EXHIBIT 10.5
CLINICAL SERVICES AGREEMENT
BY AND BETWEEN
Pharmaceutical Product Development, Inc.
000 Xxxxx Xxxxx Xxxxxx
Xxxxxxxxxx, XX 00000
AND
Xxxxxxxxxx Laboratories Inc
Xxxx Xxxxxx Xxx 000000
Xxxxxx Xxxxx 00000-0000
July 10, 1995
TABLE OF CONTENTS
SECTION 1 -DEFINITIONS........................................................1
SECTION 2 -SERVICES...........................................................2
SECTION 3 -TRANSFERRED OBLIGATIONS............................................2
SECTION 4 -PAYMENT AND COMPENSATION...........................................3
SECTION 5 -TIMELY COMPLETION..................................................4
SECTION 6 -REPRESENTATIONS....................................................4
SECTION 7 -XXXXXXXXXX'x RESPONSIBILITIES......................................5
SECTION 8 -CONFIDENTIALITY....................................................6
SECTION 9 -RELEASE OF INFORMATION.............................................7
SECTION 10 -PROPERTY OWNERSHIP................................................7
SECTION 11 -PATENT RIGHTS.....................................................7
SECTION 12 -INDEMNIFICATION...................................................8
SECTION 13 -INSURANCE.........................................................9
SECTION 14 -EARLY TERMINATION.................................................9
SECTION 15 -RECORDS..........................................................12
SECTION 16 -COMPLIANCE WITH LAWS.............................................12
SECTION 17 -MEDIATION AND ARBITRATION........................................12
SECTION 18 -MISCELLANEOUS....................................................13
EXHIBIT A
EXHIBIT B
EXHIBIT C
EXHIBIT D
EXHIBIT E
AGREEMENT FOR CLINICAL STUDY SERVICES
This agreement ("Agreement") is made by and between Pharmaceutical
Product Development, Inc. ("PPD"), located at 000 Xxxxx Xxxxx Xxxxxx Xxxxxxxxxx,
Xxxxx Xxxxxxxx 00000, and Xxxxxxxxxx Laboratories Inc. (XXXXXXXXXX), located at
Xxxx Xxxxxx Xxx 000000, Xxxxxx, Xxxxx 00000-0000.
WITNESSETH:
WHEREAS, PPD is engaged in the business of managing clinical research
programs;
WHEREAS, XXXXXXXXXX is engaged in the development, manufacture, and
distribution, of medical products; and
WHEREAS, XXXXXXXXXX wishes to retain PPD's services in helping to conduct
the Study set forth in the Protocol in accordance with the terms and conditions
herein;
NOW, THEREFORE, PPD AND XXXXXXXXXX, hereby agree to the following:
SECTION 1 -DEFINITIONS
----------------------
For purposes of this Agreement, the following terms shall have the
meanings set forth below when written with an initial capital letter.
A. "Case Report Form" or "CRF" - the patient case report form to be used in
the Study.
B. "Control Drug" - placebo or other agent as set forth in the Protocol.
C. "Evaluable Patient" - a patient who has passed the inclusion and
exclusion criteria; signed the informed consent; received the study drug
by the dose, route, regimen, and duration as specified in the Protocol;
had adequate documentation of primary efficacy and safety variables; and
been adequately followed to establish valid endpoints of safety and
efficacy.
D. "FDA" - the United States Food and Drug Administration.
E. "IND" - a claimed Investigational New Drug Application.
F. "Institutional Review Board" or "IRB" - any of the boards established
pursuant to 21 C.F.R. Part 56 for the purpose of reviewing clinical
research studies.
G. "Investigator" - the licensed physician who is a qualified clinical
investigator willing and able, and engaged by PPD in accordance with this
Agreement, to perform the Study.
H. "NDA" - a New Drug Application.
I. "Protocol" - the clinical testing procedures and conditions set forth in
XXXXXXXXXX Protocol 9008, attached hereto as EXHIBIT A and incorporated
by reference herein.
J. "SOPs" - PPD's current standard operating procedures for conducting and
monitoring clinical trials approved by XXXXXXXXXX.
K. "Study" - the clinical evaluation of the safety and efficacy of the Study
Drug pursuant to the Protocol.
1
L. "Study Drug" -Oral Acemannan.
M. "Study Period" - the period during which the Study is to be performed;
beginning at the preparatory period prior to initiating the Study, and
ending at the delivery of complete Investigator documentation files to
XXXXXXXXXX.
N. "Out of Scope Work" - any request from XXXXXXXXXX for performance of
services that have not been agreed upon and accepted by XXXXXXXXXX as
indicated in this Agreement or Exhibits.
SECTION 2 -SERVICES
-------------------
PPD shall perform services including but not limited to those set forth in
EXHIBIT B attached hereto and incorporated by reference herein.
SECTION 3 -TRANSFERRED OBLIGATIONS
----------------------------------
Notwithstanding any other provision of this Agreement, and in addition to any
other specific responsibilities of PPD which are set forth herein, pursuant to
21 CFR Section 312.52, PPD assumes the following specific responsibilities of
XXXXXXXXXX as "Sponsor" under the Federal Food and Drug Administration Act
("Act"):
a. Screening Investigators to perform the Study in accordance with
the Protocol;
b. Obtaining from Investigators information required by 21 CFR
(S)312.53(c)(1), (2) and (3);
c. Transmitting to Investigators the materials described in 21 CFR
(S)312.55(a) and (b) submitted to PPD by XXXXXXXXXX, and any other
Study-related materials by XXXXXXXXXX;
d. Selecting monitors who will monitor in accordance with 21 CFR
312.53(d) and 312.56(a) to perform the following tasks:
1. Monitor the progress of the Study;
2. Ensure the completeness and accuracy of clinical data;
3. Ensure Investigators' compliance with federal and other
applicable laws and regulations;
e. Ensuring that the Study is conducted at each site in accordance
with the Protocol, the Act, and applicable regulatory requirements
and guidelines:
f. Transmitting all relevant information concerning serious or
unexpected adverse events within twenty-four (24) hours to
XXXXXXXXXX; provided, however, that XXXXXXXXXX shall retain
responsibility for writing and filing IND Safety Reports
2
with the FDA, and PPD shall transmit information from such reports
to all Investigators.
g. Maintaining all necessary records concerning the Study as required
by law;
h. Assuring the return of all unused supplies of investigational drug
(Study Drug and Control Drug) from each site as specified by the
Protocol to XXXXXXXXXX or XXXXXXXXXX'x designee.
XXXXXXXXXX transfers the above responsibilities to PPD but retains those
responsibilities of XXXXXXXXXX not specifically listed herein. Except for the
responsibilities transferred to PPD herein, XXXXXXXXXX shall at all times be
deemed to be the "Sponsor" of the Study for purposes of the Act.
