Exhibit 10.30
CLINICAL INVESTIGATION AGREEMENT
THIS CLINICAL INVESTIGATION AGREEMENT (this "Agreement") made and effective as
of this 13th day of February, 2007 (the "Effective Date"), is by and between
HeartWare Limited, Suite 4 Xxxxx 00, 0 Xxxx Xxxxxx, Xxxxxx XXX 0000 ABN 34 111
970 257 ("Sponsor"); and St. Vincent's Hospital Sydney Limited ("Hospital")
having its address at 000 Xxxxxxxx Xxxxxx, Xxxxxxxxxxxx, XXX 0000, Xxxxxxxxx ABN
77 000 000 000, on behalf of itself and Xxxx Xxxx, ("Investigator"), Hospital's
employee.
WHEREAS, Sponsor desires Hospital and Investigator to conduct, and Hospital and
Investigator desire to conduct for Sponsor, a Clinical Study of Sponsor's
implantable left ventricular assist System "LVAD" (the "Device"), according to
the protocol number HW002 (the "Protocol"), which is attached hereto as Exhibit
A (which, upon the reasonable request of any party hereto, may be amended from
time to time as set forth in section 10.5 of this Agreement);
WHEREAS, the Clinical Study detailed in the protocol is of mutual interest and
benefit to Sponsor, Hospital and Investigator.
NOW, THEREFORE, in consideration of the mutual promises and covenants contained
herein, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties hereto mutually
covenant and agree as follows:
1. SCOPE OF WORK; TERM
1.1 Clinical Study
Hospital and Investigator agree to use best efforts and professional expertise
to perform the Clinical Study according to the Protocol as set forth in Exhibit
A. Hospital agrees to provide such qualified personnel, equipment, materials
(except materials to be provided by Sponsor as hereinafter set forth) and
facilities as are necessary to perform the Clinical Study. Hospital and
Investigator agree to comply with all applicable laws and regulations relating
to the use of such equipment, materials and facilities and to the employment of
such personnel.
1.2 Investigator
The Investigator, on behalf of the Hospital, shall undertake primary
responsibility for performing the Clinical Study in accordance with the Protocol
and the terms of this Agreement. Without limiting the generality of the
foregoing, the work to be performed hereunder shall be performed by the Hospital
solely by or under the direct supervision of the Investigator. In the event that
Investigator is unable to continue with the Clinical Study, Hospital shall
promptly notify Sponsor in writing and propose a substitute. Sponsor shall have
the right to approve any such substitute, and may terminate this Agreement upon
ten (10) days prior written notice to Hospital if the proposed substitute is not
acceptable to Sponsor in its sole discretion. Upon any such termination,
Hospital shall be reimbursed for its costs incurred through such termination
date.
Confidential
1.3 Co-Investigators
Upon the prior written consent of Sponsor, which shall not be unreasonably
withheld, Principal Investigator may appoint one or more collaborating
physicians, each of whom shall have special expertise in the field of clinical
research relating to the Study ("Co-Investigator"), to participate in this
Clinical Study. Such Co-Investigators shall work under the direct supervision of
the Investigator and shall otherwise agree to be bound by the same terms that
bind the Investigator hereunder. Prior to commencing participation in the
Clinical Study, each Co-Investigator shall execute the attached Co-Investigator
Acceptance Form attached hereto as Exhibit B and deliver the same to Sponsor,
together with a copy of such Co-Investigator's current curriculum vitae and a
signed Financial Disclosure Form attached hereto as Exhibit C.
Hospital and/or the Investigator will take all necessary countermeasures to
ensure that any Co-Investigator complies with the obligations undertaken by
Hospital and/or the Investigator under this Agreement and shall be responsible
for any and all performance of Co-Investigator.
1.4 Ethics Committee
Hospital and/or Investigator shall submit an Ethics Committee Application and
the Protocol for approval to Hospital Ethics Committee. The Ethics Committee's
unconditional approval of the Protocol and patient consent form is a
prerequisite of participation under and compensation by this Agreement.
