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Exhibit 10.14
May 13, 1996
Celecoxib Long Term Safety Study
N49-96-02-024
CLINICAL TRIAL SERVICES AGREEMENT
THIS CLINICAL TRIAL SERVICES AGREEMENT (the "Agreement"), made as of
April 26,1996, by and between Xxxxxx Research Associates, Inc., an Ohio
corporation with principal offices at 000 Xxxx Xxxxxx, Xxxxxxxxxx, Xxxx 00000
("CONTRACTOR") and X.X. XXXXXX & CO., a Delaware corporation with principal
offices at 0000 Xxx Xxxxxxx Xxxx, Xxxxxx, Xxxxxxxx 00000 X.X.X. ("XXXXXX").
WITNESSETH:
WHEREAS, CONTRACTOR is engaged in the business of managing,
monitoring and coordinating multi-site clinical research programs; and
WHEREAS, XXXXXX desires CONTRACTOR to manage, monitor and coordinate
a clinical research program, and CONTRACTOR is willing to provide such services
subject to the terms hereof.
NOW, THEREFORE, the parties agree as follows:
ARTICLE 1-- DEFINITIONS
1.1 "Act" shall mean the United States Food, Drug, and Cosmetic Act, as
amended, and any and all rules and regulations promulgated
thereunder.
1.2 "Case Resort Forms" shall mean the Case Report Forms developed
and/or approved by XXXXXX 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 a patient who meets the criteria for
payment as outlined
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in the Guidelines for Payment (see Exhibit B).
1.5 "FDA" shall mean the United States Food and Drug Administration or
any successor entity thereto.
16 "Investigator" shall mean a licensed physician engaged by XXXXXX to
conduct the Study.
1.7 "IRB" shall mean the Institutional Review Board(s) organized in
accordance with the Act.
1.8 "Protocol" shall mean protocol number N49-96-02-024, entitled
"Clinical Protocol to Evaluate the Long-Term Safety of Celecoxib
(SC-58635) in Treating the Signs and Symptoms of Osteoarthritis and
Rheumatoid Arthritis," and is incorporated herein by this
reference, and any amendments thereto. This protocol will have an
interim and a final analysis.
1.9 "Site" shall mean the physical location at which a particular
Investigator conducts the Study.
1.10 "Study" shall mean the clinical research described in the Protocol.
This Contract is for all study activities up to and including the
interim analysis.
1.11 "Study Medication" shall mean XXXXXX'x compound SC-58635.
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ARTICLE 2-- SERVICES OF CONTRACTOR
2.1 Purpose. XXXXXX hereby retains CONTRACTOR and CONTRACTOR agrees to
assist XXXXXX in the management and monitoring of the Study in
accordance with the Protocol. The Study shall be conducted at
approximately 93 Sites and involve the participation of
approximately 1,670 patients. All 93 of these sites will be
monitored by CONTRACTOR.
2.2 Specific Services. In connection with the Study, CONTRACTOR shall
provide the following services (collectively, the "Services")
within time frames mutually agreed on and documented in official
study timeliness:
(a) CONTRACTOR shall verify that the Investigators are duly
licensed, qualified to conduct the Study in accordance with the
Protocol and the Act, acceptable to the FDA and have adequate
staff and facilities.
(b) All appropriate personnel of CONTRACTOR shall attend meetings
of the Investigators and/or their Study Coordinators to review
the Protocol, Case Report Forms, and clinical laboratory and
administration procedures relevant to the Study.
(c) Prior to the initiation of the Study by each Investigator,
CONTRACTOR shall collect from the relevant Investigators all
regulatory and administrative documents (including a curriculum
vitae, medical license, signed statement of Investigator, IRB
approval, Approved Consent Form, FDA Form 1572) and forward
same to XXXXXX for filing with the FDA. CONTRACTOR shall
forward to each investigative site 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.
(d) Prior to the initiation of the Study by each Investigator,
XXXXXX will designate the amount to be paid to each
Investigator for partially completed and fully completed
patients (Study Budget). CONTRACTOR will discuss the Study
Budget with each Investigator and seek the Investigator's
agreement to the Study Budget. Any deviations to the Study
Budget must be agreed to by XXXXXX in writing. CONTRACTOR shall
enter into agreements with each Investigator for the
performance of the Study (Letter of Agreement). A standard
Letter of Agreement
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will be approved by XXXXXX in writing.