SECTION 4 -PAYMENT AND COMPENSATION
-----------------------------------
4.1 Payment. For monitoring the Study hereunder, PPD will receive a total
-------
sum not to exceed $1,727,577.00 (excludes Central Laboratory 6%
Administrative Fee). Payment shall be made in accordance with the Budget
and payment schedule set forth in EXHIBIT C.
4.2 Payable
-------
All checks shall be made payable to:
Pharmaceutical Product Development, Inc. (Fed. I.D. # 561640186)
000 Xxxxx Xxxxx Xxxxxx
Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000
4.21 Late Payment If payment is not received from XXXXXXXXXX within
------------
thirty (30) days in accordance with the payment schedule
delineated in the Proposal marked as Exhibit C, an interest charge
will be added to 4.3 the unpaid balance in the amount of 1.5% per
month.
4.3 All questions that XXXXXXXXXX may have concerning scheduled payments,
amount of payments, and other related accounting questions under this
Agreement are to be directed to:
Xxxx Xxxxxxx
Cost Accountant
(000) 000-0000, Extension 467.
3
4.4 All questions that PPD may have concerning scheduled payments, amount of
payments and other related accounting questions under this Agreement are
to be directed to:
Name: Xxxxx Xxxxxxxxxxx
Title: Controller
Phone # 214/000-0000
4.5 Taxes All taxes (and any penalties thereon) imposed on any payment by
-----
XXXXXXXXXX shall be the responsibility of PPD.
4.6 Out-of-Scope Work Any and all services that fall within the definition
-----------------
of Out-of-Scope Work will be performed by PPD provided that the following
provisions apply .
a. That XXXXXXXXXX and PPD enter into good faith negotiations
regarding the additional services to be performed and attendant
charges thereto.
b. That negotiations regarding Out-of-Scope Work are completed within
60 days of inception of same.
c. Any agreement and its resultant effect on payment related to
performance of the Out-of-Scope Work in question will be
incorporated into this Agreement.
d. All Out-of-Scope Work will be agreed upon prior to implementation
based upon the execution of the form entitled Request For Project
Change which is attached hereto, incorporated herein by reference
and marked as 1.
SECTION 5 -TIMELY COMPLETION
----------------------------
Time is of the essence to this Agreement. It is acknowledged that XXXXXXXXXX
desires to progress the Study hereunder at the maximum speed consistent with
good clinical practice and adherence to FDA regulations. PPD will make best
efforts to meet the timelines set forth in EXHIBIT D attached hereto and
incorporated by reference herein, and the Protocol. To the extent the
additional professional fees, management practices, and other incentives are
determined necessary for timely completion and were not provided for in the
Budget (EXHIBIT C), the aforesaid expenses will be added to the Budget as
mutually agreed upon in writing by the parties to the Agreement. Non-enrolling
investigational sites will be dropped and replaced by more productive
investigational sites, upon request by XXXXXXXXXX or upon PPD's suggestion with
XXXXXXXXXX'x approval.
SECTION 6 -REPRESENTATIONS
--------------------------
6.1 Conflicting Agreements. PPD represents that is not now under any
----------------------
agreement to provide services which would prevent it from fulfilling its
obligations hereunder, and that during the
4
term of this Agreement, PPD will not enter into an agreement which would
in any way restrict its ability to provide services under this Agreement.
For the duration of this Agreement, PPD will not enter into any other
Agreements to provide study services in connection with ulcerative
colitis that would result in a compromise of the timelines established
for this program.
6.2 FDA Debarment and Disqualification. PPD represents that neither PPD nor
-----------------------------------
its employees, any Investigator or any person employed by Investigator to
perform the Study pursuant to this Agreement, (i) is under investigation
by the FDA for debarment action or is presently debarred pursuant to the
Generic Drug Enforcement Act of 1992 (21 U.S.C. 301 et seq), or (ii) has
------
a disqualification hearing pending or has been disqualified by the FDA
pursuant to 21 CFR Section 312.70. If during the course of this
Agreement, any Investigator or any person employed by an Investigator to
perform the Study (i) comes under investigation by the FDA for disbarment
action or disqualification, or (ii) is disbarred or disqualified, PPD
shall immediately notify XXXXXXXXXX and terminate such Investigator's
participation in the Study, upon XXXXXXXXXX 's request.
SECTION 7 -XXXXXXXXXX'x RESPONSIBILITIES
----------------------------------------
7.1 Clinical Supplies. XXXXXXXXXX shall provide at its own expense all
-----------------
necessary clinical supplies of the Study Drug and Control Drug in time to
begin the clinical evaluations according to agreed upon timelines.
XXXXXXXXXX shall notify PPD of the amount and date of all Study Drug and
Control Drug shipped under the preceding sentence. Title to all supplies
shall remain with XXXXXXXXXX.
7.2 Protocol and CRFs. XXXXXXXXXX shall finalize the Protocol and CRFs and
-----------------
deliver copies to PPD in a timely manner consistent with adherence to
development timelines. XXXXXXXXXX agrees that the Protocol, CRFs, or
revisions thereto, which are undertaken by XXXXXXXXXX are the
responsibility of XXXXXXXXXX, even if such documents were suggested or
recommended by PPD. XXXXXXXXXX must review and approve the final CRF.
7.3 Study-Related Injury. In the event a patient participating in the Study
--------------------
is physically injured directly as a result of the Study Drug administered
in accordance with the Protocol and such patient has followed the
directions of the Investigator or other Study personnel, XXXXXXXXXX will
cover the medical expenses necessary to treat the injury, subject to
PPD's indemnification responsibilities under Section 12.2 below. No other
compensation will be provided by XXXXXXXXXX. Payments under this Section
7.3 shall be in addition to any other payments specified in this
Agreement. Upon request of PPD or an Investigator, XXXXXXXXXX will
deliver to the Investigator a letter setting forth XXXXXXXXXX'x
obligations under this Section 7.3.
7.4 Letter of Indemnity. XXXXXXXXXX shall, at the request of PPD or an
-------------------
Investigator, execute
5
and deliver to the Investigator a letter setting forth XXXXXXXXXX'x
obligations to the Investigator regarding any liability which may arise
out of the Investigator's participation in the Study.
7.5 Regulatory Developments. XXXXXXXXXX shall file IND amendments with the
-----------------------
FDA with respect to the Study Drug and promptly notify PPD of such filing
and further regulatory developments with respect to such IND/NDA
affecting the legal status of the Study.
