UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of the Securities Exchange Act of
1934
Date of Report
(Date of earliest event reported) January 13, 2020
ENDRA Life Sciences Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-37969
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26-0579295
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(State
or other jurisdiction of incorporation
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(Commission
File Number)
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(IRS
Employer Identification No.)
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3600
Green Court, Suite 350 Ann Arbor, MI
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48105
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant's
telephone number, including area code (734)
335-0468
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
below):
☐ Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)
☐ Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities
registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common
stock, par value $0.0001 per share
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NDRA
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The
Nasdaq Stock Market LLC
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Warrants,
each to purchase one share of Common Stock
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NDRAW
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The
Nasdaq Stock Market LLC
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Indicate
by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of
1934 (§240.12b-2 of this chapter).
Emerging
growth company ☑
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item
1.01 Entry into a Material Definitive Agreement.
On
January 13, 2020, ENDRA Life Sciences Inc. (the
“Company”) entered into Amendment 3 (the
“Amendment”) to that certain Collaborative Research
Agreement between the Company and General Electric Company
(“GE”), dated as of April 22, 2016, as amended by that
certain Amendment 1 to Collaborative Research Agreement, dated
April 21, 2017, and by that certain Amendment 2 to Collaborative
Research Agreement, dated January 30, 2018 (the
“Agreement”). The Amendment extends the term of the
Agreement to January 14, 2021 and modifies certain rights of first
offer held by GE with respect to manufacturing and licensing rights
for the Company’s Thermo-Acoustic Enhanced Ultrasound
technology for use in a fatty liver disease
application.
A copy
of the Amendment is filed as Exhibit 10.1 to this Current Report on
Form 8-K. The foregoing description is not complete and is
qualified in its entirety by reference to the full text of the
Amendment, which is incorporated herein by reference. In the event
of any conflict between this summary and the full text of the
Amendment, the text of the Amendment shall control.
Item
7.01 Regulation FD Disclosure
On
January 15, 2020, the Company issued a press release announcing its
entry into the Amendment. A copy of the press release is being
furnished as Exhibit 99.1 to this Current Report on Form
8-K.
The
information furnished in Item 7.01 of this Current Report on
Form 8-K, including Exhibit 99.1 attached hereto, shall
not be deemed “filed” for purposes of Section 18
of the Securities Exchange Act of 1934 (the “Exchange
Act”) or otherwise subject to the liabilities of that
section, nor shall it be deemed incorporated by reference into any
filing under the Securities Act of 1933 or the Exchange Act, except
as expressly set forth by specific reference in such
filing.
Item
9.01 Financial Statements and Exhibits.
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Exhibit No.
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Description
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Amendment
3 to Collaborative Research Agreement, dated January 13, 2020, by
and between the Company and General Electric Company.
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Press
Release dated January 15, 2020 issued by the Company, furnished
herewith.
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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ENDRA Life Sciences Inc.
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January
15, 2020
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By:
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/s/
Francois Michelon
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Name:
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Francois
Michelon
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Title:
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President
and Chief Executive Officer
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AMENDMENT 3
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TO THE
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COLLABORATIVE RESEARCH AGREEMENT
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BETWEEN
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GENERAL ELECTRIC COMPANY
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AND
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ENDRA LIFE SCIENCES INC.
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This
Amendment 3 to the Collaborative Research Agreement ("Amendment"),
effective as of the last date of signing below ("Effective Date"),
amends the Collaborative Research Agreement between General
Electric ("GE") & ENDRA Life Sciences Inc. ("ENDRA"), which
became effective as of April 22, 2016, as amended by that certain
Amendment 1 to the Collaborative Research Agreement, dated April
21, 2017, and by that certain Amendment 2 to the Collaborative
Research Agreement, dated January 30, 2018
("Agreement").
