MASTER CLINICAL SERVICES AGREEMENT
THIS AGREEMENT, effective as of January 1, 1997
by and between
XXXXXX S.p.A., a company incorporated in Italy, having its legal seat and
principal place of business at Xxx Xxxxxx Xxxxx, 00 - 00000 Xxxxxx, Xxxxx
(hereinafter referred to as "BRACCO"),
and
BIO-IMAGING TECHNOLOGIES, INC., a Delaware corporation of the United States of
America, having its legal seat and principal place of business at 000 Xxxx
Xxxxxx Xxxx, Xxxx Xxxxxxx, Xxx Xxxxxx (hereinafter referred to as
"BIO-IMAGING").
WITNESSETH
WHEREAS, BRACCO desires to execute the present Agreement with BIO-IMAGING, that
hereby declares to have the full right to execute it, and BIO-IMAGING desires to
sign said Agreement with BRACCO for the purposes of providing BRACCO with
dedicated BIO-IMAGING personnel (hereinafter referred to as Personnel) and
resources (hereinafter referred to as Resources) in order to assist BRACCO with
clinical research activities (hereinafter referred to as Clinical Programs),
described in the Exhibits attached hereto and in any Exhibits attached as
addenda to this Agreement, in Europe;
In consideration of the above premises, which form an integrate part of the
present AGREEMENT, the parties hereby agree as follows:
1. DEFINITIONS
Wherever used in the present Agreement, the following terms shall have the
following meanings:
Agreement: Agreement has the meaning specified in the preliminary
statements.
BRACCO: BRACCO has the meaning specified in the preliminary statements.
BIO-IMAGING TECHNOLOGIES, INC.: BIO-IMAGING has the meaning specified in
the preliminary statements.
Effective Date: Effective Date is January 1, 1997, irrespective of the date
of the signature of this Agreement.
Claim: claim has the meaning specified in Paragraph 11.
Indemnified Party: Indemnified Party has the meaning specified in Paragraph
11.
Loss: Loss has the meaning specified in Paragraph 11.
Drug: Drug means a new or existing drug under development by BRACCO and is
the subject of a Clinical Program.
Personnel: shall mean the persons employed by BIO-IMAGING and devoted
entirely or almost entirely as the case may be, to BRACCO Clinical Programs.
They may be used on a full-time or part-time basis, in accordance with the
Exhibit attached hereto and any Exhibits attached as addenda. They include
personnel from BIO-IMAGING departments of core laboratory services, image data
management, software development, business development and contract management,
and may include employees from other offices. BIO-IMAGING, under its control and
responsibility and maintaining any contractual liability towards BRACCO, may
have part of the activities herein specified executed by its fully owned
subsidiary, Bio-Imaging Technologies B.V., of Leiden, the Netherlands. A full
time employee is defined as one working 1600 hours in a twelve month period. All
other employees' time is a portion of a full time employee pro-rated in
accordance with the Exhibits to this Agreement.
- 2 -
Resources: shall mean the BIO-IMAGING overhead which is normally not
directly attributable to particular projects. They include office space,
information services, telephone, travel, management time, finance, legal and
administration services, etc., in order to optimize and facilitate the working
on the Clinical Programs. All the relevant costs for the Resources are included
in the fixed costs to be borne for the dedicated Personnel, as described above,
and as shown in the Exhibit here attached and which will be shown in any
Exhibits attached as Addenda.
Clinical Programs: shall mean the programs for the development of a
clinical drug at any time from Phase 1 to Phase 4 of its development, for the
particular compound for which the relevant regulatory approval must be obtained
in the designated country of Europe. This term shall refer to all the programs
for which the tasks are described in the attached Exhibit, in future Exhibits
attached as Addenda, as well as to future tasks, that may be contracted by the
parties from time to time.
