IN RE LUPRON® MARKETING SALES PRACTICES LITIGATION

RICHARD STEARNS, District Judge

As explained in previous orders, the court's consideration of the cy pres distribution of unclaimed funds in the Settlement Pool has narrowed to two proposals, both of which have as their focus research into cures for prostate cancer, precocious puberty, and other diseases treated by Lupron(r), a drug marketed and sold by TAP Pharmaceutical Products, Inc. (TAP). For legal guidance, the court has turned to three Circuit Court decisions: In re Pharm. Indus. Average Wholesale Price Litig., 588 F.3d 24, 32-35 (1st Cir. 2009); Masters v. Wilhelmina Model Agency, Inc., 473 F.3d 423, 436 (2d Cir. 2007); and Six (6) Mexican Workers v. Ariz. Citrus Growers, 904 F.2d 1301, 1306 (9th Cir. 1990). The court has carefully reviewed the submissions of the authors of the two competing proposals (which I will label for convenience as Proposal A and Proposal B), and the suggestions and comments of class members, counsel involved in the case, and the public.,

As of August 3, 2010, a total of $11,423,624.59 is on deposit in an interest-bearing account maintained by the Clerk of the District Court.

The drug leuprolide acetate, marketed as Lupron(r), is used primarily to treat patients with prostate cancer, although it is also an effective treatment for other conditions like precocious puberty. Other than skin cancer, prostate cancer is the most common cancer affecting American men. The American Cancer Society estimated that in 2009 some 192, 280 new cases of prostate cancer were diagnosed and 27,360 men died of the disease. http://www.cancer.org/Cancer/ProstateCancer/DetailedGuide/prostate-cancer-key-statistics (June 30, 2010).

In the original national Class Action Complaint, which was assigned to this court by the Multi-District Litigation Panel, a consortium of patients and health care plans alleged that defendants Abbott Laboratories, Takeda Chemical Industries, Ltd., and TAP (an Illinois corporation owned by Abbott and Takeda) conspired to artificially inflate the price for Lupron(r) in a fraudulent scheme targeting Medicare patients. Grounded on the civil provisions of the Racketeer Influenced and Corrupt Organizations Act (RICO), 18 U.S.C. § 1962 et seq., the Complaint sought recovery of the alleged overcharges for Lupron(r), as well as a punitive trebling of damages.

The court posted the two submissions on its website on May 25, 2010. The court also posted the questions it addressed to the authors of the two proposals, together with their answers and comments. (The public comment period expired on June 25, 2010). Among the comments received was that of Intervenor Valerie Samsell. See Dkt #565. She requested that the remaining settlement funds be distributed one half to Dana-Farber and "other foundations supporting research in the treatment of infertility, endometriosis, ovarian and breast cancer, and precocious puberty in memory of Dennis Rohn," and "the other half should be distributed among plaintiffs in the Lupron(r) Depot [sic] Class Action Suit. This way, both parties will be awarded and everyone may then go forward with their lives." Id., at 2. The notice program mandated by the court and conducted by Hilsoft Notifications, a Pennsylvania company that specializes in class action notice campaigns, generated nearly 11,000 responses from class members. Class members were paid 167 percent of all of their claimed out-of-pocket Lupron(r) expenditures. As was established at the initial cy pres hearing, a supplemental consumer claims process could be exorbitantly expensive (estimated at upwards of $1.74 million), time-consuming, and would likely recruit few new claimants given the high mortality rate among members of the class (persons prescribed Lupron(r) between January 1, 1991 and September 30, 2001). See May 19, 2009 Order at 2. There was no consensus among the various plaintiffs' counsel as to how the surplus funds should be distributed.

The court adds a brief reply to Dr. Kevin Loughlin's criticism that the court's deliberative process reflects a "total disregard for deadlines and for the confidentiality of competing proposals." Dkt #554 at 3. The complaint is apparently based on Dr. Loughlin's experience with the practices of the National Institutes of Health and other granting agencies. The court's role, however, is not that of a granting agency. The court is charged with the equitable distribution of the unclaimed funds in the Class Settlement Pool. Under the strictures of the cy pres doctrine, the court is obligated to distribute the funds in a way that most closely approximates the goals of the underlying class litigation (as best as they can be discerned by the court). In discharging its stewardship, the court is required by legal and constitutional constraints (and its own preference) to proceed in the most transparent way possible. The court also notes that the deadlines for consideration of submissions shifted not because of any capriciousness on the court's part, but because an intervening appeal of the court's cy pres intentions by the attorney for the Intervenors to the First Circuit Court of Appeals, which divested the court of jurisdiction from June 17, 2009 to January 7, 2010.

Proposal A was authored by Dr. Kevin Loughlin, the Director of Urologic Research at Brigham and Women's Hospital. Dkt #519-3, 541-1, 548-1. Proposal A was submitted on behalf of a committee of four Harvard Medical School professor-physicians (collectively, the Loughlin Group) who were asked by class counsel to formulate a recommendation for the distribution of a portion of the cy pres surplus. The Loughlin Group includes each of the medical disciplines involved in the diagnosis and treatment of prostate cancer (urologic surgery, medical oncology, radiation oncology, and primary care medicine). See Dkt #541, 554, 561. Proposal B was submitted by the Dana-Farber/Harvard Cancer Center (DF/HCC) and the Prostate Cancer Foundation (PCF). See Dkt #562. Its principal author was Dr. Philip W. Kantoff, the Chief Clinical Research Officer at the Dana-Farber Cancer Institute (DFCI). The public comment period expired on Friday, June 25, 2010.

The three other physicians who propose, with Dr. Loughlin, to form a committee to oversee distribution of the cy pres funds are Dr. Marc Garnick, an oncologist and prostate cancer researcher at Beth Israel-Deaconess Medical Center, Dr. Anthony Zietman, a radiation oncologist at Massachusetts General Hospital, and Dr. Michael Barry, the Chief of the General Medicine Unit at Massachusetts General Hospital. See Dkt #541-1, Ex. A.

DF/HCC is a National Cancer Institute-designated research center, consisting of over 1,100 Harvard Medical School faculty members. Established in 2001, DF/HCC's Prostate SPORE (Specialized Programs of Research Excellence) funds research and shares data with scientists both within and outside DF/HCC. The PCF, founded in 1993, has funded some 1,500 programs at 200 research centers worldwide targeted at new prostate cancer treatments, including gene therapy and potential vaccines. See Dkt #562, App. B (DF/HCC SPORE in Prostate Cancer Award History and Developmental Projects Program).

The Loughlin Group proposes to use the cy pres funds "to maximize the care of prostate cancer patients through education, diagnosis, research and treatment." Dkt #519-3 at 1. The Loughlin Group anticipates awarding grants of nearly $5.89 million over a five-year period "on any topic related to prostate cancer" that involves: (1) clinical and basic research; (2) community and patient outreach; (3) the recruitment of health care professionals into prostate cancer treatment; and (4) continuing education. Over the same period of time, the Loughlin Group intends to make an additional forty awards on a competitive basis totaling $3 million to residents, fellows, and junior faculty members who have an interest in prostate cancer research. The Loughlin Group would also make awards to forty current medical students totaling $1 million, and twenty awards to nurses totaling $200,000 to promote patient care and nurses' education. The Loughlin Group proposes to solicit grant applications through an informational campaign using free and paid media targeted at the medical community. Finally, the Loughlin Group proposes to convene research symposia at the end of years three and five to showcase grantees' research results. In sum, the Loughlin Group expects to distribute roughly $10 million in grants, with an additional $1.7 million spent for overhead costs (including roughly $1 million in salaries to be paid to the four members of the governance committee).

In its original proposal filed August 29, 2008, the Loughlin Group proposed a four-year program with a total budget of approximately $4.5 million (consisting of roughly $4 million in grants, $150,000 in overhead expenses, and $500,000 in salaries paid to the members of the governance committee). In response to the court's stated inclination to dedicate the entire fund to Lupron(r)-treated disease research programs, the Loughlin Group expanded the proposal to span five years with a budget of $11.4 million.

Under Proposal B, DF/HCC and the PCF will partner to distribute incentive awards to promote research into prostate cancer and other Lupron(r)-treatable diseases. See Dkt #562. PCF is primarily an award-granting institution, while DF/HCC is principally a research organization, although it has grant-making capability. In granting awards, PCF utilizes a venture capital model of investing in high-impact, high-risk research projects with the expectation of leveraging promising results into grants from more traditional funding sources. DF/HCC promotes collaborative interactions and encourages translational research to generate new approaches to cancer diagnosis and care.

The ultimate goal of the Proposal B partnership is "to reduce prostate cancer incidence and mortality," and "to improve [the] quality of life of those with prostate cancer." Id., at 13. Ninety percent of the cy pres funds would be dedicated to research, while ten percent ($1.1 million) would be used to support the costs of grant administration. DF/HCC proposes to oversee the design and implementation of seven DF/HCC award categories that are intended to catalyze collaborative research at a national level. PCF will independently oversee the design and implementation of a special category of awards to be given to teams of researchers on a national and international level. Potential award recipients will be recruited within Massachusetts by DF/HCC. National and international applicants will be recruited by members of the Oversight Board through their respective institutions and by PCF through its media contacts. Grant applications will be vetted by existing review committees. The Oversight Board, composed of national leaders in prostate cancer research, will oversee granting activities and the distribution of the cy pres funds.

DF/HCC and PCF propose to use their existing administrative structures rather than create a new structure for the award of the cy pres funds.

The awards (given over a two-year period) would be as follows: five High Impact Awards — $500,000; nine Project Development Awards — $100,000; six Career Development Awards — $100,000; three Lupron(r)-treatable Disease Awards — $100,000; eight Student Training Awards — $20,000; five Disparity Research Awards — $100,000; and four Community Outreach Awards — $100,000. See Dkt #562 (containing a detailed description of each proposed grant category).

The five PCF Challenge Grants will also have a two-year duration, each with $1 million in funding.

DF/HCC and PCF will convene a scientific advisory board (Oversight Board) "to ensure that Settlement Funds are distributed fairly, and in accordance with Request for Proposal guidelines and any other principles that are associated with such funds." Dkt #562 at 5-6. The Board will be composed of the following individuals: Dr. Howard Soule, PhD — Executive Vice President and Chief Science Officer at PCF; Dr. Philip Kantoff — Director of the Lank Center for Genitourinary Oncology at DFCI and Director of the Prostate Program and SPORE at DF/HCC; Dr. William Nelson, PhD — Director of the Johns Hopkins University Cancer Center and Director of the Prostate SPORE at Johns Hopkins University; Dr. Peter Nelson — Director of the Prostate SPORE at the University of Washington; Dr. Peter Scardino — Chairman of Surgery and Chief of Urology at Memorial Sloan Kettering Cancer Center and Director of the Prostate SPORE at Memorial Sloan Kettering Cancer Center; Dr. Jonathan Simons — President and Chief Executive Officer at PCF; Dr. Ken Pienta — Director of the Prostate SPORE at the University of Michigan; Dr. Donald Tindall, PhD — Director of the Prostate SPORE at The Mayo Clinic; Dr. Peter Carroll — Chief of Urology at the University of California at San Francisco and Director of the Prostate SPORE at the University of California at San Francisco; and a court-appointed member. See Dkt #562, App. F.

