Exhibit 10.21
Confidential
(HEARTWARE LOGO)
CLINICAL INVESTIGATION AGREEMENT
THIS CLINICAL INVESTIGATION AGREEMENT (this "Agreement") made and effective
as of this 17th day of May 2006 (the "Effective Date"), is by and between
Heartware, Inc., a Delaware corporation having its principal offices at ▇▇▇▇
▇▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇, ▇.▇.▇. ("Sponsor"); and Hannover Medical
School ("Hospital"), represented by the presidium, having its address at ▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇. ▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇; and ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, having his address
at ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇. ▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ("Investigator").
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 their 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
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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.
1.3 Co-Investigators.
Upon the prior written consent of Sponsor, which shall not be unreasonably
withheld, 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. Where necessary, e.g. with respect to the obligation to notify
intellectual property conceived or developed during the course of or in
connection with the Clinical Study, the Hospital shall procure that
Co-Investigator enters into appropriate agreements directly with Sponsor. 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, which is registered
with the German Federal Institute for Medicinal Products and Medical Devices
(BfArM) and therefore competent for the evaluation of clinical studies with
medical devices. 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 all applicable
European Community 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 performance and nature
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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:
(a) 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 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 that no rights will
be infringed by any activity 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
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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 is terminated for 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.
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 thirty (30) days
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.
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(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
regulatory body, including the United States Food and Drug
Administration ("FDA") or its European equivalent agency(ies).
(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 Investigator
by or on behalf of 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, or, as the case may be, shall become, the
exclusive property of the Sponsor. Hospital and Investigator shall keep all
Sponsor Materials in Hospital's 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 at any time upon Sponsor's request, except
that Institution may retain in strict confidence 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.
Hospital and Investigator agree that 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 and
hereby does assign to Sponsor all Intellectual Property to which it is
originally or derivatively entitled and in which it has acquired its rights
during the course of or in
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connection with the Clinical Study. Sponsor hereby accepts this assignment. No
consideration for this assignment is or shall he payable by Sponsor.
Investigator shall and hereby does assign to Sponsor all Intellectual Property
to which he is originally or derivatively entitled and in which he has acquired
his rights during the course of or in connection with the Clinical Study.
Sponsor hereby accepts this assignment. No consideration for this assignment is
or shall be payable by Sponsor. To the extent permitted under German employee
invention laws, Hospital shall cause its personnel who participate in the
Clincal Study to promptly assign to Sponsor and treat as Sponsor's all
Intellectual Property.
Without limiting the generality of the foregoing, with respect to employee
inventions (Diensterfindungen) as defined by Section 4(2) of the German Employee
Invention Act, the Hospital shall claim immediately and without restriction from
Investigator and other Hospital personnel who participate in the Clinical Study
all Intellectual Property notified to it by Investigator or such Hospital
personnel. Sponsor will exempt Hospital from all claims of its employees
resulting from the German Employee Invention Act.
Without prejudice to Section 5.7, insofar as a full assignment of Intellectual
Property is not legally possible Hospital and Investigator instead grant to
Sponsor a worldwide, exclusive, royalty-free, perpetual, irrevocable and
transferable right of use and commercial exploitation, with the right to
sub-license, and Hospital and Investigator acknowledge that these obligations
have been entered into in consideration of, and are discharged by, the overall
remuneration payable by Sponsor pursuant to this Agreement.
Any other intellectual property conceived and developed during the course of, or
in connection with, the Clinical Study not related to the Device ("Other
Intellectual Property") and (i) developed solely by Hospital shall belong
exclusively to Hospital, (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 or Other intellectual
Property related to the Clinical Study, Hospital and Investigator agree that any
such Intellectual Property or Other 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.
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.
Investigator undertakes vis-a-vis Sponsor to 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 Other 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 Other Intellectual Property which
option shall extend for ninety (90) days after Sponsor's receipt of an
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Other 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 Other 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 and Investigator 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 and Investigator for all reasonable and
documented out of pocket expenses of Hospital and Investigator incurred thereby.
Any patent application, continuation in-part, divisional, etc., will be filed,
paid for and prosecuted by Sponsor for Intellectual Property.
5.5 Investigator.
Hospital shall ensure that the 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 he interpreted as giving Hospital or
Investigator 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 or
hereafter owned by Hospital or 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 Investigator shall remain with the 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 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
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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
(e) the disclosure of Confidential Information required by law.