Any deviations to the standard Letter of Agreement must be
approved in writing by XXXXXX. CONTRACTOR shall make payments
for performance under each Letter of Agreement directly to each
Investigator and will be reimbursed by XXXXXX for these
payments as provided in Section 5.2 (b).
(e) With XXXXXX'x approval, CONTRACTOR shall authorize the
initiation of the Study at each Site, including without
limitation providing orientation and other training for the
Investigator and his staff.
(f) CONTRACTOR shall ship CRFs from Cincinnati to each of the
investigational sites as needed
(g) CONTRACTOR shall monitor the performance of the Study at each
Site by conducting and documenting at least the following
on-Site visits, supplemented by telephonic communications as
reasonably necessary during the course of the Study: (1)
Initiation visit to selected Sites before the first patient at
said Site enters the Study;
(2) Interim visits to each Site which shall occur in
conjunction with visits for other XXXXXX trials;
(3) Close-out visit to each Site after all Patients at said
Site have completed the Study.
In conducting the Site visits and monitoring the Study,
CONTRACTOR shall comply with the requirements of Exhibit X.
XXXXXX reserves the right at its expense, to accompany
CONTRACTOR on any or all of CONTRACTOR's Site visits and to
conduct additional visits to the Sites without representatives
of CONTRACTOR.
(h) CONTRACTOR shall keep the Investigators informed of information
provided by XXXXXX concerning the Study Medication and conduct
of the Study.
(i) CONTRACTOR shall review Case Report Forms for completeness and
in compliance with the requirements of Exhibit A, resolve
discrepancies with the Investigator.
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(j) For purposes of calculating payments to the Investigators,
CONTRACTOR's personnel will fill out payment worksheets as
shown in Exhibit B and will use worksheets to calculate
payments to Investigators. CONTRACTOR will make payments
directly to Investigators and will be reimbursed by XXXXXX as
described in Exhibit E.
(k) CONTRACTOR shall code Case Report Forms and enter data from
Case Report Forms into a database prepared by XXXXXX and
located on a XXXXXX computer in Skokie, Illinois. XXXXXX shall
provide the necessary access and data links for CONTRACTOR to
enter the data remotely.
(l) CONTRACTOR shall run automated edit checks on the data in the
database and will generate and resolve queries that result from
such checks.
(m) Using specifications and a Statistical Analysis Plan approved
by XXXXXX, CONTRACTOR shall program tables and listings which
will be used in the final report for this study. Tables and
listings will be reviewed by CONTRACTOR's Safety, CDM, Clinical
Services, and Statistics personnel and will be shared with
XXXXXX in a draft form to allow for comments.
(n) CONTRACTOR shall promptly report to XXXXXX all serious adverse
drug experiences which come to its attention, in accordance
with the Act and any instructions from XXXXXX.
(o) CONTRACTOR shall advise and consult with the Investigators
regarding questions concerning the Protocol, the conduct of the
Study, and/or the recording of data therefrom.
(p) At the conclusion of the Study at each Site and unless XXXXXX
otherwise directs, CONTRACTOR shall collect from the
Investigator and reconcile unused supplies of the Study
Medication, other drugs provided by XXXXXX, unused Case Report
Forms and any other materials or information required by the
Act to be delivered to the sponsor of the Study at its
conclusion.
(q) At the conclusion of the Study, CONTRACTOR will make copies of
all blue watermark Case Report Forms and will forward such
copies plus a copy of the study report to the clinical sites
from which the pages originated. The
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original white and blue watermark copy Case Report Forms will
be forwarded to XXXXXX for archiving, unless otherwise
instructed.
(r) CONTRACTOR shall provide such other assistance as XXXXXX may
reasonably request in order to manage, monitor and coordinate
the conduct of the Study and to collect and submit all
resulting data on a timely basis.
(s) In the event XXXXXX requests CONTRACTOR to perform any
additional services not contemplated hereunder, CONTRACTOR
shall obtain XXXXXX'x written approval of the costs associated
with such services prior to commencing performance of any such
services.
2.3 Reports.
(a) Within two (2) weeks after each visit to a Site, CONTRACTOR
shall prepare and submit to XXXXXX a Site visit report. The
Visit Report shall set forth the information described in Part
I of Exhibit C.