After careful deliberation, the court has decided to award the cy pres funds to the DF/HCC and PCF partnership, pursuant to the terms of the proposal submitted on May 20, 2010, with modifications as noted. The court's decision is influenced principally by the following considerations. DF/HCC and PCF are established non-profit organizations, each with experience in managing grant programs. Proposal B leverages existing institutional infrastructure, funding mechanisms, and the relationships established by DF/HCC and PCF, with a corresponding reduction of start-up and administrative costs. Proposal B also promises a broad national outreach to attract large-scale research collaborations, innovative pilot projects, promising young investigators, and talented graduate students. Proposal B further recognizes that not all members of the class are prostate cancer victims and proposes to dedicate an appropriate portion of the funds to research involving cures for other Lupron(r)-treated diseases and conditions, such as precocious puberty.

The court looks favorably on the fact that the grant proposals will be vetted and supervised by committees whose members will be drawn from a nationwide pool of medical talent. I am also impressed by the fact that these members, including those on the proposed Oversight Board, have agreed to serve pro bono. Finally, Proposal B speaks directly to the court's desire that a significant percentage of the funds be spent on research of a high-risk nature that might not otherwise attract funding from traditional sources.

The members of the DF/HCC and PCF review committees represent the areas of surgical urologic oncology; medical oncology and treatment sciences; immunotherapy; radiation oncology; genomics; gynecology and reproductive medicine; nutrition research; molecular imaging; and molecular pathology. Collectively, they are based at forty-five institutions throughout the United States.

None of these considerations is intended as a criticism of Proposal A. The court had the luxury of choosing between two well thought out alternatives. It simply believes that Proposal B best matches the aspirations of the underlying class action.

ORDER

For the foregoing reasons, the court awards the unclaimed funds from the Lupron(r) Class Settlement Pool to DF/HCC and PCF to be distributed according to the terms of the proposal submitted to the court on May 20, 2010, attached as Appendix A. The court also orders as follows.

(1) The funds are to be maintained and paid out of a single account to be known as the Settlement Pool Account. The court appoints Dr. Philip W. Kantoff as the individual responsible for the day-to-day management of the award program and all fund expenditures.

(2) DF/HCC and PCF are to submit an annual report on the anniversary of this Order detailing all Settlement Pool Account activity. The report is to include a summary of program awards, grantees' progress, and a summary of all expenditures, including administrative costs.

(3) DF/HCC and PCF will provide the court with interim six-month reports setting out a brief description of Settlement Pool Account activity and award-related activity.

(4) The funds will be paid by the Clerk in one-third installments as individually authorized by the court, the second and third installments subject to the court's review of the annual and semi-annual accountings.

(5) The court hereby appoints Dr. Jonathan L. Tilly as its representative on the Oversight Board. Dr. Tilly will serve as a full member of the Oversight Board in all respects, and will report to the court as directed.

Dr. Tilly is the Chief of the Division of Research at the Vincent Center for Reproductive Biology at Massachusetts General Hospital and Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School. Dr. Tilly has served as a special law clerk to the court. The undersigned judge is also the Chair of the Trustee Committee at Vincent Memorial Hospital (MGH) that oversees the work of the Vincent Center. Dr. Tilly has volunteered his services pro bono.

(6) The court reserves the right to nominate a patient advocate to the DF/HCC Prostate Cancer Program and SPORE Governance Committee. See Dkt #562. UNITED STATE DISTRICT COURT DISTRICT OF MASSACHUSETTS ___________________________________ ) IN RE: LUPRON(r) MARKETING AND ) MDL NO. 1430 SALES PRACTICES LITIGATION ) __________________________________) ) MASTER FILE NO. 01-CV-10861-RGS THIS DOCUMENT RELATES TO ALL ) ACTIONS ) Hon. Richard G. Stearns __________________________________)

Proposal for Disposition of Money Remaining in the Consumer Settlement Pool from Lupron Marketing and Sales Practices Litigation

Submitted by: Dana-Farber/Harvard Cancer Center in collaboration with the Prostate Cancer Foundation

Summary

This proposal describes a plan for the distribution of approximately $11.4M that remains in a Lupron litigation-derived consumer settlement pool. Through this plan, Dana-Farber/Harvard Cancer Center (DF/HCC) and the Prostate Cancer Foundation (PCF) will join forces to create a series of research awards that address a range of needs in prostate cancer and Lupron-treatable disease research. Ninety percent of these funds will be apportioned directly for research use, and ten percent of funds will be used to support research infrastructure and administration. DF/HCC and PCF will each administer one half of the research funds through competitive grant programs that are in place at each organization. DF/HCC will oversee the design and implementation of seven DF/HCC award categories, which are in large part intended to catalyze collaborative research at a national level. PCF will oversee the design and implementation of a single category of awards, eligible to teams of researchers on a national and international level, which are intended to address and overcome significant problems in the field of prostate cancer. Applications to each organization will be selected for funding through established review committees and procedures. An additional committee, comprised of national leaders in prostate cancer research, will provide oversight of granting activities and of stewardship of the settlement pool funds, and representative members therein will also participate in the review process itself.

Background

The major purpose of the drug leuprolide acetate, or Lupron, is to treat patients with prostate cancer. It is effective in prolonging survival in men with advanced prostate cancer, in palliating their symptoms, and in curing patients with localized or locally advanced prostate cancer. In addition to its use as a prostate cancer drug, Lupron may be used in the treatment of conditions such as endometriosis, uterine fibroids, and/or central precocious puberty.

Of the conditions cited above, prostate cancer is the most urgent public health challenge: one in six men will be diagnosed with this disease in their lifetime, and approximately 27,000 deaths resulted from prostate cancer in the U.S. in 2009, posing significant treatment and management challenges for both doctors and patients. While many patients may be cured either with surgery or with radiation, with or without hormonal therapies such as Lupron, about 20 to 30% of patients who receive treatment will have recurrences wherein the tumor metastasizes. For such patients, no curative therapies are available. Moreover, the side effects of Lupron are substantial and are being increasingly appreciated.

DF/HCC and PCF have each designed and implemented distinct and effective strategies to address the problems posed by prostate cancer. Specifically, at DF/HCC, the mission of the Prostate Cancer Program and National Cancer Institute sponsored "Specialized Program of Research Excellence" (SPORE) is to encourage and promote collaborative and translational research that will lead to new approaches to the prevention, diagnosis, and treatment of prostate cancer. The mission of PCF is to end death and suffering from prostate cancer, by funding research that will hasten the development of a cure for prostate cancer.

These complementary visions have on occasion led to targeted collaborations between DF/HCC and PCF. Accordingly, leadership at DF/HCC and PCF respectfully submit below a joint plan for the disbursement of funds made available through the consumer settlement pool resulting from Lupron marketing and sales practices litigation.

Introduction

Through this proposal, we seek to leverage the existing institutional infrastructure, funding mechanisms and relationships of DF/HCC and PCF to distribute settlement funds annually, on a competitive basis, nationally and locally, to support large scale research collaborations in prostate cancer research, cutting-edge pilot projects, develop promising young investigators, and train talented graduate students. For additional information about DF/HCC, PCF, and programs and initiatives that are funded by these organizations, refer to Appendix A. For a record of past grants and awards made by DF/HCC and PCF, refer to Appendices B and C, respectively.

The central and overarching goal of our jointly proposed program is to directly impact the treatment of prostate cancer and other Lupron-treatable diseases and conditions. Specifically, our program goals include the following objectives: • To direct leftover Settlement Pool funds from Lupron litigation to prostate cancer and other Lupron-treatable disease research initiatives of merit. • To distribute Settlement Pool funds to prostate cancer and other Lupron-treatable disease researchers at the national and local level, and to spur collaborative prostate cancer and Lupron-treatable disease research. • To distribute Settlement Pool funds through existing organizational channels that have an established record of successful grant distributions (i.e., which have advanced the state of knowledge in the grants' stated areas of research). • To increase the power and breadth of prostate cancer and other Lupron-related disease research, by (i) the strategic administration of new and existing funding mechanisms; (ii) expanding current avenues of investigation; (iii) recruiting new talent into the field; and (iv) ensuring research relevance to the primary goals advancing diagnostic, treatment, and quality of life options for patients with prostate cancer and other Lupron-treatable diseases.

Description of Award Program Grant solicitation protocol and structure of grant program:

Grant applications will be solicited by two separate organizations, DF/HCC, and PCF. DF/HCC will solicit several categories of grant applications from the faculty of Harvard University and its affiliated hospitals; many of these grants will encourage extramural collaborations. Additional categories of grant applications will be solicited from faculty and students at colleges, universities and hospitals throughout Massachusetts. PCF will solicit grant applications from interested applicants on a national basis.

Specifically, DF/HCC will create High Impact research grants, Lupron-Treatable Disease research grants, Community Outreach grants, and Student Education grants, and will add to the number of Career Development grants, Project Development grants and Disparity Research grants that it presently awards on an annual basis. PCF will add to the number of Challenge grants that it awards on an annual basis. See Appendix D for a description of each category of award that will be made possible through Settlement Pool funds.

DF/HCC and PCF will solicit applications on a yearly basis leveraging existing infrastructure. DF/HCC will utilize the Prostate Cancer Program and SPORE to solicit applications from the Harvard University-wide applicant pool and PCF will issue request-for-proposals (RFPs) through well established channels to solicit applications from a national applicant pool.

Average amount and duration of program awards:

Amount Duration # DF/HCC High Impact Award: $500K 2 years 5 DF/HCC Project Development Award: $100K 2 years 9 DF/HCC Career Development Award: $100K 2 years 6 DF/HCC Lupron-treatable Disease Award: $100K 2 years 3 DF/HCC Student Training Award: $20K 2 years 8 DF/HCC Disparity Research Award: $100K 2 years 5 DF/HCC Community Outreach Award: $100K 2 years 4 PCF Challenge Grants: $1,000K 2 years 5

Please refer to Appendix E for a complete budget of grant expenditures. Eligibility requirements for potential recipients:

DF/HCC High Impact Collaboration Award: Applicants must be on the faculty at Harvard University at the level of Assistant Professor or higher. Applications including investigators from more than one DF/HCC member institution will be encouraged. Applicants are also encouraged to have collaborators at other institutions throughout the country. Such collaborations will be viewed as important criteria for merit in the review process.

DF/HCC Project Development Award: Applicants must be on the faculty at Harvard University at the level of Instructor or higher. Applicants are encouraged to have collaborators at other institutions throughout the country. Such collaborations will be viewed as important criteria for merit in the review process.

DF/HCC Career Development Award: Applicants must be in their final year of clinical or postdoctoral fellowship or hold an academic appointment not higher than Assistant Professor at Harvard University.

DF/HCC Lupron-Treatable Disease Award: Applicants must be on the faculty at Harvard University, or any other accredited Massachusetts university, at the level of Instructor or higher. Applicants are encouraged to have collaborators at other institutions throughout the country. Such collaborations will be viewed as important criteria for merit in the review process.

DF/HCC Student Training Award: Applicants must be students in nursing, medical, or Ph.D. programs at any accredited university within Massachusetts.

DF/HCC Disparity Research Award: Applicants must be on the faculty at Harvard University at the level of Instructor or higher. Applications that include a partnership with University of Massachusetts Boston faculty, in support of the DF/HCC's U56 cancer center-minority serving institution partnership grant are encouraged.

DF/HCC Community Outreach Award: Applicants must be on the faculty at Harvard University at the level of Instructor or higher. Applications that include a partnership with University of Massachusetts Boston faculty, in support of the DF/HCC's U56 cancer center-minority serving institution partnership grant are encouraged.