7.6 Audits by XXXXXXXXXX. A number of investigational sites participating in
--------------------
the Study and/or PPD, may be selected by XXXXXXXXXX for an audit by
XXXXXXXXXX upon prior written notification to the investigational site
and PPD. PPD shall fully cooperate in such audit.
7.7 Evaluation Visits. In its capacity as sponsor of the Study, XXXXXXXXXX
-----------------
shall accompany PPD on a number of regularly scheduled investigational
site visits, including initiation, monitoring, and close-out visits.
XXXXXXXXXX shall notify PPD thirty (30) days in advance of all such
evaluation visits.
7.8 Financial Issues. Any and all types of financial matters regarding the
----------------
Study will be discussed only with PPD unless PPD is unable to provide
documents pursuant to 14.6(5).
7.9 Assays. XXXXXXXXXX shall be responsible for all assays of the Study Drug
------
and Control Drug.
SECTION 8 -CONFIDENTIALITY
--------------------------
8.1 Confidential Information. The Protocol, data forms, clinical data and
------------------------
other data and information obtained or developed by or provided to PPD
and/or Investigators in connection with the Study ("Confidential
Information") are deemed to be confidential and are to be considered as
the sole and exclusive property of XXXXXXXXXX. PPD agrees to maintain the
confidentiality of this Confidential Information and not to disclose it
to third parties who are not involved in the Study without prior written
authorization from XXXXXXXXXX. PPD has obtained or will obtain, prior to
the initiation of the study, written agreements with its employees and
agents to maintain the confidentiality of this Confidential Information
as provided herein.
8.2 Non-Disclosure Agreement. PPD further agrees that any Investigator
------------------------
selected by PPD to provide services hereunder, and his/her coworkers,
agents or assistants or his/her authorized replacement, shall sign a Non-
Disclosure Agreement, the form of which is attached hereto as EXHIBIT E
and incorporated by reference herein. At the conclusion of the Study, any
of the Investigators may publish the results in the scientific and
medical literature, following XXXXXXXXXX'x prior internal review and
written approval of the proposed publication.
6
8.3 Survival of Obligations. The obligations of PPD and Investigators with
-----------------------
regard to Confidential Information shall continue without limitation
unless modified in writing by XXXXXXXXXX and will survive, without
limitation, for a period of fifteen (15) years after the expiration or
earlier termination of the Agreement.
8.4 Obligation of PPD. These obligations of non-disclosure shall not apply
-----------------
to Confidential Information which:
a. Is already known to PPD as shown by its prior written records;
b. Is or becomes publicly available through no fault of PPD;
c. Is received from a third party which has the legal right to
disclose it to PPD; or
d. Is required by law to be disclosed, provided XXXXXXXXXX is
notified in writing ten (10) days prior to such lawful disclosure
if possible, or as soon as possible thereafter.
8.5 Injunctive Relief. PPD acknowledges and agrees that any violation of the
-----------------
terms of this Agreement relating to the disclosure or use of Confidential
Information may result in irreparable injury and damage to XXXXXXXXXX
that may not be adequately compensable in money damages, and for which
XXXXXXXXXX will have no adequate remedy at law. PPD therefore consents
and agrees that XXXXXXXXXX may obtain injunctions, orders or decrees as
may be necessary to protect its Confidential Information.
SECTION 9 -RELEASE OF INFORMATION
---------------------------------
XXXXXXXXXX may use, refer to and disseminate reprints of scientific, medical and
other published articles which disclose the name of PPD consistent with U.S.
copyright laws, provided such use does not constitute an endorsement of any
commercial product or service by PPD. PPD shall not disclose publicly or
utilize in any advertising or promotional materials the existence of this
Agreement or PPD's association with XXXXXXXXXX or the use of the name XXXXXXXXXX
or the name of any of XXXXXXXXXX'x divisions, products or investigations without
the prior written permission of XXXXXXXXXX.
SECTION 10 -PROPERTY OWNERSHIP
------------------------------
All materials, documents, information, programs and suggestions of every kind
and description supplied to PPD or Investigators by or on behalf of XXXXXXXXXX
or prepared or developed by PPD or Investigators pursuant to this Agreement,
shall be the sole and exclusive property of
7
XXXXXXXXXX.
SECTION 11 -PATENT RIGHTS
-------------------------
11.1 Inventions. PPD will disclose promptly to XXXXXXXXXX or its nominee any
-----------
and all inventions, discoveries and improvements conceived or made by PPD
or Investigators in the course of performing their duties to XXXXXXXXXX
pursuant to this Agreement and PPD
agrees to assign, and to cause Investigators to assign all their interest
therein to XXXXXXXXXX or its nominee.
11.2 Patent Assistance. Whenever requested to do so by XXXXXXXXXX, PPD will
------------------
execute and/or cause Investigators to execute any and all applications,
assignments or other instruments and give testimony which XXXXXXXXXX
shall deem necessary to apply for and obtain letters of patent of the
United States or of any foreign country or to protect otherwise
XXXXXXXXXX'x interest therein. XXXXXXXXXX shall compensate PPD and the
Investigators for their time devoted to such activities and reimburse
them for reasonable and necessary expenses incurred.
11.3 Survival of Obligations. These obligations shall continue beyond the
------------------------
termination of this Agreement with respect to inventions, discoveries and
improvements conceived or made by PPD or Investigators while providing
services to XXXXXXXXXX pursuant to this Agreement, and shall be binding
upon PPD's assigns, administrators and other legal representatives.
SECTION 12 -INDEMNIFICATION
---------------------------
12.1 XXXXXXXXXX. XXXXXXXXXX agrees to indemnify, defend and hold harmless PPD
-----------
from any loss, expense (including counsel fees), cost, liability, damage
or claim for personal injuries, including death at any time resulting
therefrom, or for damage to property arising out of or in connection with
the performance of this Agreement (hereinafter collectively "PPD Loss"),
provided that the Study is performed in complete compliance with this
Agreement and the Protocol, and that such PPD Loss does not arise out of
the negligence or willful misconduct of any person not in the employment
of XXXXXXXXXX, that XXXXXXXXXX is promptly notified of any complaint,
claim or injury to any subject arising out of or in the course of PPD's
activities in connection with the Study, and that XXXXXXXXXX has sole
control over the defense or settlement of any such compliant or claim.
12.2 PPD. PPD shall indemnify and hold XXXXXXXXXX harmless from any loss
----
expense (including counsel fees), cost, liability, damage or claim for
personal injuries, including death at any time resulting therefrom, or
for damage to property arising out of or in connection with the
performance of this Agreement (hereinafter collectively "XXXXXXXXXX
Loss") and
8
resulting from: 1) the failure of the PPD or Investigators or their
employees or agents to perform the Study in accordance with the Protocol
or in a manner required of a reasonable and prudent clinical investigator
or physician; or 2) the negligence or willful misconduct of PPD or the
employees, agents or any other persons connected with PPD or its
performance hereunder, including Investigators, except to the extent such
XXXXXXXXXX Loss is due to the negligence of XXXXXXXXXX.
