Contract analysis

Section 1: Purpose and Scope 1.1 This Exhibit J (these "Safety Reporting Procedures") sets forth the procedures applicable to the identification, documentation, assessment, reporting, and follow-up of adverse events, serious adverse events, and other safety information arising during the conduct of the Phase III clinical trial conducted under Protocol PPC-4871-III, known as the CLARION trial (Clinical Assessment of R

Section 2: Definitions For purposes of these Safety Reporting Procedures, the following terms shall have the meanings set forth below. Capitalized terms not defined in this Section 2 shall have the meanings ascribed to them in the MCTA or, if not defined therein, in Protocol PPC-4871-III. 2.1 Adverse Event ("AE"). Any untoward medical occurrence in a clinical trial subject who has been administered the investigationa

Section 3: Roles and Responsibilities 3.1 Sponsor (Penterra Pharmaceuticals Corp.) Penterra, as the holder of IND 157823, bears overall responsibility for IND safety reporting and pharmacovigilance for the investigational product penterafenib (PPC-4871) across all clinical studies conducted under the IND, including the CLARION trial. Penterra's safety reporting responsibilities include, without limitation, the follow

Section 4: Site Reporting of Adverse Events and Serious Adverse Events 4.1 Adverse Event Reporting (Non-Serious) All adverse events, whether or not considered by the investigator to be related to the investigational product (penterafenib) or placebo, must be identified, assessed, and recorded by the site investigator or designee. Non-serious adverse events must be entered into the electronic case report form ("eCRF")

Section 5: Sponsor IND Safety Reporting to the FDA 5.1 Seven (7)-Day Reports — Fatal or Life-Threatening SUSARs In accordance with 21 C.F.R. § 312.32(c)(2), the Sponsor (Penterra) must report to the FDA any SUSAR that is fatal or life-threatening within seven (7) calendar days of the Sponsor's initial receipt of the information. For purposes of this requirement, the date of "initial receipt" is the date on which the

Section 6: IRB Notification and Reporting 6.1 Site IRB Reporting Obligations Each principal investigator participating in the CLARION trial must report SAEs, SUSARs, IND safety reports, and any other safety information requiring IRB notification to the applicable Institutional Review Board in a timely manner, in accordance with: (a) The policies and procedures of the applicable IRB; (b) 21 C.F.R. § 56.108(b), which r

Section 7: Data Management and Safety Database 7.1 Global Safety Database Penterra maintains a global safety database for penterafenib (PPC-4871) under IND 157823 (the "Global Safety Database"). The Global Safety Database aggregates safety data from all clinical studies conducted under the IND, including the CLARION trial and any other ongoing or completed studies involving penterafenib. The Global Safety Database is

Section 8: Safety Monitoring and Oversight 8.1 Data Safety Monitoring Board (DSMB) An independent Data Safety Monitoring Board ("DSMB") has been established for the CLARION trial to provide independent review and assessment of accumulating safety data during the course of the study. The DSMB operates under a separate DSMB Charter, which defines the composition, operating procedures, meeting schedule, data to be revie

Section 9: Protocol Amendments and Safety-Related Actions 9.1 Safety-Related Protocol Amendments If accumulating safety data from the CLARION trial, from other penterafenib studies under IND 157823, from the published literature, or from preclinical studies necessitate amendment of Protocol PPC-4871-III, Penterra will prepare the protocol amendment and distribute it to all participating sites and to Meridian CRO. Saf