PCF Challenge Award: Teams of at least three highly experienced investigators capable of providing unique scientific expertise to the solution of a significant problem in prostate cancer research. A team may be assembled from one institution, or from several institutions. Investigators representing non-profit academic research centers worldwide are eligible to apply. Investigators from for-profit companies and government-sponsored institutions, i.e., NIH, are ineligible.

Advertisement of grant opportunities:

DF/HCC will advertise RFPs through the DF/HCC website, the Harvard University and Harvard Medical School website, the Harvard Request for Proposal process, standardized communication to grant administration offices, and email distribution lists. To encourage collaborations at a national level, RFPs will also be distributed to the members of an oversight committee who are leaders in prostate cancer research at their respective institutions, which are deemed by the National Cancer Institute to be centers of excellence by their designation as SPORE sites (refer to "Oversight SAB" description below).

To solicit grant applications from a Massachusetts-wide applicant pool, DF/HCC will advertise RFPs through the channels mentioned above, and will communicate directly with grants administration offices at major hospitals and universities in Massachusetts about these grant opportunities.

To solicit grant applications from a national and international applicant pool, PCF will advertise RFPs through its website, email distribution lists, marketing activities and public relations efforts.

The division of research grants between the investigation of prostate cancer and other Lupron-treated conditions:

In addition to its use as a prostate cancer treatment, Lupron may be used in the treatment of endometriosis, uterine fibroids, or a condition known as central precocious puberty. Endometriosis and uterine fibroids are unusually common in women — although estimates vary, certain reports place the prevalence of endometriosis at 5%, and estimate that fibroids may be found in as many as 20% of women of reproductive age. Lupron is also commonly used to manage ovulation levels during in vitro fertilization treatments. The suitability of Lupron as a treatment for additional diseases, in particular estrogen-dependent diseases, may also be the subject of academic investigations.

$300,000 has been designated for awards for research involving diseases that are or may be treatable by Lupron, representing approximately 3% of total direct award funds.

Governance of Award Process Description of oversight committee:

DF/HCC and PCF will convene a high-level scientific advisory board (the "Oversight SAB") to participate in the application review process, and to ensure that Settlement Funds are distributed fairly, and in accordance with RFP guidelines and any other principles that are associated with such funds. The board will be comprised of the following individuals: Howard Soule PhD EVP and Chief Science Officer at PCF Philip Kantoff MD Director of the Lank Center for Genitourinary Oncology at DFCI, Director of the Prostate Program and SPORE at DF/HCC William Nelson, MD, PhD Director of the John Hopkins University Cancer Center Director of the Prostate SPORE at Johns Hopkins University Peter Nelson, MD Director of the Prostate SPORE at the University of Washington Peter Scardino, MD Chairman of Surgery and Chief of Urology at Memorial Sloan Kettering Cancer Center, Director of the Prostate SPORE at Memorial Sloan Kettering Cancer Center Jonathan Simons, MD President and Chief Executive Officer at PCF Ken Pienta, MD Director of the Prostate SPORE at the University of Michigan Donald Tindall, PhD Director of the Prostate SPORE at Mayo Clinic Peter Carroll, MD Chief of Urology at University of California at San Francisco, Director of the Prostate SPORE at University of California at San Francisco Court Appointed Member TBD In addition to their leadership roles in prostate cancer research and medicine, these committee members bring with them expertise in fields such as urologic oncology, medical oncology, and basic science.

Oversight SAB members will not be compensated financially for their involvement in the Settlement Pool funds awards program. Please see Appendix F for a full description of the Oversight SAB responsibilities.

Description of governing bodies involved in award review and selection:

At DF/HCC, applications will be reviewed by members of the DF/HCC Prostate Cancer Program and SPORE Governance Committee, and by at least two non-DF/HCC members of the Oversight SAB, who will likely serve in this capacity on a rotating basis. The DF/HCC Prostate Cancer Program and SPORE Governance Committee is comprised of approximately ten Harvard faculty members representing Harvard Medical School and its affiliated institutions, and one to two patient advocates. The faculty members were chosen on the basis of their accomplishments, broad vision, impartiality, and diverse expertise. They have expertise and training in one or more of the following disciplines: medical oncology, urologic oncology, radiation oncology, population science, and basic science. The patient advocate(s) were asked to participate based on their expressed interest in patient advocacy. The prospective members of the 2010 Settlement Pool Review Committee are listed on Appendix G.

At PCF, applications will be reviewed by a subset of an established review committee comprised of seventy nine members with expertise spanning at least ten major disciplines, including medical oncology, surgical urologic oncology, immunotherapy, genomics, basic science, radiation oncology, nutrition research, molecular imaging, molecular pathology and statistics. At least two non-PCF members of the Oversight SAB will also participate in this review process, on a rotating basis. The members of the 2010-2011 review committee are listed on Appendix H.

Neither the DF/HCC review team members nor the PCF review team members will be compensated financially for their involvement in the Settlement Pool funds awards program.

Description of application review and grantee selection:

The process for selection of grantees at DF/HCC and PCF will be substantively similar. At DF/HCC, all applications submitted for each Settlement Pool award opportunity will be sent to each member of the review committee. Each application slated for review must have at least two assigned reviewers with expertise in the relevant application area. In the case of the Lupron-treatable disease awards, prominent researchers from related fields such as reproductive medicine will be recruited to temporarily sit on the review committee. At PCF, each application will be sent to three reviewers, who will be selected from a seventy-nine member board by matching areas of expertise to the scientific content of the proposal. At both organizations, if a reviewer has a real or perceived conflict of interest in the outcome of a particular application, he or she will be required to abstain from reviewing that application. Each reviewer will be asked to provide a brief written evaluation of each application. Evaluations should highlight the application's strengths and weaknesses, the track record of the applicant(s) and the project's potential impact to the field of prostate cancer. Each application will then be discussed, voted on, and ranked. The application(s) with the highest rank per award will be selected. At DF/HCC, the patient advocate(s) may not review applications per se, but they attend review meetings, participate in the proposal discussion, and lend perspective to the reviewer evaluations before voting and ranking takes place.

Avoidance of real or perceived conflict of interest in the awarding of grants:

At DF/HCC, in the event that an application is submitted by a governance committee member, an individual, under his or her supervision, or anyone who may confer a real or perceived bias to a member's judgment abilities, the committee member in question will recuse himself or herself from the discussions and abstain from voting. At PCF, to avoid real or perceived bias in the selection of grant applications, scientific reviewers will not be allowed to review or vote on proposals that are submitted by applicants at their employing institution.

Court involvement in award process:

The court appointed board member(s) will be included in all governance committee and scientific review board communique's from both DF/HCC and PCF, concerning the review, selection and monitoring of the subject awards, and will be invited to any physical meetings or conferences that involve the review, selection and/or monitoring of awards.

In addition, Judge Stearns, or any judge he so designates, will be subject to the same consideration, or aspects thereof, upon request.

Administrative Expenses Involved in Selecting and Monitoring Grants:

In total, 10% of Settlement Pool funds will be allocated to indirect institutional costs (IDC). All remaining Settlement Pool funds will be used directly by grantees for research purposes.

Description of "indirect institutional costs" and the basis for a 10% administration fee allocation:

To solicit, review, select and monitor grants, we will leverage existing DF/HCC and PCF infrastructure, including facilities, personnel, and equipment. To help support such infrastructure, 10% of Settlement Pool funds will be allocated to a general, institute-wide, "IDC pool" that is administered by DF/HCC. IDC are research related expenses that are incurred to pay for common objectives and infrastructure, and which are difficult to assign to a particular project in a clear and consistent manner. For example, administrative expenses, grants management costs, and facilities operation and maintenance expenses are all cost categories that are attributable to IDC. For a more detailed background and description of IDC, please see Appendix I.

Although it is DF/HCC's policy to apportion 20% of all non-federal programmatic gifts and grants toward IDC, we petitioned DF/HCC executive management to grant an exception to these conventional rate practices for the administration of the Settlement Pool funds. Two major factors were taken into consideration in requesting a new IDC rate: • It is likely that only one half the total funds, at maximum, will draw upon DF/HCC's research infrastructure, because: (i) 50% of the funds will be directed to PCF; and (ii) several of the DF/HCC research awards emphasize collaboration with outside institutions. • The program manager position overseeing the administration of the total Settlement Pool funds will sit at DF/HCC. DF/HCC executive management agreed that it will be acceptable to apportion 10%, or $1,140,000, of the total Settlement Pool funds to IDC, in the event that these funds are made available to DF/HCC and PCF. As PCF does not house research infrastructure it will not collect any IDC from its portion of these funds. Thus, the remainder of the funds, $10,000,000 will be designated in its entirety for research use.

Restrictions placed on overhead expenses paid to grantee institutions:

Both DF/HCC and PCF will require that no award money be directed to overhead expenses at grantee institutions. Therefore, the Settlement Pool funds would be subject to IDC at only one point in the overall award process, i.e., upon receipt of funds by DF/HCC.

Stipends or any other compensation paid to persons involved in the grant award process:

A DF/HCC program manager will be appointed to administer the Settlement Pool program. We envision that the administration of this program will require at least half time job effort, and most likely closer to full time effort. Program manager salaries are commensurate with experience: half time managers are paid approximately $40,000 per year, and full time managers are paid approximately $70,000 per year, not including benefits. Compensation for this position will be paid for by DF/HCC administration (please see IDC description in Appendix I). As such, this position will not be paid for through the Settlement Pool funds designated for direct research use.

All other people involved in the administration of the Settlement Pool funds will be involved on a pro bono basis. For example, no stipends or compensation from this fund will be paid to other members of DF/HCC or the DF/HCC Governance Committee, to members of PCF or the PCF scientific review board, or to the Oversight SAB.

Grant Management Overview: Lupron Settlement Pool program management:

A DF/HCC program manager will manage the Settlement Pool program on a day-to-day basis at DF/HCC, under the direction of Philip Kantoff, MD, Director of the Prostate Cancer Program and SPORE at DF/HCC. The program manager will also coordinate and liaison with the PCF award program. The DF/HCC program manager's responsibilities are described in more detail in Appendix J. Howard Soule, PhD, EVP and Chief Science Officer at PCF, will manage the Settlement Pool program at PCF.

Settlement Pool funds will initially be deposited into an account at DF/HCC established exclusively for the management of the funds ("Settlement Pool Account"). The Settlement Pool Account will be managed under the direction of Dr. Kantoff. No other monies will be deposited in this account. After the funds are subjected to a one-time 10% indirect cost allocation, 50% of the funds will be subcontracted to PCF.

Upon receipt of funds, the Oversight SAB and the two review committees will be notified of the commencement of the award program, and select program RFPs will be drafted, approved and advertised. After grant applications are submitted to each organization, the respective review committees will review, evaluate and score proposals. Proposals will then be ranked and those with the highest ranks will be selected for funding, with approval of the Oversight SAB. The timing of the DF/HCC awards program will be linked to the existing SPORE program, in which RFPs are released annually in July and awards are made in November. At PCF, the first series of grants will be made within six months of the award program launch. Progress and financial reports will be expected from grantees at the end of year one, and second year grant payments will be made with approval of the respective board chairs and the Oversight SAB. Final progress and financial expenditure reports will be expected at the end of the award term. An anticipated timeline of these activities is presented in Figure 1. For a more detailed description of DF/HCC's existing program management infrastructure, see Appendix K. For a more detailed description of PCF's program management activities, see Appendix L.