SECTION 13 -INSURANCE
---------------------
13.1 PPD Requirements. Unless otherwise agreed to in writing, PPD shall, at
-----------------
its own expense, carry and maintain during the performance of the Study
under this Agreement the following insurance on its employees, in amounts
no less than that specified for each type:
a. Commercial general liability insurance including premises and
operations coverage with limits of not less than $1,000,000 per
occurrence and $2,000,000 per accident;
b. Property damage liability insurance with limits of not less than
$100,000 per occurrence and $100,000 per accident; and
c. Worker's compensation insurance in the amount required by
applicable state law.
13.2 Certificates of Insurance. PPD shall, at XXXXXXXXXX'x request, have its
--------------------------
insurance carrier or carriers furnish to XXXXXXXXXX certificates of
insurance or, if self-insured, documentation stating that all insurance
required under this Agreement is in force, such certificates or
documentation to indicate any deductible and/or self-insured retention
and stipulate that the insurance will not be canceled while this
Agreement is in effect without thirty (30) days prior written notice to
XXXXXXXXXX. PPD shall on request permit XXXXXXXXXX to examine original
insurance or other protective policies issued in compliance with the
requirements hereof. Should PPD at any time neglect or refuse to provide
the insurance required herein, or should such insurance be canceled,
XXXXXXXXXX shall have the right to procure the same and the cost thereof
shall be deducted from any compensation then due or thereafter to become
due PPD. PPD shall not commence the Study hereunder until the insurance
required herein has been obtained.
13.3 XXXXXXXXXX Requirements. XXXXXXXXXX shall provide PPD, upon request,
------------------------
documentation assuring PPD that XXXXXXXXXX maintains product liability
insurance.
SECTION 14 -EARLY TERMINATION
-----------------------------
14.1 Periodic Review and Evaluation. XXXXXXXXXX shall have the right to
-------------------------------
review the progress of the Study undertaken hereunder every two weeks and
determine whether to continue or elect to terminate prior to completion
for any reason. XXXXXXXXXX may elect to terminate or not commence the
Study at any time for any reason upon thirty (30) days written notice
9
to PPD.
14.2 Immediate Termination. This Agreement may be terminated by written
---------------------
notice from XXXXXXXXXX, if any of the following conditions occur:
a. Authorization and approval to perform the Study in the United
States is withdrawn by the FDA;
b. Animal, human or toxicological test results, in the opinion of
XXXXXXXXXX, support termination of the Study;
c. The emergence of any adverse reaction or side effect with the
Study Drug administered in the Study is of such magnitude or
incidence, in the opinion of XXXXXXXXXX, to support termination;
d. PPD fails to comply with the terms of the Protocol or commits a
material breach of the Agreement for which notification has been
provided under 14.81; or
e. PPD or any of its employees is debarred by the FDA pursuant to the
Generic Drug Enforcement Act of 1992 (21 U.S.C. 301 et seq).
------
f. PPD's Medical Director, Project Manager, or Assistant Project
Manager, as delineated in Exhibit C is no longer able to provide
services hereunder.
14.3 Minimize Costs. Upon PPD's receipt of XXXXXXXXXX'x written notice of
---------------
termination or non-commencement, PPD shall use best efforts to revoke any
costs incurred, to avoid incurring any additional costs, and shall
refrain from enlisting any additional Investigators or patients. In the
event of early termination under this Section 14, PPD shall promptly
return to XXXXXXXXXX any monies paid by XXXXXXXXXX for which Study-
related services have not been provided ("Unpaid Contract Value"),
including payments for Investigator costs, as of the effective date of
termination.
14.4 Continuation of Study. In the event XXXXXXXXXX terminates this Agreement
----------------------
early pursuant to Section below, XXXXXXXXXX shall have the right without
exclusion of any other rights and remedies of XXXXXXXXXX, to attempt to
engage the Investigators, either directly or indirectly and to complete
the Study. If XXXXXXXXXX chooses to make such efforts, PPD agrees not to
interfere with these efforts and to promptly provide XXXXXXXXXX with a
list of all Investigators and copies of all records required under
Section 14.6 below.
14.5 Termination Fee. In the event XXXXXXXXXX terminates this Agreement early
----------------
pursuant to Section 14.1 above due to XXXXXXXXXX'x determination that the
Study is not worth
10
pursuing due to poor enrollment, and in view of XXXXXXXXXX'x corporate
objectives and PPD has not breached the Protocol or this Agreement, PPD's
usual termination fee of fifteen percent (15%) of the unpaid contract
value as of the date of termination will be waived due to an enrollment
deficiency.
14.6 PPD Responsibilities. In the event of termination, PPD shall: (1)
---------------------
exercise its termination rights under its agreement with Investigators or
assign such Investigator agreements to XXXXXXXXXX , at XXXXXXXXXX'x
option; (2) conduct close-out visits at each site in order to conclude
the Study; (3) perform any other monitoring services necessary to
discharge its responsibilities under 21 CFR Part 312.52; (4) perform such
services reasonably necessary or required in connection with the orderly
termination of the Study or in connection with the performance of its
obligations under the terms of this Agreement or by federal, state, or
local law or regulation, including applicable FDA regulations and
guidelines; and (5) promptly prepare and submit to XXXXXXXXXX a final
financial report, and copies of all records, including but not limited to
all financial provisions of all agreements between PPD and Investigators
and Investigator sites and all financial records relating to the Study or
its performance and all periodic reports and patient records. In the
event PPD fails to deliver to XXXXXXXXXX any of the records required
under subsection 14.6(5), XXXXXXXXXX shall have the right to enter PPD's
premises and collect such records during PPD's normal working hours. PPD
shall cooperate with XXXXXXXXXX to provide for an orderly termination and
termination of the Agreement as provided herein.
14.7 XXXXXXXXXX Responsibilities. In the event of termination, XXXXXXXXXX
----------------------------
shall: (1) pay PPD the amounts due PPD for all work and services
performed or committed through the effective date of termination; and (2)
pay the amounts due PPD for reimbursable expenses incurred by PPD in
performing services during the notice period; provided however, that PPD
returns to XXXXXXXXXX all prepaid, unearned funds as required under
Section 14.3 above.
