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TECHNOLOGY TRANSFER AGREEMENT

by and between

PENTERRA PHARMACEUTICALS CORP.

("Penterra" or "Transferor")

and

MERIDIAN BIO THERAPEUTICS LIMITED

("Meridian" or "Transferee")

Dated: October 2, 2023

Effective Date: October 20, 2023

Executed concurrently with the Exclusive License Agreement dated October 2, 2023

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RECITALS

WHEREAS, Penterra Pharmaceuticals Corp. is a corporation duly 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, and is the owner of certain proprietary rights in the selective Janus kinase 1 (JAK1) inhibitor compound designated PPC-4187 (proposed International Nonproprietary Name: Penteracitinib), including, without limitation, manufacturing process know-how, analytical methods, chemistry, manufacturing and controls documentation, and related intellectual property;

WHEREAS, Meridian Bio Therapeutics Limited is a limited company duly incorporated and existing under the laws of Hong Kong Special Administrative Region (Company Registration No. 2847631), with its registered office and principal place of business located at 18/F, Blossom Tower, 88 Queen's Road Central, Hong Kong SAR, and possesses substantial pharmaceutical development, manufacturing, and commercialization capabilities across the Asia-Pacific region;

WHEREAS, Penterra and Meridian have entered into that certain Exclusive License Agreement dated October 2, 2023, with an effective date of October 20, 2023 (the "License Agreement"), pursuant to which Penterra has granted Meridian an exclusive license to develop, manufacture, and commercialize PPC-4187 (Penteracitinib) in the Licensed Territory (as defined in the License Agreement);

WHEREAS, the License Agreement contemplates that Penterra will supply active pharmaceutical ingredient ("API") and reference standards to Meridian for the initial three (3) year period following the Closing Date under a separate Supply Agreement at a price equal to Penterra's cost plus a fifteen percent (15%) markup, and Penterra's current contract manufacturing organization for the manufacture of PPC-4187 API and finished dosage form is Alkerra Manufacturing Inc., located at 5200 Meridian Parkway, Research Triangle Park, North Carolina 27713;

WHEREAS, the License Agreement further requires Penterra to transfer its proprietary manufacturing process, analytical methods, and chemistry, manufacturing and controls documentation to Meridian's designated Asia-Pacific manufacturing facility or contract manufacturing organization to enable Meridian to independently manufacture PPC-4187 in the Licensed Territory following the expiration of the initial supply period;

WHEREAS, the parties intend that such technology transfer shall be completed within twenty-four (24) months of the Effective Date (i.e., by October 20, 2025), in order to enable Meridian to achieve self-sufficiency in the manufacture of Licensed Product in the Licensed Territory;

WHEREAS, PPC-4187 is currently formulated as 25 mg and 50 mg film-coated tablets, with the manufacturing process having been validated at Alkerra Manufacturing Inc. for both the API synthesis and finished dosage form manufacture; and

WHEREAS, Penterra and Meridian desire to set forth the terms and conditions upon which such technology transfer shall be conducted;

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, and intending to be legally bound, the parties agree as follows:

ARTICLE 1 — DEFINITIONS

1.1 Definitions. Capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to them in the License Agreement. In addition to terms defined elsewhere in this Agreement, the following terms shall have the meanings set forth below:

(a) "Acceptance Criteria" means the criteria set forth in Schedule 2 attached hereto that the Receiving Facility must satisfy to demonstrate successful completion of each Transfer Milestone, as further described in Article 4 of this Agreement.

(b) "Alkerra" means Alkerra Manufacturing Inc., a contract manufacturing organization engaged by Penterra for the manufacture of PPC-4187 API and finished dosage form, with its principal manufacturing facility located at 5200 Meridian Parkway, Research Triangle Park, North Carolina 27713.

(c) "Analytical Methods" means all proprietary analytical testing methods, reference standards, release specifications, stability-indicating methods, system suitability criteria, and related standard operating procedures used by or on behalf of Penterra in connection with the manufacture, quality control, quality assurance, and release of Licensed Product, including without limitation methods for identity testing, assay, impurity profiling, dissolution testing, content uniformity, and residual solvent analysis.

(d) "API" means the active pharmaceutical ingredient for PPC-4187 (Penteracitinib), including all polymorphic forms, salts, solvates, hydrates, co-crystals, and metabolites thereof that are used in or necessary for the manufacture of Licensed Product.

(e) "CMC Documentation" means all chemistry, manufacturing, and controls documentation, including but not limited to batch records (master and executed), process validation reports, cleaning validation documentation, equipment specifications and qualification records, raw material and excipient specifications, starting material and intermediate specifications, stability data (accelerated and long-term), environmental monitoring data, and regulatory filings (including relevant portions of Investigational New Drug applications, Common Technical Document Module 3 submissions, and Drug Master Files) pertaining to the manufacture, testing, packaging, and release of Licensed Product.

(f) "Compound" means PPC-4187 (Penteracitinib), a selective Janus kinase 1 (JAK1) inhibitor, including all polymorphic forms thereof, and specifically including Crystalline Form A as described in U.S. Patent No. 11,345,678.

(g) "Effective Date" means October 20, 2023.

(h) "Know-How" means all proprietary manufacturing process knowledge, trade secrets, technical data, formulations, processes, techniques, methods, procedures, data compilations, experimental results, and information described in Schedule B to the License Agreement, whether in written, electronic, or other tangible form or maintained as unwritten knowledge of Penterra personnel.

(i) "License Agreement" means the Exclusive License Agreement dated October 2, 2023, between Penterra Pharmaceuticals Corp. and Meridian Bio Therapeutics Limited, as may be amended, modified, or supplemented from time to time in accordance with its terms.

(j) "Licensed Product" means pharmaceutical products containing PPC-4187 (Penteracitinib) as the active pharmaceutical ingredient, including the currently approved formulations of 25 mg and 50 mg film-coated tablets, as well as any additional dosage forms, strengths, or formulations developed in accordance with the License Agreement.

(k) "Manufacturing Process" means the complete process for manufacturing, testing, releasing, and packaging API and finished dosage form of Licensed Product, including without limitation all steps of API synthesis (from designated starting materials through final API), formulation, granulation, compression, film coating, packaging, in-process testing, release testing, and related quality control and quality assurance procedures, as described in the Technology Transfer Package.

(l) "Quality Agreement" means the Quality Agreement to be executed between Penterra and Meridian within sixty (60) days of the Effective Date (i.e., by December 19, 2023), governing API supply specifications, quality standards, change control procedures, deviation handling, complaint management, and related quality matters in connection with the supply and manufacture of Licensed Product.

(m) "Receiving Facility" means Meridian's designated Asia-Pacific manufacturing facility or contract manufacturing organization approved by Meridian to receive the Technology Transfer, as designated by Meridian in accordance with Section 6.1 of this Agreement, provided that such facility meets all applicable current Good Manufacturing Practice ("cGMP") standards and regulatory requirements.

(n) "Supply Agreement" means the API Supply Agreement between Penterra and Meridian executed concurrently with this Agreement, governing the supply of PPC-4187 API and reference standards from Penterra (through Alkerra Manufacturing Inc.) to Meridian during the initial three (3) year supply period.

(o) "Technology Transfer" means the transfer of the Manufacturing Process, Analytical Methods, Know-How, and CMC Documentation from Penterra (and/or Alkerra, as applicable) to the Receiving Facility, as contemplated by the License Agreement and as set forth in this Agreement.

(p) "Technology Transfer Package" means the complete package of documents, data, information, materials, reference standards, and other items to be transferred to Meridian and the Receiving Facility in connection with the Technology Transfer, as set forth in Schedule 1 attached hereto.

(q) "Technology Transfer Plan" means the detailed plan and timeline for the Technology Transfer as set forth in Schedule 3 attached hereto, as may be updated from time to time by mutual written agreement of the parties through the Technology Transfer Sub-Committee.

(r) "Territory" means the Licensed Territory as defined in the License Agreement and set forth in Schedule D thereto, which includes the following jurisdictions: 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, Thailand, Malaysia, Indonesia, the Philippines, Vietnam, and Taiwan.

(s) "Transfer Completion Date" means the date on which all Transfer Milestones have been achieved and all Acceptance Criteria satisfied, as evidenced by the execution of the Final Acceptance Certificate pursuant to Section 4.6 of this Agreement, in no event later than October 20, 2025, subject to extension in accordance with Section 3.4.

(t) "Transfer Milestones" means the milestones set forth in Schedule 3 measuring progress toward completion of the Technology Transfer, including the Phase 1 through Phase 5 milestones described in Section 3.1 of this Agreement.

(u) "Transferring Facility" means Alkerra Manufacturing Inc.'s manufacturing facility located at 5200 Meridian Parkway, Research Triangle Park, North Carolina 27713, or such other Penterra-designated facility from which the Technology Transfer Package or any component thereof originates.

1.2 Construction. Unless the context otherwise requires, the rules of interpretation set forth in the License Agreement shall apply to this Agreement. References to Articles, Sections, and Schedules are to Articles, Sections, and Schedules of this Agreement unless otherwise indicated. The headings and captions of Articles, Sections, and Schedules are for convenience of reference only and shall not affect the interpretation of this Agreement. The words "include," "includes," and "including" shall be deemed to be followed by the phrase "without limitation." The word "or" is not exclusive. The singular includes the plural and vice versa. References to "days" mean calendar days unless otherwise specified. References to "business days" mean days other than Saturdays, Sundays, and public holidays in both New York, New York, United States, and Hong Kong SAR.

ARTICLE 2 — SCOPE OF TECHNOLOGY TRANSFER

2.1 Scope. Penterra shall transfer to Meridian (or Meridian's designated Receiving Facility) the complete Technology Transfer Package necessary to enable Meridian to independently manufacture, test, release, and package API and finished dosage form of Licensed Product (PPC-4187 (Penteracitinib), 25 mg and 50 mg film-coated tablets) in the Territory. The Technology Transfer shall encompass all technical information, documentation, know-how, methods, and materials reasonably necessary for a suitably qualified and equipped pharmaceutical manufacturing facility to replicate the Manufacturing Process and produce Licensed Product that meets all applicable release specifications, quality standards, and regulatory requirements in the Territory. The scope of the Technology Transfer is intended to be comprehensive and shall be interpreted broadly to effectuate the purposes of the License Agreement.

2.2 Technology Transfer Package Contents. The Technology Transfer Package shall include, without limitation, the following categories of documents, data, information, and materials:

(a) API Manufacturing Process Documentation. Complete Manufacturing Process documentation for the synthesis of PPC-4187 API, including process flow diagrams, descriptions of all unit operations (including but not limited to chemical reactions, crystallizations, filtrations, drying, milling, and blending), process parameters and acceptable ranges for each unit operation, in-process controls and acceptance limits, specifications for raw materials and starting materials, specifications for synthetic intermediates, solvent usage and recovery procedures, and yield expectations at each stage of the synthesis.

(b) Finished Dosage Form Manufacturing Process Documentation. Complete Manufacturing Process documentation for the manufacture of film-coated tablets in 25 mg and 50 mg strengths, including quantitative formulation composition and bill of materials, wet granulation and/or dry granulation process parameters, tablet compression parameters (including tooling specifications and compression force ranges), film coating process parameters (including coating solution composition, spray rates, inlet air temperature, and pan speed), primary and secondary packaging process documentation, and equipment specifications for each unit operation.

(c) Analytical Methods. All Analytical Methods for API and finished dosage form, including but not limited to identity tests (infrared spectroscopy, HPLC identification), assay methods (HPLC-UV), impurity profiling methods (related substances by gradient HPLC, residual solvents by headspace GC, heavy metals/elemental impurities by ICP-MS), dissolution testing methods (apparatus type, media composition, sampling times, and acceptance criteria), content uniformity methods, water content determination (Karl Fischer), particle size distribution methods for API, and stability-indicating analytical methods validated in accordance with ICH Q2(R1) guidelines.

(d) Reference Standards and Reference Materials. Reference standards for PPC-4187 API (including primary and working reference standards), reference standards for known impurities and degradation products, reference standards for starting materials and synthetic intermediates as applicable, and any proprietary reagents or specialty chemicals required for the execution of the Analytical Methods.