The court appointed board member(s), and, as requested, Judge Stearns, will be included in all governance committee and scientific review board correspondences, and will be invited to any face to face meetings or conferences that involve award governance and/or grantee presentations. Yearly reports on Settlement Pool Account financial activity will be submitted to the court designee and to Judge Stearns.

Graph

The time-frame for the expenditure of funds:

The maximum grant period will be two years, however, grant-making will be staggered over five years. A final accounting will thus be achievable within seven years from the start of the distribution of Settlement Pool funds.

Mechanism by which grant funds will be paid out and accounted for:

All grant funds will be paid to grantees in yearly installments. Annual progress reports will be required from grantees, and will include detailed narrative updates and expenditure reports. The issuance of each year's funding installment will be contingent upon satisfactory progress by grantees.

Procedures followed in evaluating the progress of the funded research:

Progress will be measured through the submission of annual reports to DF/HCC or PCF, by the publication of research in academic journals, and if relevant, by progress in clinical trial activity. Generally, progress that approximately meets benchmarks, timelines, or specific aims that are set forth within corresponding proposals will be funded on a per year basis to the completion of the grant term. Unanticipated scientific findings that delay research timelines will not exclude grantees from continued funding so long as grantee research is of a high caliber and is within the scope of the original research proposal.

Description of research award accounting:

For each award, to ensure that Settlement Pool funds are used in accordance with award intent, a research budget will be required as a component of the initial proposal and will form part of the basis of the reviewer evaluations, Financial expenditure reports will be required as part of progress reporting and will be reviewed by the Oversight SAB on a yearly basis. Awardees who do not fully spend funds by the end of the stated award term must receive special permission to extend the award term.

Provisions for the disposition of any possible intellectual property issues arising from the funded research:

Inventions and other intellectual works that arise from research funded by the Settlement Pool will be managed according to the policies and practices of the grantee's employing institution. In accordance with federal guidelines and regulations, it is expected that most if not all grantee institutions have an affirmative obligation to develop and commercialize inventions toward the public benefit (see Appendix M for information about university obligations under the Bayh-Dole Act). DF/HCC and PCF will not expect any remuneration from royalty streams associated with income from patents, copyrights or other intellectual property.

National Impact of Award Distribution Rationale for DF/HCC-PCF partnership:

Ultimately, we aim to improve the length and quality of life for patients with cancer and Lupron-treatable diseases, as efficiently as possible, through the allocation of Settlement Pool money. We believe that a research award program administered cooperatively by DF/HCC and PCF is an ideal vehicle to achieve this aim, in part by galvanizing creative, ambitious research plans that would otherwise not be undertaken. In the proposed partnership between DF/HCC and PCF we recommend that the distribution of the total direct research awards be split by DF/HCC and PCF for several key reasons:

1. PCF and DF/HCC have complementary strengths: PCF is primarily an award granting institution, and DF/HCC is first and foremost a research organization, which has a built-in grant-making capability. In granting awards, PCF specializes in a venture capital model of philanthropic investing, by providing initial funding for high-impact, and often early-stage, high-risk research projects that offer hope for new treatments. Results from these projects can then be leveraged to compete for grants from more traditional funding sources such as the National Cancer Institute or the pharmaceutical industry. DF/HCC specializes in promoting collaborative interactions and linkages between scientists across disciplines and in encouraging translational research to generate new approaches to cancer diagnosis and care. DF/HCC's focus on translational research, which refers to clinical research that incorporates laboratory generated endpoints, and conversely, laboratory research that incorporates clinical materials, encompasses all stages of research, and uniquely emphasizes research that is translatable to clinical care in the near term. Thus, an equal balance of PCF and DF/HCC grants is likely to address a full "bench-to-bedside" spectrum of innovative, high impact research projects.

2. Award funds will reach a large number of researchers: Prostate cancer researchers from across the country and globe will be eligible to apply for the Settlement Pool funds to be administered by PCF, which represents 50% percent, or $5M of the Settlement Pool research awards. Additionally, applicants to the DF/HCC High Impact, Project Development, and Lupron-Treatable Disease Awards, which represent $3.7M of the Settlement Pool funds, will be expressly encouraged to collaborate with researchers from any institution nation-wide. We believe this emphasis will have the important effect of creating additional potential collaborations where none have previously existed. The opportunity to directly compete for DF/HCC-administered awards extends well beyond the DF/HCC community: Five of the seven proposed DF/HCC grants are open to all Harvard University affiliated faculty (see Appendix N), and the remaining grants are open to eligible applicants from any accredited Massachusetts university. DF/HCC itself is comprised of over 1,100 faculty members. The distribution of all DF/HCC grants will be guided by the core mission of DF/HCC — collaboration.

3. Emphasis on public benefit: Our strong institutional emphasis on conducting research for the public benefit will increase the potential for the Settlement Pool funds to impact prostate cancer and Lupron-treatable disease patients in a positive and timely manner. For example, the freedom to publish data is a central tenet of Harvard policy, and as such, ensures that results from DF/HCC-sponsored research are likely to enter the public domain very rapidly, through publication in peer-reviewed journals and conference presentations among other mechanisms. Accordingly, research conducted through the distribution of the proposed DF/HCC Settlement Pool awards will be able to be accessed, reviewed, verified and added to by third party researchers nationally and internationally. In a similar vein, Harvard and its affiliated hospitals are obligated under government and university regulations and guidelines to steward new innovations and inventions toward the public benefit. Notably, a fundamental aspect of DF/HCC's mission is to train the next generation of physician researchers. Training awards are a key means of accomplishing this objective. It is anticipated that many recipients of training awards will move to other institutions, and as such these awards will aid in the development of new investigators nation-wide and at times world wide.

Thus, DF/HCC's expertise in patient-oriented research is complemented by PCF's expertise in early stage seed grants, and these programs together will engender high caliber research, training and outreach projects that address a continuum of prostate cancer and Lupron-treatable disease research needs. A wide variety of laboratory, clinical and translational researchers will be eligible to compete for these funds. Our expectation that innovation and publication will be key aspects of awardee work product ensures that researchers and patients, nationally and internationally, will be beneficiaries of the research made possible through this awards program.

APPENDIX A Description of DF/HCC and PCF Dana-Farber/Harvard Cancer Center

Dana-Farber Cancer Institute is the lead institution of Dana-Farber/Harvard Cancer Center (DF/HCC), whose member institutions include: Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Children's Hospital Boston, Harvard Medical School, Harvard School of Public Health, and Massachusetts General Hospital. Affiliate members hail from The Broad Institute at MIT. DF/HCC is the largest National Cancer Institute (NCI) designated Comprehensive Cancer Center in the country, consisting of over 1,100 Harvard faculty members. Founded in 1997, DF/HCC is a multi-institutional research enterprise that unites all of the cancer research efforts of the Harvard-affiliated community. The primary goal of DF/HCC is to encourage and promote collaborative interactions and translational research that will lead to new approaches to cancer prevention, diagnosis, and treatment.

DF/HCC Prostate SPORE

In 1992, the National Cancer Institute (NCI) inaugurated a funding mechanism called the Specialized Programs of Research Excellence (SPORE) to promote translational research by embracing the collaboration of basic and clinical sciences with a goal of moving basic research discoveries from the laboratory to the clinical setting. By providing this research funding, the SPORE will focus on developing novel ideas that have the potential to reduce cancer incidence and mortality, to increase survival, and to improve quality of life. The hallmark of the SPORE is in the collaboration between laboratory and clinical scientists in planning, designing, and implementing research projects that impact cancer prevention, detection, diagnosis, treatment, and control. The SPORE's program funds scientists from both within and outside of DF/HCC member institutions to increase the translational research base. SPOREs meet annually to share data, assess research progress, identify new research opportunities, and establish priorities for research most likely to reduce incidence and mortality and to increase cancer survival.

The DF/HCC SPORE in prostate cancer (Prostate SPORE) is focused on a wide range of initiatives. The Prostate SPORE has acted as a focal point for translational activities among prostate cancer researchers. Since its inception in 2001, the Prostate SPORE has achieved numerous accomplishments that are reflective of its goals: to understand genetic factors involved in risk in order to construct rational prevention strategies; to assign treatment in a more rational fashion, by the stratification of patients using molecular means; to reduce treatment-related side effects; and to improve therapy for patients with advanced disease. Among the numerous research projects funded are studies to improve clinical decision-making about initiating hormone therapy for prostate cancer and preventing adverse effects in survivors, the use of gene expression patterns to discover genes and gene products linked to tumor development and progression, and the identification of molecular markers that can serve as prognostic indicators of prostate cancer.

DF/HCC Community Outreach and Disparities Initiatives

A key center initiative is the Initiative to Eliminate Health Disparities (IECD) with one primary goal — to eliminate racial, ethnic, and socioeconomic disparities in cancer care and prevention. DF/HCC faculty conducts original research to understand the causes of cancer disparities and to devise solutions. DF/HCC also facilitates the access of underserved populations to state-of-the-art clinical trials and the delivery of culturally competent care in an effort to reduce disparities in cancer care.

Started in 2003, the mission of the UMass Boston-DF/HCC Comprehensive Cancer Partnership Program is to address health disparities in minority populations, and to improve research, training, and outreach initiatives for minority students, fellows, nurses, and scientists. The Program focuses on accomplishing this by focusing on three areas: collaborative cancer research, shared cancer training efforts, and cancer outreach. Goals include: Develop interdisciplinary programs of collaborative research that stimulate basic cancer research at UMB and health disparities research at both UMB and DF/HCC; Increase and enhance cancer-focused training opportunities for minority students, postdoctoral fellows and nursing PhD students; Increase community outreach, cancer education, and dissemination of evidenced-based programs; and Develop shared mechanisms for minority faculty recruitment and career development. The Program offers developmental funding for collaborative projects between UMB and DF/HCC that focus on any aspect of cancer, including cancer disparities. The Program also funds the development of collaborative projects in community outreach, cancer education, and dissemination of evidenced-based programs.

The Blum Family Resource Center Van provides cancer education and screening throughout the region, including local Boston neighborhoods. The Blum Van is equipped with state-of-the-art technology and was designed to accommodate space for individual or small group needs. The following is a selected list of initiatives that took place on the Blum Van in 2008: Prostate Cancer Education and Screening Program: Prostate cancer is the second leading cause of cancer deaths in African American men and is the most frequently diagnosed cancer in the US. The death rate from prostate cancer remains approximately 2.4 times higher in African American men than in white men here in the US. A total of 35 prostate cancer education and/or screening events were held this past year (with half taking place on the van) where 240 men were educated; 211 were screened; and 9 required follow-up for prostate cancer.

The Continuing Umbrella of Research Experiences (CURE) program is a DF/HCC endeavor that seeks to prepare high school and college students from underrepresented populations across the country to enter the world of cancer research, by placing them in real research settings throughout the Harvard-affiliated cancer research community. Now in its eighth year of operation, the CURE program's overarching goal is to encourage minority students to pursue future careers in the biosciences — particularly cancer research — giving practical meaning to academic course work. By participating in this program at DF/HCC, students learn from experts who are devoted to preventing, treating and curing cancer. Each year, a number of promising students are selected for this unique opportunity to expand and extend their interest in basic, clinical and/or population science cancer research. The CURE program has a proven track record of success in striving to achieve these goals in that over 80% of students that have completed the program are currently employed in the biomedical field and/or are interested in pursuing these careers; and; over 88% of graduating CURE students are enrolled in or plan to pursue graduate degrees (including M.D. and Ph.D.) in biomedical and/or cancer-related fields.

