EXHIBIT 10.35 CLINICAL SERVICES AGREEMENT

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[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDIENTIALITY HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.]

EXHIBIT 10.35

CLINICAL SERVICES AGREEMENT

BETWEEN

ALTEON INC.

AND

QUINTILES, INC.

DATED AS OF AUGUST 11, 1996
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TABLE OF CONTENTS

Page
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PRELIMINARY STATEMENTS................................................... 1

1. OBLIGATIONS OF QUINTILES........................................ 1
1.1 Protocols.......................................... 1
1.2 Services........................................... 2
1.3 Staffing........................................... 5
1.4 QUINTILES's Representations and Warranties......... 6
1.5 Communications..................................... 7

2. TRANSFER OF RIGHTS AND OBLIGATIONS.............................. 7
2.1 Transfer of Obligations to QUINTILES............... 7
2.2 Transfer of Rights and Obligations by ALTEON....... 7

3. STATUS REPORTING................................................ 8
3.1 Cooperation........................................ 8
3.2 Monthly Status Reports............................. 8

4. CLINICAL SUPPLIES............................................... 8
4.1 Clinical Supplies.................................. 8

5. COMPENSATION.................................................... 8
5.1 Budget............................................. 8
5.2 Payment Obligation................................. 8
5.3 Invoices........................................... 9
5.4 Payment of Invoices................................ 9
5.5 Disputes Regarding Invoices........................ 9
5.6 Cost Savings....................................... 9
5.7 No Interest........................................ 9
5.8 Cost Estimates..................................... 9
5.9 Cost Increases..................................... 10
5.10 Records Retention.................................. 10
5.11 Audit Request...................................... 10

6. CONFIDENTIAL INFORMATION........................................ 10
6.1 Confidentiality Obligation......................... 10
6.2 Exceptions......................................... 11
6.3 Return of Confidential Information................. 11
6.4 Remedies........................................... 11

7. OWNERSHIP OF PROPERTY........................................... 12
7.1 Ownership.......................................... 12
7.2 Data Retention..................................... 12

8. PATENT RIGHTS................................................... 13
8.1 Invention Disclosure............................... 13
8.2 Assignment......................................... 13

9. INDEMNIFICATION AND LIMITATION OF LIABILITY..................... 13
9.1 Indemnification of QUINTILES....................... 13
9.2 Indemnification of ALTEON.......................... 14
9.3 Notice; Control of Defense......................... 14
9.4 Limitation of Liability............................ 14
9.5 Investigators...................................... 14

10. TERM; TERMINATION............................................... 14
10.1 Term of Agreement.................................. 14
10.2 Termination by ALTEON.............................. 15
10.3 Breach............................................. 15
10.4 QUINTILES's Obligations Upon Early Termination..... 15
10.5 ALTEON's Obligations upon Early Termination........ 15
10.6 Survival........................................... 16

11. FORCE MAJEURE................................................... 16
11.1 Force Majeure...................................... 16

12. MISCELLANEOUS................................................... 16
12.1 Relationship of Parties............................ 16
12.2 Assignment......................................... 16
12.3 Notices............................................ 16
12.4 Amendment.......................................... 17
12.5 Waiver............................................. 17
12.6 Governing Law...................................... 17
12.7 Alternative Dispute Resolution..................... 17
12.8 Entire Agreement of the Parties.................... 18
12.9 Counterparts....................................... 18
12.10 Descriptive Headings............................... 18

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CLINICAL SERVICES AGREEMENT

THIS CLINICAL SERVICES AGREEMENT (this "Agreement"), dated as of August
11, 1996, is by and between Alteon Inc. a Delaware corporation, with offices at
000 Xxxxxxxx Xxxxx, Xxxxxx, Xxx Xxxxxx 00000, ("ALTEON"), and Quintiles, Inc., a
North Carolina corporation, with offices at 0000 Xxxxxx Xxxx, Xxxxxx, Xxxxx
Xxxxxxxx 00000 ("QUINTILES").

PRELIMINARY STATEMENTS:

A. ALTEON is in the business of developing pharmaceutical products and
is currently conducting clinical trials with respect to a drug known as
pimagedine (the "Compound").

B. QUINTILES is in the business of providing clinical trial services
for the pharmaceutical industry.

C. ALTEON desires to contract with QUINTILES, and QUINTILES desires to
be contracted by ALTEON, for the purposes of providing to ALTEON such clinical
trial services as more particularly described herein, in support of the
Protocols (as defined below).

NOW, THEREFORE, in consideration of the foregoing and of the mutual
covenants of the parties provided in this Agreement, the parties hereby agree as
follows:

1. OBLIGATIONS OF QUINTILES.

1.1 Protocols. QUINTILES shall conduct the services set forth in the
Proposal dated July 16, 1996 submitted by QUINTILES to ALTEON, as amended or
added to from time to time by the mutual agreement of the parties (the
"Proposal"), in consultation with ALTEON as provided in this Agreement, to
support ALTEON's conduct of four studies (individually, a "Study" and
collectively the "Studies") of the Compound in accordance with the following
protocols:

(a) Protocol Number AGPR0002, entitled "A Placebo-Controlled
Safety and Efficacy Study of Pimagedine in Diabetic Patients with Overt Diabetic
Nephropathy";

(b) Protocol Number AGPR0009, entitled "A Placebo-Controlled
Safety and Efficacy Study of Pimagedine in Patients with Type II Diabetes
Mellitus and Overt Diabetic Nephropathy";

(c) Protocol Number 201228-PR0016, entitled "A
Placebo-Controlled Study of the Effect of Pimagedine on Plasma Lipid Levels and
AGEs in Patients with Diabetes and Elevated Serum Cholesterol Levels"; and
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(d) Protocol Number 201228-PR0014, entitled "A
Placebo-Controlled Safety and Efficacy Study of Pimagedine in Diabetic Patients
with End-Stage Renal Disease on Hemodialysis";

(each, a "Protocol" and, collectively, the "Protocols").

1.2 Services. QUINTILES hereby agrees to use all reasonable best
efforts to conduct the project management, medical management, data management,
biostatistical analysis, report preparation, regulatory and other services, in
accordance with the Proposal, as amended or added to from time to time by mutual
agreement of the parties, (the "Services"). The Services to be provided by
QUINTILES to ALTEON, all as more particularly specified in the Proposal, will
include, but will not be limited to, the following:

(a) QUINTILES will conduct the Services in accordance with the
Protocols and as outlined in the Proposal, including performance of the Services
within the time periods set forth in the Proposal (the "Timeline"). The Services
will be conducted in accordance with all applicable Federal, national, state,
and local laws, statues, ordinances and regulations.

(b) QUINTILES will prepare necessary and appropriate
documentation for submission to the appropriate regulatory authority or ALTEON
for the conduct of the Studies and the Services, including without limitation,
as appropriate, IRB approval of Protocol amendments and annual re-approvals. For
purposes of this Agreement, "IRB" means an institution review board that
complies with the requirements of Title 21, Part 56 of the code of Federal
Regulations, as amended, supplemented or modified from time to time, or the
Canadian equivalent. For purposes of this Agreement, "Investigators" means all
investigators recruited previously by or on behalf of ALTEON, and all additional
investigators, if any recruited by QUINTILES as part of the Services.

(c) QUINTILES will provide all new Investigators with the
current Investigators' brochure and, as the investigation proceeds, will keep
each Investigator informed of new information received from ALTEON regarding the
Compound.

