Exhibit 10.20
CLINICAL INVESTIGATION AGREEMENT
THIS AGREEMENT DATED 23RD DAY OF OCTOBER 2006
IS BETWEEN
ROYAL BROMPTON & HAREFIELD NHS TRUST OF
▇▇▇▇▇▇ ▇▇▇▇▇▇,
▇▇▇▇▇▇ ▇▇▇ ▇▇▇ ▇▇
(HEREINAFTER KNOWN AS THE "TRUST")
AND
HEARTWARE, INC.
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇ U.S.A.
(HEREINAFTER KNOWN AS THE "SPONSOR")
NOW
It is hereby agreed that the Trust undertakes to participate in a Sponsored
Clinical Investigation of a medical device entitled
"Evaluation of the HeartWare LVAD System for the Treatment of Advanced Hean
Failure"
The purpose of this Agreement is to set out the terms and conditions under which
the Trust is prepared to participate in the Clinical Investigation.
1 DEFINITIONS:
The following words and phrases have the following meanings:
"Clinical Investigation" means the investigation to be conducted by the
Principal Investigator at the Investigation Site in accordance with the
Protocol.
"Device" means HeartWare left ventricular assist device (LVAD) System.
"Sponsor" means the Company that is the sponsor of the study, as specified
in the preamble hereto.
"Monitor" means the person appointed by the Sponsor to monitor and report
on the Clinical Investigation.
"Principal Investigator" means the person appointed by the Trust to lead
and co-ordinate the work in a multi-centre investigation or that of several
investigators at one Investigation Site to carry out the work of the
Clinical Investigation. The Principal Investigator at the date of this
Agreement is the person named in Clause 2.1.
"Investigation Site" means premises occupied by the Trust and located at
Hill End Road, Harefield Middlesex.
"The Protocol" means the plan of investigation (Clinical Investigation
Plan) for the Clinical Investigation titled "Evaluation of the HeartWare
LVAD System for the Treatment of Advanced Heart Failure" reference Version
2, dated February 10, 2006, a copy of which comprises Appendix 1 to this
Agreement, or such amended Protocol as which upon the reasonable request of
Sponsor, may be amended from time to time. Such amendments will be signed
and attached to this Agreement.
"MHRA" means Medicines and Healthcare Products Regulatory Agency, which is
the UK Competent Authority that administers Medical Device Regulations
within the UK.
"Intellectual Property Rights" means patents, trademarks, copyrights,
rights to extract information from a database, design rights and all rights
or forms of protection of a similar nature or having equivalent or the
similar effect to any of them which may subsist anywhere in the world,
whether or not any of them are registrable or registered, and including
applications for registration of any of them.
"Know How" means all technical and other information which is not in the
public domain, including but not limited to information comprising or
relating to concepts, discoveries, data, designs, formulae, ideas,
inventions, methods, models, procedures, designs for experiments and tests
and results of experimentation and testing, processes, specifications and
techniques, laboratory records, clinical data, manufacturing data and
information contained in submissions to regulatory authorities.
"Confidential Information" means:
(a) all information disclosed either directly or indirectly, and whether
disclosed verbally, in writing or by tangible products or samples, by
Sponsor to the Trust, the Principal Investigator or Co-Investigator or any
other person at the Investigation Site involved in the Clinical
Investigation; and
(c) any and all information developed in the course of the Clinical
Investigation, including, without limitation, information relating to the
Device, Clinical Investigation, Sponsor Materials, Intellectual Property
Rights, Know How, CRFs or Clinical Investigation results, Clinical
Investigation patients; and all other information regarding Sponsor's (or
its affiliated entities') past, present or future research technology,
designs, products, ideas, concepts, protocols, prototypes, business plans,
processes, drawings, specifications, compositions of matter, product
applications, methods, operations, trade secrets and any knowledge or
information developed by the Trust or Principal Investigator or any other
persons at the Investigation Site involved in the Clinical Investigation,
either alone or with others, as a result of their work in connection with
this Agreement.
2
"Party" means the Sponsor, or the Trust and "Parties" shall mean both of
them.
2 PRINCIPAL INVESTIGATOR
2.1 The Principal Investigator for the Clinical Investigation will be
▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, (Tel number (▇) ▇▇▇▇-▇▇▇▇▇▇). The Trust represents
that it is entitled to procure and will procure the services of the
named person to act as Principal Investigator and shall ensure the
performance of the obligations of the Principal Investigator set out
in this Agreement.
