The Max Foundation

MAX negotiated prices for GeneXpert IV System and Xpert® BCR ABL assay and eligible country list

Announcing the MAX-Cephied agreement

MAX negotiated preferential prices for GeneXpert IV System and Xpert® BCR ABL assay and eligible country list

Background

Enhancement of monitoring capacity is urgently needed to achieve optimal clinical outcomes for Chronic Myeloid Leukemia (CML) in many Emerging Countries. To help meet this challenge, The MAX Foundation (MAX) and the International CML Foundation (iCMLf) are collaborating to increase access to diagnostic and monitoring capabilities. In the context of the MAX-iCMLf partnership, MAX has entered into a collaboration agreement with Cepheid for preferential pricing of its GeneXpert IV instrument and Xpert BCR ABL monitor assay, a cartridge-based RT-PCR monitor assay intended as an aid in the monitoring of the BCR-ABL mRNA transcript in peripheral blood of patients with CML, in certain high burden low-and-middle-income countries.

The Xpert BCR-ABL Monitor Assay is an automated test for quantifying the amount of BCR-ABL transcript as a ratio of BCR-ABL/ABL. The assay is performed on Cepheid GeneXpert Instrument Systems. The GeneXpert Instrument Systems automate and integrate sample purification, nucleic acid amplification, and target sequence detection in simple or complex samples using real-time RT-PCR and PCR assays. The systems consist of an instrument, computer, and preloaded software for running tests and viewing the results. The systems require the use of single-use, disposable GeneXpert cartridges that hold the RT-PCR and PCR reagents and host the RT-PCR and PCR processes.

At the request of MAX and iCMLf, Cepheid has agreed to offer a preferential price for the GeneXpert IV System and Xpert BCR-ABL Monitor Assay for public sector end users in 68 countries. This preferential pricing has been established through a collaboration agreement between MAX and Cepheid, and will only apply to orders placed by MAX to Cepheid. End users interested in taking advantage of the preferential pricing may inquire with MAX for guidance on how to access the program.

This document outlines the pricing, establishes the relationships, and defines the applicable market as the public sector in the 68 specified low-and-middle-income countries.

About ordering

Public sector institutions in eligible countries may request a quotation, product description and order form from MAX, and subsequently place an order for GeneXpert System IV and/or Xpert BCR-ABL assays through MAX. Upon receipt of payment, MAX will forward the order to Cepheid and Cepheid will arrange delivery to the end users.

About Pricing

Assay (i.e. test cartridge) and instrument (i.e. GeneXpert device) costs under this agreement represents a 60 to 50 % reduction relative to the market price.

Public institutions treating CML in eligible countries can now purchase test cartridges at the cost of USD$50** each, and GeneXpert System IV at USD$17,000** (with PC) and USD$17,500** (with laptop).

Instrument price for MAX clients

	GeneXpert 4-module with esktop	GeneXpert 4-module with laptop	BCR-ABL Monitor Assay (10 cartridge kit)
Price (Ex orks)	US$ 17,000	US$ 17,500	US$ 500 (US$ 50 each)
	>60% reduction over Cepheid EU/US

**Other costs such as shipping and handling may apply. For orders contact The MAX Foundation (MAX) directly at the address below and mention the Cepheid-negotiated preferential price.

To request information and quotation contact:

The MAX Foundation
110 W Dayton St, ste 205
Edmonds WA 98020
Telephone +1-425-778-8660
Fax +1-425-778-8760
Email: info@themaxfoundation.org

About Instrument Warranty & Module Calibration:

Instrument Warranty: Instruments purchased under the Max Foundation Agreement will be offered the same Two-year HBDC GeneXpert Limited Warranty provisions. *Standard HBDC GeneXpert Limited Warranty can be found on the Cepheid Cares website.

Module Calibration: Calibration of each module is required after 2000 tests or 1 year, whatever occurs first. The cost of this calibration is not covered by warranty and must be purchased separately. Failure to complete module calibration certification in the first year will result in voiding the second year warranty on the modules. Pricing for the calibration will be quoted separately.

About eligible countries:

The public sector in eligible countries is defined as:

Governments or government-funded institutions;
NGOs recognized by the local Ministry of Health and UN-related organizations; and
Not-for-profit, private organizations recognized by the local Ministry of Health, whose mission is in line with humanitarian principles such as private charities and/or private not-for-profit hospitals and clinics, on a case-by-case basis

Country List

Countries for which MAX-negotiated prices are available (April 2012)

Angola	Lesotho
Azerbaijan	Madagascar
Bahamas	Malawi
Bangladesh	Mali
Barbados	Mauritania
Belarus	Moldova
Benin	Mongolia
Bhutan	Namibia
Bolivia	Nepal
Botswana	Nicaragua
Burkina Faso	Niger
Cambodia	Nigeria
Cameroon	Papua New Guinea
Central Africa	RepublicParaguay
Cote d'Ivoire	Peru*
Democratic Republic of Congo	Philippines
Dominican Republic	Republic of Congo
East Timo	Rwanda
Ecuador*	Saint Lucia
El Salvador*	Senegal
Ethiopia	Seychelles
Fiji	Sierra Leone
Gabon	Sri Lanka
Georgia	Sudan
Ghana	Surinam
Guatemala	Swaziland
Haiti	Tajikistan
Honduras	Tanzania
India**	Togo
Indonesia	Uganda
Jamaica	Uzbekistan
Kazakhstan	Vietnam
Kenya	Zambia
Kyrgyzstan	Zimbabwe

*Eligible centers in Perú, Ecuador, El Salvador End Users of The MAX Foundation

Ecuador: Cruz Roja Ecuatoriana
Perú: Instituto Nacional de Enfermedades Neoplasicas; Hospital Nacional Asenjo, and Hospital Regional Honorio Delgado,br /> El Salvador: Hospital Nacional Rosales

**Eligible India Centers End Users of The MAX Foundation