Exhibit 10.1

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (1) NOT MATERIAL AND (2) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

COVANCE MASTER SERVICES AGREEMENT

This Master Services Agreement is effective as of March 12, 2020 (“Effective
Date”) by and between

 

(1)

Covance Inc. whose registered office is at 206 Carnegie Center, Princeton, NJ
08540 USA (the Company); and

 

(2)

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

(each a Party and collectively the Parties).

RECITALS

 

(A)

WHEREAS, the Sponsor develops drugs.

 

(B)

WHEREAS, Company, through itself and its Affiliates (as defined below), provides
a wide range of product development and testing services on a worldwide basis to
the biotechnology, pharmaceutical and medical device industries, including,
without limitation, preclinical efficacy and safety laboratory services, Phase
I, II, III and IV clinical services, periapproval services, central laboratory
services, health economics services, market access and commercialization and
biotechnology services.

 

(C)

WHEREAS, the Sponsor desires to contract with Company and/or its Affiliates for
the purpose of providing services to assist the Sponsor in the execution of
various projects.

 

(D)

WHEREAS, when the Sponsor requests the services of the Company or any of its
Affiliates, and the Company or its Affiliate is able to provide such services,
the relevant parties shall enter into a separate service contract in accordance
with this Agreement (as defined below).

 

(E)

WHEREAS, each such separate contract shall be a Work Order (as defined below)
each of which shall incorporate the terms and conditions set out in this
Agreement.

IT IS AGREED

 

1

DEFINITIONS

 

1.1

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

“Affiliate” means any entity controlling, controlled by, or in common control
with a Party. For the purposes of this definition, “Control” shall mean
ownership or control, directly or indirectly of more than fifty per cent (50%)
of the common voting stock or ordinary shares in the entity or the right to
appoint fifty per cent (50%) or more of the directors of that entity. With
respect to the Company, the term Affiliate shall include Laboratory Corporation
of America Holdings and any business entity that is controlled by or under
common control with Laboratory Corporation of America Holdings.

 

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“Agreement” means this MSA and any applicable Exhibit A.

“Anti-Corruption Laws” means any anti-bribery and anti-corruption laws, rules,
regulations applicable to either Party (each as amended from time to time)
including the Prevention of Corruption Act (Cap. 241) of Singapore, the US
Anti-Kickback Law, the US Foreign Corrupt Practices Act, the UK Bribery Act 2010
and the OECD Convention Against the Bribery of Foreign Government Officials in
International Business Transactions, together with any applicable implementing
legislation, including any applicable local law addressing bribery or
corruption.

“Assumptions” means any General Assumptions and any Study/Services Specific
Assumptions.

“Background IP” means all pre-existing intellectual property belonging to or
licensed to a Party or other intellectual property created outside the scope of
the Services.

“Budget” means the fees and estimated pass through costs charged and/or incurred
by Covance in the performance of the Services or Study as set out in a Work
Order.

“CFR” mean the US Code of Federal Regulations.

“Change Order” has the meaning given in Section 10.

“Claim” means any third party claims, demands, assessments, actions, suits,
proceedings, settlements or investigations.

“Confidential Information” means any and all commercial or technical information
or materials and all derivatives thereof, in any and all forms, howsoever
disclosed or obtained including business plans, financial information, client
lists and requirements, techniques, designs, methods, processes and procedures
which: (i) is identified by a suitable legend or other marking as being
confidential (or similar designation) in a suitable prominent position; (ii) is
described as confidential at the time of disclosure; or (iii) the Receiving
Party regards or should reasonably be expected to regard as proprietary and
confidential given the nature of the information and the reasonable efforts
under the circumstances used to maintain its confidentiality; and any
improvements, enhancement or modification made, conceived or developed thereto.

“Covance” means the Company and each Company Affiliate that signs an Exhibit A
and thereby becomes a Party to this Agreement.

“Covance Property” means inventions, proprietary processes, software (including
codes) data, technology, know-how and other intellectual property that have been
independently developed, discovered or licensed by Covance, including those that
relate to the proprietary innovative testing procedures, laboratory testing,
data collection or data management, procedural manuals, delta flags, nucleic
acid based vectors, analytical procedures and approaches (even if such are
developed in the course of providing the Services or are captured in documents
pertaining to the Services i.e. laboratory notebooks), techniques, skills,
models, multimedia source codes, non-product specific components of
questionnaires, management tools and any other materials, employed, developed or
obtained by Covance, which are developed independently and not developed as a
result of the Services or a Work Order, or based on the Sponsor’s Confidential
Information.

 

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“Data Protection Laws” mean all applicable privacy, data protection or similar
laws and regulations anywhere in the World, as the same may be amended from time
to time, including to the extent applicable to the respective Services, the Data
Protection Directive (95/46/EC), the Personal Data Protection Act 2012 of
Singapore and any applicable implementing legislation or any amendment thereto
and especially from 25 May 2018, the EU Personal Data Regulation (2016/679/EU)
(which repeals Directive 95/46/EC) and the EU Personal Data Directive
(2016/680/EU).

“Delay” means a delay, suspension or postponement of the Services and “Delayed”
shall be construed accordingly.

“Deliverables” means as applicable to the Services, Results, Study Records or
any other deliverable specified in the Work Order (including physical products).

“Disclosing Party” means a Party that discloses Confidential Information.

“Exhibit A” means the additional terms and conditions of a Company Affiliate
which is executed by the Sponsor and a Company Affiliate and attached to this
MSA. If more than one Company Affiliate is a party to this MSA, Exhibit A shall
be numbered sequentially beginning with Exhibit A-1 and continuing as necessary.

“FDA” means the US Food and Drug Administration.

“Financial Interest Claims” means any claims related to the financial interest
of a third party with whom the Sponsor has entered into an agreement for the
development, licensing, and/or commercialization of the Test Materials and who
has a financial interest in the outcome of the development of such Test
Materials.

“Force Majeure Event” means any force majeure event as recognized by applicable
law, but for the purposes of this Agreement, shall include all circumstances or
causes beyond the reasonable control of a Party, including war, threat of war or
warlike conditions, blockade, embargo, fire, explosion, lightning, storm,
drought, flood, earthquake or other natural disaster, pandemic or epidemic,
power failure, shortage of labor or supplies, supply chain issues, strikes, lock
outs, acts of terrorism, riot, civil unrest, insurrection, acts of government or
other international bodies, political subdivision and any other events which by
nature could not have been foreseen by the Parties or, if it could have been
foreseen, were unavoidable by a reasonable prudent business.

“General Assumptions” means (i) the scope of the Services remains constant;
(ii) the Sponsor timely performs all of its obligations under this Agreement and
any applicable Work Order; (iii) the full cooperation of the Sponsor and any
third party not under Covance’s reasonable control in the timely performance of
Covance’s obligations under this Agreement and any applicable Work Order;
(iv) the Sponsor refrains from any actions, inactions or omissions that would
prevent Covance from performing its obligations in a timely manner; (v) the
proper and timely performance of all appropriate tasks relevant to the Services
by third parties outside of Covance’s reasonable control; and (vi) no other
event or occurrence outside of Covance’s reasonable control including Force
Majeure Events or a change in Regulatory Requirements which affects the Study.

“HBS Donor” means an individual, living or deceased, from whom the HBS was
obtained.

“Human Biological Samples” or “HBS” means any human biological material,
including human bodily parts and organs in whole or sub-samples, any tissue,
skin, bone, muscle, connective tissue, blood, cerebrospinal fluid, cells,
gametes or sub-cellular structures, such as DNA, or any derivative or product of
such human biological materials including stem cells, cell lines, bodily fluids,
blood derivatives and urine.

 

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“IEC/IRB” means an independent ethics committee or institutional review board.

“Informed Consent” means an IEC/IRB approved informed consent form signed by the
HBS Donor, their next of kin or legal representative authorizing the Use of
their HBS.

“Invention” means any patentable invention or other registerable intellectual
property rights discovered, conceived or made by Covance specifically as a
result of performing the Services for the Sponsor and directly relating to the
Test Materials and/or the Sponsor Information. For the avoidance of doubt, any
commercially available methods, processes or assays provided by or on behalf of
Sponsor shall not be deemed to be Inventions or Sponsor Information for the
purpose of this Agreement.

“Investigator” means third party principal investigators and/or investigative
sites.

“Loss” means any loss, cost, damage or expense (including reasonable legal
expenses).

“MSA” means this master services agreement document.

“Personal Data” shall have the meaning set forth in any applicable Data
Protection Legislation.

“Protocol/Scientific Plan” means a protocol or an equivalent document, which
includes a scientific plan, laboratory testing procedure or sample analysis
outline, whether provided by the Sponsor or prepared by Covance under the
Sponsor’s direction in relation to the Services, the Study and/or relevant Work
Order.

“Receiving Party” means a Party that receives Confidential Information.

“Regulatory Authority” means any national or state (in the case of the US), or
local agency, authority, of any government of any country having jurisdiction
over the respective activities contemplated by this Agreement or Work Order, or
over the respective Parties.

“Regulatory Requirements” means all laws, statutes, acts, rules, regulations,
codes, orders, directives or other legally binding requirements of any
Regulatory Authority and industry standards or codes of conduct applicable to
the Services.

“Results” mean: (i) all materials, data, documents and information produced or
developed by Covance specifically as a result of the Services and related to the
Test Materials and/or the Sponsor Information; and (ii) the Study Records (if
applicable).

“Samples” means biological samples associated with the Services.

“Serious Breach” means a reportable non-compliance issue that significantly and
negatively: impacts: (i) the safety or rights of an individual in a Study or
(ii) the reliability and robustness of the data generated in a Study.

“Services” means the services and/or applicable products provided by Covance to
the Sponsor as more particularly described in the Work Order.

“Sponsor Information” means Test Materials, data, specification or other
materials or information supplied by the Sponsor to Covance in connection with
the Services.

“Study” means a clinical trial or scientific evaluation of the Test Materials to
which the Services relate as further defined in the applicable Work Order and
Protocol/Scientific Plan.

 

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“Study/Services Specific Assumptions” means Study or project specific
assumptions set forth in the applicable Work Order.

“Study Records” means in relation to contracted activities, all records, notes,
reports (including case report forms; monitoring logs; data correction forms;
case histories; medical images; drug safety records; records of receipt, use,
processing and disposition of Test Materials and trial master file) and other
observations, notations or data of activities or procedures (in each case
whether in a written or electronic format) which Covance obtains from each
Investigator or which Covance specifically generates or produces for the
relevant Study under the Regulatory Requirements, excluding the Study subject’s
personal medical records.

“Subcontractor” means a third party service provider approved, qualified,
reviewed and contracted by Covance for services that are generally provided
directly by Covance and which are part of the Services within the scope of this
Agreement or a Work Order.

“System Data” means control data from laboratory tests or transactional, volume
and performance data related to the Services, which does not contain any:
(i) data following treatment with any Test Materials; (ii) personally
identifiable information; or (iii) Sponsor Confidential Information.

“Taxes” means VAT/GST, local, state (in the case of the US), federal sales or
use taxes, excise taxes, import tax, country specific business or professional
services tax or similar tax on international services or foreign entities
providing services or consumption taxes.

“Test Materials” means compounds, materials, other substances, devices, products
or other specific items as described in the Work Order and/or
Protocol/Scientific Plan to be tested or used in the performance of the Services
as provided to Covance by the Sponsor or that are the subject of the Services.

“Use” (in the context of Section 25) means collection, storage (including
retention period) transfer (including import and export), use and return or
disposal of HBS including by commercial organizations.

“VAT/GST” means value added tax or goods and services tax.

“Vendor” means third-party service providers other than a Subcontractor:
(i) that the Sponsor requires Covance to use; or (ii) used by Covance that are
ancillary to or outside Covance’s business activities. Vendors include, third
party service providers of electronic data capture/bedside data capture
services, specialist referral laboratories, electrocardiogram services,
interactive response technology/voice response services, drug depot and drug
supply services, patient recruitment services, transcription services and
translation services, providers of equipment or medical devices, adjudication
services, medical imaging services, 24 hour medical coverage telephone line
rental, external meeting planners, third party site networks and organisations,
regulatory support services and courier services.

“Work Order” means an individual project agreement in the form of Exhibit B or
such other mutually agreed upon form between the Sponsor and Covance containing
details of the Services to be provided by Covance, the Budget, any
Study/Services Specific Assumptions and any additional terms, conditions or
other particulars applicable to the Services.

 

1.2

In this Agreement, unless the context otherwise requires, references to:
(a) Exhibit and Section headings are inserted for convenience only and do not
affect the construction or interpretation of this Agreement; (b) defined terms
used in this Agreement, and any Work Order shall have the meanings in this
Agreement or the relevant Work Order; (c) a particular law or statutory
provision is a reference to it as it is in force for the time being taking
account of any amendment,

 

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  extension, or re-enactment and includes any subordinate legislation for the
time being in force made under it; (d) writing or written includes faxes and
e-mail; (e) a person includes a corporate or unincorporated body; (f) one gender
includes all genders; (g) including, include, in particular or any similar
expression shall be construed as illustrative and shall not limit the sense of
the words preceding those terms; and (h) words in the singular include the
plural and vice versa.

 

1.3

If this Agreement is translated, the English language text and version shall
prevail.

 

2

FORM OF CONTRACT

 

2.1

The additional terms and conditions that apply to the services provided by
Company or a Company Affiliate (and any Work Orders thereunder) are detailed in
Exhibit A. Upon execution of the relevant Exhibit A, the respective Company
Affiliate shall become an additional party to this Agreement and shall be
subject to the terms and conditions herein.

 

2.2

Each Company Affiliate that enters into a Work Order shall be bound by all
applicable terms and conditions of this Agreement and of the respective Work
Order to provide the relevant Services. For the avoidance of doubt and as
defined above “Covance” means the Company and any Company Affiliate. Each
Company Affiliate who is a Party to this Agreement shall have the respective
rights and obligations of the Company under this Agreement.

 

2.3

The terms and conditions of this Agreement shall apply to the Work Order to the
exclusion of any other terms that the Parties may seek to impose or incorporate
or which are implied by trade, custom, practice or course of dealing.

 

2.4

Each Work Order shall: (a) be entered into by Covance and the Sponsor;
(b) constitute a separate and independent contract that binds the relevant
Parties; (c) incorporate the terms and conditions of this Agreement, except to
the extent as otherwise agreed by the Parties; (d) incorporate by reference the
Protocol/Scientific Plan which shall be deemed part of the Work Order;
(e) specify the Services to be provided; (f) specify any conditions and any
information required for the Services; (g) be governed by the governing law of
this MSA; and (h) specify the Budget for the Services and any Study/Services
Specific Assumptions relating to the Budget together with a payment schedule or
payment terms.

 

2.5

The Sponsor acknowledges and agrees that: (a) all issues and correspondence
regarding the performance of such Services should be directed to the relevant
person as set out in the applicable Work Order or otherwise identified by
Covance; and (b) the relevant Company Affiliate shall be solely responsible and
liable to the Sponsor for any breach of the relevant Work Order.