2.2 The Trust represents that the Principal Investigator has the necessary
expertise to lead and perform the Clinical Investigation.
2.3 The Trust shall notify the Sponsor if the person named in Clause 2.1
ceases to be employed by or associated with the Trust, and shall use
its best endeavours to find a replacement acceptable to both the
Sponsor and the Trust. If no mutually acceptable replacement can be
found the Sponsor may terminate this Agreement pursuant to Clause 17.1
below.
2.4 Upon the prior written consent of the Sponsor, which shall not be
unreasonably withheld, the Trust may appoint one or more collaborating
physicians, each of whom shall have special expertise in the field of
clinical research relating to the Clinical Investigation (each, a
"Co-Investigator"), to participate in the Clinical Investigation. The
Trust shall ensure that the Co-Investigators shall work under the
direct supervision of the Principal Investigator, complies with the
obligations undertaken by the Trust under this Agreement and shall be
responsible for any and all performance of any such Co-Investigators.
3 CLINICAL INVESTIGATION
The Medical Contact for the Clinical Investigation will be ▇▇▇▇ ▇. ▇▇▇▇▇
(Tel number ▇▇▇-▇▇▇-▇▇▇▇) and the Sponsor shall arrange for the named
individual to be reasonably available as a point of contact.
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4 The Parties will comply, and the Trust will procure that performance of the
Clinical Investigation at the Investigation Site complies with relevant
European Directive(s) and UK Statutory Instruments (Medical Device
Regulations) concerning Medical Devices and any other law, rule, regulation
or practice applicable to the conduct of the Clinical Investigation at the
investigation Site.
5 The Parties will at all times operate in accordance with European Standard
EN540, IS014155:2003, as applicable; and with all National Health Service
and Trust policies and codes of practice, ethical and anti-corruption
guidelines requisite for the performance of this Agreement.
6 The Sponsor, the Principal Investigator and the Trust will carry out this
Clinical Investigation in accordance with and in the spirit of the Helsinki
Declaration adopted by the 18th World Medical Assembly in Helsinki,
Finland, in 1964 and as last amended.
7 SUPPORT DOCUMENTATION
7.1 The Parties will at all times comply with the Protocol.
7.2 60 day notification of this Clinical Investigation has been made to
the MHRA and no letter of objection has been received (Appendix 2),
7.3 The proposal for the Clinical Investigation has obtained the approval
of a properly constituted and competent Ethics Committee (Appendix 3).
7.4 Informed written consent, as approved by the Ethics Committee, has
been or shall be obtained by the Principal Investigator from all
patients recruited onto this Clinical Investigation, and originals of
such consent shall be retained by the Trust for a period of 15 years
from the date of termination of the Clinical Investigation unless a
longer retention period is required by law.
8 SUPPLY OF DEVICE AND EQUIPMENT
The Sponsor shall be responsible for providing to the Trust a sufficient
number of Devices to conduct the Clinical Investigation. The Sponsor and
the Trust shall work together prior to the commencement of the Clinical
Investigation to estimate the number of Devices required to carry out the
Clinical Investigation. The Principal Investigator and the Trust further
agree that:
8.1 The Principal Investigator and the Trust shall: (a) not distribute or
sell the Devices to any other person or entity, (b) use the Devices
only on Clinical Investigation patients under the Principal
Investigator's supervision: and (c) use reasonable care in storing the
Devices in a secure location.
8.2 If there is any adverse reaction or suspected adverse reaction to a
Device or if a Device fails to perform its intended function during
the Clinical Investigation, the Principal Investigator shall notify
the Sponsor immediately and return the affected Device to the Sponsor
for analysis. Unless otherwise directed by the Sponsor, the
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Trust and the Principal Investigator shall return all unused and
explanted Devices and related system components to the Sponsor if the
Clinical Investigation is terminated, suspended, discontinued or
completed.
8.3 The Device and any other materials provided hereunder are for
investigational use only and provided only for carrying out activities
within the scope of this Agreement.