(e) CMC Documentation. Complete CMC Documentation, including master batch records for API and finished dosage form, executed batch records from process validation batches manufactured at Alkerra Manufacturing Inc., process validation reports (including statistical analysis of critical quality attributes), cleaning validation reports, equipment qualification records (IQ/OQ/PQ), utility qualification records as applicable, and process characterization study reports.

(f) Stability Data. Stability data packages for API and finished dosage form, including accelerated stability data (40°C/75% RH, six months minimum), long-term stability data (25°C/60% RH for API; 30°C/65% RH and/or 25°C/60% RH for finished dosage form), photostability data in accordance with ICH Q1B, and in-use stability data as applicable. Stability protocols, including time points, test parameters, and acceptance criteria, shall also be included.

(g) Regulatory Filing Documentation. Relevant sections of regulatory submissions pertaining to the manufacturing process, including applicable portions of the Investigational New Drug (IND) application, Common Technical Document (CTD) Module 3 (Quality) sections, Drug Master File (DMF) information as applicable, and any correspondence with regulatory authorities relating to manufacturing process changes, post-approval commitments, or inspection observations. Such documentation shall be provided to the extent relevant to Meridian's regulatory filings with the National Medical Products Administration (NMPA), Pharmaceuticals and Medical Devices Agency (PMDA), Ministry of Food and Drug Safety (MFDS), Therapeutic Goods Administration (TGA), and other Territory regulatory authorities.

(h) Environmental, Health, and Safety Data. Environmental, health, and safety data related to the Manufacturing Process, including material safety data sheets (SDS) for API, intermediates, and hazardous raw materials, occupational exposure limit (OEL) assessments, containment requirements, waste stream characterization, and any environmental impact assessments conducted in connection with the Manufacturing Process.

(i) Clinical Supply Manufacturing Documentation. Documentation relating to the manufacture of clinical supplies for Penterra-sponsored Phase IIb clinical study PPC-4187-201 (four hundred twenty (420) patients), including batch records, certificates of analysis, investigational product release documentation, and any relevant process deviations or out-of-specification investigations associated with clinical supply manufacturing.

2.3 Detailed Listing. A detailed listing of all items comprising the Technology Transfer Package, organized by category and including document reference numbers, titles, version numbers, and estimated page counts, is set forth in Schedule 1 attached hereto. The parties acknowledge that Schedule 1 represents the best estimate of the Technology Transfer Package contents as of the Effective Date and may be updated by mutual written agreement through the Technology Transfer Sub-Committee as additional documents are identified during the course of the Technology Transfer.

2.4 Know-How Acknowledgment. Penterra acknowledges and confirms that the Technology Transfer Package includes all Know-How described in Schedule B to the License Agreement. To the extent any Know-How described in Schedule B is not otherwise captured in the documents listed in Schedule 1, Penterra shall supplement the Technology Transfer Package to include such Know-How in documented form or, where the Know-How is not readily reducible to writing, through practical demonstration and training during the on-site support phases of the Technology Transfer.

ARTICLE 3 — TRANSFER MILESTONES AND TIMELINE

3.1 Transfer Milestones. The Technology Transfer shall be accomplished in accordance with the Transfer Milestones set forth in Schedule 3, which shall include, at a minimum, the following five (5) phases:

(a) Phase 1 — Document Transfer (Months 1–6; Effective Date through April 20, 2024). During Phase 1, Penterra shall assemble, organize, and deliver the complete Technology Transfer Package (all documents, data, CMC Documentation, and related materials) to Meridian and the Receiving Facility. Delivery shall be in electronic format (PDF and native format where applicable) via a secure file-sharing platform designated by the parties, with hard copies of critical documents (including master batch records and process validation reports) provided upon Meridian's request. Penterra shall provide an index and transmittal log for all delivered materials. Phase 1 shall include an initial gap assessment, during which Meridian's technical team reviews the delivered materials and identifies any gaps, ambiguities, or requests for supplemental information, which Penterra shall address within thirty (30) days of receipt of Meridian's written gap assessment report.

(b) Phase 2 — Technical Training and On-Site Support (Months 4–12; February 20, 2024 through October 20, 2024). During Phase 2, Penterra shall deploy qualified technical personnel to conduct on-site training at the Receiving Facility and/or Meridian's designated facility. Training shall encompass hands-on demonstration of the Manufacturing Process (API synthesis and finished dosage form manufacture), Analytical Methods, quality control procedures, and quality assurance systems. Training shall be structured according to a training plan developed by the Technology Transfer Sub-Committee and shall include both classroom instruction and practical laboratory and manufacturing demonstrations. Penterra shall also conduct training sessions at the Transferring Facility (Alkerra Manufacturing Inc., Research Triangle Park, North Carolina) for Meridian's technical personnel, as further described in Section 7.2.

(c) Phase 3 — Analytical Method Transfer and Qualification (Months 6–15; April 20, 2024 through January 20, 2025). During Phase 3, each Analytical Method shall be transferred to the Receiving Facility's quality control laboratory and qualified to demonstrate method equivalence. Method transfer shall follow a protocol developed jointly by the parties and consistent with ICH Q2(R1) (Validation of Analytical Procedures) and applicable compendia (USP, EP, JP as relevant). Qualification shall include execution of replicate analyses at both the Transferring Facility and the Receiving Facility using the same samples (or equivalent reference materials), with statistical comparison of results to demonstrate equivalence within pre-defined acceptance limits. System suitability criteria, method robustness assessments, and intermediate precision evaluations shall be conducted at the Receiving Facility.

(d) Phase 4 — Process Demonstration and Engineering Batches (Months 10–18; August 20, 2024 through April 20, 2025). During Phase 4, the Receiving Facility shall manufacture engineering batches (also referred to as demonstration batches) of API and finished dosage form under the supervision and with the on-site support of Penterra technical personnel. A minimum of one (1) engineering batch of API and one (1) engineering batch of finished dosage form (at each strength, i.e., 25 mg and 50 mg) shall be manufactured, tested, and evaluated against pre-defined quality specifications. Engineering batches shall be used to confirm equipment suitability, optimize process parameters for the Receiving Facility's equipment and environmental conditions, identify and resolve any scale-up or process adaptation issues, and generate preliminary data on process performance and product quality.

(e) Phase 5 — Process Validation and Final Acceptance (Months 18–24; April 20, 2025 through October 20, 2025). During Phase 5, the Receiving Facility shall manufacture three (3) consecutive process validation batches of API and three (3) consecutive process validation batches of finished dosage form (for each strength, 25 mg and 50 mg), in accordance with a pre-approved process validation protocol. Each validation batch shall meet all applicable release specifications and shall demonstrate process capability, as measured by a process capability index (Cpk) of not less than 1.33 for all critical quality attributes. Process validation reports shall be prepared by the Receiving Facility and reviewed and approved by Penterra's designated quality representative. Stability studies shall be initiated on validation batches in accordance with ICH Q1A(R2) guidelines.

3.2 Transfer Completion Deadline. All Transfer Milestones shall be completed and the Transfer Completion Date shall occur no later than October 20, 2025, which is twenty-four (24) months from the Effective Date. The parties acknowledge that timely completion of the Technology Transfer is essential to Meridian's ability to exercise its manufacturing rights under the License Agreement and to ensure continuity of supply of Licensed Product in the Territory following expiration of the initial supply period under the Supply Agreement.

3.3 Technology Transfer Plan. Within thirty (30) days of the Effective Date (i.e., by November 19, 2023), the parties, through their designated project leaders and the Technology Transfer Sub-Committee, shall finalize a detailed Technology Transfer Plan in accordance with the framework set forth in Schedule 3. The Technology Transfer Plan shall include, at a minimum: (a) specific deliverables and work packages for each Transfer Milestone; (b) assignment of responsibilities between Penterra/Alkerra and Meridian/Receiving Facility for each deliverable; (c) target start and completion dates for each deliverable; (d) resource allocation, including estimated person-days of on-site support by Penterra personnel for each phase; (e) identification of critical path items and dependencies; (f) risk assessment and mitigation strategies; and (g) a communication and reporting schedule. The finalized Technology Transfer Plan shall be attached to this Agreement as an updated Schedule 3 and shall be subject to periodic review and update by the Technology Transfer Sub-Committee.

3.4 Delay and Extension. If completion of any Transfer Milestone is delayed due to causes beyond the reasonable control of the responsible party (including, without limitation, regulatory delays at the Receiving Facility, force majeure events as described in Section 17.3, equipment procurement and qualification delays, delays caused by the other party's failure to perform its obligations hereunder, or unexpected technical challenges in adapting the Manufacturing Process to the Receiving Facility's equipment), the parties shall discuss in good faith an extension of the applicable milestone date through the Technology Transfer Sub-Committee. The Technology Transfer Sub-Committee shall assess the cause of the delay, the impact on subsequent milestones and the overall timeline, and appropriate remedial actions. Any extension of individual milestone dates that does not affect the Transfer Completion Date may be approved by the Technology Transfer Sub-Committee. An extension of the Transfer Completion Date may be granted by the JSC for a period of up to six (6) months (i.e., to April 20, 2026) upon a showing of good cause by the responsible party and a revised Technology Transfer Plan setting forth a credible path to completion within the extended period. Any extension of the Transfer Completion Date beyond April 20, 2026 shall require the mutual written consent of both parties' authorized representatives.

3.5 Progress Reports. Penterra shall provide Meridian with monthly written progress reports on the status of the Technology Transfer within ten (10) business days following the end of each calendar month. Each progress report shall include: (a) a summary of activities completed during the reporting period; (b) status of each Transfer Milestone (including percentage completion); (c) identification of open issues, risks, and potential delays; (d) projected timeline adjustments, if any; and (e) a summary of resources deployed. Meridian shall similarly provide Penterra with monthly written reports on the readiness status of the Receiving Facility, including the status of equipment procurement and qualification, laboratory readiness, personnel training, and regulatory submissions. The monthly progress reports from both parties shall be submitted to the Technology Transfer Sub-Committee for review and discussion at its monthly meetings.

ARTICLE 4 — ACCEPTANCE CRITERIA

4.1 General. Each Transfer Milestone shall be deemed complete only upon satisfaction of the corresponding Acceptance Criteria set forth in Schedule 2 attached hereto. The Acceptance Criteria are designed to provide objective, measurable standards for evaluating the successful completion of each phase of the Technology Transfer. The parties acknowledge that the ultimate objective of the Technology Transfer is to enable the Receiving Facility to independently and reproducibly manufacture Licensed Product that meets all applicable quality specifications and regulatory requirements, and the Acceptance Criteria shall be interpreted in light of this objective.

4.2 Document Transfer Acceptance (Phase 1). Phase 1 shall be deemed complete upon: (a) delivery of the complete Technology Transfer Package as listed in Schedule 1 to Meridian and the Receiving Facility via the designated secure file-sharing platform and/or physical delivery, as applicable; (b) Meridian's written confirmation, signed by Meridian's Technology Transfer project leader, that all required documents have been received, are legible, complete, and in the agreed-upon format (PDF and/or native electronic format); and (c) satisfactory resolution by Penterra of any gaps or deficiencies identified in Meridian's gap assessment report within the timeframe specified in Section 3.1(a). The parties shall execute a Phase 1 Completion Certificate upon satisfaction of the foregoing criteria.

4.3 Analytical Method Transfer Acceptance (Phase 3). Phase 3 shall be deemed complete upon demonstration that each transferred Analytical Method at the Receiving Facility produces results within pre-defined equivalence parameters as compared to results obtained from the Transferring Facility (Alkerra Manufacturing Inc.), in accordance with ICH Q2(R1) analytical method validation guidelines and the method transfer protocols approved by the Technology Transfer Sub-Committee. Specifically, for each Analytical Method:

(a) The Receiving Facility's results shall fall within the pre-defined acceptance limits established in the method transfer protocol, taking into account the inherent variability of each method as determined during method validation at the Transferring Facility.