1.5 Protocol
Investigator and Hospital hereby confirm that they have each reviewed the
Protocol and have had the opportunity to ask questions and discuss any concerns
related thereto. Investigator and Hospital agree to conduct the Clinical Study
in accordance with this Agreement, the Protocol, EN540, ISO14155, ICH GCP, any
conditions of approval imposed by the Ethic Committee and in accordance with
applicable Australian laws and regulations.
1.6 Compliance With Laws
In performing the Clinical Study, Hospital and the Investigator agree to fully
comply with all applicable federal, state and local laws and regulations,
including, without limitation relevant provisions of the European Community, and
with all terms and conditions of the Protocol. Sponsor shall be responsible for
notifying competent authorities of the nature of the Clinical Study and
obtaining any required approvals. Hospital and the Investigator shall provide
such assistance in obtaining such approvals as Sponsor may reasonably require.
1.7 Supply of Device and Equipment
Sponsor shall be responsible for providing the Hospital a sufficient number of
Devices to conduct the Clinical Study. Sponsor and Hospital shall work together
prior to the commencement of the Clinical Study to estimate the number of
Devices required to carry out the Clinical Study. Investigator and Hospital
further agree that:
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(a) Principal Investigator and Hospital shall: (a) not distribute or sell the
Devices to any other person or entity, (b) use the Devices only on Study
Patients under the Principal Investigator's supervision; and (c) use
reasonable care in storing the Devices in a secure location.
(b) If there is any adverse reaction to a Device or if the Device fails to
perform its intended function during the Clinical Study, Investigator shall
notify Sponsor immediately and return the affected Device to Sponsor for
analysis. Unless otherwise directed by Sponsor, Hospital and Investigator
shall return all unused and explanted Devices and related system components
to Sponsor if the Clinical Study is terminated, suspended, discontinued or
completed.
(c) 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. Sponsor can not, and does not,
guarantee or warranty, either explicitly or implicitly, the fitness of the
Device for the purposes, the objectives and the activities to be carried
out within the scope of this Agreement or any infringement regarding the
Device or any other equipment supplied by Sponsor under, or being part, of
this Agreement or the Clinical Study. Furthermore Sponsor does not
guarantee or warrant, either explicitly or implicitly, the safety or
efficacy of the Device or any other equipment supplied by Sponsor under, or
being part of, this Agreement or the Clinical Study.
1.8 Term
This Agreement becomes effective on the Effective Date and shall continue in
effect for three (3) years unless extended or terminated earlier by mutual
agreement of the parties. Notwithstanding the foregoing, the provisions of
Section 3.3 and Articles 4 through 8 shall survive any expiration or termination
of this Agreement.
1.9 Early Termination
Sponsor may terminate this Agreement at any time by giving thirty (30) days
written notice of termination to Hospital. Sponsor reserves the right to
immediately terminate this Agreement and to exclude Hospital and Investigator
from further participation in the Clinical Study, if within three (3) months
after the Study Initiation Visit no patients are participating in the Clinical
Study. In the event of termination, Sponsor shall reimburse Hospital for all
contractual commitments and financial obligations reasonably incurred by
Hospital in the good faith performance of this Agreement prior to notice of such
termination, to the extent such financial obligations or contractual commitments
cannot be canceled by Hospital. Notwithstanding the foregoing, Sponsor and
Hospital agree that any termination requested hereunder shall not commence until
such date as patients in the Clinical Study can be transitioned out of the
Clinical Study without adverse medical effect to such patients. If the Clinical
Study any reason, Hospital and Investigator agree to conduct any follow-up
required by the Protocol or instituted by any regulatory authority as a
condition of the Clinical Study vice approval.
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2. PAYMENT
Sponsor shall compensate Hospital for the cost of completing CRF (Case Report
Form) for the Clinical Study according to the amount detailed in Exhibit D.