9 REPORTS AND ACCESS
9.1 The Trust and the Principal Investigator shall prepare and submit to
the Sponsor case report forms (each, a "CRF") for each patient, as
detailed in the Protocol and in Clause 9.2, and complete and maintain
all other patient pre-operative and post-operative records, lab test
records, follow-up reports and other records as required by the
Protocol or by the Trust's standard patient documentation practices,
the Trust's Ethics Committee, MHRA rules and regulations, and any
other applicable law, rule, regulation or practice.
9.2 The Principal Investigator and/or the Trust shall furnish to the
Monitor the records of any participating patient and the CRF so that
such Monitor is able to verify the adequacy of the data reported.
9.3 During the Clinical Investigation, the Trust and/or Principal
Investigator shall periodically retrieve and submit engineering data
recorded in the Device to the Sponsor or provide reasonable assistance
to the Sponsor to allow the Sponsor to retrieve such data.
9.4 Subject to the Data Protection ▇▇▇ ▇▇▇▇, the principles set out in the
Report of the Caldicott Committee on the review of patient
identifiable information dated December 1997 and the principles of
medical confidentiality, patient CRFs and all other records and
reports required to be kept pursuant to this Agreement or the Protocol
or otherwise related to the Clinical Investigation that have not yet
been delivered to the Sponsor shall be available for inspection and
copying at reasonable times upon the request of any authorized Sponsor
employee or agent or, upon reasonable prior notice to the Sponsor (who
shall have a right to attend such inspection), by the authorized
regulatory body, including the United States Food and Drug
Administration ("FDA") or the MHRA.
9.5 At the expense of the Sponsor, the Trust shall maintain all records
and reports required by this Agreement or the Protocol or prepared in
connection with either or both of them in a secure file for a period
of 5 years after the later of (i) the termination of this Agreement,
(ii) the completion of the Clinical Investigation, (iii) the date that
such materials are no longer required for purposes of supporting a
pre-market approval (PMA) application or a notice of completion of a
product development protocol or CE marking, or (iv) the expiry of such
longer period as the Sponsor may reasonably request in order to comply
with FDA, MHRA or other regulations.
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9.6 The Trust agrees to allow the Sponsor reasonable access to the
Principal Investigator, Co-Investigators and the Trust staff working
in the Clinical Investigation for the purpose of progress reviews,
internal reporting and other matters related to the Clinical
Investigation, including, without limitation, meetings with authorized
regulatory body representatives.
10 SPONSOR MATERIALS
All equipment, materials and documents provided to the Trust or
Principal Investigator by or on behalf of the Sponsor, or prepared in
connection with this Agreement, including without limitation, all
samples, CRFs, records, reports, communications or analyses produced
in connection with this Agreement ("Sponsor Materials") are, and shall
remain, or, as the case may be, shall become, the exclusive property
of the Sponsor. The Trust and Principal Investigator shall keep all
Sponsor Materials in the Trust's custody and control during the term
of this Agreement. All Sponsor Materials shall be returned to the
Sponsor or its designee upon termination of this Agreement or at any
time upon the Sponsor's request, except that the Trust may retain in
strict confidence one copy of all CRFs solely for archival purposes.
Patient medical charts maintained by the Trust shall not be considered
Sponsor Materials.
11 COVENANTS AND WARRANTIES
11.1 The Trust and the Principal Investigator each represent and warrant
that (a) it or he has not been found by officials from the authorized
regulatory bodies to have violated any statutes, rules, or regulations
concerning the conduct of clinical investigations, and (b) has not
been involved in any investigation or research project that has been
terminated as a result of the improper actions or inactions of either
of them.
11.2 The Trust and the Principal Investigator each represent and warrant
that it or he has the unrestricted right to disclose any information
submitted to the Sponsor. free of all claims of third parties, and
that such disclosures do not breach or conflict with any
confidentiality provisions of any agreement to which either is a
party.
11.3 The Trust and the Principal Investigator each further represent and
warrant that the services covered by this Agreement are not in
violation of any other agreement with other parties or of any
restrictions of any kind to which it or he is bound.
12 INDEMNITY AND INSURANCE
12.1 The Sponsor and the Trust shall not take any responsibility for the
acts or omissions of the other Party's servants, agents or employees.
