EXCLUSIVITY AGREEMENT
Dated as of August 4, 2023
by and between
PENTERRA PHARMACEUTICALS CORP.
and
MERIDIAN BIO THERAPEUTICS LIMITED
EXCLUSIVITY AGREEMENT
This EXCLUSIVITY AGREEMENT (this "Agreement") is entered into as of August 4, 2023 (the "Effective Date"), by and between:
PENTERRA PHARMACEUTICALS CORP., a corporation organized and existing under the laws of the State of Delaware ("Penterra" or "PPC"), with its principal offices located at 400 Pharma Drive, Suite 800, Princeton, New Jersey 08540, United States of America;
and
MERIDIAN BIO THERAPEUTICS LIMITED, a limited company incorporated and existing under the laws of Hong Kong Special Administrative Region (Company Registration No. 2847631) ("Meridian" or "MBT"), with its principal offices located at 18/F, Blossom Tower, 88 Queen's Road Central, Hong Kong SAR.
Each of Penterra and Meridian is sometimes referred to herein individually as a "Party" and collectively as the "Parties."
RECITALS
WHEREAS, Penterra is the owner of proprietary rights in the small-molecule compound designated PPC-4187 (proposed International Nonproprietary Name: Penteracitinib), a selective Janus kinase 1 (JAK1) inhibitor being developed for the treatment of moderate-to-severe atopic dermatitis in adults, including all related intellectual property rights, know-how, clinical data, pre-clinical data, regulatory filings, and manufacturing information;
WHEREAS, Penterra has completed a Phase IIb clinical trial (Study PPC-4187-201; N=420 patients; topline results announced June 2023) in the United States and the European Union, which trial demonstrated statistically significant improvement versus placebo at the primary endpoint, with p<0.001 for EASI-75 response at Week 16, and which trial results support advancement of PPC-4187 into Phase III clinical development;
WHEREAS, Meridian is a pharmaceutical company with extensive commercialization capabilities across the Asia-Pacific region, including established regulatory approvals infrastructure, commercial sales forces, distribution networks, and medical affairs organizations in China (National Medical Products Administration, "NMPA"), Japan (Pharmaceuticals and Medical Devices Agency, "PMDA"), South Korea (Ministry of Food and Drug Safety, "MFDS"), Australia (Therapeutic Goods Administration, "TGA"), and additional markets within the Association of Southeast Asian Nations ("ASEAN");
WHEREAS, the Parties have entered into a Non-Binding Term Sheet of even date herewith (the "Term Sheet") setting forth the principal commercial terms of a proposed exclusive license of PPC-4187 by Penterra to Meridian for the Asia-Pacific Territory (as defined therein), contemplating a total potential deal value of up to One Hundred Twenty Million United States Dollars ($120,000,000), comprised of upfront, milestone, and royalty payments;
WHEREAS, the Parties desire to negotiate in good faith and enter into a definitive Exclusive License Agreement (the "Definitive Agreement") on the terms and conditions substantially consistent with the Term Sheet, and each Party desires to ensure that, during the Exclusivity Period (as defined below), the other Party negotiates exclusively with it regarding the proposed transaction and refrains from pursuing competing transactions during such period;
WHEREAS, the Board of Directors of Penterra Pharmaceuticals Corp. authorized the negotiation of the proposed transaction at a duly convened meeting held on July 18, 2023, at which a quorum of directors was present and voting;
WHEREAS, in connection with the proposed transaction, Penterra has engaged Calderwood & Harkness LLP as its legal counsel and Prescott Hale & Co. LLC as its financial advisor; and
WHEREAS, in connection with the proposed transaction, Meridian has engaged Lam, Cheung & Firth LLP as its legal counsel and Eastbridge Partners Limited as its financial advisor.
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1 — DEFINITIONS
As used in this Agreement, the following terms shall have the meanings set forth below. Capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to them in the Term Sheet.
Section 1.1 "Affiliate" means, with respect to any Party, any entity that directly or indirectly controls, is controlled by, or is under common control with such Party. For purposes of this definition, "control" means the direct or indirect ownership of more than fifty percent (50%) of the outstanding voting securities of an entity, or the right to receive more than fifty percent (50%) of the profits or earnings of an entity, or the right to direct or cause the direction of the management and policies of an entity, whether through ownership of voting securities, by contract, or otherwise. Without limiting the generality of the foregoing, for purposes of this Agreement, the Affiliates of Meridian shall include Meridian Pharma (Shanghai) Co., Ltd., Meridian Japan K.K., Meridian Korea Inc., and Meridian Bio Australia Pty Ltd.
Section 1.2 "Compound" means PPC-4187 (Penteracitinib), a selective JAK1 inhibitor, including all formulations, salts, hydrates, solvates, polymorphs, co-crystals, enantiomers, racemates, prodrugs, metabolites, and crystalline forms thereof, and any pharmaceutical compositions or dosage forms containing PPC-4187 as an active ingredient.