3. REPORTS; ACCESS
3.1 Documentation Provided by Hospital
Hospital shall submit the following documents to Sponsor prior to commencing the
Clinical Study:
(a) Documentation of Hospital 's Ethics Committee's approval of the Protocol
and patient consent form:
(b) Investigator's current curriculum vita and the curriculum vitae of any
other Co-Investigators participating in the Clinical Study;
(c) A copy of the Protocol signed by Investigator and signed copy of the
financial disclosure forms by the Investigator and Co-Investigators;
(d) Signed copies of Co-Investigators' acceptance forms; and
(e) A signed copy of this Clinical Study Agreement.
3.2 Records and Reports
(a) Hospital and the Investigator shall prepare and submit to Sponsor case
report forms ("CRF") for each patient, as detailed in the Protocol, 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 Hospital's standard patient documentation practices,
Hospital's Ethics Committee, the European Community and any other
applicable law, rule, regulation or practice.
(b) The CRF must permit the verification of the accuracy of the information
furnished by the Investigator to the Sponsor. The Investigator and/or
Hospital shall furnish to any authorized Sponsor employee or agent the
records of any participating patient and the CRF so that such authorized
Sponsor employee or agent may be able to verify the adequacy of the data
reported.
(c) Hospital and/or Investigator shall periodically during the Clinical
Study retrieve and submit Engineering Data recorded in the Device to
Sponsor or provide reasonable assistance to Sponsor to allow Sponsor to
retrieve such data.
(d) Patient CRFs and all other records and reports required to be kept
pursuant to this Agreement or Protocol or are otherwise related to the
Clinical Study that have not yet been delivered to Sponsor shall be
available for inspection or copying at reasonable times upon the request of
any authorized Sponsor employee or agent or the authorized
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regulatory body, including the United States Food and Drug Administration
("FDA", or its European equivalent agency.
(e) All records and reports required by this Agreement or prepared in
connection therewith shall be maintained by Hospital and the Investigator
in a secure file for a period of ten (10) years after the latter of (i) the
termination of this Agreement, (ii) the completion of the Clinical Study,
(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) such
longer period as Sponsor may reasonably request in order to comply with FDA
or European equivalent regulations.
3.3 Access to Personnel
Hospital agrees to allow Sponsor reasonable access to Investigator,
Co-Investigators and Hospital staff working in the Clinical Study for the
purpose of progress reviews, internal reporting and other matters related to the
Clinical Study, including, without limitation, meetings with authorized
regulatory body representatives.
4. SPONSOR PROPERTY
All equipment, materials and documents provided to Hospital or Principal
Investigator by Sponsor, or prepared in connection with this Agreement,
including without limitation, all samples, case report forms, records, reports,
communications or analyses produced in connection with this Agreement ("Sponsor
Materials") are, and shall remain the exclusive property of the Sponsor.
Hospital and Principal Investigator shall keep all Sponsor Materials in its
custody and control during the term of this Agreement. All Sponsor Materials
shall be returned to the Sponsor or designee upon termination of this Agreement
or upon Sponsor's request, except that Institution may retain one copy of all
case report forms solely for archival purposes. Patient medical charts
maintained by Institution shall not be considered Sponsor Materials.
5. INTELLECTUAL PROPERTY
5.1 Ownership and Assignment of Intellectual Property
All rights to and ownership of any intellectual property conceived or developed
during the course of or in connection with the Clinical Study relating in any
whatsoever to the Device ("Intellectual Property") shall vest exclusively in
Sponsor. Hospital shall promptly assign, and shall cause its personnel who
participate in the Clincal Studyto promptly assign to Sponsor and treat as
Sponsor's all Intellectual Property. Any other intellectual property conceived
and developed during the course of, or in connection with, the Clinical Studynot
related to the Device and (i) developed solely by Hospital shall belong
exclusively to Institution, (ii) developed solely by Sponsor shall belong
exclusively to Sponsor, and (iii) jointly developed by Hospital and Sponsor
shall belong jointly to Hospital and Sponsor. Notwithstanding any ownership or
partial ownership by Hospital of any Intellectual Property related to the
Clinical Studynvestigator agree that any such Intellectual Property shall be
used exclusively for research, patient care and teaching purposes as determined
by its academic mission, and not for any commercial purposes.