(b) Statistical comparison of replicate results from the Transferring Facility and the Receiving Facility shall demonstrate equivalence at a confidence level of not less than ninety-five percent (95%), using the statistical test specified in the method transfer protocol (e.g., two one-sided t-test for equivalence, or other appropriate statistical method).

(d) An Analytical Method Transfer Report shall be prepared by the Receiving Facility, reviewed by Penterra's quality representative, and approved by both parties' Technology Transfer project leaders.

4.4 Process Demonstration Acceptance (Phase 4). Phase 4 shall be deemed complete upon successful manufacture of at least one (1) engineering batch of API and at least one (1) engineering batch of finished dosage form (for each tablet strength, 25 mg and 50 mg) at the Receiving Facility that meet the following criteria:

(a) The engineering batch API meets all pre-defined quality specifications for identity, assay (not less than 98.0% and not more than 102.0%), total impurities (not more than the specification limit established in the validated process), individual specified impurities (within specification limits), residual solvents, water content, and particle size distribution.

(b) The engineering batch finished dosage form meets all pre-defined quality specifications for identity, assay, content uniformity, dissolution, impurities (degradation products), appearance, and other applicable release tests.

(c) The manufacturing process yield for the engineering batch is within an acceptable range as compared to the Transferring Facility's historical performance (typically within ±10% of the mean historical yield, unless otherwise agreed).

(d) An Engineering Batch Report documenting the manufacturing process, in-process data, deviations (if any), and quality control test results is prepared by the Receiving Facility and reviewed by Penterra's quality representative.

4.5 Process Validation Acceptance (Phase 5). Phase 5 shall be deemed complete upon satisfaction of all of the following criteria:

(a) Successful manufacture of three (3) consecutive validation batches of API and three (3) consecutive validation batches of finished dosage form (for each tablet strength, 25 mg and 50 mg) at the Receiving Facility, manufactured in accordance with the approved process validation protocol.

(b) Each validation batch meets all applicable release specifications as set forth in the registered product specifications and the specifications agreed upon between the parties.

(c) Process capability indices for critical quality attributes demonstrate a Cpk of not less than 1.33 for each critical quality attribute, as calculated from the combined data of the three (3) consecutive validation batches. Critical quality attributes shall include, at a minimum, assay, content uniformity, dissolution, and total impurities for finished dosage form, and assay, total impurities, and particle size for API.

(d) Completed process validation reports for API and finished dosage form are prepared by the Receiving Facility, reviewed and approved by Penterra's designated quality representative, and accepted by both parties' Technology Transfer project leaders.

(e) Stability studies are initiated on at least one (1) validation batch of API and one (1) validation batch of each finished dosage form strength in accordance with ICH Q1A(R2) stability testing guidelines, with initial time-point data meeting applicable specifications.

4.6 Final Acceptance Certificate. Upon satisfaction of all Acceptance Criteria for all Transfer Milestones (Phase 1 through Phase 5), the parties shall execute a Final Acceptance Certificate in substantially the form attached as Schedule 4 hereto. The Final Acceptance Certificate shall confirm: (a) completion of all Transfer Milestones; (b) satisfaction of all Acceptance Criteria; (c) the Transfer Completion Date; (d) the identity and location of the Receiving Facility; and (e) any outstanding items or post-transfer support obligations. The Final Acceptance Certificate shall be signed by both parties' Technology Transfer project leaders and by authorized representatives of each party (at the level of Vice President or above). Execution of the Final Acceptance Certificate shall constitute conclusive evidence that the Technology Transfer has been completed in accordance with this Agreement, subject only to any exceptions or reservations expressly noted in the Final Acceptance Certificate.

4.7 Disputes Regarding Acceptance. In the event the parties disagree on whether any Acceptance Criteria have been met, the dispute shall be promptly referred to the Technology Transfer Sub-Committee for discussion and resolution. If the Technology Transfer Sub-Committee is unable to resolve the dispute within fifteen (15) business days of referral, the dispute shall be escalated to the Joint Steering Committee (JSC) established under the License Agreement. If the JSC is unable to resolve the dispute within thirty (30) days of escalation, either party may invoke the dispute resolution provisions set forth in Article 16 of this Agreement. Pending resolution of any such dispute, the parties shall continue to perform their respective obligations under this Agreement in good faith, and the Transfer Completion Date shall be tolled for the duration of the dispute resolution process (from the date of referral to the Technology Transfer Sub-Committee through the date of final resolution) if and to the extent the disputed Acceptance Criteria are on the critical path to completion of the Technology Transfer.

ARTICLE 5 — OBLIGATIONS OF PENTERRA (TRANSFEROR)

5.1 Delivery of Technology Transfer Package. Penterra shall assemble, organize, and deliver the complete Technology Transfer Package to Meridian and the Receiving Facility in accordance with the timeline set forth in Schedule 3 and the Technology Transfer Plan. Penterra shall use commercially reasonable efforts to ensure that all documents are accurate, current, complete, and in the format agreed upon by the parties. Documents shall be delivered in the English language; provided that where original documents exist only in another language, Penterra shall provide the original language version accompanied by a certified English translation. Penterra shall maintain a transmittal log documenting the date, description, and recipient of each delivered item, and shall provide copies of such log to Meridian upon request.

5.2 Personnel Support. Penterra shall make available qualified technical personnel with direct knowledge of the Manufacturing Process and Analytical Methods for PPC-4187 to support the Technology Transfer, including:

(a) On-Site Support. Penterra shall deploy qualified technical personnel to the Receiving Facility during Phases 2 through 5 of the Technology Transfer to provide hands-on guidance, troubleshooting, and process optimization support. On-site support shall be provided in accordance with the schedule and resource allocation set forth in the Technology Transfer Plan. Penterra's on-site personnel shall work collaboratively with the Receiving Facility's manufacturing, quality control, and quality assurance teams.

(b) Training. Penterra shall design and conduct structured training sessions for Meridian's and the Receiving Facility's technical personnel, covering all aspects of the Manufacturing Process (API synthesis, finished dosage form manufacture, in-process controls, and packaging), Analytical Methods (method execution, system suitability, data interpretation, and out-of-specification investigation procedures), and quality systems (change control, deviation management, CAPA, and stability programs) relevant to the manufacture and release of Licensed Product.

(c) Remote Support. Throughout the Technology Transfer period, Penterra shall provide remote technical support and consultation by telephone, videoconference, and email to address technical questions, troubleshoot issues, and provide guidance on process adaptation. Penterra shall use commercially reasonable efforts to respond to Meridian's technical inquiries within three (3) business days of receipt.

5.3 Key Personnel. Within fifteen (15) days of the Effective Date, Penterra shall designate a Technology Transfer project leader who shall serve as Penterra's primary point of contact for all Technology Transfer activities. In addition, Penterra shall identify key subject matter experts from Penterra and/or Alkerra Manufacturing Inc. with expertise in API synthesis, finished dosage form manufacturing, analytical chemistry, quality assurance, and regulatory affairs, who will be available for consultation and on-site support during the Technology Transfer. Penterra shall provide Meridian with the names, qualifications, and areas of expertise of such key personnel. Penterra shall not reassign, terminate, or replace any key personnel without at least thirty (30) days' prior written notice to Meridian, and shall ensure a reasonable transition period during which the departing key person provides a handoff briefing to his or her replacement and to Meridian's Technology Transfer team. Penterra acknowledges that continuity of key personnel is critical to the success of the Technology Transfer.

5.4 Access to Transferring Facility. Penterra shall arrange for Meridian's designated technical personnel to visit the Transferring Facility (Alkerra Manufacturing Inc., Research Triangle Park, North Carolina) to observe manufacturing operations, witness equipment operation, review production processes, and meet with Alkerra's process scientists and quality personnel. Such visits shall be subject to reasonable advance scheduling (no less than fifteen (15) business days' notice), Alkerra's standard site access and security policies, applicable confidentiality requirements, and facility capacity constraints. Penterra shall use commercially reasonable efforts to schedule at least two (2) site visits during the Technology Transfer period at mutually convenient times. Meridian's visiting personnel shall comply with all applicable safety, gowning, and conduct requirements of the Transferring Facility.

5.5 Reference Standards and Materials. Penterra shall supply Meridian with the reference standards, reference materials, and any proprietary reagents or specialty chemicals required for Analytical Method qualification at the Receiving Facility, at Penterra's actual cost (without markup). Such materials shall include primary and working reference standards for PPC-4187 API, reference standards for known impurities and degradation products, and any other reference materials identified in Schedule 1. Penterra shall provide certificates of analysis and characterization data for all reference standards supplied.

5.6 Regulatory Support. Penterra shall provide reasonable cooperation and assistance in the preparation of regulatory filings by Meridian or its subsidiaries and affiliates in the Territory, to the extent such filings relate to the transferred Manufacturing Process and CMC Documentation. Without limiting the generality of the foregoing, Penterra shall:

(a) Provide Letters of Authorization and right-of-reference letters enabling Meridian and its subsidiaries (including Meridian Pharma (Shanghai) Co., Ltd. for NMPA filings and Meridian Japan K.K. for PMDA filings) to cross-reference Penterra's regulatory filings (including Drug Master Files) in their Territory regulatory submissions.

(b) Respond to reasonable requests for technical information and clarifications from Territory regulatory authorities in connection with the review of Meridian's manufacturing-related regulatory submissions.

(c) Support Meridian's preparation of CTD Module 3 (Quality) sections for Territory regulatory filings by providing source data, reference documents, and technical review of draft submissions.

5.7 Updates and Improvements. If during the Technology Transfer period (from the Effective Date through the Transfer Completion Date), Penterra makes material improvements, modifications, or changes to the Manufacturing Process, Analytical Methods, or CMC Documentation for PPC-4187 (whether at Alkerra Manufacturing Inc. or otherwise), Penterra shall promptly disclose such improvements, modifications, or changes to Meridian in writing and shall include the relevant documentation in the Technology Transfer Package. For purposes of this Section, "material" means any change that could reasonably be expected to affect the quality, safety, efficacy, yield, or regulatory status of Licensed Product. Penterra shall make its technical personnel available to explain and provide training on any such improvements or changes.

ARTICLE 6 — OBLIGATIONS OF MERIDIAN (TRANSFEREE)

6.1 Designation of Receiving Facility. Meridian shall designate the Receiving Facility within sixty (60) days of the Effective Date (i.e., by December 19, 2023) and shall notify Penterra in writing of the identity, location, regulatory status, and manufacturing capabilities of the Receiving Facility. The notification shall include: (a) the legal name and address of the Receiving Facility; (b) the facility's current GMP certification status and the identity of the certifying regulatory authority; (c) a description of the facility's manufacturing capabilities (including available equipment for API synthesis and/or finished dosage form manufacture, as applicable); (d) the facility's quality control laboratory capabilities; and (e) a summary of the facility's relevant manufacturing experience with pharmaceutical products of similar complexity. The Receiving Facility may be a Meridian subsidiary manufacturing facility (such as a Meridian-owned facility in the Territory) or a third-party contract manufacturing organization selected and approved by Meridian, provided that in either case the facility meets all applicable current Good Manufacturing Practice (cGMP) standards and regulatory requirements. Meridian may designate separate Receiving Facilities for API manufacture and finished dosage form manufacture, subject to the foregoing requirements for each such facility.

6.2 Facility Readiness. Meridian shall ensure that the Receiving Facility is ready to receive the Technology Transfer in accordance with the timelines set forth in the Technology Transfer Plan. Facility readiness shall include, without limitation:

(a) Installation and qualification (IQ/OQ/PQ) of all manufacturing equipment and utility systems required to execute the Manufacturing Process at commercial scale, in accordance with the equipment specifications provided in the Technology Transfer Package.

(b) Availability of a suitably equipped quality control laboratory with qualified instrumentation (including HPLC, GC, ICP-MS, IR spectrophotometer, dissolution apparatus, Karl Fischer titrator, particle size analyzer, and other instruments required for the Analytical Methods) and qualified personnel.

(c) Availability of sufficient quantities of raw materials, starting materials, excipients, and packaging components to support engineering batches, process validation batches, and analytical method qualification.

