8-K - NDRA - Equibles

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)

Delaware	001-37969	26-0579295
(State<br>or other jurisdiction of incorporation	(Commission<br>File Number)	(IRS<br>Employer Identification No.)
3600<br>Green Court, Suite 350 Ann Arbor, MI	48105
---	---
(Address<br>of principal executive offices)	(Zip<br>Code)

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:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common<br>stock, par value $0.0001 per share	NDRA	The<br>Nasdaq Stock Market LLC
Warrants,<br>each to purchase one share of Common Stock	NDRAW	The<br>Nasdaq Stock Market LLC

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.

(d)

Exhibits

Exhibit No.	Description
10.1	Amendment<br>3 to Collaborative Research Agreement, dated January 13, 2020, by<br>and between the Company and General Electric Company.
99.1	Press<br>Release dated January 15, 2020 issued by the Company, furnished<br>herewith.

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.

	ENDRA Life Sciences Inc.
January<br>15, 2020
	By:	/s/<br>Francois Michelon
	Name:	Francois<br>Michelon
	Title:	President<br>and Chief Executive Officer

Blueprint

Exhibit 10.1

AMENDMENT 3
TO THE
COLLABORATIVE RESEARCH AGREEMENT
BETWEEN
GENERAL ELECTRIC COMPANY
AND
ENDRA LIFE SCIENCES INC.
This<br>Amendment 3 to the Collaborative Research Agreement ("Amendment"),<br>effective as of the last date of signing below ("Effective Date"),<br>amends the Collaborative Research Agreement between General<br>Electric ("GE") & ENDRA Life Sciences Inc. ("ENDRA"), which<br>became effective as of April 22, 2016, as amended by that certain<br>Amendment 1 to the Collaborative Research Agreement, dated April<br>21, 2017, and by that certain Amendment 2 to the Collaborative<br>Research Agreement, dated January 30, 2018<br>("Agreement").
RECITALS
WHEREAS,<br>the parties wish to amend the Agreement to provide for a revised<br>TERM, which includes changes to the Agreement as set forth below;<br>and<br><br><br><br><br><br>WHEREAS,<br>the parties wish to modify the Research Program following<br>ENDRA’s presentation of its Final Report with respect to the<br>Research Program on December 4, 2019.
THEREFORE,<br>the parties hereby agree to the following amendment:
1. Section 9.1<br>of the Agreement shall be deleted and restated as<br>follows:<br><br><br><br><br><br>This Agreement will remain in effect until January 14, 2021 unless<br>terminated sooner or extended in writing signed by the parties in<br>accordance with this Agreement.
2. Exhibit A<br>of the Agreement shall be deleted and restated with Exhibit A<br>attached hereto.
3. Capitalized<br>terms not defined in this Amendment will have the meanings assigned<br>in the Agreement.
4. Except as<br>explicitly modified, all terms, conditions and provisions of the<br>Agreement shall continue in full force and effect.
5. In the<br>event of any inconsistency or conflict between the Agreement and<br>this Amendment, the terms, conditions and provisions of this<br>Amendment shall govern and control.
6. This<br>Amendment and the Agreement constitute the entire and exclusive<br>agreement between the parties with respect to this subject matter.<br>All previous discussions and agreements with respect to this<br>subject matter are superseded by the Agreement and this<br>Amendment.

Signature Page Follows

Acceptance of these terms is documented by the signature and date of the responsible parties in the space designated below.

GE Healthcare		ENDRA Life Sciences Inc.
Signature:	/s/<br>Brian McEathron	Signature:	/s/<br>Francois Michelon
Name:	Brian<br>McEathron	Name:	Francois<br>Michelon
Title:	GM<br>General Imaging Ultrasound	Title:	CEO
Date:	January<br>13, 2020	Date:	January<br>13, 2020

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.

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.

GE will provide (within its sole discretion) ad-hoc commercial advice to assist ENDRA with the development of a TAEUS™ commercialization plan.

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:

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.

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.

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”).

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”).

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”).

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.

Blueprint

Exhibit 99.1

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.