 

2.6

Each relevant Protocol/Scientific Plan forms part of (and is incorporated into)
this Agreement. In the event of a conflict between the Protocol/Scientific Plan
and this Agreement or Work Order, the terms of the Protocol/Scientific Plan
shall prevail with respect to the scientific, medical, technical and regulatory
guidelines used in the conduct of the Services. This Agreement and the Work
Order shall govern in all other instances.

 

2.7

If there is a conflict between the provisions of this MSA, Exhibit A and the
provisions of a Work Order and its attachments and except to the extent that a
provision with a lower priority expressly states otherwise, whereby such
provision shall have a higher priority, the conflict shall be resolved by
interpreting the provisions in the following order of priority: this MSA,
Exhibit A, the provisions of the Work Order and any other attachments.

 

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3

PERFORMANCE AND PROVISION OF SERVICES AND/OR PRODUCTS

 

3.1

Covance:

(a) Shall perform the Services with due skill and care in accordance with
industry standards and the Protocol/Scientific Plan;

(b) Shall supply the Services, including any applicable products, in accordance
with this Agreement and any express terms set out in the Work Order and the
Protocol/Scientific Plan;

(c) Represents that Covance’s databases to be used by it for the tracking,
handling, recording, reporting and transmitting of data generated during the
performance of the Protocol/Scientific Plan have been fully verified and
validated according to applicable industry standards;

(d) Represents that it is not a party to any agreement that would prevent it
from fulfilling its obligations under this Agreement.

(e) Represents that it has the experience, capability and resources, including
but not limited to sufficient personnel to perform the Services under any Work
Order in a competent manner and that it shall at all times devote the necessary
personnel to perform the Services in a competent manner.

 

3.2

Represents that it will provide Services and conduct all activities pursuant to
this Agreement in accordance with all applicable laws, regulations and
applicable guidance documents, including without limitation, 21 C.F.R.
Section 312 and the International Conference on Harmonization Good Clinical
Practice Guidelines and including all requirements on clinical research
organizations, including as designees of trial sponsors that relate to Services
provided thereunder.

 

3.3

Covance shall use its commercially reasonable efforts to perform the Services
within the timeframe estimated in the Protocol/Scientific Plan or applicable
Work Order and within the Budget established under the applicable Work Order.
Sponsor agrees and acknowledges that time estimate assumes the full cooperation
of the Sponsor, Regulatory Authorities, IECs/IRBs and Investigators (if
applicable) and other third parties not under Covance’s reasonable control.
Covance shall notify Sponsor promptly whenever it becomes aware that timeframes
and Budgets may not be met, and Covance shall regularly communicate with Sponsor
about steps that can be taken to achieve the applicable timeframes and Budgets
and to mitigate any deviations from such timeframes and Budgets.

 

3.4

Covance reserves the right to refuse to perform any Services including in
relation to the Test Materials deemed by Covance, in its sole discretion, as
hazardous in nature.

 

3.5

Covance does not warrant or represent that the results of the Study will be
acceptable to any regulatory authority or governmental agency to which they are
presented or that the results of the Study will enable Sponsor to further
develop, market or otherwise exploit the Test Materials or any other product or
service.

 

3.6

Each Party is authorized to enter into this Agreement and that its execution,
delivery and performance of this Agreement will not conflict with or constitute
a default under any other agreement to which it is a party or by which its
assets are bound.

 

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4

TERM

 

4.1

This Agreement shall come into force on the Effective Date and shall remain in
force for five (5) years. Thereafter, this Agreement shall renew automatically
for successive one (1) year periods unless a Party provides the other Party with
written notice of its intention not to renew and extend this Agreement, such
notice shall be served at least sixty (60) days prior to the commencement of any
such renewal term.

 

4.2

Each Work Order shall come into force on the last date of execution by the
Parties or such date as specified in the Work Order and shall continue until the
earlier of:

(a) expiry of the period specified in the Work Order (or such extended period as
the Parties may agree in writing); or

(b) completion of Covance’s provision of the Services (excluding archival
obligations and similar ongoing obligations which would survive in accordance
with this Agreement and the respective Work Order) and the Sponsor’s payment of
the relevant fees, pass through costs and other applicable costs and expenses
incurred by Covance in the performance of the Services; or

(c) termination of this Agreement or the Work Order pursuant to Section 21.

 

5

REGULATORY COMPLIANCE

 

5.1

Each Party shall comply in all material respects with all applicable Regulatory
Requirements relevant to the Services and applicable to the location of the
Services to be provided and as may be specified in the respective Work Order or
Protocol/Scientific Plan. In the absence of an agreed Protocol/Scientific Plan
that is applicable to the Services, the Sponsor shall notify Covance of the
intended regulatory use (if any) of the Services and the applicable Regulatory
Requirements to be followed by Covance in performing the Services.

 

5.2

In the event of a conflict in any applicable Regulatory Requirements, the
Sponsor shall designate which regulations shall be followed by Covance in its
performance of the Services and the Sponsor shall be fully responsible and shall
indemnify Covance for the outcome of such a decision. In the event that Covance
cannot perform the Services in a Work Order as directed by the Sponsor under the
Regulatory Requirements or which would place the Parties at risk of a potential
Serious Breach, the Parties shall work together to agree what actions should be
taken to resolve the conflict. If the Parties cannot resolve the conflict,
Covance reserves the right to Delay or terminate any Services potentially at
risk.

 

5.3

If any Regulatory Requirements are changed, upon notification by the Sponsor of
such change, Covance shall use its reasonable commercial efforts to satisfy such
new requirements. In the event that compliance with such new requirements
necessitates a change in this Agreement or a Work Order, the Parties shall agree
in writing on a Change Order prior to performing any new or revised Services.

 

6

PROTOCOL/SCIENTIFIC PLAN

 

6.1

Covance shall, if required and at the Sponsor’s request and expense, consult
with the Sponsor and assist the Sponsor in developing the Protocol/Scientific
Plan and the design of the Services consistent with current Regulatory
Requirements. Notwithstanding such assistance, Covance does not warrant that the
Protocol/Scientific Plan, Study design or Results shall satisfy the requirements
of any Regulatory Authority at the time of submission.

 

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6.2

The Protocol/Scientific Plan shall, to the extent applicable to the Services,
specify the Study design, estimated duration, any Regulatory Authority and the
country or countries to which the Sponsor intends to submit the Results and
other matters pertinent to the completion of the Study or Services. Covance
shall perform the Services for the Sponsor in accordance with such
Protocol/Scientific Plan and the respective Work Order.

 

7

TEST MATERIALS

 

7.1

If applicable to the Services, the Sponsor shall provide Covance with sufficient
amounts of any Test Materials which shall be properly packaged and (except to
the extent that labelling is included within the Services under a Work Order)
labelled in compliance with any Regulatory Requirements. The Sponsor shall also
provide Covance with all applicable, relevant, accurate and duly authorized
Sponsor Information as may be required by Covance to perform the Services, which
relates to the Test Materials, including the purity, stability, batch number,
storage, transportation and safety requirements or other relevant information
known by the Sponsor.

 

7.2

Sponsor must provide Covance with all available information regarding known or
potential hazards associated with the use of any substances supplied to Covance
by Sponsor prior to execution of a Work Order. As an ongoing obligation, Sponsor
will promptly notify Covance of the emergence of information impacting the
safety of Study subjects or which otherwise impacts the toxicity assessment or
risk profile of the Study product.

 

7.3

Sponsor represents and warrants that all necessary approvals required under
Regulatory Requirements will be obtained prior to the shipment of Test
Materials.

 

7.4

Where the nature of the Test Materials requires additional services (including
risk assessment and documentation of genetically modified organisms,
radiolabelled material or material requiring import or export permits), Covance
reserves the right to levy a mutually agreed charge to the Sponsor for such
additional services.

 

7.5

Upon completion of the Services, and unless otherwise agreed in the
Protocol/Scientific Plan, any remaining Test Materials shall, at the Sponsor’s
expense, be destroyed or, upon the Sponsor’s request and expense, returned to
the Sponsor for retention in compliance with applicable Regulatory Requirements.

 

7.6

The Sponsor represents and warrants that the use of any Sponsor Information or
Test Materials by Covance in performing the Services shall not knowingly
infringe the intellectual property rights or breach a party’s confidentiality
obligations to a third party.

 

7.7

Covance expressly disclaims: (a) any responsibility and liability for the
accuracy of the Sponsor Information; and (b) any error or defect in the Services
as a consequence of any inaccuracies in the Sponsor Information, and in each
case Covance disclaims any responsibility and liability for any consequences of
such errors or defects.

 

7.8

Covance makes no representation, warranty or guarantee regarding the value,
prospects, performance, clinical or commercial success of any Test Material
which is the subject of any Services performed by Covance, including the
likelihood of such Test Material reaching any particular phase of development,
obtaining any regulatory approval, or obtaining any level of sales or market
acceptance.

 

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8

FEES AND INVOICES

 

8.1

The Budget and the payment schedule or payment terms for the Services or a Study
shall be detailed in a Work Order. The Budget shall be based on the scope of
work, the fees, estimated pass through costs and the Assumptions which apply to
the Services.

 

8.2

In consideration for the Services provided by Covance under the applicable Work
Order, the Sponsor hereby agrees to pay Covance the fees and actual pass through
costs incurred as specified in the applicable Work Order. Invoices shall be
issued in accordance with the payment schedule or payment terms, in the Work
Order.

 

8.3

The Sponsor shall pay Covance’s invoices within thirty (30) days of the invoice
date. Documentation for out of pocket expenses shall be provided via a summary
report or detailed on the applicable invoice. Detailed expense reports or
back-up documentation including actual expense receipts shall not be provided.
If requested by Sponsor on an exceptional basis with reasonable advance written
notice or as otherwise agreed under an applicable Work Order [*] for up to [*]
per year per project shall be provided by Covance, requests for [*] in excess of
[*] per project per year will be subject to an administrative fee of [*].

 

8.4

If the Sponsor disagrees with the accuracy of an invoice, the Sponsor shall
notify Covance of such inaccuracy within twenty-five (25) days of receipt of the
invoice. Moreover, the Sponsor agrees to pay the amounts for any items not in
dispute and agrees not to unreasonably withhold payment. Payments received after
[*] of receipt of invoice may be subject to interest computed at the rate of
[*].

 

8.5

If the Sponsor requires a purchase order for the payment of Covance invoices,
the Sponsor shall provide the purchase order at the time of returning the signed
Work Order. Failure to provide a purchase order shall not preclude Covance from
issuing an invoice in accordance with the payment schedule or payment terms,
defined in the Work Order for milestones met or work performed and the Sponsor
shall be responsible for payment of all invoices.

 

9

TAXES

 

9.1

The Budget for the Services under this Agreement shall not be construed to
include any Taxes. Such Taxes now known or which may come to be known at a later
time will be assumed by Sponsor without deduction to amounts owed to Covance.

 

9.2

Payments made by the Sponsor to Covance under this Agreement shall be inclusive
of any VAT/GST, where applicable. Where VAT/GST is properly chargeable on the
Services provided under this Agreement and Work Order, the Sponsor shall pay
such amounts of VAT/GST to Covance on receipt of a valid tax invoice issued in
accordance with the laws and regulations of the country in which the VAT/GST is
chargeable.

 

9.3

Where any Test Materials relevant to the Services are imported for the purposes
of the Services under the terms of this Agreement or a Work Order, import duty,
import VAT or other excise duties may be incurred. Where an irrevocable duty is
incurred, Covance shall charge the duty onto the Sponsor as a pass through cost.
Covance and the Sponsor shall work together such that irrevocable costs are
minimized.

 

10

CHANGE ORDER

 

10.1

If any of the Assumptions: (i) are not complied with by the Sponsor; or (ii) are
invalid or incorrect; or (iii) if the Sponsor requests a change or an extension
to the Services; or (iv) if any changes to the Protocol/Scientific Plan arise
either at the request of the Sponsor or as a result of scientific obstacles
identified during the provision of the Services (each a Deviation) then the
Services, Budget and timelines as specified in the corresponding Work Order
shall be modified in accordance with the terms of this Section 10.

 

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10.2

In addition, a Deviation may arise if the Services are Delayed for (i) a Force
Majeure Event; (ii) circumstances not attributable to Covance; or (iii) events
outside Covance’s reasonable control, including the following:

(a) failure of the Sponsor to deliver the Sponsor Information in due time; or

(b) amendments to previously agreed upon Protocol/Scientific Plans, procedures
or documents required for the Services at the request of the Sponsor; or

(c) significant delays in pre-study meetings or in other tasks to be performed
by Covance caused by the Sponsor; or

(d) Delays in obtaining or subsequent withdrawal of regulatory or ethical review
approvals concerning the Services; or

(e) death, incapacity or disability of any third party Investigator or other
research specialist to continue their services in connection with the Services;
or

(f) unforeseen changes in the relevant medical practice or Regulatory
Requirements; or

(g) if applicable, either a higher ratio of drop-outs among Study subjects or a
lower enrollment rate than expected and agreed by Covance and the Sponsor under
the applicable Work Order.

 

10.3

The Parties shall negotiate, in good faith, to agree, in writing, to a change
order setting forth the revised terms for the respective Work Order (a Change
Order) as described below.

 

10.4

Covance shall provide the Sponsor with a written estimate of the consequences
arising from a Deviation. The estimate shall be provided to the Sponsor on a
Change Order form in the form of Exhibit C or other such mutually agreed upon
form by the Parties documenting a Deviation. The Sponsor shall forward to
Covance an executed and approved Change Order or other such mutually agreed upon
form and, upon receipt thereof, Covance shall implement the Deviation.

 

10.5

To the extent reasonably practicable, Covance shall continue to provide the
Services pending approval of the Change Order by the Sponsor. Covance shall not
be obligated to implement all or any part of the changes without an agreement in
writing signed by both Parties. In the event that the Parties cannot agree on
such changes, Covance shall not be obliged to provide non-contracted Services to
the Sponsor under the relevant Work Order. In the event the Parties agree on
such changes and Covance continues to provide services before the execution of
the Change Order, Covance shall invoice the Sponsor for Services rendered.

 

11

SPONSOR VISITS

 

11.1

Sponsor or its representative (which shall not be a competitor of Covance and
which shall be required to be bound by confidentiality and non-use obligations
substantially similar to those contained herein) may visit Covance’s premises
where Services are being performed at reasonable times, on reasonable notice and
with reasonable frequency during normal business hours to observe the progress
of Services. Covance and Sponsor shall cooperate in scheduling such visits.

 

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11.2

Sponsor acknowledges that Sponsor’s representatives granted access to Covance
facilities during any such visits may have access to confidential and
proprietary information of Covance and its clients. Sponsor agrees that all such
confidential and proprietary information of Covance obtained or observed by the
Sponsor or its representatives during such visits shall remain the sole property
of Covance, other third parties or the Sponsor (as applicable). Sponsor agrees
that it and its representatives shall treat such information as Confidential
Information in accordance with Section 14.

 

12

REGULATORY INSPECTIONS AND AUDITS

 

12.1

Except as otherwise provided in the additional terms and conditions of each
Company Affiliate that apply to the services provided by a Company Affiliate
(and any Work Orders thereunder) under Exhibit A, the terms of this section
shall apply to Services provided under this Agreement and any applicable Work
Order.

