CONFIDENTIAL — TAX EXAMINATION MATERIAL
CALDERWOOD & HARKNESS LLP Attorneys at Law
1735 Market Street, Suite 3100 Philadelphia, PA 19103 Tel: (215) 448-7200
Fax: (215) 448-7201
600 Lexington Avenue New York, NY 10022 Tel: (212) 558-4000
Fax: (212) 558-3588
www.calderwoodharkness.com
June 2, 2023
C&H Matter No. 1018-00009
VIA HAND DELIVERY AND ELECTRONIC UPLOAD (IRS SECURE MESSAGING)
Revenue Agent Patricia Dunleavy Internal Revenue Service Large Business & International Division Exam Team ID: LB&I-NE-TP-2022-00641 30 South 17th Street, Suite 400 Philadelphia, PA 19103
Re: Penterra Pharmaceuticals Corp. (EIN: 22-3741856) — Response to Information Document Request No. 35 — Tax Years 2017, 2018, 2019, and 2020
Dear Revenue Agent Dunleavy:
We write on behalf of our client, Penterra Pharmaceuticals Corp. ("PPC" or the "Taxpayer"), for which Calderwood & Harkness LLP serves as authorized representative pursuant to IRS Form 2848, Power of Attorney and Declaration of Representative, filed on June 8, 2022. That Form 2848 designates the following individuals as authorized representatives: Leonard Cross (Responsible Partner), Sylvia Hartwell (Partner), Garrett Simmons (Lead Associate), and Leila Nazari (Associate), each of Calderwood & Harkness LLP. This response is submitted by the undersigned on behalf of PPC.
This letter constitutes PPC's response to Information Document Request No. 35 ("IDR No. 35"), which was issued by the Exam Team and received by PPC's authorized representatives on or about May 3, 2023. IDR No. 35 requested the production of internal documents of Penterra Biopharma International DAC ("PBI"), a Designated Activity Company organized under the laws of Ireland and a wholly owned indirect subsidiary of PPC, evidencing intercompany pricing decisions and market strategy for non-Americas territories during Tax Years 2017 through 2020. PPC provides this response in a cooperative spirit and consistent with its ongoing commitment to working constructively with the Exam Team throughout this examination. Nothing in this response or in the accompanying document production constitutes a waiver of any objections, privileges, rights, or positions that PPC may have or may assert in connection with this examination or any subsequent administrative or judicial proceeding.
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) Market entry and market strategy decisions made by PBI with respect to non-Americas territories, including memoranda, strategic plans, and related analyses regarding the selection of markets, the sequencing and timing of product launches, and the development of competitive positioning strategies;
(c) Documentation related to PBI's selection of distribution partners in non-Americas territories, including requests for proposals, evaluation criteria, selection memoranda, and related correspondence; and
(d) Any communications or approvals between PBI personnel and PPC personnel regarding pricing of products in non-Americas territories, including emails, memoranda, reports, and any documentation reflecting PPC involvement in or oversight of PBI's pricing decisions.
We understand that IDR No. 35 relates to the Exam Team's ongoing inquiry into the economic substance of PBI and whether PBI performed genuine functions associated with the Development, Enhancement, Maintenance, Protection, and Exploitation of intangible property ("DEMPE functions"), as those concepts are referenced in the OECD Transfer Pricing Guidelines and as relevant to the analysis under Sections 482 and 367(d) of the Internal Revenue Code. More specifically, we understand the Exam Team is focused on the "Exploitation" element of the DEMPE framework and is evaluating whether PBI exercised genuine, independent decision-making authority over the commercialization of PPC products in non-Americas territories, or whether, as the Exam Team has suggested, key decision-making functions with respect to pricing and commercial strategy remained in the United States under the direction or control of PPC personnel.
PPC responds to each of the foregoing categories of requested documents as set forth below.
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 Thornbury), whose offices are located at 22 Fitzwilliam Square, Dublin 2, D02 YH68, Ireland. PBI's personnel in Dublin undertook a thorough search of PBI's electronic and physical records, including PBI's document management systems, email archives, shared network drives, and board records, to identify documents responsive to the four categories enumerated in IDR No. 35.
