COLLABORATIVE RESEARCH AGREEMENT
Exhibit 10.17
THIS
AGREEMENT is made as of April 22, 2016 (“Effective
Date”) by and between General Electric Company, acting
through its GE Healthcare business and Global Research unit
(“GE”), and ENDRA Inc. a Delaware corporation having
its principal place of business at Ann Arbor, MI
(“ENDRA”).
WHEREAS, GE and
ENDRA desire to perform certain research work and are willing to
directly collaborate and/or provide GE and ENDRA with access to
proprietary research materials;
WHEREAS, the
performance of collaborative research is consistent with the
instructional, scholarship and research objectives of
GE;
NOW,
THEREFORE, in consideration of the premises and mutual covenants
herein contained, GE and ENDRA agree as follows:
1.
DEFINITIONS
As used
in this Agreement, capitalized terms have the meanings given them
below or elsewhere in this Agreement:
1.1. Research
Materials means those
experimental materials one party may provide the other in
connection with and as stated in the Research
Program.
1.2. Research
Program means the research
program set forth in Exhibit A.
1.3. Confidential
Information means ENDRA or GE
owned confidential scientific, business or financial information
which will be clearly marked as such in writing provided that such
information:
1.3.1.
is not publicly known or available from other sources who are not
under a confidentiality obligation to the source of the
information;
1.3.2.
has not been made available by its owners to others without a
confidentiality obligation;
1.3.3.
is not already known by or available to the receiving party without
a confidentiality obligation;
1.3.4.
is not independently developed by the receiving party;
1.3.5.
does not relate to potential hazards or cautionary warnings
associated with the performance of the Research Program of the
Agreement or is not required to be disclosed under operation of
law.
1.4. Invention
means all inventions, ideas,
discoveries, developments, improvements and know-how, whether or
not patentable or reduced to practice.
1.5. Equipment
means the GE ultrasound system
identified in Exhibit A.
1.6. Consignment
means the terms and conditions for
consignment of the Equipment set forth in Exhibit
B.
1.7. TAEUS
FLA IP means all intellectual
property owned or controlled by ENDRA that is necessary or useful
for commercially exploiting TAEUS technology for
FLA.
2.
RESEARCH PROGRAM
2.1. Research
Efforts. Provided ENDRA
performs all its obligations under this Agreement, GE will use its
reasonable efforts to conduct those activities for which it is
responsible under the Research Program.
2.2. GE
Principal Investigator. The
conduct of GE’s activities under the Research Program will be
under the direction of Xxxxx Xxxxxx (“GE’s Principal
Investigator”).
2.3. ENDRA’s
Principal Investigator. The
conduct of ENDRA’s activities under the Research Program will
be under the direction of Xxxxxxx Xxxxxxxx (“ENDRA’s
Principal Investigator”).
2.4. Use
of Research Materials. Any
Research Materials of one party transferred to the other in
connection with the Research Program may only be used as stated in
the Research Program.
2.5. GE
Equipment, Support and Options.
To support the Research Program, GE will consign the Equipment to
ENDRA subject to the Consignment. GE will also provide support,
advice and introductions as stated in the Research Program. In
return for such consideration, ENDRA agrees to provide GE with the
Options stated in the Research Program.
2.6. Reporting.
The parties will generally keep one another informed of the results
of the work performed in connection with the Research Program,
principally through their respective Principal Investigators. In
addition, the parties’ respective Principal Investigators
will confer and provide reports as stated in the Research
Program.
2.7. Changes
to the Research Program. During
the course of the Research Program, either or both of the Principal
Investigators may find it advantageous to modify the Research
Program. Any modifications will be documented and formalized in a
written amendment to this Agreement and any such amendment will
become effective only if signed by an authorized representative of
both parties to this Agreement.
2.8. Purposes;
Use of Facilities; No Guarantee of Results. GE acknowledges that the primary mission of
ENDRA is education and the advancement of knowledge; and,
consequently, the Research Program will be performed in a manner
best suited to carry out that mission. Specifically, ENDRA’s
Principal Investigator will determine the manner of performance of
GE’s part in the Research Program and GE does not represent
or warrant that the Research Program will be successful in any way
or that any specific results will be obtained.
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2.9. Similar
Research. Nothing in this
Agreement will be construed to limit the freedom of ENDRA or its
researchers who are participants under this Agreement, from
engaging in similar research made under other grants, contracts, or
research agreements with parties other than GE.
3.
