Contract
Exhibit 4.87
Xxxxxxxxx
Xxxxxxx-Xxxxx
Executive
Director, Marketing & Business Development
Medpace,
Inc.
0000
Xxxxxx-Xxxxxx
Xxxxxxxxxx,
XX 00000
Re:
Letter Agreement for certain initial services for the Amarin Trial A
Study
Dear
Xxxxxxxxx:
It is
understood that this Letter Agreement is intended, subject to the terms and
conditions set out below, to precede the execution of a definitive agreement
which is expected to incorporate the terms of this Letter Agreement in addition
to additional customary terms.
This
Letter Agreement is dated as of the date of last signature below (the “Effective
Date”).
Medpace
Inc. (“Medpace”), Amarin Pharma Inc (“SPONSOR”) and Amarin Pharmaceuticals
Ireland Limited (“APIL”) are currently negotiating a definitive agreement to
cover Medpace’s performance of various services for the studies referenced above
(the “Studies”) (the “Master Services Agreement” or “MSA”) and are also
currently negotiating various task orders that will detail the services to be
provided under the MSA (each a “Task Order”). This negotiation will
require more time. SPONSOR and Medpace are in agreement, however,
that certain initial activities relating to the Amarin Trial A Study cannot wait
for finalization of the MSA, and the Task Orders, and that pending execution of
the MSA, and the Task Order that will cover the Initial Trial A Services (the
“Initial Trial A Task Order”), Medpace will provide certain initial activities
relating to the Amarin Trial A Study set forth in Schedule A in accordance with
the terms of this Letter Agreement (the “Initial Trial A Services”) and SPONSOR
will pay Medpace for these initial activities according to the terms of this
Letter Agreement as set out below.
|
1
|
Initial
Trial A Services
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|
1.1
|
Medpace
shall perform the Initial Trial A Services in compliance with all
applicable laws regulations and guidelines, including without limitation
the Federal Food, Drug and Cosmetic Act and the regulations promulgated
pursuant thereto, cGCP, and all future amendments thereto, and all other
applicable laws, regulations and guidelines in all relevant jurisdictions
the timelines and specific roles and responsibilities of Medpace and
SPONSOR as set out in Schedule A, and the relevant standard operating
procedures of Medpace
|
|
1.2
|
Upon
signature of this Letter Agreement, Medpace shall provide’ SPONSOR with
copies of the standard operating procedures, of Medpace relevant to the
performance of the Initial Trial A Services as listed in Schedule
B.
|
|
1.3
|
“cGCP”
shall mean the ICH Harmonized Tripartite Guideline for Good Clinical
Practice and any subsequent versions thereof, together with such other
good clinical practice requirements as are specified in the Federal Food,
Drug and Cosmetic Act, 21 U.S.C., applicable sections of Title 21 Code, of
Federal Regulations, and any subsequent versions
thereof.
|
|
2
|
Confidentiality
|
|
2.1
|
The
terms and conditions of the confidentiality agreement between Medpace and
Amarin Corporation plc (an Affiliate of SPONSOR and APIL (as such term is
defined in Paragraph 8.2 below))
|
dated 13
November 2008 (the “CDA”) shall apply to all Confidential Information (as such
term is defined therein) provided by SPONSOR to MEDPACE.
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3
|
Rights
in Property and Patent Rights
|
|
3.1
|
All
materials documents, data, software and information of every kind and
description and all electronic data files containing all such materials,
documents, data, software and
information:
|
|
3.1.1
|
supplied
to Medpace by SPONSOR or any of its Affiliates;
or
|
|
3.1.2
|
prepared,
developed, generated, derived or otherwise created by Medpace pursuant to
this Letter Agreement, (except for the Medpace IP (as such term is defined
below))
|
(collectively
“Study Results”)
are and
shall be the exclusive and confidential property of SPONSOR,
|
3.2
|
SPONSOR
and its Affiliates shall have the right to make whatever use they deem
desirable of any Study Results. Medpace shall, not, without the
prior written consent of SPONSOR, publish, disseminate, or otherwise
disclose to any third party any Study Results (except such disclosure as
may be required by law, and in such case only to the extent required by
law), or use any such Study Results for any purpose other than the
performance of this Letter
Agreement.
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3.3
|
Any
inventions or other intellectual property, including without limitation
protectable copyrights and trademarks, that may evolve from, the Study
Results or as the result of Initial Trial A Services performed by Medpace,
under this Letter Agreement shall belong exclusively to SPONSOR, and
Medpace agrees to assign all its rights in all such inventions and/or
other intellectual property to SPONSOR consistent with the obligations set
forth in Paragraph 3.6 below.
