Exhibit 10.1

 

CONFIDENTIAL TREATMENT REQUESTED [*****] INDICATES MATERIAL THAT HAS BEEN
OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH
OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

 

MASTER SERVICE AGREEMENT

 

AGREEMENT entered into as of 18 March 2004 between GlycoGenesys Inc.
(“GlycoGenesys”), a Nevada corporation and Glenmere Clinical Research, Inc.
(“GCR”), a Delaware corporation.

 

PRELIMINARY STATEMENT

 

GlycoGenesys is a Nevada corporation with its principal place of business at 31
St. James Ave., Suite 810, Boston, MA 02116. GlycoGenesys is engaged in the
business of developing, producing, and seeking approval from the United States
Food and Drug Administration (“FDA”) for drug products.

 

GCR is a Delaware corporation with its principal place of business at 687 Pine
Hill Road, Chester, NY 10918. GCR has the necessary expertise to assist
GlycoGenesys in the clinical development of GCS 100 in a timely and
cost-efficient manner.

 

ACCORDINGLY, GlycoGenesys and GCR agree as follows:

 

1 TERM OF AGREEMENT

 

This Agreement shall commence as of 18 March 2004. Either party shall have the
right to terminate this Agreement prior to such date as set forth in Section 5
of this Agreement.

 

2 OBLIGATIONS OF GCR AND GLYCOGENESYS

 

2.1 Scope of Work

 

Subject to the terms of this Agreement, GCR shall perform the services set forth
within the Scope of Work for GlycoGenesys clinical protocol GLY-101-01, edition
1.1, entitled A Phase I Study of 5 Daily Doses of GCS-100LE Repeated Every 3
Weeks in Patients with Advanced Cancer (the “Study”) which include, but are not
limited to the following: (i) develop electronic case report form (eCRF) and
assist in training of site staff on the use of electronic data capture; (ii)
oversee and monitor conduct of the study with continual observation of data flow
into eCRF; provide 100% source document verification, documentation of site
communication and site training, as appropriate; (iii) track enrollment,
protocol deviations, etc., advise GlycoGenesys, and take appropriate action to
rectify any problems with the conduct of the study; (iv) provide medical
expertise for safety monitoring, including serious adverse events and decisions
on dose escalation; (v) review and clarify data throughout the study to ensure a
timely closure of

 

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the database (vi) produce tables from the output of electronic data capture;
(vii) collect and maintain current regulatory documents; and (viii) prepare a
clinical summary of the study results.

 

GCR may be invited to perform other duties, which should be added as Appendices
to this document, which together with the Scope of Work shall be referred to as
the Work Order. These new appendices must have every page initialed and a
signature page signed and dated by authorized representatives of GlycoGenesys
and GCR to be effective.

 

GCR shall continuously and expeditiously perform all activities necessary and
prudent to assure that GCR’s obligations under this Agreement are completed by
the Completion Date and that the costs and expenses to GlycoGenesys for such
performance do not exceed the Budget. In the event that GCR is not able to
complete its obligations hereunder (i) by the Completion Date, and/or (ii)
within the Budget, GCR shall give GlycoGenesys immediate notice in writing. Upon
receipt of such notice, GlycoGenesys and GCR will negotiate in good faith to
reach a mutually agreeable solution.

 

2.2 Conflict of Interest

 

At the time of signing this Agreement, GlycoGenesys and GCR are not aware of any
existing or potential conflict of interest. Should the possibility of such
conflicts arise GCR agrees to inform GlycoGenesys immediately and then
GlycoGenesys management may decide to take corrective action, up to and
potentially including, termination of this Agreement.

 

2.3 GCR Personnel

 

All personnel necessary for GCR to perform the Work Order shall be employees or
consultants of GCR. Payment for the services of all such employees and/or
consultants of GCR, including all state and federal tax obligations required by
applicable laws and regulations, shall be solely the responsibility and
liability of GCR.

