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Contract analysis / closing-memorandum.docx
closing-memorandum.docx
High · 9
Medium · 2
Standard · 2
I. Purpose and Executive Summary
High
⚑ Non-compete / exclusivity restraint
I. Purpose and Executive Summary This memorandum documents the closing of the exclusive out-license of compound PPC-4187 (proposed International Nonproprietary Name ("INN"): Penteracitinib; proposed trade name: PENTECLAR) by Penterra Pharmaceuticals Corp. ("Penterra" or the "Licensor"), a Delaware corporation publicly traded on the Nasdaq Global Select Market under the ticker symbol PNTR, to Meridian Bio Therapeutics
II. The Parties
II. The Parties A. Penterra Pharmaceuticals Corp. (Client / Licensor) Full Legal Name: Penterra Pharmaceuticals Corp. Entity Type and Jurisdiction: Corporation organized and existing under the laws of the State of Delaware; Employer Identification Number (EIN) 22-3948175. Headquarters: 400 Pharma Drive, Suite 800, Princeton, New Jersey 08540. Registered Agent: Cobalt Ridge Technologies, 1209 Orange Street, Wilmington
III. The Compound — PPC-4187
III. The Compound — PPC-4187 PPC-4187 is a selective Janus kinase 1 (JAK1) inhibitor being developed as an oral, once-daily tablet formulation in two dosage strengths: 25 mg and 50 mg film-coated tablets. The compound is intended for the treatment of moderate-to-severe atopic dermatitis in adult patients. JAK1 selectivity is a key differentiating feature of PPC-4187 relative to earlier-generation JAK inhibitors, as i
IV. Licensed Territory
IV. Licensed Territory The Licensed Territory (the "Territory") comprises the following countries and territories, as specified in Schedule D to the License Agreement:
1. People's Republic of China, including Hong Kong Special Administrative Region and Maca
1. People's Republic of China, including Hong Kong Special Administrative Region and Macau Special Administrative Region
10. Republic of the Philippines
10. Republic of the Philippines
11. Socialist Republic of Vietnam
11. Socialist Republic of Vietnam
12. Taiwan
High
⚑ Non-compete / exclusivity restraint
12. Taiwan The License Agreement grants Meridian an exclusive license under the Licensed Patents, Licensed Know-How, and Licensed Trademarks to develop, manufacture, have manufactured, use, import, export, offer for sale, sell, and otherwise commercialize the Licensed Product in all dosage forms and formulations within the Territory for the Field (defined as the treatment of moderate-to-severe atopic dermatitis in ad
V. Key Transaction Terms
High
⚑ Indemnity / guarantee obligation
V. Key Transaction Terms A. Financial Terms — Overview The total maximum deal value under the License Agreement is up to One Hundred Twenty Million Dollars ($120,000,000), excluding royalties on net sales. The aggregate consideration is structured as follows: In addition to the foregoing milestone-based payments, Meridian is obligated to pay tiered royalties on annual net sales of the Licensed Product in the Territor
I. Indemnification Provisions
High
⚑ Indemnity / guarantee obligation
I. Indemnification Provisions The License Agreement contains mutual indemnification obligations as set forth in Article XII. Penterra (Licensor) Indemnification: Penterra shall indemnify, defend, and hold harmless Meridian and its affiliates, and their respective officers, directors, employees, and agents (collectively, "Meridian Indemnitees") from and against any and all losses, damages, liabilities, costs, and expe
VI. Intellectual Property Portfolio Licensed
High
⚑ Non-compete / exclusivity restraint
VI. Intellectual Property Portfolio Licensed The Licensed intellectual Property encompasses seven (7) patent families, registered trademarks, and a substantial body of proprietary know-how. The complete portfolio is detailed in Schedules A, B, and C to the License Agreement. A summary of the key assets follows. Licensed Patent Families (Schedule A): The seven patent families cover the following subject matter: compos
VII. Tax Considerations
VII. Tax Considerations The tax structuring of the transaction was analyzed by Sylvia Hartwell, Specialist Partner (Tax) at Calderwood & Harkness, and is the subject of a separate and more detailed Tax Structuring Memorandum. The following is a summary of the key tax considerations identified in connection with the transaction. Withholding Tax: Royalty and milestone payments made by Meridian (a Hong Kong limited comp
VIII. Regulatory and Antitrust Matters
High
⚑ Non-compete / exclusivity restraint
VIII. Regulatory and Antitrust Matters Hart-Scott-Rodino Antitrust Improvements Act (HSR Act): The parties analyzed whether the transaction required a pre-closing notification filing under the HSR Act and the regulations of the Federal Trade Commission. It was determined that no HSR filing was required because the transaction constitutes a pure intellectual property license that does not involve the acquisition of vo
IX. Transaction Timeline
High
⚑ Penalty / liquidated damages
IX. Transaction Timeline The following table sets forth the key dates and events in the transaction: The eleven-day delay between the originally scheduled Closing Date (October 9, 2023) and the actual Closing Date (October 20, 2023) was attributable to processing delays in one or more Territory jurisdictions with respect to the recordation of intellectual property assignments or license grants. Section 8.2(d) of the
X. Advisors and Counsel
Standard
⚑ Commercial term
X. Advisors and Counsel A. Licensor's Counsel Calderwood & Harkness LLP 600 Lexington Avenue, 30th Floor New York, New York 10022 Calderwood & Harkness served as primary legal counsel to Penterra in all aspects of the transaction, including structuring, negotiation, drafting, due diligence, tax analysis, and closing. The matter team consists of the following attorneys: • Marcus Delgado — Responsible Partner, intellec
XI. Closing Deliverables Completed
XI. Closing Deliverables Completed The following is a comprehensive list of all closing deliverables that were executed, delivered, or confirmed in connection with the closing of the transaction on October 20, 2023. All executed originals and counterparts have been filed in the matter closing binder, and electronic copies have been uploaded to the firm's document management system. A. Transaction Agreements (Executed
1. Exclusive License Agreement — dated October 2, 2023; effective October 20, 2023 — amon
High
⚑ Non-compete / exclusivity restraint
1. Exclusive License Agreement — dated October 2, 2023; effective October 20, 2023 — among Penterra Pharmaceuticals Corp. and Meridian Bio Therapeutics Limited.
