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In re Lupron® Marketing and Sales Practices Litigation

United States District Court, D. Massachusetts

April 11, 2016

IN RE: LUPRON® MARKETING AND SALES PRACTICES LITIGATION Master File No. 01-CV-10861-RGS

MEMORANDUM ACKNOWLEDGING RECEIPT AND REVIEW OF MAZZONE AWARDS PROGRAMMATIC REPORT #10

RICHARD G. STEARNS, District Judge.

On March 30, 2015, Dr. Myles A. Brown of the Dana-Farber/Harvard Cancer Center (DF/HCC), the principal investigator for the A. David Mazzone Research Awards Program (Program), [1] and co-principal investigator, Dr. Jonathan Simon, President of the Prostate Cancer Foundation (PCF), submitted the tenth in a series of Program Reports. This Report covers the period from July 1, 2015, to December 31, 2015.

The Mazzone Awards Program, over its life, has supported the work of 146 investigators involved in forty-one separate prostate cancer and related research projects worldwide, as well as funding community outreach programs, career development for treatment specialists, and basic and advanced research training.[2] With the work of the Program coming to a close, Report #10 provides a cumulative summary of the Program's accomplishments. The court has appended the Report for the benefit of all of those who are interested in the achievements of this historical undertaking. The court expresses special appreciation for the stewardship of Dr. Kantoff, Dr. Brown, Dr. Simon, and Dr. Soule, and for the groundbreaking work of the many investigators whose accomplishments will be fully celebrated in the Fifth Annual Report of Scientific Progress and Accounting due on September 30, 2016.

SO ORDERED.

DF/HCC

DANA-FARBER/HARVARD CANCER CENTER

Table of Contents Introduction 2 2015 Programmatic Activity 2 Program Progress and Reporting 3 Change in Principal Investigator 4 Appendix 1: Mazzone Awards Program Funding Structure as of 2015 6 Appendix 2: Mazzone Awards Program Grantees, 2011-2014 8 Appendix 3: Program Reporting Schedule 17

A. David Mazzone Awards Program

Programmatic Report Period: July 1, 2015 to December 31, 2015

Introduction

The A. David Mazzone Awards Program is a grant awarded by the U.S. District Court for the District of Massachusetts (the Court) to Dana-Farber/Harvard Cancer Center (DF/HCC) in conjunction with the Prostate Cancer Foundation (PCF). Under the leadership of Dr. Phil Kantoff, succeeded by Dr. Myles Brown in 2015, the Mazzone Program supports collaborative and innovative cancer research, career development, community outreach, and training projects to address a range of research needs in prostate cancer and Lupron-treatable diseases. This report describes programmatic activities during the second half of calendar year 2015.

The Program was designed to issue a call for applications on an annual basis until the funding assigned to the various mechanisms was fully spent. To that end, the Program issued four rounds of requests for applications (RFAs) from 2011 to 2014 and distributed grants in accordance with the approved proposal. Appendix 1 in this report provides a financial summary of the funding distribution as approved by the Program's Scientific Advisory Board and the Massachusetts District Court.

The Program established a national presence as a source of funding for prostate cancer research. Most importantly, the Program fostered an unprecedented effort for institutions to collaborate on inter-institutional Prostate Cancer research projects breaking down barriers to knowledge dissemination and collaboration. In the coming six months, the program will continue to actively monitor and evaluate the progress of funded projects in preparation for the fifth annual report of scientific progress and accounting, which is due to the Court by September 30, 2016.

At the end of its fifth year, the program supported a total of 146 investigators working on 41 projects at institutions across the United States. Appendix 2 provides a detailed list of Mazzone Awards Program Grantees for years 2011 to 2014. These projects include thirty five projects funded by DF/HCC through six award mechanisms and six projects funded through the PCF Mazzone Challenge Awards mechanism.

2015 Programmatic Activity

As of 2015, the Program had awarded all its funding opportunities and therefore, it did not issue a request of applications this year. The activity of the Program focused primarily on monitoring existing grantees and managing administrative processes related to the maintenance and closing of those existing awards.

As it is summarized in Appendix 1, "Funding Structure", the total funding approved by the Court was issued to grantees over the agreed-upon 4-year period. The table provides information on actual grants amounts for the award mechanisms authorized for DF/HCC and PCF. DF/HCC issued grants in the total amount of $5, 530, 000 and PCF issued grants totaling $5, 000, 000 as of 2014. The total amount funded and committed plus DF/HCC overhead assessment of 1, 170, 000, total the grant actual estimated funding of $11, 700, 000. (see Table 2 Below for grants distribution as provided on the original grant application).

In accordance with the approved Funding Structure, the Court disbursed two payments of $4, 000, 000 each in November 2010 and November 2012; Payments of $2, 000, 000 and $1, 585, 000 were issued in January 2015 and December 2015 respectively. At the time of the December 2015 payment, the Court reserved a final disbursement of approximately $115, 000 to be issued to DF/HCC upon satisfactory submission and approval of progress and accounting reports due to the Court by September 2016.

It is possible that some of the remaining active Mazzone funded projects will require a no-cost extension for the period of 2016 to 2017. In such case, the Program will continue to monitor those projects and will prepare and submit a final progress and accounting report in September 2017.

Table 2. Grant Awards Approved by the Court

Number of Total Award Category Amount Awards Allocation Career Development 100, 000 6 600, 000 Community Outreach 100, 000 4 400, 000 Disparities Research 100, 000 5 500, 000 High Impact Award (Original Number was 5) 500, 000 4 2, 000, 000 Lupron-Treatable Diseases and Conditions 100, 000 3 300, 000 Project Development 100, 000 9 900, 000 Student Training 160, 000 1160, 000 New (2012): High Impact Clinical Trials (1 reallocated from High Impact) 500, 000 1 500, 000 New (2012): Seed Funding - Community Outreach Proposal Development 10, 000 110, ...


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