CONFIDENTIAL INFORMATION
3.1. A
party’s acceptance and use of any confidential information
supplied by the other party in the course of the Research Program
will be subject to the following:
3.1.1.
To
be considered Confidential Information, all written information
must be marked or designated in writing as CONFIDENTIAL by the
party providing the information, and oral communications must be
reduced to writing within thirty (30) days of the initial
communication of the information and such writing must be marked or
designated in writing as CONFIDENTIAL and provided to the other
party’s Principal Investigator.
3.1.2.
The
Principal Investigators will use reasonable efforts to limit the
exchange of Confidential Information.
3.1.3.
Where
the Principal Investigator does accept such information as
confidential, he agrees to use reasonable care to prevent the
unauthorized use, dissemination, or publication of the Confidential
Information.
3.1.4.
The
Principal Investigators’ obligation to hold Confidential
Information in confidence expires three (3) years after the
termination or expiration of this Agreement.
4.
PUBLICITY
ENDRA
and GE may identify each other as collaborative research partners
in promotional materials to be disseminated to the public. Any use
of a party’s name shall be limited to statements of fact and
shall not imply endorsement of products or services.
5.
PUBLICATION
5.1. The
basic objective of research activities at ENDRA is the generation
of new knowledge and its expeditious dissemination for the
public’s benefit. GE will provide reasonable cooperation with
ENDRA in meeting this objective.
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5.2. As
a matter of basic policy, ENDRA retains the right at its discretion
to publish freely any results of the Research Program. Principal
Investigator agrees to provide GE a copy of any manuscript at the
time it is submitted for publication. GE may review the
manuscript:
5.2.1.
To
ascertain whether GE’s Confidential Information would be
disclosed by the publication;
5.2.2.
To
identify any potentially patentable Research Program Invention so
that appropriate steps may be taken to protect such Research
Program Invention; and
5.2.3.
To
confirm that the privacy rights of individuals are adequately
protected.
GE will
provide comments, if any, within thirty (30) days of receipt of
manuscript.
5.3. ENDRA
will give GE the option of receiving an acknowledgment in such
publication.
6.
INTELLECTUAL PROPERTY RIGHTS
6.1. Ownership
of Research Program Inventions.
Research Program Inventions conceived, discovered and reduced to
practice solely by ENDRA, or its employees or agents will be owned
by ENDRA. Research Program Inventions conceived, discovered and
reduced to practice solely by GE, or its employees, or agents, will
be owned by GE (Collectively, “Sole Inventions”).
Research Program Inventions conceived, discovered and reduced to
practice jointly by at least one employee, agent, or student of
each of GE and ENDRA will be jointly owned by GE and ENDRA, without
any obligation to account to one another (“Joint
Inventions”). Inventorship will be determined according to
the principles of United States patent law. Neither party shall
make any claim to the other party’s Sole
Inventions.
6.2. Pre-Existing
Rights. Except to the limited
extent required to perform a party’s obligations under this
Agreement, neither party receives any right, title, or interest in
or to any Research Materials provided to it by the other party or
any technology, works or inventions of the other party that are not
Research Program Inventions, or any patent, copyright, trade secret
or other proprietary rights in any of the
foregoing.
6.3. Patents
will mean those United States and
foreign patents and patent applications including any continuation,
reissue, or renewal thereof, or substitute therefor, and the
patents that may be issued thereon, relating to any patentable
Research Program Invention.
6.4. Patent
Prosecution and Expenses.
Unless the parties agree in writing otherwise, the filing,
prosecution, defense and maintenance of all Patents for Joint
Inventions will be conducted jointly in the name of both parties
and controlled by them jointly, acting reasonably and in good
faith, with all associated costs shared equally. However, if one
party desires to file, prosecute or maintain any Patents for a
Joint Invention while the other party does not, the other party
shall assign its ownership rights therein to the other party (in
which case the Joint Invention will become a Sole Invention of the
other party) in exchange for a fully paid, non-exclusive worldwide
right and license (with “have made” rights but no
sublicensing rights) under such Sole Invention and any associated
Patents, after which the other party shall have no further
obligation for cost sharing.
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6.5. Licensing.
Each party reserves the right to license its interest in its Sole
Inventions or Joint Inventions, and neither party shall have any
right to compensation in connection with any such license granted
by the other.
