Contract analysis

Section 1.1 — Definitions As used in this Agreement, the following terms shall have the meanings set forth below: "Affiliate" shall have the meaning ascribed to such term in the License Agreement. For purposes of this Agreement, the Affiliates of Purchaser include, without limitation, Meridian Pharma (Shanghai) Co., Ltd., Meridian Japan K.K., Meridian Korea Inc., and Meridian Bio Australia Pty Ltd. "Alkerra" or "CMO"

Section 1.2 — Interpretation (a) Any capitalized term used in this Agreement but not defined herein shall have the meaning ascribed to such term in the License Agreement. (b) The headings of the Articles, Sections, and Exhibits in this Agreement are inserted for convenience of reference only and shall not affect the meaning or interpretation of this Agreement. (c) As used in this Agreement, the word "including" (and

ARTICLE 2 — SUPPLY OBLIGATIONS

Section 2.1 — Obligation to Supply During the Initial Term and any renewal period, Supplier shall use commercially reasonable efforts to manufacture (or cause Alkerra to manufacture) and supply to Purchaser the API and Reference Standard in accordance with the Specifications, cGMP, and the terms and conditions of this Agreement. The API shall be supplied for both Clinical Supply and Commercial Supply use by Purchaser

Section 2.2 — Reference Standard Supply Supplier shall supply Reference Standard to Purchaser in quantities reasonably requested by Purchaser for analytical testing, method validation, quality control, and other purposes related to the development, manufacture, and commercialization of PPC-4187 in the Licensed Territory. Reference Standard shall be supplied at the Supply Price (Net Cost plus fifteen percent (15%) mar

Section 2.3 — Exclusivity of Supply This Agreement does not grant Purchaser exclusivity as to the source of API for PPC-4187. Purchaser may qualify alternative sources of API supply in the Licensed Territory, subject to applicable regulatory requirements (including any necessary filings with the NMPA, PMDA, MFDS, TGA, and other applicable regulatory authorities) and the terms and conditions of the Technology Transfer

Section 2.4 — Manufacturing Site The API shall be manufactured at Alkerra Manufacturing Inc., 5200 Meridian Parkway, Research Triangle Park, North Carolina 27713, which is the approved and validated manufacturing site as of the Effective Date. Any change in the manufacturing site for the API requires: (a) prior written notice to Purchaser not less than one hundred eighty (180) days before the proposed change; (b) Pur

Section 2.5 — Subcontracting Supplier may subcontract the manufacture of API to Alkerra or to other qualified subcontractors; provided, however, that (a) Supplier shall remain fully responsible for compliance with all of its obligations under this Agreement, including, without limitation, compliance with the Specifications, cGMP, and all applicable regulatory requirements; (b) any such subcontractor shall be bound by

Section 3.1 — Specifications All API supplied under this Agreement shall conform to the Specifications set forth in Exhibit A hereto. The Specifications include, without limitation, parameters for appearance, identity (by infrared spectroscopy and high-performance liquid chromatography), assay (not less than 99.0% by HPLC), related substances (individual and total impurities), residual solvents (in accordance with IC

Section 3.2 — Quality Agreement The Parties shall execute the Quality Agreement within sixty (60) days of the Effective Date (i.e., by December 19, 2023), in substantially the form attached to the License Agreement. The Quality Agreement shall govern: (a) quality standards and acceptance criteria for the API; (b) change control procedures; (c) deviation handling and corrective and preventive action ("CAPA") procedure

Section 3.3 — Certificate of Analysis and Certificate of Compliance Each shipment of API delivered to Purchaser under this Agreement shall be accompanied by a Certificate of Analysis and a Certificate of Compliance. The COA shall include the results of all tests and analyses required by the Specifications, including the test methods employed, acceptance criteria, and actual results obtained, together with a statement

Section 3.4 — cGMP Compliance All API manufactured and supplied under this Agreement shall be manufactured in compliance with cGMP as defined by the FDA, and to the extent applicable to the importation, development, and commercialization of the API in the Licensed Territory, in compliance with the cGMP requirements of the NMPA, PMDA, MFDS, and TGA. Supplier shall maintain (and shall cause Alkerra to maintain) all nec