Interface Persons: shall mean the persons appointed by BRACCO and
BIO-IMAGING that shall have the responsibility to act as liaison between BRACCO
and BIO-IMAGING on a regular basis, in order to facilitate adherence to the
monthly priorities, relating to the clinical programs set by BRACCO and agreed
to by BIO-IMAGING in writing and to jointly solve all the problems related to
the tasks to be performed by BIO-IMAGING for the Clinical Programs. The names of
the Interface Persons are shown in the Exhibit attached hereto and will be shown
in future Exhibits attached as Addenda.
Joint Management: shall mean the BRACCO and BIO-IMAGING joint management of
the Clinical Programs through the Interface Persons. BRACCO will define and
definitely take reasonable decisions on (i) the priorities within and across the
Clinical Programs on a monthly basis, and (ii) after discussion with
BIO-IMAGING, on the relevant monthly objectives, the tasks and the allocation of
Personnel and Resources.
Milestones: shall mean the key events in the schedule of the Clinical
Programs. These Milestones are preliminary indicated in Exhibits and can be
modified by BRACCO, after discussion with BIO-IMAGING, every three ( 3 ) months.
Training: shall mean the educational programs which will be provided by
BIO-IMAGING to the Personnel in connection with the Clinical Programs. Training
if required, will be provided at BIO-IMAGING 's expense.
- 3 -
Confidential Information: shall include all information relating to plans,
products, intellectual property, analyses, projects, processes, marketing
research or development activities, and all technical or scientific know-how of
BIO-IMAGING or BRACCO disclosed by one party ( the "Disclosing Party") to the
other (the "Receiving Party") either orally, in diagram, written or other
recorded form.
2. OBJECT AND OBLIGATION
2.1 BIO-IMAGING, subject to the approval for the relevant Ethical Committee and
of any other competent regulatory authority, and/or of any other necessary
authorization, agree to diligently perform all the tasks described with full
particulars in the attached Exhibit(s) which forms an integral part of the
present Agreement, at the terms and conditions herein set forth.
2.2 BIO-IMAGING shall also devote the necessary Personnel and Resources to
perform for BRACCO the services herein described, and the core laboratory and
data management services described within the attached Exhibit and any future
Exhibits attached as Addenda. It is hereby exclusively agreed that the number of
people that will form the Personnel is detailed in the attached Exhibit and will
be detailed in any future Exhibits attached as Addenda.
The tasks provided for in the present Agreement shall be carried out by Joint
Management. It is understood that such Joint Management shall not include, in
any case, any kind of interference by BRACCO with the management of the
Personnel or of other BIO-IMAGING personnel, since they are fully under the
whole responsibility of BIO-IMAGING.
BRACCO is willing to support Bio-Imaging, if so reasonably requested, in the
performance of the tasks, specified within the present Agreement, in accordance
with the Milestones.
The parties shall measure every three (3) months the achievement of progress on
the Clinical Programs, which will be monitored with reference to the Milestones.
In case said achievement of progress in the Clinical Programs does not match the
Milestones, BIO-IMAGING undertake to take all the necessary steps, in order to
solve the situation, in the shortest possible time, unless otherwise agreed in
writing with BRACCO.
- 4 -
If no satisfactory remedy is put in practice by BIO-IMAGING, BRACCO shall have
either the right to ask for and obtain the performance from BIO-IMAGING , in a
determined period of time, free of charge, or to terminate immediately the
present Agreement for BIO-IMAGING's fault, unless BIO-IMAGING has proven that
the delay has been directly caused by evident fault or gross negligence of
BRACCO.
2.3 BIO-IMAGING undertake to perform its obligation under this Agreement in
strict accordance with EEC Directives 75/318 and 91/507 (Good Clinical Practice)
and with the provisions of the CPMP Note for Guidance on Good Clinical Practice
for Trials on Medicinal Products in the European Community (111/3976/88-EN),
with the FDA regulations (Regulations in Title 21, Code of Federal Regulations,
Parts 50, 56, 312, 314 and 320) and guidelines (Information and Points to
Consider Sheets; Bioresearch Monitoring; Compliance Program Guidance Manual), as
well as with any other law or regulation applicable in each European country, in
which the Clinical Programs will be conducted.
