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EXHIBIT 10.17
Searle/Kendle Master Agreement
CLINICAL TRIAL SERVICES AGREEMENT
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THIS CLINICAL TRIAL SERVICES AGREEMENT (the "Agreement"), made as of
September 23, 1997, by and between KENDLE INTERNATIONAL INC., a corporation
with principal offices at 700 Carew Tower, 441 Vine Street, Cincinnati, Ohio
45202-2816 ("KENDLE") and G. D. SEARLE & CO., a Delaware corporation with
principal offices at 5200 Old Orchard Road, Skokie, Illinois 60077 U.S.A.
("SEARLE").
WITNESSETH:
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WHEREAS, KENDLE is engaged in the business of managing, monitoring and
coordinating multi-site clinical research programs; and
WHEREAS, SEARLE desires KENDLE to manage, monitor and coordinate
various research programs, and KENDLE is willing to provide such services
subject to the terms hereof.
WHEREAS, SEARLE proposes to retain KENDLE as a preferred provider and
recognized expert to work in a close professional relationship with SEARLE to
assist in the worldwide development of its Pharmaceutical Products.
NOW, THEREFORE, the parties agree as follows:
ARTICLE 1 -- DEFINITIONS
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1.1 "ACT" shall mean the United States Food, Drug, and Cosmetic Act, as
amended, and any and all rules and regulations promulgated thereunder.
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1.2 "CASE REPORT FORMS" shall mean the Case Report Forms developed and/or
approved by SEARLE which are to be used by the Investigators (as
hereinafter defined) to record data from the Study (as hereinafter
defined).
1.3 "ELIGIBLE PATIENT" shall mean any patient who meets the
inclusion/exclusion criteria for participation in the Study which are
set forth in the Protocol (as hereinafter defined), signs an acceptable
Patient Informed Consent Form and participates in the Study.
1.4 "EVALUABLE PATIENT" shall mean an eligible Patient who meets the
criteria in the Protocol which must be met and documented on a Case
Report Form in order to be judged evaluable for analysis.
1.5 EXHIBIT" shall mean a mutually approved written description of the
Services that KENDLE will provide for a given Study, the manpower and
financial resources that KENDLE will use to provide those Services, the
milestones that KENDLE must achieve before they will invoice SEARLE for
the Services, and the invoice amounts that will be associated with each
of those milestones.
1.6 "FDA" shall mean the United States Food and Drug Administration or any
successor entity thereto.
1.7 "INVESTIGATOR" shall mean a licensed physician, Ph.D., or Pharm.D.
engaged by SEARLE or KENDLE to conduct the Study.
1.8 "IRB" shall mean the Institutional Review Board(s) organized in
accordance with the Act.
1.9 "PROTOCOL" shall mean the various protocols that will be incorporated
herein by this reference, and any amendments thereto.
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1.10 "SITE" shall mean the physical location at which a particular
Investigator conducts the Study.
1.11 "STUDY" shall mean the clinical research described in the Protocol.
1.12 "STUDY MEDICATION" shall mean the pharmaceutical compound that is the
subject of the Study.
ARTICLE 2 -- SERVICES OF CONTRACTOR
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2.1 PURPOSE. SEARLE hereby retains KENDLE, and KENDLE agrees to assist
SEARLE in the management and monitoring of a series of Studies in
accordance with the Protocol identified in the Exhibit.
2.2 SPECIFIC SERVICES.
(a) KENDLE will provide SEARLE with clinical, regulatory, data
management, biostatistics, pharmacoeconomics outcomes
research, medical consulting, medical writing, management and
systems, and products and consulting services specified herein
and in each Exhibit (collectively, the Services"). These
Services may include, but are not limited to the following: 1)
management consulting regarding staffing and capacity
optimization, work flow improvement, productivity management,
organizational design, standard operating procedures and
training; 2) working with SEARLE to design and implement cost
effective strategies and methods to establish convenient
electronic data communication links between KENDLE and SEARLE;
and 3) working with SEARLE to define compatible, mutually
beneficial information
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systems approaches for performing basic clinical research
operations and to provide relevant applications to support
SEARLE research and development activities. KENDLE management
shall be readily accessible to facilitate optimal management
of individual projects and to provide general management
consulting support.