6.6. Rights
Subject to Federal Patent Policy. To the extent that any Research Program
Invention has been partially funded by the Federal government, the
assignment of title or the granting of any license above is subject
to the rights of the Federal government and federal law set forth
in 35 U.S.C. §§ 200 et. seq., as amended, and the
regulations promulgated thereunder, as amended, or any successor
statutes or regulations (the “Federal Patent Policy”).
Any right granted in this Agreement greater than that permitted
under the Federal Patent Policy will be modified as may be required
to conform to the provisions of the Federal Patent
Policy.
7.
INDEMNIFICATION
7.1. As
used herein, “Claim” includes but is not limited to
every phase of any lawsuit, loss, claim, damage or liability for
death, illness or personal injury of any person (including
employees of GE or ENDRA) and/or for property damage. This
indemnity shall not be deemed excess coverage to any insurance or
self-insurance GE may have covering Claim.
7.2. ENDRA
hereby waives any Claim against GE, and agrees to indemnify,
defend, and hold harmless GE, and its trustees, directors,
employees, agents, students or volunteers from any Claim arising
out of or connected with this Agreement or the work done under this
Agreement to the extent such Claim is due to ENDRA’s gross
negligence or willful misconduct. GE shall promptly notify ENDRA of
any such Claim and shall cooperate with ENDRA and its insurance
carrier in the defense of the Claim.
7.3. GE
hereby waives any Claim against ENDRA, and agrees to indemnify,
defend, and hold harmless ENDRA, and its trustees, directors,
employees, agents or students from any Claim arising out of or
connected with this Agreement or the work done under this Agreement
to the extent such Claim is due to GE’s gross negligence or
willful misconduct. ENDRA shall promptly notify GE of any such
Claim and shall cooperate with GE and its insurance carrier in the
defense of the Claim.
7.4. ENDRA’s
indemnity shall not be limited by the amount of ENDRA’s
insurance.
8.
REPRESENTATIONS, WARRANTIES, LIABILITY LIMITS
8.1. NO
WARRANTIES. ENDRA ACKNOWLEDGES
AND AGREES THAT GE IS A COMMERCIAL INSTITUTION AND THAT THE
RESEARCH PROGRAM IS OF AN EXPERIMENTAL NATURE. AS A RESULT, ANY
RESULTS OF THE RESEARCH PROGRAM AND ANY RESEARCH MATERIALS ARE
PROVIDED AS IS AND WITH ALL FAULTS. GE MAKES NO WARRANTIES, EXPRESS
OR IMPLIED, AS TO ANY MATTER WHATSOEVER, INCLUDING, WITHOUT
LIMITATION, THE RESULTS OF THE RESEARCH PROGRAM, WHETHER ANY
RESULTS WILL OBTAIN, ANY RESEARCH MATERIALS OR ANY INVENTION,
PROCESS OR PRODUCT, WHETHER TANGIBLE OR INTANGIBLE, CONCEIVED,
DISCOVERED, DEVELOPED OR REDUCED TO PRACTICE UNDER THIS AGREEMENT;
OR THE OWNERSHIP, NONINFRINGEMENT, MERCHANTABILITY, OR FITNESS FOR
A PARTICULAR PURPOSE OF THE RESEARCH, ANY RESEARCH MATERIALS OR ANY
SUCH INVENTION OR PRODUCT.
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8.2. NO
DAMAGES. GE SHALL NOT BE LIABLE
FOR ANY DIRECT, CONSEQUENTIAL, OR OTHER DAMAGES SUFFERED BY ENDRA,
ANY LICENSEE, OR ANY OTHERS INCLUDING, BUT NOT LIMITED TO, DAMAGES
ARISING FROM LOSS OF DATA OR DELAY OR TERMINATION OF THE RESEARCH
PROGRAM, OR FROM THE USE OF THE RESULTS OF THE RESEARCH PROGRAM,
THE USE OF ANY RESEARCH MATERIALS OR ANY SUCH INVENTION OR PRODUCT.
ENDRA ACKNOWLEDGES AND AGREES THAT THIS EXCLUSION AND LIMITATION IS
REASONABLE CONSIDERING THE EXPERIMENTAL NATURE OF THE RESEARCH
PROGRAM AND THE NATURE AND TERMS OF THE PARTIES’
RELATIONSHIP.
9.
TERM AND TERMINATION
9.1. Term.
This Agreement will remain in effect for twelve (12) months from
the Effective Date unless terminated sooner or extended in writing
signed by the parties in accordance with this
Agreement.
9.2. Termination.
Either party may terminate this Agreement for any reason within its
sole discretion upon giving sixty (60) days written notice to the
other party.
