Common use of Study Protocol Clause in Contracts

Study Protocol. The scope and nature of the clinical trial to be performed will be in strict accordance with the Protocol, including Protocol Number TQ-BA-2024-1 (NCT06207370) entitled, “Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis”, and any subsequent amendments thereto, referenced and incorporated herein (the “Protocol”). The Protocol fully details the clinical research activities and responsibilities to be undertaken, pursued, and followed with all due diligence by Institution, through the Investigator. The Protocol will be considered final after it is signed by the Sponsor and approved by the pertinent Institutional Review Board (“IRB”). Thereafter, the Protocol may be amended only by the Sponsor and subsequent approval by the IRB. A copy of the signed Statement of Investigator (FDA Form 1572) or Investigator Agreement for medical device studies, the Protocol and any Protocol amendments will be maintained in the Investigator’s Study files. SPONSOR NAME Page 3 of 26 CONFIDENTIAL < Institution> CTA

Appears in 1 contract

Sources: Clinical Trial Agreement (60 Degrees Pharmaceuticals, Inc.)

Study Protocol. The scope and nature of the clinical trial to be performed will be in strict accordance with the ProtocolStudy, including Protocol Number TQ-BA-2024-1 (NCT06207370) entitled, “Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis”, and any subsequent amendments thereto, referenced and incorporated herein (the “Protocol”). The Protocol fully details the clinical research activities and responsibilities to be undertaken, pursued, and followed with all due diligence by Institution, through the Investigator. The Protocol will be considered final after it is signed by the Sponsor and approved by the pertinent Institutional Review Board (“IRB”). Thereafter, the Protocol may be amended only by the Sponsor and subsequent approval by the IRB. A copy of the signed Statement of Investigator (FDA Form 1572) or Investigator Agreement for medical device studies, the Protocol and any Protocol amendments will be maintained in the Investigator’s Study files. SPONSOR NAME Page 3 of 26 CONFIDENTIAL < Institution> CTA

Appears in 1 contract

Sources: Clinical Trial Agreement (60 Degrees Pharmaceuticals, Inc.)

Study Protocol. The scope and nature of the clinical trial to be performed will be in strict accordance with the ProtocolStudy, including Protocol Number TQ-BA-2024-1 (NCT06207370) entitled, “Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis”, and any subsequent amendments thereto, referenced and incorporated herein (the “Protocol”). The Protocol fully details the clinical research activities and responsibilities to be undertaken, pursued, and followed with all due diligence by Institution, through the Investigator. The Protocol will be considered final after it is signed by the Sponsor and approved by the pertinent Institutional Review Board (“IRB”). Thereafter, the Protocol may be amended only by the Sponsor and subsequent approval by the IRB. A copy of the signed Statement of Investigator (FDA Form 1572) or Investigator Agreement for medical device studies), the Protocol and any Protocol amendments will be maintained in the Investigator’s Study files. SPONSOR NAME Page 3 The Study will be conducted by the Institution under the direction of 26 CONFIDENTIAL [____] (“Investigator”), an employee/faculty member of Institution. < Institution> CTA

Appears in 1 contract

Sources: Clinical Trial Agreement (60 Degrees Pharmaceuticals, Inc.)