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7. PUBLICATIONS
7.1 Sponsor Review
Subject to Section 7.3 hereof, Hospital and investigator reserve the right
to publish Results. Before publishing, however, Hospital and 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 Sponsor's
intellectual property interests, or to avoid any unlawful act, or to remove from
the proposed publication or presentation any language that is incorrect or
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 Investigator has acquired
from the Study and has submitted for publication.
7.2 Acknowledgement of Sponsor: Use of Reprints
Hospital and 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 of one or more of the
Hospital 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
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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 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 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
those of Investigator's employer, where appropriate. Investigator shall secure
any necessary notifications or approvals, administrative or governmental for the
work to he performed hereunder.
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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, regulations, policies and practices
and is disclosed to and, if necessary, approved by his employer.
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 involved in any investigation or research
project that has been terminated, or which involvement has been terminated, 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's
and, if applicable. Investigator's, 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 Hospital: Medizinische Hochschule Hannover
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▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
Attention: Mr. Born
Facsimile: + 49 511 532 8504
If to Principal
Investigator: Medizinische Hochschule Hannover
Klinik fuer Thorax-, Herz- und Gefaesschirurgie
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Attention: Prof. ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇▇
Facsimile: ▇▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇
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If to Sponsor: Heartware, Inc.
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▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇ ▇. ▇▇▇▇▇
Facsimile: ▇▇▇-▇▇▇-▇▇▇▇
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.
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 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.
Study ID: HW002
May 2006
Page 12 of 17
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.
Study ID: HW002
May 2006
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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, Inc.
By: /s/ ▇▇▇▇ ▇▇▇▇▇ Date: 07/11/06
---------------------------------
Name: ▇▇▇▇ ▇. ▇▇▇▇▇
Title: Vice President of Clinical
and Marketing
Hospital:
By: /s/ ▇▇▇▇▇▇▇ Born Date: 06/23/06
---------------------------------
Name: ▇▇▇▇▇▇▇ Born
Title: Executive Manager for Legal
and Personnel Affairs
Investigator
By: /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Date: 05/18/06
---------------------------------
Name: PD ▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, M.D.
Title: Investigator
By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇ Date: 05/18/06
---------------------------------
Name: Prof. ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇▇, M.D.
Title: Head of the Department of
Thoracic and Cardiovascular
Surgery
Study ID: HW002
May 2006
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EXHIBIT A
PROTOCOL
Study ID: HW002
May 2006
Page 15 of 17
EXHIBIT B
CO-INVESTIGATOR ACCEPTANCE FORM
Sponsor, Institution, and Investigator have entered into a Clinical Study
Agreement dated May 17th, 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
investigator, for performing the obligations of Investigator in the Agreement.
The undersigned Co-Investigators vis-a-vis the Sponsor 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
Investigator under the Agreement (other that those relating to 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
Investigator); and (d) agree that their participation in the Clinical Study will
at all times be under the supervision of the Investigator.
1.
----------------------------------
Co-Investigator Signature
Print Name:
----------------------
Date:
----------------------------
2.
----------------------------------
Co-Investigator Signature
Print Name:
----------------------
Date:
----------------------------
3.
----------------------------------
Co-Investigator Signature
Print Name:
----------------------
Date:
----------------------------
4.
----------------------------------
Co-Investigator Signature
Print Name:
----------------------
Date:
----------------------------
Study ID: HW002
May 2006
Page 16 of 17
EXHIBIT D
STUDY BUDGET
Sponsor will reimburse Hospital 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 (CRFs). The Sponsor
hereby agrees to pay Hospital per patient, according to the following schedule:
TIMELINE REIMBURSEMENT
-------- -------------
At LVAD Implant and upon 1500 Euro
completion of required CRFs
90 day follow-up and upon completion 1500 Euro
of required CRFs
Completion of study and required 1000 Euro
CRFS
Money transfer to:
Payee Name Medizinische Hochschule Hannover
▇▇▇▇-▇▇▇▇▇▇▇-▇▇▇. ▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇,
Payee Address Germany
Bank name Sparkasse Hannover
Swift Code: ▇▇▇▇▇▇▇▇
IBAN: ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇
REFERENCE: A9490230 LVAD HW002
Study ID: HW002
May 2006
Page 17 of 17