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Contract analysis / term-sheet-penterra-meridian.docx
term-sheet-penterra-meridian.docx
1018-00006 · 24 clauses
High · 9 Medium · 6 Standard · 3
Section 1: Parties
Section 1: Parties Licensor: Penterra Pharmaceuticals Corp. ("Penterra" or "Licensor"), a corporation organized and existing under the laws of the State of Delaware, publicly traded on the Nasdaq Global Select Market under the ticker symbol PNTR, with its principal executive offices located at 400 Pharma Drive, Suite 800, Princeton, New Jersey 08540, United States. Licensee: Meridian Bio Therapeutics Limited ("Meridi
Section 2: Background and Recitals High
⚑ Non-compete / exclusivity restraint
Section 2: Background and Recitals The following recitals provide the background and context for the transactions contemplated by this Term Sheet: A. Penterra is the owner of proprietary rights relating to the small-molecule compound designated PPC-4187, for which the proposed International Nonproprietary Name (INN) is Penteracitinib. PPC-4187 is a selective Janus kinase 1 (JAK1) inhibitor currently being developed f
Section 3: Licensed Compound and Products Medium
⚑ Liability cap to check against exposure
Section 3: Licensed Compound and Products Compound: PPC-4187 (Penteracitinib), a selective Janus kinase 1 (JAK1) inhibitor. For purposes of this Term Sheet, "PPC-4187" refers to the free base form of Penteracitinib as well as all pharmaceutically acceptable salts, hydrates, solvates, polymorphs, enantiomers, metabolites, and prodrugs thereof. Licensed Product: Any pharmaceutical product containing PPC-4187 as an acti
Section 4: Licensed intellectual Property Medium
⚑ Confidentiality undertaking
Section 4: Licensed intellectual Property 4.1 Licensed Patents Penterra's patent portfolio covering PPC-4187 consists of seven (7) patent families, as summarized below (collectively, the "Licensed Patents"): (a) U.S. Patent No. 11,234,567 — Composition of Matter; issued March 15, 2022; expires August 12, 2037 (before any patent term extension or supplemental protection certificate). This patent covers the PPC-4187 co
Section 5: Licensed Territory
Section 5: Licensed Territory Territory: For purposes of this Term Sheet, the "Territory" means the following countries and jurisdictions within the Asia-Pacific region: People's Republic of China (including Hong Kong Special Administrative Region and Macau Special Administrative Region), Japan, Republic of Korea, Australia, New Zealand, Singapore, Thailand, Malaysia, Indonesia, Philippines, Vietnam, and Taiwan. A co
Section 6: Grant of License High
⚑ Non-compete / exclusivity restraint
Section 6: Grant of License Subject to the terms and conditions of the Definitive Agreement, Penterra shall grant to Meridian an exclusive license (exclusive even as to Penterra within the Territory) under the Licensed Patents, Licensed Know-How, and Licensed Trademarks to develop, manufacture, have manufactured, use, import, export (solely within the Territory), offer for sale, sell, distribute, and otherwise commer
Section 7: Upfront Payment Standard
⚑ Commercial term
Section 7: Upfront Payment Amount: Eighteen million U.S. dollars ($18,000,000). Timing: The upfront payment shall be due and payable upon the closing of the Definitive Agreement (the "Closing"), subject to the satisfaction or waiver of the conditions to Closing described in Section 29 below. Mechanism: The upfront payment shall be deposited by Meridian into an escrow account established with a mutually agreed, nation
Section 8: Development Milestone Payments
Section 8: Development Milestone Payments Meridian shall make the following non-refundable, non-creditable development milestone payments to Penterra upon the first achievement of each of the milestone events set forth below: Total Development Milestones: $32,000,000 Each development milestone payment shall be payable only once, regardless of the number of Licensed Products developed, the number of indications pursue
Section 9: Regulatory Milestone Payments
Section 9: Regulatory Milestone Payments Meridian shall make the following non-refundable, non-creditable regulatory milestone payments to Penterra upon the first achievement of each of the milestone events set forth below: Total Regulatory Milestones: $25,000,000 For purposes of this Term Sheet, "Regulatory Approval" means the receipt of all approvals, licenses, registrations, or authorizations from the applicable r
Section 10: Commercial / Sales Milestone Payments Standard
⚑ Commercial term
Section 10: Commercial / Sales Milestone Payments Meridian shall make the following non-refundable, non-creditable commercial milestone payments to Penterra upon the first achievement of each of the milestone events set forth below, based on aggregate Annual Net Sales of all Licensed Products in the Territory: Total Commercial Milestones: $45,000,000 For purposes of this Term Sheet, "Annual Net Sales" means the gross
Section 11: Total Deal Value Summary High
⚑ Non-compete / exclusivity restraint
Section 11: Total Deal Value Summary The total potential consideration payable by Meridian to Penterra under the Definitive Agreement, inclusive of the upfront payment and all milestone payments (but exclusive of royalties), is summarized as follows: The foregoing total of one hundred twenty million U.S. dollars ($120,000,000) represents the maximum aggregate non-royalty consideration payable upon achievement of all
Section 12: Royalties High
⚑ Non-compete / exclusivity restraint
Section 12: Royalties 12.1 Tiered Royalties on Annual Net Sales in Territory Meridian shall pay to Penterra tiered royalties on aggregate Annual Net Sales of all Licensed Products in the Territory during each calendar year, at the following rates: For clarity, the royalty rates are marginal and apply incrementally to the portion of Annual Net Sales falling within each tier. By way of example, if Annual Net Sales in a