(b) The Services shall be provided on a project-by project basis
and in accordance with the terms of each Exhibit (which shall
be subject to the mutual agreement of the parties). Prior to
commencing any Services relating to a particular Exhibit, the
parties shall each sign such Exhibit which shall be attached
to this Agreement and made a part hereof.
(c) Each project shall be governed by the terms and conditions of
this Agreement and by supplementary written amendments to this
Agreement, if any, and such Exhibits or Schedules as may be,
from time to time, executed between the parties. In the event
of a conflict between the terms of this Agreement and an
Exhibit or Schedule, the terms of this Agreement shall govern.
(d) If SEARLE wishes to change the scope of the Services covered
by a specific Exhibit to this Agreement or wishes to obtain
additional Services not initially covered by said Exhibit,
SEARLE shall so advise KENDLE and shall submit specifications
to KENDLE. After receipt of the specifications, KENDLE shall
provide SEARLE with a cost estimate for performing the changed
or additional Services. If such cost estimate is accepted by
SEARLE, the parties shall
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execute an authorization for Additional Work and, thereafter,
KENDLE shall commence performance of the changed or additional
Services.
2.3 RECORDS. KENDLE shall maintain complete and accurate records of each
visit to a Site and any and all other records and information relating
to the conduct of the Study or the performance of the Services which
may be required by the Act or any other law or regulation. Such records
shall be maintained for a period of three (3) years from the date
hereof or such longer period as may be required by law. At the end of
such retention period, KENDLE shall offer all such records to SEARLE by
written notice. If within thirty (30) days of such notice, SEARLE does
not notify KENDLE to ship such records to SEARLE, at SEARLE's expense,
KENDLE shall promptly destroy same and certify in writing to SEARLE
that such destruction has occurred.
2.4 AUDIT RIGHT. The records described in Section 2.3 above shall be made
available to SEARLE at SEARLE's request and to the FDA at the FDA's
request for inspection, copying and audit at any time with reasonable
notice during the term hereof and during the retention period described
above. Any expense associated with such a request by SEARLE for
inspection, copying and/or audit will be the responsibility of SEARLE.
2.5 VISITS BY REGULATORY AGENCIES. KENDLE shall notify SEARLE immediately
by telephone (followed by written confirmation) of any proposed or
actual visit by FDA representatives to KENDLE's offices or to any Site.
2.6 RESOLUTION OF DISPUTES AND DEFICIENCIES. Any deficiencies noted by
SEARLE in the Services performed by KENDLE or in the conduct of the
Study by any Investigator
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shall be resolved by KENDLE to the reasonable satisfaction of SEARLE.
In the event of any disputes between KENDLE and SEARLE, the parties
shall make good faith efforts to resolve any such dispute as promptly
as possible.
2.7 TRANSFER OF RESPONSIBILITIES.
(a) Pursuant to 21 Code of Federal Regulations ("CFR")
Part 312.52, SEARLE hereby transfers to KENDLE and KENDLE
hereby assumes from SEARLE, the responsibility for those
services that will be described in an Exhibit and accordingly,
KENDLE shall be responsible for performance of all such
obligations as contemplated in said Part of the CFR.
(b) Notwithstanding the foregoing, it is understood that SEARLE
shall be responsible for any obligations of clinical study
sponsors which are set forth in the Act and not specifically
transferred to KENDLE under Section 2.7(a).