 

2.4 Confidentiality Agreement:

 

GCR and GlycoGenesys have executed a Confidentially Agreement dated January 5,
2004 (the “Confidentiality Agreement”), which is made a part of this Agreement.
GCR acknowledges that the Confidentiality Agreement is still in full force and
effect and any breach under the Confidentiality Agreement shall be a default
under this Agreement. GCR will treat as Confidential Information all
information, data and materials furnished by or on behalf of GlycoGenesys or by
GlycoGenesys’s clinical investigators, or developed by GCR during the term of
this Agreement concerning GlycoGenesys, GlycoGenesys’s studies, GlycoGenesys’s
business or GlycoGenesys’s drug, GCS-100. GCR agrees not to knowingly disclose
to GlycoGenesys any information with respect to which it is under any actual or
implied duty to any third party to keep confidential.

 

2.5 Reports

 

GCR shall keep GlycoGenesys fully informed of all activities undertaken by it
for the benefit of GlycoGenesys and its progress in completing its obligations
under this

 

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Agreement. GCR shall provide GlycoGenesys, including, without limitation, the
following reports:

 

a. written monthly reports setting forth progress relative to the Work Order and
status of regulatory documents;

 

b. clinical monitor’s visit reports within 10 business days of site visit

 

c. upon the occurrence of any Serious Adverse Event, GCR shall immediately
notify GlycoGenesys by telephone (followed up in writing within one business
day) of the nature of such event, dates, locations and consequences and any
other information which GlycoGenesys may need for FDA reporting including SAE
forms, written subject narratives and MedWatch forms;

 

d. draft study report within 3 weeks of database lock

 

e. weekly conference calls or meetings to discuss Study progress

 

f. summary report of GCR estimate of maximum tolerated dose within 10 business
days after “soft-lock” of database.

 

2.6 Insider Information

 

In the course of performance of GCR’s duties, GCR will receive information which
is considered inside information within the meaning and intent of the United
States federal securities laws, rules and regulations. GCR will not disclose
this information to others, except as expressly authorized in writing by
GlycoGenesys and will not use this information directly or indirectly for the
benefit of GCR or as basis for advice to any other party concerning any decision
to buy, sell, or otherwise deal in GlycoGenesys’s securities or those of any of
its affiliated companies.

 

2.7 GCR as a Representative of GlycoGenesys

 

GCR shall act as GlycoGenesys’ representative in its acceptance of all
information, reports, correspondence or the generation of any information,
reports or correspondence pertaining to the reference protocol. Any and all such
information shall remain the sole property of GlycoGenesys, shall be treated as
Confidential Information and shall be immediately returned to GlycoGenesys upon
the termination of this Agreement.

 

2.8 GlycoGenesys Obligations

 

GlycoGenesys agrees to cooperate with GCR and its officers, directors, agents,
representatives, employees, consultants, vendors, contractors and attorneys in
the performance of this Agreement.

 

2.9 Return of Documents

 

GCR shall immediately, upon termination of this Agreement, return all Documents
to a designated representative of GlycoGenesys. For purposes herein, Document or
Documents shall be used in the broadest sense and shall mean, without
limitation, any

 

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written, recorded, electronic or graphic materials (however produced or
reproduced), computer generated or stored data (including, without limitation,
computer files, regardless of the storage media, databases and electronic mail),
documents or files, tapes or other recordings, and any other tangible objects.
All materials, documents, information and suggestions of every kind and
description supplied to GCR by GlycoGenesys or generated under this Agreement
will be the sole and exclusive property of GlycoGenesys, and GlycoGenesys will
have the right to make whatever use it deems desirable of any such materials,
documents and information.

 

2.10 Regulatory Compliance

 

To the extent applicable, GCR shall comply with the appropriate laws, rules and
regulations, policies and guidelines relating to the services set forth in each
Work Order including, without limitation, the Federal Food Drug & Cosmetic Act,
as amended, and the implementing regulations thereunder and the Health Insurance
Portability and Accountability Act, as may be amended, and the implementing
regulations thereunder (HIPPA) (collectively, the “Applicable Laws”). GCR agrees
that it will, to the best of its ability (i) ensure that investigators
understand that written informed consent must be obtained from all participating
subjects prior to enrollment in the studies in accordance with the requirements
specified with the Code of Federal Regulations, the ICH guidelines and all other
Applicable Laws, that they must give a signed copy of the informed consent to
each subject and they must keep a copy in the subject’s files, and report and
attempt to correct deficiencies in such practices, (ii) ensure that
investigators understand and comply with FDA guidelines for the conduct of
research, (iii) ensure that there will be acceptable facilities for conduct of
any study and immediately report and attempt to correct deficiencies, (iv)
ensure that investigators understand their obligation to conduct all studies in
compliance with the protocol’s requirements and to report and attempt to correct
deficiencies, (v) work with investigators to ensure that the rights, welfare and
safety of the subjects are protected, (vi) as applicable, initiate the protocol
only after written, unconditional approval is received from the appropriate and
duly constituted Institutional Review Board (“IRB”) in accordance with 21 C.F.R.
Part 56; (vii) comply with all applicable requirements pertaining to the
protection of human subjects under 45 C.F.R. Part 46; and (viii) provide
sufficient financial disclosure as required under 21 C.F.R. Part 54.