Section 1.3 "Confidential Information" has the meaning set forth in Section 6.1 of this Agreement.
Section 1.4 "Definitive Agreement" means the proposed Exclusive License Agreement to be negotiated, agreed upon, executed, and delivered by Penterra and Meridian for the exclusive license of the Compound and the Licensed IP in the Territory, together with all exhibits, schedules, and ancillary agreements thereto.
Section 1.5 "Effective Date" means August 4, 2023.
Section 1.6 "Exclusivity Period" means the period commencing on the Effective Date and ending at 11:59 p.m. (Eastern Time) on the date that is sixty (60) days after the Effective Date (i.e., October 3, 2023), unless earlier terminated pursuant to Section 3.3 or extended pursuant to Section 3.2 of this Agreement.
Section 1.7 "Licensed IP" means all patents, patent applications (including provisional and non-provisional applications, continuations, continuations-in-part, divisionals, and reissues), trademarks (including, without limitation, the PENTECLAR mark and any associated trade dress, service marks, and domain names), trade secrets, know-how, inventions (whether or not patentable), clinical data, pre-clinical data, regulatory filings and submissions, manufacturing processes, formulation information, and other intellectual property rights of Penterra relating to the Compound, in each case to the extent owned or controlled by Penterra as of the Effective Date or at any time during the Exclusivity Period.
Section 1.8 "Term Sheet" means the Non-Binding Term Sheet dated August 4, 2023, entered into by and between Penterra and Meridian, setting forth the principal commercial terms of the Proposed Transaction.
Section 1.9 "Territory" means the Asia-Pacific Territory as defined in the Term Sheet, comprising: the People's Republic of China (including Hong Kong Special Administrative Region and Macau Special Administrative Region), Japan, the Republic of Korea, Australia, New Zealand, Singapore, the Kingdom of Thailand, Malaysia, the Republic of Indonesia, the Republic of the Philippines, the Socialist Republic of Vietnam, and Taiwan (collectively, the "Territory").
Section 1.10 "Proposed Transaction" means the exclusive license of the Compound and the Licensed IP by Penterra to Meridian in the Territory, on the terms and conditions substantially described in the Term Sheet, to be set forth in the Definitive Agreement.
ARTICLE 2 — EXCLUSIVITY OBLIGATIONS
Section 2.1 — Penterra Exclusivity. During the Exclusivity Period, Penterra shall not, and shall cause its Affiliates, officers, directors, employees, agents, and representatives (including, without limitation, Calderwood & Harkness LLP and Prescott Hale & Co. LLC) not to, directly or indirectly:
(a) solicit, initiate, encourage, or facilitate any inquiry, proposal, indication of interest, or offer from any third party relating to any license, sale, transfer, assignment, option, co-development arrangement, co-promotion arrangement, or other disposition of the Compound or the Licensed IP in or for the Territory, or any portion thereof;
(b) engage in, continue, or otherwise participate in any discussions, negotiations, or communications with any third party with respect to any transaction of the type described in Section 2.1(a);
(c) enter into any agreement, arrangement, or understanding (whether binding or non-binding, including without limitation any term sheet, letter of intent, memorandum of understanding, or heads of terms) with any third party regarding any transaction of the type described in Section 2.1(a); or
(d) provide any Confidential Information or any other non-public information relating to the Compound or the Licensed IP to any third party in connection with any transaction of the type described in Section 2.1(a), or otherwise take any action to facilitate or assist any third party in making a proposal or offer with respect to any such transaction.
Section 2.2 — Meridian Exclusivity. During the Exclusivity Period, Meridian shall not, and shall cause its Affiliates (including, without limitation, Meridian Pharma (Shanghai) Co., Ltd., Meridian Japan K.K., Meridian Korea Inc., and Meridian Bio Australia Pty Ltd), officers, directors, employees, agents, and representatives (including, without limitation, Lam, Cheung & Firth LLP and Eastbridge Partners Limited) not to, directly or indirectly:
(a) solicit, initiate, encourage, or facilitate any inquiry, proposal, indication of interest, or offer from any third party relating to any license, acquisition, co-development arrangement, co-promotion arrangement, or other right to develop and commercialize any competing JAK1 inhibitor compound for the treatment of atopic dermatitis in the Territory, or any portion thereof;
(b) engage in, continue, or otherwise participate in any discussions, negotiations, or communications with any third party with respect to any transaction of the type described in Section 2.2(a) (a "Competing Transaction"); or
(c) enter into any agreement, arrangement, or understanding (whether binding or non-binding, including without limitation any term sheet, letter of intent, memorandum of understanding, or heads of terms) with any third party regarding any Competing Transaction.