2. Schedule A — Licensed Patents — attached to and incorporated by reference in the Licen
2. Schedule A — Licensed Patents — attached to and incorporated by reference in the License Agreement, setting forth the complete list of patent families, patent numbers, jurisdictions, filing dates, grant dates, and expiration dates for all Licensed Patents.
3. Schedule B — Licensed Know-How — attached to and incorporated by reference in the Lice
3. Schedule B — Licensed Know-How — attached to and incorporated by reference in the License Agreement, describing the proprietary manufacturing process, analytical methods, pre-clinical and clinical data packages, CMC documentation, and other know-how licensed to Meridian.
4. Schedule C — Licensed Trademarks — attached to and incorporated by reference in the Li
4. Schedule C — Licensed Trademarks — attached to and incorporated by reference in the License Agreement, listing all trademark registrations and applications for the PENTECLAR mark and associated logos, by jurisdiction.
5. Schedule D — Territory — attached to and incorporated by reference in the License Agre
5. Schedule D — Territory — attached to and incorporated by reference in the License Agreement, specifying the twelve (12) countries and territories comprising the Licensed Territory.
6. Schedule E — Development Plan — attached to and incorporated by reference in the Licen
6. Schedule E — Development Plan — attached to and incorporated by reference in the License Agreement, setting forth the initial development plan for PPC-4187 in the Territory, including anticipated Phase III trial design, timeline, and regulatory strategy for NMPA and PMDA submissions.
7. Schedule F — MFN Pricing Methodology — attached to and incorporated by reference in th
Standard
⚑ Commercial term
7. Schedule F — MFN Pricing Methodology — attached to and incorporated by reference in the License Agreement, setting forth the detailed methodology for determining net prices, comparable pack sizes, and MFN floor prices for quarterly reconciliation purposes.
8. Escrow Agreement — dated October 2, 2023 — among Penterra Pharmaceuticals Corp., Merid
8. Escrow Agreement — dated October 2, 2023 — among Penterra Pharmaceuticals Corp., Meridian Bio Therapeutics Limited, and Velthorn National Bank, N.A.
9. API Supply Agreement — dated October 2, 2023 — between Penterra Pharmaceuticals Corp.
9. API Supply Agreement — dated October 2, 2023 — between Penterra Pharmaceuticals Corp. and Meridian Bio Therapeutics Limited; providing for supply of API and reference standard at cost plus 15% markup for an initial term of three (3) years.
10. Technology Transfer Agreement — dated October 2, 2023 — between Penterra Pharmaceutic
10. Technology Transfer Agreement — dated October 2, 2023 — between Penterra Pharmaceuticals Corp. and Meridian Bio Therapeutics Limited; providing for transfer of manufacturing process know-how, analytical methods, and CMC documentation within twenty-four (24) months of the Effective Date.
11. Trademark License Agreement — PENTECLAR — dated October 2, 2023 — between Penterra Ph
11. Trademark License Agreement — PENTECLAR — dated October 2, 2023 — between Penterra Pharmaceuticals Corp. (as licensor) and Meridian Bio Therapeutics Limited (as licensee); granting Meridian the right to use the PENTECLAR trademark in the Territory subject to Penterra's quality control standards.
12. Pharmacovigilance Agreement — dated October 2, 2023 — between Penterra Pharmaceutical
12. Pharmacovigilance Agreement — dated October 2, 2023 — between Penterra Pharmaceuticals Corp. and Meridian Bio Therapeutics Limited; governing adverse event reporting, safety data exchange, periodic safety update reports, and coordination of global safety database responsibilities.