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3.4
|
SPONSOR
acknowledges that all computer programs, software, applications, databases
(excluding for the avoidance of doubt all electronic files containing all
Study Results), proposals and other documentation generally used by
Medpace that:
|
|
3.4.1
|
have
been independently developed without the benefit of any information
provided by SPONSOR (including without limitation any SPONSOR data,
information, materials or Confidential Information of SPONSOR (or
derivatives thereof)); and
|
|
3.4.2
|
have
not been developed solely for
SPONSOR,
|
(the
“Medpace IP”)
are the
exclusive and confidential property of Medpace or the third parties from whom
Medpace has secured the right of use. SPONSOR agrees that any
improvement, alteration or enhancement made to the Medpace IP during the course
of the Initial Trial A Services performed hereunder, without the benefit of
any information provided by SPONSOR (including without limitation any SPONSOR
data, information, materials or Confidential Information of SPONSOR (or
derivatives thereof)), shall be the property of Medpace.
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3.5
|
Medpace
shall disclose promptly to sponsor any and all inventions, discoveries,
know-how and improvements conceived or made by Medpace while providing
Initial Trial A Services to
|
-2-
SPONSOR
pursuant to the Letter Agreement, whether or not constituting a modification or
extension of use relating to SPONSOR’s proprietary rights (“Study
IP”).
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3.6
|
Subject
to Paragraph 3.4, all Study IP shall belong exclusively to SPONSOR, and
Medpace agrees to assign all its interest therein to SPONSOR or its
nominee whenever requested to do so by SPONSOR. Medpace shall
execute any and all applications, assignments, or other instruments and
give testimony which SPONSOR shall deem necessary to apply for and obtain
a patent in the United States of America and/or other applicable
jurisdiction or of any foreign country or to protect otherwise SPONSOR’s
interests and shall compensate Medpace on a reasonable basis for the time
devoted to said activities and reimburse it for reasonable out-of-pocket
expenses incurred.
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4
|
Payments
|
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4.1
|
All
payments will be payable to Medpace Inc. (Tax ID No. 00-0000000) and
sent to:
|
August X.
Xxxxxxxx, MD
Medpace
Inc.
0000
Xxxxxx Xxxxxx
Xxxxxxxxxx,
XX 00000
|
4.2
|
Payments
will be made by SPONSOR on the following
basis:
|
|
4.2.1
|
SPONSOR
shall pay Medpace fees for the provision of the Initial Trial A Services
(the “Initial Trial a Services Fees”) up to a maximum of US$1,413,974●
(the “Total Initial Trial A Services
Fees”).
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|
4.2.2
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In
no event shall SPONSOR be required to pay any amount exceeding the total
Initial Trial A Services Fees unless otherwise agreed in writing by the
parties.
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|
4.2.3
|
SPONSOR
shall reimburse Medpace for reasonable and necessary expenses and
pass-through costs incurred by Medpace in providing the Initial Trial A
Services (“Initial Trial A Services Pass-through
Costs”).
|
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4.2.4
|
In
the case of any individual Initial Trial A Services Pass-through Cost
exceeding US$5000, SPONSOR’s prior written approval must be given for such
cost:
|
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4.2.5
|
All
Initial Trial A Services Pass-through Costs invoiced by Medpace must be
accompanied by appropriate documentary evidence as, required by SPONSOR,
such as receipts or other documentation reasonably acceptable to
SPONSOR.
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4.2.6
|
Upon
execution of the relevant Task Orders, SPONSOR shall retrospectively
determine the difference between the Initial Trial A Services Fees and
Initial Trial A Services Pass-through Costs as agreed in the relevant Task
Orders and all amounts paid by SPONSOR to Medpace under this Letter
Agreement and any difference shall be credited against future amounts
owing by SPONSOR under such Task
Orders.
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4.2.7
|
In
the event that this Letter Agreement is terminated for any reason, other
than termination by SPONSOR for breach by Medpace of its obligations
hereunder, and the parties do not execute the MSA and the Initial Trial A
Task Order, Medpace shall, within 30 days of the date of termination,
provide a written account to SPONSOR of all outstanding Initial
Trial A Services Fees, Initial Trial A Services Pass-through Costs and all
non-cancelable
|
-3-
expenses
incurred by Medpace (“Total Outstanding Costs”), together with appropriate
documentary evidence as required by SPONSOR. Within 30 days of
written approval by SPONSOR of such written account, Medpace shall issue a final
invoice to SPONSOR in respect of the Total Outstanding Costs.
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4.2.8
|
APIL
shall be authorized by SPONSOR to receive invoices and to make remittances
on behalf of SPONSOR under this Agreement. All invoices should
be addressed to APIL at the following
address
|
Amarin
Pharmaceuticals Ireland Limited
1st
Floor, Block 3
The
Oval
Xxxxxxxxxx
Xxxx
Xxxxxxxxxxx
Xxxxxx
0
Xxxxxxx
Attn: Accounts
Department
|
5
|
Master
Services Agreement and Task Orders
|
|
5.1
|
When
and if SPONSOR and Medpace execute the MSA and the Initial Trial A Task
Order, this Letter Agreement shall be deemed terminate and superseded by
the MSA and the Initial Trial A Task
Order.
|
|
5.2
|
Upon
execution of the MSA and the Initial Trial A Task Order, the terms and
provisions of the MSA and the Initial Trial A Task Order shall apply to
all Initial Trial A Services provided by Medpace
hereunder.