Section 2.3 — Notification Obligation. Each Party shall promptly (and in any event within two (2) business days) notify the other Party in writing if it or any of its Affiliates, officers, directors, employees, agents, or representatives receives any unsolicited proposal, inquiry, indication of interest, or communication from a third party relating to a transaction that would constitute a breach of such Party's exclusivity obligations under Section 2.1 or Section 2.2, as applicable. Such notification shall include the identity of the third party making such proposal, inquiry, or indication of interest and the material terms and conditions thereof, in each case to the extent such disclosure is not restricted by pre-existing confidentiality obligations of the notifying Party that were entered into prior to the Effective Date; provided, however, that if a Party is subject to such a pre-existing restriction, it shall disclose as much information as is permissible under such pre-existing obligation and shall use commercially reasonable efforts to obtain the consent of the relevant third party to disclose the identity of such third party and the material terms of such proposal or inquiry.
Section 2.4 — Scope Clarification. Notwithstanding anything in this Article 2 to the contrary, nothing in this Agreement shall restrict or prohibit either Party from:
(a) continuing the development, manufacture, or commercialization of the Compound or any other compound, product, or technology outside the scope of the Proposed Transaction, including without limitation the development and commercialization of the Compound in the United States, the European Union, and all other territories outside the Territory; or
(b) engaging in, evaluating, or consummating any transaction, license, collaboration, partnership, merger, acquisition, or other business combination that does not relate to the Compound in the Territory or, in the case of Meridian, does not relate to a competing JAK1 inhibitor compound for the treatment of atopic dermatitis in the Territory.
For the avoidance of doubt, this Section 2.4 shall not be construed to limit or diminish in any way the scope of the exclusivity obligations set forth in Sections 2.1 and 2.2.
ARTICLE 3 — EXCLUSIVITY PERIOD; EXTENSION; TERMINATION
Section 3.1 — Duration. The Exclusivity Period shall commence on the Effective Date (August 4, 2023) and shall expire at 11:59 p.m. (Eastern Time) on the date that is sixty (60) days after the Effective Date (i.e., October 3, 2023), unless earlier terminated pursuant to Section 3.3 or extended pursuant to Section 3.2 of this Agreement. During the Exclusivity Period, the Parties shall devote commercially reasonable efforts and resources to the negotiation of the Definitive Agreement in accordance with Article 4.
Section 3.2 — Extension. The Exclusivity Period may be extended for one (1) additional period of thirty (30) days (i.e., through and including November 2, 2023) upon the written agreement of both Parties, which agreement shall be in the form of a written amendment to this Agreement executed by duly authorized officers of each Party. The consent of a Party to such extension shall not be unreasonably withheld, conditioned, or delayed if the Parties are at such time actively engaged in good-faith negotiations toward the Definitive Agreement and are making meaningful progress in the resolution of open issues. Any further extension beyond such thirty (30)-day period shall require the mutual written consent of both Parties in their sole and absolute discretion.
Section 3.3 — Early Termination. Notwithstanding Section 3.1, either Party may terminate this Agreement upon written notice to the other Party if:
(a) the Parties mutually agree in writing that they do not intend to pursue the Proposed Transaction and desire to terminate this Agreement;
(b) the other Party materially breaches any provision of this Agreement (including, without limitation, any breach of the exclusivity obligations set forth in Article 2 or the confidentiality obligations set forth in Article 6) and fails to cure such breach within five (5) business days after receipt of written notice from the non-breaching Party specifying the nature of such breach in reasonable detail; or
(c) the Parties execute and deliver the Definitive Agreement, in which case this Agreement shall be deemed superseded by the Definitive Agreement and shall terminate automatically upon the effective date of the Definitive Agreement, without any further action required by either Party.
Section 3.4 — Effect of Expiration or Termination. Upon the expiration or termination of the Exclusivity Period (whether by lapse of time, early termination, or otherwise), the exclusivity obligations set forth in Article 2 shall automatically terminate and be of no further force or effect. Notwithstanding the foregoing, the following provisions shall survive the expiration or termination of this Agreement in accordance with their respective terms: Article 6 (Confidentiality), Article 7 (Remedies), Article 8 (Expenses), and Article 9 (Miscellaneous). The expiration or termination of this Agreement shall not relieve either Party of any liability arising from any breach of this Agreement that occurred prior to such expiration or termination.
ARTICLE 4 — GOOD FAITH NEGOTIATION
Section 4.1 — Obligation to Negotiate in Good Faith. During the Exclusivity Period, each Party shall use commercially reasonable efforts to negotiate in good faith with the other Party to agree upon the terms and conditions of the Definitive Agreement, which shall be consistent in all material respects with the Term Sheet. The Parties shall endeavor to cause their respective internal teams, legal counsel, financial advisors, and other representatives to be available at reasonable times and upon reasonable notice for meetings, conference calls, and exchanges of draft documents in furtherance of such negotiations.