ARTICLE 3 -- STANDARD OF PERFORMANCE, STAFFING AND RECORDS
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3.1 STANDARD OF PERFORMANCE. KENDLE shall perform the Services and all of
its other obligations set forth herein and in any Exhibit in strict
accordance with:
(a) all applicable statutes, rules and regulations, including
without limitation the Act and any proposed FDA regulations
provided by SEARLE;
(b) the Protocol;
(c) the mandates of the IRB approving the Study;
(d) the SOPs (as defined in Section 3.2); and
(e) any other instructions from SEARLE.
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KENDLE shall also perform the Services in a competent and professional
manner, consistent with the current state of clinical research and
current good clinical practices acceptable to the FDA. KENDLE shall, as
necessary, consult with SEARLE on matters regarding safety
considerations and Study implementation, and will adhere to SEARLE's
advice concerning same.
3.2 SOPS. KENDLE shall make available to SEARLE for its review KENDLE's
standard operating procedures (SOPs) relating to the Services during
the time that this Agreement is in effect.
3.3 STAFFING.
(a) KENDLE shall be responsible for providing all personnel
required to perform the Services, as well as any necessary
replacements. KENDLE shall use all reasonable efforts to
provide qualified individuals to fill such positions. KENDLE
shall also give due consideration to the advice of SEARLE with
respect to the decision to use, or to continue or discontinue
the use of, specific personnel for purposes of the conduct of
Study monitoring, programming and statistical analysis. KENDLE
shall not engage any subcontractor to perform or assist in the
performance of the Services without the prior notification of
SEARLE. SEARLE retains the right to request removal of that
person from our projects.
(b) KENDLE shall not use any person (including Investigators)
debarred by the FDA in any capacity in connection with the
performance of the Services or the Study. Upon the execution
of this Agreement, KENDLE shall provide
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SEARLE with the certification attached hereto as Attachment A
in each Exhibit.
(c) KENDLE will provide SEARLE, on request, a list of all
employees, subcontractors, agents or representatives used in
any capacity in connection with the Services who have been
convicted of any of the following within the past six years:
(i) Any felony or misdemeanor under Federal law or felony
under State law for conduct relating to the
development or approval, including the process for
development or approval, of any drug product, or
otherwise relating to the regulation of drug products
under the Federal Food, Drug, and Cosmetic Act;
(ii) Any other felony that involves bribery, payment of
illegal gratuities, fraud, perjury, false statement,
racketeering, blackmail, extortion, falsification or
destruction of records, or interference with,
obstruction of an investigation into, or prosection
of, any criminal offense; or
(iii) A conspiracy to commit, or aiding or abetting, any
offense contained in paragraphs (I) or (ii).
3.4 ACCURATE INFORMATION. KENDLE hereby represents to SEARLE that KENDLE
shall take all reasonably necessary steps to assure that all data,
reports, forms or any other records generated pursuant to the Study by
KENDLE, its agents, employees,
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subcontractors or representatives or by Investigators shall be true and
accurate and shall contain no false or misleading information.
ARTICLE 4 -- OBLIGATIONS OF SEARLE
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4.1 SUPPLIES TO INVESTIGATORS. Prior to commencing any Services relating to
a particular Exhibit, SEARLE shall provide at its own expense and
directly or indirectly to each investigator, if appropriate:
(a) a copy of the investigational brochure for the Study
Medication, the Protocol and any other written information
required by the Investigator to perform the Study which is not
supplied by KENDLE under Article 2;
(b) supplies of the Study Medication and any other medications
specified in the Protocol; and
(c) a supply of Case Report Forms.
4.2 COMPLIANCE WITH LAW. SEARLE shall comply with all laws and regulations,
including without limitation the Act, which are applicable to SEARLE's
sponsorship and reporting of the Study.
ARTICLE 5 -- PAYMENTS TO CONTRACTOR
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5.1 PROFESSIONAL FEE.
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(a) In consideration for KENDLE's performance of the Services,
SEARLE shall pay KENDLE with respect to each project the
amount specified in the relevant Exhibit governing each such
project. Should the scope of a project described
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in any Exhibit change, the fee to be paid by SEARLE under such
Exhibit will be adjusted pursuant to Section 2.2(d).