14.8 Breach of Agreement and Insolvency. In addition to any other rights or
-----------------------------------
remedies contained herein, this Agreement may be terminated by either
party:
14.81 Material Breach. Should the other party commit a material breach
---------------
of this Agreement, the aggrieved party may send a written notice
of said breach to the breaching party. The breaching party must
initiate a cure of the material breach within ten (10) days of
said notice and cure the breach within thirty (30) days of said
notice. Failure to comply with the foregoing will constitute a
breach of this Agreement.
14.82 Insolvency. A breach of this Agreement will occur by a party
----------
following thirty (30) days written notice that any of the
following events has occurred: party has become insolvent,
dissolved or liquidated, has made a general assignment for the
benefit of creditors, has filed or has filed against it a petition
in bankruptcy, or has a receiver appointed for a substantial part
of its assets.
11
Notwithstanding subsection 14.81 in the event PPD commits a material breach
arising out of its failure to comply with any pertinent law or regulation as
required under Section 16 - below, XXXXXXXXXX may terminate this Agreement on
written notice effective immediately.
Upon termination pursuant to Section 14.2(d), PPD shall make available to
XXXXXXXXXX all records required pursuant to subsection 14.6(5) and the parties
shall agree upon a termination payment to PPD which will be comprised of
compensation to the extent the following are not duplicative for (i) all
services to be rendered through the effective date of termination; (ii) all
reimbursable expenses to be incurred in connection with the rendering of such
services; (iii) the amounts payable to Investigators for per patient
compensation pursuant to Investigator Agreements; and (iv) such expenses to be
reasonably incurred by PPD in connection with the orderly termination of PPD's
services reasonably required or necessary in connection with the performance of
its obligations under the terms of this Agreement or by federal or state law or
regulation, including applicable FDA guidelines and specifically requested by
XXXXXXXXXX. However, such termination payment will be reduced by the value of
damages resulting from such breach subsequent to a reasonable accounting of such
damages or payments otherwise owed to XXXXXXXXXX.
SECTION 15 -RECORDS
-------------------
PPD shall maintain adequate accounting records for all receipts and
disbursements of supplies and monies. PPD shall also make and keep systematic
written records of all services performed and expenses incurred under this
Agreement. Such records shall include records relevant to any costs or expenses
incurred by PPD including Investigator grants, and PPD shall preserve all such
records for three (3) years following completion of services hereunder or
termination of this Agreement. During the term of this Agreement and for three
(3) years thereafter, XXXXXXXXXX shall have the right to audit, inspect and copy
such records during PPD's regular working hours, and such records may be used by
XXXXXXXXXX without limitation.
SECTION 16 -COMPLIANCE WITH LAWS
--------------------------------
During the term of this Agreement, PPD and all of its employees, agents,
representatives and invitees shall fully comply with XXXXXXXXXX'x SOPs to the
extent they are not in conflict or adverse to PPD's SOPs. Should there be a
difference noted between XXXXXXXXXX'x SOPs and PPD's SOPs, the parties will
agree to follow PPD's SOPs unless otherwise requested by XXXXXXXXXX. In the
event of such a request, XXXXXXXXXX will provide written documentation of such
request and provide a written description of procedures to be followed that do
not comply with PPD SOPs. Such documentation will be housed in the sponsor
master file to be maintained by PPD. In addition during the term of the
Agreement, PPD and all of its employees, agents, representatives and invitees
will comply with all applicable laws, governmental regulations, rules,
requirements, ordinances, and other requirements of local and state authorities
and the Federal government, including but not limited to those administered by
the FDA, and the Occupational Safety and Health Act of 1970 ("OSHA"), the
Resource Conservation and Recovery Act ("RCRA"), and the Immigration Reform and
Control Act of 1986 ("IRCA") and the IRCA's implementing regulations as they
pertain to any
12
and all employees employed by PPD in connection with the services hereunder.
SECTION 17 -MEDIATION AND ARBITRATION
-------------------------------------
17.1 Resolution. If a dispute arises from or relates to this contract or a
-----------
breach thereof and if the dispute cannot be settled through direct
discussions, the parties agree to endeavor first to settle the dispute in
an amicable manner by mediation administered by the American Arbitration
Association under its Commercial Mediation Rules before resorting to
arbitration. Thereafter, any unresolved controversy or claim arising from
or relating to this contract or breach thereof shall be settled by
arbitration administered by the American Arbitration Association in
accordance with its Commercial Mediation Rules and judgement on the award
rendered by arbitrator(s) may be entered in any court having jurisdiction
thereof.
17.2 Transaction. The parties acknowledge that this agreement evidences a
-----------
transaction involving interstate commerce. The United States Arbitration
Act shall govern the interpretation, enforcement, and proceedings
pursuant to the arbitration clause in this agreement.
17.3 Location. Mediation and/or arbitration shall be held in Charlotte, North
--------
Carolina or any other place selected by mutual agreement.
17.4 Arbitration. The arbitration shall be before one neutral arbitrator to
-----------
be selected in accordance with the Commercial Rules of the American
Arbitration Association and shall proceed under the Expedited Procedure
of those rules, irrespective of the amount in dispute.
17.5 Prehearing Exchange. The arbitrator shall have the discretion to order a
-------------------
prehearing exchange of information by the parties, including, production
of requested documents, exchange of summaries of testimony of proposed
witnesses, and examination by deposition of parties.
17.6 Fees. All fees and expenses of the arbitration shall be borne by the
----
parties equally. However each party shall bear the expenses of its own
counsel, experts, witnesses, and preparation and presentation of proofs.
17.7 Disclosure. Neither a party nor the arbitrator may disclose the
----------
existence, content, or results of any arbitrative hereunder without the
prior written consent of both parties.
SECTION 18 -MISCELLANEOUS
------------------------
18.1 Modification. No modification of this Agreement shall be deemed
------------
effective unless in writing and signed by the parties hereto.
18.2 Integration of Agreement. This Agreement represents the entire and
-------------------------
integrated agreement
13
between the parties and supersedes all prior negotiations,
representations or agreements either written or oral, regarding the Study
to be performed under this Agreement.
18.3 Descriptive Headings. The descriptive heading of the sections of this
---------------------
Agreement are inserted for convenience only and shall not control or
affect the meaning or construction of any provision hereof.
18.4 Incorporation by Reference. All Exhibits attached hereto shall be deemed
---------------------------
to be incorporated herein. In case of any conflict between this Agreement
and any Exhibit, the terms of this Agreement shall prevail over the
Exhibit.
18.5 Assignment. This Agreement shall be binding upon and inure to the
----------
benefit of the parties hereto and their successors and assigns. PPD shall
not assign this Agreement in whole or in part, or any of the rights or
obligations hereunder without the prior written consent of XXXXXXXXXX.
18.6 Applicable Law. This Agreement shall be governed by and construed in
---------------
accordance with the laws of the State of North Carolina.
