Exhibit 10.18
Confidential
(LOGO)
CLINICAL INVESTIGATION AGREEMENT
THIS CLINICAL INVESTIGATION AGREEMENT (this "Agreement") made and effective
as of this 21st day of March, 2006 (the "Effective Date"), is by and between
Heartware, Inc., a Delaware corporation having its principal offices at 0000
Xxxxxxxxx Xxx, Xxxxxxx, XX 00000-0000, U.S.A. ("Sponsor"); and Medical
University of Vienna ("University") having its address at Xxxxxxxxxxx 00, 0000
Xxxxxx, Xxxxxxx.
WHEREAS, Sponsor desires University and Investigator to conduct, and
University 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
University and Investigator agree to use their best efforts and
professional expertise to perform the Clinical Study according to the Protocol
as set forth in Exhibit A. University 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. University 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 University, 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
University solely by or under the direct supervision of the Investigator. In the
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event that Investigator is unable to continue with the Clinical Study,
University 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 University if the
proposed substitute is not acceptable to Sponsor in its sole discretion. Upon
any such termination, University shall be reimbursed for its costs incurred
through such termination date.
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.
University and/or the Investigator will take all necessary countermeasures
to ensure that any Co-Investigator complies with the obligations undertaken by
University and/or the Investigator under this Agreement and shall be responsible
for any and all performance of Co-Investigator.
1.4 Ethics Committee.
University and/or Investigator shall submit an Ethics Committee Application
and the Protocol for approval to University 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 University 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 University agree to conduct the Clinical Study
in accordance with this Agreement, the Protocol, any conditions of approval
imposed by the Ethic Committee, and all relevant European Community laws,
regulations or practices applicable to the conduct of the Clinical Investigation
at the Investigational Site.
1.6 Compliance With Laws.
In performing the Clinical Study, University 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.
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1.7 Supply of Device and Equipment.
Sponsor shall be responsible for providing the University a sufficient
number of Devices to conduct the Clinical Study. Sponsor and University 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
University further agree that:
(a) Principal Investigator and Institution 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, University
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 University. Sponsor reserves the right to
immediately terminate this Agreement and to exclude University 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 University for all
contractual commitments and financial obligations reasonably incurred by
University 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 University. Notwithstanding the foregoing,
Sponsor and University agree that any termination requested hereunder shall not
commence until such date as patients in the Clinical Study can be
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transitioned out of the Clinical Study without adverse medical effect to such
patients. If the Clinical Study is terminated for any reason, University 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 or
Device approval.
2. PAYMENT
Sponsor shall compensate University/Investigator 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 University
University/Investigator shall submit the following documents to Sponsor
prior to commencing the Clinical Study:
(a) Documentation of University'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) 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, University'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 University 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) University 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.
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(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
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 University and the
Investigator in a secure file for a period of fifteen (15) 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.
University 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 University 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.
University 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. University shall promptly assign, and shall cause its personnel who
participate in the Clinical 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 Study
not related to the Device and (i) developed solely by University shall belong
exclusively to Institution, (ii) developed solely by Sponsor shall belong
exclusively to Sponsor, and (iii) jointly developed by
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University and Sponsor shall belong jointly to University and Sponsor.
Notwithstanding any ownership or partial ownership by University of any
Intellectual Property related to the Clinical Study Investigator 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.
5.2 Disclosure of Intellectual Property.
University 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 University 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 University's rights to any Intellectual Property which option shall
extend for ninety (90) days after Sponsor's receipt of an Intellectual Property
disclosure from University. 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, University 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.
For the clarification of Section 5.3, Sponsor understands and acknowledges that
University [and Principal Investigator] are currently engaged in one or more
clinical studies of a ventricular assist device of a competitor of Sponsor
("Competitor"), and may have certain intellectual property rights with respect
to information therefrom ("Competitor IP"). Each of University and Principal
Investigator covenants that no Intellectual Property shall be licensed to such
Competitor, nor shall Sponsor receive a license to any Competitor IP.
5.4 Patents: Mutual Cooperation.
University will promptly notify Sponsor and will assist Sponsor, upon
Sponsor's request, in gaining patent protection for any patentable Intellectual
Property, or patentable licensed University intellectual property, and Sponsor
will reimburse University for all reasonable and documented out of pocket
expenses of University 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.
University 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
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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 University 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
University 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 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 University and Investigator under
the terms of this Agreement in any manner deemed appropriate to Sponsor's
business interests. Anything herein to the contrary notwithstanding, University
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 University, 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 University 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.
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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
(e) the disclosure of Confidential Information required by law.
7. PUBLICATIONS
7.1 Sponsor Review
Subject to Section 7.3 hereof, University and Principal Investigator
reserve the right to publish Results. Before publishing, however, University 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, 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 shall be entitled to use any clinical data that University or the
Principal Investigator has acquired from the Study and has submitted for
publication.
