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Important Information

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

Amarexs Response to CIRMs Request for Proposal


Amarex Clinical Research, LLC Confidential and Proprietary Information

1/29/15
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Amarex Company Overview


Amarex is an award-winning
CRO founded in 1998 and
located in Germantown,
MD.

Amarex, founded in 1998 and located in Montgomery County,


Maryland, is an award-winning1 Contract Research Organization
(CRO) providing comprehensive clinical trial services to the
pharmaceutical, biotech, and medical device industries over a wide
range of therapeutic areas. Amarex holds to the principle that
defensible study design, reliable data, and thorough analyses are the
key components of a successful product development program.
Our flat organizational structure is designed to provide access to
our most senior staff and an experienced team of individuals who
develop prospective plans and provide foresight and
recommendations to our clients for the issues that inevitably arise
during study conduct and analyses.

As a full-service CRO, Amarex


can meet all of your project
needs.

We are a full-service CRO providing study management services


that include, but are not limited to: sub-vendor and site contracting,
project management, protocol development, clinical site selection
and management, clinical and medical monitoring, data
management, biostatistics, medical writing, regulatory
consulting/support, audits, FDA presentations and meetings, Data
Safety Monitoring Board and Scientific Advisory Committee
management, and a range of other consulting services.

Clinical Trial Experience


Amarexs breadth of experience
in the conduct of Phase I
Phase IV trials will be an
asset to CIRM.

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

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Amarex Clinical Research, LLC Confidential and Proprietary Information

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Table 1. Therapeutic Areas: Drug and Biologics

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

Table 2. Medical Device/Diagnostic Experience


510K Studies

Premarket Approval Studies

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

Table 3. Amarexs Clinical Trial Experience


Therapeutic Area

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

Amarexs Response to CIRMs Request for Proposal


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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

Amarex has provided clinical trial management services for more


than 300 projects; involving over 4,700 sites; and 88,000 subjects.
Qualifications and Experience of Firm
Amarex has been providing clinical trial support to clients for over
16 years. One of the many ways in which we support our clients is
in helping them to contract with vendors such as: clinical sites,
preclinical facilities, labs, contract manufacturers, drug distribution
and storage vendors, etc. The CRO direct service cost to conduct
trials for sponsors usually represents about half of a trials cost.
The majority of the remaining cost is in the site costs to actually
test the subjects. These two areas of cost are what Amarex deals
Amarexs Response to CIRMs Request for Proposal
Amarex Clinical Research, LLC Confidential and Proprietary Information

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most with on a day-to-day basis. We firmly believe we are


qualified to support CIRM with this project.
In the last 5 years Amarex has worked on over 100 projects (well
over 10 of those projects were for cell therapy/stem cell/small
molecule/biologics as indicated in the attached experience file). In
40 of those projects we handled clinical site work, and 40 of those
projects included regulatory support. These two areas of services
are where we help clients in their contracting needs with subvendors.
When Amarex manages clinical sites for clients, those sites may be
private, non-profit, academic, or even government owned. As a
result, Amarex has experience in conducting budget negotiations
for services across all types of clinical sites, and knows what
appropriate market rates are. Our clients are both privately funded,
and government funded, so we are also aware of the difference in
budgeting requirements for both types of clients.
Amarex has developed standard budget formats to use when
submitting responses to client RFPs to support them in full clinical
conduct of their trials. Amarex also has standard format budgets
for use in negotiating with clinical sites for its clients. Amarex
understands that CIRM has developed its own budget template for
this project, and that will not be an issue. Given this overall
experience, Amarex is extremely well versed in the setup and
evaluation of budgets for clinical trial work.
Qualification of Staff
Amarexs senior staff will be very involved with the CIRM
project. Following is a brief summary of their qualifications (their
curriculum vitae are available upon request):

Dr. Kazem Kazempour, PhD, Amarexs Senior Director of


Biometrics, has over 30+ years of experience in biomedical
research and has conducted research with several
universities, the NIH, the FDA, several pharmaceutical
companies, and for the past 16 years at Amarex. At Amarex,
Dr. Kazempour has had final say on all service pricing since
Amarex was started. At the FDA, Dr. Kazempour worked as
a Senior Staff Fellow and as a Mathematical Statistician
responsible for independent statistical analyses of clinical
trials and review of statistical sections of protocols and
statistical analysis plans; he received several FDA awards for
innovative problem solving and teamwork. He was a key
member of the FDA team that worked out the clinical trial

Amarexs Response to CIRMs Request for Proposal


Amarex Clinical Research, LLC Confidential and Proprietary Information

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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.

