SARC Global Collaboration

1. SARC Global Collaboration Activating SARC011/Roche NO21157

2. SARC011/Roche NO21157 • Protocol Steering Committee • Approved protocol July 2007 • Meeting with FDA • Review of proposed study • Revision of study endpoints • Finalization of protocol • September 18, 2007

3. What is the current status? • 75 sites/investigators • 31 US and 44 outside US • Total of 13 countries • Sites per country • US (31), Australia (6), Canada (2), Denmark (1), Finland (1), France (7), Germany (9), Italy (3), Netherlands (2), Norway (1), Spain (5), Sweden (2) and the UK (5) • CDA (confidentiality agreements) signed by 65 sites/investigators • Sites with signed CDA have received: • Protocol • Investigator brochure • Consent form template

4. Who will be working with sites through regulatory process? • US sites • SARC will assist with PRC/SRC queries • SARC to review consent prior to IRB submission • Outside US • Roche filing of CTA* in EU (mid November 2007) • SARC to assist with Ethic Committee queries • Covance to review consents • Covance to assist with consent/protocol translation • Covance to assist with Canadian and Australian regulatory process *CTA-Clinical Trial Application

5. What is SARC’s relationship with Covance? • SARC will direct Covance re: site specific activities • Pre-study visits • Secure regulatory documents • Site initiation • Data monitoring • Covance/ClinPhone to develop the database • SARC and Roche direction • Concerns/difficulties communicated to SARC

6. Who are our contacts at SARC and Covance? • SARC • Research Project Manager • Jessica Reed, PhD • jreed@sarctrials.org • 734-930-7600 • Covance • Project Director • Michelle LaBruyere • michelle.labruyere@covance.com • 615-313-6859

7. When can our site expect a visit/contact from Covance? • Covance to arrange time to meet • In-person or phone contact • Goal is to complete visits by late November to early December

8. When will we receive the contract and budget? • Contract and budget complete for US sites • To be sent to US sites week of 11/5/07 • Contract and budget for exUS sites • Country specific • Templates obtained/legal review • Contracts/budgets are being prepared • Modified based on country specifics • Contracts/payments through SARC and sites

9. Who will be doing contract negotiations? • SARC attorney will negotiate all contracts • Jospeh Nuyen • Nuyen, Tomtishen and Aoun, PC • For outside US • Collaborate with Covance and Roche legal

10. What will be the reimbursement? • US sites • Per Patient reimbursement • $2000 per patient (enrollment/not screen failures) • Additional $3000 per patient (week 6 tumor assessment) • Additional $3000 per patient (>24 weeks) • Annual reimbursement for each additional year the patient remains on study $1200 per year

11. Reimbursement (cont’d) • Additional funds to be provided for: • IRB/Investigational drug service (site rate) • Non-standard of care items • PET-site rate • MD visits 4 visits during 1st 6 weeks at $200/visit • PK/PD • Kits/shipping costs • Reimbursement per draw/complete set ($200 per draw for complete set and $400-3 samples/extra visit) • Costs for preparing and shipping tissue samples • Block/slides ($6/slide-40 slides or $300 block) • Preparation and shipping of images for central review • $100 per imaging study sent • ECG central review processing • Provide equipment ($75 per series of 3 x 5)

12. What will be the reimbursement outside of US? • Based on country regulations and specific requirements • Reimbursement to be aligned across the study for all sites (outside US and US)

13. How will we get the drug? • US • Roche to send directly to sites • Outside US • Drug to be shipped via a 3rd party distribution center

14. What steps are needed to activate the study at my site? • Receipt of all regulatory documents • Signed contract • Pre-study visit ensuring all needed processes are in place • ECG • Electronic data capture • Imaging • Study initiation meeting completed

15. Who will be overseeing the conduct of the trial? • Medical Monitors • Roche • Stan Frankel, MD • Queries related to AE/dosing • SARC • Shreyas Patel, MD • Queries related to patient eligibility, response evaluations, and patient related concerns during course of study • Collaborate/agree on all determinations

16. When will the study be activated? • Protocol amendment • Human anti-human antibody (HAHA) sampling needs to be added • Require consent update • Submission to IRB prior to activation • Amendment to sites by week of 11/5/07 • Goal for first patient entered • Mid November 2007

17. SARC Global Collaboration • First opportunity for global collaboration • Seek to successfully navigate logistics • Build network for sarcoma experts globally to collaborate on clinical trial research • Establish processes to be utilized in the future Patience is a Virtue