7.2 Acknowledgement of Sponsor: Use of Reprints
University 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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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 University and University
`s officers, directors, trustees, employees, Investigator and any
Co-Investigators (the " University Indemnitees") from and against any and all
liabilities, damages, losses, claims or expenses (including reasonable
attorneys' fees) incurred by or imposed upon the University Indemnitees, 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 University
Indemnitees, (c) any failure of one or more of the University Indemnitees 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 University Indemnitees.
8.2 By University.
University shall indemnify, defend and hold harmless Sponsor and Sponsor's
officers, directors, shareholders, employees and affiliates (the "Sponsor
Indemnitees") from and against any and all liabilities, damages, losses, claims
or expenses (including reasonable attorneys' fees) incurred by or imposed upon
the Sponsor Indemnitees, or any one of them, in connection with the Clinical
Study, to the extent such liability, damage, loss, claim or expenses 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 University Indemnitees, (c) any failure of one or more of the
University Indemnitees 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 University
Indemnitees.
8.3 Conditions of Indemnity.
Sponsor's and University `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
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party's prior written consent. Sponsor's agreement in Section 8.1 to indemnify
and hold the University Indemnitees harmless is further conditioned on
University 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 shall carry insurance from an insurance carrier reasonably
acceptable to the University and Investigator in amounts and under coverages in
accordance with the Austrian Medical Device Act law. The University confirms
that the hospital (Vienna General Hospital) conducting the Clinical Study and
Investigator are holding adequate liability insurance for routine care methods.
Each party shall provide to the other party evidence of such coverages upon
request.
9. COVENANTS AND WARRANTIES
9.1 Investigator represents and warrants that he 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. Investigator shall secure any
necessary notifications or approvals, administrative or governmental for the
work to be performed hereunder.
9.2 Investigator 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, regulation, policies and practices.
9.3 University 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 University 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 University 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 University and Investigator represent and warrant that all of University
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
University or Investigator, by contract or otherwise, sufficient to enable them
to fully comply with all provisions of this Agreement.
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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 University: Medical University of Vienna
Xxxxxxxxxxx 00
X-0000 Xxxxxx, Xxxxxxx
Attention: Univ. Prof. Xx.Xxxxxx X. Wieselthaler
Facsimile: 011 43 1404006735
If to Principal: Univ. Prof. Xx.Xxxxxx X. Wieselthaler
Investigator: Dept. of Cardiothoracic Surgery
Medical University of Vienna / AKH
Waehringer Guertel 18-20
X-0000 Xxxxxx, Xxxxxxx
Facsimile: 011 43 1404006735
If to Sponsor: Heartware, Inc.
0000 Xxxxxxxxx Xxx
Xxxxxxx, XX 00000-0000
XXX
Attention: Xxxx X. Xxxxx
Facsimile: 00 000-000-0000
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 the State of Florida,
United States of America, without regard to the doctrines of conflicts of law or
choice of law.
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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.
10.5 Entire Agreement.
Unless otherwise specified, this Agreement embodies the entire
understanding among University, 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, University 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, Inc.
By: /s/ Xxxx Xxxxx
---------------------------------
Name: Xxxx X. Xxxxx
Title: Vice President of Clinical and
Marketing
Medical University of Vienna:
By: /s/ Prof. Xx. X. Xxxxxxxxxxx
---------------------------------
Name: Prof. Xx. X. Xxxxxxxxxxx
Title: Head of Surgery Division
Department of Cardiothoracic Surgery
By: /s/ Xxxxx Xxxxxx
---------------------------------
Name: Xxxxx Xxxxxx, MD
Title: Head of Cardiothoracic Surgery
Department
Investigator
By: /s/ Xxxxxx X. Wieselthaler
---------------------------------
Name: Xxxxxx X. Wieselthaler
Title: Clinical Director of
Mechanical Circulatory Support
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EXHIBIT B
CO-INVESTIGATOR ACCEPTANCE FORM
Sponsor, Institution, and Principal Investigator have entered into a Clinical
Study Agreement dated March 21, 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/ Pr. Xxxxxxx Xxxxx
----------------------------------
Co-Investigator Signature
Print Name: Pr. Xxxxxxx Xxxxx
Date: March 27, 2006
2. /s/ Dr. Wilfried Roethy
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Co-Investigator Signature
Print Name: Dr. Wilfried Roethy
Date: March 27, 2006
3. /s/ Xxxx. Xxxxxxxx Xxxxxx
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Co-Investigator Signature
Print Name: Xxxx. Xxxxxxxx Xxxxxx
Date: March 27, 2006
4. ----------------------------------
Co-Investigator Signature
Print Name:
----------------------
Date:
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EXHIBIT B
CO-INVESTIGATOR ACCEPTANCE FORM
Sponsor, Institution, and Principal Investigator have entered into a Clinical
Study Agreement dated March 21, 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/ Xx. Xxxxxx Zimpler
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Co-Investigator Signature
Print Name: Xx. Xxxxxx Zimpler
Date: July 06, 2006
