CALDERWOOD & HARKNESS LLP
Attorneys at Law
600 Lexington Avenue, 30th Floor New York, New York 10022
Telephone: (212) 554-7000 Facsimile: (212) 554-7001 www.calderwoodharkness.com
October 20, 2023
Meridian Bio Therapeutics Limited 18/F, Blossom Tower 88 Queen's Road Central Hong Kong SAR
Attention: David R. Cheung, Esq., General Counsel
Re: Exclusive License Agreement dated as of October 2, 2023 (effective October 20, 2023) by and between Penterra Pharmaceuticals Corp. and Meridian Bio Therapeutics Limited — Out-License of Compound PPC-4187 (Penteracitinib)
Dear Mr. Cheung:
We have acted as counsel to Penterra Pharmaceuticals Corp., a corporation organized and existing under the laws of the State of Delaware ("Penterra" or the "Company"), in connection with the negotiation, execution, and delivery of the Exclusive License Agreement dated as of October 2, 2023, with an effective date of October 20, 2023 (the "License Agreement"), by and between Penterra and Meridian Bio Therapeutics Limited, a limited company organized under the laws of Hong Kong Special Administrative Region ("Meridian"), relating to the out-license of Penterra's proprietary compound PPC-4187 (proposed International Nonproprietary Name: Penteracitinib) in the Asia-Pacific Territory, as such term is defined in the License Agreement (the "Territory"). This opinion letter is being delivered to Meridian pursuant to Section 9.2(e) of the License Agreement as a condition precedent to the closing of the transactions contemplated thereby, and is rendered as of the Closing Date and Effective Date of October 20, 2023.
In connection with the preparation and delivery of this opinion letter, we have examined the documents, instruments, certificates, and records described in Section 1 below, and we have considered such matters of law as we have deemed necessary or appropriate to render the opinions set forth herein.
1. Documents Examined
In connection with the opinions expressed herein, we have examined originals or copies, certified or otherwise identified to our satisfaction, of the following documents:
1.1. The Exclusive License Agreement dated as of October 2, 2023 (effective October 20, 2023), by and between Penterra and Meridian (the "License Agreement");
1.2. The Escrow Agreement dated as of October 2, 2023, among Penterra, Meridian, and Velthorn National Bank, N.A., a national banking association, as escrow agent (the "Escrow Agreement");
1.3. The API Supply Agreement dated as of October 2, 2023, by and between Penterra and Meridian (the "Supply Agreement");
1.4. The Technology Transfer Agreement dated as of October 2, 2023, by and between Penterra and Meridian (the "Technology Transfer Agreement");
1.5. The Trademark License Agreement dated as of October 2, 2023, by and between Penterra and Meridian, relating to the PENTECLAR mark and associated trademarks in the Territory (the "Trademark License Agreement");
1.6. The Pharmacovigilance Agreement dated as of October 2, 2023, by and between Penterra and Meridian, governing the parties' respective obligations with respect to the reporting, exchange, and management of safety data and adverse event information relating to Penteracitinib in the Territory (the "Pharmacovigilance Agreement," and together with the License Agreement, the Escrow Agreement, the Supply Agreement, the Technology Transfer Agreement, and the Trademark License Agreement, collectively, the "Transaction Agreements");
1.7. The Restated Certificate of Incorporation of Penterra Pharmaceuticals Corp., as filed with the Secretary of State of the State of Delaware on March 14, 2016, together with all Certificates of Amendment thereto through and including the Certificate of Amendment filed on June 8, 2022, and the Amended and Restated Bylaws of Penterra, as adopted by the Board of Directors on September 12, 2022 and in effect as of the date hereof (collectively, the "Organizational Documents");
1.8. Resolutions of the Board of Directors of Penterra dated July 18, 2023, authorizing and approving the negotiation, execution, and delivery of the Transaction Agreements and the consummation of the transactions contemplated thereby, as certified to us in the Secretary's Certificate referenced below (the "Board Resolutions");
1.9. The Officer's Certificate of Anita M. Fremont, Esq., General Counsel and Secretary of Penterra, dated as of October 20, 2023, certifying certain factual matters relevant to the opinions expressed herein, including the identification of material agreements, instruments, and obligations to which Penterra is a party or by which it is bound (the "Officer's Certificate");
1.10. The Secretary's Certificate of Penterra dated as of October 20, 2023, executed by the Assistant Secretary of Penterra, certifying, among other things, the authenticity and continuing effectiveness of the Board Resolutions, the incumbency and specimen signatures of officers authorized to execute the Transaction Agreements on behalf of Penterra, and the current effectiveness of the Organizational Documents (the "Secretary's Certificate");
1.11. A Certificate of Good Standing of Penterra Pharmaceuticals Corp. issued by the Secretary of State of the State of Delaware dated October 12, 2023 (the "Good Standing Certificate"); and
1.12. Such other documents, records, instruments, agreements, certificates, and opinions as we have deemed necessary or appropriate for purposes of rendering the opinions expressed herein, including a review of the docket and records of the Delaware Court of Chancery and the United States Bankruptcy Court for the District of Delaware with respect to Penterra.