 

12.2

Covance shall during and up to two (2) years after the term of the Agreement,
permit the Sponsor or its representatives (which shall not be a competitor of
Covance) at reasonable times and on reasonable notice to: (a) audit and examine
Covance’s principal facilities, operations and quality systems and documentation
that are used or that are intended to be used in the performance of the Services
or a Study; and (b) audit and copy the Results, regardless of location. The
provisions of this Section shall also apply to Study sites managed by Covance.

 

12.3

In the event that a Party receives a notice from a Regulatory Authority which
directly relates to the Services or a Study, and where possible and permitted by
the Regulatory Authority, the Party receiving such notice shall promptly forward
to the other Party a copy of such notice (or extract thereof). Each Party shall
cooperate with the other in responding to such notice especially before
referring to the other Party in any regulatory correspondence or disclosing any
Confidential Information to a Regulatory Authority. However, each Party
acknowledges that it may not direct the manner in which the other Party fulfils
its obligations to permit inspection by Regulatory Authorities.

 

12.4

Covance shall cooperate with any inspection or audit by a Regulatory Authority
and shall, except where prohibited by the Regulatory Authority, notify the
Sponsor promptly of any request by a Regulatory Authority to conduct such audit
or inspection relating to the Services that Covance is providing under this
Agreement.

 

12.5

Where possible and permitted by the Regulatory Authority and except where the
Sponsor would be exposed to Confidential Information regarding other sponsor’s
development activities, Covance shall use its reasonable efforts to allow the
Sponsor or its representatives to be present during any such inspection. Where
possible and if acceptable to the inspecting Regulatory Authority, the Sponsor
may attend the inspection and the daily summaries/close-out meetings to discuss
topics related to any Studies where the Sponsor is the sponsor.

 

12.6

Any request by the Sponsor for Covance to provide assistance with an audit
beyond those required to confirm that Covance is in compliance with its
obligations under this Agreement and any relevant Work Orders shall be
considered a separate service for which additional fees shall apply. Covance
shall seek the Sponsor’s written approval to pay any related fees before
performing any additional audit services.

 

13

POTENTIAL FRAUD, MISCONDUCT AND SERIOUS BREACH

 

13.1

Potential Serious Breaches shall be initially assessed through Covance’s issue
escalation process. When a significant and potential regulatory reporting
requirement applicable to the issue is confirmed by Covance, Covance shall
promptly notify the Sponsor in writing.

 

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13.2

Upon notification from Covance of a potential Serious Breach, the Sponsor shall
review the issue and the Parties shall try to agree which Party shall have the
responsibility for informing the relevant Regulatory Authority. Notwithstanding
the foregoing, Covance reserves the right to act in accordance with its ethical
responsibilities and legal obligations. Covance shall provide a copy of any such
correspondence to the Sponsor.

 

14

CONFIDENTIAL INFORMATION

 

14.1

Each Party agrees that all Confidential Information of the Disclosing Party is
and shall be the sole property of the Disclosing Party. Without prejudice to any
Covance Property, all test information, Results, data and records developed by
Covance specifically as a result of performing the Services and related to the
Test Materials or Sponsor Information shall be the Confidential Information of
the Sponsor.

 

14.2

The Receiving Party shall:

(a) hold the Confidential Information of the Disclosing Party in confidence and
in a manner consistent with the way in which it maintains the confidentiality of
its own proprietary information, being at least a reasonable standard of care;
and

(b) disclose the Confidential Information of the Disclosing Party only on a
‘need to know’ basis, to its employees, officers, directors, representatives and
third party Investigators.

 

14.3

The Receiving Party agrees that, except with the Disclosing Party’s written
approval or as necessary to fulfil its obligations under this Agreement or a
Work Order and agreed by the Disclosing Party, it shall not use or disclose to
any other third party any of the Confidential Information of the Disclosing
Party.

 

14.4

The obligations of non-use and non-disclosure shall not apply to Confidential
Information of the Disclosing Party that the Receiving Party can show:

(a) was, or becomes, publicly known through no fault of the Receiving Party;

(b) was lawfully obtained from a third party without restriction as to its use
or disclosure;

(c) was already in the possession of the Receiving Party prior to disclosure; or

(d) was independently developed by the Receiving Party without the benefit of
the Confidential Information of the Disclosing Party.

 

14.5

The Receiving Party shall be entitled to disclose Confidential Information of
the Disclosing Party to the extent required by any law, rule, regulation, order,
decree or subpoena, including the public filing of this Agreement, the Exhibits
and the Work Orders with the Securities Exchange Commission, except that the
Receiving Party shall, unless restricted by law or where not practicable,
promptly notify the Disclosing Party of such requirement prior to the disclosure
and shall cooperate with the Disclosing Party to seek to oppose, minimize or
obtain the confidential treatment of the required disclosure.

 

14.6

The obligations in this Section 14 shall remain in full force and effect for a
period of seven (7) years following disclosure of the relevant Confidential
Information except with respect to Confidential Information which is considered
a trade secret under applicable laws, which shall remain confidential as long as
such Confidential Information retains its status as a trade secret.

 

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15

INTELLECTUAL PROPERTY RIGHTS

 

15.1

All Background IP is and shall remain the exclusive property of the Party owning
it and except as expressly provided in this Agreement, no Party shall acquire
any rights in or to the Background IP of the other Party.

 

15.2

The Sponsor acknowledges that Covance owns or is licensed to use Covance
Property. The Parties agree that any improvement, enhancement or modification
made, conceived or developed by or for Covance to any Covance Property in the
performance of the Services which is not developed as a result of the Services
or a Work Order, or based on the Sponsor’s Confidential Information for the
performance of the Services shall be deemed Covance Property and shall vest
absolutely and exclusively in Covance. In addition, Covance shall be entitled to
use and exploit any skills, techniques or know-how acquired, developed or used
in the course of the Services and a Work Order and not related to the Test
Materials or Sponsor Information.

 

15.3

Strategic insight and proposed project design and scope provided in any
quotation by Covance is and shall remain the property of Covance and may be used
by the Sponsor only to assess whether it wishes to pursue such work with
Covance.

 

15.4

Without prejudice to Sections 15.1 and 15.2, and as to any Deliverable upon
receipt by Covance of payment in full of all amounts due and payable under a
Work Order for such Deliverables, the Sponsor shall have title to the
Deliverables and all intellectual property rights therein. Covance agrees to
assign such rights to the Sponsor except that one (1) copy of any final report
may be retained by Covance for regulatory or legal compliance purposes.
Notwithstanding the foregoing, the Sponsor hereby grants Covance a
non-exclusive, perpetual, irrevocable, royalty-free licence to aggregate and
use, for internal quality, standards and performance measurement, instrument
calibration and method validation purposes, any System Data produced by or for
Covance as part of the Services with other System Data owned or licenced by
Covance, provided that Covance shall not identify such data as belonging to the
Sponsor.

 

15.5

Covance shall disclose to the Sponsor (or its nominee) all Inventions and,
except in relation to Covance Property and at the Sponsor’s request (provided
such request is made within one (1) year of disclosure), Covance shall assign to
the Sponsor or its nominee (as appropriate) the rights to such an Invention. At
the Sponsor’s request and expense, Covance shall do all reasonably necessary
acts to vest the Invention in the name of the Sponsor or its nominee.

 

15.6

Except for any Covance Property owned by a third party, if any Covance Property
is incorporated or included in any Deliverable (Incorporated Covance IP),
Covance grants the Sponsor a royalty-free, perpetual, non-exclusive,
non-transferable, non-sublicensable, world-wide license to use any Incorporated
Covance IP for the sole purposes of and to the extent reasonably necessary to
incorporate or explain any Deliverables (without modification) and for obtaining
regulatory approvals in connection with such Deliverables.

 

16

RECORD RETENTION

Except as otherwise directed by the Sponsor, Covance shall retain all Results
relating to a Study or the Services during the term of the applicable Work
Order. Upon completion or earlier termination of a Study or the Services or
earlier if requested by the Sponsor, the Results for the applicable Study or the
Services shall be delivered to the Sponsor. Covance shall not be required to
return ancillary documents related to the Study Records (including invoices and
other similar records). Notwithstanding the foregoing, Covance shall be
permitted to retain archival copies of such records if and to the extent that
such Results are required to be stored or maintained by Covance pursuant to
Regulatory Requirements or other requirements.

 

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17

LICENSED TECHNOLOGY

 

17.1

If any software including third party software (Software) is made available by
Covance and is used or disclosed to the Sponsor in connection with the Services,
save as permitted by law, the Sponsor agrees not to: (a) modify, copy or create
derivative works based on the Software; (b) reverse engineer, disassemble or
decompile the Software in any manner; (c) resell, sublicense, lease, or
time-share the Software; (d) publish the results of any benchmark tests run on
the Software; and (e) use the Software to build a competitive product or service
or for the purpose of copying its features or user interface.

 

17.2

To the extent that any Confidential Information includes Software that is
licensed to Covance from third parties (such as, for example, licensors of
electronic data capture software), such third parties shall be third-party
beneficiaries of this Section 17 with the right to enforce the limitations
herein, but shall not otherwise have any rights under this Agreement.

 

18

REMEDIES AND LIMIT OF LIABILITY

 

18.1

Except as otherwise provided in the additional terms and conditions of each
Company Affiliate that apply to the services provided by a Company Affiliate
(and any Work Orders thereunder) under Exhibit A, the terms of this section
shall apply to Services provided under this Agreement and any applicable Work
Order.

 

18.2

Covance’s total liability to the Sponsor as to any Work Order or under this
Agreement with respect to such Work Order, whether in contract, tort (including
negligence) or otherwise shall in no circumstances exceed [*].

 

18.3

Nothing in this Agreement excludes or limits the liability of either Party where
liability cannot be excluded or restricted as a matter of law.

 

18.4

In no event shall Covance be liable to the Sponsor for any Loss arising under or
in connection with this Agreement and the Work Order in respect of any: (a) loss
of profit, opportunity, business, saving or goodwill (in each case whether
direct or indirect); or (b) any indirect, consequential punitive, exemplary or
special damages or losses.

 

18.5

Covance shall not be liable for any failure, error or Delay in performing the
Services if such failure, error or Delay is caused by the Sponsor or is a result
of an express instruction from the Sponsor or a change in Sponsor Information.

 

18.6

Except for the representations, warranties, covenants and other obligations set
out in this Agreement and Work Order, all warranties, conditions, terms and
undertakings, express or implied, whether by statute, common law, custom, trade
usage, course of dealings or otherwise (including as to quality,
merchantability, performance or fitness or suitability for purpose) in respect
of any services to be provided by Covance are excluded to the fullest extent
permitted by law.

 

19

INDEMNITIES

 

19.1

Except as otherwise provided in the additional terms and conditions of each
Company Affiliate that apply to the services provided by a Company Affiliate
(and any Work Orders thereunder) under Exhibit A, the terms of this section
shall apply to Services provided under this Agreement and any applicable Work
Order.

 

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19.2

Covance shall indemnify, defend and hold harmless the Sponsor and its respective
officers, directors, employees and agents (the Sponsor Group) from any Loss
resulting from and against any Claim arising from or related to:

(a) a violation of any applicable law, rule or regulation;

(b) a breach of this Agreement or Work Order by Covance; or

(c) the personal injury to a Study participant or personal injury to any
employee within the Sponsor Group or property damage arising or occurring during
the conduct of the Services

 

19.3

that arises as a result of Covance’s negligence or intentional misconduct of
Covance in performing the Services provided that if such Losses or Claims arise
in whole, or in part, from the Sponsor’s Group’s negligence or intentional
misconduct, then the amount of such Losses that Covance shall be responsible for
pursuant to this Section 19.2 shall be reduced by an amount in proportion to the
percentage of the Sponsor’s Group’s responsibilities for such Losses as
determined by a court of competent jurisdiction in a final and non-appealable
decision or in a binding settlement between the Parties. The Sponsor shall
indemnify, defend and hold harmless Covance and its Affiliates and their
respective officers, directors, employees and agents from any Loss resulting
from and against any Claim arising from or related to:

(a) personal injury to a participant in a Study during the conduct of or in
connection with the Services;

(b) the harmful or otherwise unsafe effect of the Test Materials including a
Claim based upon the Sponsor’s or any other person’s use, consumption, sale,
distribution or marketing of such Test Materials;

(c) a violation of any applicable law, rule, regulation or this Agreement or
Work Order by the Sponsor;

(d) the Sponsor’s use of the Results or Deliverables or its use or marketing of
any Test Materials tested by Covance;

(e) the negligence or intentional misconduct of the Sponsor in connection with
the Test Materials, this Agreement, a Work Order or a Protocol/Scientific Plan
related to the Services; or

(f) the infringement, unlawful disclosure or misappropriation of copyright,
patent, trade secret, or other intellectual property of a third party by reason
of Covance’s use of the Sponsor Information or Test Materials in accordance with
the terms of this Agreement,

provided that if such Losses or Claims arise in whole, or in part, from
Covance’s negligence or intentional misconduct, then the amount of such Losses
that the Sponsor shall be responsible for pursuant to this Section 19.3 shall be
reduced by an amount in proportion to the percentage of Covance’s
responsibilities for such Losses as determined by a court of competent
jurisdiction in a final and non-appealable decision or in a binding settlement
between the Parties.

 

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19.4

Sponsor shall indemnify, defend, and hold harmless any third-party electronic
data capture, electrocardiogram, drug supply/depot and interactive
voice-response/interactive response technology Vendors approved by the Sponsor
and under contract with Covance to provide any Services (Ancillary Service
Provider) from any Claims to the extent the Claims arise from or relate to:

(a) the harmful or otherwise unsafe effect of the Test Materials, including a
Claim based upon the Sponsor’s or any other person’s use, consumption, sale,
distribution or marketing of such Test Material, or

(b) the negligence or intentional misconduct of the Sponsor in connection with
the Test Materials, this Agreement, a Work Order or a Protocol/Scientific Plan
related to the Services,

provided that if such Claims arise in whole or in part from such Ancillary
Service Provider’s: (i) negligence or intentional misconduct; (ii) violation of
applicable law, rule or regulation; (iii) breach of its contractual obligations
to the Sponsor or Covance; or (iv) any alleged or actual intellectual property
infringement in the performance of the Services, then the amount of such Claims
that the Sponsor shall be responsible for pursuance to this Section 19.4 shall
be reduced in proportion to the percentage of such Ancillary Service Provider’s
responsibilities for such Claims as determined by a court of competent
jurisdiction in a final and non-appealable decision or in a binding settlement
between the parties. An Ancillary Service Provider shall be an intended
third-party beneficiary of the indemnification provided in this Section 19.4,
but shall not otherwise have any rights under this Agreement.

 

19.5

The Party entitled to indemnification under this Section 19 (the Indemnified
Party) shall promptly give written notice to the other Party (Indemnifying
Party) of a Claim or other circumstances likely to give rise to a request for
indemnification after the Indemnified Party becomes aware of the same. The
Indemnifying Party shall be afforded the opportunity to undertake the defense
of, and to settle by compromise, or otherwise, any Claim for which
indemnification is available under this Section 19.