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5.2 Disclosure of Intellectual Property
Hospital shall promptly disclose to Sponsor in writing any and all Intellectual
Property conceived or developed during the course of, or in connection with, the
Clinical Study, whether or not relating to the Device.
5.3 Licensing Intellectual Property
To the extent that Hospital owns the rights of sole or joint inventorship with
respect to such Intellectual Property, Sponsor is hereby granted, without option
fee, a first right to negotiate an exclusive worldwide, royalty bearing license
to Hospital's rights to any Intellectual Property which option shall extend for
ninety (90) days after Sponsor's receipt of an Intellectual Property disclosure
from Hospital. Upon Sponsor's exercise of its first right to negotiate, the
parties shall promptly negotiate a license agreement in good faith, in
accordance with the parties normal licensing practices and policies, taking into
consideration the relative contribution of the parties and the commercial value
of such Intellectual Property. If the parties fail to enter into a license
agreement as provided herein, Hospital shall have the right to negotiate and
grant a license to a third party, provided that such license is not more
favorable to the third party licensee than the terms offered to Sponsor and
provided further that no such license shall be granted to a competitor of
Sponsor.
5.4 Patents: Mutual Cooperation
Hospital will promptly notify Sponsor and will assist Sponsor, upon Sponsor's
request, in gaining patent protection for any patentable Intellectual Property,
or patentable licensed Hospital intellectual property, and Sponsor will
reimburse Hospital for all reasonable and documented out of pocket expenses of
Hospital incurred thereby. Any patent application, continuation in-part,
divisional, etc., will be filed, paid for and prosecuted by Sponsor for
Intellectual Property.
5.5 Principal Investigator
Hospital shall ensure that the Principal Investigator (a) has signed and
delivered to Sponsor, prior to such participation, an Investigator Agreement,
(b) is bound by and has agreed to comply with the terms of this Agreement, and
(c) does not enter into agreements with third parties which would prevent him
from participating in the Clinical Study.
5.6 No Grant of Right In Intellectual Property
Nothing in this Agreement shall be interpreted as giving Hospital any rights in
or to any intellectual property rights now or hereafter owned by Sponsor.
Nothing in this Agreement should be interpreted as giving Sponsor any rights in
or to any intellectual property rights now hereafter owned by Hospital or
Principal Investigator, except as expressly provided for herein.
5.7 Ownership of Copyrights
Title to any copyrightable material reporting the Results, first produced or
composed by Principal Investigator shall remain with the Principal Investigator;
provided that Sponsor shall be granted an irrevocable, royalty-free nonexclusive
right to reproduce, translate and use such
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copyrighted material (a) for Sponsor's own internal purposes prior to
publication and (b) after its publication for any purpose subject to Section 7
below.
5.8 Use of Results
Without limiting any of the foregoing, Sponsor shall own and have the sole right
to use the Sponsor Property delivered by Hospital and Investigator under the
terms of this Agreement in any manner deemed appropriate to Sponsor's business
interests. Anything herein to the contrary notwithstanding, Hospital and
Investigator may with Sponsor's prior written consent use the results of the
Clinical Study exclusively for research, patient care and teaching purposes,
which consent will not be unreasonably withheld.
6. CONFIDENTIAL INFORMATION
6.1 Confidential Information
As used herein, "Confidential Information" shall mean (a) the terms and
existence of this Agreement, (b) all information disclosed either directly or
indirectly, and whether disclosed verbally, in writing or by tangible products
or samples, by Sponsor to Hospital, Investigator or Co-Investigator and (c) any
and all information developed in the course of the Clinical Study, including,
without limitation, information relating to the Device, Clinical Study, Sponsor
Property, Intellectual Property and Inventions, Case Reports or Clinical Study
Results, Clinical Study participants and all other information regarding
Sponsor's (or its affiliated entities') past, present or future research
technology, designs, products, know-how, 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 Hospital or Investigator, either alone or with others,
as a result of their work in connection with this Agreement.