(b) CONTRACTOR shall submit a report to XXXXXX summarizing the
progress of the Study at each Site and CONTRACTOR's performance
of the Services. Such report shall include the information
described in Part II of Exhibit C and shall be with the
frequency indicated therein.
2.4 Records. CONTRACTOR 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, CONTRACTOR
shall offer all such records to XXXXXX by written notice. If within
thirty (30) days of such notice, XXXXXX does not notify CONTRACTOR
to ship such records to XXXXXX, at XXXXXX'x expense, CONTRACTOR
shall promptly destroy same and certify in writing to XXXXXX that
such destruction has occurred.
2.5 Audit Right. The records described in Section 2.4 above shall be
made available to XXXXXX at XXXXXX'x request and to the FDA at the
FDA's request for inspection,
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copying and audit at any time during the term hereof and during the
retention period described above.
2.6 Visits by Regulatory Agencies. CONTRACTOR shall notify XXXXXX
immediately by telephone (followed by written confirmation) of any
visit to CONTRACTOR's offices or to any Site by FDA representatives.
2.7 Resolution of Disputes and Deficiencies. Any deficiencies noted by
XXXXXX in the Services performed by CONTRACTOR or in the conduct of
the Study by any Investigator shall be resolved by CONTRACTOR to the
satisfaction of XXXXXX. In the event of any disputes between
CONTRACTOR and XXXXXX, the parties shall make good faith efforts to
resolve any such dispute as promptly as possible.
2.8 Transfer of Responsibilities.
(a) Pursuant to 21 Code of Federal Regulations ( "CFR") Part
312.52, XXXXXX hereby transfers to CONTRACTOR and CONTRACTOR
hereby assumes from XXXXXX, the responsibility for those
services described in this Article 2 and accordingly,
CONTRACTOR 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 XXXXXX
shall be responsible for the following obligations set forth in
21 CFR Part 312:
(1) preparation and submission (if required) of an
Investigational New Drug Application to conduct the
Study;
(2) report to the FDA of all adverse drug reactions required
to be reported;
(3) maintenance of records concerning shipments by XXXXXX to
the Investigators of Study Medication, other drugs and
other materials; and
(4) preparation and submission to the FDA of any periodic
reports and the final report concerning the Study; and
(5) any other obligations of clinical study sponsors which
are set forth in the Act and not specifically transferred
to CONTRACTOR under Section 2.8(a).
ARTICLE 3-- STANDARD OF PERFORMANCE, STAFFING AND RECORDS
3.1 Standard of Performance. CONTRACTOR shall perform the Services and all of
its
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other obligations set forth herein in strict accordance with:
(a) all applicable statutes, rules and regulations, including
without limitation the Act and any proposed FDA regulations
provided by XXXXXX;
(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 XXXXXX.
CONTRACTOR 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.
CONTRACTOR shall, as necessary, consult with XXXXXX on matters
regarding safety considerations and Study implementation, and will
adhere to XXXXXX'x advice concerning same.
3.2 SOPs. At least five (5) days prior to the commencement of the
Services, CONTRACTOR shall submit to XXXXXX for its review and
approval CON TRACTOR's standard operating procedures (SOPs) relating
to the Services.
3.3 Staffing.
(a) CONTRACTOR shall be responsible for providing all personnel
required to perform the Services, as well as any necessary
replacements. CONTRACTOR shall use its best efforts to provide
qualified individuals to fill such positions. CONTRACTOR shall
also give due consideration to the advice of XXXXXX 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. CONTRACTOR shall not engage any subcontractor
to perform or assist in the performance of the Services without
the prior written approval of XXXXXX.
(b) CONTRACTOR 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,
3.4 CONTRACTOR shall provide XXXXXX with the certification attached hereto as
Exhibit D. Accurate Information. CONTRACTOR hereby represents to XXXXXX that
CONTRACTOR shall take all necessary steps to assure that all data, reports,
forms or any other records generated
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pursuant to the Study by CONTRACTOR, its agents, employees, subcontractors or
representatives or by Investigators shall be true and accurate and shall contain
no false or misleading information.
ARTICLE 4-- OBLIGATIONS OF XXXXXX
4.1 Supplies to Investigators. XXXXXX shall provide at its own expense
and directly to each Investigator:
(a) Supplies of the Study Medication and any other medications
specified in the Protocol. XXXXXX shall keep CONTRACTOR
informed of the recipients, contents and dates of all such
shipments.