3. CONFIDENTIAL INFORMATION
3.1 BIO-IMAGING considers all information transmitted in conjunction with the
implementation of the Clinical Programs, whether prior to or subsequent to the
execution of this Agreement, to be proprietary and confidential information from
BRACCO. This confidential information will be held in confidence by BIO-IMAGING,
not disclosed to third parties and not used outside the purpose of the present
Agreement. It shall be understood, however, that confidential information shall
not include the following disclosed information - and the relating obligations
of confidentiality, non-use and non-disclosure shall not apply to - which:
a) is already known to the Receiving Party prior to the date of this Agreement
as documented in the Receiving Party's written records prior to such date; or
b) is already publicly available or which becomes publicly available other than
through a breach of this Agreement by the Receiving Party; or
c) is rightfully received by the Receiving Party from a third party without
similar restriction from such party, where the disclosure by such third party
does not constitute a violation of an obligation by such third party to the
Disclosing Party; or
- 5 -
d) is required to be disclosed by law, rule, regulation, order, decision, decree
or subpoena or other order by a Court or administrative Authority.
3.2 The Receiving Party will use the confidential information received by the
Disclosing Party only for the purpose of fulfilling its obligations under this
Agreement. Upon the completion or earlier termination of this Agreement, the
Receiving Party will promptly return to the Disclosing Party all written
confidential information, as well as all written material which incorporates any
confidential information.
3.3 The Receiving Party will not disclose, without the prior written consent of
the Disclosing Party, such confidential information to any third party other
than employees, like (i) consultants involved in the Training, who need to know
such information, and (ii) others designated in writing by the Receiving Party,
who prior to disclosure shall have agreed to observe the confidentiality of this
information in the same manner and to the same extent as provided in this
Agreement for the Disclosing Party and its employees.
3.4 The Receiving Party will not use any such confidential information for its
own benefit or for the benefit of any third party and will not give to third
party materials which incorporate any confidential information, except as
otherwise herein above provided. All obligations of confidentiality, non-use and
non-disclosure set forth in this Agreement will survive, without limitation, for
fifteen (15) years after the expiration or earlier termination, for any reason,
of this Agreement.
4. PERSONNEL
4.1 BIO-IMAGING, as above specified, will have a dedicated team of Personnel and
specific Resources, in order to diligently fulfill all its obligations set forth
in the present Agreement. The full time Personnel shall work exclusively for
BRACCO for an agreed number of hours, as specified in the Definitions above. The
choice of individuals shall be made by BIO-IMAGING in consultation with BRACCO,
which shall have a right of veto on each single appointment.
4.2 It is hereby agreed that BIO-IMAGING will organize, at its own expenses, the
Training on Clinical Programs for the people that, during the life of the
present Agreement, shall be part of the Personnel, in order to ensure efficiency
and proper utilization of the Personnel itself. It is
- 6 -
understood that the Personnel shall report exclusively to BIO-IMAGING,
BIO-IMAGING shall have, always and in any case, the responsibility of the
Personnel.
4.3 BIO-IMAGING shall bear full and exclusive liability also for the payment of
any kind of compensation, salary or other fee or indemnity of whatsoever nature
to the Personnel, as well as any and all kind of contributions, taxes or other,
now or hereafter imposed by any governmental authority, with respect to or
measured by wages, salaries, or other compensation to be paid by BIO-IMAGING to
the Personnel. BIO-IMAGING further agrees to indemnify and save BRACCO and its
affiliates harmless against any and all such liability or claims in connection
with BIO-IMAGING's exclusive liability stated in this Paragraph 4.3.