Prostate Cancer Foundation

The Prostate Cancer Foundation (PCF) was founded in 1993 to find better treatments and a cure for prostate cancer. Through its unique model for soliciting and selecting promising research programs and rapid deployment of resources, PCF has funded more than 1,500 programs at nearly 200 research centers in 20 countries around the world. As the world's leading philanthropic organization for funding prostate-cancer research, PCF is now a foundation without borders. Its advocacy for increased government and private support of prostate cancer programs has helped build a global research enterprise of nearly $10 billion. The Prostate Cancer Foundation's primary mission is to fund promising research into better treatments and a cure for prostate cancer. PCF has provided funding for more than 1,500 research projects at nearly 200 institutions worldwide. The Prostate Cancer Foundation is now the world's largest source of philanthropic support for prostate cancer research, including the discovery and early development of promising new treatments now in clinical trials, the development of gene therapy approaches to combat prostate cancer, and the development of vaccines that work with the body's immune system to kill prostate cancer cells. Each year, PCF reviews hundreds of applications from cancer researchers around the world and provides funding to those researchers working on the most promising projects. In addition, PCF hosts an annual scientific retreat that brings together the brightest minds in prostate cancer research in an effort to break down the traditional barriers that impede progress toward better treatments and a cure for prostate cancer.

APPENDIX B DF/HCC SPORE in Prostate Cancer Award History Career Development Program

2002 PI Institution Project Title Mentor Total Direct Ed Harlow, PhD Levi Garraway, MD, PhD DFCI/MGH A "Functional Proteomics" Study of William Sellers, $40,000 Hormone Independence in Prostate Cancer MD 2003 PI Institution Project Title Menter Total Direct Pradip Majumder, PhD DFCI Discover of Molecular Markers for Prostate William Sellers, $40,000 Cancer MD A Genomic Approach to Identifying David Altschuler, $40,000 Matthew Freedman, MD MGH Inherited Variation of the HPC 1 Locus in MD Sporadic Prostate Cancer Vijay Yajnik, MD MGH DOCK4 in Prostate Cancer Progression Daniel Haber, MD $40,000 Timothy Gilligan MD DFCI Prostate Cancer Screening in Decision Aid Philip Kantoff, MD $30,000 for African-American Men in Boston Identification of Anti-Tumor Agents that Thomas Roberts, $40,000 Jean Zhao, PhD DFCI Target the P13K Pathway in Genetically PhD Engineered Human Prostate Tumor Cells Bone Metabolism in Men with Advanced Matthew Smith, Dror Michelson, MD, PhD MGH Prostate Cancer: Effects of Disease and MD, PhD $30,000 Treatment Jacqueline Banyard, PhD Children's Analysis of Collagen XXIII Expression in Bruce Zetter, PhD $40,000 Human Prostate Cancer 2004 PI Institution Project Title Mentor Total Direct Lorelei Mucci, PhD BWH Developing a Composite Biomarker for Meir Stampfer, MD $40,000 Aggressive and Indolent Prostate Cancer 2005 PI Institution Project Title Mentor Total Direct The Role of Glycogen Synthase Kinase-3 in James DcCaprio, $40,000 Larisa Litovhick, MD, DFCI Cell Cycle Progression and Survival of MD PhD Prostate Cancer Cells William Sellers, $40,000 Rameen Beroukhim, MD, DFCI High-Resolution Genome-wide Mapping of MD PhD Structural Mutations in Prostate Cancer Matthew Meyerson, MD, PhD Shao-Yong Chen, Ph.D BIDMC Peptide-Prolyl Isomerase Pinl In Prostate Stephen P. Balk, $40,000 Cancer Development MD, PhD Sang Hyun Lee, Ph.D. DFCI The Significance of the Phosphoinositide 3- Thomas M. $40,000 Kinase (PI3Ks) in Prostate Cancer Roberts, PhD 2006 PI Inst. Project Title DIR IDC Award Total Award Award Hu, James BWH $60,000 $10,500 $70,500 Not Available Wang, Qianben DFCI $60,000 $42,000 $102,000 Not Available (NIH) 2007 DIR IDC Total Aware PI Institution Project Title Award Award Zhe Li, Ph.D. Children's Probing the mechanism of $40,000 $25,600 $65,600 Hospital / pathogenesis in prostate cancer Boston with TMPRSS2-ERG gene rearrangement using preclinical mouse models Simo Arredouani, Ph.D. BIDMC Targeting novel prostate tumor $38,000 $11,900 $49,900 M.Sc. antigens for cancer immunotherapy Mark Pomerantz, M.D. DFCI Functional analysis of the 8q24 $40,000 $28,400 $68,400 prostate cancer risk locus Xin Yuan, M.D., D.Sc. BIDMC SOX9 regulated tumor $40,000 $28,000 $68,000 angiogenesis in prostate cancer Michael Rothenberg, MGH Defining the function of $40,000 $7,000 $47,000 M.D., Ph.D TMPRSS2-ERG in prostate cancer cell growth and survival 2008 PI Inst. Project Title DIR IDC Total Award Award Award Jennifer R. Stark, Sc.D. BWH The patho-epidemiology of $40,000 $7,000 $47,000 proliferative inflammatory atrophy lesions Akash Patnaik, M.D., Ph.D BIDMC Obesity and prostate cancer $40,000 $28,000 $68,000

developmental projects program

2002 2003 pi(s) institution project title total direct william c. hahn, md, phd dfci discovery of novel prostate cancer therapeutics using $50,000 reverse and chemical genetics patrick hu, md, phd mgh identification and validation of novel drug targets in muneesh tewari, md, phd dfci the insulin-like growth factor-1 signaling pathway $50,000 using c. elegans andcrs m. naar, phd mgh the role of the androgen receptor in the development $50,000 and progression of prostate cancer aria f. olumi, md bidmc the role of anti-apoptotic factors in evasion of $50,000 prostate tumors from trail-induced apoptosis matthew r. smith., md, phd insulin resistance and cardiovascular disease risk david m. nathan, md mgh associated with androgen deprivation therapy for $50,000 prostate cancer towia libermann, phd bidmc deregulated il-6 gene expression in prostate cancer: $50,000 a target for therapeutic intervention 2004 pi(s) institution project title total direct christopher carpenter md bidmc the role of bmx in prostate cancer $40,000 developing a molecular signature of aggressive matthias hofer md bwh prostate cancer based on genomic aberration and $40,000 expression array analysis in a large patient cohort jon c. aster md bwh jaggedi in human prostate cancer $40,000 2005 pi(s) institution project title total direct a computer-based intervention to promote informed jennifer allen rn, mph, scd dfci decision making about prostate cancer screening $20,000 among african american men michael r. freeman, ph.d children's akt modifiers from cholesterol-rich membrane rafts $40,000 david a. frank, m.d., ph.d. dfci stat3 in pathogenesis and treatment of prostate $40,000 cancer omid c. farokhzad, md bwh development of a microreactor for engineering of $40,000 targeted nanoparticles for prostate cancer therapy psadt as an endpoint in clinical trials for men with meredith regan, scd dfci biochemical recurrence of prostate cancer following $20,000 local therapy matthew freedman, m.d. mgh a targeted genomic approach to identifying genetic $40,000 determinants of prostate cancer aggressiveness 2006 pi institution project title dir idc total award award award mucci, lorelei bwh not available $60,000 $42,000 $102,000 (nih) balk, steven bidmc not available $60,000 $42,000 $102,000 (nih) libermann, towia bidmc not available $60,000 $28,400 $88,400 depinho ronald dfci not available $60,000 $42,000 $102,000 (nih) 2007 pi institution project title dir idc total award award award william hahn, m.d., ph.d. dfci credentialing kinases that drive $40,000 $28,400 $68,400 hormone manipulation-refractory prostate cancer lorelei a. mucci, scd bwh genetic variation and the $40,000 $30,000 $70,000 tmprss2:erg fusion in prostate pathogenesis and progression steven p. balk, m.d., bidmc targeting non-receptor tyrosine $40000 $7000 $47000 ph.d. kinase bmx/etk in prostate cancer 2008 pi institution project title dir idc total award award award x. shirley liu, ph.d. dfci epigenetic signature of hormone $40,000 $28,400 $68,400 independent prostate cancer meir stampfer, m.d. dr ph bwh dietary phytoestrogens in relation $40,000 $7,000 $47,000 to prostate cancer risk and survival

APPENDIX C Prostate Cancer Foundation Award History

Research Awards by the Prostate Cancer Foundation 1993-2009 Albert Einstein College of Medicine $75,000 Ardono Research $125,000 Assaf Harofeh Medical Center $200,000 Bar-Ilan University $225,000 Baylor College of Medicine $2,200,000 Baylor Institute for Immunology Research $300,000 Ben-Gurion University of the Negev $300,000 Ben May Institute $125,000 Boston University $25,000 Brandies University $250,000 Broad Institute of Harvard and MIT $2,994,000 British Columbia Cancer Agency $300,000 California Institute of Technology $450,000 Cancer Institute of New Jersey $75,000 Cantonal Hospital St. Gall $75,000 Carmel Medical Center $75,000 Case Western Reserve University $425,000 Cedars-Sinai Medical Center $2,648,000 Center for Prostate Cancer Disease Research $200,000 Cleveland Clinic $717,000 Cold Spring Harbor $100,000 Columbia University $2,507,000 Cornell University $3,191,000 Weill Medical College $3,091,000 Duke University $2,225,000 Eastern Virginia Medical School $150,000 Emory University $2,125,000 Erasmus University $250,000 Fox Chase Cancer Center $150,000 Fred C. Hutchinson Cancer Research Center $5,257,000 Garvan Institute of Medical Research $50,000 Gerogetown University $100,000 GMP Genetics $100,000 Hadassah University Hospital $535,000 Harvard University $31,126,000 School of Public Health $465,000 Beth Israel Deaconess Medical Center $4,639,000 Brigham Women's Hospital $8,065,000 Children's Hospital Boston $1,125,000 Dana-Farber Cancer Institute $8,790,000 Massachusetts General Hospital $8,042,000 Hebrew University $1,267,000 Henry Ford Health System $100,000 Indiana University $375,000 Innsbruck Medical University $175,000 Institute for Systems Biology $2,023,000 John Wayne Cancer Institute $200,000 Johns Hopkins University $22,753,000 Justus Liebig University $1,175,000 Karolinska Institute $10,000 La Jolla Institute for Allergy and Immunology $25,000 Lankenau Institute for Medical Research $50,000 Long Island College Hospital $25,000 Louisiana State University, Shreveport $50,000 Massachusetts Institute of Technology $1,460,000 Mayo Clinic $400,000 McGill University $551,000 Medical University of South Carolina $263,000 Memorial Sloan Kettering Cancer Center $21,693,000 Menzies Centre for Population Health Research $1,000,000 Mount Sinai School of Medicine $250,000 National Cancer Institute $425,000 New England Medical Center $230,000 New York Medical College $250,000 New York University $505,000 Northern California Institute of Research and Education $100,000 Northwestern University $1,328,000 Ohio State University $922,000 Oregon Health Science University $300,000 Pacific Northwest Cancer Foundation $475,000 Prostate Centre in Vancouver $4,025,912 Providence Portland Medical Center $425,000 Rockfeller University $300,000 Roger Williams Medical Center $300,000 Roswell Park Cancer Institute $1,475,000 The Royal Marsden $225,000 St. Louis University $150,000 Salk Institute for Biological Studies $986,000 San Diego Cancer Resaerch Institute $150,000 Scripps Clinic $175,000 Scripps Research Institute $975,000 Sheba Medical Center $200,000 Sidney Kimmel Cancer Center (San Diego) $150,000 Stanford University $1,615,000 State University of New York $250,000 Stony Brook $150,000 Upstate Medical University $100,000 Strang Cancer Prevention Center $250,000 Technion $675,000 Tel Aviv University $598,000 Temple University $33,000 TGen $1,000,000 The Burnham Institute $1,506,000 The Ordway Research Institute $175,000 Thomas Jefferson University $125,000 Translational Genomics Research Institute $400,000 Tulane University $500,000 University Hospital, Nijmegen $275,000 University of Alabama at Birmingham $200,000 University of Arizona $150,000 Unveristy of Basel $75,000 University of Bern $100,000 University of British Columbia $375,000 University of Calgary $225,000 University of California $33,866,000 University of California, Berkeley $400,000 Lawrence Livermore National Laboratory $175,000 University of California, Davis $589,000 University of California, Irvine $150,000 University of California, Los Angeles $14,345,000 University of California, Riverside $100,000 University of California, San Diego $7,475,000 University of California, San Francisco $10,632,000 University of Chicago $625,000 University of Colorado $527,000 University of Connecticut $195,000 University of Edinburgh $75,000 University of Fukui $100,000 University of Helsinki $200,000 University of Illinois $250,000 University of Iowa $575,000 University of Kentucky $200,000 University of Louisville $200,000 University of Maryland $200,000 University of Massachusetts $350,000 University of Michigan $7,278,000 University of Minnesota $325,000 University of Missouri $75,000 University of Munich $300,000 University of Nebraska $100,000 University of North Carolina, Chapel Hill $100,000 University of Pennsylvania $462,000 University of Pittsburg $1,528,000 University of Regensburg $200,000 University of Rochester $600,000 University of Southern California $779,000 University of Tampere $300,000 University of Texas $19,309,000 M. D. Anderson Cancer Center $18,234,000 University of Texas, San Antonio $150,000 University of Texas, Southerwestern $925,000 University of Toronto $275,000 University of Utah $100,000 University of Virginia $3,075,000 University of Washington $7,651,000 University of Wisconsin $4,631,000 Urological Sciences Research Foundation $100,000 Vancouver General Hospital $216,000 Vanderbilt University Medical Center $740,000 Veterans Administration, San Francisco $50,000 Volcani Center $180,000 VU Medisch Centru $100,000 Wake Forest University $215,000 Walter Reed Army Medical Center $50,000 Washington University in St. Louis $1,975,000 Wayne State University $250,000 Weizmann Institute of Science $1,850,000 Whitehead Institute for Biomedical Research $600,000 Yale University $400,000 Total $227,270,912 Number of Institutions 158