 

2.11 Recordkeeping

 

GCR agrees to take reasonable steps that are requested by GlycoGenesys as a
result of an audit to cure deficiencies in all documentation related to the
services provided hereunder. GCR will retain all documentation, raw data and
record keeping related to such services, in conformance with all applicable
laws, regulations, policies and guidelines and as specified by GlycoGenesys, but
in no event less than three years following completion of the Study. During this
period, such documentation or raw data shall be available for inspection by
GlycoGenesys or by an authorized representative designated by GlycoGenesys and
at any time, upon GlycoGenesys’ written request, GCR shall deliver all such
documentation and raw data to GlycoGenesys or its

 

4

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designee. GCR shall not discard or destroy any documentation or raw data, except
wet specimens of blood, urines, feces and biological fluids, relating to the
Study during this period ending three (3) years following completion of the
Study. Upon the expiration of such period, GCR shall contact GlycoGenesys to
determine whether (i) to return the documentation and raw data (all shipping,
handling and/or insurance charges shall be at GlycoGenesys’ expense), (ii) to
extend the storage of documentation and raw data (at rates that are in effect at
that time); and (iii) to dispose of any work product and raw data (at rates that
are in effect at that time).

 

GCR agrees to advise GlycoGenesys of any regulatory inspection, review or audit
prior thereto to the extent possible and to provide GlycoGenesys with a copy of
any inspection or audit report. Any response to a regulatory agency will be
subject to approval by GlycoGenesys prior to issuance. Such approval will not be
unreasonably withheld.

 

2.12 Right to Audit

 

During the term of this Agreement, until two (2) years after its expiration or
termination, GlycoGenesys may audit any financial records of GCR associated with
this Agreement. Such records may include invoice records, invoices from third
parties, contracts with third parties and payments relating to this Agreement.
To the extent such records are not separable from other customer records, GCR
will give reasonable access to the records to an independent auditor selected by
GlycoGenesys who will audit the records pertaining to the Study and related Work
Orders and may disclose the results of the audit only to the extent it relates
to the Study. In no event shall other customer information be disclosed to
GlycoGenesys.

 

2.13 Insurance

 

GCR shall at its expense maintain insurance coverage during the term of this
Agreement and for a period of 3 years thereafter with an established insurance
company in such amounts: (a) Commercial general liability insurance including
premises and operations with limits of not less than $1 million per occurrence
and $2 million overall (b) Property damage liability insurance with limits of
not less than $1 million per occurrence and $1 million overall (c) Professional
liability insurance with limits of not less than $1 million per occurrence and
$1 million overall. All such insurance shall cover claims made before and after
termination of this Agreement.

 

2.14 Transfer of Obligations

 

Pursuant to 21 CFR 312.52, at the request of GlycoGenesys, GCR will provide in
writing a Notice of Transfer of Obligations. GCR agrees to diligently carryout
all transferred obligations and responsibilities in compliance with all
applicable laws, regulations, policies and guidelines as well as the terms
specified herein.

 

5

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3 COMPENSATION TO GCR

 

As full and complete compensation for all services to be performed by GCR
pursuant to this Agreement, GlycoGenesys shall pay a total of $[******] to GCR
in the following staged payments:

 

  • $[*****] on signing this Agreement. Non payment of this amount within 30
days will render this Agreement null and void.

 

  • $[*****] payable within 30 days of the enrollment of the first patient into
this study.

 

  • $[*****] payable within 30 days after the 15th patient has been enrolled.

