(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

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))

Title of each class

Trading Symbol

Name of each exchange on which registered

Entry into a Material Definitive Agreement.

Financial Statements and Exhibits.

Exhibit
No.

Certain portions of the exhibit have been omitted pursuant to Regulation S-K Item 601(b) because it is both (i) not material to investors and (ii) likely to cause competitive harm to the Company if publicly disclosed.

/s/ Jack W. Callicutt

Galectin Therapeutics Inc. whose registered office is at Suite 240, 4960 Peachtree Industrial Boulevard, Norcross, Georgia 30071, USA (the Sponsor); and

Covance Inc., a corporation of the State of Delaware having its principal place of business at 206 Carnegie Center, Princeton, New Jersey 08540 USA (Covance),

WHEREAS Sponsor and Covance are parties to a Master Services Agreement effective as of March 12, 2020 (the MSA).

WHEREAS Sponsor and Covance entered in a Start-up Agreement effective as of 1st April 2019, as subsequently amended by Amendment #1, effective as of the 25th June 2019, Amendment #2, effective as of the 31st August 2019, Amendment #3, effective as of the 31st October 2019, Amendment #4, effective as of the 31st January 2020 and Amendment #5, effective as of the 30th April 2020 (hereafter the SUA) for the provision by Covance to Sponsor of preliminary services for the set-up of the study based on Sponsor’s Protocol GT-031 (NASH-RX) “A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis” (hereafter the Study).

WHEREAS subject to the terms and conditions of the MSA and the additional terms and conditions set forth in Exhibit A-2 to the MSA, the Sponsor and Covance hereby agree to execute a Work Order relating to the conduct of the Study by Covance (hereafter the “Work Order”), with the SUA to be superseded in its entirety by the Work Order.

Definitions and Interpretation

Each word and term used in this Work Order, but not defined, has the meaning specified in the MSA unless a clear contrary interpretation otherwise applies.

In this Work Order, unless the context otherwise requires, the following words and expressions shall have the following meanings:

In the event of conflict between the terms and conditions of this Work Order and those of the MSA, the terms of the MSA shall prevail except to the extent that this Work Order expressly and specifically states an intent to supersede the MSA on a specific matter.

Term and Termination

Services

The Parties acknowledge that the Services (as defined in the MSA) include the Legal Representation Services. For the avoidance of doubt, Legal Representation Services shall not include any services relating to compliance with any Data Protection Laws, which shall remain the responsibility of the Sponsor.

Covance agrees to perform the following Services for the Sponsor as set forth in the attached description of Services at Annex 1, which shall also detail the Study Specific Assumptions that apply to the Services.

The SUA is superseded entirely by the MSA and this Work Order. All services performed under the SUA shall be deemed to have been performed under the MSA and this Work Order. All sums billed or which otherwise would be billed by Covance to Sponsor under the SUA are included in the Budget as set forth in Section 4, and all payments that have been made by Sponsor under the SUA are to be credited against the invoices first issued to Sponsor by Covance under this Work Order.

Budget

The Budget for the Services is set out in the detailed Budget in this Work Order attached at Annex 2. (the “Budget”)

In consideration for its performance of the Services under this Work Order, the Sponsor shall pay Covance in accordance with the payment schedule or payment terms set out in this Work Order attached as Annex 3.

Invoices are due within [*] days of receipt by the Sponsor.

Payment and Invoice Details

All invoices to the Sponsor should be sent both via email and post to the attention of:

All payments to Covance should be sent to the following address:

Change Control

Power of Attorney

Insurance

Termination

Should the Sponsor: (a) reduce the level of Services (including the Legal Representation Services) to be provided by Covance to the extent that it is no longer commercially viable for Covance to perform the Legal Representation Services for the Sponsor; (b) become eligible to assume responsibilities of legal representative itself; (c) unable to provide the level and form of insurance required as specified above at Section 8; or (d) any regulatory or statutory requirement prevents the provision of Legal Representation Services by Covance, it shall notify Covance promptly in writing. Covance shall, upon written notice from the Sponsor have the right to: (a) terminate any Legal Representation Services; and/or (b) refuse any additional or revised Legal Representation Services which are not already ongoing under the relevant Work Order.

In the event that Covance terminates the Legal Representation Services under this Work Order, it shall cease to be the Legal Representative of the Sponsor in respect of the Services provided hereunder.