|
|
5.3
|
The
MSA and all necessary Task Orders must be executed by the parties before
any dosing of Study subjects may
commence.
|
|
5.4
|
For
the avoidance of doubt, nothing contained in this Letter Agreement shall
be construed by implication or otherwise, as an obligation upon SPONSOR,
APIL or Medpace to negotiate or enter into any further agreement or
arrangement relating to the Studies or any other clinical study, including
without limitation: the- MSA and any Task
Order.
|
|
6
|
Scope
of Letter Agreement
|
|
6.1
|
Medpace
shall perform the Initial Trial A Services described in Schedule A in
accordance with the terms of this Letter Agreement. For such
initial Trial A Services, SPONSOR shall pay Medpace the amounts and on the
terms set forth in Schedule A. It is understood that Medpace
shall not make any financial commitments extending beyond the amounts
stated in Schedule A until (and to the extent permitted) the MSA and the
relevant Task Order(s) have been executed by the parties. If a
financial commitment is required by Medpace beyond those stated in
Schedule A, and prior to-the
execution of the MSA and the relevant Task Order(s), such action will
require written consent in advance by
SPONSOR.
|
-4-
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7
|
Term
and Termination
|
|
7.1
|
The
parties agree that this Letter Agreement shall be binding upon the parties
with effect from the Effective Date and shall continue in full force and
effect until terminated by the parties in accordance with the terms of
this Letter Agreement.
|
|
7.2
|
SPONSOR
will have the right to request Medpace to immediately cease providing the
Initial Trial A Services and to forthwith terminate this Letter Agreement
and to forthwith terminate all negotiations regarding the MSA and any Task
Orders at any time by advising Medpace orally and in
writing.
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|
7.3
|
Medpace
will have the right to stop its work and terminate this Letter Agreement
only if SPONSOR is in default of its payment obligations under Schedule A
and does not pay such amount in full within 10 days after written
notice.
|
|
7.4
|
This
Letter Agreement will automatically
terminate:
|
|
7.4.1
|
upon
execution of the MSA And the Initial Trial A Task Order;
or
|
|
7.4.2
|
in
the event that SPONSOR OR and Medpace do not execute the MSA and the
Initial Trial A Task Order within 60 days from the Effective Date, upon
the 60th day after the Effective
Date.
|
|
7.5
|
In
the event of termination, other than in the case of termination upon
execution of the MSA and the Initial Trial A Task
Order:
|
|
7.5.1
|
MEDPACE
shall use its best efforts to reduce the costs incurred by SPONSOR as a
result, of such termination;
|
|
7.5.2
|
all
Study Results and Study IP shall either be delivered to SPONSOR, or
disposed of, at the direction and written request of
SPONSOR;
|
|
7.5.3
|
save
for those paragraphs that expressly deemed to survive termination of this
Letter Agreement, the Letter Agreement shall terminate and be of no
further force or effect and SPONSOR, APIL and Medpace shall have no
further obligations to each other whatsoever under this Letter
Agreement.
|
|
8
|
Indemnification
and Insurance
|
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8.1
|
SPONSOR
shall indemnify, defend and hold harmless Medpace from and against any and
all damages, losses, liabilities, costs or expenses (collectively
“Damages”), resulting or arising from any third-party claims, demands,
assessments, actions, suits, investigations or proceedings (collectively
“Claims”), relating to or arising from or in connection with this Letter
Agreement or the Initial Trial A Services (including but not limited to
any Damages arising from or in connection with any study, test, device,
product of potential product to which this Letter Agreement relates), to
the extent such Claims or Damages have not resulted from Medpace’s
negligent act or omission, or willful misconduct, or a breach of any
applicable law, regulation or guideline, or breach of this Letter
Agreement by Medpace.
|
|
8.2
|
Medpace
agrees to indemnify, defend and hold harmless SPONSOR and its Affiliates
from and against any and all Damages resulting or arising from Claims
relating to or arising from or in
|
-5-
connection
with this Letter Agreement or the Initial Trial A Services to the extent that
such Claims, or Damages have resulted from any negligent act or omission or
willful misconduct of Medpace or a breach of any applicable law, regulation or
guidelines, or a breach of this Letter Agreement by Medpace.