12.2 The Sponsor shall indemnify, defend and hold harmless the Trust and
its officers, directors, trustees, employees, the Principal
Investigator and any Co-Investigators
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(the "Trust Indemnitees") from and against any and all liabilities,
damages, losses, claims or expenses (including reasonable attorneys'
fees) incurred by or imposed upon the Trust Indemnitees, or any one of
them, to the extent that they result from a defective Device or the
negligence of Sponsor in connection with the Clinical Investigation,
except to the extent such liability, damage, loss, claim or expense is
attributable to (a) prior treatment giving rise to the condition for
which the Device is used, (b) the negligence of one or more of the
Trust Indemnitees, (c) any failure of one or more of the Trust
Indemnitees to adhere strictly to the terms of this Agreement or the
Protocol or to follow good clinical practices or (d) a breach of any
applicable local law, rule, regulation or practice by one or more of
the Trust Indemnitees.
12.3 The Sponsor's obligations pursuant to this Clause 12 are conditional
upon: (a) the Trust providing written notice to the Sponsor of any
claim for indemnification hereunder within ten (10) days after it has
knowledge of such a claim, except that the Sponsor shall not be
relieved of its duty to defend unless the Sponsor can prove that it
was materially prejudiced by any delay in notification; (b) the Trust
permitting the Sponsor to assume full responsibility for the
investigation of, preparation for, and defense of, any claim for which
indemnification is being sought, (c) the Trust assisting the Sponsor,
at the Sponsor's reasonable expense, in the investigation of,
preparation for, and defense of, any such claim, and (d) the Trust not
compromising or settling any such claim without the Sponsor's prior
written consent. The Sponsor's agreement in Clause 12.2 to indemnify
and hold the Trust Indemnitees harmless is further conditional on the
Trust and Principal investigator obtaining appropriate informed
consent from each of the patients participating in the Clinical
Investigation.
12.4 Without prejudice to Clause 12.2 the Sponsor will take out appropriate
insurance cover in respect of its potential liability hereunder and
such cover shall be for a minimum of $4,000,000 in respect of any one
incident. The Sponsor shall produce to the Trust on request
documentary evidence that such insurance covers in force (Appendix
4a). The Sponsor's authorised representative will sign the Form of
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ (▇▇▇▇▇▇▇▇ ▇▇).
12.5 The Sponsor shall keep the Trust fully informed of developments and,
subject always to the terms of its insurance policy, will not unduly
prejudice the Trust's position in so conducting the claim.
13 CONFIDENTIALITY
13.1 The Parties shall treat, and shall cause its respective employees,
servants and agents to treat as strictly confidential and not to
divulge to any third party the terms of this Agreement without prior
written consent of the other Party.
13.2 The Parties shall treat, and shall cause their respective employees,
servants and agents to treat as strictly confidential and not to
divulge to any third party the Confidential Information and not to
make use of any such Confidential
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Information without prior written consent of the other Party save
where disclosure is required for: (i) the due performance of the
Clinical Investigation; or (ii) the publication of the data or results
of the Clinical Investigation by the Trust or its employees in
accordance with Clause 13; or (iii) disclosure to a regulatory
authority or as required by law,
13.3 Save for all patient medical records, the Confidential Information is,
and shall remain, or, as the case may be, shall become, the exclusive
property of the Sponsor. The Trust and Principal Investigator shall
keep all Confidential Information in the Trust's custody and control
during the term of this Agreement. All Confidential information shall
be returned to the Sponsor or its designee upon termination of this
Agreement or at any time upon the Sponsor's request, except that the
Trust may retain in strict confidence one copy of all CRFs and
original informed written consent pursuant to clause 7.4 above solely
for archival purposes.
13.4 In the event of any party visiting the establishment of any other, the
visiting party undertakes to the disclosing party that any further
confidential information not included within the definition of
Confidential Information which may come to the visiting party's
knowledge as a result of any such visit, shall be kept strictly
confidential and that any such confidential information will not be
divulged to any third party or made use of in any way by the visiting
party without prior written permission of the disclosing party.
