Contract analysis

ARTICLE 1 — DEFINITIONS As used in this Quality Agreement (this "Agreement"), the following terms shall have the meanings set forth below. Capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to them in the License Agreement. 1.1 "Active Pharmaceutical Ingredient" or "API" shall mean the active pharmaceutical ingredient for PPC-4187 (Penteracitinib), a selective Janus ki

ARTICLE 2 — PURPOSE AND SCOPE 2.1 Purpose. The purpose of this Quality Agreement is to establish the quality-related responsibilities, obligations, and procedures governing: (a) the supply of API and Reference Standards by Penterra to Meridian; (b) the manufacture, testing, storage, release, and distribution of Licensed Products by Meridian in the Territory; and (c) the quality aspects of the technology transfer acti

ARTICLE 3 — QUALITY RESPONSIBILITIES OF PENTERRA (SUPPLIER) 3.1 Manufacturing and Supply of API. Penterra shall ensure that the API is manufactured at Alkerra Manufacturing Inc. (located at 5200 Meridian Parkway, Research Triangle Park, NC 27713), or at such other approved substitute facility as may be designated in accordance with Article 7 (Change Control), in compliance with cGMP, Applicable Laws, and all relevant

ARTICLE 4 — QUALITY RESPONSIBILITIES OF MERIDIAN (PURCHASER / LICENSEE) 4.1 Receipt and Incoming Testing. Meridian shall perform incoming quality control testing of each batch of API received from Penterra against the Specifications set forth in Appendix 1A. At a minimum, Meridian shall perform identity testing (by HPLC and IR spectroscopy) on each incoming batch of API. Full release testing, including assay, impurit

ARTICLE 5 — SPECIFICATIONS 5.1 API Specifications. The Specifications for the API (PPC-4187, Penteracitinib) are set forth in detail in Appendix 1A to this Agreement. The API Specifications include, without limitation, the following parameters and acceptance criteria: (a) Identity: Identification by high-performance liquid chromatography (HPLC) — retention time consistent with Reference Standard; identification by in

ARTICLE 6 — DEVIATION AND CAPA MANAGEMENT 6.1 Deviation Reporting. Each Party shall promptly identify, investigate, and document any Deviation from approved processes, procedures, Specifications, or quality standards occurring at its own facility or at the facility of any of its CMOs in connection with the manufacture, testing, storage, or distribution of API or Licensed Products. Each Deviation shall be classified b

ARTICLE 7 — CHANGE CONTROL 7.1 Notification of Proposed Changes. Either Party proposing a change to any aspect of the manufacture, testing, packaging, labeling, storage, or distribution of the API or Licensed Products shall notify the other Party in writing prior to implementation of such change. Without limitation, changes subject to this Article 7 include changes to: (a) Specifications; (b) manufacturing processes

ARTICLE 8 — COMPLAINT HANDLING 8.1 Product Quality Complaints. Each Party shall promptly notify the other Party's Quality Contact of any product quality complaint received relating to the API or Licensed Products. Notification shall be provided within five (5) business days of receipt of the complaint, or sooner if the complaint involves a potential patient safety concern. Notification shall include a summary of the

ARTICLE 9 — RECALLS AND FIELD SAFETY CORRECTIVE ACTIONS 9.1 Recall Decision. Meridian shall have primary decision-making authority for recalls, market withdrawals, field safety corrective actions, and field alerts relating to Licensed Products in the Territory. Penterra shall have primary decision-making authority for recalls, market withdrawals, and field safety corrective actions relating to Licensed Products in it

ARTICLE 10 — REGULATORY INSPECTIONS AND AUDITS 10.1 Regulatory Inspections. Each Party shall promptly notify the other Party's Quality Contact of any Regulatory Authority inspection that relates to or may affect PPC-4187 API or Licensed Products, whether conducted at such Party's own facility or at the facility of any of its CMOs. Notification shall be provided within forty-eight (48) hours of the inspection announce

ARTICLE 11 — ANNUAL PRODUCT QUALITY REVIEW 11.1 Scope. Each Party shall conduct an Annual Product Quality Review (APQR) for the products within its area of responsibility: Penterra shall prepare an APQR for the API (PPC-4187, Penteracitinib), and Meridian shall prepare an APQR for the finished Licensed Products (25 mg and 50 mg film-coated tablets). The APQR shall be conducted in accordance with ICH Q7 (for API), app

ARTICLE 12 — QUALITY GOVERNANCE AND COMMUNICATION 12.1 Quality Contacts. Each Party shall designate a primary Quality Contact and an alternate Quality Contact for purposes of day-to-day communication and coordination under this Agreement. The initial Quality Contacts of each Party are set forth in Appendix 3. Either Party may change its designated Quality Contact(s) at any time by providing written notice to the othe

ARTICLE 13 — DOCUMENTATION AND RECORD RETENTION 13.1 Documentation Standards. All quality documentation prepared, reviewed, approved, and maintained by either Party in connection with this Agreement shall comply with cGMP requirements and applicable data integrity standards, including the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate; plus Complete, Consistent, Enduring, and Available)