Entire Agreement

Choice of Law and Jurisdiction

Harold H. Shlevin

Michael Brooks

/s/ Harold H. Shlevin

/s/ Michael Brooks

President & CEO

President, Clinical Development and Commercialization

June 22, 2020

June 22, 2020

Legal Representation Services

The Parties have agreed that Covance shall provide the Legal Representation Services which shall form part of the Services to be provided under this Work Order. Covance shall perform the Legal Representation Services in compliance with the applicable clinical trial law in Australia, Europe, Mexico, Korea and United Kingdom, which shall include the following, in each case, only in relation to the Study:

provision of a contact address, fax number, telephone number and e-mail address along with any other necessary contact details to Regulatory Authorities for the purpose of communications with such Regulatory Authorities and third parties in connection with Covance’s role as the Sponsor’s Legal Representative;

provision of an individual employee of Covance who shall be familiar with the Study and shall act as a contact or liaison with Regulatory Authorities and third parties in connection with Covance’s role as the Legal Representative of the Sponsor;

where reasonably necessary in accordance with Regulatory Requirements, assisting the Sponsor in notifying or obtaining approval from the relevant Regulatory Authorities in respect of its appointment and in consultation with the Sponsor, preparation of any other documents that are necessary to confirm or formalise such appointment or to inform third parties;

preparation and signing of applications, notifications and other documents in connection with the Study (including, as applicable, letters of authority, applications for clinical trial authorisations and ethical approvals, applications for amendments thereto and notifications of the termination or completion of the Study);

where Covance expressly takes responsibility for compiling the clinical trial application, supervision, preparation and submission of such clinical trial application to any relevant Regulatory Authorities within Australia, Europe, Mexico, Korea, and United Kingdom;

performance of all other tasks and activities, including communication, where necessary, with the relevant Regulatory Authorities and as required in connection with the appointment and fulfilment of the regulatory obligations of Covance as the Sponsor’s Legal Representative;

seeking and obtaining the Sponsor’s instructions and approval before communicating with Regulatory Authorities and other third parties or performing any other task or activity in connection with Covance’s role as Legal Representative, provided that where urgent action is required (e.g. an urgent request is received from a Regulatory Authority) and Covance does not have and is not able to obtain instructions or approval from the Sponsor in the time available, then Covance shall take such action as it reasonably believes to be in the best interests of the Sponsor;

promptly supply to the Sponsor copies of all relevant communications made or received by Covance in connection with Covance’s role as Legal representative;

promptly notify the Sponsor of and attend and report on any meetings or hearings involving Covance in connection with Covance’s role as Legal Representative, provided that, where requested by the Sponsor, Covance shall use all reasonable efforts to ensure that representatives of Sponsor are also permitted to attend such meetings and hearings; and

in the event that legal proceedings are instigated in the Australia, Europe, Mexico, Korea, or United Kingdom, accept the service of legal documents, but not including payment of legal, consultancy, medical, specialist or expert fees associated with any claim made against either Covance or the Sponsor.

Subject to Covance acting as the Legal Representative of the Sponsor under the Agreement, the Sponsor represents and warrants that:

it shall review all information and material contained or referenced in all clinical trial notifications (CTNs) and all clinical trial applications or similar required documents (CTAs) for the investigational medicinal product to be tested or used in the performance of the Study as provided to Covance by the Sponsor or that are subject of the Services provided by Covance hereunder (Test Materials) to ensure that all such information and material is accurate, complete and not false or misleading;

it will provide sufficient amounts of the Test Materials as required by law or as reasonably requested by Covance;

the Test Materials shall be manufactured, packaged and (except to the extent that labelling, coding and distribution is to be provided as Services under the Agreement pursuant to a Work Order) labelled, coded and distributed in compliance with all applicable laws, rules, regulations and procedures, including Good Manufacturing Practice;

at the close of the Study, the Sponsor shall retain any and all records relating to the Study, including records received from Covance and shall maintain those records for twenty-five years or such other longer period of time as required by law. In addition, the Sponsor shall make such records available for inspection by any applicable Regulatory Authority; and

the Sponsor shall provide to Covance all such information as Covance may reasonably request from time to time and/or as may be necessary to enable Covance to perform all responsibilities as the Legal Representative for the Sponsor. The Sponsor shall provide all safety information pertinent to the Test Materials to Covance including, all Serious Adverse Event reports, consistent with applicable requirements as necessary to maintain in a legally compliant manner, all CTNs and CTAs.