 

  • $[*****] payable within 30 days after enrollment is completed.

 

  • The balance (and in the case that the study protocol has remained unchanged
from the March 11, 2004 Issue) of $[*****] payable within 30 days of the study
report being finalized.

 

Deviations in the scope of the protocol during the study may involve additional
costs.

 

Pass through costs, such as travel and living, will be by prior agreement and
will be payable within 30 days of GCR invoicing GlycoGenesys. Travel and living
guidelines are given in Exhibit A.

 

4 ASSUMPTIONS

 

  • The study will run from [*****] to [*****].

 

  • The FDA, investigators involved and the site(s) IRB(s) have approved the
protocol, prior to commencement of the study. Significant changes in the
protocol may change this cost estimate.

 

  • GCR has no responsibility for FDA IND-compliance or availability of the
clinical trial material supplies, except for communicating to GlycoGenesys
clinical site needs.

 

  • Travel and living detailed elsewhere in the Agreement will be paid by
GlycoGenesys.

 

  • Electronic Data Capture will be performed by Medidata Inc. New York and be
billed separately to GlycoGenesys.

 

  • Medidata and GlycoGenesys will finalise an Agreement by April 1 2004.

 

6

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5 TERMINATION

 

5.1 Breach

 

Either party may terminate this Agreement in the event there has been a breach
by the other party of its representations in this Agreement or in the event the
other party shall have materially breached or defaulted in the performance of
any of its obligations hereunder (such breaches or default shall be collectively
referred to herein as a “default”), and such default shall have continued for
ten (10) days after the written notice thereof was provided to the defaulting
party by the other party specifying the particulars of the default. Any
termination shall become effective at the end of such ten (10) day period unless
the defaulting party (or any other party on its behalf) has cured any such
default prior to the expiration of the ten (10) day period.

 

5.2 Bankruptcy

 

If voluntary or involuntary proceedings by or against GlycoGenesys or GCR are
instituted in bankruptcy under any insolvency law, or a receiver or custodian is
appointed for such party, or proceedings are instituted by or against such party
for corporate reorganization or the dissolution of such party, which
proceedings, if involuntary, shall not have been dismissed within sixty (60)
days after the date of filing, or if such party makes an assignment for the
benefit of creditors, or substantially all of the assets of such party are
seized or attached and not released within sixty (60) days, thereafter, the
other party may immediately terminate this Agreement, effective upon notice of
such termination.

 

5.3 Agreement

 

The Agreement may be terminated at any time by mutual written consent of
GlycoGenesys and GCR with 30 days written notice. Prorated payments due at that
time must be paid. For example, if the agreement is terminated after 10 patients
are enrolled, 2/3 of the staged payment due after 15 patients are enrolled will
become immediately payable.

 

If GlycoGenesys fails to make the initial payment of $[*****] within 60 days of
the effective issue date of this contract this document is voided. The
provisions of Sections 2.4, 2.6, 2.9, 2.11, 2.12, 2.13, 8 and 10 shall survive
the termination of this Agreement.

 

6 REPRESENTATIONS OF GLYCOGENESYS

 

6.1 Organization

 

GlycoGenesys (a) is a corporation duly organized, validly existing, and in good
standing under the laws of the State of Nevada, (b) has the requisite power and
authority to own, lease and operate its properties and to conduct its business
as it is presently being conducted.

 

6.2 Authority and Enforceability

 

Consummation of this Agreement will not constitute or result in a breach or
default of any provision of any charter, bylaw, indenture, mortgage, lease
agreement, or any

 

7

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order, judgment, or decree to which any property of GlycoGenesys is subject, or
by which GlycoGenesys is bound, except for breaches or defaults which, in the
aggregate, would not have a material effect on GlycoGenesys’s properties,
business operations, or financial condition. This Agreement has been duly and
validly executed and delivered by GlycoGenesys and (assuming that this Agreement
constitutes a valid and binding obligation of GCR) constitutes a valid and
binding obligation of GlycoGenesys enforceable against it in accordance with its
terms, except as enforcement may be limited by bankruptcy, insolvency,
reorganization, moratorium or similar laws from time to time in effect relating
to the rights and remedies of creditors generally or by general principles of
equity (regardless of whether such enforceability is considered in a proceeding
in equity or at law).