(b) SEARLE and KENDLE agree that they will jointly utilize all
reasonable efforts to identify and implement cost savings
opportunities throughout the performances of the services.
Savings resulting from these efforts will be passed onto
SEARLE.
5.2 EXPENSES. SEARLE shall reimburse KENDLE for all of its reasonable
out-of-pocket expenses incurred in connection with its performance of
the Services as set forth in each Exhibit. KENDLE shall not be
reimbursed for expenses in excess of the amount agreed upon in the
relevant Exhibit.
5.3 PAYMENT PROCEDURES.
(a) KENDLE shall invoice SEARLE each calendar month for Services
provided and the expenses incurred during the prior calendar
month in accordance with the schedule of payments set forth in
the relevant Exhibits or Letters of Intent governing each
project, subject to the limitation set forth in each such
Exhibit. KENDLE's invoice shall be accompanied by original
receipts or any other supporting information reasonably
satisfactory to SEARLE, and shall be sent to:
Mr. Robert Hannigan
Finance and Administration
Searle Clinical R&D
4901 Searle Parkway
Skokie, IL 60077
Telephone: 847-982-8580
FAX: 847-982-8509.
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(b) SEARLE shall pay KENDLE within thirty (30) days of receipt and
acceptance of invoices; provided they comply with the terms
hereof. Checks shall be made payable to Kendle International
Inc., Federal I.D. 31-1274091, and mailed to:
Mr. Kevin M. Schwarz
Controller
Kendle International Inc.
700 Carew Tower
441 Vine Street
Cincinnati, Ohio 45202
5.4 FINAL RECONCILIATION. At the conclusion of the Services for each
Exhibit, KENDLE shall submit to SEARLE a final invoice which shall
include an accounting reconciling all payments made by SEARLE and all
amounts invoiced by KENDLE.
5.5 RECORDS AND AUDIT. KENDLE shall keep and maintain complete and accurate
books and records in sufficient detail to determine amounts owed to
KENDLE hereunder. Such books and records shall be maintained for at
least two (2) years following completion of the Study or termination of
this Agreement and shall be made available for inspection, copying and
audit by SEARLE, upon reasonable notice by SEARLE, for the sole purpose
of determining the accuracy of amounts invoiced hereunder. If any such
audit discloses an underpayment or overpayment of amounts due
hereunder, the party owing same shall pay the amount due to the other
party within thirty (30) days of written notice.
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ARTICLE 6 -- TERM AND TERMINATION
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6.1 TERM. The term of this Agreement shall begin as of the date of the last
signature on this Agreement and shall continue until December 31, 2001.
6.2 EXTENSIONS OF TERM. SEARLE and KENDLE may extend the term of this
Agreement upon mutual written agreement.
6.3 TERMINATION BY SEARLE. SEARLE may terminate this Agreement or a project
to be performed pursuant to an Exhibit to this Agreement at any time on
forty-five (45) days prior written notice to KENDLE.
6.4 TERMINATION BY EITHER PARTY. In addition to any other rights or
remedies available at law or in equity, this Agreement may be
terminated by either party:
(a) on written notice effective immediately if the other party
commits a material breach of this Agreement which is not cured
within thirty (30) days of receipt of written notice from the
other party; or
(b) on thirty (30) days written notice if the other party becomes
insolvent, is dissolved or liquidated, makes a general
assignment for the benefit of its creditors, files or has
filed against it, a petition in bankruptcy, or has a receiver
appointed for a substantial part of its assets.
6.5 OBLIGATIONS ON EXPIRY OR TERMINATION.
(a) Upon early termination (other than for KENDLE's default),
KENDLE shall be entitled to a PRO-RATA portion of the
compensation as provided under Article 5, based on the degree
of completion of the Services described in each Exhibit as
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of the date of termination. SEARLE shall also reimburse KENDLE
for any accrued, but unpaid expenses incurred as permitted
under Article 5.