(d) QUINTILES will monitor the Studies to verify that each is
being conducted in accordance with the applicable Protocol and with all now or
hereafter applicable Federal, national, state, and local laws, statutes,
ordinances, and regulations, including, without limitation, Food and Drug
Administration (or any other government body or agency that succeeds it) ("FDA")
(or the equivalent Canadian regulatory authority) guidelines on the
responsibilities of sponsors, (relating to those responsibilities delegated to
QUINTILES under EXHIBIT B), monitors, clinical Investigators and informed
consents.

(e) QUINTILES shall provide all data management services as
set forth in EXHIBIT A.

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(f) ALTEON shall have the right, but not the obligation, to
co-monitor, in conjunction with QUINTILES, those Investigators being monitored
by QUINTILES with respect to the Services provided hereunder. In the event
ALTEON determines there is substantial cause for independent monitoring by
ALTEON, it may do so following prior written notification to QUINTILES and
QUINTILES will assist and cooperate with ALTEON therein. In addition, ALTEON may
also conduct random site inspections for quality control purposes without prior
notice to QUINTILES.

(g) QUINTILES agrees that throughout the duration of this
Agreement with respect to all Investigator sites participating in the Studies,
and at any subsequent time when QUINTILES shall receive information regarding
the safety of the Compound used in the Studies as it pertains to serious adverse
experiences, it shall notify ALTEON in writing, in English. Such notification
shall be in such a timely fashion so as to permit compliance with all regulatory
requirements (e.g. 21 CRF 312.32 and its Canadian equivalent) for the handling
and disclosure of any information concerning any serious or unexpected event,
injury, toxicity or sensitivity reaction or any unexpected incidence, or the
severity thereof, associated with the clinical use, studies, investigations,
tests, whether or not determined to be attributable to the Compound. "Serious,"
as used in this Section, refers to an experience which results in death,
permanent or substantial disability, in-patient hospitalization, prolongation of
hospitalization, or is a congenital anomaly, cancer, the result of an overdose,
or life threatening. "Unexpected," as used in this Section, refers to conditions
or developments not previously submitted to governmental agencies or encountered
during clinical studies of the Compound(as represented by ALTEON to QUINTILES),
and conditions or developments, at a rate higher than shown by information
previously submitted to an agency or other governmental agencies or encountered
during clinical studies of the Compound(as represented by ALTEON to QUINTILES)
or, if applicable, conditions or developments not identified in the approved
product information.

All serious adverse events ("SAEs") will be summarized in the
monthly status report. QUINTILES shall be responsible for collecting all
relevant information and for evaluating SAE's (including, causality
assessments). QUINTILES shall provide ALTEON with all documentation and data
concerning SAEs, such as are required for evaluation. QUINTILES shall be
responsible for making all FDA (or the equivalent Canadian regulatory authority)
or other regulatory filings required regarding SAEs, subject to the prior review
and approval by ALTEON.

QUINTILES will be responsible for distributing all notices of
SAEs and IND safety reports to all Investigators, and ALTEON will receive copies
of all such reports distributed by QUINTILES. On request, QUINTILES shall supply
ALTEON with the original documents. For purposes of this Agreement, "IND" means
an investigational new drug application filed with the FDA (or the equivalent
Canadian regulatory authority).

(h) QUINTILES will collect the evidence related to the safety
of the Compound as it is obtained from all Investigators, whether being
monitored by QUINTILES or ALTEON, and make such evidence available to ALTEON.
ALTEON will make available to QUINTILES relevant safety information from
Investigators being monitored solely by ALTEON.

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(i) QUINTILES will store copies of all data and records in
accordance with local and FDA (or the equivalent Canadian regulatory authority)
regulations. The originals of all such information will be forwarded to ALTEON
at the termination of this Agreement, subject to ALTEON having made all payments
contemplated in Section 5 except those payments subject to a bona fide dispute
as contemplated by Section 5.5.

(j) With respect to Investigators being monitored by
QUINTILES, QUINTILES will report to ALTEON any such Investigator that is not
complying with his/her signed agreement (Form FDA-1572, or the Canadian
equivalent) and, after approval is received from ALTEON, will assist ALTEON to
end such Investigator's participation in the Studies, and recover the Compound.

(k) QUINTILES will be responsible for the selection of
monitors qualified by training and experience to monitor the progress of the
investigation, subject to reasonable review and approval by ALTEON.

(l) QUINTILES will verify that any clinical laboratory used in
the conduct of the Studies at all monitored sites shall be appropriately
licensed and/or approved as required in the location where such laboratories are
situated. ALTEON will make available to QUINTILES relevant information from
sites monitored solely by ALTEON.

(m) QUINTILES will undertake coordination of the shipment of
the Compound to all participating Investigators. During the Studies, each
clinical Investigator shall keep a record of the dates and amounts of Compound
supplies received at the applicable Study location; the dates, amount and
patients to whom the test Compound has been administered; the dates (when known)
and amount of the Compound broken, spilled, or lost; and the dates and amount of
the Compound supply which is being refused. At the completion or early
termination of each Study, QUINTILES will make an accounting of all clinical
supplies based upon such investigator's records. ALTEON will make available to
QUINTILES relevant information from sites monitored solely by ALTEON. QUINTILES
will verify that each Investigator has returned to ALTEON or to another location
specified by ALTEON, after the completion or earlier termination of any such
Studies, all unused Compound supplies and account for all Compound supplies
which have been lost or missing.

(n) QUINTILES will prepare materials necessary to permit
ALTEON to maintain an IND in effect, with respect to all Investigators,
including the submission of annual reports.

(o) Should appropriate regulatory authorities or any other
Federal, national, state, or local government authority conduct, or give notice
of intent to conduct, an inspection at any investigational site or take any
other regulatory action with respect to Services provided for in this Agreement,
then QUINTILES will promptly give ALTEON notice thereof and supply all
information pertinent thereto, and ALTEON shall have the right, but not the
obligation, to be

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present at any such inspection or regulatory action. ALTEON will give reciprocal
notice to QUINTILES as to those sites being monitored solely by ALTEON.

(p) From time to time, at the request of ALTEON or QUINTILES,
the parties may agree to increases, decreases, or changes in the scope of
Services to be provided by QUINTILES and the Budget and Timeline which shall be
reflected in an written amendment or change order to one or more of the Exhibits
under this Agreement signed by both parties. No amendment or change order shall
serve to supersede or replace any material provision in the body of this
Agreement unless it is duly executed by the Chief Executive Officer of Alteon.
When considering any request pursuant to this Section, the parties shall act in
good faith and promptly. Neither party shall unreasonably withhold consent to a
request.

1.3 Staffing.

(a) QUINTILES agrees to appoint an employee of QUINTILES,
reasonably acceptable to ALTEON, to be the project leader for QUINTILES for the
performance of the Services to be provided pursuant to this Agreement (the
"Project Leader"). Thereafter, at any time that QUINTILES desires to change to
Project Leader, QUINTILES may do so, subject to the reasonable review and
approval by ALTEON.

(b) QUINTILES agrees to appoint Xxxxx Xxxxxxxx, Ph.D. to be a
scientific advisor for QUINTILES for the performance of the Services to be
provided pursuant to this Agreement for a period of at least twelve months from
the effective date of this Agreement. Thereafter, or sooner if Xx. Xxxxxxxx
becomes unable or unwilling to act in such capacity, at any time that QUINTILES
desires to replace Xx. Xxxxxxxx as a scientific advisor, QUINTILES may do so,
subject to the reasonable review and approval by ALTEON.

