Contract analysis

Section 1: Scope of IDR No. 15 IDR No. 15, dated September 23, 2022, contained four principal categories of requests relating to the regulatory activities of PBI in non-Americas territories during the period under examination. We set forth below our understanding of the scope of each request and confirm that PPC and PBI have undertaken a diligent search for responsive materials. First, IDR No. 15 requested detailed r

Section 2: Overview of PBI's Regulatory Function To provide appropriate context for the enclosed documentation, we briefly describe below PBI's organizational structure, its role within the Penterra group of companies, and the nature and scope of its regulatory affairs function. 2.1 Entity Overview. Penterra Biopharma International DAC ("PBI") is a Designated Activity Company organized and existing under the laws of

Section 3: Summary of Regulatory Expenditures (2017–2020) 3.1 Cumulative Regulatory Expenditures During the period under examination (tax years 2017 through 2020), PBI incurred cumulative regulatory expenditures of approximately €47.2 million (€47,200,000) in connection with regulatory submissions and compliance activities across non-Americas markets. These expenditures were recorded on PBI's books and records mainta

Section 4: Description of Enclosed Documents PPC is enclosing with this response six sets of documents, designated Enclosures A through F. Each enclosure is described below. Enclosure A — PBI Annual Regulatory Expenditure Reports (2017–2020) Enclosure A consists of four internal management reports prepared by PBI's regulatory affairs team in Dublin, Ireland, summarizing PBI's annual regulatory expenditures for each o

Section 5: Relevance to PBI's Economic Substance and Transfer Pricing Positions While PPC reserves all rights to present its transfer pricing positions in full at the appropriate stage of the examination, PPC respectfully notes that the enclosed documentation is directly relevant to PBI's economic substance and to PPC's transfer pricing positions for the tax years under examination. The documentation enclosed with th

Section 6: Privilege Reservation PPC has produced with this response all non-privileged documents identified as responsive to IDR No. 15 following a diligent search of PPC's and PBI's records as described in Section 1 above. PPC expressly reserves all rights under the attorney-client privilege, the work-product doctrine (as articulated in Hickman v. Taylor, 329 U.S. 495 (1947), and codified in Federal Rule of Civil P

Section 7: Reservation of Rights PPC's production of documents in response to IDR No. 15 does not constitute a waiver of any objections that PPC may have, now or in the future, to the scope, relevance, or propriety of IDR No. 15 or any other information document request issued in connection with this examination. PPC specifically reserves all rights to challenge any proposed adjustments that the Internal Revenue Serv

Section 8: Contact Information and Closing We trust that the foregoing narrative and the enclosed documents are responsive to the requests set forth in IDR No. 15. Should Revenue Agent Dunleavy or any member of the examining team have questions regarding this response or the enclosed documents, or should the examining team wish to discuss the enclosed materials in greater detail, please do not hesitate to contact the