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Contract analysis / client-letter-closing-confirmation.docx
client-letter-closing-confirmation.docx
1018-00006 · 32 clauses
High · 3 Medium · 1 Standard · 4
I. Confirmation of Closing High
⚑ Non-compete / exclusivity restraint
I. Confirmation of Closing Calderwood & Harkness LLP is pleased to confirm that the closing (the "Closing") of the out-license of compound PPC-4187 (proposed International Nonproprietary Name: Penteracitinib; proposed trade name: PENTECLAR) by Penterra Pharmaceuticals Corp., a Delaware corporation ("Penterra"), to Meridian Bio Therapeutics Limited, a Hong Kong limited company ("Meridian"), occurred today, October 20,
II. Summary of Key Transaction Terms High
⚑ Indemnity / guarantee obligation
II. Summary of Key Transaction Terms The following is a summary of the principal terms of the License Agreement and the transactions consummated at the Closing. This summary is qualified in its entirety by reference to the License Agreement and the other Transaction Documents. Licensed Compound. The licensed compound is PPC-4187, a selective Janus kinase 1 (JAK1) inhibitor being developed for the treatment of moderat
III. Escrow Payment Release Confirmation Standard
⚑ Commercial term
III. Escrow Payment Release Confirmation We confirm that the upfront payment of Eighteen Million Dollars ($18,000,000) (the "Upfront Payment"), which was held in escrow by Velthorn National Bank, N.A. (the "Escrow Agent"), has been released to Penterra in full upon satisfaction of all closing conditions under the License Agreement, effective as of October 20, 2023. The Upfront Payment was funded into the escrow accou
IV. Enclosed Fully Executed Transaction Documents
IV. Enclosed Fully Executed Transaction Documents Set forth below is a list of all fully executed Transaction Documents being delivered to you in connection with the Closing. Unless otherwise indicated, each document listed below is enclosed in its execution version. Copies of all documents are being retained in the firm's files, and originals are being delivered under separate cover, where applicable, by overnight c
1. Exclusive License Agreement, dated as of October 2, 2023 (effective October 20, 2023), High
⚑ Non-compete / exclusivity restraint
1. Exclusive License Agreement, dated as of October 2, 2023 (effective October 20, 2023), by and between Penterra Pharmaceuticals Corp. and Meridian Bio Therapeutics Limited.
2. Schedule A — Licensed Patents, listing seven (7) patent families, including:
2. Schedule A — Licensed Patents, listing seven (7) patent families, including: • U.S. Patent Nos. 11,234,567 and 11,345,678; • PCT/US2019/045123 national phase entries; • CN Patent No. ZL 2020 1 0456789.0; • JP Patent No. 7,012,345; • KR Patent No. 10-2345678; and • AU Patent No. 2020234567.
3. Schedule B — Licensed Know-How, describing the proprietary know-how, trade secrets, te
3. Schedule B — Licensed Know-How, describing the proprietary know-how, trade secrets, technical data, and regulatory documentation licensed to Meridian under the License Agreement.
4. Schedule C — Licensed Trademarks, identifying the PENTECLAR trademark, including U.S.
4. Schedule C — Licensed Trademarks, identifying the PENTECLAR trademark, including U.S. Registration No. 6,789,012 and corresponding trademark applications and registrations in the Territory.
5. Schedule D — Territory, setting forth the complete list of countries and territories c
5. Schedule D — Territory, setting forth the complete list of countries and territories comprising the Territory.
6. Schedule E — Development Plan, outlining the proposed Phase III clinical development p
6. Schedule E — Development Plan, outlining the proposed Phase III clinical development program, regulatory strategy, and associated timelines for PPC-4187 in the Territory.
7. Schedule F — MFN Pricing Methodology, detailing the methodology for calculating net pr Standard
⚑ Commercial term
7. Schedule F — MFN Pricing Methodology, detailing the methodology for calculating net prices, conducting quarterly reconciliations, and determining compliance with the most favored nation pricing clause.
8. Escrow Agreement, dated as of October 2, 2023, by and among Penterra, Meridian, and Ve
8. Escrow Agreement, dated as of October 2, 2023, by and among Penterra, Meridian, and Velthorn National Bank, N.A.
9. API Supply Agreement, dated as of October 2, 2023, by and between Penterra and Meridia
9. API Supply Agreement, dated as of October 2, 2023, by and between Penterra and Meridian, providing for the supply of active pharmaceutical ingredient and reference standard at cost plus a fifteen percent (15%) markup, for an initial term of three (3) years from the Effective Date.
10. Technology Transfer Agreement, dated as of October 2, 2023, by and between Penterra a
10. Technology Transfer Agreement, dated as of October 2, 2023, by and between Penterra and Meridian, providing for the transfer of manufacturing process know-how, analytical methods, and CMC documentation, with a completion deadline of twenty-four (24) months from the Effective Date.
11. Form of Quality Agreement, attached as an exhibit to the License Agreement, to be exe
11. Form of Quality Agreement, attached as an exhibit to the License Agreement, to be executed by the parties within sixty (60) days of the Effective Date (i.e., by December 19, 2023).
12. Trademark License Agreement for PENTECLAR, dated as of October 2, 2023, granting Meri
12. Trademark License Agreement for PENTECLAR, dated as of October 2, 2023, granting Meridian a license to use the PENTECLAR trademark in the Territory in connection with the commercialization of PPC-4187.
13. Pharmacovigilance Agreement, dated as of October 2, 2023, by and between Penterra and
13. Pharmacovigilance Agreement, dated as of October 2, 2023, by and between Penterra and Meridian, establishing the parties' respective obligations with respect to adverse event reporting, safety data exchange, signal detection, and periodic safety reporting.