9.3. Survival.
The provisions of Articles 3, 4, 5, 6, 7, 8, 9, 10 and 11 and
GE’s Options stated in the Research Program will survive any
expiration or termination of this Agreement.
10.
DISPUTE RESOLUTION
Any
controversy, claim or other dispute arising out of this Agreement
or relating to the subject matter of this Agreement hereof will be
decided by binding arbitration in accordance with the Rules of
Conciliation and Arbitration of The American Arbitration
Association before one or more arbitrators appointed in accordance
with those Rules. Any arbitration will take place in New York, NY,
or at any other mutually agreeable location.
11.
GENERAL
11.1. Binding
Effect; Assignment. Neither
party may assign or delegate its rights or obligations under this
Agreement without the express written consent of the other
party.
11.2. Entire
Agreement. This Agreement
constitutes the entire agreement between the parties relating to
the Research Program, and any and all prior or contemporaneous
negotiations, representations, agreements and understandings are
superseded hereby. No amendment or change to this Agreement may be
made except by means of a written document signed by duly
authorized representatives of the parties.
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11.3. Notices.
Any notice or communication required or permitted to be given
hereunder will be in writing and, except as otherwise expressly
provided in this Agreement, will be deemed given and effective (i)
when delivered personally or by fax or (ii) when received if sent
by email, overnight courier, or mail:
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To
GE:
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To
ENDRA:
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0000
Xxxxxxxxxx Xxxxx
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3600
Green Court
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Attn:
Ultrasound Xxxxx Xxxxxxx
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Xxx.
000
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Xxxxxxxxx,
XX 00000
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Xxx
Xxxxx, XX 00000
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11.4. Applicable
Law. This Agreement will be
construed and enforced in accordance with the laws of the State of
New York, without regard to any choice or conflict of laws, rule or
principle that would result in the application of the laws of any
other jurisdiction.
11.5. Headings.
Headings included herein are for convenience only, and will not be
used to construe this Agreement.
11.6. Relationship
of Parties. For the purposes of
this Agreement, each party will be, and will be deemed to be, an
independent contractor and not an agent or employee of the other
party. Neither party will have authority to make any statements,
representations or commitments of any kind, or to take any action
that is binding on the other party, except as explicitly provided
for herein or authorized in writing.
11.7. Severability.
If any provision of this Agreement will be found by a court of
competent jurisdiction to be void, invalid or unenforceable, the
same will either be reformed to comply with applicable law or
stricken if not so conformable, so as not to affect the validity or
enforceability of this Agreement.
11.8. Force
Majeure. Neither party will be
liable for any failure to perform as required by this Agreement, if
the failure to perform is caused by circumstances reasonably beyond
a party’s control, such as labor disturbances or labor
disputes of any kind, accidents, failure of any governmental
approval required for full performance, civil disorders or
commotions, acts of aggression, acts of God, energy or other
conservation measures, explosions, failure of utilities, mechanical
breakdowns, material shortages, disease, pandemics, thefts, or
other such occurrences.
11.9. Electronic
Copy. The parties to this
document agree that a copy of the original signature (including an
electronic copy) may be used for any and all purposes for which the
original signature may have been used. The parties further waive
any right to challenge the admissibility or authenticity of this
document in a court of law based solely on the absence of an
original signature.
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IN
WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives as of the
Effective Date.
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GE
Healthcare
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ENDRA
Inc.
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By: /s/
Xxxxx XxXxxxxxx
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By: /s/
Xxxxxxxx Xxxxxxxx
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Typed
Name: Xxxxx XxXxxxxxx
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Typed
Name: Xxxxxxxx Xxxxxxxx
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Title:
VP/GM Ultrasound
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Title:
CEO
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Date:
April 22, 2016
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Date:
April 22, 2016
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I,
Xxxxxxx Xxxxxxxx,
named as Principal Investigator for ENDRA, acknowledge that I have
read this Agreement in its entirety and will use reasonable efforts
to uphold my obligations and responsibilities set forth
herein:
Signature:
/s/ Xxxxxxx
Xxxxxxxx
Date:
April 22, 2016
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I,
Xxxxx Xxxxxx, named
as Principal Investigator for GE, acknowledge that I have read this
Agreement in its entirety and will use reasonable efforts to uphold
my obligations and responsibilities set forth
herein:
Signature:
/s/ Xxxxx
Xxxxxx
Date:
April 22, 2016
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EXHIBIT A:
RESEARCH PROGRAM COMPONENTS
ENDRA
wishes to commercialize its Thermo-Acoustic Enhanced UltraSound
(TAEUSTM)
technology, and GE wishes to assist ENDRA in this
goal.