 

19.6

If the Indemnifying Party assumes the defense of any Claim, the Indemnified
Party may participate in such defense with legal counsel of its selection and at
its expense. If the Indemnifying Party, prior to the expiration of thirty
(30) days after receipt of written notice of the Claim by the Indemnified Party
under this Section 19.5, has not assumed the defense thereof, the Indemnified
Party may thereupon undertake the defense on behalf of, at the risk and expense
of, the Indemnifying Party with all reasonable costs and expenses of such
defense to be paid by the Indemnifying Party.

 

19.7

In the event that the Indemnified Party assumes the defense of any Claim, no
compromise or settlement of any such claim shall be made without the prior
written consent of the Indemnifying Party, which consent shall not be
unreasonably withheld or delayed.

 

19.8

To the extent that Covance has to indemnify the Sponsor Group for Financial
Interest Claims, Covance’s indemnification obligations for such claims shall not
exceed and shall be subject to the limitation of liability terms in Section 18.

 

19.9

Nothing in this Section 19 shall restrict or limit an Indemnified Party’s
general obligation at law to mitigate a loss it may suffer or incur as a result
of an event that may give rise to a Claim under this Section.

 

20

CARRIER LIABILITY

 

20.1

In the event that either: (i) the Sponsor delivers, ships or mails (Transports)
substances, samples, material or documents (Packages) to Covance; (ii) the
Sponsor requests that Covance Transports Packages; or (iii) Covance Transports
Packages as part of the Services to the Sponsor, a Sponsor Affiliate, another
Covance entity or a third party, then the expense and risk of damage (insurance)
and loss of the Packages for such Transport together with any expenses

 

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  required under applicable Regulatory Requirements shall be borne by the
Sponsor; provided however if such damage or loss of the Packages arises as a
direct result of Covance’s negligence or intentional misconduct in the manner in
which the Package was prepared for shipment, or the manner and time in which it
was consigned for shipment, or the way in which the Package was transported by
Covance, then Covance shall bear such damage or loss in proportion to the
percentage of Covance’s responsibility for such damage or loss.

 

20.2

Subject to the foregoing, Covance shall have no liability whatsoever for any
loss or damage to the Packages or delay, non-delivery or non-collection of the
Packages caused by the acts or omissions of any third party delivery services or
carrier (Carrier). Notwithstanding the foregoing, to the extent permitted by
law, Covance shall have the benefit of any right or remedy permitted under
international or domestic law and any sums recovered by Covance from a Carrier
as a consequence of a loss incurred by the Sponsor due to the Carrier’s
involvement with the Services shall be paid to the Sponsor. For the avoidance of
doubt, a Carrier is not considered a Subcontractor for the purposes of this
Agreement.

 

20.3

Unless otherwise agreed in writing between the Parties, any physical
Deliverables to be shipped to the Sponsor shall be to the delivery address
specified in the Work Order. Upon delivery of any physical Deliverables, the
Sponsor shall be responsible for carefully examining such Deliverables. The
Sponsor shall be deemed to have accepted such Deliverables if Covance has not
been notified by the Sponsor within thirty (30) business days of delivery of any
defect in such Deliverables.

 

21

TERMINATION

 

21.1

On termination of this Agreement, howsoever arising, each Work Order then in
force at the date of such termination shall nevertheless continue in full force
and effect for the remainder of the term of such Work Order, unless expressly
terminated in accordance with this Section 21. Termination of any Work Order
shall not affect any other Work Order or this Agreement.

 

21.2

A Party may terminate a Work Order prior to completion of the applicable
Services at any time for any reason upon ninety (90) days written notice to the
other Party, except when the reason for termination is the safety of Study
participants, whereupon it may be terminated immediately. Covance shall use
reasonable efforts to conclude or transfer the Study as expeditiously as
practicable and in accordance with all applicable Regulatory Requirements.
Covance and the Sponsor shall cooperate with each other during such termination
to safeguard patient safety, continuity of patient treatment and to comply with
all applicable Regulatory Requirements.

 

21.3

To the extent permitted by law, either Party may terminate this Agreement and
all relevant Work Orders with immediate effect by notice in writing to the other
Party if:

(a) the other Party commits a material breach of any term of this Agreement
which breach is irremediable or (if such breach is remediable) fails to remedy
that breach within a period of forty-five (45) days after being notified in
writing to do so; or

(b) the other Party repeatedly breaches any of the terms of this Agreement in
such a manner as to reasonably justify the opinion that its conduct is
inconsistent with it having the intention or ability to give effect to the terms
of this Agreement; or

(c) the other Party suspends, or threatens to suspend, payment of its debts or
is unable to pay its debts as they fall due or admits inability to pay its debts
or is deemed unable to pay its debts; or the other Party suspends, or threatens
to suspend, or ceases or threatens to cease to carry on, all or substantially
the whole of its business; or

 

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(d) the other Party presents a petition or has a petition presented for its
winding-up or has a receiver or an administrative receiver appointed of all or
any part of its assets or undertaking or if a notice of intention to appoint an
administrator is served in respect of it or calls a meeting of, or enters into
any composition or arrangement with, its creditors; or

(e) the financial position of either Party deteriorates to such an extent that
in the other Party’s reasonable opinion a Party’s capability to adequately
fulfil its obligations under the Agreement has been placed in jeopardy; or

(f) any event occurs, or proceeding is taken, in any jurisdiction to which it is
subject that has an effect equivalent or similar to any of the events mentioned
above.

 

21.4

Termination of this Agreement, or Work Order, shall not relieve either Party of
their obligations to the other in respect of:

 

  (a)

maintaining the confidentiality of the Confidential Information;

 

  (b)

assignment of Inventions and assistance with respect thereto;

 

  (c)

obtaining consents for the use of names;

 

  (d)

indemnification;

 

  (e)

limitation of liability;

 

  (f)

compensation for the Services performed;

 

  (g)

retention of records;

 

  (h)

reimbursement and payment for legal proceedings;

 

  (i)

non-solicitation of employees.

The provisions of this Section together with and any other section which is
necessary for the interpretation or enforcement of this Agreement shall survive
the expiry or termination of this Agreement howsoever arising.

 

22

CONSEQUENCES OF DELAY, CANCELLATION OR TERMINATION

 

22.1

Except as otherwise provided in the additional terms and conditions of each
Company Affiliate that apply to the services provided by a Company Affiliate
(and any Work Orders thereunder) under Exhibit A, the terms of this section
shall apply to Services provided under this Agreement and any applicable Work
Order.

 

22.2

If the scheduled start up of the Services are Delayed due to: (i) delay by the
Sponsor (e.g. due to non-delivery of Test Materials or any Sponsor Information
required to begin or perform the Services); (ii) delay in any approval by a
Regulatory Authority or IEC/IRB; (iii) at the request of the Sponsor; or
(iv) any other reason outside the reasonable control of Covance, Covance shall
be entitled to full payment for:

(a) all work properly performed by Covance for the Services up to the
notification of Delay;

(b) all pass through costs related directly to the Services and incurred up to
the notification of Delay;

(c) all other non-cancellable actual, non-refundable or irrevocably incurred
expenses and financial obligations that Covance has incurred or undertaken in
support of the Delayed Services or as a consequence of the Delay (e.g. the cost
of staff members allocated to a Study which is Delayed who are not re-assigned
to other work during the period of the Delay and regulatory expenses); and

 

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(d) any additional fees listed in the relevant Exhibit A or Work Order as a
consequence of the Delay.

 

22.3

In the event that the Services are cancelled or terminated in accordance with
Sections 21.2 or 21.3, Covance shall be entitled to full payment for:

(a) all work properly performed by Covance for the Services up to the effective
date of cancellation or termination regardless of the achievement of any
milestones used as payment triggers (including any agreed wind down costs);

(b) all pass through costs related directly to the Services and incurred up to
the effective date of cancellation or termination;

(c) all other non-cancellable actual, non-refundable or irrevocably incurred
expenses and financial obligations that Covance has incurred or undertaken on
the Sponsor’s behalf up to the effective date of cancellation or termination;
and

(d) any additional termination for convenience fees listed in the relevant
Exhibit A or Work Order.

 

23

INSURANCE

Each Party shall secure and maintain in full force and effect through the
performance of the Services the necessary insurance coverage in amounts
appropriate to the conduct of its business. Certificates evidencing such
insurance shall be made available for examination upon written request by the
Sponsor or Covance. The additional insurance requirements that may apply to any
specific Services are detailed in the relevant Exhibit A.

 

24

SAMPLE RETENTION

 

24.1

Subject to Section 24.2 and any provisions in Exhibit A, all Samples associated
with the Services shall be retained, returned to the Sponsor or disposed of
(including destruction) in accordance with the Work Order, Protocol/Scientific
Plan or the Sponsor’s reasonable written instructions and applicable Regulatory
Requirements. Where no provision is made in the Work Order or
Protocol/Scientific Plan, the Sponsor shall be contacted to determine whether
the Samples should be destroyed, returned to the Sponsor or retained by Covance
subject to agreement of the Parties on the time period and fees payable for
retention.

 

24.2

Regulatory samples obtained from drug substance or drug product shall be
retained and disposed of in accordance with the Protocol/Scientific Plan.
Samples obtained from clinical trials and HBS shall be retained and disposed of
in accordance with the provisions of Section 25 of this Agreement.

 

25

HUMAN BIOLOGICAL SAMPLES

 

25.1

Where Covance is performing Services that includes monitoring activities of a
Study on behalf of the Sponsor at investigative sites, Covance shall:

(a) verify that the HBS Donor has given Informed Consent;

(b) confirm that any HBS and associated data are managed in full compliance with
any and all applicable national laws, regulations, or codes of practice
(including any submissions, approvals and registrations to any applicable
Regulatory Authority) relating to the Use of HBS providing protection for human
subjects in the country of origin;

 

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(c) use its reasonable efforts to ensure that any HBS shall be de-identified or
‘coded’ according to applicable Regulatory Requirements to protect the identity
and confidentiality of the HBS Donor; and

(d) in the event of a withdrawal of or a material variation to the Informed
Consent, promptly notify all relevant parties of such withdrawal or variation.

 

25.2

In all other circumstances, where the Sponsor or third parties for which the
Sponsor is responsible supply HBS to Covance in connection with the Services,
the Sponsor represents and warrants that:

(a) all HBS supplied in connection with the Services under this Agreement and
any relevant Work Order are or have been procured and supplied to Covance
ethically in full compliance with any and all applicable national laws,
regulations, or codes of practice (including any submissions, approvals and
registrations to any applicable Regulatory Authority) relating to the Use of HBS
providing protection for human subjects in the country of origin;

(b) the HBS Donor has given Informed Consent;

(c) all HBS shall be de-identified or ‘coded’ according to applicable Regulatory
Requirements to protect the identity and confidentiality of the HBS Donor and
shall be supplied to Covance without any information or data that could allow
Covance to personally identify the HBS Donor under applicable Data Protection
Laws and other applicable Regulatory Requirements;

(d) all HBS supplied to Covance (i) may be Used for the Services; (ii) may be
used to provide data in support of commercial product development by Sponsor;
and (iii) were procured without inappropriate financial benefit to the HBS
Donor; and

(e) in the event of a withdrawal of, or a material variation to the Informed
Consent (including any material changes that may affect the Services), it shall
promptly notify Covance and any other relevant parties of such changes or
withdrawal.

 

25.3

The Sponsor shall: (a) upon request, provide a copy of the relevant Informed
Consent template; and (b) upon request, provide a copy of the relevant documents
certifying that the HBS provided to Covance has completed the necessary
submissions, approvals and registrations required to be made to any applicable
Regulatory Authority. The Sponsor agrees that full date of birth shall only be
collected if medically relevant to the Services (unless legally restricted in
the country of operation).

 

25.4

Covance agrees to use the HBS in accordance with all applicable laws,
regulations and codes of practice. Covance shall not use the HBS, even on a
de-identified or coded basis for any purpose other than in accordance with the
signed Informed Consent form.

 

25.5

Upon the Sponsor’s request, Covance shall retain, return or dispose of all HBS
in accordance with the Informed Consent, the Sponsor’s reasonable instructions
or any other specific requirements under applicable national law.

 

25.6

The Sponsor acknowledges that where Covance enters into a material transfer
agreement (MTA) with the provider of any HBS, Covance shall act in accordance
with the terms of the MTA and the disposition of the relevant HBS shall be as
prescribed in the MTA. In the event of a conflict between the terms of the MTA,
this Agreement, any Work Order and any instructions provided by the Sponsor, the
terms of the MTA shall prevail.

 

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26

DATA PROTECTION

 

26.1

Where Covance processes any Personal Data on behalf of the Sponsor, Covance
shall process such Personal Data in accordance with all applicable Data
Protection Laws in the territories in which the Services are performed
(Protected Data).

 

26.2

If Covance processes any Protected Data on behalf of the Sponsor, Covance and
the Sponsor each agree and acknowledge that the Sponsor shall be the data
controller and Covance shall be the data processor with respect to the
processing of such Protected Data. Covance shall only process such Protected
Data on behalf and upon the reasonable instructions of the Sponsor for purposes
notified to it by the Sponsor for which consent from the relevant data subjects
has been obtained in accordance with all applicable Regulatory Requirements.
Covance shall follow such procedures, policies and reasonable instructions as
may be agreed by the Parties from time to time.

 

26.3

Covance shall take reasonable technical and organizational measures that are
necessary to protect against the unauthorized or unlawful processing of or the
unauthorized or unlawful disclosure of such personal data. Covance shall
promptly notify the Sponsor in the event of a security breach involving any
personal data which Covance is processing on behalf of the Sponsor.

 

26.4

The Sponsor warrants that it has complied with any and all notification and
information requirements under the applicable Data Protection Laws.

 

27

SUBCONTRACTORS AND VENDORS

 

27.1

Notwithstanding Section 33.2, certain tasks other than data processing tasks
specified in the Work Order or Protocol/Scientific Plan may be subcontracted by
Covance to its Affiliates or Subcontractors. Covance shall be responsible for
the performance of Subcontractors contracted by Covance for services within the
scope of this Agreement.

 

27.2

Covance shall diligently identify, vet, engage, manage and monitor the
performance of Vendors, but shall not otherwise be responsible for performance
by Vendors that are not Subcontractors. The liability of Covance to the Sponsor
with respect to Vendors shall be limited to the extent Covance defaults in the
performance of its obligations under this Agreement or a Work Order. At the
reasonable request of Sponsor Covance shall pursue on Sponsor’s behalf and at
Sponsor’s expense any claims that Sponsor or Covance may have against Vendors as
a consequence of a loss incurred by Sponsor as a result of any error or service
failure on the part of such Vendors in connection with this Agreement or any
Services under a Work Order, and Covance shall pay over to Sponsor any amounts
that Covance may recover from such Vendors on account thereof.