Without limiting the generality of the foregoing, the Definitive Agreement is expected to address and include, among other things, the following principal commercial terms:
(a) an upfront, non-refundable, non-creditable cash payment by Meridian to Penterra of Eighteen Million United States Dollars ($18,000,000), payable within thirty (30) days following the effective date of the Definitive Agreement;
(b) development milestone payments by Meridian to Penterra totaling up to Thirty-Two Million United States Dollars ($32,000,000), payable upon the achievement of specified development milestones relating to the Compound in the Territory, including initiation and completion of Phase III clinical trials, acceptance of regulatory filings, and related events;
(c) regulatory milestone payments by Meridian to Penterra totaling up to Twenty-Five Million United States Dollars ($25,000,000), payable upon the achievement of specified regulatory milestones relating to the Compound in the Territory, including the grant of marketing authorizations by the NMPA, PMDA, MFDS, TGA, and other regulatory authorities in the Territory;
(d) commercial and sales milestone payments by Meridian to Penterra totaling up to Forty-Five Million United States Dollars ($45,000,000), payable upon the achievement of specified aggregate annual net sales thresholds for the Compound in the Territory;
(e) tiered royalties payable by Meridian to Penterra on annual aggregate net sales of the Compound in the Territory at the following rates: eight percent (8%) on the portion of annual net sales up to a specified threshold; eleven percent (11%) on the portion of annual net sales exceeding such threshold but below a higher specified threshold; and fourteen percent (14%) on the portion of annual net sales exceeding such higher threshold;
(f) most favored nation pricing provisions designed to ensure that the pricing terms granted to Meridian are no less favorable than those granted by Penterra to any other licensee of the Compound in any other territory;
(g) sublicensing rights, including the right of Meridian to grant sublicenses to its Affiliates and to third-party distributors in specified markets within the Territory, subject to Penterra's prior written consent (not to be unreasonably withheld) for sublicenses to non-Affiliate third parties; and
(h) mutual indemnification provisions, with each Party agreeing to indemnify and hold harmless the other Party from and against losses arising out of breaches of representations, warranties, and covenants, product liability claims, and other specified matters.
Section 4.2 — Due Diligence Access. During the Exclusivity Period, Penterra shall provide Meridian and its authorized representatives (including, without limitation, Lam, Cheung & Firth LLP and Eastbridge Partners Limited) with reasonable access to information, documentation, data, records, and personnel relating to the Compound and the Licensed IP for purposes of conducting due diligence in connection with the evaluation and negotiation of the Proposed Transaction, subject in all cases to the confidentiality provisions set forth in Article 6 of this Agreement.
Without limiting the generality of the foregoing, such access shall include, to the extent reasonably requested by Meridian:
(a) patent and trademark files, prosecution histories, freedom-to-operate analyses, and related intellectual property documentation pertaining to the Compound;
(b) pre-clinical data packages, including pharmacology, toxicology, pharmacokinetic, and ADME studies relating to PPC-4187;
(c) clinical data packages, including the complete clinical study report, statistical analysis plan, individual patient-level data, safety databases, and interim analyses from Study PPC-4187-201, as well as any additional clinical studies completed or in progress;
(d) chemistry, manufacturing, and controls ("CMC") documentation, including analytical methods, specifications, stability data, and manufacturing process descriptions;
(e) manufacturing process information, including information relating to the current contract manufacturer, Alkerra Manufacturing Inc., and any related supply agreements, quality agreements, and manufacturing capacity assessments; and
(f) regulatory correspondence with the U.S. Food and Drug Administration, the European Medicines Agency, and any other regulatory authority relating to the Compound.
Penterra shall use commercially reasonable efforts to respond to Meridian's due diligence requests in a timely manner, and shall designate a primary contact person (and a backup contact person) to coordinate and facilitate the due diligence process. The Parties acknowledge that all information and materials provided in connection with due diligence shall constitute Confidential Information of Penterra under this Agreement.
Section 4.3 — No Binding Obligation to Consummate. Notwithstanding anything in this Agreement to the contrary, neither Party shall be obligated to enter into the Definitive Agreement or to consummate the Proposed Transaction. Each Party retains the right, in its sole and absolute discretion, to determine whether to proceed with or withdraw from the Proposed Transaction at any time; provided, however, that each Party shall comply with its exclusivity obligations under Article 2 during the Exclusivity Period and with its confidentiality obligations under Article 6 during the term of such obligations. The Proposed Transaction shall be subject to and conditioned upon the negotiation, execution, and delivery of the Definitive Agreement and such ancillary agreements (including, without limitation, any supply agreement, pharmacovigilance agreement, quality agreement, and transition services agreement) as the Parties may agree upon, and the satisfaction or written waiver of all conditions precedent to closing as may be set forth in the Definitive Agreement.
ARTICLE 5 — REPRESENTATIONS AND WARRANTIES
Section 5.1 — Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party that, as of the Effective Date:
(a) Organization and Good Standing. It is a corporation or company, as applicable, duly organized, validly existing, and in good standing (or the equivalent thereof) under the laws of its jurisdiction of organization (the State of Delaware, in the case of Penterra, and Hong Kong Special Administrative Region, in the case of Meridian), and has all requisite corporate power and authority to own, lease, and operate its properties and to carry on its business as presently conducted.