 

6.3 Consents and Approvals

 

The execution and delivery of this Agreement and the consummation of the
transactions contemplated by this Agreement have been duly and validly
authorized by all necessary corporate action on the part of GlycoGenesys and no
other corporate proceedings on the part of GlycoGenesys is necessary to
authorize the execution and delivery of this Agreement or to consummate the
transactions contemplated by this Agreement.

 

6.4 Representations

 

a. Except as described in Current Reports on Form 8-K filed by GlycoGenesys on
February 4, 20 and 24, 2004, to the best of GlycoGenesys’s knowledge and belief,
there is no litigation or claim and no threatened litigation or claim, nor does
GlycoGenesys know of any basis for any such litigation or claim, that would
prevent or hinder the performance of GlycoGenesys hereunder;

 

b. Except as described in Current Reports on Form 8-K filed by GlycoGenesys on
February 4, 20 and 24, 2004, GlycoGenesys, to the best of its knowledge and
belief, has good, valid and marketable title to all of its assets, including
particularly GCS 100;

 

c. Except as described in Current Reports on Form 8-K filed by GlycoGenesys on
February 4, 20 and 24, 2004, GlycoGenesys, to the best of its knowledge and
belief, is not in violation in any material respect with any agreement, order,
judgment, law or regulation applicable to it, including particularly securities
laws and regulations, and it has obtained all governmental permits or licenses
required to conduct its business;

 

d. GlycoGenesys, to the best of its knowledge and belief, all applications,
documents and other material, whether oral or written, presented by
GlycoGenesys, its officers, directors, representatives, attorney and agents to
the FDA are complete and accurate and do not contain any false or misleading
statement or any basis for assertion by the FDA that the information is not
full, complete and accurate or contains any false or misleading statement.

 

8

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7 REPRESENTATIONS OF GCR

 

7.1 Organization

 

GCR: (1) is a corporation duly organized, validly existing, and in good standing
under the laws of the State of Delaware, (ii) has the requisite power and
authority to own, lease and operate its properties and to conduct its business
as it is presently being conducted, and (iii) has qualified to do business as a
corporation in any jurisdiction.

 

7.2 Authority and Enforceability

 

Consummation of this Agreement will not constitute or result in a breach or
default of any provision of any charter, bylaw, indenture, mortgage, lease
agreement, or any order, judgment, or decree to which any property of GCR is
subject, or by which GCR is bound. This Agreement has been duly and validly
executed and delivered by GCR and (assuming that this Agreement constitutes a
valid and binding obligation of GlycoGenesys) constitutes a valid and binding
obligation of GCR enforceable against it in accordance with its terms, except as
enforcement be limited by bankruptcy, insolvency, reorganization, moratorium or
similar laws from time to time in effect relating to the rights and remedies of
creditors generally or by general principles of equity (regardless of whether
such enforceability is considered in a proceeding in equity or at law).

 

7.3 Performance

 

GCR represents to GlycoGenesys that its officers and employees have the
expertise, experience and scientific, regulatory and business affiliations to
perform all the obligations undertaken by it under this Agreement. GCR will use
its best efforts to minimize the amount of turnover of key personnel on the
Study. Changes of key personnel or director level personnel will not be done
without prior notification to GlycoGenesys. GCR further represents and warrants
that all GCR employees/contractors (i) are duly qualified and that no person has
been debarred under subsections (a) or (b) of Section 306 of the Federal Food,
Drug, and Cosmetic Act, as amended, 31 U.S.C. Section 335a(a) and (b), (ii) are
not and have not been under investigation by the U.S. Food and Drug
Administration (“FDA”), and (iii) has a disqualification hearing pending or has
been disqualified by the FDA pursuant 21.C.F.R. Section 312.70. No debarred
person will in the future be employed by GCR in connection with responsibilities
or obligations of GCR under this Agreement. . GCR agrees to immediately disclose
in writing to GlycoGenesys if any employee or agent is debarred or disqualified
or if any action, suit, claim, investigation, or legal or administrative
proceeding is pending or, to the best of GCR’s knowledge, threatened, relating
to the debarment or disqualification of GCR or any person performing services
hereunder.