(d) Designation and training of qualified technical personnel at the Receiving Facility who will participate in all phases of the Technology Transfer.

(e) Implementation of quality management systems (including document control, change control, deviation management, CAPA, stability programs, and training systems) that meet applicable cGMP requirements and are compatible with the quality standards set forth in the Quality Agreement.

6.3 Personnel. Meridian shall designate a Technology Transfer project leader within fifteen (15) days of the Effective Date, who shall serve as Meridian's primary point of contact for all Technology Transfer activities and shall coordinate day-to-day interactions with Penterra's project leader. Meridian shall also designate qualified technical personnel from its organization and/or the Receiving Facility to participate in all phases of the Technology Transfer, attend training sessions conducted by Penterra, collaborate with Penterra's technical personnel during on-site activities, and provide timely feedback and information necessary for the successful execution of the Technology Transfer Plan.

6.4 Regulatory Approvals. Meridian shall be solely responsible for identifying, applying for, and obtaining any regulatory approvals, manufacturing licenses, GMP certifications, or other governmental authorizations required for the Receiving Facility to manufacture Licensed Product in the Territory. Such regulatory approvals may include, without limitation, manufacturing licenses from the NMPA (for manufacture in the People's Republic of China), PMDA (for manufacture in Japan), MFDS (for manufacture in the Republic of Korea), TGA (for manufacture in Australia), and equivalent authorizations from other Territory regulatory authorities. Penterra shall provide reasonable regulatory support as set forth in Section 5.6, but Meridian acknowledges that the responsibility for obtaining and maintaining all such regulatory approvals rests solely with Meridian.

6.5 Cooperation. Meridian shall cooperate fully and in good faith with Penterra in executing the Technology Transfer Plan, including by: (a) responding promptly to requests for information, data, and feedback; (b) providing Penterra's on-site personnel with reasonable access to the Receiving Facility's manufacturing areas, laboratories, and quality systems; (c) making Receiving Facility personnel available for training, meetings, and collaborative activities; (d) procuring equipment, materials, and services necessary for the Technology Transfer in a timely manner; and (e) promptly communicating to Penterra any issues, concerns, or risks that may affect the Technology Transfer timeline or outcome.

6.6 Quality Agreement. The parties acknowledge that the Quality Agreement governing API supply specifications, quality standards, change control, deviation handling, complaint management, and related quality matters is to be executed within sixty (60) days of the Effective Date (i.e., by December 19, 2023). Meridian shall cooperate with Penterra in finalizing and executing the Quality Agreement in a timely manner. The parties further acknowledge that the Quality Agreement, once executed, shall govern quality-related aspects of the Technology Transfer process, including quality oversight of engineering batches and process validation batches manufactured at the Receiving Facility, change control procedures for Manufacturing Process modifications, and deviation investigation and resolution procedures.

ARTICLE 7 — PERSONNEL AND TRAVEL

7.1 Penterra Personnel On-Site at Receiving Facility. Penterra shall provide on-site technical personnel at the Receiving Facility for a total of no fewer than the number of person-days specified in the Technology Transfer Plan during the Technology Transfer period, allocated across Phases 2 through 5. The Technology Transfer Plan shall specify the minimum and estimated number of person-days for each phase, based on the complexity of the activities to be performed and the Receiving Facility's capabilities. As a general guideline, the parties anticipate that Penterra will provide approximately one hundred fifty (150) to two hundred (200) person-days of on-site support across all phases, subject to adjustment based on the Receiving Facility's specific needs and the progress of the Technology Transfer. The deployment of Penterra personnel shall be coordinated through the Technology Transfer Sub-Committee, with schedules agreed upon at least thirty (30) days in advance.

7.2 Meridian Personnel at Transferring Facility. Meridian may send up to eight (8) technical personnel to the Transferring Facility (Alkerra Manufacturing Inc., Research Triangle Park, North Carolina) for observation of manufacturing operations and hands-on training, subject to: (a) reasonable advance scheduling, with requests for site visits submitted to Penterra's project leader at least fifteen (15) business days in advance; (b) Alkerra's standard site access policies and capacity limitations (with no more than four (4) Meridian personnel visiting at any one time unless otherwise agreed); (c) execution of Alkerra's standard visitor confidentiality agreements, to the extent not superseded by the confidentiality provisions of this Agreement and the License Agreement; and (d) the visiting personnel's compliance with all applicable facility rules, gowning requirements, and safety procedures. Penterra shall use commercially reasonable efforts to accommodate Meridian's visit requests.

7.3 Travel and Expenses. Each party shall bear its own personnel costs (salaries, wages, benefits, and related employment costs) for its employees and contractors engaged in the Technology Transfer. Travel and accommodation expenses for Penterra personnel providing on-site support at the Receiving Facility shall be borne by Meridian, subject to Meridian's standard corporate travel and expense policy, a copy of which shall be provided to Penterra within thirty (30) days of the Effective Date. Penterra personnel shall submit travel expense reports to Meridian's project leader within thirty (30) days following each on-site visit. Travel, accommodation, and related expenses for Meridian personnel visiting the Transferring Facility shall be borne by Meridian.

7.4 Conduct. All personnel of either party visiting or working at the other party's facilities or the Receiving Facility or Transferring Facility shall comply with the host facility's site rules, standard operating procedures, safety requirements, environmental regulations, gowning and hygiene procedures, and confidentiality requirements. Each party shall ensure that its personnel conduct themselves in a professional manner and cooperate with the host facility's management and staff. Each party shall be responsible for any damage to the host facility's equipment or property caused by the negligence or willful misconduct of its personnel.

ARTICLE 8 — COSTS AND EXPENSES

8.1 Internal Costs. Except as otherwise expressly provided in this Agreement, each party shall bear its own internal costs (including personnel costs, overhead, and administrative expenses) associated with performing its obligations under this Agreement in connection with the Technology Transfer.

8.2 Out-of-Pocket Costs. Meridian shall reimburse Penterra for reasonable, documented, pre-approved out-of-pocket costs actually incurred by Penterra in connection with the Technology Transfer, including the following categories of costs:

(a) Third-party laboratory costs incurred by Penterra at Alkerra Manufacturing Inc. or other third-party laboratories specifically in connection with the Technology Transfer (e.g., preparation of duplicate samples for method transfer, re-testing for method equivalence assessment).

(b) Costs of procuring and shipping reference standards, reference materials, and proprietary reagents to the Receiving Facility, as described in Section 5.5.

(c) Document reproduction, formatting, and certified translation costs incurred in preparing the Technology Transfer Package for delivery.

(d) Travel and accommodation expenses for Penterra personnel providing on-site support at the Receiving Facility, as described in Section 7.3.

(e) Any other out-of-pocket costs specifically approved by Meridian in writing in advance.

For the avoidance of doubt, Penterra shall not incur any reimbursable out-of-pocket cost in excess of five thousand U.S. dollars ($5,000.00) per individual expense item without obtaining Meridian's prior written approval, which shall not be unreasonably withheld.

8.3 No Additional Technology Transfer Fee. The parties acknowledge and agree that the economic terms of the License Agreement, including the eighteen million U.S. dollar ($18,000,000.00) upfront payment, the development and regulatory milestone payments, the commercial milestone payments, and the royalty structure set forth therein, constitute full and adequate consideration for the Technology Transfer contemplated by this Agreement. No separate technology transfer fee, success fee, or additional consideration shall be payable by Meridian to Penterra in connection with the Technology Transfer, except for the reimbursable out-of-pocket costs described in Section 8.2.

8.4 Invoicing and Payment. Penterra shall invoice Meridian quarterly (within thirty (30) days following the end of each calendar quarter) for all reimbursable out-of-pocket costs incurred during such quarter, accompanied by reasonable supporting documentation (including itemized expense reports, receipts, and third-party invoices). Meridian shall pay all undisputed amounts within thirty (30) days of receipt of a properly submitted invoice. If Meridian disputes any invoiced amount, Meridian shall notify Penterra in writing within fifteen (15) days of receipt, specifying the disputed amount and the basis for the dispute. The parties shall use commercially reasonable efforts to resolve any invoice disputes promptly through good faith discussions. All payments shall be made in U.S. dollars by wire transfer to the account designated by Penterra.

ARTICLE 9 — INTELLECTUAL PROPERTY

9.1 Ownership of Transferred Technology. All Know-How, Manufacturing Process information, Analytical Methods, CMC Documentation, and other proprietary technology and intellectual property transferred by Penterra to Meridian pursuant to this Agreement remain the exclusive property of Penterra. The transfer of the Technology Transfer Package does not convey to Meridian any ownership interest in the underlying intellectual property. Meridian's rights to use the transferred technology are governed by and limited to the scope of the license granted under the License Agreement, including the territorial, field-of-use, and sublicensing restrictions set forth therein. Meridian shall not use the transferred technology for any purpose outside the scope of the License Agreement, including without limitation for the development, manufacture, or commercialization of any product other than Licensed Product, or in any territory other than the Territory.

9.2 Improvements by Meridian. Any improvements, modifications, enhancements, or adaptations to the Manufacturing Process, Analytical Methods, or formulations developed by or on behalf of Meridian (including by the Receiving Facility) during or after the Technology Transfer that relate specifically to PPC-4187 or Licensed Product ("Meridian Improvements") shall be jointly owned by the parties, subject to and in accordance with the intellectual property allocation provisions set forth in the License Agreement. Meridian hereby grants Penterra a non-exclusive, royalty-free, perpetual, irrevocable license to use, practice, and sublicense Meridian Improvements outside the Territory for any purpose, including the manufacture, development, and commercialization of products containing PPC-4187. Meridian shall promptly disclose all Meridian Improvements to Penterra in writing, including sufficient technical detail to enable Penterra to practice such improvements.

9.3 Improvements by Penterra. Any improvements, modifications, enhancements, or adaptations to the Manufacturing Process, Analytical Methods, or formulations developed by or on behalf of Penterra during the Technology Transfer period (from the Effective Date through the Transfer Completion Date) that relate specifically to PPC-4187 or Licensed Product ("Penterra Improvements") shall be the sole property of Penterra and shall be included in the Technology Transfer Package and licensed to Meridian under the terms of the License Agreement. Penterra shall promptly disclose all Penterra Improvements to Meridian in writing and shall provide all documentation and training necessary for Meridian and the Receiving Facility to implement such improvements.

9.4 Patent Portfolio. The parties acknowledge the Licensed Patents set forth in Schedule A to the License Agreement, which include, without limitation:

(a) U.S. Patent No. 11,234,567 — "Selective JAK1 Inhibitor Compounds and Compositions" (Composition of Matter patent), with an expiration date of August 12, 2037;

(b) U.S. Patent No. 11,345,678 — "Crystalline Forms of PPC-4187 and Methods of Preparation Thereof" (Crystalline Form A patent), with an expiration date of November 3, 2038;

(i) CN Patent No. ZL 2020 1 0456789.0 (People's Republic of China);

(ii) JP Patent No. 7,012,345 (Japan);

(iii) KR Patent No. 10-2345678 (Republic of Korea);

(iv) AU Patent No. 2020234567 (Australia);

together with all continuations, continuations-in-part, divisionals, reissues, reexaminations, extensions, and supplementary protection certificates relating thereto.

The Joint Patent Committee (JPC) established under the License Agreement shall oversee the prosecution, maintenance, and enforcement of Licensed Patents in the Territory, in accordance with the terms of the License Agreement. The parties' rights and obligations with respect to patent prosecution, maintenance, enforcement, and defense in the Territory are governed by the License Agreement and are not modified by this Agreement.