Each of Hospital and Investigator hereby agrees not to disclose, either directly
or indirectly, the Confidential Information to any third party or use such
Confidential Information for any purpose other than the performance of the
Clinical Study or as may be required by law or regulation.
For purposes of this Agreement, for foregoing obligation of confidentiality
shall not apply to:
(a) information that was known to the recipient from a source(s) other than
Sponsor or its agents prior to its disclosure hereunder, and this is
demonstrably documented in written records of recipient;
(b) 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;
(c) information was 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;
(d) information can be shown to have been independently developed by the
recipient without access to such information; or
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(e) the disclosure of Confidential Information required by law.
7. PUBLICATIONS
7.1 Sponsor Review
Subject to Section 7.3 hereof, Hospital and Principal Investigator reserve the
right to publish Results. Before publishing, however, Hospital and Principal
Investigator shall submit copies of any proposed publication or presentation to
Sponsor for review at least 60 days in advance of submission for publication or
presentation to a publisher or other third party. Sponsor shall review the data
provided in the proposed publication against the Study database for consistency.
Sponsor shall also review the proposed publication and reserves the right to
delete any Confidential Information from the proposed publication or
presentation. In addition, Sponsor may extend such review period for up to
another 60 days to allow for filing of patent applications or take other steps
to protect the Sponsor's intellectual property interests, or to otherwise avoid
a breach of law, or to remove from the proposed publication or presentation any
language that is incorrect or otherwise detrimental to Sponsor's intellectual
property interests or that discloses any Confidential Information.
Sponsor, and any participating center designated by Sponsor, shall be entitled
to use any clinical data that Hospital or the Principal Investigator has
acquired from the Study and has submitted for publication.
7.2 Acknowledgement of Sponsor: Use of Reprints
Hospital 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.
7.3 Use of Names
Except as required by law, no party may use the name of any other party in any
advertising or other form of publicity without the written permission of the
party whose name is to be used (such permission not to be unreasonably
withheld).
8. INDEMNITIES AND INSURANCE
8.1 By Sponsor
Sponsor shall indemnify, defend and hold harmless Hospital and Hospital 's
officers, directors, trustees, employees, Investigator and any Co-Investigators
(the "Hospital Indemnities") from and against any and all liabilities, damages,
losses, claims or expenses (including reasonable attorneys' fees) incurred by or
imposed upon the Hospital Indemnities, or any one of them, that result from any
allegation that the Device was defective or the negligence of Sponsor in
connection with the Clinical Study, 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, reckless or willful
misconduct of one or more of the Hospital
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Indemnities, (c) any failure of one or more of the Hospital Indemnities to
adhere strictly to the terms of 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 Hospital Indemnities.
8.2 By Hospital
Hospital shall indemnify, defend and hold harmless Sponsor and Sponsor's
officers, directors, shareholders, employees and affiliates (the "Sponsor
Indemnities") from and against any and all liabilities, damages, losses, claims
or expenses (including reasonable attorneys' fees) incurred by or imposed upon
the Sponsor Indemnities, or any one of them, in connection with the Clinical
Study, 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, reckless or willful misconduct of one or
more of the Hospital Indemnities, (c) any failure of one or more of the Hospital
Indemnities to adhere strictly to terms of the Protocol or to follow good
clinical practices, or (d) a breach of any applicable federal, state or local
law, rule, regulation or practice by one or more of the Hospital Indemnities.