18.7 Counterparts. This Agreement may be executed in several counterparts,
------------
each of which shall be deemed an original but all of which shall
constitute one and the same instrument.
18.8 Waiver. Waiver or forbearance by either party or the failure by either
-------
party to claim a breach of any provision of the Agreement or exercise any
right or remedy provided by this Agreement or applicable law, shall not
be deemed to constitute a waiver with respect to any subsequent breach of
any provision hereof.
18.9 Independent Contractor. It is understood and agreed that PPD shall act
----------------------
at all times as an independent contractor. Nothing contained in this
Agreement shall be construed to create the relationship of principal and
agent or employer and employee between XXXXXXXXXX and PPD or PPD's
employees, servants, agents or independent contractors. Neither PPD nor
its employees, servants, agents or independent contractors shall have
authority to act on behalf of or bind XXXXXXXXXX in any manner whatsoever
unless otherwise authorized in this Agreement or in a separate writing
signed by XXXXXXXXXX. It is further understood that no Investigator shall
be construed to be an employee of XXXXXXXXXX.
18.10 Equal Employment Opportunity Policy
-----------------------------------
It is the express written policy of PPD to provide equal opportunities in
recruiting, hiring, training and promoting individuals in all job
categories without regard to race, color, religion, national origin, sex,
age, disability, or veteran status.
PPD remains committed to the elimination of discrimination in the
workplace. PPD shall
14
ensure that all hiring and promotion decisions are consistent with the
principles of equal employment opportunity and are based strictly on
merit. In addition, PPD affirms that all compensation, benefits, company
sponsored training, educational assistance, social and recreational
programs and other human resources programs, are administered without
regard to race, color, sex, religion, national origin, age, veteran
status or disabilities. It is the intent of PPD to support equal
employment opportunity and affirmative action by adhering to both the
letter and spirit of the law.
18.11 Notices. Except as otherwise provided, all communications and notices
--------
under this Agreement shall be mailed by first class mail, postage
prepared, to the addresses as the parties from time to time specify in
writing.
If to PPD: Xxxxx X. Xxxx, M.D.
----------
President/COO
Pharmaceutical Product Development, Inc.
000 Xxxxx Xxxxx Xxxxxx
Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000
If to XXXXXXXXXX: Xxxx X. Xxxx, DDS
----------------
Xxxxxxxxxx Laboratories Inc.
Xxxx Xxxxxx Xxx 000000
Xxxxxx, Xxxxx 00000-0000
IN WITNESS WHEREOF, the undersigned have executed this Agreement of the
day and year first written below.
Xxxxxxxxxx Laboratories Inc. Pharmaceutical Product Development, Inc.
By: By:
--------------------------------- -----------------------------------
Name: Xxxxx Record Name: Xxxxx X. Xxxx, M.D.
------------------------------- ---------------------------------
Title: Vice-President Title: President
------------------------------ --------------------------------
Date: July 10, 1995 Date: July 10, 1995
------------------------------- ---------------------------------
15
EXHIBIT A
PROTOCOL
16
EXHIBIT B
SERVICES
--------
1.PPD Assistance. PPD will provide assistance for Protocol and case report form
---------------
development, and review of other reports and publications as requested by
XXXXXXXXXX. PPD will not write supplemental NDA's or manuscripts for the Study
unless requested by XXXXXXXXXX.
2.PPD Consultation. PPD will provide consultation to XXXXXXXXXX for XXXXXXXXXX
-----------------
meetings, FDA meetings, and Investigator meetings as reasonably requested by
XXXXXXXXXX. Reasonable and necessary travel expenses for such meetings are
included in the Budget attached hereto as EXHIBIT C.
3.Investigator or Study Coordinator Meetings. PPD shall provide XXXXXXXXXX
-------------------------------------------
assistance in planning the Investigator or Study Coordinator meetings for the
Study, provided, however, that XXXXXXXXXX shall determine and approve in advance
the location and budget for such meetings in accordance with the terms and
conditions of a separate written agreement.
4.Pre-Study Meetings. PPD and XXXXXXXXXX via telephone conference shall discuss
-------------------
monthly the status of pre-study work. PPD's project manager for the Study will
be available for any and all such discussions. Upon agreement by both parties,
the frequency of such meetings shall be adjusted upon XXXXXXXXXX'x request.
5.Investigator Selection. PPD will use due diligence in selecting Investigators
-----------------------
to participate in the Study in accordance with guidelines for Investigator
selection and required Investigator credentials provided by XXXXXXXXXX. PPD
shall provide to XXXXXXXXXX a list of prospective Investigators for
consideration and comment by XXXXXXXXXX, which listing shall specify credentials
required by XXXXXXXXXX. XXXXXXXXXX shall have the right of approval or
(disapproval) of Investigators.
6.Investigator/PPD Agreements. PPD shall take all due steps to assure
----------------------------
Investigators are selected and conduct the study in strict accordance with the
Protocol and the terms of this Agreement and the written agreements described
immediately below. The engagement of Investigators shall be by written
agreement between the PPD and Investigator. Such agreements shall require that
each Investigator shall:
a. Exercise independent medical judgement as to the compatibility of each
patient with Protocol requirements;
b. Obtain from each patient in the Study a signed consent form which has
been approved by the IRB and XXXXXXXXXX in accordance with the 21 C.F.R.
Part 50 ;
c. Properly perform the Study in accordance with the Protocol and good
clinical practice;
17
d. Review all patient case report forms (hereinafter "CRFs") to assure their
accuracy and completeness;
e. Submit all data and information, and undertake all activities, so that
the time schedules set forth in the Protocol and this Agreement are
strictly met;
f. Notify immediately, in no event later than the time periods specified in
the SOPs, PPD and the IRB of any serious or unexpected adverse reactions
to the Study or Control Drug using the Adverse Drug Reaction reporting
form set forth in the SOPs;
g. Notify PPD and the IRB of any deviations from the Protocol;
h. Maintain adequate records of patient identification, clinical
observations, laboratory tests, and drug receipt and disposition, as
specified in the Protocol;
i. Cooperate with PPD and XXXXXXXXXX in all of their efforts to monitor the
Study;
j. Submit any proposed publication of Study results to XXXXXXXXXX for review
and written approval by XXXXXXXXXX'x research management;
k. Represent that neither the Investigator nor any of Investigator's
employees performing the Study i) is under investigation by the FDA for
debarment action or is presently debarred pursuant to the Generic Drug
Enforcement Act of 1992 (21 U.S.C. 301 et seq) or ii) has a
------
disqualification hearing pending or has been disqualified by the FDA
pursuant to 21 CFR Section 312.70; and
l. Agree that during the term of the agreement, neither Investigator nor any
personnel working with the Investigator to perform the Study shall work
independently or for a third party with respect to any product competing
directly or indirectly or in the same therapeutic category as the
XXXXXXXXXX compound or product which is the subject of the Study.