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RECITALS
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WHEREAS,
the parties wish to amend the Agreement to provide for a revised
TERM, which includes changes to the Agreement as set forth below;
and
WHEREAS,
the parties wish to modify the Research Program following
ENDRA’s presentation of its Final Report with respect to the
Research Program on December 4, 2019.
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THEREFORE,
the parties hereby agree to the following amendment:
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1. Section 9.1
of the Agreement shall be deleted and restated as
follows:
This Agreement will remain in effect until January 14, 2021 unless
terminated sooner or extended in writing signed by the parties in
accordance with this Agreement.
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2. Exhibit A
of the Agreement shall be deleted and restated with Exhibit A
attached hereto.
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3. Capitalized
terms not defined in this Amendment will have the meanings assigned
in the Agreement.
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4. Except as
explicitly modified, all terms, conditions and provisions of the
Agreement shall continue in full force and effect.
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5. In the
event of any inconsistency or conflict between the Agreement and
this Amendment, the terms, conditions and provisions of this
Amendment shall govern and control.
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6. This
Amendment and the Agreement constitute the entire and exclusive
agreement between the parties with respect to this subject matter.
All previous discussions and agreements with respect to this
subject matter are superseded by the Agreement and this
Amendment.
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Signature Page Follows
Acceptance
of these terms is documented by the signature and date of the
responsible parties in the space designated below.
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GE Healthcare
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ENDRA Life Sciences Inc.
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Signature:
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/s/
Brian McEathron
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Signature:
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/s/
Francois Michelon
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Name:
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Brian
McEathron
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Name:
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Francois
Michelon
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Title:
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GM
General Imaging Ultrasound
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Title:
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CEO
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Date:
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January
13, 2020
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Date:
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January
13, 2020
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Signature Page to Amendment No 3 to Collaborative Research
Agreement
EXHIBIT A:
RESEARCH PROGRAM COMPONENTS
ENDRA
wishes to commercialize its Thermo-Acoustic Enhanced UltraSound
(TAEUS™) technology, and GE wishes to assist ENDRA in this
goal.
To this
end, GE agrees to provide ENDRA with the 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
TAEUS™ 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
TAEUS™ 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.
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.
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 (each, an
“Option” and, collectively, the “Options”)
shall each start as of the Effective Date and each automatically
terminate after the earlier of (i) thirty (30) days following
ENDRA’s offering to negotiate with GE with respect to such
Option and (ii) ninety (90) days after the 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 (the “Negotiation
Period”), ENDRA and GE agree to negotiate in good faith to
draft and execute a written agreement consistent with GE’s
Option selection. Notwithstanding the foregoing, ENDRA shall not be
prevented during the Negotiation Period from negotiating with third
parties the subject of any Option. 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 (the “Tail Period”)
not to enter into a similar agreement with a third party on terms
and conditions that are materially better for the third party in
any respect than, or substantially equal for the
third party 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. If at any time during the Negotiation Period or
the Tail Period ENDRA submits to GE terms proposed by a third party
for a transaction that would be subject to an Option (the
“Third Party Terms”), GE shall have twenty (20) days
from such submission to notify ENDRA in writing that it elects to
contract with ENDRA on the Third Party Terms, in which case GE and
ENDRA shall thereafter enter into a contract reflecting such Third
Party Terms as promptly as practicable. If GE does not notify ENDRA
of such election in such 20-day period, ENDRA shall have satisfied
its obligations to GE with respect to the applicable Option and be
entitled to contract with a third party on terms substantially
similar to those submitted to GE.
ENDRA Life Sciences Renews GE
Healthcare Collaboration Agreement
Supports Commercialization of TAEUS Liver Product Targeting
NAFLD-NASH
ANN ARBOR, MI / ACCESSWIRE / January 15, 2020 / ENDRA Life Sciences
Inc. ("ENDRA") (NASDAQ:NDRA), a pioneer of Thermo Acoustic
Enhanced UltraSound (TAEUS™), today announced it has renewed
its collaboration agreement with the GE Healthcare unit of General
Electric Company, extending the agreement's term to January
2021.