8.3 Conditions of Indemnity
Sponsor's and Hospital's obligations pursuant to this Article 8 are conditioned
upon: (a) the indemnified party providing written notice to the indemnifying
party of any claim for indemnification hereunder within ten (10) days after such
party has knowledge of such a claim, except that the indemnifying party shall
not be relieved of its duty to defend unless the indemnifying party can prove
that it was materially prejudiced by any delay in notification; (b) the
indemnified party permitting the indemnifying party to assume full
responsibility for the investigation of, preparation for, and defense of, any
claim for which indemnification is being sought, (c) the indemnified party
assisting the indemnifying party, at the indemnifying party's reasonable
expense, in the investigation of, preparation for, and defense of, any such
claim, and (d) the indemnified party not compromising or settling any such claim
without the indemnifying party's prior written consent. Sponsor's agreement in
Section 8.1 to indemnify and hold the Hospital Indemnities harmless is further
conditioned on Hospital and Investigator obtaining (i) Ethics Committee approval
of the Clinical Study, including without limitation, the Protocol and (ii)
informed consent from each of the patients participating in the Clinical Study.
8.4 Insurance
Sponsor, Investigator and Hospital shall each carry insurance from an insurance
carrier reasonably acceptable to the others in amounts and under coverages in
accordance with country laws. Each party shall provide to the other party
evidence of such coverages upon request.
9. COVENANTS AND WARRANTIES
9.1 Hospital represents and warrants that Investigator has full right and
authority to enter into this Agreement under applicable law, and the internal
rules of any institution where work pursuant to this Agreement is performed, and
Investigator's employer, where appropriate. Hospital shall secure from
Investigator any necessary notifications or approvals, administrative or
governmental for the work to be performed hereunder.
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9.2 Hospital represents and warrants that all amounts received under this
Agreement are only for legitimate expenses, reimbursement of such expenses, or
compensation for the performance of the activities described in this Agreement,
and that receipt of such amounts is in all respects in full accordance with all
applicable laws, rules, regulations, policies and practices.
9.3 Hospital and the Investigator warrant that they (a) have 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)
have not been terminated from any investigation or research project for reasons
other than completion of the research project.
9.4 Hospital and Investigator warrant that they have the unrestricted right to
disclose any information submitted to 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.
9.5 Hospital and Investigator further 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 either is bound.
9.6 Hospital and Investigator represent and warrant that all of Hospital
employees, agents and associates whose services may be used to fulfill their
respective obligations under this Agreement are or will be appropriately
informed of the terms of this Agreement and are under legal obligation to either
Hospital or Investigator, by contract or otherwise, sufficient to enable them to
fully comply with all provisions of this Agreement.
10. MISCELLANEOUS
10.1 Notices
All notices or other communication which are required or permitted hereunder
shall be in writing and sufficient if delivered personally, sent by prepaid
nationally recognized overnight courier, sent by mail or sent by facsimile
transmission (with confirmation of receipt), addressed as follows:
If to Institution: St. Vincent's Hospital
000 Xxxxxxxx Xxxxxx
Xxxxxxxxxxxx XXX 0000
Attention: Xx. Xxxx Xxxxxx
Title: Director of Clinical Services
Phone: 00 0000 0000
Facsimile: 02 8382 3002
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If to Principal
Investigator: Xx. Xxxx Xxxxx
St. Vincent's Clinic
000 Xxxxxxxx Xxxxxx
Xxxxxxxxxxxx XXX 0000
Phone: 00 0000 0000
Facsimile: 02 8382 6869
If to Sponsor: Heartware Limited Copy to: HeartWare, Inc.
Suite 4 0000 Xxxxxxxxx Xxx
Xxxxx 00 Xxxxxxx, XX 00000
0 Xxxx Xxxxxx
Xxxxxx XXX 0000 Attention: Legal
Department
Attention: Xxxxx XxXxxxxx Phone: (000)000-0000
Title: Chief Financial Office
Phone: 0000 0000
Any such communication shall be deemed to have been given when delivered if
personally delivered, on the business day after sent if sent by nationally
recognized overnight courier, on the fifth business day following the date of
mailing if sent by prepaid first class certified mail, return receipt requested,
and on the date transmitted if sent by facsimile.
