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Contract analysis / idr-07-response.docx
idr-07-response.docx
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I. Description of IDR No. 7 Request
I. Description of IDR No. 7 Request IDR No. 7, dated August 4, 2022, requests the following categories of documents:
1. The Irish statutory financial statements (audited) of Penterra Biopharma International
1. The Irish statutory financial statements (audited) of Penterra Biopharma International DAC for fiscal years ending December 31, 2017, December 31, 2018, December 31, 2019, and December 31, 2020; and
2. The Irish income tax returns (Corporation Tax returns, Form CT1) of Penterra Biopharma
2. The Irish income tax returns (Corporation Tax returns, Form CT1) of Penterra Biopharma International DAC, together with all schedules and attachments, as filed with the Irish Revenue Commissioners for fiscal years ending December 31, 2017, December 31, 2018, December 31, 2019, and December 31, 2020. We note that PPC's fiscal year-end is December 31, and PBI follows the same fiscal year-end. Accordingly, the fiscal
II. Identification of Penterra Biopharma International DAC
II. Identification of Penterra Biopharma International DAC For purposes of contextualizing the documents produced, we provide the following background information regarding PBI: Full Legal Name: Penterra Biopharma International DAC Entity Type: Designated Activity Company organized and existing under the laws of Ireland pursuant to the Irish Companies Act 2014 Registered Office: 4th Floor, Claremont House, Sandyford
III. Description of Documents Produced
III. Description of Documents Produced The documents responsive to IDR No. 7 are organized into three tabs, as described in detail below. A. Tab 1: PBI Irish Statutory Financial Statements (Fiscal Years 2017–2020) Tab 1 contains the audited statutory financial statements of Penterra Biopharma International DAC for the four fiscal years ended December 31, 2017, December 31, 2018, December 31, 2019, and December 31, 20
1. Intercompany Transactions Schedule. A schedule reflecting intercompany transactions be
1. Intercompany Transactions Schedule. A schedule reflecting intercompany transactions between PBI and related parties for each of the fiscal years 2017 through 2020. This schedule details (a) royalty payments made by PBI to PPC under the legacy intellectual property license agreement (calculated at 4.5% of non-Americas net sales), and (b) cost-sharing payments made by PBI to PPC under the qualified cost-sharing arra
2. Revenue Breakdown by Product Line and Territory. A schedule setting forth PBI's revenu
2. Revenue Breakdown by Product Line and Territory. A schedule setting forth PBI's revenue for each of the fiscal years 2017 through 2020, disaggregated by product line (Veritaxol, Imvara, and Cerulon) and by geographic territory (sub-divided within the non-Americas regions, including key EMEA and APAC markets). This schedule is derived from management reporting data underlying the financial statements and is consist
3. Headcount Information. A schedule reflecting PBI's employee headcount at year-end for
3. Headcount Information. A schedule reflecting PBI's employee headcount at year-end for each fiscal year from 2012 (the year of incorporation) through 2020. PBI's workforce grew from 52 employees at its establishment in 2012 to 185 employees by the end of fiscal year 2020. The schedule includes a breakdown by functional category (including commercial operations, regulatory affairs, supply chain management, finance a
4. Related-Party Disclosures. A compilation of the related-party transaction disclosures
4. Related-Party Disclosures. A compilation of the related-party transaction disclosures from the Notes to the Financial Statements for each of the fiscal years 2017 through 2020, noting transactions between PBI and (a) PPC (the U.S. parent company), (b) PHL (the Luxembourg intermediate holding company), and (c) PMI (Penterra Manufacturing Ireland Ltd., Irish CRO Number 512347), PBI's affiliated Irish contract manufa
IV. Coordination with Irish Tax Advisors
IV. Coordination with Irish Tax Advisors We wish to note for the record that the production of the documents described herein was coordinated with Thornbury & Keogh, Chartered Tax Advisors (Lead Partner: Ciarán Thornbury), PBI's Irish tax advisors, and with PBI's Managing Director, Aidan Naughton. Mr. Naughton and Mr. Thornbury authorized the release of these documents to Calderwood & Harkness LLP for production to t
V. Privilege Reservation
V. Privilege Reservation The production of the documents described herein is made without waiver of any applicable privilege, including, without limitation, the attorney-client privilege, the tax practitioner privilege under Internal Revenue Code § 7525, and the work-product protection afforded under Federal Rule of Civil Procedure 26(b)(3) and its equivalents. PPC expressly reserves all rights and objections with re
VI. Document Inventory / Index
VI. Document Inventory / Index The following table provides a complete index of the documents produced in response to IDR No. 7: Total pages produced: 862
VII. Offer of Cooperation
VII. Offer of Cooperation PPC remains committed to cooperating fully and transparently with the Service throughout the current examination. We stand ready to provide any additional information, documentation, or clarification that the exam team may require in connection with its review of the documents produced herein or otherwise. We note that PPC's U.S. consolidated federal income tax returns (Forms 1120) for the T