“Affiliate”
shall mean a corporation or entity controlling, controlled by, or under the
common control with SPONSOR, APIL, or Medpace, as the case may
be. For the purposes of this, Agreement, “control” shall mean the
direct or indirect ownership of more than 50% of the issued voting shares or
other voting rights of the subject entity to elect, directors, or if not meeting
the preceding criteria, any entity owned or controlled by or owning or
controlling at the maximum control or ownership right permitted in the country
where such entity exists.
|
8.3
|
Nothing
in this; Letter Agreement shall limit the liability of any Party for
fraud, or limit the liability of any Party to any third party under
applicable laws where any act, or omission of any Party results in death
or personal injury.
|
|
8.4
|
Any
Party providing indemnification under this Letter Agreement shall have the
right to control the defense and settlement of any Claims or
Damages. The indemnified party shall have’ the right to obtain
separate legal counsel at its own expense if it so chooses. The
indemnifying party shall not unreasonably withhold consent for settlement
and the indemnified party shall reasonably cooperate in the defense of any
Claims or Damages and provide prompt notice to the indemnifying party of
any Claims or Damages for which indemnification is sought, and shall
reasonably and regularly consult with the indemnified party in relation to
the progress and status of such Claim or Damages. Save as
aforesaid, neither the indemnifying party nor the party to be indemnified
shall acknowledge the validity of, compromise or otherwise settle any
Claim without the prior written consent of the other, which consent shall
not be unreasonably withheld. The Party seeking indemnification
shall take all reasonable steps to mitigate any loss, or liability in
respect of any such Claim or
Damages.
|
|
8.5
|
Notwithstanding
the terms of this paragraph 8, in 00 event shall SPONSOR or Medpace be
liable by reason of any representation or warranty,: condition or other
term or any duty of common law, or under the express terms of this
agreement, for any consequential, special or incidental or punitive loss
or damage whether for loss of current or future profits, loss of
enterprise value or otherwise) and whether occasioned by thenegligence of
the respective parties, their employees or agents or otherwise, even if
the breaching party has been advised of the possibility of such
damages.
|
|
8.6
|
Medpace
shall at its own expense obtain and maintain insurance of a type and
amount adequate to cover all loss,, damage, liability or costs in respect
of which it is liable to indemnify Sponsor under the provisions of this
Letter Agreement and shall not do or omit any act, matter or thing which
may prejudice or render voidable any such insurance. Such
insurance shall be for an amount of not less than €7,500,000 per claim and
in aggregate. Medpace will, immediately upon the, request of
SPONSOR, provide SPONSOR with evidence of the insurance as SPONSOR may
reasonably require.
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|
9
|
Publicity
|
|
9.1
|
Medpace
shall not make any public announcements concerning this Letter Agreement
or the subject matter hereof, nor use SPONSOR’s name, logo or trademark in
any communication, release, notice or other publication, without the prior
written consent of SPONSOR.
|
-6-
|
10
|
Miscellaneous
|
|
10.1
|
This
Letter Agreement and the performance hereof shall be governed, interpreted
and construed in all respects by the internal laws of the State of New
York. All disputes and claims arising under this Letter
Agreement shall be resolved exclusively in a court of applicable
jurisdiction located in New York, New York and each Party consents to the
venue of any such action.
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|
10.2
|
Medpace
may not subcontract any portion of the Initial Trial A Services hereunder
without the prior written consent of SPONSOR. Should Medpace
subcontract with any third party upon such written consent of SPONSOR,
Medpace represents and warrants that such third-party subcontractor shall
comply with all obligations of Medpace under this Letter Agreement,
including but not limited to, obligations of confidentiality and ownership
rights of the Study Results and Study IP, and Medpace shall remain fully
liable for its and such third party’s performance of the Initial Trial A
Services and the obligations of Medpace
hereunder.
|
|
10.3
|
The
provisions of paragraphs 2, 3, 5.2, 8, 9, 10.1, 10.6 and this paragraph
10.3 shall survive the termination of this Letter
Agreement.
|
|
10.4
|
Medpace
shall not assign this Letter Agreement without the prior written consent
of SPONSOR.
|
|
10.5
|
This
Letter Agreement shall not be amended, modified or supplemented in any way
except in writing and signed by a duly authorized representative of
SPONSOR, APIL and Medpace.
|
|
10.6
|
At
the request of any of the parties, the other parties shall (and shall use
reasonable efforts to procure that any other necessary third parties
shall) execute and do all such documents, acts and things as may
reasonably be required subsequent to the signing of this Letter Agreement
for assuring to or vesting in the requesting party the full benefit of the
terms hereof.
|
If the
terms of this Letter Agreement are acceptable to you, please have an appropriate
officer of Medpace sign and date both copies of this letter agreement and return
one copy to Amarin Pharma Inc, Mystic Packer Building, 00 Xxxxxxxxx Xxxxxx,
Xxxxxx, Xxxxxxxxxxx, XX 00000.
Sincerely,
Amarin
Pharma Inc
by: /s/ Xxxxxx
Xxxx
Name: Xxxxxx
Xxxx
Title: SVP,
Head of Development
Date: 18FEB09
-7-
Amarin
Pharmaceuticals Ireland Limited
by:
Name:
Title:
Date:
AGREED
TO: Medpace Inc.
by:
Name:
Title:
Date:
|
10.7
|
At
the request of any of the parties, the other parties shall (and shall use
reasonable efforts to procure that any other necessary, third parties
shall) execute and do all such documents, acts, and things as may
reasonably be required
subsequent to, the signing of this Letter
Agreement for assuring to or vesting in the
requesting party the full benefit of the terms
hereof.
|
If the
terms of this Letter Agreement are acceptable to you, please have an appropriate
officer of Medpace sign and date both copies of this letter agreement and return
one copy to Amarin Pharma Inc, Mystic Packer Building, 00 Xxxxxxxxx Xxxxxx,
Xxxxxx, Xxxxxxxxxxx, XX 00000.