10.2 Assignment
This Agreement shall not be assignable by any party without the prior written
consent of the other parties, provided that Sponsor may, without such consent,
assign this Agreement and its rights and obligations hereunder in connection
with the transfer or sale of all or substantially all of its business, or in the
event of its merger or consolidation or change in control or similar
transaction.
10.3 Governing Law
This Agreement shall be governed by the laws of New South Wales, Australia.
10.4 Force Majeure
No party hereto shall be liable to another for its failure to perform any of the
obligations imposed by this Agreement, provided such failure shall be occasioned
by fire, flood, explosion, earthquake, discontinuity in the supply of power,
governmental interference, civil commotion, riot, war, strikes, labor
disturbance, or any cause beyond the reasonable control of the non-performing
party, provided that if such failure lasts for more than 30 days, either party
may terminate this Agreement.
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10.5 Entire Agreement
Unless otherwise specified, this Agreement embodies the entire understanding
among Hospital, Investigator and Sponsor for this project, and any prior or
contemporaneous agreements between the parties relating to the subject matter
hereof, either oral or written, are hereby superseded. No amendments or changes
to this - Agreement, including without limitation, changes to Exhibit A, shall
be effective unless made in writing and signed by authorized representatives of
the parties.
10.6 Headings
The headings in this Agreement are intended solely for convenience or reference
and shall be given no effect in the construction or interpretation of this
Agreement.
10.7 Counterparts
This Agreement may be executed and delivered in one or more counterparts, each
of which when executed and delivered shall be deemed to be an original but all
of which when taken together shall constitute one and the same Agreement.
10.8 Validity of the Agreement
Should any article of this Agreement be declared void, this will not imply or
constitute the avoidance of the entire agreement. The other articles will then
be interpreted in such a way, to comply with the meaning and intention of the
article which has been declared void.
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IN WITNESS WHEREOF, Sponsor, Hospital and Investigator have caused this
Agreement to be executed as of the date first set forth above by their
respective officers thereunto duly authorized.
HEARTWARE LIMITED
Signature /S/ Xxxxx XxXxxxxx
---------------------------
Name (print) Xxxxx XxXxxxxx
Title Chief Financial Officer &
Company Secretary
ST. VINCENT'S HOSPITAL
Signature /S/ G. B. Xxxxxx
---------------------------
Name (print) Dr. G.B. Xxxxxx
Title Director of Clinical Services
PRINCIPAL INVESTIGATOR (acknowledgement purposes only)
Signature /S/ Xxxx Xxxxx
---------------------------
Name (print) Xxxx Xxxxx
EXHIBIT A
PROTOCOL
EXHIBIT B
CO-INVESTIGATOR ACCEPTANCE FORM
Sponsor, Institution, and Principal Investigator have entered into a Clinical
Study Agreement dated February 1, 2006 ("Agreement"). Each of the undersigned
collaborating physicians ("Co-Investigators"), acting as either the Research
Institution's employee or agent, will be primarily responsible, together with
Principal Investigator, for performing the obligations of Principal Investigator
in the Agreement. The undersigned Co-Investigators each hereby expressly: (a)
acknowledge that they have received copies of the Agreement and the Protocol;
(b) acknowledge that they have read and understand the Agreement, the Study and
the Protocol, and have had the opportunity to ask questions and discuss any
concerns related thereto; (c) make the representations and warranties and agree
to keep and perform each and every obligation of Principal Investigator under
the Agreement (other that those relating to Principal Investigator's obligations
to supervise the Clinical Study and use of the Devices in connection with the
Clinical Study, which obligations shall be performed solely by Principal
Investigator); and (d) agree that their participation in the Clinical Study will
at all times be under the supervision of the Principal Investigator.
