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Contract analysis / schedule-e-development-plan.docx
schedule-e-development-plan.docx
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1. BACKGROUND AND PURPOSE
Medium
⚑ Liability cap to check against exposure
1. BACKGROUND AND PURPOSE 1.1 Purpose. The purpose of this Schedule E is to set forth the Phase III clinical development plan for PPC-4187 (Penteracitinib) in the Licensed Territory (as defined below and as further described in Schedule D to the Agreement). This Development Plan describes in detail the anticipated clinical program, including trial design, enrollment targets, regulatory submission strategy, clinical s
2. LICENSED TERRITORY
2. LICENSED TERRITORY 2.1 Cross-Reference to Schedule D The Licensed Territory is defined in and subject to the terms set forth in Schedule D to the Agreement. For convenience and clarity, the full list of countries and jurisdictions comprising the Licensed Territory is reproduced below. 2.2 Countries and Jurisdictions The Licensed Territory comprises the following countries and jurisdictions:
1. People's Republic of China (including Hong Kong Special Administrative Region and Maca
1. People's Republic of China (including Hong Kong Special Administrative Region and Macau Special Administrative Region)
3. Republic of Korea (South Korea)
3. Republic of Korea (South Korea)
12. Taiwan
12. Taiwan 2.3 Primary Regulatory Jurisdictions The primary regulatory jurisdictions targeted for Phase III clinical development and NDA/BLA submissions under this Development Plan are as follows: • 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
3. PHASE III CLINICAL DEVELOPMENT PROGRAM
3. PHASE III CLINICAL DEVELOPMENT PROGRAM 3.1 Overview of Phase III Strategy Meridian shall design and conduct one or more pivotal Phase III clinical trials sufficient to support New Drug Application (NDA) or Biologics License Application (BLA) submissions, or their regulatory equivalents, in each of the primary regulatory jurisdictions within the Licensed Territory. The Phase III program shall be designed to build u
4. CLINICAL SUPPLY
4. CLINICAL SUPPLY 4.1 Active Pharmaceutical Ingredient Supply Penterra shall supply the active pharmaceutical ingredient (PPC-4187 API) and all necessary reference standards for all Phase III clinical trial activities conducted under this Development Plan, pursuant to and in accordance with the terms and conditions of the Supply Agreement between the parties (the "Supply Agreement"). The API shall be manufactured an
5. ANTICIPATED DEVELOPMENT TIMELINE
Medium
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5. ANTICIPATED DEVELOPMENT TIMELINE 5.1 Key Milestones and Timeline The following table sets forth the key activities and anticipated dates or timeframes for the Phase III development of PPC-4187 in the Licensed Territory: The foregoing timeline represents Meridian's current best estimate of the development trajectory for PPC-4187 in the Licensed Territory and is subject to the assumptions and qualifications set fort
6. DEVELOPMENT MILESTONE PAYMENTS AND TRIGGER EVENTS
Medium
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6. DEVELOPMENT MILESTONE PAYMENTS AND TRIGGER EVENTS 6.1 Development Milestone Payments The following Development Milestone Payments shall be payable by Meridian to Penterra pursuant to Article 5 of the Agreement, upon the first occurrence of each milestone event set forth below: 6.2 Total Development Milestone Payments The total aggregate Development Milestone Payments payable by Meridian to Penterra under this Sect
7. REGULATORY STRATEGY
Medium
⚑ Notice / time limit to track
7. REGULATORY STRATEGY 7.1 Regulatory Submissions Meridian shall serve as the regulatory sponsor for all Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), and their regulatory equivalents filed in the Licensed Territory, as well as for all New Drug Applications (NDAs), Biologics License Applications (BLAs), and their regulatory equivalents submitted to regulatory authorities in the Lic
8. DEVELOPMENT GOVERNANCE
8. DEVELOPMENT GOVERNANCE 8.1 Joint Steering Committee Oversight All clinical development activities under this Development Plan shall be subject to oversight by the Joint Steering Committee (JSC), established pursuant to Article 3 of the Agreement. The JSC shall comprise three (3) representatives designated by each party, for a total of six (6) members, and shall meet on a quarterly basis (or more frequently as circ
9. PHARMACOVIGILANCE AND SAFETY REPORTING
Medium
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9. PHARMACOVIGILANCE AND SAFETY REPORTING 9.1 Pharmacovigilance Agreement The exchange of safety data and the reporting of adverse events during Phase III development of PPC-4187 in the Licensed Territory shall be governed by the Pharmacovigilance Agreement to be executed between the parties (the "Pharmacovigilance Agreement"), which shall set forth in detail the respective responsibilities, procedures, timelines, an
10. INTELLECTUAL PROPERTY CONSIDERATIONS DURING DEVELOPMENT
Medium
⚑ Forum / governing law
10. INTELLECTUAL PROPERTY CONSIDERATIONS DURING DEVELOPMENT 10.1 Licensed Patent Portfolio The patent portfolio covering PPC-4187, as licensed to Meridian under the Agreement, is set forth in Schedule A to the Agreement (Licensed Patents). Meridian acknowledges that the Licensed Patents include, without limitation, the following key patents relevant to the development and commercialization of PPC-4187 in the Licensed
11. DEVELOPMENT COSTS AND FUNDING
Medium
⚑ Liability cap to check against exposure
11. DEVELOPMENT COSTS AND FUNDING 11.1 Meridian's Cost Responsibility All costs associated with the Phase III clinical development of PPC-4187 in the Licensed Territory, including but not limited to clinical trial site costs, investigator fees, patient recruitment expenses, CRO fees, bioanalytical and central laboratory costs, data management and statistical analysis costs, regulatory submission preparation and filin
12. AMENDMENTS AND UPDATES
Medium
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12. AMENDMENTS AND UPDATES 12.1 Amendment Procedure This Development Plan may be amended or updated from time to time by mutual written agreement of the parties, subject to approval by the JSC. Any amendment to this Development Plan shall be documented in writing and signed by authorized representatives of both parties, and shall be attached to and form part of this Schedule E. 12.2 Quarterly Updates Meridian shall p