(b) A supply of Case Report Forms which will be forwarded to
investigational sites by CONTRACTOR's personnel. CONTRACTOR
shall keep XXXXXX informed of the recipients, contents, and
dates of all such shipments.
4.2 Compliance with Law. XXXXXX shall comply with all laws and
regulations, including without limitation the Act, which are
applicable to XXXXXX'x sponsorship and reporting of the Study.
4.3 Data Processing~ Activities. XXXXXX shall provide a database, DLB
data entry software, data edit checks and computerized tools to
allow the CONTRACTOR to code CRFs, enter data, and generate and
process queries on XXXXXX computer systems located in Chicago.
(a) XXXXXX shall provide adequate computer access to the XXXXXX
clinical database to allow up to 30 simultaneous users
consisting of CDM and Statistics personnel in up to 3
different locations by October 1996. This access will consist
of the existing network link with Xxxxxx in Cincinnati plus
links to be established with XXXXXX'x offices in Chicago and
New Jersey. In the event that network
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links with XXXXXX'x offices in Chicago and New Jersey cannot
be established prior to the initiation of this study, modem
connections will serve as an interim solution. XXXXXX will at
least provide up to 4 modem connections with the Chicago
office by the end of July 1996 and up to 4 modem connections
with the New Jersey office by the end of August 1996. Network
links will be provided to these sites by October 1996.
(b) XXXXXX shall provide necessary access and data links to allow
operations 24 hours, 7 days a week during the study (except
when maintenance downtime is required).
(c) XXXXXX shall provide remote printing capability at CONTRACTOR
offices in Cincinnati, Chicago, and New Jersey, sufficient to
allow timely data review and clean-up. XXXXXX shall provide
printer equipment.
(d) XXXXXX shall make reasonable efforts to provide sufficient
computing resources for efficient use of automated edits and
other tools provided by XXXXXX and used during the data
clean-up process. XXXXXX'x commitments to rapid turnaround
assume that automated edits and other tools will execute in I
to 8 hours. Longer run times for the automated edits and other
tools may adversely impact these turnaround times.
(e) XXXXXX shall review and provide feedback to the CONTRACTOR on
all information provided XXXXXX for approval (e.g., code
listings) generally within I to 2 working days of submission to
XXXXXX.
(f) Within I week of receipt, XXXXXX shall load all external
laboratory data received from SCICOR.
(g) XXXXXX shall provide such other assistance as CONTRACTOR may
reasonably request in order to manage, monitor, code, enter,
and process CRF data on a timely basis.
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ARTICLE 5-- PAYMENTS TO CONTRACTOR
5.1 Compensation. In consideration for CONTRACTOR's performance of the
Services, XXXXXX shall (a) pay CONTRACTOR up to Two Million Eight
Hundred Forty-Six Thousand Three Hundred Fifty Dollars ($2,846,350)
for Services completed in accordance with the activities and
associated costs set forth on the fee schedule attached hereto as
Exhibit E, and (b) reimburse CONTRACTOR for expenses (as provided
under 5.2 below) in an amount up to Two Million Twenty-Two Thousand
Six Hundred Dollars ($2,022,600). CONTRACTOR's total compensation
under (a) and (b) shall not exceed Four Million Eight Hundred Sixty
Eight Thousand Nine Hundred Fifty Dollars ($4,868,950).
5.2
Expenses.
(a) XXXXXX shall reimburse CONTRACTOR for all of its reasonable
out-of-pocket expenses incurred in connection with its performance
of the Services for travel, meetings, and shipping in an amount not
to exceed Two Hundred Eighty Thousand Dollars ($280,000). CONTRACTOR
shall not incur additional expenses for travel, meetings, and
shipping without XXXXXX'x prior written consent.
(b) XXXXXX shall provide funds to CONTRACTOR for all payments made to
Investigators, in an amount not to exceed One Million Seven Hundred
Thirty-Five Thousand One Hundred Dollars ($1,735,100). CONTRACTOR
shall provide detailed listings of such payments, including the name
and Taxpayer Identification Number or Social Security Number of the
Payee, five (5) days before the payments are made. XXXXXX will send
funds to CONTRACTOR by wire transfer directly into CONTRACTOR's
account within five (5) business days of receipt of each detailed
listing. Payments to Investigators shall not exceed One Million
Seven Hundred Thirty-Five Thousand One Hundred Dollars ($1 .735,100)
without XXXXXX'x prior written consent.