ARTICLE 10 — CONFIDENTIALITY

10.1 Confidential Information. All information disclosed by either party to the other party (or to the Receiving Facility or Transferring Facility, as applicable) in connection with the Technology Transfer, including without limitation the Technology Transfer Package, the Technology Transfer Plan, the Acceptance Criteria, progress reports, and all technical, scientific, business, financial, and regulatory information exchanged in connection with the performance of this Agreement, constitutes "Confidential Information" subject to the

TECHNOLOGY TRANSFER AGREEMENT
by and between
PENTERRA PHARMACEUTICALS CORP.
("Penterra" or "Transferor")
and
MERIDIAN BIO THERAPEUTICS LIMITED
("Meridian" or "Transferee")
Dated: October 2, 2023
Effective Date: October 20, 2023
Executed concurrently with the Exclusive License Agreement dated October 2, 2023
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RECITALS
WHEREAS, Penterra Pharmaceuticals Corp. is a corporation duly 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, and is the owner of certain proprietary rights in the selective Janus kinase 1 (JAK1) inhibitor compound designated PPC-4187 (proposed International Nonproprietary Name: Penteracitinib), including, without limitation, manufacturing process know-how, analytical methods, chemistry, manufacturing and controls documentation, and related intellectual property;
WHEREAS, Meridian Bio Therapeutics Limited is a limited company duly incorporated and existing under the laws of Hong Kong Special Administrative Region (Company Registration No. 2847631), with its registered office and principal place of business located at 18/F, Blossom Tower, 88 Queen's Road Central, Hong Kong SAR, and possesses substantial pharmaceutical development, manufacturing, and commercialization capabilities across the Asia-Pacific region;
WHEREAS, Penterra and Meridian have entered into that certain Exclusive License Agreement dated October 2, 2023, with an effective date of October 20, 2023 (the "License Agreement"), pursuant to which Penterra has granted Meridian an exclusive license to develop, manufacture, and commercialize PPC-4187 (Penteracitinib) in the Licensed Territory (as defined in the License Agreement);
WHEREAS, the License Agreement contemplates that Penterra will supply active pharmaceutical ingredient ("API") and reference standards to Meridian for the initial three (3) year period following the Closing Date under a separate Supply Agreement at a price equal to Penterra's cost plus a fifteen percent (15%) markup, and Penterra's current contract manufacturing organization for the manufacture of PPC-4187 API and finished dosage form is Alkerra Manufacturing Inc., located at 5200 Meridian Parkway, Research Triangle Park, North Carolina 27713;
WHEREAS, the License Agreement further requires Penterra to transfer its proprietary manufacturing process, analytical methods, and chemistry, manufacturing and controls documentation to Meridian's designated Asia-Pacific manufacturing facility or contract manufacturing organization to enable Meridian to independently manufacture PPC-4187 in the Licensed Territory following the expiration of the initial supply period;
WHEREAS, the parties intend that such technology transfer shall be completed within twenty-four (24) months of the Effective Date (i.e., by October 20, 2025), in order to enable Meridian to achieve self-sufficiency in the manufacture of Licensed Product in the Licensed Territory;
WHEREAS, PPC-4187 is currently formulated as 25 mg and 50 mg film-coated tablets, with the manufacturing process having been validated at Alkerra Manufacturing Inc. for both the API synthesis and finished dosage form manufacture; and
WHEREAS, Penterra and Meridian desire to set forth the terms and conditions upon which such technology transfer shall be conducted;
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, and intending to be legally bound, the parties agree as follows:
ARTICLE 1 — DEFINITIONS
1.1 Definitions. Capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to them in the License Agreement. In addition to terms defined elsewhere in this Agreement, the following terms shall have the meanings set forth below:
(a) "Acceptance Criteria" means the criteria set forth in Schedule 2 attached hereto that the Receiving Facility must satisfy to demonstrate successful completion of each Transfer Milestone, as further described in Article 4 of this Agreement.
(b) "Alkerra" means Alkerra Manufacturing Inc., a contract manufacturing organization engaged by Penterra for the manufacture of PPC-4187 API and finished dosage form, with its principal manufacturing facility located at 5200 Meridian Parkway, Research Triangle Park, North Carolina 27713.
(c) "Analytical Methods" means all proprietary analytical testing methods, reference standards, release specifications, stability-indicating methods, system suitability criteria, and related standard operating procedures used by or on behalf of Penterra in connection with the manufacture, quality control, quality assurance, and release of Licensed Product, including without limitation methods for identity testing, assay, impurity profiling, dissolution testing, content uniformity, and residual solvent analysis.
(d) "API" means the active pharmaceutical ingredient for PPC-4187 (Penteracitinib), including all polymorphic forms, salts, solvates, hydrates, co-crystals, and metabolites thereof that are used in or necessary for the manufacture of Licensed Product.
(e) "CMC Documentation" means all chemistry, manufacturing, and controls documentation, including but not limited to batch records (master and executed), process validation reports, cleaning validation documentation, equipment specifications and qualification records, raw material and excipient specifications, starting material and intermediate specifications, stability data (accelerated and long-term), environmental monitoring data, and regulatory filings (including relevant portions of Investigational New Drug applications, Common Technical Document Module 3 submissions, and Drug Master Files) pertaining to the manufacture, testing, packaging, and release of Licensed Product.
(f) "Compound" means PPC-4187 (Penteracitinib), a selective Janus kinase 1 (JAK1) inhibitor, including all polymorphic forms thereof, and specifically including Crystalline Form A as described in U.S. Patent No. 11,345,678.
(g) "Effective Date" means October 20, 2023.
(h) "Know-How" means all proprietary manufacturing process knowledge, trade secrets, technical data, formulations, processes, techniques, methods, procedures, data compilations, experimental results, and information described in Schedule B to the License Agreement, whether in written, electronic, or other tangible form or maintained as unwritten knowledge of Penterra personnel.
(i) "License Agreement" means the Exclusive License Agreement dated October 2, 2023, between Penterra Pharmaceuticals Corp. and Meridian Bio Therapeutics Limited, as may be amended, modified, or supplemented from time to time in accordance with its terms.
(j) "Licensed Product" means pharmaceutical products containing PPC-4187 (Penteracitinib) as the active pharmaceutical ingredient, including the currently approved formulations of 25 mg and 50 mg film-coated tablets, as well as any additional dosage forms, strengths, or formulations developed in accordance with the License Agreement.
(k) "Manufacturing Process" means the complete process for manufacturing, testing, releasing, and packaging API and finished dosage form of Licensed Product, including without limitation all steps of API synthesis (from designated starting materials through final API), formulation, granulation, compression, film coating, packaging, in-process testing, release testing, and related quality control and quality assurance procedures, as described in the Technology Transfer Package.
(l) "Quality Agreement" means the Quality Agreement to be executed between Penterra and Meridian within sixty (60) days of the Effective Date (i.e., by December 19, 2023), governing API supply specifications, quality standards, change control procedures, deviation handling, complaint management, and related quality matters in connection with the supply and manufacture of Licensed Product.
(m) "Receiving Facility" means Meridian's designated Asia-Pacific manufacturing facility or contract manufacturing organization approved by Meridian to receive the Technology Transfer, as designated by Meridian in accordance with Section 6.1 of this Agreement, provided that such facility meets all applicable current Good Manufacturing Practice ("cGMP") standards and regulatory requirements.
(n) "Supply Agreement" means the API Supply Agreement between Penterra and Meridian executed concurrently with this Agreement, governing the supply of PPC-4187 API and reference standards from Penterra (through Alkerra Manufacturing Inc.) to Meridian during the initial three (3) year supply period.
(o) "Technology Transfer" means the transfer of the Manufacturing Process, Analytical Methods, Know-How, and CMC Documentation from Penterra (and/or Alkerra, as applicable) to the Receiving Facility, as contemplated by the License Agreement and as set forth in this Agreement.
(p) "Technology Transfer Package" means the complete package of documents, data, information, materials, reference standards, and other items to be transferred to Meridian and the Receiving Facility in connection with the Technology Transfer, as set forth in Schedule 1 attached hereto.
(q) "Technology Transfer Plan" means the detailed plan and timeline for the Technology Transfer as set forth in Schedule 3 attached hereto, as may be updated from time to time by mutual written agreement of the parties through the Technology Transfer Sub-Committee.
(r) "Territory" means the Licensed Territory as defined in the License Agreement and set forth in Schedule D thereto, which includes the following jurisdictions: 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, Thailand, Malaysia, Indonesia, the Philippines, Vietnam, and Taiwan.
(s) "Transfer Completion Date" means the date on which all Transfer Milestones have been achieved and all Acceptance Criteria satisfied, as evidenced by the execution of the Final Acceptance Certificate pursuant to Section 4.6 of this Agreement, in no event later than October 20, 2025, subject to extension in accordance with Section 3.4.
(t) "Transfer Milestones" means the milestones set forth in Schedule 3 measuring progress toward completion of the Technology Transfer, including the Phase 1 through Phase 5 milestones described in Section 3.1 of this Agreement.
(u) "Transferring Facility" means Alkerra Manufacturing Inc.'s manufacturing facility located at 5200 Meridian Parkway, Research Triangle Park, North Carolina 27713, or such other Penterra-designated facility from which the Technology Transfer Package or any component thereof originates.
1.2 Construction. Unless the context otherwise requires, the rules of interpretation set forth in the License Agreement shall apply to this Agreement. References to Articles, Sections, and Schedules are to Articles, Sections, and Schedules of this Agreement unless otherwise indicated. The headings and captions of Articles, Sections, and Schedules are for convenience of reference only and shall not affect the interpretation of this Agreement. The words "include," "includes," and "including" shall be deemed to be followed by the phrase "without limitation." The word "or" is not exclusive. The singular includes the plural and vice versa. References to "days" mean calendar days unless otherwise specified. References to "business days" mean days other than Saturdays, Sundays, and public holidays in both New York, New York, United States, and Hong Kong SAR.
ARTICLE 2 — SCOPE OF TECHNOLOGY TRANSFER
2.1 Scope. Penterra shall transfer to Meridian (or Meridian's designated Receiving Facility) the complete Technology Transfer Package necessary to enable Meridian to independently manufacture, test, release, and package API and finished dosage form of Licensed Product (PPC-4187 (Penteracitinib), 25 mg and 50 mg film-coated tablets) in the Territory. The Technology Transfer shall encompass all technical information, documentation, know-how, methods, and materials reasonably necessary for a suitably qualified and equipped pharmaceutical manufacturing facility to replicate the Manufacturing Process and produce Licensed Product that meets all applicable release specifications, quality standards, and regulatory requirements in the Territory. The scope of the Technology Transfer is intended to be comprehensive and shall be interpreted broadly to effectuate the purposes of the License Agreement.
2.2 Technology Transfer Package Contents. The Technology Transfer Package shall include, without limitation, the following categories of documents, data, information, and materials:
(a) API Manufacturing Process Documentation. Complete Manufacturing Process documentation for the synthesis of PPC-4187 API, including process flow diagrams, descriptions of all unit operations (including but not limited to chemical reactions, crystallizations, filtrations, drying, milling, and blending), process parameters and acceptable ranges for each unit operation, in-process controls and acceptance limits, specifications for raw materials and starting materials, specifications for synthetic intermediates, solvent usage and recovery procedures, and yield expectations at each stage of the synthesis.
(b) Finished Dosage Form Manufacturing Process Documentation. Complete Manufacturing Process documentation for the manufacture of film-coated tablets in 25 mg and 50 mg strengths, including quantitative formulation composition and bill of materials, wet granulation and/or dry granulation process parameters, tablet compression parameters (including tooling specifications and compression force ranges), film coating process parameters (including coating solution composition, spray rates, inlet air temperature, and pan speed), primary and secondary packaging process documentation, and equipment specifications for each unit operation.
(c) Analytical Methods. All Analytical Methods for API and finished dosage form, including but not limited to identity tests (infrared spectroscopy, HPLC identification), assay methods (HPLC-UV), impurity profiling methods (related substances by gradient HPLC, residual solvents by headspace GC, heavy metals/elemental impurities by ICP-MS), dissolution testing methods (apparatus type, media composition, sampling times, and acceptance criteria), content uniformity methods, water content determination (Karl Fischer), particle size distribution methods for API, and stability-indicating analytical methods validated in accordance with ICH Q2(R1) guidelines.
