amarex cirm budget prep proposal january 2015

8/9/2019 Amarex CIRM Budget Prep Proposal January 2015

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Important Information

This document is provided to California Institute for Regenerative Medicine (CIRM) solely forthe 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 ClinicalResearch, 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 orobligations 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 StreetSan Francisco, CA 94107

Prepared by:Amarex Clinical Research, LLC

20201 Century Boulevard, Suite 450G t MD 20874


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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-winning

1 Contract Research Organization

(CRO) providing comprehensive clinical trial services to the

pharmaceutical, biotech, and medical device industries over a widerange of therapeutic areas. Amarex holds to the principle that

defensible study design, reliable data, and thorough analyses are thekey components of a successful product development program.

Our flat organizational structure is designed to provide access toour most senior staff and an experienced team of individuals who

develop prospective plans and provide foresight andrecommendations 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 selectionand management, clinical and medical monitoring, data

management, biostatistics, medical writing, regulatory

consulting/support, audits, FDA presentations and meetings, DataSafety Monitoring Board and Scientific Advisory Committee

management, and a range of other consulting services.

Clinical Trial Experience


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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 – Intra-

Articular Injection

RLPC Measuring

Wound Healing – Diabetic

Foot Ulcer, Venous Leg

Ulcer, and Burn Grafts

Orthopedic Nerve

Stimulator

Table 3. Amarex’s Clinical Trial Experience

Therapeutic Area Phase # Studies # Sites # Patients

Antiseptic I 4 10 143


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Infectious Disease II 21 172 11935

Infectious Disease III 8 406 4268

Metabolic I 2 4 18

Metabolic II 9 67 591

Metabolic III 10 312 2637

Metabolic IV 4 159 1240

Oncology I 12 72 338

Oncology II 7 21 144Oncology III 4 131 714

Oncology IV 1 50 500

Orthopedic I 1 6 74

Orthopedic II 2 26 340

Pain Management I 12 15 258

Pain Management II 4 34 267

Pain Management III 2 90 280

Pain Management IV 1 50 500

Respiratory I 2 8 90

Respiratory III 2 81 1220

Rheumatology II 2 15 83

Rheumatology III 1 7 350

Rheumatology IV 1 6 340

Urology I 1 1 128

Urology II 1 10 60

Urology III 1 6 570

Vaccine I 26 122 6034

Vaccine II 28 181 14048


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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/smallmolecule/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 sub-vendors.

When Amarex manages clinical sites for clients, those sites may be

private, non-profit, academic, or even government owned. As aresult, 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 budgetsfor 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 overallexperience, Amarex is extremely well versed in the setup and

evaluation of budgets for clinical trial work.

Qualification of Staff


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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 studydesigns 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 inmany Data Safety Monitoring Committees for a wide range

of clinical products. Dr. Kazempour has been active in the biomedical research.

Peter Frantz, MS, MBA, Amarex’s Senior Director of

Finance, has over ten years of experience in drug

development. He has primary responsibility for thedevelopment 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 developmentassignments. 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 projectshere e ere responsible for contracting ith sites labs and


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project a success. our services for each project we take on.

Amarex’s ability to deliver is demonstrated by the company’s

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-of-mouth endorsements of our clients. We understand the value of a

satisfied client; and as loyal as our clients have been to us, we areloyal to them.


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Our Understanding of CIRM’s 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 toCIRM

Our Solut ion to CIRM’s Needs

Budget Review

Based on the templates designed by CIRM, on an ongoing basis,

Amarex may review incoming grant applications and provideCIRM 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 undermore 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 CRO’s 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.


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Proposed Amarex Direct Services Budget(US Dollars)

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 priceassociated 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 actualreceipts.

AMAREX DIRECT SERVICES FEES

Bid

ID Service Unit Description Unit Cost $

No.

Units

Total

Cost $

1 Budget Reviews per budget $ 703.00 TBD TBD


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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 Amount

Monthly Unit-Based Billing 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 otherreasonable 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


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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 (hereunderreferred 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 “EffectiveDate”) and based on terms, items and budget presented herein below, prior to the signing of adefinitive 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 agreementand 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 theProject 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 withthird 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 entitledto receive payment for all work actually performed, for all verifiable out-of-pocket expenses


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If the terms of the foregoing meet with your approval, please indicate your acceptance by signingtwo copies of this Agreement in Principle and returning both to the undersigned for counter-

signature.

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 forRegenerative Medicine:

For and on behalf of Amarex ClinicalResearch, LLC:

Print Name: Print Name: Kazem Kazempour

Signature: Signature:

Title: Title: President and CEO (Member)

Date: Date:


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Amarex 5 Year Experience Record

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


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amarex cirm budget prep proposal january 2015

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