To this
end, GE agrees to provide ENDRA with following:
1.
The Consignment of a cart-based GE ultrasound system,
of GE’s choosing, which ENDRA can use to develop an interface
for its TAEUS technology. The GE equipment will at all times remain
the property of GE. ENDRA may access the internal hardware and
software components of GE’s ultrasound system to develop the
TAEUS interface. ENDRA may request drawings or information from GE
to achieve a successful interface, which GE may provide under
confidentiality and the terms of this Agreement at its sole
discretion. ENDRA will take reasonable measures to protect the GE
system from damage or theft, as it would for an ENDRA-owned piece
of capital equipment.
2.
GE will provide (within its sole discretion) ad-hoc
engineering support to assist ENDRA with the development of the
TAEUS interface, and to help avoid damage to the GE ultrasound
system.
3.
GE will provide (within its sole discretion) ad-hoc
commercial advice to assist ENDRA with the development of a
TAEUSTM
commercialization plan.
4.
GE will facilitate (within its sole discretion) introductions for
ENDRA to GE clinical ultrasound customers, as potential beta-users
and clinical advisors for ENDRA’s TAEUS technology. GE cannot
guarantee these introductions will lead to formal customer
collaborations.
In
return for GE’s assistance with development of the
TAEUSTM
technology, ENDRA agrees to the following:
1.
ENDRA will keep GE informed of progress it makes in developing a
TAEUS-GE product interface, and any contact or collaboration ENDRA
undertakes with GE-introduced clinical customers. ENDRA will
participate in regular update telephone calls with designated GE
representatives. Within sixty (60) days following completion of the
Research Program, ENDRA will present the final results to GE of
what was accomplished during the study along with an identification
of any associated Research Program Inventions (“Final
Report”).
2.
Prior to ENDRA commercially
releasing (directly or indirectly) the TAEUS technology for a Fatty
Liver Application (“FLA”), ENDRA will offer to
negotiate in good faith an exclusive ultrasound manufacturer
relationship with GE for a period of at least one (1) year of
commercial sales (“Sales Option”). The commercial sales
will involve, within ENDRA’s sole discretion, either (1)
ENDRA commercially selling GE Healthcare ultrasound systems as the
exclusive ultrasound system with their TAEUS FLA embedded, or (2)
GE Healthcare being the exclusive ultrasound manufacturer to sell
ultrasound systems with the TAEUS FLA technology embedded.
Notwithstanding the foregoing, the Sales Option will in no way
prevent Endra from selling its TAEUS FLA technology to distributors
or directly to non-manufacturer purchasers.
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3.
In addition, prior to
ENDRA offering to license any of the TAEUS FLA IP to a third party,
ENDRA will first offer to negotiate in good faith to license such
TAEUS FLA IP to GE (“License Option”).
4.
Moreover, prior to ENDRA offering to sell any equity interests to a
healthcare device manufacturer, ENDRA will first offer to negotiate
in good faith to sell such equity interests to GE (“Equity
Option”).
5.
The Sales Option, License Option and Equity Option (collectively
the “Options”) shall each start as of the Effective
Date and automatically terminate ninety (90) days after the earlier
of (i) ENDRA presenting its Final Report to GE and (ii) termination
or expiration of the Agreement (“Option
Period”).
6.
GE may exercise any of its Options by providing written notice to
ENDRA prior to the expiration of the Option Period. Upon exercise
of the Option and for a period of three (3) months thereafter, or
in the case of the Equity Option, for a period of one (1) month
thereafter (“Negotiation Period”), ENDRA and GE agree
to negotiate in good faith to draft and execute a written agreement
consistent with GE’s Option selection. If the Parties are
unable to agree on mutually acceptable terms and conditions for
such an agreement within the Negotiation Period, then ENDRA agrees
for a period of one (1) year thereafter not to enter into a similar
agreement with a third party on terms and conditions that are
materially better in any respect than, or substantially equal with
respect to, the comparable terms and conditions last proposed by GE
without first offering such materially better or substantially
equal terms and conditions to GE.