(c) The parties acknowledge and agree that, because QUINTILES
must undertake to provide the Services as expeditiously possible, QUINTILES
initially may provide a maximum of 60% of the Services (calculated on the basis
of the number of personhours necessary to provide the Services) through the use
of clinical research associates who are independent contractors of QUINTILES.
However, QUINTILES shall use its best efforts so that, within a reasonable
period of time after the date of this Agreement, it provides such percentage of
the Services (calculated on the same basis) through the use of individuals who
are full-time employees of QUINTILES as QUINTILES and ALTEON shall determine is
appropriate. During the term of this Agreement, QUINTILES shall keep ALTEON
informed as to the key team members (including, but not limited to, CRAs,
biostatistician, programmer, project medical officer, data manager, regulatory
affairs representative and project leader) assigned to provide the Services from
time to time. Subject to the foregoing, if, at any time, ALTEON is not satisfied
with any or all of the staffing providing Services, ALTEON may request a change
to satisfy its concerns. In such event, ALTEON and QUINTILES shall conduct good
faith discussions regarding changes in the staffing used to provide the
Services, in an effort to reach a mutually acceptable resolution.

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1.4 QUINTILES's Representations and Warranties. QUINTILES represents
and warrants to ALTEON that:

(a) It has the facilities, personnel and experience sufficient
in quantity and quality to perform all Services pursuant to this Agreement;

(b) All of the personnel assigned to perform the Services and
the Studies shall be qualified and properly trained;

(c) QUINTILES shall perform the Services in a manner
commensurate with professional standards generally applicable among its
industry;

(d) QUINTILES will maintain strict budgetary controls, it will
use reasonable efforts to not exceed any of the itemized costs in the Budget,
and it will use its best efforts not to exceed the total cost figure for each
Protocol, or Major Area thereof (as defined in Section 5.8), contained in the
Budget;

(e) QUINTILES will use its best efforts to meet the time
periods for completion of the Services to be provided pursuant to the Agreement;
and

(f) All statements of fact set forth in the Proposal
concerning the qualifications and activities of QUINTILES are true in all
material respects.

1.5 Communications. All communications and day-to-day or regular
reports to be made pursuant to this Agreement (other than legal notices, which
shall be delivered pursuant to Section 12.3), shall be made in the same manner
as provided in Section 12.3, but shall be made as follows (or to such other
person as such party may designate from time to time):

(a) If to ALTEON, addressed to:

Alteon Inc.
000 Xxxxxxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000-0000
Attention: Xxxxxxx Xxxxxxxxxx, MB, ChB,
MFCM, MRCPsych
Telephone No.: (000) 000-0000
Facsimile No.: (000) 000-0000

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(b) If to QUINTILES, addressed to:

Quintiles, Inc.
0000 Xxxxxx Xxxx
Xxxxxx, Xxxxx Xxxxxxxx 00000
Attention: Xxxxx Xxxxxxxx, Ph.D.
Telephone No.: (000)000-0000
Facsimile No.: (000)000-0000

2. TRANSFER OF RIGHTS AND OBLIGATIONS.

2.1 Transfer of Obligations to QUINTILES. Pursuant to 21 CFR 312.52 (or
the Canadian equivalent), ALTEON shall transfer to QUINTILES all of the
obligations identified in EXHIBIT B to be so transferred and agrees that the
same description and extent of obligations transferred shall be included in Form
FDA 1571, Section #13 (or the Canadian equivalent). QUINTILES agrees to carry
out diligently all transferred obligations.

2.2 Transfer of Rights and Obligations by ALTEON. The parties
acknowledge and agree that ALTEON may have one or more strategic development
partners involved in the Studies from time to time during the term of this
Agreement. ALTEON shall have the right to grant any of its rights and
obligations under this Agreement to one or more such partners upon notice to
QUINTILES from time to time; provided however, that in the event that any such
partner is financially less stable than ALTEON, then ALTEON shall guarantee any
financial obligations transferred to such partner unless QUINTILES otherwise
agrees.

3. STATUS REPORTING.

3.1 Cooperation. All of the Services shall be performed in close
cooperation with ALTEON, and designated ALTEON personnel will be kept frequently
and regularly informed of the progress of the Studies as contemplated by the
Proposal.

3.2 Monthly Status Reports.

(a) QUINTILES will provide monthly status reports on each
Study within ten (10) days after the end of each month which shall include, but
not be limited to, the number of patients entered, dropped and completed in such
Study, reports of monitoring site visits, CRF's reviewed, safety reports, and
data entered into each Study database.

(b) QUINTILES will also provide a monthly report containing a
comparison of the actual cost to Alteon of each Study for Services performed
from the effective date of this Agreement through the end of such month to the
costs for such Services as set forth in the Budget (as defined in Section 5.1).

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4. CLINICAL SUPPLIES.

4.1 Clinical Supplies. QUINTILES will coordinate and have day-to-day
responsibilities for directing ALTEON's distributor with regard to the supply to
the Investigators of the Compound and other non-drug study supplies for the
timely completion of the Studies and will instruct the distributor selected by
ALTEON in the shipment of any such supplies.

5. COMPENSATION.

5.1 Budget. The total estimated budget for the Services is attached as
EXHIBIT C,, as amended or added to from time to time by mutual agreement of the
parties (the "Budget"). Following receipt by Alteon of the report provided
pursuant to Section 3.2, the parties shall review, on a monthly basis, the
budgeted costs associated with the ongoing performance of the Services to be
provided by QUINTILES. In addition, at the end of each calendar quarter during
the term of this Agreement, ALTEON and QUINTILES shall meet and conduct such a
review of the Budget in detail, and ALTEON shall have the right to review, on a
line-by-line basis, each invoice for Services rendered to ALTEON by QUINTILES in
comparison to the Budget for such Services.

5.2 Payment Obligation. ALTEON shall pay to QUINTILES the fees and
other out-of-pocket costs set forth in the Proposal. QUINTILES warrants that all
out-of-pocket expenses incurred by QUINTILES in connection with the Studies,
including, without limitation, travel and printing expenses, are billed to
ALTEON at the same cost as incurred by QUINTILES. All fees for Investigators'
services will be billed by the Investigators directly to ALTEON.

5.3 Invoices. QUINTILES will submit to ALTEON monthly invoices
approximately twenty (20) days after the end of each calendar month during the
term of this Agreement. All invoices from QUINTILES shall be itemized to reflect
activities performed, time spent and costs incurred, in such detail as ALTEON
shall reasonably request from time to time. In addition, QUINTILES will
supplement each invoice within ten (10) days thereafter with information
reflecting the names of the individuals who performed the services invoiced and
time spent by each individual reflected in such invoice. Such invoices will
specify QUINTILES' fees, based on its daily rates, as specified in the Proposal,
and out-of-pocket expenditures for the applicable month.

5.4 Payment of Invoices. All QUINTILES invoices are payable within ten
(10) business days after the receipt by ALTEON of the invoice and supplemental
information (as contemplated by Section 5.3).

5.5 Disputes Regarding Invoices. QUINTILES shall not suspend work or
seek to terminate this Agreement on account of ALTEON's failure to pay any
invoiced amount which is the subject of a good faith bone fide dispute, provided
that ALTEON pays all non-disputed

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amounts. In the event there is a good faith bone fide dispute as to the timing
or amount of a payment to be made under this Agreement which the parties cannot
resolve amicably, then upon the request of either party, such matter shall be
referred for expedited resolution pursuant to the provisions of Section 12.7 of
this Agreement.

