Contract analysis

1. Pre-Clinical Data Packages The Licensed Know-How includes the following pre-clinical data packages generated by or on behalf of Licensor in connection with the research and development of PPC-4187 (Penteracitinib). 1.1 In Vitro Pharmacology Data The Licensed Know-How includes all in vitro pharmacology data generated for PPC-4187, comprising the following: (a) Selective JAK1 inhibitor activity assays, including hal

2. Clinical Data Packages The Licensed Know-How includes the following clinical data packages generated by or on behalf of Licensor from clinical trials conducted with PPC-4187 (Penteracitinib) in human subjects. 2.1 Phase I Clinical Data (a) Phase I single ascending dose (SAD) study report (Study PPC-4187-101): a first-in-human, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability,

3. Proprietary Manufacturing Process The Licensed Know-How includes the following proprietary manufacturing process information relating to the synthesis, formulation, and manufacture of PPC-4187 (Penteracitinib) active pharmaceutical ingredient and drug product. 3.1 Active Pharmaceutical Ingredient (API) Manufacturing Process (a) The detailed synthetic route and process description for the manufacture of PPC-4187 AP

4. Analytical Methods The Licensed Know-How includes the following validated analytical methods, method validation reports, and reference standard documentation relating to PPC-4187 API and drug product. 4.1 API Analytical Methods (a) Validated analytical methods for the following quality attributes of PPC-4187 API: (i) identity (by infrared spectroscopy (IR) and high-performance liquid chromatography (HPLC) retentio

5. Stability Data The Licensed Know-How includes the following stability data packages for PPC-4187 API and drug product. 5.1 API Stability Data (a) Long-term stability data for PPC-4187 API stored at 25°C ± 2°C / 60% RH ± 5% RH, with data available through a minimum of 36 months as of the Effective Date, and accelerated stability data for PPC-4187 API stored at 40°C ± 2°C / 75% RH ± 5% RH, with data available throug

6. Chemistry, Manufacturing, and Controls (CMC) Documentation The Licensed Know-How includes the following CMC documentation prepared by or on behalf of Licensor for regulatory submissions relating to PPC-4187. 6.1 Drug Substance (API) CMC (a) Module 3.2.S sections of the Common Technical Document (CTD) as filed with or prepared for filing with the FDA, EMA, and other regulatory authorities, including: Section 3.2.S.

7. Regulatory Dossier Components The Licensed Know-How includes the following regulatory dossier components prepared by or on behalf of Licensor for PPC-4187: (a) Common Technical Document (CTD) modules or sections prepared by or on behalf of Penterra Pharmaceuticals Corp. for PPC-4187, to the extent such modules or sections constitute Know-How within the meaning of the Agreement, specifically including Modules 2, 3,

8. Additional Know-How 8.1 Crystalline Form Information The Licensed Know-How includes the following solid-state characterization data and crystalline form information for PPC-4187: (a) Polymorphic form characterization data for PPC-4187, including identification, characterization, and physicochemical properties of the designated crystalline forms: Form A (the thermodynamically stable form selected for commercial dev

9. Format and Delivery of Licensed Know-How All Licensed Know-How described in this Schedule B shall be delivered to Licensee in electronic format via Licensor's secure file transfer platform (currently Citrix ShareFile, with AES-256 encryption) within thirty (30) calendar days of the Effective Date (i.e., no later than November 19, 2023), except as otherwise specified in the Technology Transfer Agreement referenced

10. Confidentiality and Use Restrictions All Licensed Know-How described in this Schedule B constitutes Confidential Information of Licensor and is subject to the confidentiality obligations set forth in Article 12 (Confidentiality) of the Agreement. Without limiting the generality of the foregoing: (a) Licensee shall treat all Licensed Know-How as Confidential Information of Licensor and shall protect and safeguard

11. Updates and Supplements Licensor shall supplement this Schedule B with additional Know-How generated or obtained by Licensor during the term of the Agreement to the extent such additional Know-How relates to PPC-4187 (Penteracitinib) in the Territory, in accordance with the information-sharing obligations set forth in Section 4.6 of the Agreement. Such supplements shall be provided to Licensee in the format and m