definiens: shall mean, as the term is defined in the U.S. Code of Federal Regulations21 CFR § 312.3(b ), a human who participates in the Study, either as a recipient of the investigational new drugor as a control . Once the Protocol has been agreed and has been approved by MD Anderson ’s InstitutionalReview Board ( or ) under Section 2.2 below, ( i ) Cyclacel, as Study sponsor, shall obtain regulatory approval for the Study as required by FDA ; and ( ii ) the detailed provisions forperformance of the Study by the Parties including by MD Anderson and the MD Anderson principalinvestigator(s ) responsible for the performance of such Study ( or ), shall be set out in a Study Order to be agreed between the Parties but substantially in the form attached asAppendix III to this Agreement which shall detail the specifics of the Study to be performed under such StudyOrder including, without limitation, ( i ) the detailed Protocol, ( ii ) the Principal Investigator, ( iii ) identify anyproject - specific resources or support provided by Cyclacel including quantities of Cyclacel Drug Candidate andtiming of delivery . Any changes to the Protocol must be agreed upon in writing in advance by Cyclacel unlessnecessary to protect the safety, rights or welfare of the Subjects