(b) Corporate Authority. It has full corporate power and authority to execute, deliver, and perform its obligations under this Agreement, and has taken all corporate action necessary to authorize the execution, delivery, and performance of this Agreement.
(c) Due Authorization. The execution, delivery, and performance of this Agreement have been duly authorized by all necessary corporate action on the part of such Party, including, to the extent required by its organizational documents or applicable law, approval by its board of directors (or equivalent governing body).
(d) Binding Obligation. This Agreement constitutes the legal, valid, and binding obligation of such Party, enforceable against such Party in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, and other similar laws affecting creditors' rights generally and to general principles of equity (regardless of whether enforcement is sought in a proceeding at law or in equity).
(e) No Conflicts. The execution, delivery, and performance of this Agreement by such Party do not and will not: (i) violate, conflict with, or result in a breach of any provision of its certificate of incorporation, bylaws, articles of association, memorandum of association, or other organizational documents; (ii) violate, conflict with, or 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, any material agreement, contract, license, or instrument to which such Party is a party or by which it or any of its properties or assets are bound; or (iii) violate any applicable law, rule, regulation, order, judgment, or decree of any court, governmental authority, or regulatory body having jurisdiction over such Party.
Section 5.2 — Penterra Representations and Warranties. Penterra hereby represents and warrants to Meridian that, as of the Effective Date:
(a) Ownership of Compound and Licensed IP. Penterra is the sole and exclusive owner of the Compound and the Licensed IP, free and clear of all liens, encumbrances, security interests, claims, and restrictions (other than licenses granted in territories outside the Territory that do not encumber or impair the rights to be licensed to Meridian under the Proposed Transaction).
(b) No Conflicting Agreements. To Penterra's knowledge, after due inquiry, Penterra is not a party to any agreement, arrangement, understanding, commitment, or obligation (whether written, oral, or implied) that would prevent, prohibit, or materially impair the grant of the exclusive license to Meridian contemplated by the Term Sheet and the Proposed Transaction.
(c) Board Authorization. The Board of Directors of Penterra Pharmaceuticals Corp. has duly authorized the negotiation of the Proposed Transaction at a meeting duly convened and held on July 18, 2023, at which a quorum of directors was present, and such authorization has not been revoked, rescinded, or modified in any respect as of the Effective Date.
ARTICLE 6 — CONFIDENTIALITY
Section 6.1 — Definition of Confidential Information. As used in this Agreement, "Confidential Information" means all non-public, confidential, or proprietary information disclosed by one Party (the "Disclosing Party") to the other Party (the "Receiving Party") in connection with this Agreement, the Term Sheet, or the Proposed Transaction, including, without limitation, all scientific, technical, clinical, pre-clinical, regulatory, manufacturing, chemical, biological, pharmacological, financial, commercial, business, strategic, legal, and other information, in each case whether disclosed orally, in writing, electronically, by visual inspection, or by any other means, and whether or not marked, identified, or designated as "confidential" at the time of disclosure.
Without limiting the generality of the foregoing, Confidential Information shall include, without limitation: (i) the Compound's patent portfolio (comprising seven (7) patent families and all related patent applications, prosecution files, and opinions of counsel); (ii) all clinical data, clinical study reports, statistical analyses, safety data, and regulatory submissions relating to Study PPC-4187-201 and any other studies of the Compound; (iii) manufacturing processes, formulations, analytical methods, and related know-how, including information provided by or relating to Alkerra Manufacturing Inc.; (iv) proposed commercial terms, pricing strategies, sales projections, and market analyses; (v) the existence, terms, and conditions of this Agreement and the Term Sheet; and (vi) all notes, analyses, compilations, studies, summaries, memoranda, and other documents or materials prepared by the Receiving Party or its representatives that contain, reflect, or are based upon, in whole or in part, any Confidential Information of the Disclosing Party.
Section 6.2 — Exclusions. Notwithstanding Section 6.1, Confidential Information shall not include any information that the Receiving Party can demonstrate by competent evidence:
(a) was or becomes generally available to the public or within the relevant industry other than as a result of a disclosure by the Receiving Party or its representatives in violation of this Agreement;
(b) was independently developed by the Receiving Party or its representatives without reference to, use of, or reliance upon the Disclosing Party's Confidential Information, as evidenced by contemporaneous written records;
(c) was rightfully obtained by the Receiving Party from a third party who was not, at the time of such disclosure, subject to any obligation of confidentiality to the Disclosing Party with respect to such information; or
(d) was already known to the Receiving Party at the time of disclosure by the Disclosing Party, as evidenced by the Receiving Party's contemporaneous written records existing prior to such disclosure.