5.6 Cost Savings. Should there be a cost or expense savings under this
Agreement, QUINTILES shall refund such savings to ALTEON at the termination of
this Agreement.

5.7 No Interest. All payments under this Section 5, including the
refund of savings by QUINTILES under Section 5.5, shall be made free of
interest.

5.8 Cost Estimates. The time and cost estimates contained in the
Proposal represent the best judgment QUINTILES can render at the outset of this
Agreement. ALTEON and QUINTILES agree that any unforeseen cost increases of up
to 5% of the total Budget amount for each Major Area of each Study will be
permitted as a legitimate cost modification, provided that QUINTILES shall
notify ALTEON promptly of any such excess costs. QUINTILES will document actual
hours expended. It is understood that QUINTILES shall use its good faith efforts
to control and limit the costs and expenses associated with this Agreement,
consistent with the quality of work and time for completion of services required
of QUINTILES as provided in this Agreement. For purposes of this Agreement,
"Major Area" means each of the sections in the Budget appearing therein in all
capital letters, such as PROJECT SET-UP/INITIATION, CLINICAL TRIAL MANAGEMENT,
MEDICAL SUPPORT, CLINICAL DATA MANAGEMENT, BIOSTATISTICAL ANALYSIS, SUPPORT
SERVICES and MISCELLANEOUS COSTS.

5.9 Cost Increases. In the event that QUINTILES determines that a cost
increase of more than 5% of the total Budget amount for any Major Area of any
Study is necessary, QUINTILES shall provide ALTEON with the reason(s) for the
requested modification to the Budget and an estimate of the overall increase in
costs. ALTEON and QUINTILES shall meet and confer regarding their requested
modifications and shall use their best efforts to agree on modifications to the
Budget that are mutually acceptable.

5.10 Records Retention. QUINTILES shall keep complete and accurate
records pertaining to the Services performed and costs incurred in connection
with the Services for a period of three years after the termination of this
Agreement, and in sufficient detail to permit ALTEON to confirm the accuracy of
the invoices submitted pursuant to this Section 5.

5.11 Audit Request. At the request and expense of ALTEON, QUINTILES
shall permit a representative of ALTEON (provided such representative is not in
competition with QUINTILES) or an independent, certified public accountant
appointed by ALTEON, at reasonable times and upon reasonable notice, to examine
those records and all other material documents relating to or relevant to the
Services and costs thereof in the possession or control of QUINTILES, for a
period of three years after the termination of this Agreement, as may be
necessary to determine the correctness of any payment made under this Agreement.
Results of

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any such examination shall be made available to QUINTILES if a claim is made for
overpayment by ALTEON. ALTEON shall bear the full cost of the performance of any
such audit, unless such audit demonstrates overbilling by QUINTILES of more than
five percent (5%) from the amount of the original invoice submitted by QUINTILES
for such Services and costs. In such event, QUINTILES shall bear the full cost
of the performance of such audit.

6. CONFIDENTIAL INFORMATION.

6.1 Confidentiality Obligation. QUINTILES agrees that all materials,
documents, data, reports and information provided to it by ALTEON and, except as
provided in Section 7, all materials, documents, data, reports and information
developed by QUINTILES pursuant to this Agreement, is and shall be considered as
confidential information of ALTEON (collectively, the "ALTEON Confidential
Information") and the sole property of ALTEON. ALTEON agrees that all
information disclosed to ALTEON about QUINTILES' internal operations and
systems, including but not limited to QUINTILES Property described in Section 7
below, is and shall be considered as confidential information of QUINTILES
(collectively, the "QUINTILES Confidential Information") and is the sole
property of QUINTILES.

Each party agrees to hold the Confidential Information of the other party in
strict confidence during the term of this Agreement and for 10 years after the
termination of this Agreement and shall not, without the consent of the other
party, (a) reveal, publish, report or disclose any Confidential Information to
any person or entity, or (b) use any of such party's Confidential Information
for the benefit of any person or entity, or for any purpose, other than as may
reasonably be necessary for the conduct of the Services and the Studies as
contemplated by this Agreement, except that either party may disclose
Confidential Information of the other party to hospital authorities, IRBs,
employees and representatives only on a need-to-know basis (including fulfilling
corporate reporting obligations) and only if the foregoing parties (other than
hospital authorities and IRBs) are bound and obligated by similar to provisions
of confidentiality similar to as provided in this Agreement.

6.2 Exceptions. The obligations of the parties regarding Confidential
Information shall not apply to information which: (a) is or becomes available to
the public other than as a result of disclosure by the receiving party: (b)
becomes available to the receiving party on a non-confidential basis from a
source which is not obligated to hold such information in confidence; (c) is
developed by the receiving party independently, and not as part of the Services
provided under this Agreement, as evidenced by written records; (d) was in the
possession of the receiving party prior to the receipt from the disclosing party
or the creation of the information pursuant to this Agreement; or (e) is
required by law to be disclosed, provided that the owner of the Confidential
Information shall be notified in advance and given a reasonable opportunity to
oppose such disclosure.

6.3 Return of Confidential Information. Upon the completion or earlier
termination of this Agreement, QUINTILES will promptly return to ALTEON all of
the ALTEON

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Confidential Information, as well as all applicable portions of the written or
computer stored material which incorporates any ALTEON Confidential Information,
provided that QUINTILES may retain in its confidential files one copy of such
documents as it may determine reasonably necessary for regulatory, legal or
insurance purposes.

6.4 Remedies. Each party acknowledges that the disclosure of
Confidential Information of the other party without such party's express,
written permission will cause such party irreparable harm and that the breach or
threatened breach of the nondisclosure provisions of this Agreement will entitle
the owner of the Confidential Information to injunctive relief, in addition to
any other legal remedies that may be available to it.

7. OWNERSHIP OF PROPERTY.

7.1 Ownership. All materials, documents, data, information, reports and
suggestions of every kind and description supplied to QUINTILES by ALTEON or
prepared or developed by QUINTILES pursuant to this Agreement (except for
QUINTILES Property described below ) shall be the sole and exclusive property of
ALTEON and ALTEON shall have the right to make whatever use it deems desirable,
without objection or liability to QUINTILES of any such materials, documents,
data reports and information. All such materials, records, documents, data,
information and reports are subject to audit by ALTEON during regular business
hours, at ALTEON's discretion and upon reasonable notice to QUINTILES, to verify
QUINTILES's compliance with this Agreement and the Protocols. It is acknowledged
that QUINTILES is possessed of certain technical expertise relating to
computers, software, and drug development which have been independently
developed by QUINTILES without the benefit of any information provided by
ALTEON. The parties agree that any computer software programs, statistical
methodologies, processes, methods and other analyses used by QUINTILES under or
during the term of this Agreement (except where such program, methodology,
process, method or analyses is created or developed at the request and expense
of ALTEON or with the assistance of ALTEON) are the product of QUINTILES'
technical expertise possessed and developed by QUINTILES prior to the date of
this Agreement and are the sole and separate property of QUINTILES (the
"QUINTILES Property").