The documents described in clauses 1.1 through 1.6 above are collectively referred to herein as the "Transaction Agreements." The documents described in clauses 1.7 through 1.12 above, together with the Transaction Agreements, are collectively referred to herein as the "Reviewed Documents."
2. Assumptions
In rendering the opinions set forth in this letter, we have, with your permission and without independent investigation or verification, assumed the following:
2.1. Authenticity and Conformity of Documents. All documents submitted to us as originals are authentic, complete, and accurate, and all documents submitted to us as copies conform in all material respects to the originals thereof. All signatures on all documents are genuine, other than the signatures of officers and authorized representatives of Penterra, as to which we have satisfied ourselves through examination of the Secretary's Certificate and incumbency certifications.
2.2. Authority and Execution by Other Parties. Each party to the Transaction Agreements other than Penterra (including, without limitation, Meridian and Velthorn National Bank, N.A.) has the requisite corporate or other organizational power and authority under all applicable laws and its respective constituent or organizational documents, and has taken all necessary corporate or other organizational action, to authorize the execution, delivery, and performance of each Transaction Agreement to which it is a party. Each such party has duly executed and delivered each Transaction Agreement to which it is a party, and the signature of each person signing on behalf of each such party is genuine and such person has been duly authorized to sign on behalf of such party.
2.3. Binding Obligations of Other Parties. Each of the Transaction Agreements constitutes a legal, valid, and binding obligation of each party thereto other than Penterra, enforceable against each such party in accordance with its terms, subject to qualifications comparable to the Enforceability Qualifications described in Section 4.1 hereof.
2.4. Accuracy of Certificates and Statements of Fact. The factual matters, representations, warranties, and statements of fact set forth in the Officer's Certificate and the Secretary's Certificate delivered to us by representatives and officers of Penterra are true, correct, and complete as of the date hereof. We have relied upon such certificates and statements without independent verification or investigation of the underlying factual matters stated therein.
2.5. Legal Capacity of Natural Persons. All natural persons who have executed any of the Reviewed Documents or who have otherwise acted on behalf of any party to any of the Reviewed Documents had, at all relevant times, the legal capacity to do so.
2.6. Continuing Accuracy of Good Standing Certificate. The Good Standing Certificate issued by the Secretary of State of the State of Delaware dated October 12, 2023 accurately reflects the status of Penterra as of the date of its issuance and continues to be accurate in all respects as of the date hereof, and no event has occurred between the date of such certificate and the date hereof that would cause such certificate to be inaccurate or misleading.
2.7. Absence of Undisclosed Agreements or Facts. There are no agreements, instruments, obligations, orders, judgments, decrees, or other matters that are material to the opinions expressed herein that have not been disclosed to us by Penterra in the Officer's Certificate, the Secretary's Certificate, or in the other Reviewed Documents. The Transaction Agreements, as executed and delivered, are identical in all material respects to the final drafts reviewed and approved by the Board of Directors of Penterra pursuant to the Board Resolutions.