14. Officer's Certificate — Penterra Pharmaceuticals Corp., executed by Anita M. Fremont,
14. Officer's Certificate — Penterra Pharmaceuticals Corp., executed by Anita M. Fremont, Esq., General Counsel, dated October 20, 2023.
15. Officer's Certificate — Meridian Bio Therapeutics Limited, executed by David R. Cheun
15. Officer's Certificate — Meridian Bio Therapeutics Limited, executed by David R. Cheung, Chief Executive Officer, dated October 20, 2023.
16. Secretary's Certificate — Penterra Pharmaceuticals Corp., certifying copies of resolu
16. Secretary's Certificate — Penterra Pharmaceuticals Corp., certifying copies of resolutions of the Board of Directors authorizing the transaction, incumbency of officers, and organizational documents (including Certificate of Incorporation and Bylaws) (EIN: 22-3948175).
17. Secretary's Certificate — Meridian Bio Therapeutics Limited, certifying copies of res
17. Secretary's Certificate — Meridian Bio Therapeutics Limited, certifying copies of resolutions of the Board of Directors, incumbency of officers, and constitutional documents (HK Company Registration No. 2847631).
18. Good Standing Certificate — Penterra Pharmaceuticals Corp., issued by the Secretary o
18. Good Standing Certificate — Penterra Pharmaceuticals Corp., issued by the Secretary of State of the State of Delaware, obtained October 12, 2023.
19. Legal Opinion — Calderwood & Harkness LLP to Meridian Bio Therapeutics Limited, dated
19. Legal Opinion — Calderwood & Harkness LLP to Meridian Bio Therapeutics Limited, dated October 20, 2023, delivered on behalf of Penterra in accordance with Section 8.2(d) of the License Agreement.
20. Legal Opinion — Lam, Cheung & Firth LLP to Penterra Pharmaceuticals Corp., dated Octo
20. Legal Opinion — Lam, Cheung & Firth LLP to Penterra Pharmaceuticals Corp., dated October 20, 2023, delivered on behalf of Meridian in accordance with Section 8.3(d) of the License Agreement.
21. Escrow Funding Confirmation Letter — Velthorn National Bank, N.A., dated October 6, 2
21. Escrow Funding Confirmation Letter — Velthorn National Bank, N.A., dated October 6, 2023, confirming receipt of $18,000,000 from Meridian into the escrow account. Please review the enclosed documents carefully and contact us promptly if you identify any discrepancies or if any documents appear to be missing.
V. Antitrust and Regulatory Clearance Standard
⚑ Commercial term
V. Antitrust and Regulatory Clearance We confirm that no filing under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"), was required in connection with the Closing. The transaction constitutes a pure intellectual property license and does not involve the acquisition of voting securities, assets, or a controlling interest in any entity. Moreover, the transaction does not meet the ap
VI. Post-Closing Obligations and Deadlines Medium
⚑ Notice / time limit to track
VI. Post-Closing Obligations and Deadlines Set forth below is a summary of the principal post-closing obligations of the parties under the License Agreement and the ancillary Transaction Documents, together with the associated deadlines. We will be maintaining a detailed post-closing obligations tracker and will proactively advise Penterra as deadlines approach. A. Quality Agreement Execution The form of Quality Agre
I. Withholding Tax and Transfer Pricing
I. Withholding Tax and Transfer Pricing Royalty and milestone payments under the License Agreement are subject to applicable withholding taxes. We note the following considerations: • Direct payments from Meridian Bio Therapeutics Limited (Hong Kong) to Penterra should be subject to a zero percent (0%) withholding tax rate under the U.S.–Hong Kong arrangement, subject to confirmation that no "permanent establishment"
VII. Counterparty Counsel and Advisors
VII. Counterparty Counsel and Advisors For your reference, the following firms served as counsel and advisors to Meridian in connection with the transaction: Meridian's Legal Counsel: Lam, Cheung & Firth LLP • Lead Partner: Jonathan M. Firth, Esq. • Associate: Rebecca S. Liang, Esq. • Hong Kong Office: 25/F, Jardine House, 1 Connaught Place, Central, Hong Kong SAR • New York Office: 1345 Avenue of the Americas, 22nd
VIII. Calderwood & Harkness LLP Engagement Team
VIII. Calderwood & Harkness LLP Engagement Team The following members of Calderwood & Harkness LLP comprised the engagement team for this transaction: • Marcus Delgado — Responsible Partner, intellectual Property • Catherine Bloom — Billing Partner, intellectual Property • Peter Vassiliev — Lead Associate, intellectual Property • Wendy Schultz — Working Associate, intellectual Property • Sylvia Hartwell — Specialist
IX. Fee and Billing Matters Standard
⚑ Commercial term
IX. Fee and Billing Matters We will be issuing a final invoice for all professional fees and disbursements incurred through the Closing Date in accordance with the terms of our engagement letter dated July 10, 2023. Based on the scope of work performed, we estimate that total fees for the engagement will fall within the range of Eight Hundred Fifty Thousand Dollars ($850,000) to One Million One Hundred Thousand Dolla
X. Closing Remarks
X. Closing Remarks On behalf of the entire Calderwood & Harkness team, we extend our sincere congratulations to Penterra on the successful closing of this transaction. The out-license of PPC-4187 to Meridian represents a significant milestone in Penterra's pipeline monetization strategy and provides a compelling pathway for the commercialization of Penteracitinib across the Asia-Pacific region. This transaction meani