1. /S/ Xxxxx XxxXxxxxx
----------------------------------
Co-Investigator Signature
Print Name: Xxxxx XxxXxxxxx
Date: 19/2/07
2. /S/ Xxxxxx Xxxxxxx
----------------------------------
Co-Investigator Signature
Print Name: Xxxxxx Xxxxxxx
Date: 19/2/7
3. /S/ Xxxxx Xxxxxxx
----------------------------------
Co-Investigator Signature
Print Name: Xxxxx Xxxxxxx
Date: 21/2/07
4. /S/ Xxxx Xxxxx
-------------------------------------
Co-Investigator Signature
Print Name: Xxxx Xxxxx
Date: 21/2/07
5.
-------------------------------------
Co-Investigator Signature
Print Name: Xxxxxxx Xxxxxx
Date: 6/3/07
6.
-------------------------------------
Co-Investigator Signature
Print Name:
------------------
Date:
-----------
EXHIBIT C
FINAL DISCLOSURE FORM
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
Please complete all of the information below and retain a copy of this form for
your records.
1. Study Name: _______________
2. Protocol number: _______________
3. Investigator [ ] Subinvestigator [ ]
4. Investigator/Subinvestigator Name: _______________
Institution Name (if applicable): ________________
5. Address: __________________
6. Telephone: __________________ 7. Fax: __________________
8. Indicate by marking YES or NO if any of the financial interests or
arrangements of concern to FDA (and described below) apply to you, your spouse,
or dependent children:
YES NO Financial arrangements whereby the value of the compensation
[ ] [ ] could be influenced by the outcome of the study. This could
include, for example, compensation that is explicitly greater
for a favorable outcome, or compensation to the investigator in
the form of an equity interest in the sponsor or in the form of
compensation tied to sales of the product, such as a royalty
interest.
If yes, please describe:
________________________________________________________________
YES NO Significant payments of other sorts, excluding the costs of
[ ] [ ] conducting the study or other clinical studies. This could
include, for example, payments made to the investigator or the
institution to support activities that have a monetary value
greater than $25.000 U.S. (i.e. a grant to fund ongoing
research, compensation in the form of equipment, or retainers
for ongoing consultation or honoraria).
If yes, please describe:
________________________________________________________________
YES NO A proprietary or financial interest in the test product such as
[ ] [ ] a patent, trademark, copyright, or licensing agreement.
If yes, please describe:
________________________________________________________________
YES NO A significant equity interest in the sponsor of the study. This
[ ] [ ] would include, for example, any ownership interest, stock
options, or other financial interest whose value cannot be
easily determined through reference to public prices, or an
equity interest in a publicly traded company exceeding
$50,000 U.S.
If yes, please describe:
________________________________________________________________
or
[ ] I hereby certify that none of the financial interests listed above exist for
myself, my spouse, or dependent children.
In accordance with 21 CFR Parts 54.1 to 54.6, I declare that the information
provided on this form is, to the best of my knowledge and belief, true, correct,
and complete. Furthermore, if my financial interests and arrangements, or those
of my spouse and dependent children, change from the information provided above
during the course of the study or within one year after the last patient has
completed the study as specified in the protocol, I will notify HeartWare
promptly.
9. Signature: 10. Date: ________
---------------------
EXHIBIT D
STUDY BUDGET
Sponsor will reimburse Institution for the time associated for a research nurse
and/or other personnel to manage patient adherence to follow-up requirements of
the protocol and the time to prepare case report forms. The Sponsor hereby
agrees to pay Institution 6600 Australian Dollars (AUS) for each study subject
upon completion of all required case report forms. HeartWare is providing all
devices at no cost to the institution.
Printed name of Participating Center St. Vincent's Hospital Sydney
Xx. Xxxxx Xxxxxxx Trust Fund
Name to be Printed on Reimbursement
Check ABN: 77 000 000 000
Tax ID# for Payee Identified Above 000 Xxxxxxxx xxxxxx
Address to Which Checks Should be
Mailed (Include Department and/or
Mail Stop) Xxxxxxxxxxxx XXX 0000
____________________________________
____________________________________
City/State/Zip ____________________________________