Section 6.3 — Confidentiality Obligations. The Receiving Party shall:
(a) use the Disclosing Party's Confidential Information solely for the purpose of evaluating, negotiating, and consummating the Proposed Transaction, and for no other purpose whatsoever;
(b) maintain the confidentiality of the Disclosing Party's Confidential Information using at least the same degree of care as it uses to protect its own confidential information of a similar nature, but in no event less than a reasonable degree of care; and
(c) restrict access to and disclosure of the Disclosing Party's Confidential Information to those of its officers, directors, employees, Affiliates, and professional advisors (including, without limitation, legal counsel, financial advisors, accountants, and auditors) who have a bona fide need to know such information for the purposes contemplated by this Agreement and who are bound by written confidentiality obligations no less restrictive than those set forth in this Article 6 (or, in the case of professional advisors, who are subject to professional duties of confidentiality).
The Receiving Party shall be responsible for any breach of this Article 6 by any of its officers, directors, employees, Affiliates, or professional advisors to whom Confidential Information has been disclosed.
Section 6.4 — Permitted Disclosures. Notwithstanding Section 6.3, a Receiving Party may disclose Confidential Information of the Disclosing Party to the extent required by applicable law, regulation, or rule (including, without limitation, the rules and regulations of the U.S. Securities and Exchange Commission, the Nasdaq Stock Market, the Stock Exchange of Hong Kong, or any other applicable securities exchange or regulatory authority), or by any judicial, administrative, or governmental order, decree, subpoena, or similar process; provided, however, that the Receiving Party shall (to the extent legally permitted):
(a) give the Disclosing Party prompt written notice of such requirement prior to making any such disclosure, so as to afford the Disclosing Party a reasonable opportunity to seek a protective order, injunction, or other appropriate remedy and/or to waive compliance with the provisions of this Article 6;
(b) cooperate with the Disclosing Party, at the Disclosing Party's expense, in seeking such protective order or other remedy; and
(c) disclose only that portion of the Confidential Information that is legally required to be disclosed, and use commercially reasonable efforts to ensure that any Confidential Information so disclosed is accorded confidential treatment by the recipient thereof.
Section 6.5 — Return or Destruction of Confidential Information. Upon the expiration or termination of this Agreement without the execution of the Definitive Agreement, and at the written request of the Disclosing Party, the Receiving Party shall promptly (and in any event within fifteen (15) business days following such request):
(a) return to the Disclosing Party all originals and copies of documents, materials, and other tangible media containing or embodying the Disclosing Party's Confidential Information; or
(b) at the Disclosing Party's election, destroy all such documents, materials, and tangible media, together with any notes, analyses, compilations, summaries, or other documents or materials prepared by the Receiving Party that contain, reflect, or are derived from the Disclosing Party's Confidential Information.
Notwithstanding the foregoing, the Receiving Party may retain one (1) archival copy of such Confidential Information in a secure location, solely for the purpose of monitoring and ensuring compliance with its obligations under this Agreement and applicable law, and such retained copy shall remain subject to the confidentiality obligations set forth in this Article 6. Upon completion of the return or destruction of Confidential Information as required by this Section 6.5, a duly authorized officer of the Receiving Party shall provide written certification to the Disclosing Party confirming compliance with this Section 6.5.
Section 6.6 — Survival. The confidentiality obligations set forth in this Article 6 shall survive the expiration or termination of this Agreement for a period of three (3) years from the date of such expiration or termination; provided, however, that the confidentiality obligations with respect to any Confidential Information that constitutes a trade secret under applicable law (including, without limitation, the Defend Trade Secrets Act of 2016 (18 U.S.C. § 1836 et seq.) and the Hong Kong Trade Descriptions Ordinance (Cap. 362), as applicable) shall survive for so long as such information continues to qualify as a trade secret under such applicable law.
ARTICLE 7 — REMEDIES
Section 7.1 — Injunctive Relief. Each Party acknowledges and agrees that: (a) the covenants and agreements set forth in Article 2 (Exclusivity Obligations) and Article 6 (Confidentiality) are an essential element of this Agreement and a material inducement for the other Party to enter into this Agreement; (b) a breach or threatened breach of any provision of Article 2 or Article 6 would cause the non-breaching Party irreparable injury and harm for which monetary damages alone would be an inadequate remedy; and (c) in the event of any such breach or threatened breach, the non-breaching Party shall be entitled to seek specific performance, temporary restraining orders, preliminary and permanent injunctive relief, and any other form of equitable relief, in addition to any other remedies available at law or in equity, without the necessity of demonstrating actual damages, proving the inadequacy of monetary damages, or posting any bond, surety, or other security. The Parties consent to the exclusive jurisdiction of the United States District Court for the Southern District of New York, or if such court lacks subject matter jurisdiction, the Supreme Court of the State of New York, New York County, for purposes of any action seeking interim or permanent injunctive relief under this Section 7.1, and each Party waives any objection to venue or personal jurisdiction in such courts.