 

27.3

For the avoidance of doubt, the Parties acknowledge and agree that third party
Investigators shall not be considered Subcontractors of Covance. All third party
Investigators shall exercise their own independent medical judgement and shall
be considered independent contractors and shall not be deemed employees,
subcontractors or agents of Covance. Covance’s responsibilities with respect to
third party Investigators shall be limited to those responsibilities
specifically set forth in the Agreement and the applicable Work Order.

 

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28

FORCE MAJEURE

 

28.1

No Party shall be in breach of this Agreement or Work Order nor liable for delay
in performing, or failure to perform, any of its obligations under this
Agreement or Work Order as appropriate, if such delay or failure results from a
Force Majeure Event. In such circumstances, any time specified for completion of
performance in the Work Order or Protocol/Scientific Plan falling due during or
subsequent to the occurrence of a Force Majeure Event shall be automatically
extended for a period of time equal to such event. The Party whose performance
is delayed by Force Majeure shall use commercially reasonable efforts to
mitigate any delays cause by the Force Majeure Event. Covance shall promptly
notify the Sponsor if, by reason of a Force Majeure Event, Covance is unable to
meet any critical timelines or critical deliverables specified in any Work
Order.

 

28.2

Should any part of the Services be rendered invalid as a result of a Force
Majeure Event, Covance shall, upon written request from the Sponsor, and at the
Sponsor’s sole cost and expense, repeat the affected part of the Services.

 

29

NOTICES

 

29.1

Except for the purposes of any legal notice or proceedings, which shall not
include email or fax, all communications and notices required under this
Agreement shall be in writing and deemed to be given if delivered personally, or
mailed by overnight delivery or first class mail, postage prepaid, to the
addresses set forth below, or via electronic mail or fax with hard copy
confirmation, or to such other addresses as the Parties from time to time
specify in writing.

 

29.2

Notices shall be treated as having been given upon delivery if delivered by hand
or by commercial courier at the time of signature of receipt; if sent by prepaid
first class mail or recorded delivery three (3) days from the date of posting;
and if by airmail seven (7) days from the date of posting.

 

29.3

Notice shall be given to the parties at the addresses listed below or at such
other place as a Party shall nominate:

 

  (a)

If to Sponsor to:

Galectin Therapeutics, Inc.

4960 Peachtree Industrial Boulevard, Suite 240

Norcross, Georgia 30071, Unites States

Attention: Chief Executive Officer

 

  (b)

If to Covance, the address set forth in the Notice Section of any relevant
Exhibit A, with a copy to Covance Inc. at the following address:

Covance Inc.

3147 S. 17th Street, Suite 300 Wilmington, NC 28412

United States

Attention: General Counsel

 

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30

PUBLICITY AND PUBLICATION

Neither Party shall (a) use the name, trademark or the name of any
representative of the other, or the existence of this Agreement for any
promotional or advertising purposes, or any other publication, without the prior
written consent of the other Party; or (b) state or imply that the other Party
endorses or approves any service, material, product or compound of the other
Party without the prior written consent of the other Party. Such restrictions
shall not apply to internal communications and publications to a Party’s
Affiliates or to communications or publications that are required for Sponsor to
comply with US Securities laws.

 

31

PERSONNEL

 

31.1

Except as provided in Section 31.2, neither Party shall solicit or otherwise
encourage any personnel or employees of the other Party with whom it has contact
pursuant to this Agreement to seek employment with a Party throughout the course
of the Agreement and for a period of twelve (12) months thereafter.

 

31.2

Section 31.1 shall not apply in the event: (i) the potential recruiting Party
has consulted with the other Party and obtained permission to solicit such
employee; (ii) an employee of a Party seeks employment with the other Party in
response to an unsolicited response to a general advertisement or recruiting
effort not directed at such employee or Party; or (iii) an employee of either
Party who is terminated or otherwise released from employment by Party or its
Affiliates.

 

31.3

The Services with respect to each Work Order shall be performed by Covance under
the direction of the person identified as the operational lead in the applicable
Work Order or other Services relevant documentation. Where reasonably
practicable, Covance shall retain the operational lead for a Study in place
during the term of the applicable Work Order unless Sponsor requests a change in
writing. In the event that a change in the operational lead occurs, then Covance
will discuss and make available to Sponsor qualified candidates to fill the role
of the operational lead and will consult with the Sponsor about such
replacement. After such consultation and review, Sponsor’s acceptance and
approval of the replacement operational lead shall not be unreasonably withheld
or delayed.

 

32

COMPLIANCE

 

32.1

Debarment. Covance represents and warrants that to its knowledge it does not use
and shall not use in any capacity the services of any person debarred under
subsections §306(A) or §306(B) of the U.S. Generic Drug Enforcement Act 1992,
disqualified as a testing facility under 21 CFR Part 58 Subpart K. or
disqualified, restricted or having made assurances as a clinical investigator
under 21 CFR §312.70 or otherwise debarred, restricted or disqualified under the
corresponding laws of an applicable jurisdiction in connection with any of the
Services performed under this Agreement. Covance shall promptly disclose in
writing to the Sponsor if it becomes aware that any: (a) person who is
performing the Services is debarred, disqualified or restricted; or (b) action,
suit, claim, investigation or legal or administrative proceeding is pending
relating to the debarment, disqualification, restriction of Covance or any
person performing Services under this Agreement.

 

32.2

Anti-Bribery. Each Party agrees that it has not and shall not, either directly
or indirectly, engage in the following conduct: bribery or offer, promise,
authorize to pay, or make any improper payment of any monies or financial or
other advantage, including cash, loan, gift, travel, entertainment, hospitality,
facilitation payment, kickback, political or philanthropic contribution,
anything of value, or any other perceived benefit to improperly obtain or retain
a business advantage in violation of any Anti-Corruption Laws and further, each
Party agrees that it shall not take any action that would cause the other Party
to be in violation of such Anti-Corruption Laws.

 

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32.3

Trade Control. Notwithstanding any other provision of this Agreement to the
contrary, each Party shall comply with, and retain responsibility for its
compliance with, all applicable export control laws (e.g., the U.S. Export
Administration Regulations) and economic sanctions programs (e.g., economic
sanctions maintained by the U.S. Treasury Department, as well as Specially
Designated Nationals and Blocked Persons (SDNs)) relating to its respective
business, facilities, and the provision of services to third parties
(collectively, Trade Control Laws). It shall be in the sole discretion of
Covance to refrain from being directly or indirectly involved in the provision
of goods, software, services and/or technical data that may be prohibited by
applicable Trade Control Laws, including sanctions currently in place against
Cuba, Iran, North Korea, Sudan, Syria and SDNs.

 

33

GENERAL

 

33.1

Independent Contractor. It is understood and agreed that Covance shall perform
its duties as an independent contractor and not as an agent, employee, partner
or joint venture of the Sponsor. Neither Party shall have the authority to bind
or commit the other Party in any manner whatsoever and shall not, at any time,
hold itself out to third parties as having authority to enter into or incur any
commitments, expenses, liabilities or obligations of any nature on behalf of the
other party except as permitted in this Agreement, a Work Order, or other
document expressly providing such authority.

 

33.2

Assignment. Each Party may transfer or subcontract any or all of its rights and
obligations under this Agreement or a Work Order to its Affiliates. The
assigning Party shall continue to remain liable for any accrued obligations
under this Agreement or a Work Order prior to such assignment. Notwithstanding
the foregoing and except in connection with an internal reorganization of a
Party’s corporate structure or in connection with a merger or sale of
substantially all of the assets of a Party, this Agreement shall not be assigned
in whole or in part by either Party without the prior written consent of the
other Party, which consent shall not be unreasonably withheld or delayed.

 

33.3

Waiver. A waiver of any term, provision or condition of this Agreement or Work
Order shall be effective only if it is in writing and no waiver, in any one or
more instances, shall be deemed to be or construed as a further or continuing
waiver or estoppel of any such term, provision or condition or any other term of
this Agreement or a Work Order. No failure or delay by either Party in
exercising any right or remedy under this Agreement shall constitute a waiver of
such right, nor shall it prevent or restrict its further exercise. The Parties
acknowledge and agree that they have not relied upon any representations made
before contract in deciding to enter into this Agreement and the Parties waive
all and any right to pursue any claim for misrepresentation except for
fraudulent misrepresentation.

 

33.4

Variation. No provision of this Agreement or Work Order may be amended,
modified, varied, discharged or terminated except by the express written
agreement signed by an authorized representative of each of the Parties.

 

33.5

Severability. If any court or competent authority finds that any provision of
this Agreement (or part of any provision) is invalid, illegal or unenforceable,
that provision or part-provision shall, to the extent required, be deemed to be
deleted, and the validity and enforceability of the other provisions of this
Agreement shall not be affected. If any invalid, unenforceable or illegal
provision of this Agreement would be valid, enforceable and legal if some part
of it were deleted, the provision shall apply with the minimum modification
necessary to make it legal, valid and enforceable.

 

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33.6

Entire Agreement. This MSA together with the Exhibits and Work Order sets forth
the entire agreement between the Parties with respect to the performance of the
Services and as such, supersedes all prior and contemporaneous negotiations,
agreements, representations, understandings, and commitments with respect
thereto and shall take precedence over all terms, conditions, and provisions on
any purchase order or other form of other acknowledgment or order release
purporting to address the same subject matter; except that any agreement entered
into prior to the Effective Date with respect to any Services that are being
performed before the Effective Date shall remain effective and shall continue to
govern such existing Services.

 

33.7

Legal Testimony. If Covance is obliged to provide testimony or records regarding
the Services for the Sponsor in any legal or administrative proceeding other
than testimony or records related to any alleged improper performance by Covance
of its obligations under this Agreement or a Work Order, then the Sponsor shall
reimburse Covance for its out of pocket costs plus a reasonable hourly fee for
the involvement of its employees or representatives in such proceedings equal to
the internal fully burdened cost of such employees or representatives.

 

33.8

Third Party Rights. Except as expressly set forth in this Agreement in respect
of Covance Affiliates and Sections 17 and 19.3, nothing in this Agreement is
intended to confer any rights, benefits or remedies of any kind whatsoever, and
a person who is not a Party to this Agreement shall have no right to enforce any
of its terms.

 

33.9

Counterparts. This Agreement may be executed in any number of counterparts, each
of which when executed and delivered shall constitute an original to this
Agreement but all of which together shall constitute the same Agreement.

 

33.10

Dispute Resolution. It is the intention of the Parties that in the event
disputes should arise over the interpretation and application of this Agreement,
the Parties shall first attempt to settle such disputes by negotiation and
consultation between the senior executives of the Sponsor and Covance and other
parties familiar with this Agreement, any Work Order or Protocol/Scientific
Plan. To the extent permitted by law, and except for any indemnity claim under
Section 19, no claim or action arising out of or relating to this Agreement or
any Work Order may be brought by a Party more than three (3) years after the
termination of this Agreement, or an applicable Work Order, whichever is longer.

 

33.11

Law. All matters affecting the interpretation, validity and performance of this
Agreement shall be governed by the laws of Delaware, without regard or giving
effect to its principles of conflicts of law and, if applicable, with the
express exclusion of the United Nations Convention on the International Sale of
Goods.

 

33.12

Jurisdiction. The Parties irrevocably agree that any dispute or claim arising
out of or in connection with this Agreement or its subject matter or formation
(including non-contractual disputes or claims) shall be governed by the
exclusive jurisdiction of the courts of State of Delaware.

Signed by the Parties or their duly authorized officers on the dates set forth
below, to be effective on the date set forth on the first page of this
Agreement.

 

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Galectin Therapeutics Inc.     Covance Inc. Signature     /s/ Harold Shlevin    
Signature     /s/ Pam Saker Name:   Harold Shlevin     Name:   Pam Saker Title:
  CEO     Title:   Director, Contract Management Date:   March 12, 2020    
Date:   March 12, 2020

 

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EXHIBIT A-1 – ADDITIONAL TERMS & CONDITIONS FOR THE PROVISION OF EARLY
DEVELOPMENT SERVICES

WHEREAS

 

(A)

GALECTIN THERAPEUTICS INC. (the Sponsor) and COVANCE INC. (the Company) are
parties to a Master Services Agreement effective as of March 12, 2020 (the MSA).

 

(B)

COVANCE LABORATORIES INC. with its principal address of 3301 Kinsman Blvd,
Madison, Wisconsin 53704, USA, together with its Named Affiliates (as defined
below), (collectively “CL-ED”) shall be considered parties to the MSA for the
Services provided under this Exhibit A-1.

 

(C)

This Exhibit A-1 to the MSA is for the provision of early development services
to the Sponsor by CL-ED.

NOW THEREFORE the Parties agree as follows:

 

1.

Definitions

 

1.1

Each capitalized term used in this Exhibit A-1, but not defined, has the meaning
specified in the MSA unless a clear contrary interpretation otherwise applies.

 

1.2

For the purposes of this Exhibit A-1, the following definitions shall apply:

“Inspection Cycle” means the time period between inspections by Regulatory
Authorities (if applicable) which shall be at least annually but will vary
between Covance sites and according to applicable Regulatory Requirements.

“Named Affiliates” mean Covance Bioanalytical Services LLC, with its address of
8211 SciCor Drive, Suite B, Indianapolis, Indiana, 46214, USA; Covance
Laboratories Limited with its registered office at Otley Road, Harrogate, North
Yorkshire, HG3 1PY UK, and Covance Preclinical Services GmbH, with its
registered office at Kesselfeld 29, DE48163, Muenster, Germany.

 

2.

Protocol/Scientific Plan

 

2.1

In the absence of a Protocol/Scientific Plan agreed to by the Parties, the
Sponsor shall notify CL-ED of the intended regulatory use (if any) of the Study
and the applicable Regulatory Requirements to be followed by CL-ED.
Notwithstanding any assistance provided by CL-ED in the development of the
Protocol/Scientific Plan, CL-ED does not warrant that such Protocol/Scientific
Plan sill satisfy the requirements of any Regulatory Authority at the time of
submission.

 

2.2

Where applicable to the Services, the Sponsor and CL-ED shall agree to a quality
agreement detailing the technical and regulatory matters associated with the
provision of a Study (Quality Agreement). If there is any inconsistency between
the MSA, this Exhibit A-1 and the Quality Agreement, the Quality Agreement shall
prevail for quality and relevant regulatory matters.

 

3.

Form of Contract

Upon receipt of the Sponsor’s request for Services, Covance shall provide a
written quotation pursuant to and referencing this Agreement. Upon signature by
both Parties, a binding contract shall be formed and the document shall become
the Work Order for the purposes of this Agreement, and for the purposes of
Services provided by CL-ED, Exhibit B of this Agreement shall not apply.

 

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4.

Study Performance, Materials and Resources

The Sponsor shall provide CL-ED with any relevant occupational safety
information known by the Sponsor, including a safety data sheet (SDS) and, if
applicable, a certificate of analysis for the Test Materials. The SDS must
conform to globally accepted standards for the applicable Test Materials of the
Global Harmonization Standard.

 

5.

Deliverables

 

5.1

All reports shall be prepared in a CL-ED standard format unless otherwise agreed
upon by the Parties.