Section 3.5 — Regulatory Inspections and Audits (a) Purchaser Audit Rights. Purchaser shall have the right, upon not less than thirty (30) days' prior written notice, to audit or inspect the manufacturing facility (including Alkerra's facility) for compliance with cGMP, the Specifications, and the Quality Agreement, not more than once per calendar year during the term of this Agreement; provided, however, that in the

Section 3.6 — Change Control No changes shall be made to the API manufacturing process, Specifications, analytical methods, raw material suppliers, starting materials, manufacturing equipment, or facility without prior written notice to Purchaser and compliance with the change control procedures set forth in the Quality Agreement. Supplier shall classify all proposed changes in accordance with the change control proc

Section 3.7 — Stability Testing Supplier shall maintain ongoing stability programs for the API in accordance with ICH guidelines Q1A (Stability Testing of New Drug Substances and Products) and Q1B (Photostability Testing of New Drug Substances and Products), and such other stability protocols as may be specified in the Quality Agreement. Supplier shall share all stability data with Purchaser on a semi-annual basis, o

ARTICLE 4 — FORECASTING AND ORDERING

Section 4.1 — Rolling Forecast Beginning within thirty (30) days of the Effective Date and continuing on a quarterly basis thereafter, Purchaser shall provide Supplier with a rolling eighteen (18)-month forecast of anticipated API requirements, broken down by Calendar Quarter. Each Forecast shall specify the estimated quantity of API (in kilograms) required for each Calendar Quarter during the forecast period, togeth

Section 4.2 — Purchase Orders / Firm Orders Purchaser shall place Firm Orders for API by submitting written purchase orders to Supplier at least one hundred twenty (120) days prior to the requested delivery date. Each purchase order shall be substantially in the form set forth in Exhibit C and shall specify: (a) the quantity of API ordered (in kilograms); (b) the requested delivery date; (c) shipping instructions and

Section 4.3 — Minimum and Maximum Order Quantities (a) Minimum Order Quantity. The minimum order quantity per Firm Order shall be one (1) Batch, as defined in the Specifications set forth in Exhibit A. Purchase orders for quantities less than one Batch shall require Supplier's prior written consent. (b) Maximum Annual Supply Obligation. Supplier's maximum annual supply obligation under this Agreement shall not exceed

Section 4.4 — Failure to Order Minimum If Purchaser does not place Firm Orders for at least seventy-five percent (75%) of the aggregate Firm Forecast quantity in any Calendar Quarter, Supplier may invoice Purchaser for Supplier's documented, incremental costs actually incurred in reasonable reliance on the binding portion of the Forecast, including, without limitation, costs of raw materials procured, production capa

Section 4.5 — Allocation In the event of a supply shortage or capacity constraint affecting Supplier's or Alkerra's ability to fulfill orders from multiple customers or for Supplier's own requirements, Supplier shall allocate the available supply of API among its own requirements and the requirements of its customers, including Purchaser, on a pro rata basis based on historical purchase volumes during the preceding t

ARTICLE 5 — PRICING AND PAYMENT

Section 5.1 — Supply Price The Supply Price for API supplied under this Agreement shall be calculated as the Net Cost plus a markup of fifteen percent (15%) (the "Cost Plus 15%" methodology). By way of illustration, if the Net Cost per kilogram of API is one hundred thousand United States Dollars ($100,000), the Supply Price per kilogram shall be one hundred fifteen thousand United States Dollars ($115,000). The Supp

Section 5.2 — Cost Transparency and Audit Rights Supplier shall maintain complete and accurate books and records of all components of Net Cost, including detailed records of raw material costs, direct labor costs, manufacturing overhead allocations, quality testing costs, packaging costs, and facility cost allocations, in sufficient detail to verify the calculation of the Supply Price in accordance with U.S. GAAP and

Section 5.3 — Invoicing Supplier shall issue an invoice for each shipment of API upon delivery to the Delivery Point. Each invoice shall be in writing and shall itemize: (a) the quantity of API shipped (in kilograms); (b) the Supply Price per kilogram; (c) the total amount due; (d) the Batch number(s) applicable to the shipment; (e) the applicable COA reference number(s); (f) the purchase order number; and (g) the de