Section 7.2 — Cumulative Remedies. All remedies available to the Parties under this Agreement, whether at law, in equity, or otherwise, are cumulative and not exclusive of any other remedies to which a Party may be entitled. The exercise of any one remedy by a Party shall not preclude the exercise of any other remedy available to such Party under this Agreement, at law, or in equity. No failure or delay by any Party in exercising any right, power, or remedy under this Agreement shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power, or remedy preclude any other or further exercise thereof or the exercise of any other right, power, or remedy.
ARTICLE 8 — EXPENSES
Section 8.1 — Own Expenses. Except as otherwise expressly provided in this Agreement, each Party shall bear and be solely responsible for all costs and expenses incurred by it in connection with this Agreement, the Term Sheet, the Proposed Transaction, and the negotiation, preparation, and execution of the Definitive Agreement and any ancillary agreements, including, without limitation, all fees, costs, and expenses of its financial advisors, legal counsel, accountants, auditors, consultants, and other advisors.
For the avoidance of doubt, Penterra shall be solely responsible for the fees and expenses of its advisors, which include: Calderwood & Harkness LLP (legal counsel), Prescott Hale & Co. LLC (financial advisor), Whitford & Cascade Insurance Brokers (patent prosecution counsel), and Clarendon Bates LLP (auditors). Meridian shall be solely responsible for the fees and expenses of its advisors, which include: Lam, Cheung & Firth LLP (legal counsel), Eastbridge Partners Limited (financial advisor), and Nakamura & Takeda Law Offices (Japan regulatory counsel).
Section 8.2 — No Break-Up Fee. No break-up fee, termination fee, reverse termination fee, expense reimbursement obligation, or other similar payment shall be payable by either Party to the other Party upon the expiration or termination of this Agreement, regardless of the reason for such expiration or termination. Each Party acknowledges that it is entering into this Agreement with the understanding that neither Party has any obligation to consummate the Proposed Transaction and that neither Party shall be entitled to any compensation or reimbursement from the other Party if the Proposed Transaction is not consummated.
ARTICLE 9 — MISCELLANEOUS
Section 9.1 — Governing Law. This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, United States of America, without regard to any conflicts of law principles thereof that would require or permit the application of the laws of any other jurisdiction. The application of the United Nations Convention on Contracts for the International Sale of Goods is expressly excluded.
Section 9.2 — Dispute Resolution. Any dispute, controversy, or claim arising out of or relating to this Agreement, or the breach, termination, or validity hereof, that is not resolved by good-faith negotiation between the Parties within thirty (30) days after one Party delivers written notice to the other Party of such dispute (a "Dispute Notice"), shall be finally resolved by binding arbitration administered by the International Court of Arbitration of the International Chamber of Commerce (the "ICC") in accordance with the ICC Rules of Arbitration then in effect at the time of filing. The seat (legal place) of arbitration shall be New York, New York, United States of America. The arbitration shall be conducted by a panel of three (3) arbitrators, one appointed by each Party in accordance with the ICC Rules, and the third (who shall serve as the presiding arbitrator) appointed by the two Party-appointed arbitrators or, failing agreement, by the ICC. The language of the arbitration shall be English. The award rendered by the arbitral tribunal shall be final and binding upon the Parties and may be entered and enforced in any court of competent jurisdiction. Notwithstanding the foregoing, either Party may seek interim or provisional injunctive or other equitable relief from any court of competent jurisdiction as set forth in Section 7.1 of this Agreement, and the filing of any such judicial action shall not constitute a waiver of the right to submit any dispute to arbitration hereunder.
Section 9.3 — Notices. All notices, requests, demands, consents, waivers, and other communications required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been duly given: (a) when delivered personally; (b) when sent by confirmed electronic mail (with a copy sent by overnight courier on the following business day); (c) one (1) business day after deposit with a nationally recognized overnight courier service (charges prepaid); or (d) three (3) business days after being mailed by certified or registered mail, return receipt requested, postage prepaid, in each case to the following addresses (or to such other address as a Party may designate by written notice delivered in accordance with this Section 9.3):
If to Penterra:
Anita M. Fremont, Esq. General Counsel Penterra Pharmaceuticals Corp. 400 Pharma Drive, Suite 800 Princeton, New Jersey 08540 United States of America
Email: afremont@penterra.com
with a copy (which shall not constitute notice) to:
Marcus Delgado, Esq. Calderwood & Harkness LLP 600 Lexington Avenue, 30th Floor New York, New York 10022 United States of America
Email: mdelgado@calderwoodharkness.com
If to Meridian:
David R. Cheung, Esq. General Counsel Meridian Bio Therapeutics Limited 18/F, Blossom Tower 88 Queen's Road Central Hong Kong SAR
Email: dcheung@meridianbio.com
with a copy (which shall not constitute notice) to:
Jonathan M. Firth, Esq. Lam, Cheung & Firth LLP 25/F, Jardine House 1 Connaught Place Central, Hong Kong SAR
Email: jfirth@lcflaw.com
Section 9.4 — Entire Agreement. This Agreement, together with the Term Sheet (to the extent referenced herein), constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, understandings, negotiations, discussions, representations, warranties, and communications, whether oral or written, between the Parties relating to such subject matter. No Party has relied on any statement, representation, warranty, or agreement of the other Party except for those expressly set forth in this Agreement.