4.4 BIO-IMAGING shall also be responsible for any injuries (including death)
occurred to the Personnel and other BIO-IMAGING's agents, employees,
representatives or invitees and in general to any and all other persons acting
under or by reason of the present Agreement, unless this is due to willful
misconduct or gross negligence of BRACCO in providing the information regarding
the known hazards.
4.5 It is hereby agreed that if the number of the persons being part of the
Personnel, during the validity of this Agreement, should be too great or too
small, with respect to the Clinical Programs to be performed by BIO-IMAGING, the
parties hereto shall agree upon the exact number of persons to be dedicated to
the Personnel and BIO-IMAGING shall immediately give prompt execution to said
decision.
4.6 BIO-IMAGING agrees to inform BRACCO in writing, thirty (30) days in advance,
if possible and, anyway, as soon as possible, in any case of intended changes in
the Personnel, due to whatsoever reason. BIO-IMAGING hereby ensures that the
substitutes will be educated by the Training on Clinical Programs prior to
joining the Personnel and prior to performing any tasks related to the Clinical
Programs.
4.7 BRACCO hereby agrees not to hire the Personnel, and in general the parties
hereby agree not to hire the personnel of the other party, without a prior
discussion and agreement between them, and, in any case, fully respecting all
the applicable laws and regulations then in force in the field of labor. Any
infringement of this provision made by one of the parties will entitle the other
party to terminate the present Agreement in accordance with Article 7
hereinbelow.
- 7 -
5. CO-OPERATION BETWEEN THE PARTIES
5.1 The parties will discuss in good faith any terms and conditions of new
Clinical Programs that may be assigned to BIO-IMAGING by BRACCO in the future,
to ensure that the Personnel can be properly technically and adequately staffed
and educated with the Training, as well as to ensure that BIO-IMAGING will
dedicate proper Resources to the new Clinical Programs. BRACCO, in disclosing
new compounds and their development plan to BIO-IMAGING, agrees to perform the
Joint Management also for the possible and future new Clinical Programs, in
order to ensure the fastest and most efficient manner for the European
development for the compound.
5.2 The Parties agree to invite each other to seminars and training workshops on
topics of interest to the Parties, so to enhance the Joint Management between
them. Such seminars and training workshops will be free of charge. The Parties
will keep each other constantly informed about the training opportunities. Each
Party shall bear its own out of pocket costs, relating to the mentioned
workshops.
6. CONSIDERATION
6.1 The consideration for the diligent performance of the obligations undertaken
by BIO-IMAGING is specified in the attached Exhibit, and will be specified in
any future Exhibits attached as Addenda, by means of a cost estimate which
specifies all the costs to be borne by BRACCO under this Agreement and contains
also the anticipated costs for providing a dedicated team of Personnel, together
with Resources. It is hereby agreed that all the costs related to the present
Agreement shall be only fixed costs that have been proposed by BIO-IMAGING, and
accepted by BRACCO, in good knowledge of the services required hereunder by
BRACCO.
6.2 BIO-IMAGING will submit invoices to BRACCO at the end of each calendar month
during the term of the Agreement. Payments will be made by BRACCO accordingly
and will be made sixty (60) days after receipt by BRACCO of the relevant
invoices from BIO-IMAGING. The invoice will include the BIO-IMAGING fees
calculated in accordance with the attached Exhibit and any future Exhibits
attached as Addenda and out-of-pocket expenses. Possible revisions of said costs
may be made after a specific agreement of the parties hereto, and may only take
place annually, as of the Effective Date of the present Agreement.
- 8 -
6.3 It is expressly understood and agreed between the parties that all direct
BIO-IMAGING out-of-pocket expenses incurred on behalf of BRACCO such as, but not
limited to, travel and shipping expenses, shall be detailed to BRACCO by means
of proper documentation and will involve no administration fee. The bills for
such out-of-pocket expenses will be summarized and attached to each invoice.