7.2 Data Retention. QUINTILES may retain copies of all such materials,
records, documents, data, information and reports as required by applicable
laws, rules and regulations. Unless otherwise required by law or by the terms of
this Agreement, all such ALTEON property which QUINTILES shall have in its
possessions shall be maintained by QUINTILES for a period of not less than three
(3) years from the date of receipt thereof and shall be organized in such manner
that it will be ready for immediate reference. After three (3) years or such
longer period as may be required by applicable laws or regulations, QUINTILES
may dispose of such property in accordance with ALTEON's instructions. If ALTEON
fails to give said instructions, QUINTILES shall so notify ALTEON; and if said
instructions are still not forthcoming within thirty (30) days of said
notification, then QUINTILES may destroy such property as it determines.

-11-
15
8. PATENT RIGHTS.

8.1 Invention Disclosure. QUINTILES will disclose promptly to ALTEON or
its nominee any and all patentable inventions, discoveries and improvements
conceived or made by QUINTILES as a result of providing the Services to ALTEON
pursuant to this Agreement and relating to such Services, and agrees to assign
all its interest therein to ALTEON or its nominee; provided, that QUINTILES
shall retain all rights to QUINTILES Property and improvements thereto (except
where such improvement is created or developed at the request and expense of
ALTEON or with the assistance of ALTEON), including any data, processes,
software (including codes) technology, means, and know-how developed by
QUINTILES which relate generally to data collection, data management or
statistical analyses.

8.2 Assignment. Whenever requested to do so by ALTEON, QUINTILES will
execute any and all applications, assignments or other instruments and give
testimony which ALTEON shall deem necessary to apply for and obtain Letters of
Patent of the United States or of any foreign country or to protect otherwise
ALTEON's interests therein, and ALTEON shall compensate QUINTILES for the time
devoted to said activities and in reimburse it for expenses incurred.

9. INDEMNIFICATION AND LIMITATION OF LIABILITY.

9.1 Indemnification of QUINTILES. ALTEON will defend, indemnify and
hold harmless QUINTILES, its affiliates and its and their respective directors,
officers, employees and agents (each an "Indemnified Party") from and against
all losses, claims, actions, damages, liabilities, costs and expenses (including
reasonable attorney's fees and court costs) (collectively, "Losses") from any
claim from any third party relating to or arising out of or in connection with
the performance of the Services to be provided by QUINTILES pursuant to this
Agreement or conducted in accordance with the Protocol, ALTEON's instructions,
or any applicable FDA (or the equivalent Canadian regulatory authority) or other
governmental requirements, except to the extent that such Losses are determined
to be attributable to:

(a) the failure by QUINTILES or any of the QUINTILES's
personnel (including employees, agents or independent contractors) involved in
the Study to adhere to the terms of the applicable Protocol or this Agreement;
or

(b) any negligent or wrongful act or omission, or willful
malfeasance, of QUINTILES or any of the QUINTILES's personnel (including
employees, agents or independent contractors) involved in the Services being
provided by the QUINTILES pursuant to this Agreement.

-12-
16
9.2 Indemnification of ALTEON. QUINTILES will defend, indemnify and
hold harmless Alteon, its affiliates and its and their respective directors,
officers, employees and agents (each an "Indemnified Party"), from and against
all Losses from any claims from any third party, to the extent such Losses are
determined to be attributable to:

(a) the willful failure by QUINTILES or any of the QUINTILES's
personnel (including employees, agents or independent contractors) involved in
the Study to adhere to the terms of the applicable Protocol or this Agreement;
or

(b) any deliberate or wrongful act or omission, or willful
malfeasance, of QUINTILES or any of the QUINTILES's personnel (including
employees, agents or independent contractors) involved in the Services to be
provided by the QUINTILES pursuant to this Agreement.

9.3 Notice; Control of Defense. Each Indemnified Party shall promptly
notify the indemnifying party of the assertion of any claim or suit for which
indemnity hereunder may be sought. Each such Indemnified Party shall permit the
indemnifying party to conduct and control the defense and disposition (including
all decisions relative to litigation, appeal or settlement) thereof with counsel
selected by the indemnifying party and shall cooperate with the indemnifying
party in connection therewith. The Indemnified Party shall have the right, at
its option and its sole expense, to be represented by separate counsel of its
selection in connection with any such claim or suit. Each Indemnified Party
shall not unreasonably withhold approval of the settlement of any claim which is
approved by the indemnifying party.

9.4 Limitation of Liability. Except as may otherwise be provided in
Section 9.2, all liability of QUINTILES for any breach of this Agreement, shall
be limited to damages directly attributable to such breach, (excluding any
special, incidental or consequential damages, even if QUINTILES shall have been
advised of the possibility of such damages) and shall also be limited to the
aggregate compensation received by QUINTILES from ALTEON under this Agreement.

9.5 Investigators. For purposes of this Section 9, the parties
acknowledge that Investigators shall be deemed to be independent contractors of
ALTEON and not of QUINTILES.

10. TERM; TERMINATION.

10.1 Term of Agreement. This Agreement shall become effective on the
date set forth above and shall continue until all Services have been fully and
completely performed by QUINTILES, unless earlier terminated as provided for
herein.

10.2 Termination by ALTEON. ALTEON may terminate either Study, the
scope of Services or any particular project to be performed under this Agreement
for any reason upon thirty (30) days' written notice to QUINTILES. ALTEON may
terminate this Agreement, in its entirety, for any reason upon sixty (60) days'
written notice to QUINTILES.

-13-
17
10.3 Breach. Subject to Section 5.5, upon failure by either party to
cure a material breach of this Agreement within sixty (60) days (or, if such
default cannot be cured within such sixty (60) day period, if the party in
default does not commence and diligently continue actions to cure such default)
after a written demand for performance, the notifying party shall have the right
at any time to terminate this Agreement. Such right to terminate shall be in
addition to any and all other legal remedies which such party may have for the
enforcement of any and all terms hereof, and does not in any way limit any other
legal remedy such party may have. No delay or failure to enforce this or any
other provision, or failure to give notice under this Agreement shall constitute
a waiver or limitation of rights enforceable under this Agreement.

10.4 QUINTILES's Obligations Upon Early Termination. In the event of
any termination of this Agreement, any Study or any portion thereof by either
party pursuant to Section 10.2 or 10.3, QUINTILES shall use all reasonable
efforts to conclude or transfer such Study or Studies or portion thereof, as the
case may be, as expeditiously as practicable and in accordance with all
applicable laws, rules and regulations, including those of the FDA (or the
equivalent Canadian regulatory authority) to terminate all obligations as soon
as possible to avoid incurring additional expenses. Further, QUINTILES and
ALTEON shall cooperate with each other during each termination of such Study or
Studies or portion thereof, as the case may be, to safeguard patient safety,
continuity of patient treatment and to comply with applicable laws, rules and
regulations.

10.5 ALTEON's Obligations upon Early Termination. In the event of
termination of this Agreement, any Study or any portion thereof by ALTEON
pursuant to Section 10.2 or by QUINTILES pursuant to Section 10.3, QUINTILES
shall be promptly paid in full for all work and service performed pursuant to
this Agreement, or relating to such Study or portion thereof, as the case may
be, including all fees and other out-of-pocket expenses, as of the date work
pursuant to this Agreement, or on such Study or portion thereof, as the case may
be, is actually concluded, plus all reasonable costs associated with termination
of such Services, such as non-cancelable third party costs associated therewith.
In the event of termination by ALTEON pursuant to Section 10.3, ALTEON shall pay
all costs which have been incurred by QUINTILES through the date of such
termination, but shall not be responsible for non-cancelable third party costs
associated therewith.