APPENDIX D Award Descriptions DF/HCC High Impact Collaboration Awards ($500,000 over 2 yrs.)

The High Impact Collaboration Awards are for multi-year, large-scale research projects for teams of at least two highly experienced investigators capable of providing unique scientific expertise to the solution of a significant problem in prostate cancer research. Applications that include investigators from at least two DF/HCC member institutions will be encouraged. Collaborators from additional institutions throughout the country will also be encouraged, and such collaborations will be viewed as important criteria for merit in the review process.

DF/HCC Career Development Awards ($100,000 over 2 yrs.)

The Career Development Awards support promising young investigators to promote prostate cancer translational research. A track record of interest and productivity in prostate cancer research is required. Awardees would become a member of the DF/HCC Prostate Cancer Program and the DF/HCC Prostate Cancer SPORE and would be expected to attend SPORE activities (meetings, retreats, research presentations).

DF/HCC Project Development Awards ($100,000 over 2 yrs.)

The Developmental Project Awards support faculty conducting cutting-edge prostate cancer translational research. Research may span the disciplines of basic biology, population studies, outcomes, or social science. All basic research must have a plan for translation into application or studies in humans. Collaborations with researchers from additional institutions throughout the country will be encouraged. Awardees would become a member of the DF/HCC Prostate Cancer Program and the DF/HCC Prostate Cancer SPORE and would be expected to attend SPORE activities (meetings, retreats, research presentations).

DF/HCC Lupron-Treatable Disease Awards ($100,000 over 2 yrs.)

The Lupron-Treatable Disease Awards support physicians and researchers who are faculty at university and major hospitals across Massachusetts focused on diseases and conditions that are Lupron-treatable including but not limited to endometriosis, uterine fibroids, and precocious puberty. Collaborations with researchers from additional institutions throughout the country will be encouraged. Such collaborations will be viewed as important criteria for merit in the review process.

DF/HCC Student Training Awards ($20,000 over 2 yrs.)

The Student Training Awards support students in nursing, medical, PhD programs and minority students eligible for participation in the CURE Program as well as UMass Boston-DF/HCC Comprehensive Cancer Partnership Program.

DF/HCC Disparity Research Awards ($100,000 over 2 yrs.)

The Disparity Research Awards are multi-year awards to support research efforts to understand and eliminate racial, ethnic, and socioeconomic disparities in cancer care and prevention.

DF/HCC Community Outreach Awards ($100,000 over 2 yrs.)

The Community Outreach Awards are multi-year awards to support research and increase access of minority and underserved populations to culturally competent care, screening, diagnostics, state of the art clinical trials as well as to provide education and awareness, early detection screening and prevention strategies.

PCF Challenge Awards ($1,000,000 over 2 yrs.)

The Challenge Awards support large-scale research projects. The proposal must be from teams of at least three highly experienced investigators capable of providing unique scientific expertise to the solution of a significant problem in prostate cancer research. A team may be assembled from one institution, or from several institutions, from across the country or globe.

APPENDIX E Award Program Budget

Amount Number DF/HCC Awards High Impact Grants $ 500,000 5 $ 2,500,000.00 Career Development Awards $ 100,000 6 $ 600,000.00 Project Development Awards $ 100,000 9 $ 900,000.00 Lu ron-Treatable Disease Awards $ 100,000 3 $ 300,000.00 Student Training Awards $ 20,000 8 $ 160,000.00 Community Outreach Awards $ 100,000 5 $ 500,000.00 Disparity Grants Awards $ 100,000 4 $ 400,000.00 PCF Awards Challenge Awards $ 1,000,000 5 $ 5,000,000.00 Subtotal $ 10,360,000.00 IDC $ 1,036,000,00 Total $ 11,396,000.00

APPENDIX F Oversight Scientific Advisory Board Responsibilities

Responsibilities of the Oversight SAB will include the following with respect to the Settlement Pool funds: * Review of request-for-proposals (RFPs) from both DF/HCC and PCF previous to their release, to ensure alignment with the spirit and letter of this program. * For each award, after reviews are complete and before selections are announced, an audit of the highest ranking application, to ensure conformance with selection criteria and award intent. In the event that the majority (51%) of SAB members agree that the finalist application does not match selection criteria or award intent, the application with the next highest ranking will undergo the same scrutiny. * For each award granted, the review of progress reports before second year funds are released, to assess conformance, on a general level, to the original proposal. In the event that a majority of SAB members agree that the subject grant recipient has not made satisfactory progress, second year funds will not be released and the grant will be terminated. * Participation in the application review process, upon request from DF/HCC or PCF.

APPENDIX G DF/HCC Review Committee 2010

DF/HCC Members Philip Kantoff, MD (Chair) Professor, Department of Medicine, HMS Director, Lank Center for Genitourinary Oncology, DFCI Chief Clinical Research Officer, DFCI Chief, Division of Solid Tumor Oncology, DFCI Matthew Smith, MD, PhD (Co-Chair) Associate Professor, Department of Medicine, HMS Assistant in Medicine, Hematology/Oncology, MGH Martin Sanda, MD (Co-Chair) Associate Professor, Department of Urology, HMS Director, Prostate Center, Urology, BIDMC Glenn Bubley, MD Associate Professor, Department of Medicine, HMS Director, Genitourinary Medical Oncology, BIDMC Steven Balk, MD, PhD Associate Professor, Department of Medicine, HMS Staff Physician, Hematology/Oncology, BIDMC Lewis Cantley, PhD William Bosworth Castle Professor of Medicine, HMS Professor, Department of Systems Biology, HMS Chief, Signal Transduction, BIDMC Meir Stampfer, PhD MD Professor of Epidemiology and Nutrition, HSPH Physician, Channing Laboratory, BWH William Hahn, MD PD Associate Professor, Department of Medicine, HMS Director, Center for Cancer Genome Discovery, DFCI Associate Professor of Medicine, Medical Oncology, DFCI Meredith M. Regan, ScD Assistant Professor, Department of Medicine, HMS Senior Research Scientist, Biostatistics and Computational Biology, DFCI Anthony D'Amico, MD PhD Professor, Department of Radiation Oncology, HMS Chief, Genitourinary Radiation Oncology, DFCI Chief, Genitourinary Radiation Oncology, BWH Patient Advocate(s) Stanley Klein Initial Oversight SAB Members (reviewers may rotate over time) William Nelson, MD, PhD Director of the John Hopkins University Cancer Center Director of the Prostate SPORE at Johns Hopkins University Peter Scardino, MD Chairman of Surgery and Chief of Urology at Memorial Sloan Kettering Cancer Center, Director of the Prostate SPORE at Memorial Sloan Kettering Cancer Center Court Appointee Guest Reviewers Gynecology and Reproductive Medicine experts

