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Contract analysis / schedule-a-licensed-patents.docx
schedule-a-licensed-patents.docx
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Section 1: Overview of Licensed Patent Portfolio
Section 1: Overview of Licensed Patent Portfolio The Licensed Patents licensed to Licensee under the Agreement consist of seven (7) patent families covering the following subject matter areas relating to the compound designated PPC-4187 (Penteracitinib): The Licensed Patents include all patents and patent applications listed below in Sections 2 through 8 of this Schedule A, together with all continuations, continuati
Section 2: Patent Family 1 — Composition of Matter
Section 2: Patent Family 1 — Composition of Matter Description: Patent Family 1 covers the novel chemical compound PPC-4187 (Penteracitinib), a selective Janus kinase 1 (JAK1) inhibitor, including its free base, pharmaceutically acceptable salts (including, without limitation, hydrochloride, mesylate, tosylate, fumarate, and tartrate salts), solvates, hydrates, polymorphs, and prodrugs thereof. This patent family pro
Section 3: Patent Family 2 — Crystalline Forms
Section 3: Patent Family 2 — Crystalline Forms Description: Patent Family 2 covers Crystalline Form A of PPC-4187 (Penteracitinib), including its characterization by X-ray powder diffraction (XRPD) pattern, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and other solid-state characterization data. The claims in this patent family cover Crystalline Form A as characterized by specific 2-thet
Section 4: Patent Family 3 — Methods of Use
Section 4: Patent Family 3 — Methods of Use Description: Patent Family 3 covers methods of treating moderate-to-severe atopic dermatitis in adult patients using PPC-4187 (Penteracitinib), including dosage-specific method claims for 25 mg and 50 mg once-daily oral administration. The claims in this patent family are supported by clinical data from Study PPC-4187-201, a multi-center, randomized, double-blind, placebo-c
Section 5: Patent Family 4 — Pharmaceutical Formulations
Section 5: Patent Family 4 — Pharmaceutical Formulations Description: Patent Family 4 covers oral pharmaceutical compositions comprising PPC-4187 (Penteracitinib), including film-coated tablet formulations at 25 mg and 50 mg dosage strengths, and specific excipient combinations including microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and an Thackeray Systems® II film coati
Section 6: Patent Family 5 — Manufacturing Process
Section 6: Patent Family 5 — Manufacturing Process Description: Patent Family 5 covers proprietary manufacturing processes for the synthesis and purification of PPC-4187 (Penteracitinib) active pharmaceutical ingredient (API), including key synthetic intermediates, catalytic coupling reactions, crystallization conditions, and critical process parameters for commercial-scale manufacturing. The manufacturing process de
Section 7: Patent Family 6 — Combination Therapy
Section 7: Patent Family 6 — Combination Therapy Description: Patent Family 6 covers methods and compositions for administering PPC-4187 (Penteracitinib) in combination with other therapeutic agents for the treatment of atopic dermatitis and related inflammatory conditions. Specifically, the claims encompass the co-administration of PPC-4187 with one or more topical corticosteroids, topical calcineurin inhibitors, ph
Section 8: Patent Family 7 — Dosage Regimen
Section 8: Patent Family 7 — Dosage Regimen Description: Patent Family 7 covers specific dosage regimens for once-daily oral administration of PPC-4187 (Penteracitinib) at specified dose levels for the treatment of moderate-to-severe atopic dermatitis, including titration protocols (e.g., initiation at 25 mg once daily for two weeks followed by escalation to 50 mg once daily), patient selection criteria based on base
Section 9: Summary Table — All Licensed Patents
Section 9: Summary Table — All Licensed Patents The following consolidated summary table lists all patents and patent applications across all seven (7) patent families and all jurisdictions. Entries marked with an asterisk (*) under the "Jurisdiction" column denote United States patents and applications that are listed for cross-reference and patent coordination purposes only pursuant to Article 12 of the Agreement a
Section 10: PCT Applications
Section 10: PCT Applications The following PCT applications serve as the basis for the national phase entries in the Licensed Patent portfolio: In each case, national phase entries from the respective PCT applications have been filed in the United States and in each of the Territory jurisdictions identified in Sections 2 through 8 above and in the Summary Table in Section 9 above. The PCT applications themselves are
Section 11: Notes and Qualifications
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⚑ Non-compete / exclusivity restraint
Section 11: Notes and Qualifications 11.1 Expiration Dates. All expiration dates set forth in this Schedule A are stated before any patent term extension ("PTE"), patent term adjustment ("PTA"), supplementary protection certificate ("SPC"), or equivalent extension that may be available under the applicable laws of the relevant jurisdiction. To the extent that any PTE, PTA, SPC, or equivalent extension is obtained for