 

5.2

In the event that six (6) months from the date of the audited draft report (the
Draft Report), CL-ED has received neither requested revisions nor instructions
to finalise the Draft Report, CL-ED reserves the right to consider the Draft
Report as “final” and issue it as the complete, approved output of the Study
(the Final Report). The Final Report shall be signed by CL-ED and submitted to
the Sponsor. Any modification or changes to the Final Report shall be performed
at additional cost to the Sponsor. Where required by law or regulation, the
Sponsor shall provide a copy of each Draft Report to CL-ED submitted to a
regulatory authority within thirty (30) days of the submission.

 

5.3

The nature of the Services is experimental, and any timelines or quantities
shown in the Work Order or Protocol/Scientific Plan are estimates only.

 

6.

Raw Data and Sample Retention

 

6.1

All experimental data arising from the specific performance of the Services
including tissues, blocks, slides, records, original laboratory accounts of the
work performed and authorised documents, but excluding Samples and Test
Materials (Raw Data) shall, unless otherwise agreed in the Work Order or
Protocol/Scientific Plan be retained by CL-ED for one (1) Inspection Cycle from
the date of the Final Report.

 

6.2

In the event that Raw Data is returned to the Sponsor within the Inspection
Cycle, the Sponsor agrees that should the Raw Data be required by a Regulatory
Authority conducting an inspection of CL-ED facilities, the Raw Data shall be
immediately returned to CL-ED at the Sponsor’s cost.

 

6.3

Subject to Section 24 of the MSA, all Samples associated with the Services shall
be retained, returned or destroyed in accordance with the Sponsor’s
instructions. Where no instructions are received, after ninety (90) days
following submission of the first Draft Report the Samples shall be retained by
Covance and invoiced to the Sponsor. In the event that invoices are unpaid and
no instructions are received, Covance reserves the right to dispose of the
Samples

 

6.4

If the Sponsor instructs CL-ED to retain any Samples or Raw Data beyond the
agreed retention period, CL-ED shall levy a charge on the Sponsor based on the
amount and type of materials to be retained. Any Raw Data or samples not
required to be retained shall, at the Sponsor’s cost and expense, either be
returned to the Sponsor or destroyed. The Sponsor shall be responsible for any
regulatory implications of the fate of the Samples or Raw Data.

 

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6.5

CL-ED reserves the right to levy a charge for the handling, tracking, and
storage of any Samples received which are ultimately not required by the Sponsor
to be analysed as part of the Services.

 

7.

Fees and Invoices

 

7.1

Any amount shown in the Work Order in respect of a Final Report shall become due
and payable if CL-ED has not received any comments from the Sponsor forty-five
(45) days after delivery of the Draft Report.

 

7.2

For a Study with a stated duration of more than twelve (12) months, CL-ED
reserves the right to adjust prices annually based on the CPI rates published by
the Organisation for Economic Co-operation (OECD) upon thirty (30) days prior
written notice to the Sponsor. CL-ED reserves the right to adjust prices for
Services if the initiation of the work is delayed by more than six (6) months
beyond the original estimated start date as at the date of the Work Order.

 

8.

Additional Fees for Delay or Termination for Convenience

 

8.1

In the event that the Study is Delayed for any reason as set out in Section 22.1
of the MSA, the fees listed in the table below shall be levied to the Sponsor in
addition to the amounts due under [*].

 

Notice Period

   Study Type     Charge Incurred  

[*]

     [ *]      [ *]       [ *]      [ *] 

[*]

     [ *]      [ *]       [ *]      [ *] 

[*]

     [ *]      [ *]       [ *]      [ *]       [ *]      [ *]       [ *]      [
*] 

 

*

Values shown are in USD. Where the fees are in any other currency, the
appropriate delay fee shall be applied based on the average New York or London
spot rate for the year.

 

8.2

The Sponsor may terminate a Work Order by giving written notice of such
termination to CL-ED in accordance with Section 21.2 of the MSA. In the event
the Sponsor terminates a Work Order prior to completion of the Study, the fees
listed in the table below shall be levied to the Sponsor in addition to the
amounts due under Section 22.2 of the MSA:

 

Notice Period

   Charges Incurred     Administrative Fee  

[*]

     [ *]      [ *] 

[*]

     [ *]      [ *] 

[*]

     [ *]      [ *] 

[*]

     [ *]      [ *] 

 

8.3

Following a Delay of a Study, if the Sponsor agrees to a revised start date at
the convenience of CL-ED, the number of weeks used to calculate the additional
fees payable by the Sponsor pursuant to this Paragraph 7 shall be reduced by one
(1) week for every two (2) weeks of flexibility that the Sponsor is willing to
move the revised start date.

 

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9.

Payment Terms

The following payment schedule shall be followed for all Work Orders between the
Sponsor [*].

 

    

Study Type

  

Payment Schedule

[*]

   [*]    [*]    [*]    [*]

[*]

   [*]    [*]

[*]

   [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]

 

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10.

Notices

All notices to CL-ED shall be sent to: Covance Laboratories Ltd., Otley Road,
Harrogate, North Yorkshire, HG3 1PY, UK; Attention: Contracts Lead, Early
Development.

SIGNED by an authorised signatory for and on behalf of:

 

Galectin Therapeutics Inc.     Covance Laboratories Inc. By:         By:    
Date:         Date:                Covance Inc.       By:           Date:    

 

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EXHIBIT A-2 – ADDITIONAL TERMS AND CONDITIONS FOR THE PROVISION OF CLINICAL
RESEARCH SERVICES IN CLINICAL TRIAL SUBJECTS

WHEREAS

 

(A)

GALECTIN THERAPEUTICS INC. (the Sponsor) and Covance Inc. (the Company or
Covance Clinical) are parties to a Master Services Agreement effective as of
March 12, 2020 (the MSA).

 

(B)

This Exhibit A-2 to the MSA is for the provision of clinical research services
in patients to the Sponsor by Covance Clinical.

NOW THEREFORE the Parties agree as follows:

 

1.

Definitions

 

1.1.

Each capitalized term used in this Exhibit A-2, but not defined, has the meaning
specified in the MSA unless a clear contrary interpretation otherwise applies.

 

2.

Transfer of Obligations

 

2.1.

Covance Clinical acknowledges and agrees that the responsibility for Services
performed as set forth under the applicable Work Order are being transferred to
Covance Clinical in accordance with 21 CFR §312.52, EU Clinical Trial Directive
(2001/20/EC), International Conference on Harmonization of GCP E6 (R2) (ICH GCP)
or any other applicable regulations. The Sponsor shall at all times be
considered the “Sponsor” of the Study pursuant to the terms of the Federal Food,
Drug, and Cosmetic Act (as amended), the regulations of the US FDA (as
promulgated in 21 CFR), and the regulations of the US FDA (as promulgated in 21
CFR) or any other applicable national regulations and ICH GCP. The obligations
transferred should be included in Form FDA 1571, Section #14, the EudraCT form
or an equivalent in the country in which the Services are being performed
(Transfer of Obligations Form).

 

2.2.

The Parties acknowledge and agree that although Covance Clinical may recommend
investigative sites be closed (for example due to site non-performance), the
Sponsor shall retain responsibility for formally approving the closing of such
investigative sites.

 

2.3.

For any Change Order that affects the scope of the regulatory obligations that
have been transferred to Covance Clinical, the Sponsor and Covance Clinical
shall execute a corresponding amendment to any Transfer of Obligations Form. The
Sponsor shall file such amendment where appropriate or as required by any
applicable Regulatory Requirements.

 

3.

Insurance

 

3.1.

The Sponsor hereby represents and warrants that it maintains adequate clinical
trial and product liability insurance coverage consistent with industry
standards through a reputable insurance carrier and in compliance with all
applicable Regulatory Requirements with minimum coverage of ten million US
dollars (US $10,000,000) per occurrence. The Sponsor further represents and
warrants that such insurance policies shall not contains any additional
exclusions clauses not normally found in insurance of such type that might limit
and would not extend to the clinical trial for which the Services are being
provided. Covance Clinical hereby represents and warrants that it maintains
adequate general liability and errors and omissions / professional liability
insurance coverage consistent with industry standards through a reputable
insurance carrier and in compliance with all applicable Regulatory Requirements
with minimum coverage of ten million US dollars (US $10,000,000) per occurrence.

 

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3.2.

Covance Clinical shall be listed as an additional insured on the Sponsor’s
clinical trial policy. The insurance of Sponsor shall insure Sponsor and Covance
Clinical against third party claims asserted by all subjects screened or treated
as part of the relevant clinical trial for personal injury suffered as a result
of the participation in the Study and/or the Study screening process. Upon
request Sponsor shall be listed as an additional insured on Covance’s general
liability insurance coverage.

 

3.3.

The Sponsor and Covance Clinical shall each provide the other with a copy of its
certificate of insurance to confirm that it has such insurance coverage. The
insurance of each of Sponsor and Covance Clinical shall be with a company having
a minimum of an A-rating by Best’s rating service. The Sponsor shall maintain
such insurance through the entire duration of Study and for three (3) years
thereafter and shall immediately notify Covance Clinical in writing of any
changes in coverage that impact the coverage requirements set forth above. In
the event coverage is not maintained, a minimum three (3) year extended
reporting period shall be purchased by the Sponsor.

 

3.4.

In the event that either the Sponsor or Clinical Covance is unable to provide an
appropriate: (i) certificate of insurance; or (ii) level of insurance cover as
specified in this Paragraph 3, then the other party shall be entitled to
terminate the relevant Work Order in which case the relevant Services thereunder
will cease.

 

4.

Delays or Cancellation

 

4.1.

In the event that a Study is Delayed or placed on-hold for more than thirty
(30) calendar days the Sponsor shall have the right to retain at their expense
all core team members as defined in the applicable Work Order on a full time
equivalent basis for the duration of the delay or on-hold period. If the Sponsor
does not wish to retain any core team members for the duration of the on-hold or
Delay period, Covance Clinical shall have the right to reallocate any and all
such staff after a thirty (30) calendar day period. If the Delay or on-hold
period continues for ninety (90) days either Party may, by provision of written
notice, terminate the applicable Work Order.

 

4.2.

If the scheduled start-up of any Study under a Work Order to this Exhibit A-[ 2]
is Delayed or cancelled by the Sponsor, pursuant to Section 22 of the MSA,
Covance Clinical shall be entitled to payment in full on a time and materials
basis for all work properly performed by Covance Clinical for the Services
(inclusive of wind-down costs) up through the effective day or Delay or
termination regardless of: (i) the achievement of any milestones used as payment
triggers for Fixed Price Work Orders or (ii) the achievement of any units or
partial units as outlined in the Budget for Fixed Unit Price Work Orders.

 

5.

Data Management Services

 

5.1.

According to Covance Clinical’s licensing agreements, Covance Clinical is
prohibited from sharing dictionary terminology or data with any non-subscribing
client. In offering Covance Clinical’s coding services for a particular Study,
the Sponsor undertakes that it has or shall obtain a current subscription for
using such coding with the applicable licensor (including, Northrop Grumman/MSSO
for MedDRA and Uppsala Monitoring Center for WHODRUG). Covance shall assist
Sponsor in obtaining such subscription(s)

 

5.2.

Covance Clinical is required to verify the Sponsor’s subscription to such
dictionary and data services before the start of a particular Study. If it is
determined that the Sponsor does not have an appropriate subscription, Covance
Clinical shall have the right to: (a) inform the applicable licensor; (b) cease
provision of any of the terminology or data; and (c) be reimbursed all costs,
expenses and damages associated with Sponsor’s failure to be properly licensed
to use such dictionary and data services.

 

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6.

Notices

All notices to Covance Clinical shall be sent to Covance Inc., 210 Carnegie
Center, Princeton, NJ 08540-6233, USA, Attention: Global Director Contract
Management.

SIGNED by an authorised signatory for and on behalf of:

 

Galectin Therapeutics Inc.     Covance Inc. By:    

 

                 By:    

 

Date:         Date:    

 

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EXHIBIT A-3 – ADDITIONAL TERMS AND CONDITIONS FOR THE PROVISION OF CENTRAL
LABORATORY TESTING SERVICES

WHEREAS

 

(A)

GALECTIN THERAPEUTICS INC. (the Sponsor) and Covance Inc. (the Company) are
parties to a Master Services Agreement effective as of March 12, 2020 (the MSA).

 

(B)

COVANCE CENTRAL LABORATORY SERVICES LP an Indiana limited partnership, with its
principal place of business at 8211 SciCor Drive, Indianapolis, Indiana 46214,
USA; and COVANCE CENTRAL LABORATORY SERVICES SÀRL, with its principal place of
business at Rue Moise-Marchines 7, 1217 Meyrin, Geneva Switzerland (collectively
CCLS) shall be considered to be a parties to the MSA for the Services provided
under this Exhibit A-3.

 

(C)

This Exhibit A-3 to the MSA is for the provision of central laboratory testing
services to the Sponsor by CCLS.

NOW THEREFORE the Parties agree as follows:

 

1.

Definitions

 

1.1.

Each capitalized term used in this Exhibit A-3, but not defined, has the meaning
specified in the MSA unless a clear contrary interpretation otherwise applies.

 

2.

Advance Payments

 

2.1.

Upon execution of a Work Order, CCLS shall assess a fee equal to [*] of the
value of the Budget (Deposit).

 

2.2.

Each month, CCLS shall invoice the Sponsor for all fees due and pass through
costs incurred while providing Services during the previous month. The Deposit
shall be retained by Covance until the Study reaches final account
reconciliation. CCLS will issue repayment of the balance of the Deposit by first
applying it to outstanding unpaid invoices.

 

2.3.

If the Study is terminated before the Deposit is exhausted, and assuming all
prior invoices have been paid by the Sponsor, CCLS shall apply the Deposit funds
to the final invoice, then refund any remaining Deposit funds to the Sponsor
within sixty (60) days.

 

3.

Payment Dispute

In the event Sponsor disputes any charge in an invoice Sponsor may elect to
withhold payment for the portion of the invoice that is in dispute, but shall
pay any undisputed amounts in accordance with the payment terms provided in
Section 8.3. The Parties hereby agree to use good faith efforts to reconcile the
disputed amount as soon as practically possible. If the resolution of such
dispute results in a credit to Sponsor, such credit will be reflected on the
next monthly invoice of the applicable Work Order.

 

4.

Additional Services

 

4.1.

If the Sponsor requests additional Services that require modifications to an
existing Protocol/Scientific Plan, CCLS will provide the Sponsor with the
revised Protocol/Scientific Plan for review and approval.

 

4.2.

Notwithstanding Section 10 of the MSA, upon CCLS’ receipt of the Sponsor’s
written approval of the revised Protocol/Scientific Plan (as evidenced by
Sponsor’s signature on the revised Protocol/Scientific Plan), CCLS shall provide
such services to the Sponsor and the Sponsor shall pay for costs associated with
such services at its current standard rates.

 

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4.3.

During performance of Services, CCLS may be required to provide certain items
including but not limited to ancillary supplies, logistics and minor
modifications to database design (the Items). [*]

 

5.

Billing and Invoicing

 

5.1.

