Professional Documents
Culture Documents
This document is provided to California Institute for Regenerative Medicine (CIRM) solely for
the purpose of its evaluation. The information contained herein is not intended to be used by
CIRM for any other purpose and CIRM agrees not to voluntarily disclose any of the information
contained herein to any third party without the prior written consent of Amarex Clinical
Research, LLC (Amarex).
This document and the proposal contained herein are subject to negotiation and execution of a
mutually-acceptable definitive agreement between Amarex and CIRM as well as the requisite
corporate approval of both parties. Accordingly, this document shall not create any legal rights or
obligations on the part of either party except for the confidentiality obligation noted above.
Proposal Expiration Date: March 28, 2015
Prepared for:
California Institute for Regenerative Medicine (CIRM)
210 King Street
San Francisco, CA 94107
Prepared by:
Amarex Clinical Research, LLC
20201 Century Boulevard, Suite 450
Germantown, MD 20874
Phone: (301) 528-7000
Fax: (301) 528-2300
1/29/15
Page i
Amarex has managed studies ranging in size from singlecenter/Phase I trials to multi-center/1000+ subject/multi-national
Phase III trials. The services provided for these trials include: subvendor and site contracting, protocol development, project
management, vendor management, GCP audits, FDA Advisory
Committee presentations, Data Safety Monitoring Board
representation, site selection and management, SOP development,
clinical monitoring, data management, statistical programming and
analyses, vendor management, clinical study supplies logistics,
medical monitoring, statistical analyses, clinical study report
composition, and manuscript writing for publication.
The following tables list our experience in various therapeutic
areas for drugs, biologics, and medical devices.
Employer of the Year: 2002, Montgomery County Workforce and Economic Development Award
1/29/15
Page 1
Anti-Infective
Antibiotics
Anti-Viral
Asthma
Cardiovascular
CNS
Dermatology
Diabetes
Endocrine
Gastrointestinal
Hematology
Infectious Disease
Metabolic
Oncology
Orthopedics
Pain Management
Respiratory
Rheumatology
Travelers Diarrhea
Urology
Vaccines
Wound Care/Healing
Antiseptics
Glucose Meters
Incontinence
Joint Pain Relief IntraArticular Injection
RLPC Measuring
Wound Healing Diabetic
Foot Ulcer, Venous Leg
Ulcer, and Burn Grafts
Orthopedic Nerve
Stimulator
Phase
# Studies
# Sites
# Patients
Antiseptic
Antiseptic
Cardiovascular
Cardiovascular
Cardiovascular
Cardiovascular
CNS
CNS
CNS
Dermatology
Dermatology
GI
GI
GI
Hematology
Hematology
Hematology
Infectious Disease
I
II
I
II
III
IV
I
II
III
I
III
I
II
III
I
II
III
I
4
5
4
4
10
2
20
6
5
1
1
3
3
2
2
3
2
26
10
26
11
337
592
140
24
50
80
2
30
3
10
38
3
11
36
138
143
259
200
3160
8855
2000
564
442
967
44
296
136
84
520
39
155
367
11707
1/29/15
Page 2
Infectious Disease
Infectious Disease
Metabolic
Metabolic
Metabolic
Metabolic
Oncology
Oncology
Oncology
Oncology
Orthopedic
Orthopedic
Pain Management
Pain Management
Pain Management
Pain Management
Respiratory
Respiratory
Rheumatology
Rheumatology
Rheumatology
Urology
Urology
Urology
Vaccine
Vaccine
Vaccine
Wound Healing
Wound Healing
Wound Healing
Wound Healing
II
III
I
II
III
IV
I
II
III
IV
I
II
I
II
III
IV
I
III
II
III
IV
I
II
III
I
II
III
I
II
III
IV
21
8
2
9
10
4
12
7
4
1
1
2
12
4
2
1
2
2
2
1
1
1
1
1
26
28
4
14
13
8
10
172
406
4
67
312
159
72
21
131
50
6
26
15
34
90
50
8
81
15
7
6
1
10
6
122
181
60
36
123
192
719
11935
4268
18
591
2637
1240
338
144
714
500
74
340
258
267
280
500
90
1220
83
350
340
128
60
570
6034
14048
1412
410
1501
1547
6545
1/29/15
Page 3
1/29/15
Page 4
design for the first HIV drugs. During his years in industry he
implemented ICH guidelines, validated biometrics
department systems, prepared and presented statistical study
designs of INDs, IDEs, NDAs, BLAs, PMAs, and other
submissions to U.S. and EU regulatory agencies. He has
prepared Integrated Summary of Safety (ISS) and Integrated
Summary of Efficacy (ISE) reports. Additionally, Dr.