Section 9.5 — Amendment and Waiver. No amendment, modification, supplement, or waiver of any provision of this Agreement shall be effective unless set forth in a written instrument duly executed by authorized representatives of both Parties. No waiver by either Party of any breach of or default under this Agreement shall be deemed a waiver of any other or subsequent breach or default, and no waiver shall be effective unless made in writing and signed by the waiving Party.
Section 9.6 — Assignment. Neither Party may assign, transfer, delegate, or otherwise dispose of any of its rights or obligations under this Agreement without the prior written consent of the other Party, which consent may be withheld in such other Party's sole discretion; provided, however, that either Party may assign this Agreement, in whole or in part, to any of its Affiliates without such consent, so long as: (a) the assigning Party provides written notice of such assignment to the other Party within ten (10) business days after the effective date of such assignment; and (b) the assigning Party remains primarily liable for the full and timely performance of all obligations of the assignee under this Agreement. Any attempted assignment in violation of this Section 9.6 shall be null and void and of no force or effect.
Section 9.7 — No Third-Party Beneficiaries. This Agreement is entered into for the sole benefit of the Parties and their respective permitted successors and assigns. Nothing in this Agreement, express or implied, is intended to or shall confer upon any person or entity other than the Parties and their permitted successors and assigns any right, remedy, claim, benefit, or cause of action of any nature whatsoever under or by reason of this Agreement.
Section 9.8 — Severability. If any provision of this Agreement (or any portion thereof) is held to be invalid, illegal, or unenforceable by a court of competent jurisdiction or arbitral tribunal, such invalidity, illegality, or unenforceability shall not affect any other provision of this Agreement, and this Agreement shall be construed and enforced as if such invalid, illegal, or unenforceable provision (or portion thereof) had never been contained herein. In such event, the Parties shall negotiate in good faith to agree upon a valid and enforceable provision that is a reasonable substitute for the invalid, illegal, or unenforceable provision, taking into account the Parties' original intent and the economic effect of the original provision.
Section 9.9 — Counterparts; Electronic Execution. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument. This Agreement may be executed and delivered by electronic transmission, including by means of portable document format (.pdf) files transmitted via electronic mail or by electronic signature platforms such as Brightwater Software or Ashford Health IT, and any such electronic execution and delivery shall be deemed to be an original execution and delivery of this Agreement for all purposes.
Section 9.10 — Relationship of the Parties. The Parties are independent contractors, and nothing in this Agreement shall be construed to create or imply any relationship of partnership, joint venture, agency, fiduciary duty, franchisor-franchisee, employer-employee, or principal-agent between the Parties. Neither Party shall have any authority to bind or commit the other Party, or to create any obligation or liability on behalf of the other Party, without the prior written consent of such other Party.
Section 9.11 — Non-Binding Nature of Term Sheet. The Parties hereby acknowledge and agree that the Term Sheet is non-binding in its entirety, except for the confidentiality, exclusivity, and governing law provisions thereof (which are binding and enforceable in accordance with their terms), and that neither Party shall have any obligation to enter into the Definitive Agreement or to consummate the Proposed Transaction by virtue of the Term Sheet. The terms and conditions set forth in the Term Sheet are intended to serve as a framework for the negotiation of the Definitive Agreement and are subject to modification, revision, and further negotiation by the Parties.
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SIGNATURE PAGE TO EXCLUSIVITY AGREEMENT
IN WITNESS WHEREOF, the Parties have caused this Exclusivity Agreement to be executed and delivered by their duly authorized representatives as of the date first written above.
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Dr. Raymond K. Ostrowski
Title: Chief Executive Officer
Date: August 4, 2023
MERIDIAN BIO THERAPEUTICS LIMITED
By: ________
Name: Angela C.Y. Fong
Title: Chief Executive Officer
Date: August 4, 2023
ACKNOWLEDGMENT BY COUNSEL
Each of the undersigned, in its capacity as legal counsel to its respective client, hereby acknowledges receipt and review of this Exclusivity Agreement and confirms that it has advised its client as to the terms and legal effect hereof. Each of the undersigned further acknowledges and agrees that the exclusivity obligations set forth in Article 2 and the confidentiality obligations set forth in Article 6 of this Agreement are binding upon it as a representative of its respective client, and that it shall comply, and shall cause its partners, associates, and staff to comply, with such obligations in all respects.
CALDERWOOD & HARKNESS LLP Counsel to Penterra Pharmaceuticals Corp.
By: ________
Name: Marcus Delgado
Title: Partner
Date: August 4, 2023
LAM, CHEUNG & FIRTH LLP Counsel to Meridian Bio Therapeutics Limited
By: ________
Name: Jonathan M. Firth
Title: Partner
Date: August 4, 2023