(d) Reference Standards and Reference Materials. Reference standards for PPC-4187 API (including primary and working reference standards), reference standards for known impurities and degradation products, reference standards for starting materials and synthetic intermediates as applicable, and any proprietary reagents or specialty chemicals required for the execution of the Analytical Methods.
(e) CMC Documentation. Complete CMC Documentation, including master batch records for API and finished dosage form, executed batch records from process validation batches manufactured at Alkerra Manufacturing Inc., process validation reports (including statistical analysis of critical quality attributes), cleaning validation reports, equipment qualification records (IQ/OQ/PQ), utility qualification records as applicable, and process characterization study reports.
(f) Stability Data. Stability data packages for API and finished dosage form, including accelerated stability data (40°C/75% RH, six months minimum), long-term stability data (25°C/60% RH for API; 30°C/65% RH and/or 25°C/60% RH for finished dosage form), photostability data in accordance with ICH Q1B, and in-use stability data as applicable. Stability protocols, including time points, test parameters, and acceptance criteria, shall also be included.
(g) Regulatory Filing Documentation. Relevant sections of regulatory submissions pertaining to the manufacturing process, including applicable portions of the Investigational New Drug (IND) application, Common Technical Document (CTD) Module 3 (Quality) sections, Drug Master File (DMF) information as applicable, and any correspondence with regulatory authorities relating to manufacturing process changes, post-approval commitments, or inspection observations. Such documentation shall be provided to the extent relevant to Meridian's regulatory filings with the National Medical Products Administration (NMPA), Pharmaceuticals and Medical Devices Agency (PMDA), Ministry of Food and Drug Safety (MFDS), Therapeutic Goods Administration (TGA), and other Territory regulatory authorities.
(h) Environmental, Health, and Safety Data. Environmental, health, and safety data related to the Manufacturing Process, including material safety data sheets (SDS) for API, intermediates, and hazardous raw materials, occupational exposure limit (OEL) assessments, containment requirements, waste stream characterization, and any environmental impact assessments conducted in connection with the Manufacturing Process.
(i) Clinical Supply Manufacturing Documentation. Documentation relating to the manufacture of clinical supplies for Penterra-sponsored Phase IIb clinical study PPC-4187-201 (four hundred twenty (420) patients), including batch records, certificates of analysis, investigational product release documentation, and any relevant process deviations or out-of-specification investigations associated with clinical supply manufacturing.
2.3 Detailed Listing. A detailed listing of all items comprising the Technology Transfer Package, organized by category and including document reference numbers, titles, version numbers, and estimated page counts, is set forth in Schedule 1 attached hereto. The parties acknowledge that Schedule 1 represents the best estimate of the Technology Transfer Package contents as of the Effective Date and may be updated by mutual written agreement through the Technology Transfer Sub-Committee as additional documents are identified during the course of the Technology Transfer.
2.4 Know-How Acknowledgment. Penterra acknowledges and confirms that the Technology Transfer Package includes all Know-How described in Schedule B to the License Agreement. To the extent any Know-How described in Schedule B is not otherwise captured in the documents listed in Schedule 1, Penterra shall supplement the Technology Transfer Package to include such Know-How in documented form or, where the Know-How is not readily reducible to writing, through practical demonstration and training during the on-site support phases of the Technology Transfer.
ARTICLE 3 — TRANSFER MILESTONES AND TIMELINE
3.1 Transfer Milestones. The Technology Transfer shall be accomplished in accordance with the Transfer Milestones set forth in Schedule 3, which shall include, at a minimum, the following five (5) phases:
(a) Phase 1 — Document Transfer (Months 1–6; Effective Date through April 20, 2024). During Phase 1, Penterra shall assemble, organize, and deliver the complete Technology Transfer Package (all documents, data, CMC Documentation, and related materials) to Meridian and the Receiving Facility. Delivery shall be in electronic format (PDF and native format where applicable) via a secure file-sharing platform designated by the parties, with hard copies of critical documents (including master batch records and process validation reports) provided upon Meridian's request. Penterra shall provide an index and transmittal log for all delivered materials. Phase 1 shall include an initial gap assessment, during which Meridian's technical team reviews the delivered materials and identifies any gaps, ambiguities, or requests for supplemental information, which Penterra shall address within thirty (30) days of receipt of Meridian's written gap assessment report.
(b) Phase 2 — Technical Training and On-Site Support (Months 4–12; February 20, 2024 through October 20, 2024). During Phase 2, Penterra shall deploy qualified technical personnel to conduct on-site training at the Receiving Facility and/or Meridian's designated facility. Training shall encompass hands-on demonstration of the Manufacturing Process (API synthesis and finished dosage form manufacture), Analytical Methods, quality control procedures, and quality assurance systems. Training shall be structured according to a training plan developed by the Technology Transfer Sub-Committee and shall include both classroom instruction and practical laboratory and manufacturing demonstrations. Penterra shall also conduct training sessions at the Transferring Facility (Alkerra Manufacturing Inc., Research Triangle Park, North Carolina) for Meridian's technical personnel, as further described in Section 7.2.
(c) Phase 3 — Analytical Method Transfer and Qualification (Months 6–15; April 20, 2024 through January 20, 2025). During Phase 3, each Analytical Method shall be transferred to the Receiving Facility's quality control laboratory and qualified to demonstrate method equivalence. Method transfer shall follow a protocol developed jointly by the parties and consistent with ICH Q2(R1) (Validation of Analytical Procedures) and applicable compendia (USP, EP, JP as relevant). Qualification shall include execution of replicate analyses at both the Transferring Facility and the Receiving Facility using the same samples (or equivalent reference materials), with statistical comparison of results to demonstrate equivalence within pre-defined acceptance limits. System suitability criteria, method robustness assessments, and intermediate precision evaluations shall be conducted at the Receiving Facility.
(d) Phase 4 — Process Demonstration and Engineering Batches (Months 10–18; August 20, 2024 through April 20, 2025). During Phase 4, the Receiving Facility shall manufacture engineering batches (also referred to as demonstration batches) of API and finished dosage form under the supervision and with the on-site support of Penterra technical personnel. A minimum of one (1) engineering batch of API and one (1) engineering batch of finished dosage form (at each strength, i.e., 25 mg and 50 mg) shall be manufactured, tested, and evaluated against pre-defined quality specifications. Engineering batches shall be used to confirm equipment suitability, optimize process parameters for the Receiving Facility's equipment and environmental conditions, identify and resolve any scale-up or process adaptation issues, and generate preliminary data on process performance and product quality.
(e) Phase 5 — Process Validation and Final Acceptance (Months 18–24; April 20, 2025 through October 20, 2025). During Phase 5, the Receiving Facility shall manufacture three (3) consecutive process validation batches of API and three (3) consecutive process validation batches of finished dosage form (for each strength, 25 mg and 50 mg), in accordance with a pre-approved process validation protocol. Each validation batch shall meet all applicable release specifications and shall demonstrate process capability, as measured by a process capability index (Cpk) of not less than 1.33 for all critical quality attributes. Process validation reports shall be prepared by the Receiving Facility and reviewed and approved by Penterra's designated quality representative. Stability studies shall be initiated on validation batches in accordance with ICH Q1A(R2) guidelines.
3.2 Transfer Completion Deadline. All Transfer Milestones shall be completed and the Transfer Completion Date shall occur no later than October 20, 2025, which is twenty-four (24) months from the Effective Date. The parties acknowledge that timely completion of the Technology Transfer is essential to Meridian's ability to exercise its manufacturing rights under the License Agreement and to ensure continuity of supply of Licensed Product in the Territory following expiration of the initial supply period under the Supply Agreement.
3.3 Technology Transfer Plan. Within thirty (30) days of the Effective Date (i.e., by November 19, 2023), the parties, through their designated project leaders and the Technology Transfer Sub-Committee, shall finalize a detailed Technology Transfer Plan in accordance with the framework set forth in Schedule 3. The Technology Transfer Plan shall include, at a minimum: (a) specific deliverables and work packages for each Transfer Milestone; (b) assignment of responsibilities between Penterra/Alkerra and Meridian/Receiving Facility for each deliverable; (c) target start and completion dates for each deliverable; (d) resource allocation, including estimated person-days of on-site support by Penterra personnel for each phase; (e) identification of critical path items and dependencies; (f) risk assessment and mitigation strategies; and (g) a communication and reporting schedule. The finalized Technology Transfer Plan shall be attached to this Agreement as an updated Schedule 3 and shall be subject to periodic review and update by the Technology Transfer Sub-Committee.
3.4 Delay and Extension. If completion of any Transfer Milestone is delayed due to causes beyond the reasonable control of the responsible party (including, without limitation, regulatory delays at the Receiving Facility, force majeure events as described in Section 17.3, equipment procurement and qualification delays, delays caused by the other party's failure to perform its obligations hereunder, or unexpected technical challenges in adapting the Manufacturing Process to the Receiving Facility's equipment), the parties shall discuss in good faith an extension of the applicable milestone date through the Technology Transfer Sub-Committee. The Technology Transfer Sub-Committee shall assess the cause of the delay, the impact on subsequent milestones and the overall timeline, and appropriate remedial actions. Any extension of individual milestone dates that does not affect the Transfer Completion Date may be approved by the Technology Transfer Sub-Committee. An extension of the Transfer Completion Date may be granted by the JSC for a period of up to six (6) months (i.e., to April 20, 2026) upon a showing of good cause by the responsible party and a revised Technology Transfer Plan setting forth a credible path to completion within the extended period. Any extension of the Transfer Completion Date beyond April 20, 2026 shall require the mutual written consent of both parties' authorized representatives.
3.5 Progress Reports. Penterra shall provide Meridian with monthly written progress reports on the status of the Technology Transfer within ten (10) business days following the end of each calendar month. Each progress report shall include: (a) a summary of activities completed during the reporting period; (b) status of each Transfer Milestone (including percentage completion); (c) identification of open issues, risks, and potential delays; (d) projected timeline adjustments, if any; and (e) a summary of resources deployed. Meridian shall similarly provide Penterra with monthly written reports on the readiness status of the Receiving Facility, including the status of equipment procurement and qualification, laboratory readiness, personnel training, and regulatory submissions. The monthly progress reports from both parties shall be submitted to the Technology Transfer Sub-Committee for review and discussion at its monthly meetings.
ARTICLE 4 — ACCEPTANCE CRITERIA
4.1 General. Each Transfer Milestone shall be deemed complete only upon satisfaction of the corresponding Acceptance Criteria set forth in Schedule 2 attached hereto. The Acceptance Criteria are designed to provide objective, measurable standards for evaluating the successful completion of each phase of the Technology Transfer. The parties acknowledge that the ultimate objective of the Technology Transfer is to enable the Receiving Facility to independently and reproducibly manufacture Licensed Product that meets all applicable quality specifications and regulatory requirements, and the Acceptance Criteria shall be interpreted in light of this objective.
4.2 Document Transfer Acceptance (Phase 1). Phase 1 shall be deemed complete upon: (a) delivery of the complete Technology Transfer Package as listed in Schedule 1 to Meridian and the Receiving Facility via the designated secure file-sharing platform and/or physical delivery, as applicable; (b) Meridian's written confirmation, signed by Meridian's Technology Transfer project leader, that all required documents have been received, are legible, complete, and in the agreed-upon format (PDF and/or native electronic format); and (c) satisfactory resolution by Penterra of any gaps or deficiencies identified in Meridian's gap assessment report within the timeframe specified in Section 3.1(a). The parties shall execute a Phase 1 Completion Certificate upon satisfaction of the foregoing criteria.
4.3 Analytical Method Transfer Acceptance (Phase 3). Phase 3 shall be deemed complete upon demonstration that each transferred Analytical Method at the Receiving Facility produces results within pre-defined equivalence parameters as compared to results obtained from the Transferring Facility (Alkerra Manufacturing Inc.), in accordance with ICH Q2(R1) analytical method validation guidelines and the method transfer protocols approved by the Technology Transfer Sub-Committee. Specifically, for each Analytical Method:
(a) The Receiving Facility's results shall fall within the pre-defined acceptance limits established in the method transfer protocol, taking into account the inherent variability of each method as determined during method validation at the Transferring Facility.