19. -Sant Chawla, MD Century City Hospital -Arthur Staddon, MD Pennsylvania Oncology -Amir Shahlaee, MD University of Florida -William Tapp, MD UCLA -Dennis Priebat, MD Washington Cancer Institute -Chris Ryan, MD Oregon Health Science -Margaret Von Mehren, MD Fox Chase -James Whitlock, MD Vanderbilt -Doug Hawkins, MD University of Washington -Kristen Ganjoo, MD Stanford -Albert Pappo, MD* Texas Children’s -Shreyaskumar Patel, MD MDAnderson Cancer Center -Robert Maki, MD, PhD MSKCC -Scott Schuetze, MD, PhD University of Michigan -Lee Helman, MD NCI-Pediatric Branch -Gina D’Amato, MD Moffitt Cancer Center -Nabil Saba, MD Emory -George Demetri, MD Dana Farber -David Harmon, MD Massachusetts General -Scott Okuno, MD Mayo Clinic SARC-011 Potential Investigators

20. -Kevin Patterson, MD Queen Elizabethl- Australia -Ross Pinkerton, MD Mater Children’s-Australia -Jayesh Desai, MD Royal Melbourne-Australia -David Thomas, MD Peter MacCallum-Australia -Martin Tatersall, MD Prince Alfred, Australia -Geoffrey McCowage, MD Children’s at Westmead-Australia -Martin Blackstein, MD Mt. Sinai –Canada -Margaret Knowling, MD Vancouver Cancer center-Canada -Ole Steel Nielsen,MD Aarhus- Denmark -Heikki Joensuu,MD Helsinki-Finland -Charles Forscher, MD Cedar Sinai -Warren Chow, MD City of Hope -Michael Livingston, MD Carolinas Hem Onc. -Thomas Budd, MD Cleveland Clinic -Kirsten Leu, MD Onc.Hem.West -Richard Gorlick, MD Albert Eistein -Paul Savage,MD Wake Forest -Kimo Stine, MD Arkansas -Brian Samuels, MD Kootenai -R.Lor Randall, MD Huntsman Cancer Institute -David Loeb, MD Johns Hopkins SARC011 Potential Investigators

21. -Peter Hohenberger, MD Heidelberg-Germany -Herbert Jurgens, MD Wilhelms University-Germany -Wolfgang Berdel, MD Wilhelms University-Germany -Stephan Bielak, MD Olgahospital-Germany -Jorg Hartmann, MD Tubingen-Germany -Piero Picci, MD Isituti Ortopedici Rizzoli-Italy -Stafano Ferrari, MD Isituti Ortopedici Rizzoli-Italy -Paolo Casali, MD Istituto Nazionale Tumori- Italy -Jaap Verwejj, MD Erasmus- Netherlands -Pancras Hogendoorn, MD Leiden-Netherlands -Binh Bui, MD Institut Bergonie-France -Nicholas Penel, MD Centre Oscar Lambert-France -Jean-Yves Blay, MD Centre Leon Berard-France -Florence Duffaud, MD Hopital La Timone-France -Sophie Piperno-Neumann, MD Institut Curie-France -Axel Le Cesne, MD Institut Gustave Roussy-France -Gilles Vassal, MD* Institut Gustave Roussy-France -Peter Reichardt, MD Bad Saarow-Germany Berlin-Germany-Germany -Thomas Klingelbiel, MD Goethe University-Germany -Christian Manegold, MD Heidelberg-Germany SARC011 Potential Investigators

22. -David Peake, MD University Hospital Birmingham-UK -Bruce Moorland, MD Birmingham Children’s-UK -Mike Leahy, MD Christie Hospital -UK -Beartrice Seddon, MD Middlesex Hospital-UK -Ian Judson, MD Royal Marsden-UK -Sigbjorn Smeland, MD Norwegian Radium- Norway -Jose Antonio Lopez Martin, MD Madrid-Spain -Jaume Mora, MD Sant Joan de Deu-Spain -Xavier Garcia Del Muro, MD Institue Catala d’Oncologia- Spain -Antonio Lopez Pousa,MD Barcelona-Spain -Javier Martin, MD Hospital Son Dureta-Spain -Thor Alvegard, MD Lund University-Sweden -Ake Jakobson, MD Karolinska Institute-Sweden SARC011 Potential Investigators