Sincerely,
Amarin
Pharma Inc
by:
Name:
Title:
Date:
Amarin
Pharmaceuticals Ireland Limited
by: /s/ Xxxx
Xxxxx
Name: Xxxx
Xxxxx
Title: Director
Date: 23/Feb./2009
AGREED
TO: Medpace Inc.
by:
Name:
Title:
Date:
-8-
SCHEDULE
A
Initial
Service Fees
|
Item
|
Amount
|
|
eCRF
Development
|
$15,112.00
|
|
Project
Specific Training
|
$8,818.00
|
|
Regulatory
Agency Clinical
Trial Submissions
|
$112,542.00
|
|
IVRS
Development
|
$26,830.00
|
|
Investigator
and Vendor Contract Negotiation
|
$45,686.00
|
|
Investigator
Files Setup
|
$20,198.00
|
|
Initial
Essential Document Collection
|
$146,303.00
|
|
Project
Management
|
$365,601.00
|
|
Conference
Calls
|
$31,121.00
|
|
Pre-Study
Visits
|
$44,640.00
|
|
Monitoring
Plan Development and Maintenance
|
$8,558.00
|
|
Data
Management Manual,
|
$9,735.00
|
|
Database
Development
|
$29,018.00
|
|
Total
|
$864,162.00
|
Escrow
|
Item
|
Amount
|
|
Investigator
Meeting Planner and Travel Fees
|
$264,878.00
|
|
Central
IRB Fees
|
$27,750.00
|
|
Investigator
Payments
|
$127,500.00
|
|
Medpace
Reference Laboratories Fees
|
$35,315.00
|
|
EDC
Vendor Fees
|
$77,069.00
|
|
Total
|
$532,512.00
|
Pass-Through
|
Item
|
Amount
|
|
Monitoring
travel
|
$16,000.00
|
|
Conference
Calls
|
$800.00
|
|
Misc.
Printing/Copying/Shipping
|
$500.00
|
|
Total
|
$17,300.00
|
|
Note:
|
Pass-through
costs listed above are not exhaustive and may include, but are nor limited
to, CRF printing costs, courier costs, teleconference fees, drug packaging
and labeling, pharmacy fees, travel costs, subsistence costs, and
accommodation costs. Escrow costs listed above may not be
exhaustive.
|
|
Note:
|
Medpace
service-fees will be billed in two payments; 50% at signing and 50% twenty
days after signing. Escrow costs will be billed, at
signing. Pass-through costs will be billed
monthly.
|
SCHEDULE
B
Medpace will follow their SOPs as
listed in this Schedule B and the regulations set forth in 21 CFR, Section 312,
Subpart D (Responsibilities of Sponsors and Investigators) and appropriate EU
Directives 2001/20EC, 2005/28/EC and any other applicable international
regulatory requirements.
|
Medpace
SOP
Index
|
|||
|
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
|
Biometrics
|
|||
|
XX-XX-01-84
|
Data
Analysis Plan
|
1/31/2008
|
N/A
|
|
XX-XX-02-S4,1
|
Analysis
Validation and Generation
|
1/31/2008
|
N/A
|
|
XX-XX-03-34
|
Data
Listing Validation and Generation
|
1/31/2008
|
N/A
|
|
XX-XX-04-S4
|
Randomization
Code
|
1/31/2008
|
N/A
|
|
XX-XX-05-S4
|
Interim
Analysis:
|
1/31/2008
|
N/A
|
|
Clinical
Operations
|
|||
|
BE-CO-01-S1
|
Clinical
Trial Submissions in Belgium
|
4/4/2008
|
N/A
|
|
GL-CO-01-S4.4
|
Trial
Document Management
|
3/1/2007
|
11/01/2008
|
|
GL-CO-02-S3,1
|
Protocol
Review
|
3/26/2007
|
11/01/2008
|
|
GL-CO-03-S3.2
|
Investigator
Meeting
|
3/26/2007
|
11/01/2008
|
|
GL-CO-05-S4.1
|
Study
Initiation Visit
|
3/2/2007
|
N/A
|
|
GL-GO-05-S5
|
Study
Initiation Visit
|
2/12/2009
|
N/A
|
|
GL-GO-06-S4.3
|
Monitoring
Plan Development
|
1/12/2007
|
11/01/2008
|
|
GL-GO-06-S5
|
Monitoring
Plan Development
|
2/5/2009
|
N/A
|
|
GL-CO-07-S4.2
|
Investigational
Product Tracking.