Section 5.4 — Payment Terms Payment of each invoice shall be due within forty-five (45) days of the date of such invoice. All payments shall be made in United States Dollars by wire transfer of immediately available funds to Supplier's designated bank account, as set forth in Exhibit D, or to such other account as Supplier may designate from time to time by written notice to Purchaser. Any amounts not paid when due s

Section 5.5 — Taxes The Supply Price is exclusive of all taxes, duties, tariffs, customs charges, and similar governmental assessments of any kind. Purchaser shall be solely responsible for the payment of all import duties, customs charges, value-added taxes (VAT), goods and services taxes (GST), and any other taxes, fees, or charges applicable to the importation of API into any country or jurisdiction in the License

Section 5.6 — Currency All amounts payable under this Agreement shall be denominated and payable in United States Dollars (USD). In the event that any conversion from a local currency to United States Dollars is required for purposes of calculating Net Cost or any other amount under this Agreement, such conversion shall be made using the spot exchange rate published by the Wall Street Journal (or, if not available, b

ARTICLE 6 — DELIVERY AND SHIPPING

Section 6.1 — Delivery Terms All deliveries of API under this Agreement shall be made FCA (Incoterms® 2020) Alkerra Manufacturing Inc., 5200 Meridian Parkway, Research Triangle Park, North Carolina 27713. Risk of loss of, and damage to, the API, together with title thereto, shall pass from Supplier to Purchaser at the Delivery Point upon delivery to the carrier designated by Purchaser or upon loading of the API at th

Section 6.2 — Shipping and Transportation Purchaser shall be solely responsible for arranging and paying for all transportation, freight, insurance (including transit insurance and cargo insurance), and all other shipping costs from the Delivery Point to the final destination(s) in the Licensed Territory. Purchaser shall designate a freight forwarder or carrier and shall provide Supplier with shipping instructions, i

Section 6.3 — Packaging and Labeling The API shall be packaged in accordance with the Specifications set forth in Exhibit A and in a manner suitable for international transport, including compliance with applicable United Nations packaging requirements for the transport of hazardous materials, if applicable, and any cold chain or temperature-controlled shipping requirements specified in the Specifications. Each conta

Section 6.4 — Delivery Schedule Supplier shall use commercially reasonable efforts to deliver API within the timeframe specified in each accepted purchase order. Supplier acknowledges that timely delivery of API is critical to Purchaser's clinical development and commercialization timelines in the Licensed Territory. If Supplier anticipates a delay of more than fifteen (15) days beyond the delivery date specified in

Section 6.5 — Shortage and Force Majeure Deliveries In the event of an anticipated shortage of API supply (whether due to raw material constraints, capacity limitations, equipment failure, or any other cause), Supplier shall provide Purchaser with at least sixty (60) days' advance written notice of such anticipated shortage, together with an assessment of the expected duration and impact on Purchaser's orders. The al

ARTICLE 7 — ACCEPTANCE AND REJECTION

Section 7.1 — Inspection and Testing Purchaser shall have thirty (30) days from the date of receipt of each shipment of API at Purchaser's designated facility in the Licensed Territory (or such other location as Purchaser may designate for initial receipt and inspection) to inspect and test the API against the Specifications and the accompanying COA (the "Inspection Period"). During the Inspection Period, Purchaser s

Section 7.2 — Rejection Purchaser may reject all or any portion of a shipment of API if, upon inspection and testing during the Inspection Period, Purchaser determines that the API does not conform to the Specifications, was not manufactured in accordance with cGMP, or is otherwise Defective Product. Written notice of rejection shall be provided to Supplier within the Inspection Period and shall: (a) identify the Bat

Section 7.3 — Dispute Resolution on Rejection In the event that Supplier disputes a rejection under Section 7.2 and the Parties are unable to resolve the dispute within twenty (20) business days of Supplier's receipt of the rejection notice, the Parties shall jointly select and submit a representative sample of the disputed API to an independent testing laboratory mutually agreed upon by the Parties. The independent