(b) Within thirty (30) days of the expiration or termination of
this Agreement, an Exhibit, or the Study for any reason,
KENDLE shall return to SEARLE all completed, partially
completed and unused Case Report Forms and all other materials
in KENDLE's possession or control and relating to the Study,
including but not limited to all data (in any form, including
electronic) and other information resulting from the Study or
provided by SEARLE.
(c) If this Agreement and/or the Study is prematurely terminated,
KENDLE shall conclude the Study as expeditiously as possible
and in accordance with SEARLE's reasonable instructions and
all applicable federal, state and local laws, regulations and
guidelines. KENDLE shall use its best efforts to minimize any
expenses resulting from such early termination.
ARTICLE 7 -- INDEMNIFICATION
7.1 INDEMNIFICATION OF SEARLE. KENDLE shall defend, indemnify and hold
harmless SEARLE and its directors, officers and employees, from and
against any and all liabilities, costs and expenses (including
reasonable attorneys' fees and court costs) arising from any third
party claim, action, lawsuit or other proceeding to the extent such
liability, cost or expense is attributable to any negligent or willful
act or omission or breach of this Agreement on the part of KENDLE or
any of its employees in the course of performing KENDLE's obligations
hereunder; provided however that:
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(a) SEARLE shall have notified KENDLE within ten (10) working days
after receipt of notice of the claim, action, lawsuit or other
proceeding; and
(b) SEARLE shall fully cooperate in the investigation and defense
of any such claim, action, lawsuit or other proceeding and
shall not agree to any settlement thereof without KENDLE's
prior written consent.
Notwithstanding the foregoing, KENDLE shall not be required to
indemnify SEARLE for any liability, cost or expense attributable to any
negligent or willful act or omission or breach of this Agreement on the
part of SEARLE or any of its employees, agents, subcontractors or other
representatives of SEARLE in the course of performing its obligations
hereunder.
7.2 INDEMNIFICATION OF KENDLE. SEARLE shall defend, indemnify and hold
harmless KENDLE and its directors, officers and employees, from and
against any and all liabilities, costs and expenses (including
reasonable attorneys' fees and court costs) arising from any claim,
action, lawsuit or other proceeding (I) arising out of or in connection
with the conduct of the Study, or (ii) to the extent such liability,
cost or expense is attributable to any negligent or willful act or
omission or breach of this Agreement on the part of SEARLE or any of
its employees in the course of performing SEARLE's obligations
hereunder; provided however that:
(a) KENDLE shall have notified SEARLE within ten (10) working days
after receipt of notice of the claim, action, lawsuit or other
proceeding; and
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(b) KENDLE shall fully cooperate in the investigation and defense
of any such claim, action, lawsuit or other proceeding and
shall not agree to any settlement thereof without SEARLE's
prior written consent.
Notwithstanding the foregoing, SEARLE shall not be required to
indemnify KENDLE for any liability, cost or expense attributable to any
negligent or willful act or omission or breach of this Agreement on the
part of KENDLE or any of its employees, agents, subcontractors or other
representatives of KENDLE in the course of performing its obligations
hereunder.
7.3 CONFLICTS OF INTEREST.
(a) SEARLE shall have the right to select defense counsel and to
direct the defense or settlement of any claim, action, lawsuit
or other proceeding described in Paragraph 7.2.
(b) Kendle shall have the right to select defense counsel and to
direct the defense of any claim, action, lawsuit or other
proceeding described in Paragraph 7.1.
7.4 LIMITATION OF DAMAGES. Notwithstanding the foregoing, neither party
shall be liable for any special, indirect, incidental or consequential
damages, including lost profits, incurred by the other party, for any
reason.