|
5/31/2007
|
11/01/2008
|
|
GL-CO-08-S9
|
Monitoring
Visit
|
12/21/2004
|
N/A
|
|
GL-CO-09-S4
|
Documenting
Protocol Deviations
|
1/10/2009
|
N/A
|
|
GL-CO-11-S4
|
Reporting
and Managing Problem Issues at a Clinical Research Site
|
3/30/2009
|
N/A
|
|
GL-CO-12-S3.1
|
Study
Closeout
|
4/15/2007
|
N/A
|
|
GL-CO-13-S4.2
|
Study
Site Close-out Visit
|
2/15/2007
|
12/5/2008
|
|
GL-CO-14-S2.2
|
Archiving
of Study Material
|
3/1/2007
|
N/A
|
|
GL-CO-15-S3
|
Recruitment
and Retention Plan
|
6/2/2008
|
N/A
|
|
GL-CO-16-S5.1
|
Clinical
Research Associate Orientation and Continuing Education
Processes
|
9/21/2008
|
N/A
|
|
GL-CO-18-S3.2
|
Clinical
Trial Manager Orientation and Evaluation Process
|
4/9/2007
|
12/5/2008
|
|
GL-CO-19-S2.1
|
Projection
Evaluation
|
4/15/2007
|
N/A
|
Page 1 of
6
|
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
|
GL-CO-20-S5.1
|
General
Study Start-up
|
4/10/2008
|
N/A
|
|
GL-CO-21-S4
|
Trial
Master File – Essential Documents
|
4/10/2008
|
N/A
|
|
GL-CO-22-S3.2
|
Updated
and Additional Essential Documents
|
3/12/2007
|
12/5/2008
|
|
GL-CO-23-S5.2
|
Translation
of Essential Documents
|
2/25/2008
|
12/5/2008
|
|
GL-CO-24-S4
|
Informed
Consent Form
|
4/10/2008
|
N/A
|
|
GL-CO-25-S4
|
Pre-study
Visit
|
3/1/2007
|
N/A
|
|
GL-CO-26-S3.1
|
Selecting
Study Principal Investigators
|
12/1/2007
|
12/5/2008
|
|
GL-CO-27-S3.2
|
Quality
Control of Essential Documents
|
3/12/2007
|
12/5/2008
|
|
GL-CO-28-S3.2
|
Lead
Clinical Research Associate
|
9/21/2008
|
N/A
|
|
GL-CO-29-S4
|
Clinical
Research Associate Oversight
|
9/21/2008
|
N/A
|
|
GL-CO-30-S6
|
FDA
Compliance Checks
|
10/20/2008
|
N/A
|
|
GL-CO-31-S4.1
|
Investigational
Product Storage
|
9/28/2008
|
N/A
|
|
GL-CO-32-S2
|
Clinical
Trial Submissions
|
4/10/2008
|
N/A
|
|
GL-CO-33-S1.2
|
Project
Training/Project and Investigative Site Hand-over Process
|
11/16/2007
|
N/A
|
|
GL-CO-33-S2
|
Project
Training/Project and Investigative Site Hand-over Process
|
3/1/2009
|
N/A
|
|
GL-CO-34-S2.1
|
Internal
Quality Check (QC) of Study Files in the Document Center
|
11/15/2007
|
12/5/2008
|
|
GL-CO-35-S1.1
|
Conference
Call and Meeting Conduct
|
9/10/2007
|
N/A
|
|
GL-CO-36-S1.3
|
Site
Feasibility
|
12/1/2007
|
N/A
|
|
GL-CO-37-S1
|
Document
Quality Control
|
7/11/2008
|
N/A
|
|
In-Co-01S1.1
|
Clinical
Trial Submissions in India
|
2/21/2008
|
N/A
|
|
Corporate
Affairs
|
|||
|
GL-CA-01-S1
|
Document
Room Maintenance
|
1/16/2008
|
N/A
|
|
GL-CA-02-S1
|
Authorized
Signatory Tables
|
7/3/2008
|
N/A
|
|
GL-CA-03-S1
|
Entry
Structure and Controls
|
7/9/2008
|
N/A
|
|
GL-CA-04-S2.1
|
Corporate
Records Retention
|
12/24/2008
|
N/A
|
Page 2 of
6
|
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
|
GL-CA-05-S1
|
Non-Study
Contracts Indexing and Tracking
|
7/16/2008
|
N/A
|
|
US-CA-01-S1
|
Board
of Directors Meetings
|
7/7/2008
|
N/A
|
|
US-CA-02-S1
|
Annual
and Special Shareholder Meetings
|
7/11/2008
|
N/A
|
|
Data
Management
|
|||
|
Xx-XX-02-S14
|
Data
Entry System
|
1/31/2008
|
N/A
|
|
Xx-XX-02-S15
|
Data
Entry System
|
2/18/2009
|
N/A
|
|
Xx-XX-03-S11
|
Edit