13.5 Confidentiality will not apply to:
13.5.1 information that was known to the recipient from a source(s)
other than the Sponsor or its employees, servants or agents prior
to its disclosure hereunder, and this is demonstrably documented
in written records of the recipient; or
13.5.2 information that can be shown to have been public knowledge
prior to or after its disclosure, other than through acts or
omissions attributable to the recipient; or
13.5.3 information that was or is disclosed to the recipient by a
third party who did not derive such information from the
originator or otherwise in violation of law or an obligation not
to disclose such information; or
13.5.4 information that can be shown to have been independently
developed by the recipient without access to such Confidential
Information; or
13.5.5 the disclosure of Confidential Information required by law,
provided that if a receiving Party becomes legally compelled to
disclose any Confidential Information, such receiving Party shall
provide the disclosing Party with prompt notice so that the
disclosing Party may seek a protective order or other appropriate
remedy and/or waive compliance with the provisions of this
Section 13, and provided further that in the event that
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such protective order or other remedy is not obtained, or the
disclosing Party waives compliance with the provisions of this
Agreement, the receiving Party will furnish only that portion of
the Confidential Information that it is advised by counsel is
legally required and will exercise its best efforts to obtain
reliable assurance that confidential treatment will be accorded
the Confidential Information
13.6 The Sponsor agrees to adhere to the principles of medical
confidentiality in relation to patients involved in the Clinical
Investigation under the terms of this Agreement, and Appendices and
Schedules relating thereto
13.7 Except as required by law or regulations, the Sponsor will not use the
name of the Trust, nor of any member of the Trust staff, in any
publicity, advertising or news release without the prior written
approval of an authorised representative of the Trust, such approval
not to be unreasonably withheld. The Trust will not use the name of
the Sponsor nor of any of its employees, in any publicity without the
prior written approval of the Sponsor, such approval not to be
unreasonably withheld. The names of the parties to this Agreement may
be used if they are part of the publication of the data or results of
the Clinical Investigation.
14 PUBLICATION
14.1 The Trust and the Principal Investigator acknowledge and agree that
the Sponsor has the unrestricted and exclusive right to use the
results of the Clinical Investigation in whatever manner it desires,
both during and following termination of this Agreement.
14.2 The Sponsor recognises that: (i) the Trust may wish to publish the
results of the Clinical Investigation; and (ii) the Trust employees
engaged in the Clinical Investigation may wish to present at symposia,
national or regional professional meetings, and to publish in
journals, theses or dissertation, or otherwise of their own choosing,
methods and results of the Clinical Investigation. The Sponsor agrees
to such publications by the Trust or Trust employees, provided that
they comply with the terms of this Clause 14.
14.3 The Sponsor shall receive copies of any proposed publication or
presentation at least 60 days in advance of the submission of such
proposed publication or presentation to a journal, editor or other
third party.
14.4 The Sponsor shall have 30 days, after receipt of said copies, to
object to such proposed presentation or proposed publication on the
grounds that its publication may prejudice the obtaining of a patent
or the obtaining or maintenance of any other Intellectual Property
Rights or that it contains commercially sensitive subject matter or
Confidential Information which needs protection. The Sponsor reserves
the right to delete any Confidential Information from the proposed
publication or presentation
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In the event that the Sponsor makes such objection, the Trust shall
and shall procure that the said Trust employees shall refrain from
making such publication or presentation for a maximum of six months
from the date of receipt of such objection in order for the Sponsor to
file UK and/or other patent application(s) or obtain or maintain other
available Intellectual Property Rights protection directed to the
patentable or commercially sensitive subject matter contained in the
proposed publication or presentation.
14.5 Sponsor, and any participating centre designated by Sponsor, shall be
entitled to use any clinical data that Trust or the Principal
Investigator has acquired from the Study and has submitted for
publication.
14.6 Trust and Principal Investigator shall properly acknowledge Sponsor in
all publications or presentations resulting from the performance of
the Study. Sponsor shall be permitted to use reprints of any
publications resulting from the Study for its own purposes in a manner
that is consistent with industry practice.
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APPENDIX 1
PROTOCOL AND AMENDMENTS
15 INTELLECTUAL PROPERTY
15.1 All Intellectual Property Rights and Know How owned by or licensed to
the Trust prior to and after the date of this Agreement other than
those in the Results (as defined below) are and shall remain the
property of the Trust.
15.2 All Intellectual Property Rights and Know How owned by or licensed to
the Sponsor prior to and after the date of this Agreement are and
shall remain the property of the Sponsor.
15.3 All Intellectual Property Rights and Know How subsisting in or arising
from the Clinical Investigation results of the Clinical Investigation
(the "Results") shall vest in or be exclusively licensed to the
Sponsor in accordance with Clauses 15.4 and 15.5 below.