(b) Statistical comparison of replicate results from the Transferring Facility and the Receiving Facility shall demonstrate equivalence at a confidence level of not less than ninety-five percent (95%), using the statistical test specified in the method transfer protocol (e.g., two one-sided t-test for equivalence, or other appropriate statistical method).
(c) System suitability criteria shall be met at the Receiving Facility for each test occasion.
(d) An Analytical Method Transfer Report shall be prepared by the Receiving Facility, reviewed by Penterra's quality representative, and approved by both parties' Technology Transfer project leaders.
4.4 Process Demonstration Acceptance (Phase 4). Phase 4 shall be deemed complete upon successful manufacture of at least one (1) engineering batch of API and at least one (1) engineering batch of finished dosage form (for each tablet strength, 25 mg and 50 mg) at the Receiving Facility that meet the following criteria:
(a) The engineering batch API meets all pre-defined quality specifications for identity, assay (not less than 98.0% and not more than 102.0%), total impurities (not more than the specification limit established in the validated process), individual specified impurities (within specification limits), residual solvents, water content, and particle size distribution.
(b) The engineering batch finished dosage form meets all pre-defined quality specifications for identity, assay, content uniformity, dissolution, impurities (degradation products), appearance, and other applicable release tests.
(c) The manufacturing process yield for the engineering batch is within an acceptable range as compared to the Transferring Facility's historical performance (typically within ±10% of the mean historical yield, unless otherwise agreed).
(d) An Engineering Batch Report documenting the manufacturing process, in-process data, deviations (if any), and quality control test results is prepared by the Receiving Facility and reviewed by Penterra's quality representative.
4.5 Process Validation Acceptance (Phase 5). Phase 5 shall be deemed complete upon satisfaction of all of the following criteria:
(a) Successful manufacture of three (3) consecutive validation batches of API and three (3) consecutive validation batches of finished dosage form (for each tablet strength, 25 mg and 50 mg) at the Receiving Facility, manufactured in accordance with the approved process validation protocol.
(b) Each validation batch meets all applicable release specifications as set forth in the registered product specifications and the specifications agreed upon between the parties.
(c) Process capability indices for critical quality attributes demonstrate a Cpk of not less than 1.33 for each critical quality attribute, as calculated from the combined data of the three (3) consecutive validation batches. Critical quality attributes shall include, at a minimum, assay, content uniformity, dissolution, and total impurities for finished dosage form, and assay, total impurities, and particle size for API.
(d) Completed process validation reports for API and finished dosage form are prepared by the Receiving Facility, reviewed and approved by Penterra's designated quality representative, and accepted by both parties' Technology Transfer project leaders.
(e) Stability studies are initiated on at least one (1) validation batch of API and one (1) validation batch of each finished dosage form strength in accordance with ICH Q1A(R2) stability testing guidelines, with initial time-point data meeting applicable specifications.
4.6 Final Acceptance Certificate. Upon satisfaction of all Acceptance Criteria for all Transfer Milestones (Phase 1 through Phase 5), the parties shall execute a Final Acceptance Certificate in substantially the form attached as Schedule 4 hereto. The Final Acceptance Certificate shall confirm: (a) completion of all Transfer Milestones; (b) satisfaction of all Acceptance Criteria; (c) the Transfer Completion Date; (d) the identity and location of the Receiving Facility; and (e) any outstanding items or post-transfer support obligations. The Final Acceptance Certificate shall be signed by both parties' Technology Transfer project leaders and by authorized representatives of each party (at the level of Vice President or above). Execution of the Final Acceptance Certificate shall constitute conclusive evidence that the Technology Transfer has been completed in accordance with this Agreement, subject only to any exceptions or reservations expressly noted in the Final Acceptance Certificate.
4.7 Disputes Regarding Acceptance. In the event the parties disagree on whether any Acceptance Criteria have been met, the dispute shall be promptly referred to the Technology Transfer Sub-Committee for discussion and resolution. If the Technology Transfer Sub-Committee is unable to resolve the dispute within fifteen (15) business days of referral, the dispute shall be escalated to the Joint Steering Committee (JSC) established under the License Agreement. If the JSC is unable to resolve the dispute within thirty (30) days of escalation, either party may invoke the dispute resolution provisions set forth in Article 16 of this Agreement. Pending resolution of any such dispute, the parties shall continue to perform their respective obligations under this Agreement in good faith, and the Transfer Completion Date shall be tolled for the duration of the dispute resolution process (from the date of referral to the Technology Transfer Sub-Committee through the date of final resolution) if and to the extent the disputed Acceptance Criteria are on the critical path to completion of the Technology Transfer.
ARTICLE 5 — OBLIGATIONS OF PENTERRA (TRANSFEROR)
5.1 Delivery of Technology Transfer Package. Penterra shall assemble, organize, and deliver the complete Technology Transfer Package to Meridian and the Receiving Facility in accordance with the timeline set forth in Schedule 3 and the Technology Transfer Plan. Penterra shall use commercially reasonable efforts to ensure that all documents are accurate, current, complete, and in the format agreed upon by the parties. Documents shall be delivered in the English language; provided that where original documents exist only in another language, Penterra shall provide the original language version accompanied by a certified English translation. Penterra shall maintain a transmittal log documenting the date, description, and recipient of each delivered item, and shall provide copies of such log to Meridian upon request.
5.2 Personnel Support. Penterra shall make available qualified technical personnel with direct knowledge of the Manufacturing Process and Analytical Methods for PPC-4187 to support the Technology Transfer, including:
(a) On-Site Support. Penterra shall deploy qualified technical personnel to the Receiving Facility during Phases 2 through 5 of the Technology Transfer to provide hands-on guidance, troubleshooting, and process optimization support. On-site support shall be provided in accordance with the schedule and resource allocation set forth in the Technology Transfer Plan. Penterra's on-site personnel shall work collaboratively with the Receiving Facility's manufacturing, quality control, and quality assurance teams.
(b) Training. Penterra shall design and conduct structured training sessions for Meridian's and the Receiving Facility's technical personnel, covering all aspects of the Manufacturing Process (API synthesis, finished dosage form manufacture, in-process controls, and packaging), Analytical Methods (method execution, system suitability, data interpretation, and out-of-specification investigation procedures), and quality systems (change control, deviation management, CAPA, and stability programs) relevant to the manufacture and release of Licensed Product.
(c) Remote Support. Throughout the Technology Transfer period, Penterra shall provide remote technical support and consultation by telephone, videoconference, and email to address technical questions, troubleshoot issues, and provide guidance on process adaptation. Penterra shall use commercially reasonable efforts to respond to Meridian's technical inquiries within three (3) business days of receipt.
5.3 Key Personnel. Within fifteen (15) days of the Effective Date, Penterra shall designate a Technology Transfer project leader who shall serve as Penterra's primary point of contact for all Technology Transfer activities. In addition, Penterra shall identify key subject matter experts from Penterra and/or Alkerra Manufacturing Inc. with expertise in API synthesis, finished dosage form manufacturing, analytical chemistry, quality assurance, and regulatory affairs, who will be available for consultation and on-site support during the Technology Transfer. Penterra shall provide Meridian with the names, qualifications, and areas of expertise of such key personnel. Penterra shall not reassign, terminate, or replace any key personnel without at least thirty (30) days' prior written notice to Meridian, and shall ensure a reasonable transition period during which the departing key person provides a handoff briefing to his or her replacement and to Meridian's Technology Transfer team. Penterra acknowledges that continuity of key personnel is critical to the success of the Technology Transfer.
5.4 Access to Transferring Facility. Penterra shall arrange for Meridian's designated technical personnel to visit the Transferring Facility (Alkerra Manufacturing Inc., Research Triangle Park, North Carolina) to observe manufacturing operations, witness equipment operation, review production processes, and meet with Alkerra's process scientists and quality personnel. Such visits shall be subject to reasonable advance scheduling (no less than fifteen (15) business days' notice), Alkerra's standard site access and security policies, applicable confidentiality requirements, and facility capacity constraints. Penterra shall use commercially reasonable efforts to schedule at least two (2) site visits during the Technology Transfer period at mutually convenient times. Meridian's visiting personnel shall comply with all applicable safety, gowning, and conduct requirements of the Transferring Facility.
5.5 Reference Standards and Materials. Penterra shall supply Meridian with the reference standards, reference materials, and any proprietary reagents or specialty chemicals required for Analytical Method qualification at the Receiving Facility, at Penterra's actual cost (without markup). Such materials shall include primary and working reference standards for PPC-4187 API, reference standards for known impurities and degradation products, and any other reference materials identified in Schedule 1. Penterra shall provide certificates of analysis and characterization data for all reference standards supplied.
5.6 Regulatory Support. Penterra shall provide reasonable cooperation and assistance in the preparation of regulatory filings by Meridian or its subsidiaries and affiliates in the Territory, to the extent such filings relate to the transferred Manufacturing Process and CMC Documentation. Without limiting the generality of the foregoing, Penterra shall:
(a) Provide Letters of Authorization and right-of-reference letters enabling Meridian and its subsidiaries (including Meridian Pharma (Shanghai) Co., Ltd. for NMPA filings and Meridian Japan K.K. for PMDA filings) to cross-reference Penterra's regulatory filings (including Drug Master Files) in their Territory regulatory submissions.
(b) Respond to reasonable requests for technical information and clarifications from Territory regulatory authorities in connection with the review of Meridian's manufacturing-related regulatory submissions.
(c) Support Meridian's preparation of CTD Module 3 (Quality) sections for Territory regulatory filings by providing source data, reference documents, and technical review of draft submissions.
5.7 Updates and Improvements. If during the Technology Transfer period (from the Effective Date through the Transfer Completion Date), Penterra makes material improvements, modifications, or changes to the Manufacturing Process, Analytical Methods, or CMC Documentation for PPC-4187 (whether at Alkerra Manufacturing Inc. or otherwise), Penterra shall promptly disclose such improvements, modifications, or changes to Meridian in writing and shall include the relevant documentation in the Technology Transfer Package. For purposes of this Section, "material" means any change that could reasonably be expected to affect the quality, safety, efficacy, yield, or regulatory status of Licensed Product. Penterra shall make its technical personnel available to explain and provide training on any such improvements or changes.
ARTICLE 6 — OBLIGATIONS OF MERIDIAN (TRANSFEREE)
6.1 Designation of Receiving Facility. Meridian shall designate the Receiving Facility within sixty (60) days of the Effective Date (i.e., by December 19, 2023) and shall notify Penterra in writing of the identity, location, regulatory status, and manufacturing capabilities of the Receiving Facility. The notification shall include: (a) the legal name and address of the Receiving Facility; (b) the facility's current GMP certification status and the identity of the certifying regulatory authority; (c) a description of the facility's manufacturing capabilities (including available equipment for API synthesis and/or finished dosage form manufacture, as applicable); (d) the facility's quality control laboratory capabilities; and (e) a summary of the facility's relevant manufacturing experience with pharmaceutical products of similar complexity. The Receiving Facility may be a Meridian subsidiary manufacturing facility (such as a Meridian-owned facility in the Territory) or a third-party contract manufacturing organization selected and approved by Meridian, provided that in either case the facility meets all applicable current Good Manufacturing Practice (cGMP) standards and regulatory requirements. Meridian may designate separate Receiving Facilities for API manufacture and finished dosage form manufacture, subject to the foregoing requirements for each such facility.
6.2 Facility Readiness. Meridian shall ensure that the Receiving Facility is ready to receive the Technology Transfer in accordance with the timelines set forth in the Technology Transfer Plan. Facility readiness shall include, without limitation:
(a) Installation and qualification (IQ/OQ/PQ) of all manufacturing equipment and utility systems required to execute the Manufacturing Process at commercial scale, in accordance with the equipment specifications provided in the Technology Transfer Package.
(b) Availability of a suitably equipped quality control laboratory with qualified instrumentation (including HPLC, GC, ICP-MS, IR spectrophotometer, dissolution apparatus, Karl Fischer titrator, particle size analyzer, and other instruments required for the Analytical Methods) and qualified personnel.