Section 13: Most Favored Nation Pricing Medium
⚑ Notice / time limit to track
Section 13: Most Favored Nation Pricing Meridian shall not offer, or cause any of its Affiliates or sublicensees to offer, PPC-4187 (under the PENTECLAR trade name or any other trade name) in any country in the Territory at a net price that is more than fifteen percent (15%) below the lowest net price at which Penterra (or any of Penterra's licensees in the Retained Territory) sells PPC-4187 in the United States or a
Section 14: Sublicensing High
⚑ Non-compete / exclusivity restraint
Section 14: Sublicensing Meridian may grant sublicenses under the license granted pursuant to Section 6 to third parties within the Territory, subject to the prior written consent of Penterra, which consent shall not be unreasonably withheld, conditioned, or delayed. Penterra acknowledges that Meridian may seek to sublicense rights in certain countries within the Territory where Meridian does not maintain direct comm
Section 15: Supply of API and Technology Transfer Medium
⚑ Confidentiality undertaking
Section 15: Supply of API and Technology Transfer 15.1 API Supply Penterra shall supply (or cause to be supplied) active pharmaceutical ingredient (PPC-4187 API) and reference standard material to Meridian at a price equal to Penterra's fully loaded cost of goods manufactured (including direct materials, direct labor, manufacturing overhead, quality control and release testing costs, and applicable regulatory complia
Section 16: Development and Commercialization Obligations
Section 16: Development and Commercialization Obligations Meridian shall use commercially reasonable efforts to develop and commercialize Licensed Products in the Territory in accordance with a comprehensive development and commercialization plan (the "Development Plan") to be mutually agreed by the Parties and attached as a schedule to the Definitive Agreement. The Development Plan shall include, at a minimum, propo
Section 17: Governance
Section 17: Governance 17.1 Joint Steering Committee (JSC) The Parties shall establish a Joint Steering Committee (the "JSC") within thirty (30) days of the Effective Date of the Definitive Agreement. The JSC shall serve as the primary governance body for overseeing and coordinating the development, regulatory, and commercialization activities for Licensed Products in the Territory. The JSC shall be comprised of thre
Section 18: Representations and Warranties High
⚑ Non-compete / exclusivity restraint
Section 18: Representations and Warranties Each Party shall make the following customary representations and warranties in the Definitive Agreement: (a) such Party is duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization; (b) such Party has full corporate power and authority to enter into and perform its obligations under the Definitive Agreement and all ancilla
Section 19: Indemnification High
⚑ Indemnity / guarantee obligation
Section 19: Indemnification 19.1 Indemnification by Penterra (Licensor) Penterra shall indemnify, defend, and hold harmless Meridian and its Affiliates, and their respective officers, directors, employees, agents, successors, and permitted assigns (collectively, the "Meridian Indemnitees"), from and against any and all losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees and costs o
Section 20: Insurance Standard
⚑ Commercial term
Section 20: Insurance Meridian shall obtain and maintain, at its own cost and expense, the following insurance coverage for its activities under the Definitive Agreement: (a) Clinical Trial Insurance: Coverage for clinical trial activities conducted by Meridian (or on Meridian's behalf) in the Territory, with policy limits and terms reasonably acceptable to Penterra, in amounts no less than customary for comparable c
Section 21: Intellectual Property Ownership and Prosecution High
⚑ Non-compete / exclusivity restraint
Section 21: Intellectual Property Ownership and Prosecution Ownership. All Licensed IP, including the Licensed Patents, Licensed Know-How, and Licensed Trademarks, shall remain the sole and exclusive property of Penterra. Nothing in this Term Sheet or the Definitive Agreement shall be construed as transferring ownership of any Licensed IP to Meridian, except to the extent of the license expressly granted hereunder. I
Section 22: Term and Termination High
⚑ Unilateral / for-convenience termination
Section 22: Term and Termination Term. The Definitive Agreement shall commence on the Effective Date and shall continue in full force and effect on a country-by-country basis until the expiration of the Royalty Term for each country in the Territory, unless earlier terminated in accordance with the provisions of this Section 22. Termination for Convenience. Meridian may terminate the Definitive Agreement on a country
Section 23: Confidentiality Medium
⚑ Notice / time limit to track
Section 23: Confidentiality This Section 23 is legally binding on the Parties. The Parties acknowledge that they are party to an existing Confidential Disclosure Agreement (the "CDA") and that confidential information has been and will continue to be exchanged between them in connection with the transactions contemplated by this Term Sheet. The confidentiality obligations set forth in this Section 23 shall be in addi
Section 24: Regulatory and Tax Considerations Medium
⚑ Forum / governing law
Section 24: Regulatory and Tax Considerations 24.1 Antitrust / Regulatory Approvals The Parties shall assess whether the transactions contemplated by this Term Sheet and the Definitive Agreement require any antitrust filings, competition law notifications, or other regulatory or governmental approvals in any relevant jurisdiction, including, without limitation: (a) an analysis of whether a filing is required under th