APPENDIX H PCF Review Committee (2010-2011) From the Prostate Cancer Foundation

Howard Soule, Chairman

Jonathan Simons

Stuart Holden

Surgical Urologic Oncology

Robert Reiter, UCLA

Martin Sanda, Harvard Medical School

Joel Nelson, University of Pittsburgh

Ash Tewari, Weil Cornell Medical College

Bal Carter, Johns Hopkins Medicine

Skip Holden, Cedars-Sinai Medical Center

Peter Carroll, UCSF

Laurence Klotz, University of Toronto

Ian Thompson, UT Health Sciences Center at San Antonio

Martin Gleave, University of British Columbia

Tom Guzzo, University of Pennsylvania

Medical Oncology Treatment Science

Ken Pienta, University of Michigan

Neal Rosen, Memorial Sloan-Kettering Cancer Center

Peter Nelson, Fred Hutchinson Cancer Research Center

Howard Scher, Memorial Sloan-Kettering Cancer Center

Chris Logothetis, M.D. Anderson Cancer Center

Daniel Haber, Mass General Hospital

George Wilding, University of Wisconsin

Phil Kantoff, Dana-Farber Cancer Institute

Dan George, Duke University

Roberto Pili, Roswell Park Cancer Institute

Walter Stadler, University of Chicago

Elizabeth Heath, Wayne State University

David Solit, Memorial Sloan-Kettering Cancer Center

Matthew Smith, Mass General Hospital

Tia Higano, University of Washington

Tom Beer, Oregon Health Science University

Bill Dahut, National Cancer Institute

William Oh, Mt. Sinai School of Medicine

Johann DeBono, Royal Marsden Hospital

Immunotherapy

Chuck Drake, Johns Hopkins Medicine

Jim Allison, Memorial Sloan-Kettering Cancer Center

Eric Small, UCSF

James Gulley, National Cancer Institute

Jedd Wolchok, Memorial Sloan-Kettering Cancer Center

Larry Fong, UCSF

Genomics

Levi Garraway, Dana-Farber Cancer Institute

Colin Collins, Univ of British Columbia

Bill Hahn, Dana-Farber Cancer Institute

Lorelei Mucci, Harvard School of Public Health

John Carpten, Translational Genomics Institute

William Isaacs, Johns Hopkins Medicine

Basic Science

Candace Johnson, Roswell Park Cancer Institute

John Isaacs, Johns Hopkins Medicine

Lucia Languino, University of Massachusetts

Rob Getzenberg, Johns Hopkins Medicine

Owen Witte, UCLA

Cory Abate-Shen, Columbia University

Don Coffey, Johns Hopkins Medicine

Tim Thompson, M.D. Anderson Cancer Center

Jack Schalken, University Hospital of Nijmegen

Colleen Nelson, Queensland Univ. of Technology

Radiation Oncology

Howard Sandler, Cedars-Sinai Medical Center

Adam Dicker, Thomas Jefferson University

Ted DeWeese, Johns Hopkins Medicine

Rob Bristow, University of Toronto

Anthony D'Amico, Brigham and Women's Hospital

Nutrition Research

David Heber, UCLA

June Chan, UCSF

Meir Stampfer, Harvard School of Public Health

William Nelson, Johns Hopkins Medicine

Molecular Imaging

Peter Choyke, National Cancer Institute

Steve Larson, Memorial Sloan-Kettering Cancer Center

Lily Wu, UCLA

Sam Gambhir, Stanford University

Martin Pomper, Johns Hopkins Medicine

Molecular Pathology

Angelo DeMarzo, Johns Hopkins Medicine

Michael Ittmann, Baylor College of Medicine

Tim McDonnell, M.D, Anderson Cancer Center

Arul Chinnaiyan, University of Michigan

Scott Tomlins, University of Michigan

Jeffrey Simko, UCSF

Karen Kaul, Northwestern University

Max Loda, Dana-Farber Cancer Institute

Mahul Amin, Cedars-Sinai Medical Center

Mark Rubin, Weil Cornell Medical College

Statistics

Bruce Trock, Johns Hopkins Medicine

Susan Halabi, Duke University

Steve Piantadosi, Cedars-Sinai Medical Center

Initial Oversight SAB Members (reviewers may rotate over time)

Peter Nelson MD, Director of the Prostate SPORE at the University of Washington

Don Tindall PhD, Director of the Prostate SPORE at Mayo Clinic

Court Appointee APPENDIX I Indirect Cost Background and Description

Indirect costs (IDC) are those that are incurred for common or joint objectives, and which cannot be easily identified with a particular sponsored project in a straightforward manner. The concept of IDC evolved along with the inception of significant government research funding during and after World War II. It became evident that university-based research programs could only expand to incorporate new projects if infrastructure costs were supported in tandem with "direct" research expenses. Although it was technically possible to parse out each sponsored project's use of facilities and administrative resources per government grant, it proved difficult to establish uniform accounting procedures for this practice, and correspondingly, to audit such practices.

For this reason, government funding agencies and research institutions developed a specific formula to calculate overall IDC rate on all government grants, a practice which continues today. This rate is calculated on a per institution basis. The federal overhead rate for DF/HCC is 75%. Federal regulations spell out explicitly which type of research costs should be attributed to indirect costs and which should be attributed to direct costs.

To maintain consistent accounting procedures, DF/HCC abides by federal IDC guidelines for the identification and assignment of IDC costs, uniformly for all federal and non-federal grants and gifts. DF/HCC applies a 20% IDC rate on non-federal programmatic gifts and grants made to the Institute. Although the actual cost of maintaining research infrastructure is much higher (see federal rate above), DF/HCC is generally able to employ discretionary funds to reimburse these additional infrastructure costs. These costs include but are not limited to: departmental administration costs, general administration costs, research computing costs, grants administration costs, facilities operation and maintenance expenses, and more.

APPENDIX J Program Manager Responsibilities

The responsibilities of the Settlement Pool Program Manager will include the following: • Act as program authority and point person for DF/HCC applicant, grantee and administrator questions. • Act as program liaison with PCF, University of Massachusetts and other Massachusetts universities. Be available to answer applicant, grantee and administrator questions as needed. • Draft, publish and promote program-related DF/HCC RFPs. Oversight of program-related PCF RFP drafts, publication and promotion. • Act as liaison to the Oversight SAB. Provide Oversight SAB with pertinent materials and solicit feedback as warranted throughout the life cycle of each grant. • Manage DF/HCC program funds. Distribute Settlement Funds to PCF, collect relevant account information from PCF for reporting and oversight purposes. • Provide overall annual reports to the First Circuit Court of Appeals, and/or a court designee.

APPENDIX K DF/HCC SPORE Program Management Activities 2010-11

The anticipated dates and activities for the DF/HCC SPORE award program, below, will serve as a template for Settlement Pool award program dates and activities:

07/15/10: An invitation is sent out to the SPORE Review Committee asking for their participation in reviewing new applications (due 10/01/10). Responses are tallied and a face-to-face Review Committee Meeting is scheduled for mid-October.

08/15/10: 2010 RFAs are distributed to DF/HCC membership list (maintained by DF/HCC administrator) and DF/HCC SPORE in Prostate Cancer Pls (past and present) and collaborators list (maintained by DF/HCC SPORE in Prostate Cancer administrator) and to DFCI Investigators (maintained by DFCI Grants and Contracts). RFAs and program information is also made available to all DFCI faculty via the DFCI intranet, and all DF/HCC faculty via the DF/HCC internet.

10/01/10: Due date for 2010 SPORE Applications.

10/01/10-10/07/10: All review committee members receive a Reviewer Packet (including reviewer's letter, scoring sheets, copies of the RFAs, and a copy of all applications received), provided in hard copy and by email. Each reviewer is responsible for scoring, ranking, and commenting on all proposals, except those which pose a conflict of interest.

10/1/10-10/15/10: For all applications, reviewers score (NIH scoring) and rank in order of fundability with consideration focused on 1) quality of the science, 2) quality of the investigator, 3) translational potential, 4) potential to help the program and SPORE. The purpose of the ranking is to eliminate the lower approximate 50% which will allow us to review the top 50% in greater detail at our face-to-face review session.

10/15/10: Reviewer scores, ranks and comments are due to the Program Administrator, who will integrate all responses into a combined scoring spreadsheet, which will be provided to all at the face-to-face meeting.

10/17/10: Approximate date for face-to-face 2010 SPORE Review Committee Meeting. The merits of each proposal and investigator are discussed and a final ranking is conducted. The new projects are selected.

10/22/10: All applicants are notified regarding their application funding status, and if awarded, the next steps required for account setup. Next steps may include submission of a revised budget, Statement of Work (for outside institutions), and IRB/IACUC approval information (as applicable, depending whether human or animal protocols are involved).

11/1/10-11/15/10: All requested documentation is received and forwarded on to Grant and Contracts for Account Setup.

11/1/10-11/30/10: All selected projects are funded. Grants and Contracts issues accounts for personnel and executes subcontract agreements for collaborating institutions.

07/01/11: Progress reports and requests for no-cost extensions must be received.

08/15/11: Financial expenditure reports and subcontract agreement invoices due to DF/HCC for preparation of Financial Summary Report.

APPENDIX L PCF Program Management Activities

The Prostate Cancer Foundation's rigorous grant review process is modeled on the NIH peer-review system. Each application will be sent to three reviewers who are selected by matching areas of expertise to the scientific content of the proposal. Each reviewer is asked to score the application in 5 to 10 relevant areas, using NIH scoring methodology. Review criteria include, as examples: qualification of investigator, quality of scientific environment, level of scientific innovation of the proposal, strength of the collaborative team, and likelihood that the research will benefit patients in the near term. Additionally, a brief written critique concerning the strengths and weaknesses of the proposal and investigator is requested. Grants will be selected and funded within six months of program launch.

For each of five selected $1M Challenge Grant awardees, grantee progress will be reviewed quarterly through verbal communications, and annually via written reports. Grant payments will be made upon grantee achievement of key research milestones. Additionally, the Chief Scientific Officer of PCF will make a site visit to each grantee research team during the term of the award to ensure proper stewardship of these funds.

Grantees will be expected to attend the Annual PCF Scientific Retreat, and to submit all papers published as a result of grants to PCF.

APPENDIX M Information about the Bayh-Dole Act

The Bayh-Dole Act, passed in 1980, enables universities to retain ownership of federally funded inventions, in accordance with federal regulations ( 37 CFR part 401) which are designed in part to promote the commercialization and public availability of inventions made in the United States.

Universities are subject to the a number of provisions under Bayh-Dole Act, including the following: they may elect to retain title to innovations developed under federally-funded research programs; they are encouraged to promote the utilization of inventions that arise from federal funding; they are expected to file patent applications on their inventions; and they are expected to prioritize small businesses as potential licensees.

A May 3, 2010 press release issued by the Association of University Technology Managers (www.autm.net) describes the Bayh-Dole Act as "an enduring example of a public-private sector partnership addressing a common problem — turning taxpayer funded research into products the public can use, along with creating jobs and new companies." A website dedicated to providing information about the Bayh-Dole Act can be found at http://www.b-d30.org.

APPENDIX N Harvard Medical School Affiliates and DF/HCC Member Institutions Harvard Medical School Affiliates:

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Cambridge Health Alliance

Children's Hospital Boston

Dana-Farber Cancer Institute

Forsyth Institute

Harvard Pilgrim Healthcare

Hebrew SeniorLife

Joslin Diabetes Center

Judge Baker Children's Center

Massachusetts Eye and Ear Infirmary

Massachusetts General Hospital

McLean Hospital

Mount Auburn Hospital

Schepens Eye Research Institute

Spaulding Rehabilitation Hospital

Veterans Affairs Boston Healthcare System

DF/HCC Member Institutions:

Dana-Farber Cancer Institute

Beth Israel Deaconness Medical Center

Brigham and Women's Hospital

Children's Hospital Boston

Harvard Medical School

Harvard School of Public Health

Massachusetts General Hospital

SUPPORTING DOCUMENTS

October 8, 2009

Marsha K. Zierk

Law Clerk to the Honorable Richard G. Stearns

United States District Court

Suite 7130, One Courthouse Way

Boston, MA 02210

Dear Judge Stearns:

It is with great pleasure that I provide this letter of institutional support for the enclosed "Proposal for Disposition of Money Remaining in the Consumer Settlement Pool from Lupron Marketing and Sales Practices Litigation," an initiative that has been developed under the direction of Philip W, Kantoff, M.D. at the Dana-Farber/Harvard Cancer Center (DF/HCC) in collaboration with the Prostate Cancer Foundation (PCF).

The enclosed proposal highlights the importance of funding to address the very significant problem of treating and managing men living with prostate cancer. DF/HCC in conjunction with PCF are ideally poised to address this problem as well as the other Lupron treatable conditions and diseases, by leveraging proven funding mechanisms to distribute and monitor the settlement pool funds to the high impact research projects and talented investigators throughout Massachusetts and the nation.

Since its inception in 1998, DF/HCC seamlessly integrates the cancer research efforts of seven Harvard-affiliated medical institutions and supports the collective efforts of over 1,000 faculty members including basic scientists, translational researchers, clinical researchers and clinicians. DF/HCC's construct encourages powerful research collaborations, shared resource utilization and access new technologies on a scale that is unmatched by any other cancer center in the Nation. Central to DF/HCC's mission is to eliminate cancer disparities in cancer care for underrepresented populations throughout Massachusetts. DF/HCC's effective local and national community outreach programs, including the Blum Family Resource Van, provide access to these patients for who care and services would not otherwise be possible. In fact, the National Cancer Institute regards DF/HCC as "the model" toward which other cancer centers should aspire. For these reasons, I am confident that DF/HCC is outstandingly qualified to fulfill the task of distributing the Lupron settlement funds for maximum impact on research and care benefiting patients throughout the Commonwealth.