3. Opinions
Based upon and subject to the foregoing, and subject further to the qualifications, limitations, and exceptions set forth in Section 4 of this opinion letter, we are of the opinion that:
3.1 Due Organization and Good Standing
Penterra Pharmaceuticals Corp. is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware. In rendering this opinion, we have relied upon the Good Standing Certificate issued by the Secretary of State of the State of Delaware dated October 12, 2023 and the Organizational Documents of Penterra. Penterra was originally incorporated in the State of Delaware on February 9, 2012 and has continuously maintained its corporate existence since that date. Penterra's federal employer identification number is 22-3948175, and its shares of common stock are listed and publicly traded on The Nasdaq Global Select Market under the ticker symbol "PNTR." We note that this opinion as to good standing is based solely on the Good Standing Certificate and speaks only as to the status of Penterra under the laws of the State of Delaware; we express no opinion as to the qualification or good standing of Penterra in any other jurisdiction.
3.2 Corporate Power and Authority
Penterra has the requisite corporate power and authority under the General Corporation Law of the State of Delaware and its Organizational Documents to execute, deliver, and perform its obligations under each of the Transaction Agreements, and to consummate the transactions contemplated thereby. We have reviewed Penterra's Restated Certificate of Incorporation, as amended, including the provisions relating to the purposes and powers of the Company, and its Amended and Restated Bylaws, and we have determined that nothing in the Organizational Documents prohibits, restricts, or limits Penterra's ability to enter into the Transaction Agreements or to perform the obligations contemplated thereby, including without limitation the granting of the exclusive licenses under the License Agreement, the supply of active pharmaceutical ingredients under the Supply Agreement, the transfer of technology and know-how under the Technology Transfer Agreement, the licensing of trademarks under the Trademark License Agreement, the establishment of the escrow arrangement under the Escrow Agreement, and the exchange of pharmacovigilance data and the undertaking of safety reporting obligations under the Pharmacovigilance Agreement.
3.3 Due Authorization
The execution, delivery, and performance by Penterra of each of the Transaction Agreements, and the consummation by Penterra of the transactions contemplated thereby, have been duly authorized by all necessary corporate action on the part of Penterra. The Board of Directors of Penterra, at a meeting duly called and held on July 18, 2023 at which a quorum was present and acting throughout, adopted the Board Resolutions authorizing and approving the negotiation, execution, and delivery of the Transaction Agreements and the performance by Penterra of its obligations thereunder, and authorizing and directing the officers of Penterra to execute and deliver the Transaction Agreements and to take all such further actions and to execute all such further documents and instruments as may be necessary or desirable to consummate the transactions contemplated thereby. The Board Resolutions have not been amended, modified, rescinded, or revoked and remain in full force and effect as of the date hereof, as certified to us in the Secretary's Certificate. No approval of the stockholders of Penterra is required under the General Corporation Law of the State of Delaware, Penterra's Organizational Documents, the rules and regulations of The Nasdaq Stock Market LLC, or otherwise, for the execution, delivery, and performance by Penterra of the Transaction Agreements or for the consummation of the transactions contemplated thereby.
3.4 Due Execution and Delivery
Each of the Transaction Agreements has been duly executed and delivered by Penterra. Based upon our review of the Secretary's Certificate, including the incumbency and specimen signature certifications contained therein, the Transaction Agreements have been executed on behalf of Penterra by officers duly authorized to do so. Specifically, the License Agreement, the Escrow Agreement, and the Supply Agreement were executed by Leland J. Cho, Senior Vice President, Business Development, and Anita M. Fremont, Esq., General Counsel and Secretary, each of whom is a duly appointed officer of Penterra and each of whom was duly authorized by the Board Resolutions to execute the Transaction Agreements on behalf of Penterra. The Technology Transfer Agreement, the Trademark License Agreement, and the Pharmacovigilance Agreement were executed by Anita M. Fremont, Esq., General Counsel and Secretary, who was duly authorized to do so as set forth in the Board Resolutions and as certified in the Secretary's Certificate.
3.5 Enforceability. Each of the Transaction Agreements constitutes a legal, valid, and binding obligation of Penterra, enforceable against Penterra in accordance with its respective terms, subject, however, to the Enforceability Qualifications set forth in Section 4.1 of this opinion letter and the additional qualifications, limitations, and exceptions set forth in Section 4.2 and Section 4.3 hereof.
