Contract analysis

I. Executive Summary This memorandum sets forth the findings of the comprehensive intellectual property due diligence conducted by Calderwood & Harkness LLP ("C&H") in connection with Penterra Pharmaceuticals Corp.'s ("Penterra" or the "Company") proposed exclusive out-license of compound PPC-4187 (proposed International Nonproprietary Name: Penteracitinib) to Meridian Bio Therapeutics Limited ("Meridian") for the As

II. Background A. The Compound — PPC-4187 PPC-4187 is a selective Janus kinase 1 ("JAK1") inhibitor under development by Penterra for the treatment of moderate-to-severe atopic dermatitis in adult patients. The compound has been designed as an oral, once-daily tablet formulation, offering a convenient dosing regimen intended to improve patient compliance relative to existing treatment modalities. The proposed Interna

1. People's Republic of China (including Hong Kong Special Administrative Region and Macau Special Administrative Region)

12. Taiwan Meridian's regional presence in the Territory is supported by several subsidiaries: Meridian Pharma (Shanghai) Co., Ltd., a PRC wholly foreign-owned enterprise ("WFOE") established to conduct regulatory and commercial operations in mainland China; Meridian Japan K.K., headquartered in Tokyo, which will serve as the Japanese development and commercialization entity; Meridian Korea Inc., based in Seoul, resp

III. Patent Portfolio Overview A. Summary of Patent Families Penterra's PPC-4187 patent portfolio comprises seven (7) patent families, each directed to a distinct aspect of the compound's intellectual property: These seven patent families collectively provide a layered intellectual property strategy designed to protect PPC-4187 from multiple angles — the compound itself (Family 1), its preferred crystalline form (Fam

IV. Patent Validity and Enforceability Analysis A. Methodology Our patent validity and enforceability analysis was conducted through a multi-faceted review process encompassing the following elements:

1. Prosecution History Review. We reviewed the complete prosecution histories (file wrappers) for all granted patents in the PPC-4187 portfolio, including examiner actions, applicant responses, claim amendments, declarations, and notices of allowance. For pending applications, we reviewed all prosecution correspondence to date.

2. Prior Art Analysis. We analyzed all prior art references cited during prosecution — both by patent examiners and by the applicant through Information Disclosure Statements — to assess whether any cited references, individually or in combination, could support a potential invalidity challenge based on anticipation (35 U.S.C. § 102 or foreign equivalents) or obviousness (35 U.S.C. § 103 or foreign equivalents).

3. Invalidity Challenge Assessment. We evaluated the vulnerability of each granted patent to potential invalidity challenges on the grounds of anticipation, obviousness, lack of enablement, insufficient written description, and indefiniteness. This assessment was informed by the prosecution histories, the cited prior art landscape, and relevant case law in each jurisdiction.

4. Post-Grant Proceedings Review. We searched for and reviewed any post-grant proceedings, including inter partes review ("IPR") petitions in the United States, invalidation requests before CNIPA in China, oppositions before the JPO in Japan, invalidation trials before KIPO in South Korea, and re-examination or opposition proceedings before IP Australia. No such proceedings were identified for any patent in the PPC-4

V. Freedom-to-Operate Analysis A. Summary of Whitford & Marsh FTO Opinion Dr. Alan J. Whitford of Whitford & Cascade Insurance Brokers prepared a comprehensive Freedom-to-Operate ("FTO") opinion, dated August 22, 2023, analyzing the risks associated with the manufacture, use, sale, offer for sale, and importation of PPC-4187 (Penteracitinib) in the Licensed Territory. The FTO opinion was prepared at Penterra's direct

1. No composition-of-matter overlap. PPC-4187's novel chemical structure is not encompassed by any identified third-party composition-of-matter patent claim in any Territory jurisdiction. The selective JAK1 mechanism and the distinctive chemical scaffold of PPC-4187 differentiate it from the compounds claimed in existing JAK inhibitor patents, which are directed to structurally distinct molecules (e.g., tofacitinib,

2. Formulation and manufacturing process claims. The 25 mg and 50 mg film-coated tablet formulation of PPC-4187 does not infringe any identified third-party formulation claims. The excipient compositions, film-coating specifications, and dissolution profiles of PPC-4187 tablets are distinct from those claimed in third-party formulation patents. Similarly, Penterra's proprietary manufacturing process does not overlap

3. Method-of-use patents — Japan. Three Japanese method-of-use patents were identified as potentially relevant: JP Patent Nos. 6,789,012; 6,890,123; and 6,901,234. Upon detailed claim construction analysis, Dr. Whitford concluded that these patents are distinguishable from PPC-4187 on the following grounds: • JP Patent No. 6,789,012 (Astellas): Claims are limited to methods of treating dermatological conditions using

1. Ongoing Monitoring. Penterra and Meridian should implement a systematic patent watch service to monitor new third-party patent filings in all Territory jurisdictions, with particular emphasis on Japan and China, where the JAK inhibitor patent landscape is most active.

2. Design-Around Strategies. If any pending third-party applications in the Territory (particularly CN Application No. 202010890123.4) issue with claims broader than currently anticipated, Penterra and Meridian should consider formulation design-around strategies to further mitigate risk.

3. Indemnification Protections. Penterra's indemnification obligation under the proposed License Agreement covers pre-existing IP infringement claims arising from the Licensed IP as of the Effective Date. This indemnification, which is uncapped (carved out from the general indemnification cap), provides Meridian with significant protection against third-party infringement claims.

4. Coordination with Patent Prosecution. Penterra should coordinate with Whitford & Cascade Insurance Brokers to ensure that prosecution of pending PPC-4187 applications does not create prosecution history estoppel issues that could affect the FTO position.

VI. Trademark Analysis A. PENTECLAR Trademark Portfolio PENTECLAR is the proposed commercial trade name for PPC-4187 (Penteracitinib) in the Licensed Territory and worldwide. Penterra has pursued a global trademark strategy to secure registration of the PENTECLAR mark in all key markets, including all Territory jurisdictions. The following table sets forth the current status of PENTECLAR trademark registrations and a

1. Proceed with Registrations. Continue prosecution of pending trademark applications in all Territory jurisdictions (Hong Kong SAR, Australia, Thailand, Malaysia, Indonesia, and Vietnam) and maintain registrations in jurisdictions where the mark has been granted.

2. Chinese-Language Trade Name. Develop and file a Chinese-language equivalent trade name for the PRC market as a priority. The selected Chinese name should undergo full clearance searching and should be filed for registration with CNIPA promptly upon selection. This process should be coordinated with Meridian Pharma (Shanghai) Co., Ltd., given Meridian's familiarity with the Chinese pharmaceutical market and regulat

3. Monitoring. Implement trademark watch services in all Territory jurisdictions to monitor for any third-party filings that could conflict with PENTECLAR or the Chinese-language trade name. This is particularly important in jurisdictions with first-to-file trademark systems, such as China, where bad-faith trademark squatting remains a concern.

4. Trademark License. Under the proposed Transaction, Meridian will be granted an exclusive license to use the PENTECLAR trademark in the Territory pursuant to a separate Trademark License Agreement. This agreement should include provisions for quality control, brand standards, trademark maintenance obligations, and post-termination transition requirements.

VII. Identification of Third-Party IP Risks A. Third-Party Patent Risks While the overall FTO analysis concludes that the risk of third-party patent infringement is low, several third-party patents and pending applications have been identified during the diligence process that, while not creating a high infringement risk, warrant ongoing monitoring and, in certain cases, proactive risk management. Japanese Method-of-