Common use of Provision and Use of Study Drug Clause in Contracts

Provision and Use of Study Drug. Company shall be responsible for providing and delivering to the research pharmacy of each site of Institution, at no charge, sufficient quantities of the labeled Study Drug (paxalisib 15mg Capsules, bottled and identified with lot number) as may be required for the Study in accordance with the Study schedule. Institution, through Principal Investigator, will safeguard such Study Drug with the degree of care used for its own property and shall return or otherwise dispose of any remaining Study Drug at the Study Conclusion in accordance with Company’s instructions and Institution’s pharmacy’s Standard Operating Procedures (SOP’s) for drug destruction. Institution and Principal Investigator shall not use any Study Drug for any purpose other than the Study, unless otherwise agreed. Company represents and warrants that it is in compliance with federal, state, and local laws and regulations relating to the manufacture and formulation of any investigational drug and to any other materials supplied, and with all applicable legal requirements. Responsibilities between the Parties are provided in Exhibit C.

Provision and Use of Study Drug. Company shall be responsible for providing and delivering to the research pharmacy of each site of Institution, at no charge, sufficient quantities of the labeled Study Drug (paxalisib GDC-0084 15mg Capsules, bottled and identified with lot number) as may be required for the Study in accordance with the Study schedule. Institution, through Principal Investigator, will safeguard such Study Drug with the degree of care used for its own property and shall return or otherwise dispose of any remaining Study Drug at the Study Conclusion in accordance with Company’s instructions and Institution’s pharmacy’s Standard Operating Procedures (SOP’s) for drug destruction. Institution and Principal Investigator shall not use any Study Drug for any purpose other than the Study, unless otherwise agreed. Company represents and warrants that it is in compliance with federal, state, and local laws and regulations relating to the manufacture and formulation of any investigational drug and to any other materials supplied, and with all applicable legal requirements. Responsibilities between the Parties are provided in Exhibit C.x