The Sponsor shall indemnify, defend and hold harmless Covance from any Loss resulting from any means, any claim, demand, assessment, action, suit, proceeding, settlement or investigation arising from or related any liability imposed on the Covance Group as a result of its responsibilities as a Legal Representative, local sponsor or a similar role for the Sponsor under this Work Order; provided that Sponsor shall not be obliged to indemnify, defend or hold harmless Covance to the extent any Loss arises from (i) any act or omission of Covance, their Affiliates or Subcontractors or Vendors that is a breach of any provision of the Agreement, Work Order or this Annex; (ii) any negligence, recklessness or wilful misconduct of Covance, their Affiliates or Subcontractors or Vendors; or (iii) any losses arising from Covance, or their respective Affiliate’s or Subcontractor’s or Vendor’s failure to mitigate any such claim, demand, assessment, action, suit, proceeding, settlement, investigation

Clinical Services

General Assumptions

The current scope of the Study Scope and Budget do not include [*]. An increase in [*] will result in a Budget change.

The current scope of the Study and Budget include [*].

The Study has an adaptive design, and the decision to enter [*]. Earlier termination of this Work Order by Sponsor at any time shall be governed by Section 21.2 and 22.3 of the MSA. For avoidance of doubt, the Parties acknowledge that [*].

Current assumptions, timeline and the Budget for [*].

Phase IIb

Phase III

Part IIb Budget

SERVICE FEES [*]

TOTAL INDIRECT FEES

PASS-THROUGH EXPENSES

VENDOR BID EXPENSES

TOTAL FEES INCLUDING PASS-THROUGHS / VENDOR BIDS

Part III Budget

SERVICE FEES [*]

TOTAL INDIRECT FEES

PASS-THROUGH EXPENSES

VENDOR BID EXPENSES

TOTAL FEES INCLUDING PASS-THROUGHS / VENDOR BIDS

Phase IIb

Clinical Fees

Indirect Fees – Covance Central Laboratories Services

Pass Through Cost (PTC)

Phase III

Clinical Fees

Indirect Fees – Covance Central Laboratories Services

Pass Through Cost (PTC)

APPOINTMENT AND POWERS

The Principal hereby appoints COVANCE INC. with its principal place of business at 206 Carnegie Center, Princeton, New Jersey, 08540 USA as its attorney in fact (the “Attorney”) and gives authority for the Attorney to act in the Principal’s name or otherwise and on its behalf to the extent necessary to perform the following activities relating to the conduct of the clinical trial under Protocol Number GT-031 (NASH-RX) and with study title: “A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis” (the “Clinical Trial”) and provided that any powers granted herein shall apply only to the conduct of the Clinical Trial in [insert relevant country/region]:

prepare and sign documents required for the Clinical Trial by the local ethics committees and central ethics committees;

correspond with ethics committees for purposes related to the Clinical Trial;

handle, negotiate and sign site agreements and other agreements relating to the provision of clinical services for the Clinical Trial on its behalf and/or, subject to approval by the Principal in writing, in the Principal’s name as its Attorney;

monitor and manage the Clinical Trial;

import any investigational medicinal product required for the Clinical Trial in accordance with the relevant customs procedures;

store and distribute materials related to the Clinical Trial;

obtain export licenses for the Clinical Trial if required;

assist the Principal to report serious adverse events related to the Clinical Trial to ethics committees in accordance with local requirements; or

collect any investigational medicinal product from sites at which the Clinical Trial is conducted and return to the Principal or arrange for destruction as required by the Principal,

Except for those agreements referred to in Paragraph 1.1(c) above, the Attorney shall have no authority to enter into any agreements in the name or on behalf of the Principal or otherwise act on behalf of or bind the Principal, and the Attorney shall not hold itself out as having authority to do the same.

This Power of Attorney cannot be transferred or delegated by the Attorney to any other persons or entity.

DURATION

Subject to Paragraphs 2.2 and 2.3, this Power of Attorney shall be valid until completion of the Clinical Trial in accordance with the protocol for the Clinical Trial.

The Principal may revoke the Power of Attorney in relation to the Attorney with immediate effect by written notice at any time to the relevant Attorney at the relevant address above.

The Attorney may revoke the Power of Attorney with immediate effect in accordance with paragraph 9 of the relevant work order forming part of the Agreement.

The Attorney must immediately cease to exercise any of the powers granted by this Power of Attorney if this Power of Attorney expires, terminates or is revoked by the Principal.

RATIFICATION

VALIDITY

LANGUAGE

JURISDICTION