3.6 No Conflicts
The execution, delivery, and performance by Penterra of each of the Transaction Agreements, and the consummation of the transactions contemplated thereby, do not and will not:
(a) violate or conflict with, or result in a breach or violation of, any provision of the Restated Certificate of Incorporation, as amended, or the Amended and Restated Bylaws of Penterra;
(b) violate or conflict with any law, statute, rule, or regulation of the State of New York or the State of Delaware, or any federal law of the United States of America, that, in our experience, is normally applicable to transactions of the type contemplated by the Transaction Agreements (without our having made any special investigation as to the applicability of any specific law, rule, or regulation), it being noted that (i) we have confirmed that no filing under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"), is required in connection with the transactions contemplated by the Transaction Agreements, as the transaction constitutes a pure intellectual property license that does not meet the applicable HSR Act reporting thresholds, and (ii) no review by the Committee on Foreign Investment in the United States ("CFIUS") under Section 721 of the Defense Production Act of 1950, as amended, is applicable to the transactions contemplated by the Transaction Agreements, based on our analysis of the nature of the licensed technology and the absence of any critical technology, critical infrastructure, or sensitive personal data implicated by the transaction as those terms are defined under the applicable CFIUS regulations; or
(c) result in a breach of, or constitute a default (or an event that, with notice or lapse of time or both, would constitute a default) under, or give rise to any right of termination, amendment, acceleration, or cancellation under, any agreement, instrument, or obligation known to us and set forth in the Officer's Certificate to which Penterra is a party or by which it or any of its properties or assets is bound. We note that our opinion in this clause (c) is limited to the agreements, instruments, and obligations identified in the Officer's Certificate, and we have made no independent investigation of the contracts, agreements, or obligations of Penterra beyond those so identified.
3.7 No Governmental Approvals Required
No consent, approval, authorization, order, registration, qualification, license, permit, or filing with or by any governmental authority or regulatory body under the federal laws of the United States of America, or the laws of the State of New York or the State of Delaware, is required for the valid execution, delivery, and performance by Penterra of any of the Transaction Agreements or for the consummation by Penterra of the transactions contemplated thereby, other than such consents, approvals, authorizations, orders, registrations, qualifications, licenses, permits, and filings as have been obtained or made prior to the date hereof. Without limiting the generality of the foregoing, we confirm that (i) no filing under the HSR Act is required in connection with the transactions contemplated by the Transaction Agreements, based on our analysis completed as of October 5, 2023, which concluded that the transaction constitutes a pure intellectual property license that does not satisfy the applicable reporting thresholds under the HSR Act and the rules promulgated thereunder, and (ii) no filing, notification, or review under the CFIUS regulations is applicable to the transactions contemplated by the Transaction Agreements. We express no opinion as to any consent, approval, authorization, order, registration, qualification, license, permit, or filing that may be required under the laws of any jurisdiction other than the federal laws of the United States, the laws of the State of New York, and the General Corporation Law of the State of Delaware, or that may be required in connection with the commercial exploitation, manufacture, importation, marketing, distribution, or sale of any product incorporating or relating to Penteracitinib in the Territory or elsewhere.
4. Qualifications and Limitations
The opinions expressed in this letter are subject to the following qualifications, limitations, and exceptions:
4.1 Enforceability Qualifications
The opinion expressed in Section 3.5 above with respect to the enforceability of the Transaction Agreements is subject to, and limited and qualified by:
(a) applicable bankruptcy, insolvency, reorganization, receivership, moratorium, fraudulent conveyance, fraudulent transfer, preference, and similar laws relating to or affecting the enforcement of creditors' rights generally, now or hereafter in effect;
(b) general principles of equity (regardless of whether such enforceability is considered in a proceeding at law or in equity), including, without limitation, principles relating to the possible unavailability of specific performance, injunctive relief, or other equitable remedies, concepts of materiality, reasonableness, good faith, and fair dealing, and the discretion of any court or tribunal of competent jurisdiction in granting or denying equitable relief; and
(c) the discretion of any court or tribunal of competent jurisdiction in awarding attorneys' fees, costs, expenses, or indemnification amounts, and limitations that may exist under applicable law upon the enforceability of provisions relating to indemnification or contribution.
The qualifications set forth in clauses (a), (b), and (c) above are collectively referred to herein as the "Enforceability Qualifications."