BRACCO shall have the right to audit out-of-pocket expenses on a quarterly basis
after advance written notice as of the effective date.
6.4 BRACCO agrees also to make advance payments not higher than the fixed
BIO-IMAGING cost estimates of a three-(3) month period as well as estimated
out-of-pocket costs of a three-(3) month period. Said advance payments shall be
discharged on the relevant costs to be paid by BRACCO and shall be made within
thirty (30) days of signing this Agreement.
6.5 All payments to be made by BRACCO shall not bear interest if paid in due
time. Interest may be charged at the rate of four percent (4%) over the
Interbank Rate of the major bank in the country relating to the currency used
for the relevant payments.
6.6 It is hereby specified that the costs have been estimated on the basis of
the assumptions described in the Exhibit attached hereto, and will be described
in any future Exhibits attached as Addenda. Should an increase in the Personnel
become necessary, the parties will negotiate in good faith such price or amount
of adjustments. Any additional Personnel requested by BRACCO and not specified
in the Exhibit, requires the prior written approval of BIO-IMAGING. The parties
agree that the costs will then be subject to adjustment.
6.7 BRACCO shall inform immediately in writing BIO-IMAGING in case BRACCO needs
a reduction in the Personnel, and BIO-IMAGING shall agree accordingly. However,
it is hereby agreed that the consequent decrease of the relevant costs, due to
the reduction in the Personnel shall take place only three (3) months after the
date of receipt by BIO-IMAGING of the notice hereabove mentioned.
7. TERMINATION
This Agreement may be terminated by BRACCO at any time and without cause upon a
written notice to BIO-IMAGING. In such event, BIO-IMAGING shall be entitled to
receive payments for all the work and services
- 9 -
performed under this Agreement until the above written notice is received by
BIO-IMAGING. BIO-IMAGING shall use its best efforts to conclude the Clinical
Programs as quickly as possible and in accordance with all the laws and
regulations mentioned in Para. 2.3. It is understood that the out-of-pocket
expenses and BIO-IMAGING costs, due and outstanding at the time of termination,
shall be entirely paid by XXXXXX.
0. DEFAULT
BIO-IMAGING shall be in default under the terms and conditions of the Agreement
if BIO-IMAGING negligently fails to perform the Clinical Programs accordingly
with the provisions herein specified. Notwithstanding the foregoing, if any
default occurs, BRACCO shall promptly notify BIO-IMAGING in writing of any such
default. BIO-IMAGING shall have a period of thirty (30) days of the date of
receipt of such notice, to cure such default. If BIO-IMAGING shall fail to cure
it, then this Agreement shall terminate at the end of said thirty (30) day
period.
9. FORCE MAJEURE
Either party shall be excused from performing their obligations under this
Agreement, if its performance is delayed or prevented by any event beyond such
party's reasonable control, including, but not limited to, acts of God, fire,
explosion, disease, weather, war, insurrection, civil strike, 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 or performance of the services under this
Agreement or the applicable Clinical Programs falling during (or subsequent) to
the occurrence of any of such events shall be automatically extended for a
period of time equal to the time of such disability.
BIO-IMAGING will promptly notify BRACCO if, by reason of any of the events
referred to herein, BIO-IMAGING is unable to meet such time for performance of
the services hereunder. If any part of the services rendered hereunder is
invalid as a result of such disability, BIO-IMAGING will, upon written request
from BRACCO, at XXXXXX'x sole cost and expense, repeat that part of the services
rendered hereunder, which are affected by the disability.
- 10 -
Resignation, sickness or pregnancy of the Personnel will impose the use of
alternative Personnel.
10. LIABILITY
BIO-IMAGING assumes full responsibility and liability, either towards BRACCO or
towards third parties, in order to perform all the obligations and tasks
provided for in the present Agreement, in strict accordance with the provisions
of all the laws and regulations mentioned in Para. 2.3 hereinbefore.