10.6 Survival. Termination, relinquishment or expiration of this
Agreement for any reason shall be without prejudice to any rights which shall
have accrued to the benefit of either Party prior to such termination,
relinquishment or expiration. The rights and obligations of the parties under
Sections 5.10, 5.11, 6, 7, 8, 9, 10.4, 10.5, 12.6 and 12.7 shall survive the
termination of this Agreement.

11. FORCE MAJEURE.

11.1 Force Majeure. The parties shall be excused from performing their
obligations under this Agreement if its performance is delayed or prevented by
any event beyond such party's

-14-
18
reasonable control, including, but not limited to acts of God, fire, explosion,
weather, disease, war, insurrection, civil strife, riots, government action, or
power failure, provided that such performance shall be excused only to the
extent of and during such disability. Any time specified for completion of
performance in this Agreement falling due during or subsequent to the occurrence
of any of such events shall be automatically extended for a period of time equal
to the period of such disability. QUINTILES will promptly notify ALTEON if, by
reason of any of the events referred to herein, QUINTILES is unable to meet any
such time for performance specified in this Agreement.

12. MISCELLANEOUS.

12.1 Relationship of Parties. Nothing in this Agreement is intended or
shall be deemed to constitute a partnership, agency, employer-employee or joint
venture relationship between the parties. No party shall incur any debts or make
any commitments for the other, except to the extent, if at all, specifically
provided herein.

12.2 Assignment. This Agreement may not be assigned, and the
obligations hereunder cannot be delegated, in whole or in part by QUINTILES
without the prior written consent of ALTEON. QUINTILES may delegate or
subcontract Services to be provided under this Agreement to any other subsidiary
of Quintiles Transnational Corporation. In no event shall any assignment or
subcontract of work release QUINTILES from any of its obligations hereunder and
any assignee or subcontractor shall agree to be bound by the terms of this
Agreement as if it were an original party hereto. This Agreement shall be
binding upon the successors and permitted assigns of the parties. Any assignment
not in accordance with this Section 12.3 shall be void.

12.3 Notices. All legal notices hereunder shall be in writing and shall
be deemed given if delivered personally or by facsimile transmission (receipt
verified), telexed, mailed by registered or certified mail (return receipt
requested), postage prepaid, or sent by express courier service, to the parties
at the following addresses (or at such other address for a party as shall be
specified by like notice; provided, that notices of a change or address shall be
effective only upon receipt thereof):

(a) If to ALTEON, addressed to:

Alteon Inc.
000 Xxxxxxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000-0000
Attention: Xx. Xxxxx X. Xxxxxx, Chairman and Chief
Executive Officer
Telephone No.: (000) 000-0000
Facsimile No.: (000) 000-0000

cc:

-15-
19
Xxxxxxx X. Xxxxx, Esq.
Smith, Stratton, Wise, Xxxxx & Xxxxxxx
000 Xxxxxxx Xxxx Xxxx
Xxxxxxxxx, Xxx Xxxxxx 00000

(b) If to QUINTILES, addressed to:

Quintiles, Inc.
0000 Xxxxxx Xxxx
Xxxxxx, Xxxxx Xxxxxxxx 00000
Attention: Xxxxxxx X. Xxxxxxxx, Dr. P.H.
Telephone No.: (000)000-0000
Facsimile No.: (000)000-0000

12.4 Amendment. No amendment, modification or supplement of any
provision of this Agreement shall be valid or effective unless made in writing
and signed by a duly authorized officer of each party.

12.5 Waiver. No provision of this Agreement shall be waived by any act,
omission or knowledge of a party or its agents or employees except by an
instrument in writing expressly waiving such provision and signed by the waiving
party.

12.6 Governing Law. This Agreement shall be governed by and interpreted
in accordance with the laws of the State of New Jersey, applicable to contracts
executed and performed wholly within the State of New Jersey.

12.7 Alternative Dispute Resolution. Except with respect to breaches
for which a Party is seeking injunctive relief, all disputes between the Parties
relating to this Agreement or the subject matter hereof which cannot be resolved
by the Parties, shall, upon written notice by one Party to the other, be
submitted for settlement by means of alternative dispute resolution, which can
include moderated settlement, minitrial, use of expert advisor mediation or
non-binding arbitration, as provided in the New Jersey Alternative Procedure for
Dispute Resolution Act, N.J.S.A. 2A:23A-1 et seq. (the "Act"). All proceedings
for the alternative resolution of a dispute (an "ADR Proceeding") shall be
designed to conclude within four (4) months of the original notice and shall be
held at a mutually agreeable location or in New York City. If the Parties cannot
agree on the form of ADR Proceeding to be used, then binding arbitration, with
an independent arbitrator acceptable to both Parties, shall be used. The Parties
shall have ten (10) days after notice is received by the other Party to mutually
agree on an umpire for the ADR Proceeding, who shall be selected from among the
members of J-A-M-S Endispute, located in Morristown, New Jersey. If the Parties
cannot agree on the umpire to be used within such period, J-A-M-S Endispute
shall appoint one of its members to serve as umpire for the ADR Proceeding. All
fees and expenses associated with the ADR Proceeding shall be divided equally
between the parties; provided that each party shall be responsible for such
party's own attorneys' fees and disbursements. The Act shall govern the
procedures and methods for any ADR

-16-
20
Proceeding demanded or undertaken pursuant to this Agreement. The Parties will
cooperate with each other in causing the ADR Proceeding to be held in as
efficient and expeditious a manner as practicable.

12.8 Entire Agreement of the Parties. This Agreement, together with all
Exhibits attached hereto, constitutes and contains the entire understanding and
agreement of the parties and cancels and supersedes any and all prior
negotiations, correspondence, understandings and agreements, whether oral or
written, between the parties respecting the subject matter hereof.

12.9 Counterparts. This Agreement may be executed simultaneously in two
counterparts, either one of which need not contain the signature of more than
one party but both such counterparts taken together shall constitute one and the
same agreement.

12.10 Descriptive Headings. The descriptive headings of this Agreement
are for convenience only, and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.

IN WITNESS WHEREOF, each of the parties has caused this Agreement to be
executed by its duly authorized officer as of the date first above written.

ALTEON INC.

By: /s/ Xxxxx X. Xxxxxx
-------------------
Name: Xxxxx X. Xxxxxx
---------------
Title: Chairman, CEO
---------------

QUINTILES, INC.