I can think of no person more suited to lead this program than Philip W. Kantoff, M.D. He has been the driving force in establishing and leading the nationally recognized Prostate Cancer Program and National Cancer Institute sponsored SPORE in Prostate Cancer at the Dana-Farber/Harvard Cancer Center. He is Chief Clinical Research Officer, Director of the Lank Center for Genitourinary Oncology, and Chief of the Division of Solid Tumor Oncology at Dana-Farber Cancer Institute, Brigham and Women's Hospital. He also serves as Professor of Medicine at Harvard Medical School. As both an institutional leader and a physician-researcher, Dr. Kantoff has earned the esteem of his colleagues at Dana-Farber and within the broader prostate research community for over 20 years — he is well known for his collaborative nature and he is a model mentor to numerous young investigators across Harvard and its affiliated hospitals. I have no doubt that Dr. Kantoff will apply these same traits to the program proposed herein.

Please do not hesitate to contact my office for any additional information that you may require. Thank you for your consideration of this request.

Sincerely,

Edward J. Benz, Jr., M.D.

March 23, 2010

Marsha K. Zierk

Law Clerk to the Honorable Richard G. Stearns

United States District Court

Suite 7130, One Courthouse Way

Boston, MA 02210

Re: Response to memorandum dated March 2, 2010 regarding the disposition of consumer settlement pool funds

Dear Judge Stearns:

Thank you for your review of our November 24, 2009 proposal for the distribution of funds in the Lupron litigation settlement pool. In formulating our response to your insightful and thought-provoking questions, we closely examined our proposed award mechanism. We remain convinced that a partnership approach between DF/HCC and PCF is a unique way to catalyze diverse and innovative research that has great potential to advance the state of care for prostate cancer and Lupron treatable disease patients.

Please do not hesitate to contact me at 617-632-1914 or philip_kantoff@dfci.harvard.edu should you have any additional questions,-or feedback, either about the enclosed response or our original proposal. Thank you again for your consideration.

Sincerely,

Philip Kantoff, M.D.

March 18, 2010

Judge Richard G. Stearns

United States District Court

Suite #7130

1 Courthouse Way

Boston, MA 02210

Dear Judge Stearns:

Prostate cancer is the second leading cause of death from cancer in U.S. men. A man is diagnosed every 4 minutes. Every 19 minutes a man dies from prostate cancer.

On behalf of the Prostate Cancer Foundation, I strongly endorse the plan that Dr. Philip Kantoff and others on his team have developed for your consideration. By way of introduction, the Prostate Cancer Foundation (PCF) was founded in 1993 to find better treatments and a cure for prostate cancer. Through its unique model for soliciting and selecting promising research programs and rapid deployment of resources, the PCF has funded more than 1,500 programs at nearly 200 research centers in 20 countries around the world. As the world's leading philanthropic organization for funding prostate-cancer research, the PCF is now a foundation without borders. Its advocacy for increased government and private support of prostate cancer programs has helped build a global research enterprise of nearly $10 billion.

Dr. Kantoff is a world leader in prostate cancer research and is nationally admired for having, in the best sense of the word, a "judicial spirit" of evaluating the merits of other scientists' work and supporting it. I cannot think of a wiser research leader in American to be involved in the implementation and stewardship of this project.

In this severe recession, and with a flat federal budget for cancer research, some of the nation's best prostate cancer research ideas will achieve funding with this proposal. This would not have occurred, In all likelihood, without the judicial system catalyzing a form of justice in supporting transformational research for prostate cancer patients.

Thank you for your thoughtful consideration.

Sincerely yours,

Jonathan W. Simons, MD

President and CEO

Prostate Cancer Foundation

David H. Koch Chair

April 10, 2010

Philip W. Kantoff, MD

Chief Clinical Research Officer

Chief, Division of Solid Tumor Oncology

Director of the Lank Center for Genitourinary Oncology

Dana-Farber Cancer Institute

44 Binney Street

Suite D1230

Boston, MA 02115-6013

Dear Dr. Kantoff:

Thank you for your recent request for information concerning the process of awarding research funds by the Prostate Cancer Foundation (PCF). The following should fulfill your request. Please do not hesitate to contact us you need further detail or clarification.

In 2010 PCF formed a Standing Committee for Research Award Application review. As the PCF Chief Science Officer, I chair this committee. Dr. Jonathan Simons, PCF President and CEO, is a member of the committee. The full referee committee is presented on the PCF website ("http://www.pcf.org/review). The Standing Committee is composed of international experts in all areas of prostate cancer research from basic science through drug development. Represented disciplines include: surgical urologic oncology, medical oncology and treatment science, immunotherapy, genomics, basic laboratory science, radiation oncology, nutrition research, molecular imaging, molecular pathology, and statistics. The list of 79 experts on this committee is appended to this letter. The PCF Research Awards Standing Review Committee works pro bono. There are no stipends. Reviewers are required to recuse themselves if there is an actual or perceived conflict of interest regarding a specific award application.

The grant review process is rigorous and modeled on the NIH peer-review system, but to a shorter timeframe to notification of funding. Each application is sent to three reviewers selected by matching areas of expertise to the scientific content of the proposal. Each is asked to score the application in 5-10 relevant areas using NIH scoring methodology. Review criteria include, as examples: qualification of investigator, quality of scientific environment, level of scientific innovation of the proposal, strength of the collaborative team, likelihood that the research will benefit patients in the near term, etc. A brief written critique coneerning the strengths and weaknesses of the proposal and investigator(s) is also requested.

PCF plans, after an international research proposal competition, to award five interdisciplinary team research awards for $1 million each. This is payable against highly scrutinized budgets submitted from each research team. Payment is made upon achievement of key research milestones. Generally, these awards are made over 24 months. These five awards will fund research with the high likelihood of translation to the clinic in the near term for patients with advanced prostate cancer, and will "fast-forward" improvements in treatment. The number and timing of awards is dependent on the schedule for distribution of the settlement proceeds.

Our financial accountability mechanism is based on achievement of research milestones that are reviewed quarterly by the PCF Chief Science Officer. The Chief Science Officer will site visit each research team to ensure good and timely stewardship of these precious research funds.

One hundred percent of the funds will be applied to the research awards and their respective teams. PCF will absorb the entire cost of administering the five research awards from beginning to end.

The research award cycle at PCF is highly responsible but swift, based on the urgency of "fast-forwarding" solutions for patients with advanced prostate cancer. Within six months of program launch, applications will be solicited, reviewed, and five interdisciplinary, highly translational research programs focused on improved treatments for advanced prostate cancer will be funded.

Communication of results at the Annual PCF Scientific Retreat, and dissemination of published papers via the office of the Chief Science Officer are a core requisite of our funded research programs.

I hope that this information clarifies any procedures of the PCF grant-making process.

Sincerely yours,

Howard R. Soule, PhD

PCF Research Awards Standing Review Committee Members 2010-2011

From the Prostate Cancer Foundation: Howard Soule, Chairman Jonathan Simons Stuart Holden Surgical Urologic Oncology Medical Oncology Treatment 1. Robert Reiter UCLA Science, con't. 20. Dan George Duke University 2. Martin Sanda Harvard Medical School 21. Roberto Pili Roswell Park Cancer Institute 3. Joel Nelson University of Pittsburgh 22. Walter Stadler University of Chicago 4. Ash Tewari Well Cornell Medical College 23. Elizabeth Heath Wayne State University 5. Bal Carter Johns Hopkins Medicine 24. David Solit Memorial Sloan-Kettering 6. Skip Holden Cedars-Sinai Medical Center Cancer Center 7. Peter Carroll UCSF 25. Matthew Smith Mass General Hospital 8. Laurence Klotz University of Toronto 26. Tia Higano University of Washington 9. Ian Thompson UT Health Sciences 27. Tom Beer Oregon Health Science Center at San Antonio University 10. Martin Gleave University of British Columbia 28. Bill Dahut National Cancer Institute 11. Tom Guzzo University of Pennsylvania 29. William Oh Mt. Sinai School of Medicine Medical Oncology Treatment Science 30. Johann DeBono Royal Marsden Hospital 12. Ken Pienta University of Michigan Immunotherapy 13. Neal Rosen Memorial Sloan-Kettering 31. Chuck Drake Johns Hopkins Medicine Cancer Center 32. Jim Allison Memorial Sloan-Kettering 14. Peter Nelson Fred Hutchinson Cancer Cancer Center Research Center 33. Eric Small UCSF 15. Howard Scher Memorial Sloan-Kettering Cancer Center 34. James Gulley National Cancer Institute 16. Chris Logothetis M.D. Anderson Cancer Center 35. Jedd Wolchok Memorial Sloan-Kettering Cancer Center 17. Daniel Haber Mass General Hospital 36. Larry Fong UCSF 18. George Wilding University of Wisconsin Genomics 19. Phil Kantoff Dana-Farber Cancer Institute 37. Levi Garraway Dana-Farber Cancer Institute 38. Colin Collins Univ of British Columbia 39. Bill Hahn Dana-Farber Cancer Institute 40. Lorelei Mucci Harvard School of Public Health Genomics, con't. Molecular Imaging 41. John Carpten Translational Genomics 62. Peter Choyke National Cancer Institute Institute 63. Steve Larson Memorial Sloan-Kettering Cancer 42. William Isaacs Johns Hopkins Medicine Center Basic Science 64. Lily Wu UCLA 43. Candace Johnson Roswell Park Cancer Institute 65. Sam Gambhir Stanford University 44. John Isaacs Johns Hopkins Medicine 66. Martin Pomper Johns Hopkins Medicine 45. Lucia Languino University of Massachusetts Molecular Pathology 46. Rob Getzenberg Johns Hopkins Medicine 67. Angelo DeMarzo Johns Hopkins Medicine 47. Owen Witte UCLA 68. Michael Ittmann Baylor College of Medicine 48. Cory Abate- Columbia University 69. Tim McDonnell M.D. Anderson Cancer Center Shen 70. Arul Chinnaiyan University of Michigan 49. Don Coffey Johns Hopkins Medicine 71. Scott Tomlins University of Michigan 50. Tim Thompson M.D. Anderson Cancer Center 72. Jeffrey Simko UCSF 51. Jack Schalken University Hospital of Nijmegen 73. Karen Kaul Northwestern University 52. Colleen Nelson Queensland Univ. of Technology 74. Max Loda Dana-Farber Cancer Institute Radiation Oncology 75. Mahul Amin Cedars-Sinai Medical Center 53. Howard Sandler Cedars-Sinai Medical Center 76. Mark Rubin Weil Cornell Medical College 54. Adam Dicker Thomas Jefferson Statistics University 77. Bruce Trock Johns Hopkins Medicine 55. Ted DeWeese Johns Hopkins Medicine 78. Susan Halabi Duke University 56. Rob Bristow University of Toronto 79. Steve Piantadost Cedars-Sinai Medical Center 57. Anthony D'Amico Brigham and Women's Hospital Nutrition Research 58. David Heber UCLA 59. June Chan UCSF 60. Meir Stampfer Harvard School of Public Health 61. William Nelson Johns Hopkins Medicine