13. Quality Agreement (Form) — form attached to the License Agreement; to be finalized an
Medium
⚑ Notice / time limit to track
13. Quality Agreement (Form) — form attached to the License Agreement; to be finalized and executed by December 19, 2023 (within 60 days of the Effective Date). B. Certificates.
14. Officer's Certificate — Penterra — executed by Anita M. Fremont, General Counsel; dat
14. Officer's Certificate — Penterra — executed by Anita M. Fremont, General Counsel; dated October 20, 2023; certifying the accuracy of Penterra's representations and warranties as of the Effective Date and the satisfaction of Penterra's conditions precedent to closing.
15. Officer's Certificate — Meridian — executed by David R. Cheung, General Counsel; date
15. Officer's Certificate — Meridian — executed by David R. Cheung, General Counsel; dated October 20, 2023; certifying the accuracy of Meridian's representations and warranties as of the Effective Date and the satisfaction of Meridian's conditions precedent to closing.
16. Secretary's Certificate — Penterra — dated October 20, 2023; certifying the board res
16. Secretary's Certificate — Penterra — dated October 20, 2023; certifying the board resolutions adopted on July 18, 2023, authorizing the transaction, incumbency of officers executing transaction documents, and authenticity of organizational documents (Certificate of Incorporation, Bylaws); EIN 22-3948175.
17. Secretary's Certificate — Meridian — dated October 20, 2023; certifying board resolut
17. Secretary's Certificate — Meridian — dated October 20, 2023; certifying board resolutions authorizing the transaction, incumbency of authorized signatories, and authenticity of organizational documents (Memorandum and Articles of Association); HK Company Reg. No. 2847631.
18. Good Standing Certificate — Penterra — issued by the Delaware Secretary of State; obt
18. Good Standing Certificate — Penterra — issued by the Delaware Secretary of State; obtained October 12, 2023; confirming that Penterra Pharmaceuticals Corp. is in good standing under the laws of the State of Delaware. C. Legal Opinions
19. Legal Opinion — Calderwood & Harkness LLP to Meridian — delivered by Marcus Delgado,
19. Legal Opinion — Calderwood & Harkness LLP to Meridian — delivered by Marcus Delgado, Partner; dated October 20, 2023; opining on: (i) due organization and valid existence of Penterra under Delaware law; (ii) good standing in Delaware; (iii) due authorization of the License Agreement and ancillary agreements by Penterra; (iv) enforceability of the License Agreement and ancillary agreements against Penterra; and (v
20. Legal Opinion — Lam, Cheung & Firth LLP to Penterra — dated October 20, 2023; opining
20. Legal Opinion — Lam, Cheung & Firth LLP to Penterra — dated October 20, 2023; opining on: (i) due authorization of the License Agreement and ancillary agreements by Meridian under Hong Kong law; (ii) enforceability of the License Agreement and ancillary agreements against Meridian; and (iii) no conflicts with Meridian's constitutional documents or, to their knowledge, any material agreement to which Meridian is a
21. Escrow Funding Confirmation Letter — issued by Velthorn National Bank, N.A. (Teresa M
21. Escrow Funding Confirmation Letter — issued by Velthorn National Bank, N.A. (Teresa M. D'Angelo, Escrow Officer); dated October 6, 2023; confirming receipt of $18,000,000 from Meridian Bio Therapeutics Limited into the escrow account established pursuant to the Escrow Agreement.
22. Escrow Release Instruction and Confirmation — dated October 20, 2023; joint release i
22. Escrow Release Instruction and Confirmation — dated October 20, 2023; joint release instructions executed by Penterra and Meridian, directing the Escrow Agent to release $18,000,000 to Penterra's designated account; confirmation of release issued by the Escrow Agent on the same date. E. Other.
23. Confirmation of No HSR Filing Requirement — confirmed October 5, 2023; memorandum doc
23. Confirmation of No HSR Filing Requirement — confirmed October 5, 2023; memorandum documenting analysis that the transaction does not meet HSR thresholds and constitutes a pure intellectual property license not requiring pre-closing notification.
24. IP Assignment Recordation Filings — completed across all Territory jurisdictions; las
High
⚑ Non-compete / exclusivity restraint
24. IP Assignment Recordation Filings — completed across all Territory jurisdictions; last jurisdiction completed on October 18, 2023. Recordation filings documented the exclusive license grant in favor of Meridian in each applicable Territory patent and trademark registry. Confirmations and official receipts from each jurisdiction have been collected and filed (with follow-up pending for any jurisdictions where offi
XII. Post-Closing Obligations
Medium
⚑ Assignment / subcontracting
XII. Post-Closing Obligations The following post-closing obligations remain outstanding or require ongoing attention. Wendy Schultz is responsible for maintaining the Post-Closing Obligations Tracker and coordinating with the client team and opposing counsel as necessary. A. Quality Agreement Execution Deadline: Within sixty (60) days of the Effective Date — by December 19, 2023. The Quality Agreement is to be finali