4.2 Limitations on Scope
The opinions expressed in this letter are limited in scope as follows:
(a) Governing Law Limitation. The opinions expressed herein are limited to, and we express no opinion as to the laws of any jurisdiction other than, (i) the federal laws of the United States of America, (ii) the laws of the State of New York (which is the governing law of the Transaction Agreements, such governing law being the laws of the State of New York without regard to principles of conflicts of law that would require or permit the application of the laws of another jurisdiction), and (iii) the General Corporation Law of the State of Delaware. Without limiting the foregoing, we express no opinion as to the laws of Hong Kong Special Administrative Region, the People's Republic of China, Japan, the Republic of Korea, the Commonwealth of Australia, the Republic of Singapore, the Republic of the Philippines, the Kingdom of Thailand, the Republic of Indonesia, Malaysia, the Socialist Republic of Vietnam, the Republic of India, or any other jurisdiction within or outside of the Territory.
(b) Subject-Matter Exclusions. We express no opinion with respect to (i) federal or state securities laws, including the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or any state "blue sky" laws; (ii) federal, state, or local tax laws, including the Internal Revenue Code of 1986, as amended, and any regulations promulgated thereunder; (iii) antitrust or competition laws, other than the confirmation regarding the HSR Act set forth in Sections 3.6(b) and 3.7 above; (iv) environmental laws; (v) labor and employment laws; (vi) the Employee Retirement Income Security Act of 1974, as amended ("ERISA"), or any laws relating to employee benefit plans; (vii) intellectual property laws, including, without limitation, the Patent Act (35 U.S.C.), the Lanham Act (15 U.S.C. § 1051 et seq.), the Copyright Act (17 U.S.C.), or the Defend Trade Secrets Act of 2016 (18 U.S.C. § 1836), and we express no opinion on the validity, enforceability, scope, claim construction, freedom to operate, or non-infringement of any patents, patent applications, trademarks, trademark applications, trade secrets, copyrights, or other intellectual property rights that are the subject of, or are licensed under, the Transaction Agreements; or (viii) regulatory laws relating to the development, manufacture, testing, approval, importation, marketing, distribution, or sale of pharmaceutical products, biologic products, or medical devices, including, without limitation, the Federal Food, Drug, and Cosmetic Act, as administered by the U.S. Food and Drug Administration ("FDA"), and the analogous regulatory regimes administered by the National Medical Products Administration ("NMPA") of the People's Republic of China, the Pharmaceuticals and Medical Devices Agency ("PMDA") of Japan, the Ministry of Food and Drug Safety ("MFDS") of the Republic of Korea, the Therapeutic Goods Administration ("TGA") of Australia, or any other regulatory authority in the Territory or elsewhere.
(c) Specific Provision Exclusions. We express no opinion on the enforceability of any provision of the Transaction Agreements to the extent that such provision:
(i) constitutes or may be deemed to constitute a penalty or forfeiture, rather than a reasonable estimate of damages or a permissible liquidated damages provision;
(ii) purports to waive or limit any right, defense, or protection available under applicable law to the extent that such waiver or limitation is prohibited or rendered unenforceable by applicable law;
(iii) relates to forum selection, submission to jurisdiction, arbitration, or choice of law, to the extent that such provisions may be subject to the discretion of the relevant tribunal or court, it being noted that the Transaction Agreements provide for arbitration before the International Court of Arbitration of the International Chamber of Commerce ("ICC"), seated in New York, New York, before a panel of three (3) arbitrators in accordance with the ICC Rules of Arbitration, and further provide that either party may seek preliminary injunctive or other interim relief in the United States District Court for the Southern District of New York or the Supreme Court of the State of New York, New York County, pending the constitution of the arbitral tribunal or in aid of arbitration, and we express no opinion as to the enforceability of such arbitration, forum selection, or injunctive relief provisions to the extent that such enforcement may be subject to the discretion of the applicable court or tribunal; or
(iv) relates to indemnification, contribution, exculpation, or limitation of liability to the extent that such provisions may be limited or rendered unenforceable by applicable law, regulation, or public policy, including, without limitation, any provision that purports to indemnify a party against its own negligence, willful misconduct, or violation of law.