ARTICLE 8 -- INSURANCE
8.1 INSURANCE REQUIREMENT. As an independent contractor, KENDLE will carry
the policies of insurance described below for the term of this
Agreement. Such policies shall not be cancelable or subject to material
amendment which would materially and
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adversely harm SEARLE's interests without sixty (60) days' prior
written notice to SEARLE. KENDLE shall furnish SEARLE with certificates
of insurance for all such policies before commencing work hereunder and
the General Liability policy shall name SEARLE and its affiliates and
subsidiaries as additional insureds. The type and limits of such
policies shall be as follows:
1) Workmen's Compensation Statutory
2) Employer's Liability $500,000 each person each accident
3) Commercial General Liability $1,000,000 combined limit each
occurrence for Bodily Injury and
Property Damage. This policy must
include blanket contractual
liability coverage.
4) Automobile Liability Bodily Injury and Property Damage
(including Hired $500,000 combined limit each
Automobile and Non- occurrence
Ownership Liability)
ARTICLE 9 -- PROPERTY OWNERSHIP AND RETENTION
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9.1 OWNERSHIP. The following materials shall be deemed to be the exclusive
property of SEARLE and are hereinafter collectively referred to as
"Searle Information":
(a) All materials, documents and information of every kind and
description supplied to KENDLE by SEARLE;
(b) All materials, documents and information of every kind and
description prepared or developed by KENDLE pursuant to this
Agreement or an Exhibit, except for procedural manuals, personnel
data and computer software existing at the time of this Agreement;
and
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(c) All clinical data (including Case Report Forms and the data
contained therein) and reports prepared by any of the
Investigators. Nothing in this paragraph shall preclude the
publishing of the results of any clinical trial(s) by the
Investigators in accordance with the terms of their respective
contracts.
9.2 INVENTIONS AND DISCOVERIES.
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(a) KENDLE will promptly disclose to SEARLE or its nominee any and all
inventions, discoveries and improvements conceived, made or
reduced to practice by KENDLE or any agent, employee,
subcontractor or other representative of KENDLE in the course of
performing the Services. KENDLE hereby agrees to assign all its
right, title and interest therein to SEARLE or its nominee.
(b) Whenever requested to do so by SEARLE, KENDLE will execute any and
all applications, assignments or other instruments and give
testimony which SEARLE shall deem necessary to apply for and
obtain patent letters of the United States or of any foreign
country or to protect otherwise SEARLE's interest therein. KENDLE
shall ensure that its contractual arrangements with its agents,
employees, subcontractors and other representatives provide for
their automatic assignment to SEARLE of all such inventions,
discoveries and improvements.
ARTICLE 10 -- CONFIDENTIALITY
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10.1 UNDERTAKING. During the term hereof and for a period of ten (10) years
following the expiration or termination hereof, KENDLE shall keep
confidential and not use (other
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than to perform the Services) any of the Searle Information. KENDLE
further agrees to limit disclosure of the Searle Information to agents,
subcontractors, employees and other representatives of KENDLE who have
signed agreements with KENDLE reiterating the provisions of this
Article and to Investigators who have signed Investigator Contracts.
10.2 EXCEPTIONS. The obligations set forth in Paragraph 10.1 shall not apply
to Searle Information which:
(a) is already known to KENDLE as shown by its prior written records;
(b) is or becomes publicly available through no fault of KENDLE;
(c) is received from a third party which KENDLE believes in good faith
has a right to disclose it; or
(d) is required by law to be disclosed.
10.3 PUBLICATIONS. It is expressly understood that neither KENDLE nor any
agent, employee, subcontractor or other representative of KENDLE shall
have the right to publish any information concerning any Searle Study.
ARTICLE 11 -- ASSIGNMENT
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11.1 BY KENDLE. KENDLE may not assign, transfer or attempt to assign or
transfer any of its rights or obligations hereunder without the prior
written consent of SEARLE. Any attempt by KENDLE without SEARLE's prior
written consent shall constitute a material default hereunder.
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11.2 BY SEARLE. SEARLE shall have the right to assign this Agreement, in
whole or in part, on thirty (30) days' prior written notice to KENDLE.