 

7.4 Ancillary Agreements

 

GCR has no undisclosed agreement or understanding, actual or contingent, of any
kind or nature whatsoever, with any officer, director or shareholder of
GlycoGenesys, or any other person, corporation, partnership, other entity or
organization relating to (i) this Agreement or the consummation of the
transactions contemplated by this Agreement,

 

9

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(ii) the present or future ownership, whether directly, indirectly, actual,
beneficial or contingent, of the common stock of GlycoGenesys, or (iii) the
present or future management of GlycoGenesys.

 

8 INDEMNIFICATION

 

8.1 Indemnification of GCR

 

GlycoGenesys agrees to defend, indemnify, and hold harmless GCR and its
respective shareholders, employees, sub-contractors, consultants and agents from
and against any claims, proceedings, or investigations arising out of or in
connection with this Agreement and agrees to reimburse GCR for all reasonable
costs and expenses, including, without limitation reasonable attorney’s fees
incurred in advance of judgment; provided, however that GlycoGenesys shall not
be responsible for the indemnification of GCR if such claim, proceeding or
investigation arises out of or in connection with the negligence, fraudulent
behavior, intentional misconduct or violation of the laws, rules, regulations or
policies of the United States, applicable states, or the FDA. GCR shall promptly
notify GlycoGenesys of any claim, proceeding or investigation to allow
GlycoGenesys to assume the defense thereof, including without limitation, the
right to select defense counsel and the right to settle any claims or suits at
its discretion. The indemnified parties shall fully cooperate with GlycoGenesys
in defense of any claim, proceeding or investigation subject to GlycoGenesys
reimbursing reasonable out-of-pocket expenses involved in such cooperation.

 

9 DELAYS, DELIVERIES, DISCLAIMERS AND REMEDIES

 

9.1 Deliveries by GlycoGenesys

 

GlycoGenesys acknowledges that GCR will require documents, data, records from
and cooperation by GlycoGenesys to properly perform the services hereunder and
that GCR is not responsible for the errors, delays or other consequences arising
from the failure of GlycoGenesys to provide such data, records or cooperation.

 

9.2 Delays

 

GlycoGenesys acknowledges that GCR will present timetables with each Work Order
which have been carefully considered, planned, and optimized using its expertise
and knowledge of the industry, however, reasonable delays and unforeseen
difficulties may arise. In the event of such delay or difficulty, GCR shall
notify GlycoGenesys within ten (10) business days of knowledge of such delay and
the parties shall negotiate in good faith to resolve such delays or difficulty
and to adjust the Budget or Completion Date, as necessary.

 

9.3 Nature of GCR Services

 

GCR agrees to use its best efforts to complete each Work Order within the Budget
and by the Completion Date; however, GlycoGenesys acknowledges that, despite the
best efforts of GCR, the results of the services to be provided hereunder are
inherently

 

10

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uncertain. Accordingly, GCR makes no guarantee of the results of the referenced
protocol or the FDA’s acceptance of those results.

 

9.4 Remedies

 

The sole remedy to GlycoGenesys for breach or default by GCR shall be
termination of this Agreement as herein provided, and in no event shall GCR be
liable for special, indirect, incidental or consequential damages or for any
liability to a third party except when such liability is caused by its
negligence, fraudulent behavior, intentional misconduct or violation of the
laws, rules, regulations or policies of the United States, applicable States,
and the FDA by GCR and its respective employees, sub-contractors, consultants,
and agents.

 

10 INTELLECTUAL PROPERTY

 

GCR will disclose promptly to GlycoGenesys any and all inventions, discoveries
and improvements related to GlycoGenesys’s product conceived or made by GCR or
its agents while providing services to GlycoGenesys and relating to services or
within twelve (12) months after the provision thereof, and agrees to assign all
its interest therein to GlycoGenesys whenever requested to do so by
GlycoGenesys. GCR and its agents will execute any and all applications,
assignments, or other instruments and give testimony and provide information
which GlycoGenesys will deem necessary to apply for and obtain Letters of Patent
in the United States or of any foreign country or to protect otherwise
GlycoGenesys’s interests therein, and GlycoGenesys will compensate GCR for the
time devoted to said activities and reimburse for expenses incurred.