"2020
is off to an exciting start and we are pleased to renew our
collaboration agreement with GE Healthcare, the global leader in
clinical ultrasound and ENDRA's partner since 2016," said Francois
Michelon, CEO of ENDRA. "Last month we submitted the technical file
for ENDRA's CE Mark review, and we are looking forward to working
with GE Healthcare as we progress towards commercializing TAEUS in
2020."
Under
the terms of the agreement, GE Healthcare will continue to support
ENDRA's commercialization activities for its TAEUS technology for
use in a fatty liver application by, among other things,
facilitating introductions to GE Healthcare clinical ultrasound
customers. In return for this assistance, ENDRA will afford GE
Healthcare certain rights of first offer with respect to
manufacturing and licensing rights for the target application. In
addition to extending the agreement's term, the renewal modified
the terms of these rights of first offer.
"ENDRA's
technology has the potential to bring significant new capabilities
to ultrasound and address unmet clinical needs in point-of-care
NAFLD-NASH assessment and monitoring, which aligns with GE
Healthcare's mission to increase access to high-quality,
cost-effective healthcare," said Brian McEathron, GE Healthcare's
Vice President and General Manager for General Imaging Ultrasound.
"We're excited to bring the TAEUS fatty liver product to market and
help improve patient outcomes."
About ENDRA Life Sciences Inc.
ENDRA
Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound
(TAEUS™), a ground-breaking technology that visualizes tissue
like CT or MRI, but at 50X lower cost, at
the point of patient care. TAEUS is designed to work in concert
with an estimated 365,000 cart-based, non-prenatal ultrasound
systems in global use today. TAEUS is initially focused on the
measurement of fat in the liver, as a means to assess and monitor
NAFLD and NASH, chronic liver conditions that affect over 1 billion
people globally, and for which there are no practical diagnostic
tools. Beyond the liver, ENDRA is exploring several other clinical
applications of TAEUS, including visualization of tissue
temperature during energy-based surgical
procedures. www.endrainc.com
Forward-Looking Statements
All
statements in this release that are not based on historical fact
are "forward-looking statements" within the meaning of Section 27A
of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Forward-looking statements, which are based
on certain assumptions and describe our future plans, strategies
and expectations, can generally be identified by the use of
forward-looking terms such as "believe," "expect," "may," "will,"
"should," "could," "seek," "intend," "plan," "goal," "estimate,"
"anticipate," or other comparable terms. Examples of
forward-looking statements include, among others, statements we
make regarding the timing of the commercialization of our TAEUS
technology, the continuation of our agreement with GE Healthcare,
expectations concerning ENDRA's ability to secure regulatory
approvals; anticipated product pricing; expectations with respect
to current and future partnerships, including that with GE
Healthcare; estimates of the timing of future events and
achievements;and expectations concerning ENDRA's business strategy.
Forward-looking statements involve inherent risks and uncertainties
which could cause actual results to differ materially from those in
the forward-looking statements, as a result of various factors
including, among others, the following: our ability to develop a
commercially feasible technology; receipt of necessary regulatory
approvals; our ability to find and maintain development partners,
market acceptance of our technology, the amount and nature of
competition in our industry; our ability to protect our
intellectual property; and the other risks and uncertainties
described in ENDRA's filings with the Securities and Exchange
Commission. The forward-looking statements made in this release
speak only as of the date of this release, and ENDRA assumes no
obligation to update any such forward-looking statements to reflect
actual results or changes in expectations, except as otherwise
required by law.
Company Contact:
David
Wells
Chief
Financial Officer
(734)
997-0464
investors@endrainc.com
www.endrainc.com
Media & Investor Relations Contact:
MacDougall
Amanda
Houlihan
(781)
235-3060
endra@macbiocom.com
SOURCE: ENDRA Life Sciences Inc.