For budgeting purposes, CCLS creates a Budget using local unit pricing which is
then converted to the billing currency, as agreed between the Parties using the
Reuters exchange rate at the time the Budget is first created. Unless specified
otherwise, this exchange rate remains unchanged during the course of the Study
to simplify Budget comparisons and enable the Sponsor to track changes to the
Study unrelated to changes in currency exchange rates.

 

5.2.

For invoicing purposes, Services are billed based on the contracted local unit
prices. Each month, at the time of invoice creation, the local unit prices are
converted to the billing currency using the Reuters exchange rate for the month
in which the Services were performed.

 

5.3.

[*]

 

6.

Auditing

Where an audit of CCLS concerns or relates to referral laboratory testing or
shipping methods of CCLS, the Sponsor or its representative (which shall not be
a competitor of Covance) may only confirm whether or not CCLS is properly
billing such costs. The Sponsor expressly agrees that Sponsor’s representatives
may not directly or indirectly provide any details of the charges to the
Sponsor, such as the actual amount of the referral laboratory testing or
shipping costs incurred by CCLS.

 

7.

Transportation Charges

Shipping costs are included in the Budget of the applicable Work Order as
estimated pass-through costs. For the avoidance of doubt, shipping costs charged
to the Sponsor within an applicable Work Order shall be inclusive of a
logistical support fee with respect to the management and tracking of specimens.

 

8.

Provision of Kits

 

8.1.

In accordance with the Work Order, CCLS shall provide each Investigator site
with Study and visit specific specimen collection supplies needed to collect and
ship specimens back to CCLS for analysis (Specimen Kit). Each Specimen Kit may
include test tubes, pipettes, collection needles and other required materials
together with instructions for collection and shipment. Specimen Kits shall also
have a test requisition form or other instructions to allow for the electronic
capture of such data designated for the particular Study. Each Specimen Kit
shall be barcoded to ensure tracking and testing audit trails upon its return to
CCLS.

 

8.2.

In the event that a Specimen Kit is lost, expired or otherwise rendered unusable
for reasons outside the CCLS’ reasonable control or should a Specimen Kit expire
at an Investigator site, CCLS shall replace such Specimen Kits at a cost equal
to the amount listed in the Budget of the applicable Work Order for each
Specimen Kit that is replaced.

 

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9.

Storage of Samples

CCLS shall not destroy any Samples without giving prior written notice to
Sponsor and giving Sponsor a reasonable opportunity to provide directions for
the Samples to be sent to a different location for storage. If Sponsor does not
respond to CCLS’s request for Sample disposition within thirty (30) days, CCLS
may return such Samples to Sponsor at Sponsor’s cost. CCLS’s liability for any
breach or default for the storage of Samples shall not exceed the fees it has
been paid for storage of such Samples for the previous twelve (12) months.

 

10.

Samples During Force Majeure

 

10.1.

In the event of Force Majeure Event, CCLS shall take all reasonable commercial
steps to re-route Samples to another CCLS facility or to another qualified
laboratory for testing.

 

10.2.

If the Samples are routed to a non-CCLS laboratory for testing, the Sponsor
agrees to pay all fees and charges related to those samples and testing.

 

11.

Notices

All notices to CCLS shall be sent to Covance Central Laboratory Services LP,
8211 SciCor Drive, Indianapolis, Indiana 46214, USA, Attention: VP Finance.

 

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SIGNED by an authorised signatory for and on behalf of:

 

Galectin Therapeutics Inc.     Covance Central Laboratory Services LP By:    

 

                 By:    

 

Date:         Date:       Covance Central Laboratory Services Sàrl

 

 

 

                 By:    

 

      Date:       Covance Inc.

 

 

 

                 By:    

 

      Date:    

 

Page 39 of 60

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EXHIBIT A-4 - ADDITIONAL TERMS & CONDITIONS FOR THE PROVISION OF PHASE I HEALTHY
VOLUNTEER CLINICAL RESEARCH SERVICES

WHEREAS

 

(A)

GALECTIN THERAPEUTICS INC. (the Sponsor) and Covance Inc. (the Company) are
parties to a Master Services Agreement effective as of March 12, 2020 (the MSA).

 

(B)

COVANCE CLINICAL RESEARCH UNIT INC. with its principal address of 3402 Kinsman
Blvd, Madison, Wisconsin 53704, USA; and COVANCE CLINICAL RESEARCH UNIT LIMITED
with its registered office at Springfield House, Hyde Street, Leeds, LS2 9LH, UK
(collectively CRU) shall be considered to be parties to the MSA for the Services
provided under this Exhibit A-4.

 

(C)

This Exhibit A-4 to the MSA is for the provision of Phase 1 healthy volunteer
clinical research services to the Sponsor by the CRU.

NOW THEREFORE the Parties agree as follows:

 

1.

Definitions

 

1.1.

Each capitalized term used in this Exhibit A-4, but not defined, has the meaning
specified in the MSA unless a clear contrary interpretation otherwise applies.

 

1.2.

For the purposes of this Exhibit A-4, the following definitions shall apply:

“Completion” means the final visit by the last subject for the relevant Study.

“Forgone Revenue” means the revenue that would have been earned by CRU under a
Work Order if the Sponsor had not cancelled or Delayed the Study (or part
thereof) (such as lost bed space that had been reserved for Sponsor); and

“Scheduled Start Date” means the first subject first visit for a particular
Study under a Work Order.

 

2.

Transfer of Obligations

 

2.1.

The CRU acknowledges and agrees that the responsibility for Services performed
as set forth under the applicable Work Order are being transferred to the CRU in
accordance with 21 CFR §312.52, EU Clinical Trial Directive (2001/20/EC),
International Conference on Harmonization of GCP E6 (R2) (ICH GCP) or any other
applicable regulations. The Sponsor shall at all times be considered the
“Sponsor” of the Study pursuant to the terms of the Federal Food, Drug, and
Cosmetic Act (as amended) and the regulations of the US FDA (as promulgated in
21 CFR) or any other applicable national regulations and ICH GCP. The
obligations transferred should be included in Form FDA 1571, Section #14, the
EudraCT form or an equivalent in the country in which the Services are being
performed (Transfer of Obligations Form).

 

2.2.

For any Change Order that affects the scope of the regulatory obligations that
have been transferred to the CRU, the Sponsor and CRU, shall execute a
corresponding amendment to any Transfer of Obligations Form. The Sponsor shall
file such amendment where appropriate or as required by applicable Regulatory
Requirements.

 

3.

Safety Data and Clinical Holds

The Sponsor shall promptly inform the CRU in writing in accordance with all
applicable Regulatory Requirements if: (i) the Sponsor is aware of any safety
data from any source which is applicable to the Study and which may indicate a
negative impact on subject safety or well-being; or (ii) if there is a clinical
hold on the Study by the applicable Regulatory Authority.

 

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4.

Volunteer Compensation for UK Phase I Trials

Where applicable, the Sponsor agrees to abide by the current Association of the
British Pharmaceutical Industry “Guidelines for Phase 1 Clinical Trials” (the
Guidelines) and agrees that it understands the section entitled “Risk
Management”. The Guidelines may be found at the following link:
http://www.abpi.org.uk/our-work/library/guidelines/Pages/phase-1-trials-2012.aspx.

 

5.

Informed Consent Forms

The Sponsor hereby directs and authorizes the CRU to act as the Sponsor’s agent
with actual authority to enter into and execute for and on behalf of the Sponsor
and in the Sponsor’s name a subject informed consent form for each volunteer
study performed under the Agreement and a Work Order in accordance with all
applicable Regulatory Requirements. The current informed consent form template
is available upon request.

 

6.

CRU Data Management Services

 

6.1.

According to the CRU’s licensing agreements, the CRU is prohibited from sharing
dictionary terminology or data with any non-subscribing client. In offering the
CRU’s coding services for a particular Study, the Sponsor undertakes that it has
or shall obtain a current subscription for using such coding with the applicable
licensor (including, Northrop Grumman/MSSO for MedDRA and Uppsala Monitoring
Center for WHODRUG).

 

6.2.

The CRU is required to verify the Sponsor’s subscription to such dictionary and
data services before the start of a particular Study. If it is determined that
the Sponsor does not have an appropriate subscription, the CRU shall have the
right to: (a) inform the applicable licensor; (b) cease provision of any of the
terminology or data; and (c) be reimbursed all costs, expenses and damages
associated with Sponsor’s failure to be properly licensed to use such dictionary
and data services.

 

7.

Record Storage and Retention

 

7.1.

All reports shall be prepared in the CRU’s standard format unless otherwise
specified in the Work Order.

 

7.2.

All primary investigator-related data generated by the CRU, or copies thereof
(for example, laboratory records, CRFs, data sheets, correspondence, photographs
and computer records etc.) that are a result of the original observations and
activities of the Study and are necessary for the reconstruction and evaluation
of the Study (Investigator Records) shall, unless specifically stated otherwise
in the Work Order or Protocol/Scientific Plan, be collated by the CRU after
issuing the final report. The Investigator Records shall be retained as required
under current regulatory requirements after Completion of the Study.

 

7.3.

Frozen Samples shall be shipped to the appropriate analytical laboratory
according to the Sponsor’s instructions or other requirements in the Work Order
or Protocol/Scientific Plan. All other frozen Samples (e.g. secondary/backup or
unanalysed samples) shall be retained by the CRU for a period of six (6) months
after Completion unless otherwise specified in the Work Order or
Protocol/Scientific Plan. Refrigerated Samples shall be retained for one
(1) week after their analysis and then destroyed unless otherwise agreed upon by
the Parties (each a Retention Period).

 

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7.4.

The Budget shall include the costs for archiving frozen Samples for the relevant
Retention Period. At the end of the relevant Retention Period, the CRU shall
contact the Sponsor to determine if a longer Retention Period for each of the
Samples is required. If a longer retention period is not required, CRU shall
ship the samples to the archive facility of the Sponsor’s choice at Sponsor’s
expense

 

7.5.

Where the Sponsor wishes the CRU to retain the Samples beyond the relevant
Retention Period and/or Investigator Records beyond the current Regulatory
Requirements, the CRU shall levy a periodic charge on the Sponsor based on the
amount and type of materials retained. All records, raw data, Samples and
materials not required for retention shall, at the Sponsor’s expense, either be
returned to the Sponsor or destroyed. The Sponsor shall be responsible for any
regulatory implications of either option.

 

8.

Insurance

 

8.1.

The Sponsor hereby represents and warrants that it maintains adequate separate
clinical trial and product liability insurance coverage consistent with industry
standards through a reputable insurance carrier and in compliance with all
applicable Regulatory Requirements. The sum insured shall be in compliance with
all applicable Regulatory Requirements, but shall not be less than five million
pounds sterling (£5,000,000) per occurrence for trials in the UK or five million
US dollars ($5,000,000) per occurrence for trials in the US, except where the
Study is a first-in-human study, where the minimum coverage of such insurance
shall ten million US Dollars (US $10,000,000) per occurrence. The Sponsor
further represents and warrants that such insurance policies shall not contain
any additional exclusion clauses not normally found in insurance of this type
that might limit such cover for the Study. CRU hereby represents and warrants
that it maintains adequate general liability and errors and omissions /
professional liability insurance coverage consistent with industry standards
through a reputable insurance carrier and in compliance with all applicable
Regulatory Requirements with minimum coverage of ten million US dollars (US
$10,000,000) per occurrence.

 

8.2.

The insurance of Sponsor shall identify the CRU as an additional insured and
shall cover all subjects screened or treated as part of the Study for personal
injury suffered as a result of the participation in the Study and/or the Study
screening process. Upon request Sponsor shall be listed as an additional insured
on CRU’s general liability insurance coverage.

 

8.3.

The Sponsor and CRU shall each provide the other with a copy of its certificate
of insurance or such other documented evidence to confirm that it has such
insurance coverage. For the avoidance of doubt, a statement of self-insurance is
not acceptable. The insurance of each of Sponsor and Covance shall be with a
company having a minimum of an A-rating by Best’s rating. The Sponsor and CRU
shall maintain such insurance through the entire duration of Study and for the
duration according to applicable Regulatory Requirements, which shall be at
least three (3) years thereafter. The Sponsor shall immediately notify the CRU
in writing of any changes in coverage that affects the requirements above. In
the event coverage is not maintained, a minimum three (3) year extended
reporting period must be purchased by the Sponsor

 

8.4.

In the event that the Sponsor or CRU is unable to provide an appropriate:
(i) certificate of insurance; or (ii) level of insurance cover as specified in
this Paragraph 8, then the CRU shall be entitled to cease the relevant Services
whereupon the relevant Work Order may be terminated.

 

9.

Additional Fees for Delay or Termination for Convenience

 

9.1.

Except to the extent that any Services under a Work Order are Delayed or
cancelled as a result of the CRU’s breach of the Work Order, if the Scheduled
Start Date to this Exhibit A-4 is Delayed or cancelled by the Sponsor within the
following time periods, the Sponsor shall pay the CRU the following fees in
addition to the amounts due under Section 22 of the MSA:

 

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  9.1.1.

if the Services are cancelled or Delayed: (i) [*] before the Scheduled Start
Date; or (ii) at any time where more than [*] of the Budget payable under a
particular Work Order have been incurred and invoiced to the Sponsor[*];

 

  9.1.2.

if the Services are cancelled [*], the Sponsor shall pay the CRU [*];

 

  9.1.3.

if the Services: (i) are cancelled [*] before the Scheduled Start Date; or
(ii) are cancelled after [*], the Sponsor shall pay the CRU a fee of [*];

 

  9.1.4.

if the Study or part of the Study is Delayed by [*], the Sponsor shall pay the
CRU [*]. If the CRU is unable to reschedule the Study or part of the Study on
the date requested by the Sponsor and the Sponsor elects to cancel the Study (or
part thereof), [*].

 

9.2.

Pursuant to Paragraphs 9.1.2 and 9.1.3, the additional fee shall be calculated
on the standard rates of the CRU personnel assigned to the affected Work Order,
provided that such personnel’s time is not already being billed to the Sponsor
for close out activities. The CRU shall act in good faith and use its reasonable
commercial endeavours to promptly re-assign such personnel.

 

10.

Third Party Investigator Sites

 

10.1.

If the Sponsor requests that the CRU contracts with an Investigator for conduct
of a Study, the Sponsor shall provide the authority for the CRU to contract with
the Investigator on behalf of the Sponsor. Any indemnification rights granted to
the Investigator shall be provided exclusively by the Sponsor and in the event
that the Investigator invokes such rights, the Investigator shall deal directly
with the Sponsor.

 

10.2.

The Parties agree that Investigators shall be deemed to be independent
contractors exercising independent judgment and shall not be considered either
Subcontractors or Vendors of the CRU. The CRU’s responsibility in connection
with the contract with the Investigator shall be for the CRU to make payments
that are payable to Investigator in connection with its services in accordance
with the respective budget for the Investigator, (such budget shall be subject
to review and approval by the Sponsor). The CRU shall cooperate with the Sponsor
in accordance with the Sponsor’s instructions in enforcing the contract with the
Investigator sites.

 

11.

Notices

 

11.1.