 

GlycoGenesys acknowledges that GCR possesses certain inventions, processes,
know-how, trade secrets, improvements, other intellectual properties and other
assets, including but not limited to analytical methods, procedures and
techniques, procedure manuals, personnel data, computer technical expertise, and
software, which have been independently developed by GCR and which relate to its
business or operations (collectively “GCR Property”). GlycoGenesys and GCR agree
that any GCR Property or improvements thereto which are used, improved, or
developed by GCR under or during the term of this Agreement or any Work Order
are the sole and exclusive property of GCR.

 

Any copyrightable work created by GCR in connection with or during the
performance of this Agreement by GCR shall be considered a work made for hire,
whether published or unpublished, and all rights therein shall be the property
of GlycoGenesys as employer, author and owner of the copyright in such work.
GCR, without charge to GlycoGenesys other than reasonable payment for time
involved in the event the Agreement shall have terminated, but at GlycoGenesys’
expense, shall duly execute, acknowledge, and deliver to GlycoGenesys all such
further papers, including assignments and applications for copyright
registration or renewal, as may be necessary to enable GlycoGenesys to publish
or protect said works by copyright or otherwise in any and all countries and to
vest title to said works in GlycoGenesys, or its nominees, their successors or
assigns. GCR shall promptly notify GlycoGenesys of any copyrightable work
contemplated herein.

 

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11 ARBITRATION

 

Any controversy or claim arising out of or relating to this Agreement, or breach
thereof, shall be settled by arbitration in accordance with the current
Commercial Arbitration Rules of the American Arbitration Association and any
judgment upon the award shall be deemed to be binding by both GCR and
GlycoGenesys. In the case of a dispute that is likely to involve arbitration,
each party shall designate one arbitrator and these two arbitrators will pick a
mutually agreed upon third arbitrator. Both sides will work towards selecting an
arbitration body in good faith and in a timely manner.

 

12 MISCELLANEOUS

 

12.1 Notices

 

All notices, requests, consents, and other communications, required or permitted
to be given hereunder, shall be in writing and shall be deemed to have been duly
given if delivered personally, or mailed first-class, postage prepaid, by
registered or certified mail (notices mailed shall be deemed to have been given
on the date sent) or by facsimile, as follows (or to such other addresses as
either party shall designate by notice in writing to the other in accordance
herewith):

 

(a) if to GCR:

Simon Welch, Glenmere Clinical Research 687 Pine Hill Road Chester, NY 10918;
fax:

 

(b) if to GLYCOGENESYS:

31 St. James Ave., Suite 810, Boston, MA 02116, Attn: Bradley Carver; fax:
617-422-0675

 

12.2 Article and Sections Headings:

 

The article and section headings of this Agreement are inserted for convenience
of reference and shall not be considered a part of this Agreement or used in its
interpretation.

 

12.3 Rules of Construction

 

For all purposes of this Agreement, unless the context shall otherwise indicate;
(i) all pronouns and any variations thereof shall be deemed to refer to the
masculine, feminine, neuter, singular or plural, as the identity of the person,
firm, or corporation, may require; (ii) plurals of defined terms shall include
the singular; (iii) the words “hereof and “herein” shall be construed to refer
to the entirety of this Agreement and not restricted to the particular Article,
Section, subsection, or paragraph in which they occur; and (iv) GlycoGenesys and
GCR will be deemed to have participated in the negotiation and drafting of this
Agreement.

 

12.4 Severability:

 

If any one or more phrases, sentences, clauses, or paragraphs of this Agreement
shall be held invalid or unenforceable by a court of competent jurisdiction,
such holding shall

 

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not invalidate or render unenforceable any other portions of this Agreement, or
any part thereof

 

12.5 Execution of Counterparts

 

This Agreement may be executed in any number of counterparts, each of which
shall for all purposes be deemed to be an original, and all of which are
identical.

 

12.6 Applicable Law:

 

This Agreement shall be governed in all respects, including validity,
interpretation and effect, by the laws of the State of Massachusetts.

 

12.7 Prior Agreements

 

This Agreement constitutes the entire Agreement and cancels and supersedes all
prior agreements and undertakings, oral or written, among or between the parties
hereto relating to the subject matter of this Agreement. This Agreement is
solely for the benefit of GlycoGenesys and GCR and does not confer on any other
entity or person any rights or remedies under this Agreement.