(d) intellectual Property Scope. We express no opinion as to the validity, enforceability, scope, patentability, claim construction, freedom to operate, or non-infringement of any patents, patent applications, trademarks, trademark registrations, trademark applications, copyrights, trade secrets, or other intellectual property rights that are the subject of, licensed under, or otherwise contemplated by the Transaction Agreements, including without limitation any patents or patent applications covering Compound PPC-4187 (Penteracitinib), any formulations thereof, any methods of use thereof, or any manufacturing processes therefor, or the PENTECLAR mark or any associated trademarks licensed under the Trademark License Agreement.
(e) Tax and Payment Characterization. We express no opinion regarding the characterization of any payment, fee, royalty, milestone payment, or other amount payable under the Transaction Agreements as a royalty, license fee, milestone payment, or otherwise for U.S. federal, state, or local income tax purposes or for financial accounting purposes, or regarding any withholding tax obligations of any party under the Transaction Agreements or applicable law with respect to any such payment.
4.3 Reliance on Certificates and Factual Matters
In rendering the opinions set forth in this letter, we have relied as to certain matters of fact upon the representations, warranties, certifications, and statements of fact set forth in the Officer's Certificate and the Secretary's Certificate delivered to us by officers and representatives of Penterra, and we have made no independent investigation or verification of such factual matters. To the extent that any opinion expressed herein is based upon or qualified by reference to matters of fact, we have assumed the accuracy and completeness of such factual matters as set forth in the Officer's Certificate, the Secretary's Certificate, and the other Reviewed Documents. We have assumed that the officers and representatives of Penterra who have provided such certificates and statements are competent and reliable and have acted in good faith in providing such certificates and statements.
We have also relied on the Good Standing Certificate issued by the Secretary of State of the State of Delaware dated October 12, 2023, without independent verification that the facts stated therein remain accurate as of the date hereof, and we have assumed, with your permission, that no event has occurred between October 12, 2023 and the date hereof that would cause the Good Standing Certificate to be inaccurate or that would adversely affect the good standing of Penterra under the laws of the State of Delaware.
5. Reliance and Benefit
This opinion letter is rendered solely for the benefit of Meridian Bio Therapeutics Limited in connection with the Transaction Agreements described herein, and may not be relied upon by any other person or entity, or for any other purpose, without our prior written consent in each instance. Notwithstanding the foregoing, we hereby consent to reliance on this opinion letter by Lam, Cheung & Firth LLP, in its capacity as counsel to Meridian, solely in connection with the Transaction Agreements and the transactions contemplated thereby, and solely for the purposes for which this opinion is rendered.
This opinion letter is rendered as of the date hereof, and we speak only as of such date. We assume no obligation to update, revise, or supplement this opinion letter to reflect any facts, circumstances, events, changes in law, or developments that may hereafter come to our attention or occur after the date hereof, regardless of whether any such change may affect the opinions expressed herein. The opinions expressed herein are not to be construed as a guarantee or warranty of any particular result in any proceeding or dispute, and are subject to all limitations inherent in legal opinions of this nature.
6. Governing Law of This Opinion
The Transaction Agreements are governed by the laws of the State of New York, without regard to principles of conflicts of law that would require or permit the application of the laws of another jurisdiction. The opinions expressed in this letter with respect to the enforceability of the Transaction Agreements have been rendered on the basis of New York law as the governing law of the Transaction Agreements, and the opinion expressed in Section 3.1 with respect to the due organization and good standing of Penterra has been rendered on the basis of the General Corporation Law of the State of Delaware.
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Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Marcus Delgado Partner, intellectual Property Transactions 600 Lexington Avenue, 30th Floor New York, New York 10022 Telephone: (212) 554-7214
Email: mdelgado@calderwoodharkness.com
cc: Anita M. Fremont, Esq., General Counsel and Secretary, Penterra Pharmaceuticals Corp., 400 Pharma Drive, Suite 800, Princeton, NJ 08540
cc: Jonathan M. Firth, Esq., Lam, Cheung & Firth LLP, 25/F, Jardine House, 1 Connaught Place, Central, Hong Kong SAR
cc: Leland J. Cho, Senior Vice President, Business Development, Penterra Pharmaceuticals Corp., 400 Pharma Drive, Suite 800, Princeton, NJ 08540
cc: Catherine Bloom, Esq., Calderwood & Harkness LLP (internal file copy)