The Amarex Difference


Amarex offers CIRM
performance, reliability,
demonstrated experience,
and responsive customer
service that leads to highquality results. Amarex has
the right resources and
approach to deliver the
results that will make this

Amarex is a technologically advanced CRO with experienced


professionals who apply innovative tools and processes to their
clinical development research. Our experience has enabled us to be
successful through repeat and new business over the last 15 years.
In addition to knowledgeable personnel, Amarex uses proven
procedures for swift project completion and reduced project cost.
Most importantly, we commit to strive for a quality result in all of

Amarexs Response to CIRMs Request for Proposal


Amarex Clinical Research, LLC Confidential and Proprietary Information

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project a success.

our services for each project we take on.


Amarexs ability to deliver is demonstrated by the companys
growth from a two-person statistical consulting and report writing
niche business to a full-service, award-winning CRO in less than
four years. This growth can be attributed mainly to the word-ofmouth endorsements of our clients. We understand the value of a
satisfied client; and as loyal as our clients have been to us, we are
loyal to them.

Amarexs Response to CIRMs Request for Proposal


Amarex Clinical Research, LLC Confidential and Proprietary Information

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Our Understanding of CIRMs Needs


Based on the Request for Proposal and our discussions with CIRM,
Amarex understands that the general requirements for this project
are as follows:

Review budgets submitted as part of grant applications to


CIRM

Our Solution to CIRMs Needs


Budget Review
Based on the templates designed by CIRM, on an ongoing basis,
Amarex may review incoming grant applications and provide
CIRM a recommendation on the appropriateness of the budget.
The output will be an indication of whether the budget is over or
under what Amarex believes is appropriate by [x]% using a CIRM
provided report template. Budgets that are either over or under
more than [x]% will be considered flawed by CIRM and the project
will be ineligible for review until the budget is revised. Amarex
understands that there will be several CROs involved in this
project to avoid potential conflicts of interest.
Specifically, Amarex will be expected to:
-

Test validity and sensitivity of budget assumptions.

Compare proposed budget against established market rates


for similar activities.

Assess integrity and completeness of budget.

Provide information regarding financial accuracy, potential


variance and impact of the budget portion of grant
applications. This information will include the expected
minimum and maximum range the Firm believes budget
should be inside based on Firms expertise. The Review
Report template is included in the RFP.

The budget review will need to be performed in a two-week


period following the delivery of the applicant budget to
Firm from CIRM.

Amarexs Response to CIRMs Request for Proposal


Amarex Clinical Research, LLC Confidential and Proprietary Information

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Proposed Amarex Direct Services Budget


(US Dollars)
AMAREX DIRECT SERVICES FEES
Bid
ID
Service
1 Budget Reviews

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.

Estimated Pass-Through Costs


Pass-through expenses, such as: approved travel, document shipping and printing, and other
project related out-of-pocket expenses incurred by Amarex in the conduct of the study will be
invoiced to CIRM at the actual cost plus 10% to cover administrative services required to
process the expenses. These expenses will be supported by acceptable documentation or actual
receipts.

Amarexs Response to CIRMs Request for Proposal


Amarex Clinical Research, LLC Confidential and Proprietary Information

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Payment Schedule and Terms


Payment Schedule for Services
The payment terms and obligations for the services outlined in this proposal are as follows:
Payment Description

Monthly Unit-Based Billing

Amount

TBD

Client Billing Information


Payments will be billed to:
California Institute for Regenerative Medicine (CIRM)
210 King Street
San Francisco, CA 94107

Payment Schedule for Pass-Through Expenses


Pass-through expenses such as approved travel, document shipping and printing, and other
reasonable expenses will be invoiced to CIRM at cost plus 10%. These expenses will be
supported by acceptable documentation or actual receipts and will be invoiced on a monthly
basis.

Payment Terms

Payments are due 30 days after delivery of an invoice.


Late payment fee: 1% per month interest on all past due, unpaid balances.
Payments will be made out to: Amarex Clinical Research, LLC
Tax ID: 52-2138315
Payments will be sent to:
Kazem Kazempour, President and CEO (Member)
Amarex Clinical Research, LLC
20201 Century Boulevard, Suite 450
Germantown, MD 20874
Phone (301) 528-7000

Amarexs Response to CIRMs Request for Proposal


Amarex Clinical Research, LLC Confidential and Proprietary Information

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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.

Amarexs Response to CIRMs Request for Proposal


Amarex Clinical Research, LLC Confidential and Proprietary Information

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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:

For and on behalf of Amarex Clinical


Research, LLC:

Print Name:

Print Name:

Signature:

Signature:

Title:

Title:

Date:

Date:

Amarexs Response to CIRMs Request for Proposal


Amarex Clinical Research, LLC Confidential and Proprietary Information

Kazem Kazempour

President and CEO (Member)

1/29/15
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Amarex 5 Year Experience Record


(this document was supplied to CIRM last year in support of another RFP)

Amarexs Response to CIRMs Request for Proposal


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