11. INDEMNITY
BIO-IMAGING hereby agrees to indemnify, defend, and hold BRACCO, its affiliates,
agents, servants and employees, safe and harmless against any and all liability,
loss, actions or suites (including reasonable attorney's fees) suffered or
incurred by BRACCO, its affiliates, agents servants and employees in force of
this Agreement as a result of acts or omissions of BIO-IMAGING, except for the
extent that any such liability, loss, actions or suits is caused, totally or
partially, by:
- a gross negligence or intentional misconduct of BRACCO, its affiliates,
servants, agents and employees;
- a violation by BRACCO, its affiliates, servants, agents and employees, of any
laws or regulations applicable to this Agreement and to the tasks provided for
therein;
BIO-IMAGING agrees to provide a diligent defense against any claims or actions
brought against BRACCO, its affiliates, agents, servants and employees, whether
such claim or actions are rightly or wrongly brought or filed. BRACCO shall have
the right to participate, at its own discretion, to such a defense, bearing the
relevant expenses.
BRACCO hereby agrees to indemnify, defend, and hold BIO-IMAGING, its affiliates,
agents, servants and employees, safe and harmless against any and all liability,
loss, actions or suites (including reasonable attorney's fees) suffered or
incurred by BIO-IMAGING, its affiliates, agents servants and employees in force
of this Agreement as a result of acts or omission of
- 11 -
BRACCO, except for the extent that any such liability, loss, actions or suits is
caused, totally or partially, by:
- a gross negligence or intentional misconduct of BIO-IMAGING, its affiliates,
servants, agents and employees;
- a violation by BIO-IMAGING, its affiliates, servants, agents and employees, of
any laws or regulations applicable to this Agreement and to the tasks provided
for therein;
BRACCO agrees to provide a diligent defense against any claims or actions
brought against BIO-IMAGING, its affiliates, agents, servants and employees,
whether such claim or actions are rightly or wrongly brought or filed.
BIO-IMAGING shall have the right to participate, at its own discretion, to such
a defense, bearing the relevant expenses.
12. PROPERTY OWNERSHIP
All materials, documents, information and suggestions of any kind and
description supplied to BIO-IMAGING by BRACCO or prepared or developed by
BIO-IMAGING pursuant to this Agreement shall be the sole and exclusive property
of BRACCO and BRACCO shall have the right to make whatever use it deems
desirable of any such materials, documents and information. All technology and
software however developed by BIO-IMAGING on the basis of information, documents
and materials supplied by BRACCO, in the execution of the present Agreement,
shall be the sole property of BIO-IMAGING and BIO-IMAGING hereby undertakes to
license the right to use such technology of software to BRACCO free of charge
for at least 15 years from termination of the present Agreement, at XXXXXX'x
sole request. BIO-IMAGING procedural manuals and Personnel data, as well as
pre-existing BIO-IMAGING developed computer software or technology shall be the
sole and exclusive property of BIO-IMAGING.
In case of termination of the present Agreement for whatever reason BIO-IMAGING
will immediately make at XXXXXX'x disposal all the documents concerning the
activities ruled under this Agreement.
- 12 -
13. PATENT RIGHTS
BIO-IMAGING will disclose promptly to BRACCO or its nominee any and all
inventions, discoveries and improvements, related to the drug(s) under
development by BRACCO, conceived or made by BIO-IMAGING while providing the
services to BRACCO pursuant to this Agreement and relating to such services, and
agrees to assign all its interest therein to BRACCO or its nominee. Whenever
requested to do so by BRACCO, BIO-IMAGING will execute any and all applications,
assignments or other instruments, and give testimony which BRACCO shall xxxx
necessary, to apply for and to obtain the patent rights in any European country
and to protect otherwise XXXXXX'x interests therein. BRACCO shall compensate
BIO-IMAGING for the time devoted to said activities and reimburse BIO-IMAGING
for incurred expenses. These obligations shall continue beyond the termination
of the Agreement with respect to inventions, discoveries and improvements
conceived or made by BIO-IMAGING while providing Personnel and Resources to
BRACCO pursuant to the Agreement, and shall be binding upon BIO-IMAGING's
assignees, administrators and other legal representatives.