 

12.8 Amendments

 

This Agreement may not be amended, supplemented or discharged except by accepted
performance or by an instrument in writing signed by both GlycoGenesys and GCR.

 

12.9 Waiver

 

GlycoGenesys or GCR may waive performance by the other party of any of the
covenants or agreements, or satisfaction of any of the conditions, contained in
this Agreement. Any agreement on the part of GlycoGenesys or GCR to any such
waiver shall be valid only if set forth in an instrument in writing signed on
behalf of such party.

 

12.10 Assignment

 

Except as otherwise provided in this Agreement, neither this Agreement nor any
of the rights, interests or obligations under this Agreement shall be assigned
by either GlycoGenesys or GCR (whether by operation of law or otherwise) without
the prior written consent of the other party. In the event of any assignment,
the representations, warranties and covenants made by the assigning Party herein
must also be able to be made by the acquirer. Subject to the preceding
sentences, this Agreement shall be binding upon and inure to the benefit of the
parties hereto, their heirs and assigns.

 

12.11 Publicity

 

Neither party shall disclose the business relationship formed by this Agreement
without the prior written consent of the other party, which consent shall not be
unreasonably withheld. Such limitations shall not apply to disclosures which the
parties are required to make by law; provided, however, that the disclosing
party shall, if reasonably possible, prior to such disclosure allow the other
party an opportunity to intercede in such disclosure and obtain confidential
treatment of any Confidential Information contained in such disclosure.

 

 

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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
date first above written.

 

GLYCOGENESYS, INC.

     

GLENMERE CLINICAL RESEARCH, INC

/s/    Bradley J Carver               /s/    Simon A Welch        

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Name:   Bradley J Carver       Name:   Simon A Welch Title:    CEO & President  
    Title:    President Date:       Date:

 

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EXHIBIT A

 

GUIDELINES FOR OUT OF TOWN BUSINESS TRAVEL AND LIVING EXPENSES

 

The following policy applies to all GCR Company employees, monitors and
consultants.

 

RESERVATION/TICKET REQUESTS

 

AIR TRAVEL

 

Maximum lead-time should be provided when requesting reservations to take
advantage of the numerous excursion and discount fares offered. Normal lead-time
requirement: 7-14 days for domestic travel; 21 days for international travel.

 

Last-minute changes before/during a trip that result in higher airfare should be
avoided.

 

Personal stopovers, which increase airfare or impact the ability to utilize a
discount airfare will be at the employee’s expense and should be deducted from
the related expense report.

 

AUTOMOBILE RENTAL

 

If possible, a credit card featuring CDW (collision damage waiver) and PAI
(personal accident insurance) coverage should be utilized to limit liability in
the event of damage to the rental vehicle.

 

Rental company refueling charges are considerably higher than local gas station
rates. It is recommended that gas tanks be filled prior to drop-off whenever
possible. Gas receipts will be reimbursed to traveler on the expense report.

 

SURFACE TRAVEL

 

As a general guideline, you should select the mode of transportation which
minimizes expenses without causing undue inconvenience or significantly greater
travel time to your destination. For instance, when available and convenient,
airport or hotel shuttle/limousine service should be used instead of taxis.
Consideration should be given to the cost of rental car and hotel parking as
opposed to taxi charges.

 

HOTEL ACCOMODATIONS

 

Hotels offering corporate rates to the Company should be used unless a specific
hotel requested does not exceed available corporate rates in the same area. It
is the responsibility of the traveler to verify that the correct room rate has
been applied upon check-in.

 

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Should your plans change, reservations confirmed on a guaranteed payment basis
must be cancelled in a timely fashion to avoid “no show” charges. A cancellation
number and/or the name of the individual accepting the cancellation should be
obtained.

 

TRAVEL AND ENTERTAINMENT EXPENSES

 

You will be reimbursed for actual, reasonable expenses incurred for meals and
drinks, including tips. Receipts must accompany expenditures of $25 or more. If
you are required to entertain while traveling, please be sure to identify the
person or persons entertained with a clear explanation of the business purpose
of the entertainment on your expense report.

 

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