For Phase 1 CRU services in the US, all notices shall be sent to Covance
Clinical Research Unit Inc. 3402 Kinsman Boulevard, Madison, Wisconsin 53704,
USA; Attention: Manager Contract Management.

 

11.2.

For Phase 1 CRU services in the UK, all notices shall be sent to Covance
Clinical Research Unit Ltd., Springfield House, Hyde Street, Leeds West
Yorkshire, LS2 9LH, UK; Attention: Managing Director.

SIGNED by an authorised signatory for and on behalf of:

 

Galectin Therapeutics Inc.     Covance Clinical Research Unit Inc. By:        
By:     Date:         Date:    

 

Page 43 of 60

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Covance Clinical Research Unit Limited By:     Date:    

 

Covance Inc. By:     Date:    

 

Page 44 of 60

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EXHIBIT B1 - PRO-FORMA WORK ORDER: LEGAL REPRESENTATIVE SERVICES

This WORK ORDER is made the date the last party signs below between:

 

(1)

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

 

(2)

COVANCE [    ] whose registered office is at [insert address] (Covance),

(each a Party and collectively the Parties).

RECITALS

 

(A)

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

 

(B)

WHEREAS subject to the terms and conditions of the MSA [and the additional terms
and conditions set forth in [insert any relevant Exhibits]], the Sponsor and
Covance hereby agree to execute a Work Order relating to the Services for
Sponsor’s Protocol/Scientific Plan [insert reference].

NOW THEREFORE the Parties agree as follows:

 

1.

Definitions and Interpretation

 

1.1.

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.

 

1.2.

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

“Legal Representative” shall mean Covance’s role in providing the Legal
Representation Services to the Sponsor.

“Legal Representation Services” shall mean Covance’s agreement to act as the
agent of the Sponsor as legal representative in [ insert relevant
country/region] and to provide the Services described at Annex 1 to this Work
Order under the heading “Legal Representation Services”.

 

1.3.

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.

 

2.

Term and Termination

The term of this Work Order [shall commence on …] [shall be deemed to have
commenced on ...] and shall continue until completion of the Services or earlier
termination of the MSA in accordance with the termination provisions set out in
the MSA (the Term).

 

3.

Services

 

3.1.

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 in [country], which shall remain the responsibility of the
Sponsor.

 

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3.2.

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/Services Specific Assumptions that apply to the Services.

 

4.

Budget

 

4.1.

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

 

4.2.

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.

 

4.3.

Invoices are due within thirty (30) days of receipt by the Sponsor.

 

5.

Payment and Invoice Details

 

5.1.

All invoices to the Sponsor should be sent to the following address:

[insert]

 

5.2.

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

Covance Inc.

210 Carnegie Center

Princeton, New Jersey 08540-6233

United States

Attention: [insert]

 

6.

Change Control

In the event that any of the Assumptions used to calculate the Budget or in the
provision the Services change, in accordance with Section [insert – NB: usually
section 10] of the MSA, the Parties shall negotiate an amendment to this Work
Order if appropriate. No amendment to this Work Order shall be binding unless
agreed in writing.

 

7.

Power of Attorney

The Power of Attorney appended to this Work Order at Annex 4 shall be completed
by the Parties and executed appropriately prior to the commencement of the Legal
Representation Services. The Parties acknowledge that the Power of Attorney
shall give Covance the authority to act as Legal Representative for the Sponsor
when providing the Legal Representation Services.

 

8.

Insurance

This paragraph shall replace Section 23 of the MSA. The Sponsor hereby
represents and warrants that it maintains adequate separate clinical trial
insurance and product liability coverage consistent with industry standards and
in compliance with all Regulatory Requirements through a reputable insurance
carrier having a minimum of an A-rating by Best’s rating service or higher which
shall have a minimum discovery period of three (3) years inclusive of the period
covering clinical trials insurance. For the avoidance of doubt, if the
certificate of liability covers a period of twelve (12) months, the insurance
coverage must include an extended reporting period of an

 

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additional two (2) years. Sponsor shall be required to maintain such insurance
through the life of the study and shall notify Covance in writing of any changes
in coverage which impact requirements set forth above. The sum insured shall not
be less than ten million US dollars (US $10,000,000) per occurrence. The Sponsor
further represents and warrants that such insurance policies shall not contains
any additional exclusions clauses not normally found in insurance of such type
that might limit and would not extend to the study for which the Services are
being provided. Covance shall be an additional insured under Sponsor’s policy of
insurance. The insurance of Sponsor shall insure against third party claims
asserted by all subjects screened or treated as part of the Study for personal
injury suffered as a result of the participation in the Study and/or the Study
screening process.

 

9.

Termination

 

9.1.

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.

 

9.2.

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.

 

10.

Entire Agreement

This Work Order (including any annexes hereto) and the terms of the MSA
represent the entire and integrated agreement between the Sponsor and Covance
and supersede all prior negotiations, representations or agreements, either
written or oral, regarding the Services.

 

11.

Choice of Law and Jurisdiction

Any contractual dispute or claim arising between the Parties to this Work Order
arising out of or in connection with the MSA or the Services defined herein
shall be construed, governed, interpreted, and applied in accordance with the
provisions of Section 33.11 of the MSA.

 

Galectin Therapeutics Inc.     Covance [    ]: Name:         Name:    
Signature:         Signature:     Title:         Title:     Date:         Date:
   

 

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ANNEX 1 – DESCRIPTION OF SERVICES

 

1.

Legal Representation Services

 

1.1.

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 [insert relevant clinical trial law], which shall include the following, in
each case, only in relation to the Study:

 

  a)

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;

 

  b)

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;

 

  c)

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;

 

  d)

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);

 

  e)

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 [specify relevant
Country or region];

 

  f)

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;

 

  g)

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;

 

  h)

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

 

  i)

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

 

  j)

in the event that legal proceedings are instigated in the [Territory specify
relevant Country or region],    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.

 

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1.2.

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

 

  a)

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;

 

  b)

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

 

  c)

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;

 

  d)

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

 

  e)

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.

 

1.3.

The Sponsor shall indemnify, defend and hold harmless [*] 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

 

2.

Services

[insert any other general Services]

 

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ANNEX 2 – BUDGET

The pricing for the Work Order shall be deemed to be a Fixed [Unit] Price Work
Order, which means a fixed set of Services and delivered in accordance with the
fixed [fees]/[unit budget] outlined in this Annex.

Additional paragraph for Fixed Unit Price: Fixed Unit Prices reflect the average
unit price to perform the task and are not illustrative of the actual effort
associated with the unit. If the scope of an individual unit changes or the
projected number of units are not achieved, adjustments shall be made to the
Fixed Unit Price or the development of a new unit (as the case may be) in
accordance with Section 10 of the MSA to reflect the actual effort associated
with the unit.]

 

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ANNEX 3 – PAYMENT SCHEDULE OR PAYMENT TERMS

[insert]

 

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ANNEX 4 – POWER OF ATTORNEY FOR LEGAL REPRESENTATION SERVICES

THIS POWER OF ATTORNEY is made on [insert date] by, a company with its
[principal place of business] [registered office] at [insert address] and
[registered number [insert if applicable]] (the “Principal”).

 

1.

APPOINTMENT AND POWERS

 

  1.1

The Principal hereby appoints COVANCE INC. with its principal place of business
at 210 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:[insert] and with study title: [“insert name of Study”] (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]:

 

  (a)

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

 

  (b)

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

 

  (c)

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;

 

  (d)

monitor and manage the Clinical Trial;

 

  (e)

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

 

  (f)

store and distribute materials related to the Clinical Trial;

 

  (g)

obtain export licenses for the Clinical Trial if required;

 

  (h)

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

 

  (i)

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,

in each case, in accordance with and subject to the Covance Master Services
Agreement entered into between the Principal and the Attorney on [insert]
relating to the conduct of the Clinical Trial.

 

  1.2

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.

 

  1.3

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

 

2.

DURATION

 

  2.1

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.

 

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  2.2

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.

 

  2.3

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.

 

  2.4

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.

 

3.

RATIFICATION

The Principal undertakes to ratify and confirm whatever the Attorney does or
purports to do in good faith in the exercise of any power conferred by this
Power of Attorney.

 

4.

VALIDITY

The Principal declares that a person who deals with the Attorney in good faith
may accept a written statement signed by the Attorney to the effect that this
Power of Attorney has not been revoked as conclusive evidence of that fact.

 

5.

LANGUAGE

The official text of this Power of Attorney and any notices given hereunder
shall be in English. If any dispute occurs concerning the construction or
interpretation of this Power of Attorney, reference shall be made only to the
Power of Attorney as written in English and not to any translation into any
other language.

 

6.

JURISDICTION

This Power of Attorney (and any dispute, controversy, proceedings or claim of
whatever nature arising out of or in any way relating to this Power of Attorney
or its formation or any act performed or claimed to be performed under it) shall
be governed by and construed in accordance with [insert relevant law].

[INSERT RELEVANT EXECUTION BLOCK]

 

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EXHIBIT B2 - PRO-FORMA WORK ORDER: NO LEGAL REPRESENTATIVE SERVICES

This WORK ORDER is made the date the last party signs below between:

 

(1)

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

 

(2)

COVANCE [    ] whose registered office is at [insert address] (Covance),

(each a Party and collectively the Parties).

RECITALS

 

(A)

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

 

(B)

WHEREAS Covance is a party to the MSA by virtue of Exhibit A-[ ] to the
Agreement [intent/language needs to be clarified about which Covance entity will
be a party. Language suggest that the entity to sign this is not the party to
the Master Agreement]

 

(C)

WHEREAS subject to the terms and conditions of the MSA and the additional terms
and conditions set forth in the relevant Exhibit A, the Sponsor and Covance
hereby agree to execute a Work Order relating to the Services for Sponsor’s
Protocol/Scientific Plan [insert reference].

NOW THEREFORE the Parties agree as follows:

 

1.

Definitions and Interpretation

 

1.1

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

 

1.2

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

 

2.

Term and Termination

 

2.1

The term of this Work Order [shall commence on …] [shall be deemed to have
commenced on ...] and shall continue until completion of the Services or earlier
termination of the Agreement in accordance with the termination provisions set
out in the Agreement (the Term).

 

3.

Services

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/Services Specific Assumptions that apply to the Services.

 

4.

Budget

 

4.1

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

 

4.2

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.

 

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4.3

Invoices are due within thirty (30) days of receipt by the Sponsor.

 

5.

Payment and Invoice Details

All invoices to the Sponsor should be sent to the following address:

[insert]

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

[insert]

 

6.

Change Control

In the event that any of the Assumptions used to calculate the Budget or in the
provision the Services change, in accordance with Section 10 of the MSA, the
Parties shall negotiate an amendment to this Work Order if appropriate. No
amendment to this Work Order shall be binding unless agreed in writing.

 

7.

Insurance [FOR COVANCE CLINICAL, CRU]

[Sponsor hereby represents that insurance referred to in Paragraph 3 of Exhibit
A-[ ] (Covance Clinical) of the Agreement is applicable to and valid for the
duration of this Study.]

[Sponsor hereby represents that insurance referred to in Paragraph 8 of Exhibit
A-[ ] (CRU) of the Agreement is applicable to and valid for the duration of this
Study.]

 

8.

Entire Agreement

This Work Order and the terms of the Agreement represent the entire and
integrated agreement between the Sponsor and Covance and supersede all prior
negotiations, representations or agreements, either written or oral, regarding
the Services.

 

9.

Choice of Law and Jurisdiction

Any contractual dispute or claim arising between the Parties to this Work Order
arising out of or in connection with the Agreement or the Services defined
herein shall be construed, governed, interpreted, and applied in accordance with
the provisions of Section 33.11 of the Agreement.

 

Galectin Therapeutics Inc.     Covance [    ].

Signature          Signature      Name:         Name:     Title:         Title:
    Date:         Date:    

 

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ANNEX 1 – DESCRIPTION OF SERVICES

 

Page 56 of 60

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ANNEX 2 – BUDGET

[Wording for Covance Clinical: The pricing for the Work Order shall be deemed to
be a Fixed [Unit] Price Work Order, which means a fixed set of Services and
delivered in accordance with the fixed [fees]/[unit budget] outlined in this
Annex.

Additional paragraph for Fixed Unit Price: Fixed Unit Prices reflect the average
unit price to perform the task and are not illustrative of the actual effort
associated with the unit. If the scope of an individual unit changes or the
projected number of units are not achieved, adjustments shall be made to the
Fixed Unit Price or the development of a new unit (as the case may be) in
accordance with Section 10 of the MSA to reflect the actual effort associated
with the unit.]

 

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ANNEX 3 – PAYMENT SCHEDULE OR PAYMENT TERMS

 

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EXHIBIT C - PRO-FORMA CHANGE ORDER

This CHANGE ORDER is made the date the last party signs below between:

 

(1)

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

 

(2)

COVANCE [    ] whose registered office is at [insert address] (Covance),

(each a Party and collectively the Parties).

RECITALS

 

(A)

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

 

(B)

WHEREAS Covance is a party to the MSA by virtue of Exhibit A-[    ] to the MSA.

 

(C)

WHEREAS the Sponsor and Covance are Parties to a work order effective as of
[date] under the Agreement relating to the Services (the Work Order).

 

(D)

WHEREAS subject to the terms and conditions of the Agreement the Sponsor and
Covance hereby agree to amend the Work Order.

NOW THEREFORE the Parties agree as follows:

 

1.

Scope and Definitions

 

  1.1.

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

 

  1.2.

Pursuant to Section 10 of the MSA, the Parties have agreed to vary the terms
agreed in the Agreement or Work Oder by the terms set out in this Change Order
No #.

 

  1.3.

In the event of conflict, the terms in this Change Order shall take precedence
over the Agreement or the Work Order.

 

2.

Term and Termination

The term of this Change Order [shall commence on …] [shall be deemed to have
commenced on ...] and shall continue until completion of the Services or earlier
termination of the Agreement in accordance with the termination provisions set
out in the Agreement (the Term).

 

3.

Amendments

 

  3.1.

It has been agreed between the Parties that the Work Order shall be extended for
a further term of ... until ....

 

  3.2.

In consideration of agreeing to provide the Services as amended by this Change
Order:

 

  3.2.1.

the description of Services (Annex 1) of the Work Order is hereby replaced in
its entirety by revised description of Services attached at Annex 1 of this
Change Order.

 

  3.2.2.

the Budget attached at Annex 2 of the Work Order is hereby replaced in its
entirety by the revised Budget attached at Annex 2 of this Change Order. [The
revised Budget reflects the revised description of Services and Study/Services
Specific Assumptions contained in Annex 1 to this Change Order.]

 

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  3.2.3.

the payment schedule (Annex 3) of the Work Order is hereby replaced in its
entirety by the revised payment schedule attached at Annex 3 of this Change
Order.

 

  3.3.

In all other respects the Agreement and the Work Order shall continue in full
force and effect.

SIGNED in duplicate by an authorised signatory for and on behalf of:

 

Galectin Therapeutics Inc.     Covance [    ]

Signature          Signature      Name:         Name:     Title:         Title:
    Date:         Date:    

 

Page 60 of 60