(c) XXXXXX shall reimburse CONTRACTOR for expenses related to
duplicating
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Study Document Binders. CONTRACTOR shall not exceed total
expenses of Seven Thousand Five Hundred Dollars ($7,500)
without XXXXXX'x prior written consent.
5.3 Payment Procedures.
(a) Within fifteen (15) days after the execution of this Agreement,
XXXXXX shall make an initiation payment to CONTRACTOR in the
amount of Four Hundred Twenty-Seven Thousand Dollars ($427,000)
which represents fifteen percent (15%) of the amount set forth
in Section 5.1(a). If any advance payments for CONTRACTOR fees
for tasks covered by this contract have already been made, they
will be credited against this initiation payment.
(b) XXXXXX shall pay the remainder of the amount set forth in
Section 5.1(a) in seventeen (17) milestone payments of One
Hundred Twenty-Five Thousand Six Hundred Dollars ($125,600)
each as provided in Exhibit E and one final installment of Two
Hundred Eighty-Four Thousand One Hundred Fifty Dollars
($284,150), representing 10% of the amount sent forth in
Section 5.1(a) which shall be paid only after all data from the
contract period has been coded and entered, all queries for the
contract period have been resolved, and the statistical report
for the contract period has been received by XXXXXX from
CONTRACTOR and has been accepted by~XXXXXX as satisfactory.
(c) XXXXXX shall advance 15% (Forty-Two Thousand Dollars; $42,000)
of the estimated travel expenses to CONTRACTOR within fifteen
(15) days after the execution of this Agreement. CONTRACTOR
shall invoice XXXXXX each calendar month for the expense
incurred during the prior calendar month, subject to the
limitation set forth in Sections 5.1 and 5.2. CONTRACTOR's
invoice shall be accompanied by original receipts or any other
supporting information reasonably satisfactory to XXXXXX. A
final accounting of expenses shall occur at the end of the
contract period and any unused advance will be returned at that
time (estimated January 1998).
(d) XXXXXX shall reimburse CONTRACTOR for payments to
Investigators. CONTRACTOR shall invoice XXXXXX for these
expenses as they are incurred,
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subject to the limitation set forth in Section 5.2. XXXXXX
shall reimburse CONTRACTOR for these expenses by wire transfer
directly to CONTRACTOR's account within 5 working days of
receiving the invoice.
(e) XXXXXX shall reimburse CONTRACTOR for payments related to the
reproduction of Case Report Forms and Study Document Books.
CONTRACTOR shall invoice XXXXXX for these expenses as they are
incurred, subject to the limitation set forth in Section 5.2.
(f) XXXXXX shall pay CONTRACTOR within thirty (30) days of receipt
of invoices; provided they comply with the terms hereof. Checks
shall be made payable to Xxxxxx, Federal x.X. 00-0000000, and
mailed to the address first set forth above, attention:
Controller.
5.4 Final Reconciliation. Within 30 days after the conclusion of the
Services, CONTRACTOR shall submit to XXXXXX a final invoice which shall
include an accounting reconciling all activities actually performed and
associated costs (as set forth in Exhibit E, all payment made by XXXXXX
and all amounts invoiced by CONTRACTOR. Any overpayment by XXXXXX shall
be credited or refunded to XXXXXX by CONTRACTOR at the time of
submission of such final invoice. Any underpayment by XXXXXX shall be
paid to CONTRACTOR, subject to the limitations set forth in Sections
5.1 and 5.2, within thirty (30) days after receipt and acceptance by
XXXXXX of such final invoice. Records and Audit. CONTRACTOR shall keep
and maintain complete and accurate books and records in sufficient
detail to determine amounts owed to CONTRACTOR 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 XXXXXX, upon
reasonable notice by XXXXXX, 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.
ARTICLE 6-- TERM AND TERMINATION
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6.1 Term. The term of this Agreement shall begin as of March 11,1996 and
shall continue until completion of the interim analysis of the
Study, which shall occur no later than January 26,1998.
6.2 Extensions of Term. XXXXXX shall have the right to extend the term
described above without an increase in the fees payable to
CONTRACTOR on written notice to CONTRACTOR, provided such extension
is not the result of a delay by XXXXXX in performing its obligations
hereunder or of a change in the Protocol required by XXXXXX which
materially affects the performance of the Study.