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EXHIBIT
B
CONSIGNMENT TERMS
AND CONDITIONS
Article 1. Scope
of Consignment
These
terms & conditions form part of a Collaborative Research
Agreement between GE and ENDRA entered into as of March __,
2016 (“CRA”). All capitalized terms used herein have
the meanings ascribed in the CRA unless specifically defined
otherwise below.
Article 2. Consignment
Term
GEHC
shall deliver to ENDRA the Equipment in furtherance of the Research
Program (the “Purpose”). ENDRA further agrees to return
the Equipment to GE promptly on termination or expiration of the
CRA.
Article 3. Use
of Equipment
GE
agrees to allow ENDRA to use the Equipment solely for the Purpose
and for no other purposes, including pre-clinical or clinical
research. ENDRA shall only use the Equipment for its intended
purpose and consistently with its labeled purpose. ENDRA shall not
use in clinical practice, display, or show the Equipment with any
device or technology that is not cleared by the United States Food
and Drug Administration. The use of the Equipment by ENDRA shall
not obligate ENDRA in any way to purchase or lease the Equipment
from GE nor is it contingent in any way on ENDRA purchasing or
leasing any other equipment, product, or services from
GE.
Article 4. Intellectual
Property Rights
Except
for the rights granted by GE herein, ENDRA shall acquire no right
or interest in the Equipment or the patent, copyright, trademark or
other proprietary rights therein, which proprietary rights shall
remain the property of GE, and any and all goodwill associated with
the Equipment shall enure exclusively to the benefit of
GE.
Article 5. Protected
Health Information
Prior
to return of the Equipment to GE, ENDRA agrees to remove any
Protected Health Information (“PHI”) (as that term is
defined under the Health Insurance Portability and Accountability
Act Privacy Rule) that has been saved on the Equipment during the
consignment thereof. ENDRA further agrees to indemnify, defend and
hold GE harmless against any loss, claim, damage or liability
arising as a result of ENDRA’s failure to remove all PHI from
the Equipment.
Article 6. Reimbursement/Billing
ENDRA
agrees that the Equipment will not be used on human subjects for
any clinical diagnostic purposes. Accordingly, ENDRA agrees that it
will not submit any claims to any patient, government healthcare
program or third party payor involving the use of the
Equipment.
Article 7. Liability
ENDRA
agrees that GE and GE representatives have no liability to ENDRA
for (1) any penal, incidental or consequential damages, (2) any
assistance not required under the CRA, or (3) anything occurring
after the termination of the CRA. EACH PARTY EXPRESSLY WAIVES ALL
RIGHTS TO A JURY TRIAL IN CONNECTION WITH ANY DISPUTE ARISING UNDER
THE CRA. GE'S (AND ITS REPRESENTATIVES') LIABILITY FOR DAMAGES
UNDER THE CRA RELATING TO THE CONSIGNMENT OF THE EQUIPMENT,
REGARDLESS OF THE FORM OF ACTION, SHALL NOT EXCEED THE LIST PRICE
OF THE CONSIGNED EQUIPMENT. ENDRA agrees to defend, indemnify and
hold GE harmless against any liability arising from ENDRA's: (i)
negligent or inappropriate use of the Equipment; and/or (ii)
allegations that a use to which the Equipment are put, other than
for Purpose, infringes the intellectual property rights of any
third party during the term of the CRA.
Article 8. Title
and Risk of Loss
Title
and risk of loss to the Equipment will remain with GE until
delivery to the ENDRA, at which time all risk of loss and/or damage
to the Equipment will pass to ENDRA. ENDRA agrees to maintain the
Equipment in proper operating condition and return it to GE in this
condition, normal wear and tear excepted. ENDRA will not repair or
maintain the Equipment, or permit others to do so, without the
prior written consent of GE.
Article 9. Conformity
to the Laws
The
parties agree to comply with all (1) applicable federal, state
and local laws including but not limited to: fraud and abuse
statutes; physician self-referral law; Medicare and Medicaid laws;
laws affecting the tax-exempt status of hospital (e.g. IRS
regulations); state hospital licensure regulations; and federal,
state and local civil rights laws; and (2) applicable rules
and regulations of applicable healthcare accreditation
organizations.
Article 10. Reporting
Obligations
Consignment of GE
Equipment may be reported to the government through GE's reporting
obligations under the Patient Protection and Affordable Care Act
("Sunshine Act"). If GE Equipment is provided to ENDRA and the
Equipment is lost or misplaced by ENDRA, the total value of the
lost or misplaced items may be reported and/or allocated to ENDRA,
as required by the Sunshine Act.
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