Investigator Obligations. Investigator will devote his/her best efforts to accurately and efficiently perform the work required under this Agreement, which efforts shall include but are not limited to the following: (i) exercise of independent medical judgment as to the compatibility of each Study patient with the Protocol requirements; (ii) notification of Labcorp and Sponsor, if required of any deviations from or failure to comply with the Protocol; (iii) promptly replying to any questions from Labcorp or Sponsor regarding any matter related to the Study; (iv) promptly notifying Labcorp of any significant changes that occur at any time during the Study which may affect Investigator or Institution’s ability to conduct the Study, including but not limited to, changes in personnel involved in the Study (v) record and document all Adverse Events and laboratory abnormalities identified in the Protocol as critical to the safety evaluation; (vi) report all Serious Adverse Events to Labcorp and/or the Sponsor without undue delay but not later than within twenty-four (24) hours of obtaining knowledge of the events, unless, for certain Serious Adverse Events, the Protocol provides that no immediate reporting is required. (c)

Investigator Obligations. As indicated on FDA Form 1572, the Principal Investigator is responsible for ensuring that all study site personnel, including Sub-Investigators and other study staff members, adhere to all FDA regulations and guidelines regarding clinical trials both during and after study completion.

Investigator Obligations. Sponsoring Institution will require the SCOR Director, all Key Sponsoring Institution Investigators, or all Sponsoring Institution Investigators (as applicable) to acknowledge the provisions of Sections 3.1, 6, 7 and 8 of this Agreement (“Investigator Obligations”). Sponsoring Institution will be responsible for all Sponsoring Institution Investigators’ compliance with such provisions.

Investigator Obligations. Investigator agrees to devote his/her best efforts to accurately and efficiently, with all due skill, care and diligence, perform the work required under this Agreement, which efforts shall include by are not limited to the following: (i) exercise of independent medical judgment as to the compatibility of each Study patient with the Protocol requirements; (ii) getting fully acquainted with the Protocol and all information and documents concerning the Study; 3.

Investigator Obligations. 4.1 The Investigator shall adhere to any and all laws, regulations and guidelines, including (a) any applicable Guidelines for Good Clinical Practice, (b) the laws and customs governing medical practice and ethics prevailing in the country where the Study takes place, and (c) all guidelines and instructions supplied by POI and/or the Sponsor. Strict compliance by the Investigator with the Study Protocol is required (slight deviations based on medical necessity will not violate this provision). Any modifications recommended by the Investigator or the Institution's Institutional Review Board ("IRB") before initiation of the Study or during the review process must be brought to the attention of POI. The Protocol may not be altered without the prior written consent of POI and/or the Sponsor for the Study, and a subsequent review and approval by the IRB. The Principal Investigator thoroughly understands the Protocol and, as of the date of signing this Agreement, has no further questions or concerns about the Study's design or conduct.

Investigator Obligations. 31 14. ADMINISTRATIVE CONSIDERATIONS .............................................. 32 15. REFERENCES ................................................................. 34 APPENDIX A: STUDY DIAGRAM ...................................................... 40 APPENDIX B: PERFORMANCE STATUS ................................................. 41 APPENDIX C: SKIN TESTING PROCEDURE ............................................. 42 APPENDIX D: QUALITY OF LIFE QUESTIONAIRE ....................................... 44 APPENDIX E: BRIEF PAIN INVENTORY ............................................... 47 APPENDIX F: PATIENT REGISTRATION FORM........................................... 49 APPENDIX G: NPCP CRITERIA....................................................... 51 APPENDIX H: OFF STUDY FORM...................................................... 53 APPENDIX I: OFF STUDY PATIENT RE-ENTRY FORM..................................... 54 APPENDIX J: LEUKAPHERESIS PROCEDURE INFORMATION................................. 55 APPENDIX K: INFORMED CONSENT.................................................... 57 APPENDIX L: NCI COMMON TOXICITY CRITERIA ....................................... 61 APPENDIX M: TOXICITY MODULE .................................................... 64

Investigator Obligations. Investigator agrees to devote his/her best efforts to accurately and efficiently perform the work required under this Agreement, which efforts shall include but are not limited to the following: (i) exercise of independent medical judgment as to the compatibility of each Study patient with the Protocol requirements; (ii) notification of Covance and Sponsor, if required of any deviations from or failure to comply with the Protocol; (iii) promptly replying to any questions from Covance or Sponsor regarding any matter related to the Study; (iv) promptly notifying Covance of any significant changes that occur at any time during the Study which may affect Investigator or Institution’s ability to conduct the Study, including but not limited to, changes in Research Staff (c) Institution Obligations Zdravotnické zařízení a Zkoušející provedou Studii v souladu s Protokolem, touto Smlouvou, písemnými pokyny Zadavatele nebo společnosti Covance (dále jen "Pokyny"), příslušnými profesními normami lékařské praxe, všemi příslušnými mezinárodními, federálními, státními a místními zákony, směrnicemi, pravidly a předpisy, platnými právními předpisy na ochranu soukromí, pravidly a předpisy a směrnicemi ICH-GCP (CPMP/ICH/135/95). 3. POVINNOSTI (a) Proti uplácení a proti korupci Zkoušející a Zdravotnické zařízení nesmí přímo ani nepřímo zaplatit, slíbit nebo autorizovat zaplacení peněz, ani poskytnout, slíbit či autorizovat poskytnutí čehokoli hodnotného jakékoliv osobě nebo subjektu, ať už se jedná o osobu či subjekt vládní, kvazi-vládní nebo soukromý, s cílem získat nebo zachovat obchodní vztah či zajistit jinou neoprávněnou výhodu pro společnost Covance nebo pro Zadavatele. Zkoušející a Zdravotnické zařízení nejsou oprávněni přímo či nepřímo přijímat ani vyžadovat peníze ani jakoukoli cennou věc od jakékoli osoby či subjektu, ať už se jedná o osobu či subjekt vládní, kvazi-vládní nebo soukromý, s cílem získat od této osoby či subjektu neoprávněnou výhodu. Zkoušející a Zdravotnické zařízení nepodniknou žádné kroky, které by mohly společnost Covance nebo Zadavatele činit odpovědným podle jiných platných právních předpisů o boji proti podvodům, korupci, vydírání, praní špinavých peněz a/nebo terorismu. (b)

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