6.3 Termination by XXXXXX. XXXXXX may terminate this Agreement at any
time on thirty (30) days prior written notice to CONTRACTOR.
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 CONTRACTOR's default),
CONTRACTOR shall be entitled to a pro-xxxx portion of the
compensation as provided under Article 5, based on the degree
of completion of the Services as of the date of termination.
XXXXXX shall also reimburse CONTRACTOR 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 or the Study for any reason, CONTRACTOR shall
return to XXXXXX all completed, partially completed and unused
Case Report Forms and all other materials in CONTRACTOR'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
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XXXXXX.
(c) If this Agreement and/or the Study is prematurely terminated,
CONTRACTOR shall conclude the Study as expeditiously as
possible and in accordance with XXXXXX'x reasonable
instructions and all applicable federal, state and local laws,
regulations and guidelines. CONTRACTOR shall use its best
efforts to minimize any expenses resulting from such early
termination.
ARTICLE 7--INDEMNIFICATION
7.1 Indemnification of XXXXXX. CONTRACTOR shall defend, indemnify and
hold harmless XXXXXX and its directors, officers and employees, from
and against any and all liabilities, costs and expenses (including
reasonable attorneys' fees and court costs) 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
CONTRACTOR or any of its agents, employees, subcontractors
(including Investigators, if CONTRACTOR should reasonably have
anticipated such action and taken measures to prevent it) or
representatives in the course of performing CONTRACTOR's obligations
hereunder; provided however that:
(a) XXXXXX has performed its obligations hereunder; and
(b) XXXXXX shall have notified CONTRACTOR within ten (10) working
days after receipt of notice of the claim, action, lawsuit or
other proceeding; and
(c) XXXXXX shall fully cooperate in the investigation and defense of
any such claim, action, lawsuit or other proceeding.
7.2 Indemnification of CONTRACTOR. XXXXXX shall defend, indemnify and
hold harmless CONTRACTOR and its directors, officers, employees, and
subcontractors 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 (a)
alleging personal injury or death arising out of or in connection
with any procedure required by the Protocol or with the
administration or use of the Study Medication or any control drug by
any Investigator in the performance of the Study in accordance with
the Protocol or (b) to the extent such liability, cost or expense is
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attributable to any negligent or willful act or omission or breach
of this Agreement on the part of XXXXXX or any of its agents,
employees or representatives; provided however that:
(a) CONTRACTOR has performed its obligations hereunder; and
(b) CONTRACTOR shall have notified XXXXXX within ten (10) working
days after receipt of notice of the claim, action, lawsuit or
other proceeding; and
(c) CONTRACTOR shall fully cooperate in the investigation and
defense of any such claim, action, lawsuit or other proceeding.
7.3 Notwithstanding the foregoing, XXXXXX shall not be required to
indemnify CONTRACTOR for any liability, cost or expense
attributable to any negligent or willful act or omission or breach
of this Agreement on the part of CONTRACTOR or any agent, employee,
subcontractor (including Investigators, if CONTRACTOR should
reasonably have anticipated such action and taken measures to
prevent it) or other representative of CONTRACTOR in the course of
performing its obligations hereunder. Conflicts of Interest. XXXXXX
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 Paragraphs 7.2. If representation of
CONTRACTOR and any other defendant by the same legal counsel in any
lawsuit or claim would be a conflict of interest for such counsel,
XXXXXX shall retain additional independent counsel for one or more
of said defendants to eliminate such conflict.
ARTICLE 8-- PROPERTY OWNERSHIP AND RETENTION
8.1 Ownership. The following materials shall be deemed to be the
exclusive property of XXXXXX and are hereinafter collectively
referred to as "Xxxxxx Information":
(a) All materials, documents and information of every kind and
description supplied to CONTRACTOR by XXXXXX;
(b) All materials, documents and information of every kind and
description prepared or developed by CONTRACTOR pursuant to this
Agreement, except for
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procedural manuals, personnel data and computer software; and
(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.
8.2 Inventions and Discoveries.
(a) CONTRACTOR will promptly disclose to XXXXXX or its nominee any
and all inventions, discoveries and improvements conceived,
made or reduced to practice by CONTRACTOR or any agent,
employee, subcontractor or other representative of CONTRACTOR
in the course of performing the Services. CONTRACTOR hereby
agrees to assign all its right, title and interest therein to
XXXXXX or its nominee. CONTRACTOR shall ensure that its
contractual arrangements with its agents, employees,
subcontractors and other representatives provide for their
automatic assignment to XXXXXX of all such inventions,
discoveries and improvements.