15.4 The Trust and the Principal investigator hereby assign, to the extent
legally possible (and where a future assignment is not possible but an
agreement to assign once rights come into existence is possible,
hereby agree to assign with effect from that time) their respective
rights, in the Results to the Sponsor, throughout the world, for the
full term of such rights (including all extensions and renewals) and
free of all liens and encumbrances. At the request and expense of the
Sponsor, the Trust and the Principal Investigator shall execute all
such documents and do all such other acts and things as the Sponsor
may reasonably require in order to vest fully and effectively all such
rights in the Sponsor or its nominee.
15.5 The Trust and the Principal Investigator shall promptly disclose to
the Sponsor any and all Results and undertake not to use the Results
other than: (i) for the purposes of this Agreement; or (ii) subject to
the prior written consent of the Sponsor, such consent not to be
unreasonably withheld, for the purpose of treatment of patients at any
premises occupied by the Trust. To the extent the Results cannot be
fully assigned (now or in the future) to the Sponsor, the Trust and
the Principal Investigator hereby grant to the Sponsor an exclusive,
worldwide, irrevocable, perpetual, fully paid up, royalty free and
assignable licence, with the right to sub-license, to exploit the
Results for any purpose whatsoever.
15.6 The Trust and the Principal Investigator will promptly notify the
Sponsor and will assist the Sponsor, upon the Sponsor's request, in
gaining patent or other Intellectual Property Rights protection for
any Results, and the Sponsor will reimburse the Trust and the
Principal Investigator for all reasonable and documented out of pocket
expenses of the Trust and the Principal Investigator incurred thereby.
Any patent application, continuation in-part, divisional, will be
filed, paid for and prosecuted by the Sponsor if it so chooses.
16 FINANCIAL AGREEMENT
16.1 Arrangements relating to the financing of this Clinical Investigation
by the Sponsor are set out in Appendix 5 hereto.
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16.2 All payments will be made according to the schedule contained in
Appendix 5 against presentation of a valid invoice to the Sponsor by
the Trust. The Principal Investigator enters into this Agreement in
consideration of the obligations undertaken by the other parties.
16.3 The Sponsor shall make payment within thirty (30) days of the date of
receipt of the invoice mentioned in Clause 16.2 above.
16.4 Any delay in the payment of the invoices by the Sponsor will incur an
interest charge payable monthly on any amounts overdue at the rate of
2 per cent per annum above the National Westminster Bank plc base rate
prevailing on the date the payment is due.
16.5 All payments should be made to The Royal Brompton & Harefield NHS
Trust as per the invoice's payment instructions.
17 TERM
The Clinical Investigation will have an anticipated duration of 24 months
or if longer until completion of the data for the last follow up of any
patient in the Clinical Investigation, unless terminated earlier pursuant
to Clause 18 below. The duration of the Clinical Investigation may be
modified by mutual written agreement of the parties hereto under acceptable
terms.
18 TERMINATION
18.1 The Trust or the Sponsor may (by notice in writing to the other)
terminate this Agreement at any time on any of the following events
occurring:
18.1.1 Should the other party be declared insolvent or have an
Administrator or Receiver appointed over all or any part of their
assets;
18.1.2 Should the other party be reasonably of the opinion that the
Clinical Investigation should cease in the interests of the
patients involved in the Clinical Investigation;
18.1.3 Should patient recruitment, in the reasonable opinion of the
Sponsor, be unsatisfactory;
18.1.4 Should the Sponsor require termination due to significant
protocol deviation or violation;
18.1.5 Should the person from time to time appointed with the
Sponsor's consent as Principal Investigator cease to be employed
by the Trust or otherwise cease to be able to fulfil her/his
duties and no mutually acceptable replacement can be found.
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18.2 After receipt of any and all documentation, data, and information
regarding the Clinical Investigation, including but not limited to the
Confidential Information, by the Sponsor from the Trust and the
Principal Investigator, the Sponsor shall make payment for reasonable
costs necessarily and irrevocably incurred and committed (as supported
by written evidence) up to the date of receipt of the notice of
termination by the Trust. Upon receipt of the notice of termination,
the Trust shall use best efforts to mitigate costs related to the
termination. The Sponsor shall not be liable for any costs if
termination is caused by or is in any way related to the negligence,
breach of contract or misconduct of the Trust or the Principal
Investigator, or is a result of a force majeure event pursuant to
Clause 21. Any funds not expended by the Trust for the Clinical
Investigation prior to the effective termination date shall be
credited or returned by the Trust to the Sponsor.