14. MODIFICATIONS
No changes may be made in this Agreement except by a written agreement of both
parties.
15. ENTIRETY
This Agreement, together with the attached Exhibit, and any future Exhibits to
be attached as Addenda, is the entire and complete understanding between the
parties in regard to the covered subject matter. It replaces, supersedes and
renders void any and all previous agreements between the parties, whether
written or oral.
- 13 -
16. INDEPENDENT CONTRACTOR
BIO-IMAGING's relationship with BRACCO under this Agreement shall be that of an
independent contractor and nothing in this Agreement for which it is made shall
make BIO-IMAGING, or anyone furnished or used by BIO-IMAGING in the performance
of the services contemplated by this Agreement, a right to be considered as a
joint venturer, partner, employee, or servant of XXXXXX.
00. NOTICES
Any notices to the other party shall be deemed to be duly given, when delivered
personally or mailed by telefax and confirmed by certified or registered mail,
postage prepaid, to the party to whom notice is to be given at the address first
given above or at any other address or addresses of which such party shall have
given written notice.
18. SEVERABILITY
If any provisions hereof shall be determined to be invalid or unenforceable, the
validity and effects of the other provisions of this Agreement shall not be
affected thereby.
19. GOVERNING LAW
This Agreement is governed, construed and interpreted in accordance with the
substantive law of Switzerland.
20. ARBITRATION
The parties will attempt to amicably settle any divergencies or disputes which
may arise in connection with the Agreement.
- 14 -
If a divergency or a dispute between the parties arising out of this Agreement
cannot be settled by them through negotiations in good faith, the parties
reciprocally agree that such divergency or dispute shall be finally settled by a
Panel of three (3) Arbitrators in Geneva (Switzerland) under the UNCITRAL Rules.
Each party will appoint one Arbitrator and the third Arbitrator, acting as
Chairman, will be appointed by the two Arbitrators so appointed or, in case of
their disagreement, according to said Rules. The language to be used will be
English.
The award to be rendered shall be final and conclusive and binding upon all the
parties. The parties hereby exercise the right granted to them by art. 192 of
the Swiss Private International Law and waive their rights to file an appeal
against the arbitral award pursuant to art. 190 of the Swiss International
Private Law.
21. WAIVER
The waiver by either party or the failure by either party to claim a breach of
any provision of this Agreement shall not be deemed to constitute a waiver or a
precedent with respect to any subsequent breach or with respect to any provision
thereof.
22. TERM OF AGREEMENT
This Agreement takes effect as of the Effective Date and shall last for a period
of two (2) years. Thereafter, the parties may agree in writing to extend the
duration term of the present Agreement. Any and all extensions to this Agreement
shall be agreed in writing no later than 90 days prior to any extension.
23. CAPTIONS
Any caption used in this Agreement is inserted only for convenience and
reference and is to be ignored in the construction and interpretation of the
provisions hereof.
- 15 -
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized officers.
Date: Milan 03-June-1997 Xxxxxx S.p.A.
------------------
Name: Xxxxxx Xxxxxxxx, MD
Title: Director,
International Medical
Affairs
Signature: /s/ Xxxxxx Xxxxxxxx, MD
-------------------------------
Name: Pietro Mascherpa
Title: Administrative
Director
Signature: /s/ Pietro Mascherpa
-------------------------------
Date: West
Trenton June 10, 1997 Bio-Imaging Technologies, Inc.
----------------
Name: Xxxxxx X. Xxxxx
Title: President and CEO
Signature: /s/ Xxxxxx X. Xxxxx
-------------------------------
- 16 -