By: /s/ X.X. Xxxxxxxx
-------------------
Name: X.X. Xxxxxxxx
---------------
Title: Vice President
---------------

-17-
21
EXHIBIT A

DATA MANAGEMENT REQUIREMENTS

------------------------------------------------------------------------------------------------------------
1. DATABASE STRUCTURE
1. Provide completed database
specifications for how data will be
returned to Alteon following Kickoff
meeting in Kansas City
5 Days Approval X

------------------------------------------------------------------------------------------------------------
2. Design and create database structure
within 1 week of fully executed contract. 7 Days X
------------------------------------------------------------------------------------------------------------
3. Provide Screen Layouts and report
documentation showing number of data
records imported to establish the CRO
database as "live" and fully operational. 14 Days X
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
B. EXCEPTION CRITERIA
------------------------------------------------------------------------------------------------------------
1. Develop CRF exception criteria (data 15 Days
edit checks). Alteon will provide support Coding
& previous exception criteria used by 15 Days
HMR at Kickoff Meeting in Kansas City. Debug Final Approval X
15 Days
Modifications

------------------------------------------------------------------------------------------------------------
2. First "Live" exception run & status 30 Days X
reports
------------------------------------------------------------------------------------------------------------
3. All exceptions that are generated will 3 Days from
be audited to ensure authenticity (not X
erroneous)

"live" run
------------------------------------------------------------------------------------------------------------
4. Prepare audit reports detailing
exceptions generated. Submit plan to
complete backlog processing within 45
days. Including any outstanding (current) 7 Days from
HMR edits that will be supplied by X
Alteon (Not to exceed 250). "live" run
------------------------------------------------------------------------------------------------------------
5. Generate second exception run within
45 days of first run. Every run thereafter
shall not exceed a 30 day interval. All
open exceptions shall be resolved within 45 Days from
the normal 30 day interval prior to "live" run X
subsequent exception runs.
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
6. Provide monthly report showing all
exceptions completed within last 30 days
showing exception #, Description, Date
completed, Date entered to system, CRA 30 Days
Responsible, Site number, Resolution following 2nd Approval X
run
------------------------------------------------------------------------------------------------------------
7. Provide monthly report showing all
outstanding Exceptions showing
exception #, description, Date generated,
Status, expected completion date, 30 Days
comments, Site #, and CRA responsible following 2nd Approval X
run
------------------------------------------------------------------------------------------------------------
8. Assist Alteon in monthly review of
the exception system to identify problems
and jointly suggest and effect corrections 30 Days
and modifications following 2nd X X
run
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
3. CRF TRACKING , DATA ENTRY, DATA
REVIEW
------------------------------------------------------------------------------------------------------------
1. Independent double data entry with
100% validation. X
------------------------------------------------------------------------------------------------------------
2. Data online for all CRF pages
received in-house within 7 Days. X
------------------------------------------------------------------------------------------------------------
3. All data online and exceptions
resolved prior to semi-annual safety Semi- X
meeting. Annual
------------------------------------------------------------------------------------------------------------
4. Perform an in-house quality control
review of CRFs prior to data entry for
missing pages, legibility of comments,
clarification of medication names,
accuracy of patient identification, on each
page and correct pagination throughout Daily X
the CRF.
------------------------------------------------------------------------------------------------------------
5. Comments or other textual information
must be redirected to an appropriate
comment/data field on the CRF or
deleted following Alteon approval. Daily X
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
4. AUDIT TRAIL
------------------------------------------------------------------------------------------------------------
1. Maintain an audit trail log for all
changes to the database and/or the CRF.
Make audit log available for review
during monthly Alteon audit. Daily X
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
2. Audit trail will show the history of
all study data including Old Value, New
Value, Date/Time Changed, who made
the change, reason for the change. Make
Log available to Alteon during monthly Daily X
audit trips.
------------------------------------------------------------------------------------------------------------
3. Perform a final CRF inventory
before database finalization to ensure that 45 Days prior
all CRFs have been collected from the to the end of
sites and transferred to the CRO. both protocols X
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
5. CODING
------------------------------------------------------------------------------------------------------------
1. Coding of adverse events will be
done using the WHO data dictionary
with HMR modifications supplied by
Alteon to be incorporated into the CRO 10 Days X
dictionary.
------------------------------------------------------------------------------------------------------------
2. For previous/concomitant medications
the CRO can utilize their in-house data Daily X
dictionary.
------------------------------------------------------------------------------------------------------------
3. Alteon to provide resolution to
medication names which do not code
against the dictionary. CRO to make any
necessary database corrections. Daily X
------------------------------------------------------------------------------------------------------------
6. MANAGEMENT REVIEW OF DATA
------------------------------------------------------------------------------------------------------------
1. A 100% verification of all data fields
(CRF versus database) will be done for a
sample of patients at timepoints
determined by Alteon. Any errors
identified will be corrected. Performed
when Alteon feels is appropriate for the As- Approval X
study. Done jointly by Alteon & CRO Determined
Staff.
------------------------------------------------------------------------------------------------------------
2. If error rate from review exceed 5%
of samples reviewed the CRO will
perform a full in-depth audit of the
database versus the CRF forms to ensure
accuracy within a 30 day period
following the original review and report
to Alteon the problems found, resolutions
made, procedures adopted to prevent
subsequent failure percentages. As-required X
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
7. ADVERSE EVENTS
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
1. Import the HMR Serious Adverse
Event (SAE) database into the CRO
desired database format (ie. SAS, Oracle, 30 Days X
etc.)
------------------------------------------------------------------------------------------------------------
2. Continue entering Adverse Event data
including, XX Xxx, AE Module, Study
Termination, dose/dispensing
information, patient disposition. Daily X
------------------------------------------------------------------------------------------------------------
3. SAE Reporting
a. Provide monthly Reports of all SAE Monthly
data entries for
the proceeding month including XX
Xxx, AE Module, Study
Termination, dose/dispensing
information, patient disposition (or
data CRO deems pertinent).
b. Database of adverse events provided As-Required X
at Alteon's request for IND reporting
and NDA submission preparation.
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
8. END-STUDY AUDIT
------------------------------------------------------------------------------------------------------------
1. Performed after all CRF's have been
entered, exception processing and
corrections have been completed, all Prior to
outstanding updated have been Database
reconciled. Audit will be completed Finalization X
prior to Database Finalization.
------------------------------------------------------------------------------------------------------------
2. Minimum * data fields verified (CRF
versus database); acceptable error rate
*%. If audit reveals greater error rate
than *% an additional * data fields(or Prior to
*% of remaining fields, whichever is Database
greater) will be sampled and corrected. X
Finalization
------------------------------------------------------------------------------------------------------------
3. Alteon will provide complete
guidelines for end study audit with input X
from the CRO.
------------------------------------------------------------------------------------------------------------
4. Documentation for the audit will
include: who performed the audit, dates
audit performed, patient numbers
verified, total number of fields verifies,
number and description. X
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
9. DATABASE FINALIZATION
------------------------------------------------------------------------------------------------------------

* Confidential Treatment Requested
25

------------------------------------------------------------------------------------------------------------
Database finalization within 4 weeks of 30 Days
last patient data in-house and End-Study from X
Audit completed. last data
entry
------------------------------------------------------------------------------------------------------------
2. All data inhouse and online, Patient 30 Days from
disposition coding complete, End study X
audit complete and with acceptable error last data entry
rate, Alteon approval of adverse coding,
TAN reconciliation (treatment assignment
number) if the CRF differs from the
TAN on any study medication label.
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
10. RANDOMIZATION VERIFICATION
------------------------------------------------------------------------------------------------------------
1. 100% verification of the TAN 14 days from
recorded in the CRF, the drug assigned X
to the patient in the database, and the database
drug assigned to the TAN on the finalization
randomization schedule.
------------------------------------------------------------------------------------------------------------
2. Provide Alteon an electronic copy of
the randomization schedule. X
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
11. DATA DOCUMENT SUMMARY IN
CLINICAL STUDY REPORT (CSR)
------------------------------------------------------------------------------------------------------------
1. Summary of data quality procedures
used for the study, including exception
criteria and end study audit results
(patient numbers verified , errors Two weeks of
identified, total number of data fields Database
verified, and calculated error rate) within X
two weeks of database finalization. Finalization
------------------------------------------------------------------------------------------------------------
2. Standard template provided by Alteon X
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
12. POST FINALIZATION CHANGES
------------------------------------------------------------------------------------------------------------
1. If any post finalization changes are
identified after the database has been
finalized, and the drug coded unblinded,
evaluate the impact of making the
change(s) and provide recommendation. As- X
Database will be updated at the sole Required
discretion of Alteon.
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
13. DATABASE DOCUMENTATION
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
1. All computer programs used to
support creation, clean-up, and reporting
of the database will be provided to
Alteon within 6 weeks of the CSR. 6 weeks from
(This includes derived data) CSR X
------------------------------------------------------------------------------------------------------------
2. The disposition criteria, programs
used to assign disposition codes, major
and minor protocol violation codes, and
the disposition and violation codes X
assigned to each patient.
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
14. SAS DATASETS
------------------------------------------------------------------------------------------------------------
1. Complete datasets and all copies of 6 weeks from
CRFs provided within 6 weeks of final X
CSR. CSR
------------------------------------------------------------------------------------------------------------
2. Alteon will load datasets inhouse data
management system.
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------
15. COMMUNICATIONS
------------------------------------------------------------------------------------------------------------
1. All communications with Alteon
Clinical Data Management will be
documented and distributed within 5 As-Required X
working days.
------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------

