Contract analysis

ARTICLE 1 — DEFINITIONS Capitalized terms used in this Agreement and not otherwise defined herein shall have the meanings ascribed to them in the License Agreement. The following terms shall have the meanings set forth below for purposes of this Agreement: 1.1 "Adverse Drug Reaction" or "ADR" means any noxious, unintended response to PPC-4187 at any dose used for prophylaxis, diagnosis, or therapy of disease or for m

ARTICLE 2 — SCOPE AND PURPOSE 2.1 Scope. This Agreement governs the exchange of safety information between Penterra and Meridian (and their respective Affiliates, agents, contractors, and Sublicensees) relating to PPC-4187 (Penteracitinib) in all jurisdictions worldwide, including both the Territory and the Retained Territory. The obligations set forth in this Agreement apply to safety information arising from any an

ARTICLE 3 — ROLES AND RESPONSIBILITIES 3.1 Penterra (Licensor) Responsibilities. Penterra shall have the following pharmacovigilance roles and responsibilities under this Agreement: 3.1.1 Penterra shall maintain and host the Global Safety Database (GSD) for PPC-4187 at Penterra's pharmacovigilance facilities in Princeton, New Jersey, or at such other validated location as Penterra may designate from time to time. Pen

ARTICLE 4 — GLOBAL SAFETY DATABASE 4.1 Database Holder. Penterra shall be the sole holder and maintainer of the Global Safety Database (GSD) for PPC-4187. As Database Holder, Penterra shall have overall responsibility for the design, validation, operation, integrity, security, and maintenance of the GSD, and for ensuring that the GSD contains a complete and accurate record of all safety data relating to PPC-4187 from

ARTICLE 5 — INDIVIDUAL CASE SAFETY REPORTS (ICSRs) — EXCHANGE TIMELINES 5.1 Serious Adverse Events (SAEs) — Expedited Exchange. The Parties shall exchange ICSRs for Serious Adverse Events in accordance with the following timelines: 5.1.1 Fatal or Life-Threatening SAEs. For any Serious Adverse Event that results in death or is life-threatening, the Party first becoming aware of the event shall transmit the initial ICS

ARTICLE 6 — REGULATORY REPORTING RESPONSIBILITIES 6.1 Penterra's Reporting Obligations (Retained Territory). 6.1.1 Penterra shall be solely responsible for the preparation and submission of all regulatory safety reports, including ICSRs, Expedited Reports (IND safety reports under 21 C.F.R. § 312.32, NDA safety reports under 21 C.F.R. § 314.80, and equivalent reports under the regulations of other Retained Territory

ARTICLE 7 — PERIODIC SAFETY UPDATE REPORTS (PSURs) AND PBRERs 7.1 Global PSUR/PBRER Preparation. Penterra shall be responsible for preparing global Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) for PPC-4187 in accordance with ICH E2C(R2) and all applicable regulatory requirements. Penterra shall utilize data from the GSD, together with Territory-specific data and input p

ARTICLE 8 — SIGNAL DETECTION AND RISK MANAGEMENT 8.1 Signal Detection. Penterra shall conduct signal detection activities for PPC-4187 on a global basis, using data from the GSD and such other data sources as Penterra deems appropriate, including published scientific and medical literature, pharmacoepidemiological databases, and regulatory databases. Signal detection methodologies shall include, at a minimum, regular

ARTICLE 9 — JOINT SAFETY REVIEW COMMITTEE 9.1 Establishment. A Joint Safety Review Committee ("JSRC") shall be established by the Parties within thirty (30) days of the Effective Date (i.e., by no later than November 19, 2023). The JSRC shall serve as the primary governance body for pharmacovigilance matters relating to PPC-4187, providing oversight and coordinatio