FR EA
1018-00006 · Penterra Pharmaceuticals Corp · Transaction Documents
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SCHEDULE D

LICENSED TERRITORY

Schedule D to the Exclusive License Agreement (the "Agreement") dated October 2, 2023 (Effective Date: October 20, 2023), by and between Penterra Pharmaceuticals Corp., a Delaware corporation ("Licensor"), and Meridian Bio Therapeutics Limited, a Hong Kong limited company ("Licensee").

Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Agreement.

1. Definition of Territory

The "Territory," as such term is used in the Agreement, means the countries, territories, and jurisdictions listed in the table set forth in Section 2 below, including all political subdivisions, provinces, states, prefectures, special administrative regions, and dependent territories expressly specified therein. For the avoidance of doubt, the Territory encompasses all land areas, territorial waters, and exclusive economic zones of each listed country or jurisdiction to the extent relevant to the regulatory approval, distribution, marketing, sale, and importation of pharmaceutical products under the applicable laws of such jurisdiction.

The Territory is granted on an exclusive basis to Licensee, pursuant to and subject to the terms and conditions of the Agreement, for the development, manufacture (subject to the limitations and conditions set forth in Article 5 of the Agreement), and commercialization of the Licensed Product (designated by Licensor under the development code PPC-4187, with the international nonproprietary name Penteracitinib) in all dosage forms, formulations, presentations, and strengths covered by the Agreement.

2. List of Countries and Jurisdictions Comprising the Territory

The following table sets forth each country and jurisdiction included within the Territory:

3. Clarifications and Exclusions

3.1 Included Sub-Jurisdictions. For all purposes under the Agreement, references to the People's Republic of China in this Schedule D and throughout the Agreement shall be deemed to include the Hong Kong Special Administrative Region ("Hong Kong SAR") and the Macau Special Administrative Region ("Macau SAR"). Licensee's exclusive rights with respect to the development, manufacture (subject to the terms of the Agreement), and commercialization of the Licensed Product extend to each of Hong Kong SAR and Macau SAR to the same extent and on the same terms as they extend to all other parts of the People's Republic of China. Separate regulatory filings, pricing approvals, or import licenses required in Hong Kong SAR or Macau SAR under their respective local laws shall be the responsibility of Licensee in accordance with Article 4 of the Agreement.

3.2 Retained Territory. All countries, territories, and jurisdictions not expressly listed in the table set forth in Section 2 above are excluded from the Territory and are retained by Licensor (collectively, the "Retained Territory"). The Retained Territory includes, without limitation, (a) the United States of America (including all states, the District of Columbia, and all territories and possessions thereof), (b) Canada, (c) each member state of the European Union and the European Economic Area, (d) the United Kingdom of Great Britain and Northern Ireland, (e) all countries and territories in Latin America and the Caribbean, (f) all countries and territories in the Middle East, (g) all countries and territories in Africa, (h) the Republic of India, and (i) all other countries, territories, and jurisdictions worldwide not enumerated in Section 2 of this Schedule D. Licensor retains all rights under the Licensed Patents and Licensed Know-How to develop, manufacture, and commercialize the Licensed Product, or to grant licenses to third parties to do the same, throughout the Retained Territory, without restriction and without any obligation to Licensee.

3.3 Future Territories. Any expansion of the Territory to include additional countries or jurisdictions not listed in Section 2 above, or any modification of the boundaries or scope of the Territory, shall require a written amendment to the Agreement duly executed by authorized representatives of both Licensor and Licensee. No course of dealing, verbal agreement, or other conduct by either Party shall be construed as an expansion or modification of the Territory absent such a written amendment. In the event Licensee wishes to request the inclusion of one or more additional jurisdictions in the Territory, Licensee shall submit a written proposal to Licensor that includes a commercially reasonable development and commercialization plan for the Licensed Product in each such proposed jurisdiction, and the Parties shall negotiate in good faith the terms and conditions, including any additional milestone payments, royalty rates, and development timelines, upon which such expansion would be granted, it being understood that Licensor shall have no obligation to agree to any such expansion.

4. Regulatory Authorities in Key Territory Jurisdictions

The following table identifies the principal regulatory authority in each of the major Territory jurisdictions, for purposes of cross-reference to the milestone events, regulatory filing obligations, and development plan provisions set forth in the Agreement and the Development Plan attached as Schedule E thereto:

The applicable regulatory authorities for each of the remaining Territory jurisdictions — namely Singapore, Thailand, Malaysia, Indonesia, the Philippines, Vietnam, New Zealand, and Taiwan — shall be as defined and designated by the applicable local laws and regulations of each such jurisdiction in effect from time to time. A detailed listing of such regulatory authorities and the corresponding regulatory pathways applicable to the Licensed Product in each such jurisdiction is set forth in the Development Plan attached to the Agreement as Schedule E. In the event of any reorganization, renaming, or restructuring of any regulatory authority listed in this Section 4 or referenced in Schedule E, references to such regulatory authority in the Agreement and this Schedule D shall be deemed to refer to the successor authority exercising substantially the same regulatory functions.

This Schedule D is incorporated into and forms an integral part of the Agreement. This Schedule D has been executed by the Parties as part of the Agreement as of October 2, 2023, and no separate signature is required herein. In the event of any conflict between the terms of this Schedule D and the terms of the body of the Agreement, the terms of the Agreement shall control.

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No.Country / JurisdictionNotes
1People's Republic of ChinaIncluding Hong Kong Special Administrative Region and Macau Special Administrative Region
2Japan—
3Republic of Korea—
4Australia—
5New Zealand—
6Singapore—
7Thailand—
8Malaysia—
9Indonesia—
10Philippines—
11Vietnam—
12Taiwan—
Country / JurisdictionRegulatory Authority
People's Republic of ChinaNational Medical Products Administration (NMPA)
JapanPharmaceuticals and Medical Devices Agency (PMDA)
Republic of KoreaMinistry of Food and Drug Safety (MFDS)
AustraliaTherapeutic Goods Administration (TGA)