, and entered into the
applicable database in accordance with a Plan.

16.6

Termination Survival.  Notwithstanding any termination or expiration of this
Agreement, or any Study Addendum hereto, Sections 2, 3, 4, 6, 7, 8, 9, 10, 11,
12, 13, 14, 17, 19 and 22 shall survive any termination of this Agreement.

17.

Notices.

Any notice or other communication required or permitted under this Agreement
shall be in writing and shall be deemed given as of the date it is received by
the receiving Party. Notice shall be given to the Parties at the addresses
listed below, or such alternative address as may be provided by one Party to the
other in writing:

If to Duke:

Office of Research Administration

2200 W. Main St., Suite 820

Durham, NC 27705

Phone: 919-684-5175

Facsimile: 919-684-6278

with a copy to:

Contracts Management

Duke Clinical Research Institute

300 W. Morgan Street, Suite 800

Durham, NC 27701

Phone: 919-668-8081

Facsimile: 919-668-8100

If to Sponsor:

ARCA biopharma Inc.

11080 CirclePoint Road, Suite 140

Westminster, CO 80020

With a copy to:

Chief Executive Officer

18.

Relationship of the Parties.

Duke’s relationship to Sponsor under this Agreement shall be that of an
independent contractor and not an agent, joint venture, or partner of Sponsor.
No Party hereto shall have, or shall represent that it has, any power, right or
authority to bind the other Party hereto to any obligation or liability without
express authorization from such other Party.

19.

Arbitration.

The Parties agree to attempt to resolve promptly any dispute arising out of or
relating to this Agreement by good faith negotiation; provided, however, if such
attempts at dispute resolution shall fail, disputes relating to the terms and
conditions of

 

[*] = 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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this Agreement shall be exclusively resolved, upon written request by either
Party, by final and binding arbitration in a mutually agreed location, or a
location chosen by the chair of the arbitration panel if the Parties cannot
agree, pursuant to the commercial arbitration rules of the American Arbitration
Association, in accordance with the following procedures:

(a)

The arbitration tribunal shall consist of three arbitrators.  The Parties shall
respectively nominate one arbitrator in the request for arbitration and one
arbitrator in the answer thereto, and the two arbitrators so named will then
jointly appoint a third arbitrator as chairperson of the arbitration tribunal.

(b)

The decision of the arbitration tribunal shall be final and binding upon the
Parties hereto, and judgment upon such decision may be entered in any competent
court for juridical acceptance of such an award and order of enforcement.  Each
Party hereby submits itself to the courts of the place of arbitration, but only
for the entry of judgment with respect to the decision of the arbitrators
hereunder.  Each Party in any arbitration hereunder shall be responsible for its
own attorney’s fees in prosecuting such arbitration claim.

20.

Similar Research.

Nothing in this Agreement shall be construed to limit the freedom of Duke or its
researchers who are participants under this Agreement, from engaging in similar
research made under other grants, contracts or agreements with parties other
than the Sponsor.

21.

Force Majeure.

If either Party hereto shall be delayed or hindered in, or prevented from, the
performance of any act required hereunder for any reason beyond such Parties
reasonable control, including but not limited to, strike, lockouts, labor
troubles, governmental or judicial actions or orders, riots, insurrections, war,
acts of God (a “Disability”) then such Party’s performance shall be excused for
the period of the Disability.  Any Study timelines affected by a Disability
shall be extended for a period equal to the delay and any affected Budget shall
be adjusted upon mutual agreement of the Parties to account for cost increases
or decreases resulting from the Disability. The Party affected by the Disability
shall notify the other Party of such Disability as provided for herein.  

22.

Non-Solicitation.

During the term of this Agreement and for a one year period thereafter, Sponsor
shall not solicit for hire (or the provisions of services under contract) any
employee of Duke University that is involved in the conduct of the Study.

23.

Entire Agreement.

This Agreement constitutes the full and complete understanding of the Parties
hereto with respect to the subject matter hereof and supersedes all prior
understandings and agreements with respect to such subject matter. Any
amendments or revisions to this Agreement must be proposed in writing by either
Party and accepted in writing by the other Party before they will become
effective and binding. Any handwritten modifications to this Agreement shall be
null and void unless such modifications are initialed by both Parties.

24.

No Waivers.

No delay or omission by a Party hereto to exercise any right under this
Agreement shall impair any such right or power or be construed to be a waiver
thereof.  A waiver by any of the Parties hereto of any of the covenants,
conditions or agreements herein contained shall not be construed to be a waiver
of any succeeding breach thereof or of any covenant, condition or agreement
herein contained.  No waiver or discharge of any provisions of this Agreement
shall be valid unless it is in writing and is executed by the Party against whom
such change or discharge is sought to be enforced.

25.

Severability.

If a judicial determination is made that any of the provisions contained in this
Agreement constitute an unreasonable restriction against a Party or are
otherwise unenforceable, such provision or provisions shall be rendered void or
invalid only to the extent

 

[*] = 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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that such judicial determination finds such provision or provisions to be
unreasonable or otherwise unenforceable, and the remainder of this Agreement
shall remain operative and in full force and effect.

26.

Assignment and Subcontracting.

Duke may not assign this Agreement or subcontract or delegate any of the
activities to be performed by it hereunder without the prior written consent of
Sponsor.  Sponsor may assign this Agreement in connection with in connection
with the transfer or sale of all or substantially all of its assets or business
or the acquisition of Sponsor or its merger or consolidation with a third party,
in connection with a clinical or commercial partnership, or with the prior
written consent of Duke.  Any attempted assignment of this Agreement not in
compliance with this Section 26 will be null and void and of no legal force or
effect.  This Agreement will inure to the benefit of and be binding upon each
Party signatory hereto, its successors and permitted assigns.  No assignment
will relieve either Party of the performance of any accrued obligation that such
Party may then have under this Agreement.

27.

Headings.

The headings contained in this Agreement do not form a substantive part of this
Agreement and shall not be construed to limit or otherwise modify its
provisions.

 

 

 

 

[*] = 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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IN WITNESS WHEREOF, this Agreement is entered into as of the date first written
above.

 

ARCA biopharma Inc.

 

Duke University:

 

 

 

 

 

 

 

By:  

 

/s/ Michael R. Bristow

 

By:  

 

/s/ Barbara C. Hall

Name:

 

Michael R. Bristow

 

Name:

 

Barbara C. Hall

Title:

 

Chief Executive Officer

 

Title:

 

Assistant Director

Date:

 

November 5, 2013

 

Date:

 

October 30, 2013

 

 

REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK

 

 

 

 

 

[*] = 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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APPENDIX A

[* 29 pages of text omitted]

[*] = 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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