18.3 Either Party may withdraw from this Clinical Investigation at any time
if the other Party is in breach of any of its obligations hereunder
and fails to remedy such breach, where it is capable of remedy, within
30 days of a written notice from the non-breaching Party to the other,
specifying the nature of the breach.
18.4 Immediately upon receipt of a notice of termination, the Trust and the
Principal investigator shall stop any further enrolling of patients
into the Clinical Investigation.
18.5 Termination of this Agreement will be without prejudice to the accrued
rights and liabilities of the parties under this Agreement.
18.6 Notwithstanding the foregoing, the Parties agree that any termination
notified hereunder shall not commence until such date as patients in
the Clinical Investigation can be transitioned out of the Clinical
Investigation without adverse medical effect to such patients. If the
Clinical Investigation is terminated for any reason, the Trust and
Principal Investigator agree to conduct any follow-up required by the
Protocol or instituted by any regulatory authority as a condition of
the Clinical Investigation approval.
18.7 If this Agreement is terminated before completion of the Clinical
Investigation, the Trust and the Principal Investigator shall furnish
the Sponsor with an acceptable investigator's report for the Clinical
Investigation as soon as reasonably practicable.
18 RELATIONSHIP BETWEEN THE PARTIES
18.1 In the performance of all services hereunder the Trust and the
Principal Investigator shall each be deemed to be and shall be an
independent contractor of the Sponsor.
18.2 Neither Party is authorised to act as agent for the other for any
purpose and shall not on behalf of the other enter into any contract,
warranty or representation as to any matter. Neither shall be bound by
the acts or conduct of the other.
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18.3 Neither Party may assign its rights under this Agreement or any part
thereof and may not delegate the performance of its obligations under
this Agreement without the prior written consent of the other, such
consent shall not be unreasonably withheld.
18.4 Any formal notices or communications between the Parties must be in
writing and either delivered personally, via facsimile (with
confirmation of receipt), by internationally recognized overnight
courier service, or by recorded delivery post.
19 GOVERNING LAW
This Agreement shall be interpreted and governed by English Law.
20 AGREEMENT AND MODIFICATION
20.1 Any agreement to change the terms of this Agreement in any way shall
be valid only if the change is made in writing and approved by mutual
agreement of authorised representatives of the parties hereto.
20.2 This Agreement including its Appendices and Schedules contains the
entire understanding between the Parties and replaces all other
Agreements of prior date between the Parties relating to the Clinical
Investigation which is the subject of this Agreement. Accordingly, all
other terms, conditions, representations, warranties and other
statements which would otherwise be implied (by law or otherwise)
shall not form part of this Agreement.
21 FORCE MAJEURE
Neither the Sponsor nor the Trust shall be in default of its obligations
hereunder if such default is the result of war, hostilities, revolution,
civil commotion, strike, epidemic, accident, fire, wind, flood or because
of any law, order, proclamation, regulation or ordinance, or any act of God
or other cause beyond the reasonable control of the Party affected,
provided that if the force majeure event continues for more than 90 days,
the unaffected Party, without limiting the termination right provided for
in Clause 17, may terminate this Agreement forthwith by notice to the
other.
22 THIRD PARTIES
Nothing in this Agreement is intended to confer on any person any right to
enforce any term of this Agreement which that person would not have had but
for the Contracts (Rights of Third Parties) ▇▇▇ ▇▇▇▇.
14
Signed on behalf of
HEARTWARE, INC.
/s/ ▇▇▇▇ ▇. ▇▇▇▇▇ Date 09/11/06
-------------------------------------
▇▇▇▇ ▇. ▇▇▇▇▇
Vice President - Clinical and
Marketing
Signed on behalf of
ROYAL BROMPTON & HAREFIELD NHS TRUST
/s/ ▇▇▇▇▇▇ ▇▇▇▇▇ Date 10/25/2006
-------------------------------------
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇,
Director of Research and Development
Appendices
1 The Clinical Investigation Protocol and Schedules
2 MHRA Approval - Letter of Agreement
3 Ethics Committee Approval
4 (a) Insurance
(b) Form of Indemnity
5 Investigator/Financial Agreement
15