27
EXHIBIT B

TRANSFER OF OBLIGATIONS TO QUINTILES

ALTEON shall report to the FDA (or the equivalent Canadian regulatory
authority) that QUINTILES will assume the following obligations with respect to
the Studies:

1. QUINTILES will maintain or update each, as necessary, of the following
documents with respect to each Study from each Investigator to be
monitored by QUINTILES:

a. A completed and signed Form FDA-1572 (or the Canadian
equivalent).

b. Current curriculum vitae of the principal Investigator and all
secondary Investigators identified on Form FDA- 1572 (or the
Canadian equivalent).

c. Protocol signature page signed by the principal Investigator.

d. A copy of the informed consent form to be used by the
Investigator.

e. IRB approval of the Protocol and informed consent form.

f. As appropriate, IRB approval of Protocol amendments and annual
reapprovals.

2. QUINTILES will provide all participating Investigators with updated
investigators' brochures, as appropriate, and, as the investigation
proceeds, keep each participating Investigator informed of new
information received from ALTEON regarding the Compound.

3. In accordance with 21 CRF 312.32 (or the Canadian equivalent),
QUINTILES will promptly inform Investigators and ALTEON of any
important safety information, including serious adverse experiences
received by QUINTILES.

4. QUINTILES will report to ALTEON any Investigator that is not complying
with his/her signed agreement (Form FDA-1572, or the Canadian
equivalent), end the Investigators participation in the Studies, and
recover unused Compound.

5. QUINTILES will select qualified personnel by training and experience to
manage and monitor the progress of the investigation. QUINTILES shall
use such percentage of individuals who are QUINTILES employees as CRAs
as QUNITLIES and ALTEON shall determine is appropriate (calculated on
the basis of the number of CRA personhours necessary). All CRAs shall
be subject to ALTEON's reasonable approval.

6. QUINTILES will monitor the Studies in accordance with all now or
hereafter applicable Federal, national, state and local laws, statutes,
ordinances and regulations, including without limitation, FDA (or the
equivalent Canadian
28
regulatory authority) guidelines on the responsibilities of sponsors,
monitors and clinical Investigators and informed consents.

7. QUINTILES will summarize the evidence related to the safety of the
Compound as it is obtained from the Investigators being monitored by
QUINTILES and make such evidence available to ALTEON.

8. QUINTILES will undertake the management of the shipment of Compounds to
Investigators and the maintenance of adequate records showing receipt,
shipment, and disposition of Compound in accordance with 21 CRF
312.57(a) (or the Canadian equivalent).

9. QUINTILES will verify the proper return of all unused supplies of
Compound from each Investigator whose participation in the Studies is
completed or terminated.

10. QUINTILES will retain records and reports associated with the Studies
in accordance with 21 CRF 312.57(b) (or the Canadian equivalent).
29
EXHIBIT C

BUDGET
30
BUDGET
PROTOCOL 0002

PROJECT SET-UP/INITIATION
Project Transfer and Start-up *
Development of Study Files *
SUBTOTAL PROJECT SET-UP INITIATION: *

CLINICAL TRIAL MANAGEMENT
Clinical Monitoring - Interim, Close-Out Visits *
Clinical In-House Administration *
Drug Distribution Management *
GCP/GMP Site Audits *
SUBTOTAL CLINICAL TRIAL MANAGEMENT *

MEDICAL SUPPORT
AE Processing and Reporting *
SUBTOTAL MEDICAL SUPPORT *

CLINICAL DATA MANAGEMENT
Database Design and Maintain *
CRF Tracking *
Edit Specifications, Pre-Entry Edit, DCF/Queries Resolution *
Data Entry, Database Audit *
Coding - Disease, Medication, Adverse Events *
SUBTOTAL CLINICAL DATA MANAGEMENT *

BIOSTATISTICAL ANALYSIS
Annotated Report Outline *
Statistical/Integrated Study Report *
SUBTOTAL BIOSTATISTICAL ANALYSIS *

SUPPORT SERVICES
Project Management *
Administrative Support *
Client Meetings *
SUBTOTAL SUPPORT SERVICES *

TOTAL QUINTILES FEES *

MISCELLANEOUS COSTS
Monitoring Travel *
Client Meeting Travel *
Investigator Meeting Travel *
GCP Audit Travel *
Computer Support *
Copying/Printing, Postage, Telephone, Supplies *
SUBTOTAL MISCELLANEOUS COSTS *

GRAND TOTAL *

*CONFIDENTIAL

TREATMENT

REQUESTED
31
BUDGET
PROTOCOL 0009

PROJECT SET-UP/INITIATION
Project Transfer and Start-up *
Development of Study Files *
SUBTOTAL PROJECT SET-UP INITIATION: *

MEDICAL SUPPORT
AE Processing and Reporting *
SUBTOTAL MEDICAL SUPPORT *

CLINICAL DATA MANAGEMENT
Database Design and Maintain *
CRF Tracking *
Edit Specifications, Pre-Entry Edit, DCF/Queries *
Data Entry, Database Audit *
Coding - Disease, Medication, Adverse Events *
SUBTOTAL CLINICAL DATA MANAGEMENT *

BIOSTATISTICAL ANALYSIS
Annotated Report Outline *
Statistical/Integrated Study Report *
SUBTOTAL BIOSTATISTICAL ANALYSIS *

SUPPORT SERVICES
Project Management *
Administrative Support *
Client Meetings *
SUBTOTAL SUPPORT SERVICES *

TOTAL QUINTILES FEES *

GRAND TOTAL *

*CONFIDENTIAL

TREATMENT

REQUESTED
32
ALTEON
SAE REPORTING FOR PROTOCOL PR0014 AND PR0016

MEDICAL MANAGEMENT
Medical Monitoring *
AE Processing and Reporting *
SUBTOTAL MEDICAL MANAGEMENT *

TOTAL QUINTILES FEES *

MISCELLANEOUS COSTS
Computer Support, Copying, Printing, Shipping, *
Communication, Supplies *

QUINTILES TOTAL ESTIMATED COST *

*CONFIDENTIAL

TREATMENT

REQUESTED

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Table of Contents

EXHIBIT 10.35 CLINICAL SERVICES AGREEMENT

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