Check Specifications
|
1/20/2008
|
N/A
|
|
Xx-XX-04-S12
|
CRF
Processing and Data Entry
|
1/25/2008
|
N/A
|
|
Xx-XX-06-S13
|
Database
Cleanup
|
1/25/2008
|
N/A
|
|
Xx-XX-08-S10
|
Coding
Process
|
1/20/2008
|
N/A
|
|
Xx-XX-09-S10
|
Edit
Check System
|
1/31/2008
|
N/A
|
|
Xx-XX-12-S9
|
External
Data Base Import System
|
1/31/2008
|
N/A
|
|
Xx-XX-13-S7
|
Database
Generation System
|
1/31/2008
|
N/A
|
|
Xx-XX-15-S3
|
SAS
Programming Conventions
|
1/31/2008
|
N/A
|
|
Xx-XX-17-S2
|
Database
Quality Control Review
|
1/25/2008
|
N/A
|
|
Xx-XX-17-S3
|
Data
Quality Control Review
|
2/15/2009
|
N/A
|
|
Xx-XX-20-S2
|
Electronic
Data Capture System Administration
|
1/31/2008
|
N/A
|
|
ECG
Core Laboratory
|
|||
|
GL-EL-01-S1.1
|
ECG
Shipment, Tracking, and Qualification
|
9/19/2007
|
11/26/2008
|
|
GL-EL-02-S1.1
|
ECG
Electronic Receipt and Processing
|
9/19/2007
|
11/26/2008
|
|
GL-EL-03-S1.1
|
ECG
Data Review and Cleanup
|
9/19/2007
|
11/26/2008
|
|
GL-EL-04-S1.1
|
ECG
Data Format and Delivery
|
9/19/2007
|
11/26/2008
|
|
GL-EL-05-S1
|
ECG
Study Set Up
|
10/31/2008
|
N/A
|
|
GL-EL-06-S1
|
Continuous
Electrocardiogram Data Receipt and Processing
|
10/31/2008
|
N/A
|
|
GL-EL-07-S1
|
H-Scribe
Study Set Up
|
10/31/2008
|
N/A
|
|
Finance
|
|||
|
GL-AA-02-S1
|
Payroll
|
4/30/2007
|
N/A
|
Page 3 of
6
|
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
|
GL-AC-01-S2.1
|
General
ledger System Management
|
3/15/2007
|
N/A
|
|
GL-AC-03-S3
|
Procurement
|
3/31/2007
|
N/A
|
|
GL-AC-06-S6
|
Accounts
Receivable
|
3/31/2007
|
N/A
|
|
GL-AC-11-S2.1
|
Revenue
Recognition
|
5/4/2007
|
N/A
|
|
GL-AC-15-S3
|
Site
Payments
|
5/15/2008
|
N/A
|
|
General
|
|||
|
XX-XX-01-S15.1
|
Procedures
for Standard Operating Procedures
|
4/30/2008
|
N/A
|
|
XX-XX-02-S3
|
Training
& Development
|
11/30/2008
|
N/A
|
|
XX-XX-03-S1.2
|
Office
Security
|
9/19/2007
|
6/5/2008
|
|
XX-XX-06-S4
|
Customer
Service
|
12/19/2008
|
N/A
|
|
XX-XX-07-S3.1
|
Correspondence
Distribution
|
9/26/2005
|
11/14/2008
|
|
HR
& Administration
|
|||
|
GL-HR-01-S1.2
|
Employment
|
7/14/2008
|
N/A
|
|
GL-HR-02-S1
|
Employee
Compensation
|
7/14/2008
|
N/A
|
|
Information
Technology
|
|||
|
GL-IT-01-S14
|
Study
Setup
|
5/30/2008
|
N/A
|
|
GL-IT-02-S14.2
|
System
Validation
|
1/28/2008
|
N/A
|
|
GL-IT-03-S9.1
|
Transfer
of Electronic Record
|
3/1/2008
|
N/A
|
|
GL-IT-04-S13.2
|
System
Maintenance
|
1/28/2008
|
N/A
|
|
GL-IT-05-S12.1
|
System
Security
|
1/25/2008
|
N/A
|
|
GL-IT-06-S9.1
|
Disaster
Recovery Plan
|
1/31/2008
|
N/A
|
|
GL-IT-08-S6
|
21
CFR Part 11 Compliance
|
1/28/2008
|
N/A
|
|
GL-IT-09-S13
|
System
Development Life Cycle
|
1/28/2008
|
N/A
|
|
GL-IT-S14.1
|
Change
Control
|
1/28/2008
|
N/A
|
|
GL-IT-11-S10
|
System
Backup, Restore, and Archive
|
1/28/2008
|
N/A
|
|
GL-IT-12-S4.2
|
Request
for Hardware, Software, and Support
|
1/25/2008
|
N/A
|
|
GL-IT-13-S3
|
Directory
Structure and Naming Conventions
|
3/1/2008
|
N/A
|
Page 4 of
6
|
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
|
GL-IT-14-S3
|
Computer
System Set Up
|
3/1/2008
|
N/A
|
|
GL-IT-17-S2.2
|
Clin
Trak IVRS Randomization Procedure