(c) Availability of sufficient quantities of raw materials, starting materials, excipients, and packaging components to support engineering batches, process validation batches, and analytical method qualification.
(d) Designation and training of qualified technical personnel at the Receiving Facility who will participate in all phases of the Technology Transfer.
(e) Implementation of quality management systems (including document control, change control, deviation management, CAPA, stability programs, and training systems) that meet applicable cGMP requirements and are compatible with the quality standards set forth in the Quality Agreement.
6.3 Personnel. Meridian shall designate a Technology Transfer project leader within fifteen (15) days of the Effective Date, who shall serve as Meridian's primary point of contact for all Technology Transfer activities and shall coordinate day-to-day interactions with Penterra's project leader. Meridian shall also designate qualified technical personnel from its organization and/or the Receiving Facility to participate in all phases of the Technology Transfer, attend training sessions conducted by Penterra, collaborate with Penterra's technical personnel during on-site activities, and provide timely feedback and information necessary for the successful execution of the Technology Transfer Plan.
6.4 Regulatory Approvals. Meridian shall be solely responsible for identifying, applying for, and obtaining any regulatory approvals, manufacturing licenses, GMP certifications, or other governmental authorizations required for the Receiving Facility to manufacture Licensed Product in the Territory. Such regulatory approvals may include, without limitation, manufacturing licenses from the NMPA (for manufacture in the People's Republic of China), PMDA (for manufacture in Japan), MFDS (for manufacture in the Republic of Korea), TGA (for manufacture in Australia), and equivalent authorizations from other Territory regulatory authorities. Penterra shall provide reasonable regulatory support as set forth in Section 5.6, but Meridian acknowledges that the responsibility for obtaining and maintaining all such regulatory approvals rests solely with Meridian.
6.5 Cooperation. Meridian shall cooperate fully and in good faith with Penterra in executing the Technology Transfer Plan, including by: (a) responding promptly to requests for information, data, and feedback; (b) providing Penterra's on-site personnel with reasonable access to the Receiving Facility's manufacturing areas, laboratories, and quality systems; (c) making Receiving Facility personnel available for training, meetings, and collaborative activities; (d) procuring equipment, materials, and services necessary for the Technology Transfer in a timely manner; and (e) promptly communicating to Penterra any issues, concerns, or risks that may affect the Technology Transfer timeline or outcome.
6.6 Quality Agreement. The parties acknowledge that the Quality Agreement governing API supply specifications, quality standards, change control, deviation handling, complaint management, and related quality matters is to be executed within sixty (60) days of the Effective Date (i.e., by December 19, 2023). Meridian shall cooperate with Penterra in finalizing and executing the Quality Agreement in a timely manner. The parties further acknowledge that the Quality Agreement, once executed, shall govern quality-related aspects of the Technology Transfer process, including quality oversight of engineering batches and process validation batches manufactured at the Receiving Facility, change control procedures for Manufacturing Process modifications, and deviation investigation and resolution procedures.
ARTICLE 7 — PERSONNEL AND TRAVEL
7.1 Penterra Personnel On-Site at Receiving Facility. Penterra shall provide on-site technical personnel at the Receiving Facility for a total of no fewer than the number of person-days specified in the Technology Transfer Plan during the Technology Transfer period, allocated across Phases 2 through 5. The Technology Transfer Plan shall specify the minimum and estimated number of person-days for each phase, based on the complexity of the activities to be performed and the Receiving Facility's capabilities. As a general guideline, the parties anticipate that Penterra will provide approximately one hundred fifty (150) to two hundred (200) person-days of on-site support across all phases, subject to adjustment based on the Receiving Facility's specific needs and the progress of the Technology Transfer. The deployment of Penterra personnel shall be coordinated through the Technology Transfer Sub-Committee, with schedules agreed upon at least thirty (30) days in advance.
7.2 Meridian Personnel at Transferring Facility. Meridian may send up to eight (8) technical personnel to the Transferring Facility (Alkerra Manufacturing Inc., Research Triangle Park, North Carolina) for observation of manufacturing operations and hands-on training, subject to: (a) reasonable advance scheduling, with requests for site visits submitted to Penterra's project leader at least fifteen (15) business days in advance; (b) Alkerra's standard site access policies and capacity limitations (with no more than four (4) Meridian personnel visiting at any one time unless otherwise agreed); (c) execution of Alkerra's standard visitor confidentiality agreements, to the extent not superseded by the confidentiality provisions of this Agreement and the License Agreement; and (d) the visiting personnel's compliance with all applicable facility rules, gowning requirements, and safety procedures. Penterra shall use commercially reasonable efforts to accommodate Meridian's visit requests.
7.3 Travel and Expenses. Each party shall bear its own personnel costs (salaries, wages, benefits, and related employment costs) for its employees and contractors engaged in the Technology Transfer. Travel and accommodation expenses for Penterra personnel providing on-site support at the Receiving Facility shall be borne by Meridian, subject to Meridian's standard corporate travel and expense policy, a copy of which shall be provided to Penterra within thirty (30) days of the Effective Date. Penterra personnel shall submit travel expense reports to Meridian's project leader within thirty (30) days following each on-site visit. Travel, accommodation, and related expenses for Meridian personnel visiting the Transferring Facility shall be borne by Meridian.
7.4 Conduct. All personnel of either party visiting or working at the other party's facilities or the Receiving Facility or Transferring Facility shall comply with the host facility's site rules, standard operating procedures, safety requirements, environmental regulations, gowning and hygiene procedures, and confidentiality requirements. Each party shall ensure that its personnel conduct themselves in a professional manner and cooperate with the host facility's management and staff. Each party shall be responsible for any damage to the host facility's equipment or property caused by the negligence or willful misconduct of its personnel.
ARTICLE 8 — COSTS AND EXPENSES
8.1 Internal Costs. Except as otherwise expressly provided in this Agreement, each party shall bear its own internal costs (including personnel costs, overhead, and administrative expenses) associated with performing its obligations under this Agreement in connection with the Technology Transfer.
8.2 Out-of-Pocket Costs. Meridian shall reimburse Penterra for reasonable, documented, pre-approved out-of-pocket costs actually incurred by Penterra in connection with the Technology Transfer, including the following categories of costs:
(a) Third-party laboratory costs incurred by Penterra at Alkerra Manufacturing Inc. or other third-party laboratories specifically in connection with the Technology Transfer (e.g., preparation of duplicate samples for method transfer, re-testing for method equivalence assessment).
(b) Costs of procuring and shipping reference standards, reference materials, and proprietary reagents to the Receiving Facility, as described in Section 5.5.
(c) Document reproduction, formatting, and certified translation costs incurred in preparing the Technology Transfer Package for delivery.
(d) Travel and accommodation expenses for Penterra personnel providing on-site support at the Receiving Facility, as described in Section 7.3.
(e) Any other out-of-pocket costs specifically approved by Meridian in writing in advance.
For the avoidance of doubt, Penterra shall not incur any reimbursable out-of-pocket cost in excess of five thousand U.S. dollars ($5,000.00) per individual expense item without obtaining Meridian's prior written approval, which shall not be unreasonably withheld.
8.3 No Additional Technology Transfer Fee. The parties acknowledge and agree that the economic terms of the License Agreement, including the eighteen million U.S. dollar ($18,000,000.00) upfront payment, the development and regulatory milestone payments, the commercial milestone payments, and the royalty structure set forth therein, constitute full and adequate consideration for the Technology Transfer contemplated by this Agreement. No separate technology transfer fee, success fee, or additional consideration shall be payable by Meridian to Penterra in connection with the Technology Transfer, except for the reimbursable out-of-pocket costs described in Section 8.2.
8.4 Invoicing and Payment. Penterra shall invoice Meridian quarterly (within thirty (30) days following the end of each calendar quarter) for all reimbursable out-of-pocket costs incurred during such quarter, accompanied by reasonable supporting documentation (including itemized expense reports, receipts, and third-party invoices). Meridian shall pay all undisputed amounts within thirty (30) days of receipt of a properly submitted invoice. If Meridian disputes any invoiced amount, Meridian shall notify Penterra in writing within fifteen (15) days of receipt, specifying the disputed amount and the basis for the dispute. The parties shall use commercially reasonable efforts to resolve any invoice disputes promptly through good faith discussions. All payments shall be made in U.S. dollars by wire transfer to the account designated by Penterra.
ARTICLE 9 — INTELLECTUAL PROPERTY
9.1 Ownership of Transferred Technology. All Know-How, Manufacturing Process information, Analytical Methods, CMC Documentation, and other proprietary technology and intellectual property transferred by Penterra to Meridian pursuant to this Agreement remain the exclusive property of Penterra. The transfer of the Technology Transfer Package does not convey to Meridian any ownership interest in the underlying intellectual property. Meridian's rights to use the transferred technology are governed by and limited to the scope of the license granted under the License Agreement, including the territorial, field-of-use, and sublicensing restrictions set forth therein. Meridian shall not use the transferred technology for any purpose outside the scope of the License Agreement, including without limitation for the development, manufacture, or commercialization of any product other than Licensed Product, or in any territory other than the Territory.
9.2 Improvements by Meridian. Any improvements, modifications, enhancements, or adaptations to the Manufacturing Process, Analytical Methods, or formulations developed by or on behalf of Meridian (including by the Receiving Facility) during or after the Technology Transfer that relate specifically to PPC-4187 or Licensed Product ("Meridian Improvements") shall be jointly owned by the parties, subject to and in accordance with the intellectual property allocation provisions set forth in the License Agreement. Meridian hereby grants Penterra a non-exclusive, royalty-free, perpetual, irrevocable license to use, practice, and sublicense Meridian Improvements outside the Territory for any purpose, including the manufacture, development, and commercialization of products containing PPC-4187. Meridian shall promptly disclose all Meridian Improvements to Penterra in writing, including sufficient technical detail to enable Penterra to practice such improvements.
9.3 Improvements by Penterra. Any improvements, modifications, enhancements, or adaptations to the Manufacturing Process, Analytical Methods, or formulations developed by or on behalf of Penterra during the Technology Transfer period (from the Effective Date through the Transfer Completion Date) that relate specifically to PPC-4187 or Licensed Product ("Penterra Improvements") shall be the sole property of Penterra and shall be included in the Technology Transfer Package and licensed to Meridian under the terms of the License Agreement. Penterra shall promptly disclose all Penterra Improvements to Meridian in writing and shall provide all documentation and training necessary for Meridian and the Receiving Facility to implement such improvements.
9.4 Patent Portfolio. The parties acknowledge the Licensed Patents set forth in Schedule A to the License Agreement, which include, without limitation:
(a) U.S. Patent No. 11,234,567 — "Selective JAK1 Inhibitor Compounds and Compositions" (Composition of Matter patent), with an expiration date of August 12, 2037;
(b) U.S. Patent No. 11,345,678 — "Crystalline Forms of PPC-4187 and Methods of Preparation Thereof" (Crystalline Form A patent), with an expiration date of November 3, 2038;
(c) Corresponding Territory patents, including:
(i) CN Patent No. ZL 2020 1 0456789.0 (People's Republic of China);
(ii) JP Patent No. 7,012,345 (Japan);
(iii) KR Patent No. 10-2345678 (Republic of Korea);
(iv) AU Patent No. 2020234567 (Australia);
together with all continuations, continuations-in-part, divisionals, reissues, reexaminations, extensions, and supplementary protection certificates relating thereto.
The Joint Patent Committee (JPC) established under the License Agreement shall oversee the prosecution, maintenance, and enforcement of Licensed Patents in the Territory, in accordance with the terms of the License Agreement. The parties' rights and obligations with respect to patent prosecution, maintenance, enforcement, and defense in the Territory are governed by the License Agreement and are not modified by this Agreement.
ARTICLE 10 — CONFIDENTIALITY
10.1 Confidential Information. All information disclosed by either party to the other party (or to the Receiving Facility or Transferring Facility, as applicable) in connection with the Technology Transfer, including without limitation the Technology Transfer Package, the Technology Transfer Plan, the Acceptance Criteria, progress reports, and all technical, scientific, business, financial, and regulatory information exchanged in connection with the performance of this Agreement, constitutes "Confidential Information" subject to the

TECHNOLOGY TRANSFER AGREEMENT

PENTERRA PHARMACEUTICALS CORP.

MERIDIAN BIO THERAPEUTICS LIMITED

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