ARTICLE 12 -- ENTIRE AGREEMENT; AMENDMENTS
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12.1 ENTIRE AGREEMENT. This Agreement, together with each Exhibit and each
Protocol, constitutes the entire agreement between the parties with
respect to the subject matter hereof. All projects and contracts
entered into prior to the signing of this Agreement remain in full
force and effect.
12.2 AMENDMENTS. This Agreement may not be amended except in writing signed
by both parties.
ARTICLE 13 -- MISCELLANEOUS
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13.1 CONFLICT OF INTEREST. KENDLE represents to SEARLE that it has no
obligations, contractual or otherwise, that would conflict with its
entering into this Agreement or performing the Services and that it
will undertake no such obligations during the term hereof.
13.2 INDEPENDENT CONTRACTOR. KENDLE is an independent contractor and nothing
in this Agreement shall be construed to create a partnership, joint
venture or employment relationship between the parties. KENDLE shall
have no authority to bind SEARLE to any commitment whatsoever, and
KENDLE shall not hold itself out to third parties as having authority
to do so.
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13.3 NOTICES. Any notice which either party may be required to give the
other shall be deemed to be duly given when mailed by certified or
registered mail, postage prepaid, return receipt requested, to the
other party at the addresses first given above, addressed to the
attention of the person signing this Agreement for such party or to
such other addresses and recipients as the parties may direct in
writing. Notices shall be deemed to be effective five (5) days after
mailing.
13.4 SEVERABILITY. If any provision hereof shall be determined to be invalid
or unenforceable, such determination shall not affect the validity of
the other provisions of this Agreement; provided that the parties shall
promptly agree upon replacement provision(s) which approximate as
closely as possible the spirit and intent of the invalid provision(s).
13.5 SURVIVAL. Sections 2.3 (Records), 2.4 (Audit Right), 6.3 (Termination
by Searle), 6.4 (Termination by Either Party), 6.5 (Obligations on
Expiry or Termination), Articles 7 (Indemnification), Article 9
(Property Ownership and Retention), Article 10 (Confidentiality), shall
survive the expiration or earlier termination of this Agreement.
13.6 GOVERNING LAW. This Agreement shall be governed by and interpreted in
accordance with the laws of the state of Illinois, regardless of its
choice of law principles.
13.7 WAIVERS. 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 estoppel with respect to any subsequent breach
of any provision hereof.
13.8 USE OF NAMES. Each party, on behalf of itself, its agents, employees,
subcontractors and representatives agrees not to use the name of the
other party or its agents,
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employees, subcontractors and representatives in any publication,
promotional material or other writing or oral statement for public
distribution, relative to the subject matter or existence of this
Agreement, except as otherwise required by law or previously consented
to in writing by the other party. Notwithstanding the foregoing, SEARLE
consents to KENDLE advising prospective clients that KENDLE has
performed clinical research services for SEARLE.
13.9 FORCE MAJEURE. Either party's failure to perform its obligations
hereunder shall be excused to the extent and for the period of time
such nonperformance is caused by an event of FORCE MAJEURE, including
but not limited to, the occurrence of war, invasion, fire, explosion,
flood, riot, strikes, acts of God, acts of government or governmental
agencies or instrumentalities or contingencies or causes beyond such
party's reasonable control.
IN WITNESS WHEREOF, the parties have executed this Agreement the day and year
set forth above.
KENDLE INTERNATIONAL INC. G.D. SEARLE & CO.
By: Timothy M. Mooney By:
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Title: V.P. - C.F.O. Title:
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LIST OF ATTACHMENTS
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A Certification
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ATTACHMENT A
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KENDLE hereby certifies that, to the best of its ability and/or knowledge, it
will not or has not employed or otherwise used in any capacity the services of
any person debarred under section 306(a) or (b) of the Federal Food, Drug, and
Cosmetic Act in connection with its activities related to Protocol No. ________
entitled____________________________________________________________.
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KENDLE INTERNATIONAL INC
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