Agreements between PPD and Investigators will state that the agreement is
between PPD and the Investigator and that XXXXXXXXXX is not responsible
thereunder for any obligation.
7.SOP's. PPD shall conduct the Study and complete forms for observations and
------
other aspects of the Study according to the formats and procedures set forth in
the SOPs. These SOPs are subject to revision by XXXXXXXXXX and in the event of
such SOP revision, XXXXXXXXXX may require PPD to comply with the new SOPs. In
such event, XXXXXXXXXX shall promptly provide PPD with copies of the new SOPs.
If any such SOP revision can reasonably be expected to affect the budget or
timelines for the Study, PPD shall submit to XXXXXXXXXX revised cost estimates
or timelines for the relevant services which will become a part of this
Agreement upon written approval by XXXXXXXXXX.
18
8.Investigator Qualification. PPD shall further do all things necessary to
---------------------------
qualify the Investigators in accordance with FDA regulations and forms, obtain
the approval of the Investigators and the Protocol by the appropriate IRB in
accordance with the guidelines established by the FDA, and if applicable, verify
the certification of the laboratory and normal ranges for each laboratory used
by the Investigators, and all other such things as may be necessary to qualify
the study procedures under FDA regulations.
9.Investigator Identification. PPD shall choose qualified Investigators in
----------------------------
accordance with this Agreement and Protocol parameters who are not restricted
from receiving investigational supplies. Geographical distribution of
investigational sites to XXXXXXXXXX'x satisfaction will be provided.
10.Pre-Study Site Visits. PPD shall conduct pre-study site visits at each site
----------------------
to assess facility and Investigator compliance with particular needs called for
by the Protocol and the SOPs. XXXXXXXXXX may join with PPD or conduct separate
site visits as desired. XXXXXXXXXX shall provide PPD written notice of such
separate site visits. Pre-study site visits will be conducted at the same time
as initiation visits if XXXXXXXXXX or PPD has used the investigational site
satisfactorily on a similar study within the preceding twelve (12) months.
11.Investigator Resources. PPD shall assure that each Investigator has adequate
-----------------------
staff, time and patient pool to be able to timely complete the required number
of patients according to the Protocol.
00.Xxxxx Documentation. PPD shall be responsible for timely delivery to and
--------------------
retrieval from Investigators of an adequate supply of all necessary Protocols,
generic CRFs, Investigator brochures, and all other documentation required for
the Study.
13.Shipment of Study Drug. Prior to shipment of Study Drug to any
-----------------------
investigational site, PPD shall provide to XXXXXXXXXX all documentation
necessary for submission to the FDA, including completed and signed FDA form
1572, curricula vitae, and signed Investigator Statement and a copy of the IRB-
approved patient consent form from each Investigator, written approvals from the
IRB and all such other documents as XXXXXXXXXX may reasonably require (upon
written notice) to obtain FDA approval of the Study at each site. PPD shall be
responsible for reviewing the documentation for completeness and accuracy prior
to submission to XXXXXXXXXX. XXXXXXXXXX shall file with the FDA all
documentation referred to herein and necessary for submission to the FDA in
order to obtain approval of each investigational site.
14.Initiation Visits. PPD will conduct an initiation visit at each
------------------
investigational site and perform a thorough review of the Protocol, patient case
report form, and investigators' brochure (or official prescribing information),
study drug dispensing, storage and record keeping procedures with the
Investigator prior to the commencement of the Study.
15.Investigator Files. PPD will create and maintain an Investigator file for
-------------------
each Investigator as specified in the SOPs. The random code will be maintained
in project files at XXXXXXXXXX. The
19
random code section of the Investigator file will contain a memo stating the
random code is filed in the project file. Upon request by XXXXXXXXXX, PPD shall
make Investigator files available for inspection.
PPD shall complete such Investigator files and deliver them to XXXXXXXXXX in
accordance with timelines set forth in the Protocol and this Agreement. In the
event XXXXXXXXXX requests copies of any such Investigator files prior to the
dates established in such timelines, PPD shall promptly deliver such copies to
XXXXXXXXXX.
16.Monitoring. During the Study Period, using PPD's forms set forth in the
-----------
SOPs, PPD will:
. negotiate investigator clinical grants; XXXXXXXXXX will pay
investigator clinical grants via fixed price estimate
. train study site personnel
. pre-study and initiation visit can be combined if PPD or
XXXXXXXXXX has previous experience (within the past 12 months)
with the investigative site. XXXXXXXXXX will have final
approval to combine site visits.
. provide site evaluation reports within 2 weeks of visit date
. verify pre-study regulatory documentation including FDA Form
1572, informed consent form, investigator and associated study
personnel CVs, signed Investigator's Statement, licensure, lab
certification, etc.
. the PPD Medical Director will perform a clinical review of all
SAEs; investigative sites will notify PPD directly in the event
that an SAE occurs; PPD will notify XXXXXXXXXX within 24 hours
of learning of the event
. perform interim monitoring visits at each investigative site at
intervals determined by enrollment and at the discretion of the
PPD Project Manager
. provide monitoring reports and site follow-up letters within 2
weeks of visit date
. maintain weekly phone contact with investigative sites
. provide written project status report to XXXXXXXXXX weekly
after 1st patient is enrolled
. review and report adverse events at each visit
. perform drug accountability audits at each visit
. perform 100% of source document verification
. retrieve 100% of the Patient Chart Records (PCR)
. obtain copies of completed PCR
. transcribe PCR data into appropriate CRF
. return completed CRF to investigator for review, approval and
signature
. provide pre-entry review of CRFs
. document CRF corrections at study site via site correction
forms signed by the investigator
. submit completed and resolved CRFs to data management for entry
. respond to data management queries generated from data
validation
20
. conduct GCP audits on a subset of study sites
. return drug supplies to XXXXXXXXXX or designee at end of study
. perform a final close-out visit on all investigative sites
00.Xxxx Visits. In carrying out its monitoring and oversight obligations, PPD
------------
shall perform interim monitoring visits at each investigative site at six (6)
week intervals. PPD shall visit each investigational site within two (2) weeks
of the site's enrollment of the first patient in the Study.
18.Periodic Meetings. Upon commencement of the Study, PPD and XXXXXXXXXX shall
------------------
discuss by way of telephone conference at least monthly to evaluate the rates
of patient enrollment and CRF delivery and other project issues. Upon agreement
by both parties, such rates shall be adjusted upon written request by
XXXXXXXXXX. If such adjustments affect the minimum patient enrollment rates set
forth above, timelines set forth in EXHIBIT D shall be adjusted accordingly.