Kazempour has established, presented, and participated in
many Data Safety Monitoring Committees for a wide range
of clinical products. Dr. Kazempour has been active in the
biomedical research.
Peter Frantz, MS, MBA, Amarexs Senior Director of
Finance, has over ten years of experience in drug
development. He has primary responsibility for the
development of all contracts and study budgets at Amarex for
the last seven years. Those efforts include contracts with
both clients and subcontractors. Prior to working at Amarex,
Mr. Frantz was a Portfolio Manager at a biotech startup, and
was responsible for the day-to-day management of two
clinical projects, along with other business development
assignments. Prior to that, Mr. Frantz worked for a
consulting company supporting the FDA and EPA in
reviewing preclinical study reports.
Comparable Projects
In the last 3 years Amarex has worked on 19 clinical projects
where we were responsible for contracting with sites, labs, and
other vendors for our clients, in addition to providing clinical trial
services ourselves. 14 of the trials were registration trials. Four of
the trials were Phase II trials, and the last is a Phase I. 11 of the
studies have been completed, and the remaining ones are still in
progress. At least four different current employees at Amarex
have been involved with the budget negotiations with the subvendors and sites on these trials.
1/29/15
Page 5
project a success.
1/29/15
Page 6
1/29/15
Page 7
Unit Description
per budget
Unit Cost $
$
703.00
No.
Units
TBD
Total
Cost $
TBD
CIRM will be billed for each budget proposal reviewed according to the unit cost stated above.
Amarex budgets services by tasks as opposed to by hours. Each task has a fixed unit price
associated with it, and covers the work to be provided under that task. Amarex reserves the right
to increase its rates on an annual basis. This increase will not exceed 5% per year.
1/29/15
Page 8
Amount
TBD
Payment Terms
1/29/15
Page 9
Agreement in Principle
SIR/MADAM:
This Letter sets forth our mutual understanding and Agreement in Principle pursuant to which
California Institute for Regenerative Medicine (hereunder referred to as Company) authorizes
Amarex Clinical Research, LLC, a for-profit Maryland limited liability company (hereunder
referred to as Amarex) to commence certain works (herein referred to as Services) for
budget review (the Project) as outlined in this Proposal dated January 29, 2015 (the Effective
Date) and based on terms, items and budget presented herein below, prior to the signing of a
definitive agreement that is currently being negotiated between the parties.
The signatures below indicate the existence of this Agreement in Principle between the parties
whereby Amarex will perform the Services until a definitive agreement is reached and signed
between the parties. This Agreement in Principle is not a substitute for the definitive agreement
and will expire upon signing of said definitive agreement. The definitive agreements with
respect to the Services contemplated hereby will contain mutually agreeable provisions,
representations, warranties, and any other appropriate and customary terms and conditions.
The purpose of this Agreement in Principle is to authorize commencement of work on the
Project with the understanding that the definitive agreement shall be executed in the future.
Company shall have the right to terminate this Agreement in Principle, with or without cause,
upon written notice to Amarex. In the event that Company decides to terminate Services under
this Agreement in Principle, Amarex shall not undertake any further work, except as agreed to by
Amarex and Company, or incur any additional expenses, or enter into further commitments with
third parties in regard to this Agreement in Principle after receiving notice of termination from
Company. Upon submission of reasonable documentation to Company, Amarex shall be entitled
to receive payment for all work actually performed, for all verifiable out-of-pocket expenses
incurred, and for non-cancellable commitments actually entered into with regard to this
Agreement in Principle. If the amount that Company has previously paid to Amarex exceeds the
amount that Amarex is actually owed, Amarex shall reimburse the balance to Company within
60 days of receipt of the notice of termination. Nothing in this paragraph shall affect Companys
rights in the event of failure by Amarex to perform its obligations under this Agreement in
Principle.
This Letter shall be governed by, and construed in accordance with, the laws of the State of
Maryland.
1/29/15
Page 10
If the terms of the foregoing meet with your approval, please indicate your acceptance by signing
two copies of this Agreement in Principle and returning both to the undersigned for countersignature.
Peter Frantz, MS, MBA
Senior Director, Finance
Amarex Clinical Research, LLC
20201 Century Boulevard, Suite 450
Germantown, MD 20874
Phone (301) 528-7000
ACKNOWLEDGED, ACCEPTED, AND AGREED TO:
For and on behalf of California Institute for
Regenerative Medicine:
Print Name:
Print Name:
Signature:
Signature:
Title:
Title:
Date:
Date:
Kazem Kazempour
1/29/15
Page 11
1/29/15
Page 12