|
3/30/2007
|
10/6/2006
|
|
GL-IT-18-S2.1
|
Clin
Trak IVRS Subject Tracking Study Implementation
|
3/30/2007
|
10/6/2008
|
|
GL-IT-19-S2.1
|
Clin
Trak IVRS Study Support and Maintenance
|
3/31/2007
|
10/6/2008
|
|
US-IT-15-S4
|
Message
Notification
|
3/1/2008
|
N/A
|
|
IVRS
|
|||
|
GL-IV-01-S2
|
IVRS
Study Setup Validation
|
12/10/2008
|
N/A
|
|
Marketing
& BD
|
|||
|
XX-XX-01-S3.2
|
Request
For Proposal Handling and Proposal Preparation
|
12/11/2006
|
N/A
|
|
XX-XX-02-S3
|
Sponsor
Contract Handling
|
4/25/2008
|
N/A
|
|
XX-XX-03-S3
|
Change
in Scope Process
|
3/1/2008
|
N/A
|
|
XX-XX-04-S3
|
Press
Release Process
|
1/31/2008
|
N/A
|
|
XX-XX-05-S2
|
Procedures
for Site Contracts
|
3/1/2008
|
N/A
|
|
Medical
Writing
|
|||
|
XX-XX-01-S8
|
Clinical
Study Report
|
3/10/2008
|
N/A
|
|
XX-XX-04-S4
|
Preparation
of the Study Protocol
|
3/10/2008
|
N/A
|
|
XX-XX-07-S6
|
Procedures
for Compiling Appendices
|
3/10/2008
|
N/A
|
|
XX-XX-08-S6
|
Document
Quality Control
|
3/10/2008
|
N/A
|
|
Quality
Assurance
|
|||
|
BE-QA-01-S1
|
Disaster
Recovery Plan - Belgium Facilities
|
10/25/2008
|
NA
|
|
BE-QA-02-S1
|
Diesel
Power Generator
|
10/12/2008
|
NA
|
|
BE-QA-03-S1
|
Freezer
CO2 Backup System
|
12/12/2008
|
NA
|
|
GL-QA-01-S13
|
Investigative
Site Audit
|
6/2/2008
|
NA
|
|
GL-QA-04-S11
|
System
Audits
|
5/5/2008
|
NA
|
|
GL-QA-05-S9
|
Regulatory
Authority Inspections
|
4/20/2008
|
NA
|
Page 5 of
6
|
SOP ID
|
SOP Name
|
Effective
Date
|
Reapproval Date
|
|
GL-QA-06-S9
|
Prevention
and Detection of Fraud and Other Misconduct
|
10/20/2008
|
NA
|
|
GL-QA-07-S3.2
|
Sponsor
Audit Preparation
|
1/31/2008
|
NA
|
|
GL-QA-08-S4
|
Good
Documentation Practices
|
1/31/2008
|
NA
|
|
GL-QA-09-S3
|
Quality/Assurance
Oversight Plan
|
5/1/2008
|
NA
|
|
GL-QA-10-S3
|
Vendor
Audits
|
5/5/2008
|
N/A
|
|
GL-QA-11-S1
|
Confidentiality
of Data/HIPAA
|
12/15/2008
|
N/A
|
|
NA-QA-01-S1
|
QA
Responsibilities for GLP Compliance
|
10/31/2008
|
N/A
|
|
NA-QA-02-S1
|
Quality
Assurance Good Laboratory Practice Inspection and Audit
Program
|
11/30/2008
|
N/A
|
|
NA-QA-03-S1.2
|
QA
Statement for GLP Study Reports
|
10/31/2008
|
N/A
|
|
NA-QA-04-S1
|
Generation
and Maintenance of the Master Schedule
|
10/31/2008
|
N/A
|
|
Regulatory
Affairs
|
|||
|
US-RA-05-S10
|
New
Drug Applications
|
8/15/2008
|
N/A
|
|
US-RA-12-S3
|
Investigational
New Drug Application Submission Process
|
3/15/2008
|
N/A
|
|
Safety
|
|||
|
XX-XX-01-S5
|
Serious
Adverse Event Reporting
|
1/20/2008
|
N/A
|
|
XX-XX-02-S7
|
Withdrawal
due to Adverse Event and Other Event Reporting
|
1/20/2008
|
N/A
|
|
XX-XX-03-S4
|
Study
Report Narratives
|
1/20/2008
|
N/A
|
|
XX-XX-04-S3
|
Safety
Reporting to Regulatory Authorities
|
1/20/2008
|
N/A
|
|
GA-SA-05-S3
|
Managing
Adverse Events/Reactions in Blinded Clinical Trials
|
1/20/2008
|
N/A
|
|
XX-XX-06-S3
|
Reconciliation
of Serious Event Data
|
1/20/2008
|
N/A
|
|
XX-XX-07-S1
|
Safety
Event Reporting System Project Set Up
|
9/19/2008
|
N/A
|
|
Strategic
Development
|
|||
|
GL-SD-01-S2
|
Managing
Strategic Transactions
|
1/31/2009
|
N/A
|
Page 6 of 6