Section 7.4 — Remedies for Defective Product For any API that is confirmed to be Defective Product (whether by mutual agreement, Purchaser's testing, or the independent laboratory's determination under Section 7.3), Supplier shall, at Purchaser's election, either: (a) replace the Defective Product with conforming API at no additional cost to Purchaser, within a commercially reasonable time (not to exceed ninety (90)

Section 7.5 — Latent Defects With respect to any defect in API that is not reasonably discoverable by Purchaser during the Inspection Period through the exercise of commercially reasonable incoming quality control testing (a "Latent Defect"), Purchaser may provide written notice of rejection to Supplier at any time within twelve (12) months following the date of delivery of the applicable shipment, together with supp

ARTICLE 8 — REGULATORY MATTERS

Section 8.1 — Regulatory Filings Supplier shall support Purchaser's regulatory filings in the Licensed Territory, including filings with the NMPA, PMDA, MFDS, TGA, and other applicable regulatory authorities, by providing Purchaser with access to the Drug Master File, Chemistry, Manufacturing, and Controls ("CMC") data, validation reports, stability data, analytical method validation data, and other documentation as

Section 8.2 — Regulatory Changes Supplier shall promptly notify Purchaser in writing of any changes to applicable regulatory requirements (including changes to FDA requirements, ICH guidelines, or pharmacopeial standards) that may affect the manufacture, testing, packaging, labeling, storage, or supply of the API under this Agreement. The Parties shall cooperate in good faith on the implementation of any post-approva

Section 8.3 — Recalls In the event that a recall, market withdrawal, or field safety corrective action involving the API or any finished drug product manufactured using the API supplied under this Agreement is initiated by either Party, a regulatory authority, or is otherwise required by applicable law, the Parties shall cooperate in carrying out such recall or withdrawal in accordance with the procedures set forth i

ARTICLE 9 — INTELLECTUAL PROPERTY

Section 9.1 — Ownership All intellectual property rights related to the API, including, without limitation, patents, trade secrets, know-how, and proprietary information relating to the manufacturing process, analytical methods, and Specifications, shall remain the sole and exclusive property of Supplier, as set forth in the License Agreement. Purchaser's right to use the API is limited to the development, manufactur

Section 9.2 — Improvements Any improvements, modifications, or enhancements to the API manufacturing process, analytical methods, or Specifications developed by or on behalf of Supplier during the term of this Agreement shall be subject to the technology transfer and licensing provisions of the License Agreement and the Technology Transfer Agreement. Supplier shall promptly disclose any such improvements to Purchaser

Section 9.3 — Confidentiality The Supply Price details, Net Cost information, manufacturing process know-how, Specifications, and all other technical and commercial information exchanged between the Parties in connection with this Agreement are Confidential Information of the disclosing Party, subject to the confidentiality obligations set forth in Article 11 of this Agreement and the corresponding provisions of the

ARTICLE 10 — INDEMNIFICATION AND LIABILITY

Section 10.1 — Supplier Indemnification Supplier shall indemnify, defend, and hold harmless Purchaser and its Affiliates, and their respective directors, officers, employees, agents, and representatives (collectively, "Purchaser Indemnified Parties"), from and against any and all Losses incurred by any Purchaser Indemnified Party arising out of or resulting from: (a) any breach by Supplier of its representations, war

Section 10.2 — Purchaser Indemnification Purchaser shall indemnify, defend, and hold harmless Supplier and its Affiliates, and their respective directors, officers, employees, agents, and representatives (collectively, "Supplier Indemnified Parties"), from and against any and all Losses incurred by any Supplier Indemnified Party arising out of or resulting from: (a) any breach by Purchaser of its representations, war

Section 10.3 — Limitation of Liability EXCEPT IN CASES OF FRAUD, WILLFUL MISCONDUCT, OR BREACH OF THE CONFIDENTIALITY OBLIGATIONS SET FORTH IN ARTICLE 11, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER BASED ON CONTRACT, TORT, STRICT LIABILITY, OR ANY OTHER LEGAL OR EQUITABLE THE

Section 10.4 — Insurance (a) Purchaser Insurance. Purchaser shall obtain and maintain, or cause to be obtained and maintained, during the term of this Agreement and for a period of not less than three (3) years following expiration or termination, product liability ins