(b) Whenever requested to do so by XXXXXX, CONTRACTOR will execute
any and all applications, assignments or other instruments and
give testimony which XXXXXX shall deem necessary to apply for
and obtain letters patent of the United States or of any
foreign country or to protect otherwise XXXXXX'x interest
therein. CONTRACTOR shall be reimbursed for reasonable expenses
and personnel charges in complying with XXXXXX'x request.
CONTRACTOR shall ensure that its contractual arrangements with
its agents, employees, subcontractors and other representatives
provide for their automatic assignment to XXXXXX of all such
inventions, discoveries and improvements.
ARTICLE 9-- CONFIDENTIALITY
9.1 Undertaking. During the term hereof and for a period of ten (10)
years following the expiration or termination hereof, CONTRACTOR
shall keep confidential and not use (other than to perform the
Services) any of the Xxxxxx Information. CONTRACTOR further agrees
to limit disclosure of the Xxxxxx Information to agents,
subcontractors,
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employees and other representatives of CONTRACTOR who have signed
agreements with CONTRACTOR reiterating the provisions of this
Article and to Investigators who have signed Investigator Contracts.
9.2 Exceptions. The obligations set forth in Paragraph 9.1 shall not
apply to Xxxxxx Information which:
(a) is already known to CONTRACTOR as shown by its prior written
records
(b) is or becomes publicly available through no fault of CONTRACTOR;
(c) is received from a third party which CONTRACTOR believes in good
faith has a right to disclose it; or
(d) is required by law to be disclosed.
9.3 Publications. It is expressly understood that neither CONTRACTOR nor
any agent, employee subcontractor or other representative of
CONTRACTOR shall have the right to publish any information
concerning the Study.
ARTICLE 10--ASSIGNMENT
10.1 BY CONTRACTOR. CONTRACTOR may not assign, transfer or attempt to
assign or transfer any of its rights or obligations hereunder
without the prior written consent of XXXXXX. Any attempt by
CONTRACTOR without XXXXXX'x prior written consent shall constitute a
material default hereunder.
10.2 By XXXXXX. XXXXXX shall have the right to assign this Agreement, in
whole or in part, on thirty (30) days' prior written notice to
CONTRACTOR.
ARTICLE 11--ENTIRE AGREEMENT; AMENDMENTS
11.1 Entire Agreement. This Agreement, together with its Exhibits and the
Protocol, constitutes the entire agreement between the parties with
respect to the subject matter hereof and supersedes all prior
agreements or understandings, whether verbal or written, concerning
said subject matter.
11.2 Amendments. This Agreement may not be amended except in writing
signed by both parties.
ARTICLE 12--MISCELLANEOUS
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12.1 Conflict of Interest. CONTRACTOR represents to XXXXXX 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.
12.2 Independent Contractor. CONTRACTOR is an independent contractor and
nothing in this Agreement shall be construed to create a
partnership, joint venture or employment relationship between the
parties. CONTRACTOR shall have no authority to bind XXXXXX to any
commitment whatsoever and CONTRACTOR shall not hold itself out to
third parties as having authority to do so.
12.3 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.
12.4 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).
12.5 Survival. Sections 2.6, 2.7, and 6.5 and Articles 7, 8 and 9 shall
survive the expiration or earlier termination of this Agreement.
12.6 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.
12.7 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.
12.8 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, employees, subcontractors and
representatives in any publication, promotional material or other
writing or oral statement for public distribution, relative to the
subject matter
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or existence of this Agreement, except as otherwise required by law
or previously consented to in writing by the other party.
Notwithstanding the foregoing, XXXXXX consents to CONTRACTOR
advising prospective clients that CONTRACTOR has performed clinical
research services for XXXXXX.
12.9 Force Maieure. 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.
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IN WITNESS WHEREOF, the parties have executed this Agreement the day and year
set forth above.
XXXXXX RESEARCH ASSOCIATES, INC. X.X. XXXXXX & CO.
By: /s/ Xxxxxxx Xxxxxx Xxxxx By: /s/ X.X. Xxxxxxx
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Title: CEO Title: CEO
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Date: 5/13/96 Date: 8/7/96
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