19.Consent Forms. PPD shall be responsible for ensuring that the final consent
--------------
form is approved by the IRB prior to use and that all consent forms are signed
by patients prior to their participation in the Study.
00.Xxxx Source Documents. It is understood that any medical and/or office
----------------------
records which are pertinent to the Study will be made available upon request by
either XXXXXXXXXX or the FDA. Patient permission for such access should be
covered during the process of obtaining informed consent. Patients and/or
Investigators who are unwilling to allow inspection of their medical records
should not be entered into the Study.
21.Status Reports. A written project status report will be provided to
---------------
XXXXXXXXXX by PPD monthly, or more frequently if requested by XXXXXXXXXX. Such
reports shall be in a form acceptable to XXXXXXXXXX and shall include at a
minimum patient enrollment; patient completion; patient dropouts and the reasons
for such dropouts; and CRFs in the field, at PPD and delivered to XXXXXXXXXX.
PPD shall provide XXXXXXXXXX information regarding enrollment status or other
study data on an ad hoc or more frequent basis, upon XXXXXXXXXX'x reasonable
request. Upon reasonable advance notice from XXXXXXXXXX, PPD shall provide to
XXXXXXXXXX other information as necessary to fulfill XXXXXXXXXX'x annual
reporting obligations to the FDA.
00.Xxxxx Completion. At the conclusion or termination of the Study, PPD shall
-----------------
deliver to XXXXXXXXXX all completed Investigator files, complete and clean CRFs,
copies of all source documents including laboratory reports, other required
documents, pertinent supporting information for serious adverse events (i.e.,
discharge summaries), analyses, conclusions and all other data and information
pertaining to the Study including any items described in Section 10 above and
shall retrieve from the Investigators and deliver to XXXXXXXXXX all unused
clinical supplies of the Study Drug and Control Drug.
00.Xxxxx Monitoring Visit. PPD shall conduct a final monitoring visit at each
-----------------------
site within sixty (60)
21
days of completion of the last Study patient. For sites which do not enroll any
patients, this final monitoring visit must be conducted within twelve (12) weeks
after the site's initiation visit and receipt of the Study Drug. These time
periods may be extended on a case-by-case basis as mutually agreed upon by
XXXXXXXXXX and PPD.
24.Central Laboratory. XXXXXXXXXX shall be responsible for making all necessary
-------------------
arrangement for services from the central clinical laboratory ("CCL") selected
by XXXXXXXXXX for tests specified by the Protocol. PPD shall review for
completeness and accuracy all billing from the CCL and signify its approval for
payment thereon. PPD shall on a monthly basis deliver to XXXXXXXXXX such
xxxxxxxx for direct payment by XXXXXXXXXX to the CCL.
22
EXHIBIT C
PROPOSAL
--------
23
EXHIBIT D
TIMELINES
---------
ESTIMATED DURATION OF PPD ACTIVITIES
Letter of Intent (LOI) signed, begin identifying investigative sites .....................Completed
Final Protocol received at PPD .............................................................Month 0
Investigative sites identified ...........................................................Month 0.5
Begin obtaining IRB approvals ............................................................Month 1.0
Study Drug available .....................................................................Month 1.5
Patient enrollment ......................................................................Months 2-7
Active patient participation ..........................................................Months 2-8.5
Last CRF to PPD data management ...........................................................Month 10
Last data query to PPD data management ....................................................Month 11
Transfer of original investigative files to XXXXXXXXXX ....................................Month 12
Total PPD Commitment: 12 Months
24
EXHIBIT E
WHEREAS, ________________________ ("INVESTIGATOR") is contracted by
Pharmaceutical Product Development ("PPD");
WHEREAS, PPD and Xxxxxxxxxx Laboratories Inc. ("XXXXXXXXXX") have entered
into an agreement whereby pursuant to 21 C.F.R. 312.52 XXXXXXXXXX has
transferred to PPD responsibility for selecting and providing the services of
Principal Investigators to conduct a clinical research study entitled:
"Double-Blind Randomized Placebo-Controlled Study of the Safety and
Efficacy of Three Dose Regimens of Oral Acemannan in the Treatment of
Active Ulcerative Colitis" (the "Study") according to Xxxxxxxx # 0000
(the "Protocol");
WHEREAS, CRO has agreed to furnish the services of investigators to
perform the services called for in the Agreement;
NOW THEREFORE, in consideration of employment of INVESTIGATOR by PPD in
connection with the services to be provided in the Agreement, INVESTIGATOR
hereby agrees as follows:
INVESTIGATOR shall ensure that all individuals assisting in the
performance of the Study who are in the employment of or under the direction of
INVESTIGATOR shall conduct the Study in conformance with generally accepted
standards of good clinical practice, with the Study Protocol incorporated by
reference herein, and with all local, state and federal laws and regulations
governing the administration of drugs and the performance of clinical
investigations including, but not limited to, the Federal Food, performance of
clinical investigations including, but not limited to, the Federal Food, Drug
and Cosmetic Act and the regulations of the Food and Drug Administration.
INVESTIGATOR agrees that any and all information, data reports or
documents ("Information") of any kind heretofore or hereafter learned, disclosed
to or generated by INVESTIGATOR regarding any phase of the work to be performed
hereunder for XXXXXXXXXX shall not be disclosed by Investigator to any third
party or be used for any purpose other than the performance of this agreement
without the prior written consent of XXXXXXXXXX, during or at any time after the
termination of the performance of services by INVESTIGATOR; provided, however,
that such obligations of secrecy shall not apply to:
(a) Any information which is or becomes through no fault of
INVESTIGATOR, part of the public knowledge;
(b) Information which INVESTIGATOR can demonstrate was already
lawfully in INVESTIGATOR's possession on the date of disclosure to INVESTIGATOR
and not subject to prior confidentiality obligations; and
25
(c) Information acquired by INVESTIGATOR from any third party without
restrictions on disclosure.
Title to all inventions, improvements and data, whether or not
patentable, and all copyrightable works (hereinafter "Inventions") resulting
from the performance of the services hereunder shall reside in XXXXXXXXXX. The
work preformed under this Agreement shall be considered a work for hire for
purpose of the transfer of any ownership rights. INVESTIGATOR agrees to furnish
and execute any additional documents as XXXXXXXXXX may require to establish
XXXXXXXXXX'x ownership of the copyright, patent, or any other rights or interest
resulting from the services performed hereunder.
Signed this _______ day of ____________________, 19 ____ by
INVESTIGATOR.
By: _________________________________________________
Name: _______________________________________________
Title: ______________________________________________
26
