Contract analysis

I. Description of IDR No. 35 Request As we understand IDR No. 35, the Exam Team has requested the following categories of internal PBI documents for Tax Years 2017, 2018, 2019, and 2020: (a) Internal PBI documents evidencing how PBI independently determined pricing for pharmaceutical products sold in non-Americas markets, including any pricing committee records, pricing approval forms, and related analyses; (b) Marke

II. Scope of Production In order to respond to IDR No. 35, PPC has coordinated with PBI to identify, collect, and produce responsive documents from PBI's records maintained at PBI's offices in Dublin, Ireland. This effort was coordinated through PBI's Managing Director, Aidan Naughton, and was conducted with the assistance of PBI's Irish tax advisors, Thornbury & Keogh, Chartered Tax Advisers (Lead Partner: Ciarán Th

III. Attachment A — PBI Pricing Committee Meeting Minutes (2017–2020) Attachment A (Bates Nos. PPC-IDR35-000001 through PPC-IDR35-000847) comprises the minutes from PBI's internal Pricing Committee meetings held in Dublin, Ireland, during Tax Years 2017, 2018, 2019, and 2020. PBI maintained a formal Pricing Committee throughout the examination period. The Pricing Committee was composed of senior commercial, regulator

IV. Attachment B — Market Entry Strategy Memoranda Attachment B (Bates Nos. PPC-IDR35-000848 through PPC-IDR35-001623) comprises internal PBI memoranda prepared by PBI's commercial strategy team in Dublin analyzing potential market entry opportunities in non-Americas jurisdictions during Tax Years 2017 through 2020. These memoranda were prepared by PBI's Dublin-based personnel as part of PBI's ongoing evaluation of c

V. Attachment C — Country-Level Pricing Approval Forms Attachment C (Bates Nos. PPC-IDR35-001624 through PPC-IDR35-002719) comprises the standardized internal PBI pricing approval forms used for each of the 68 non-Americas country markets in which PBI commercialized products during Tax Years 2017 through 2020. PBI maintained a formal, standardized pricing approval process under which proposed product pricing for each

VI. Attachment D — Distribution Partner Selection Documentation Attachment D (Bates Nos. PPC-IDR35-002720 through PPC-IDR35-003412) comprises internal PBI documents related to the selection, evaluation, and contracting of third-party distribution partners in non-Americas territories during Tax Years 2017 through 2020. PBI's commercial strategy for non-Americas territories involved the engagement of third-party distri

VII. Attachment E — PBI Board Resolutions on Pricing and Commercial Strategy Attachment E (Bates Nos. PPC-IDR35-003413 through PPC-IDR35-003958) comprises extracts from the minutes of PBI Board of Directors meetings that specifically address pricing authority and commercial strategy approvals during Tax Years 2017 through 2020. During the four examination years, the PBI Board of Directors held a total of 42 board mee

VIII. Attachment F — Communications Between PBI and PPC Regarding Pricing Attachment F (Bates Nos. PPC-IDR35-003959 through PPC-IDR35-004512) comprises internal emails, memoranda, and reports exchanged between PBI personnel in Dublin and PPC personnel in the United States relating to pricing matters during Tax Years 2017 through 2020. PPC understands that the Exam Team's request for communications between PBI and PPC

IX. Attachment G — Market Strategy Presentations (Annual Strategic Plans) Attachment G (Bates Nos. PPC-IDR35-004513 through PPC-IDR35-004837) comprises the annual commercial strategy presentations prepared by PBI's Dublin-based commercial strategy team for Tax Years 2017, 2018, 2019, and 2020. Each annual commercial strategy presentation covers PBI's strategic plan for non-Americas markets for the applicable year and

X. Factual Context Regarding PBI's Operations and Independent Pricing Authority Without prejudice to any legal arguments or positions that PPC may assert in connection with this examination, PPC provides the following factual context to assist the Exam Team in understanding the documents produced with this response: PBI was incorporated on March 15, 2012, as a Designated Activity Company organized under the laws of I

XI. Privilege Reservation PPC has withheld certain documents that would otherwise be responsive to IDR No. 35 on the basis of the attorney-client privilege and/or the work-product doctrine. These withheld documents include, without limitation, communications between PBI or PPC personnel and their respective legal counsel (including in-house counsel and outside counsel) reflecting the provision of legal advice regardi

XII. Reservation of Rights PPC does not waive any objections, positions, or rights by producing the documents described in this response. This production is made in the spirit of cooperation and in furtherance of the examination process and does not constitute an admission or concession regarding any factual or legal issue in the examination, including, without limitation, any issue relating to the economic substance

XIII. Contact Information Any questions regarding this production or this response should be directed to the undersigned at Calderwood & Harkness LLP, 1735 Market Street, Suite 3100, Philadelphia, PA 19103, telephone (215) 448-7264, email gsimmons@calderwoodharkness.com, or to Leonard Cross (Responsible Partner) at Calderwood & Harkness LLP, 600 Lexington Avenue, New York, NY 10022, telephone (212) 558-4123, email lc