The responsive documents have been organized into the following seven categories and are being produced as Attachments A through G to this response:
Attachment A — PBI Pricing Committee Meeting Minutes (2017–2020)
Attachment B — Market Entry Strategy Memoranda
Attachment C — Country-Level Pricing Approval Forms
Attachment D — Distribution Partner Selection Documentation
Attachment E — PBI Board Resolutions on Pricing and Commercial Strategy
Attachment F — Communications Between PBI and PPC Regarding Pricing
Attachment G — Market Strategy Presentations (Annual Strategic Plans)
All documents produced in connection with this response have been Bates-stamped sequentially from PPC-IDR35-000001 through PPC-IDR35-004837, consistent with the Bates-numbering conventions previously agreed upon between PPC's authorized representatives and the Exam Team. Each document has been stamped with the confidentiality designation "CONFIDENTIAL — IRS EXAMINATION" in accordance with the parties' established protocols for the handling of confidential business information.
PPC notes that certain documents that would otherwise be responsive to IDR No. 35 have been withheld on the grounds of attorney-client privilege and/or the work-product doctrine. These withheld documents are identified on the privilege log being maintained by PPC in connection with this examination (the "Master IDR Privilege Log"), which has been supplemented to reflect the additional privilege entries arising from this production. The supplemented privilege log entries for IDR No. 35 are being provided concurrently with this response.
Each of the Attachments is described in further detail in Sections III through IX below.
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, regulatory, and finance personnel based at PBI's offices in Dublin, including, during the relevant period, the following individuals:
• Aidan Naughton, Managing Director (Committee Chair)
• Fiona O'Dowd, Vice President, Commercial Strategy, EMEA
• Seamus Byrne, Vice President, Finance and Commercial Operations
• Dr. Niamh Callaghan, Vice President, Regulatory Affairs
• Lars Eriksen, Vice President, Commercial Strategy, APAC
• Orla Fitzpatrick, Director, Market Access and Pricing
The Pricing Committee met on a regular basis, generally on a monthly cycle, to review and approve product pricing for non-Americas territories. During the four examination years, the Committee held approximately 47 formal meetings, with additional ad hoc sessions convened as needed to address time-sensitive pricing matters, such as responses to government-mandated pricing reviews in certain European markets or competitive pricing pressures arising from biosimilar entry.
The minutes document the Committee's deliberations and independent pricing authority exercised by PBI across 68 country markets spanning the EMEA and APAC regions. The deliberations covered pricing decisions for PBI's key commercialized products, including:
• Veritaxol (oncology therapeutic) — Non-Americas net sales of approximately $1.34 billion in Tax Year 2020, making it PBI's largest revenue-generating product. The Pricing Committee minutes reflect extensive deliberations on Veritaxol pricing across major markets including Germany, the United Kingdom, France, Japan, Australia, and South Korea, as well as numerous smaller markets across Central and Eastern Europe, the Middle East, and Southeast Asia.
• Imvara (immunology therapeutic) — Non-Americas net sales of approximately $790 million in Tax Year 2020. The minutes reflect the Committee's analysis of competitive positioning relative to established immunology therapies, reimbursement negotiations with national health authorities, and market-specific pricing adjustments.
• Cerulon (rare disease therapeutic) — Non-Americas net sales of approximately $280 million in Tax Year 2020. Given the specialized nature of rare disease products, the minutes reflect the Committee's consideration of orphan drug pricing frameworks, patient access programs, and value-based pricing methodologies applicable in various jurisdictions.
The meeting minutes consistently demonstrate that PBI personnel — not PPC U.S.-based personnel — made the final pricing determinations for each product in each territory. The Committee's deliberations were informed by local market conditions, competitive dynamics, regulatory and reimbursement frameworks specific to each jurisdiction, health technology assessment outcomes, and PBI's own financial and commercial objectives. The minutes reflect that the Committee considered detailed analyses prepared by PBI's Dublin-based commercial strategy and market access teams and that pricing decisions were approved by PBI management in Dublin.
These documents are responsive to categories (a) and (d) of IDR No. 35 and cover all four examination years (Tax Years 2017, 2018, 2019, and 2020).
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 commercial opportunities in existing and new markets. The memoranda include the following types of analyses:
• Market assessments: Detailed evaluations of the size, growth trajectory, epidemiological profile, and competitive landscape of specific country markets, prepared by PBI's commercial strategy team with inputs from PBI's local market experts and, in some cases, third-party market research firms engaged and directed by PBI.
• Competitive landscape analyses: Assessments of existing and anticipated competitive products in each target market, including branded therapies, biosimilars, and generic alternatives, as well as analyses of competitor pricing and market share data.
• Regulatory pathway evaluations: Memoranda prepared by PBI's regulatory affairs team evaluating the regulatory requirements, expected timelines, and costs associated with obtaining marketing authorizations in each target jurisdiction. These documents reflect the substantial regulatory expertise maintained by PBI in Dublin and PBI's management of the regulatory submission process across multiple jurisdictions.
• Financial projections: Revenue and profitability projections prepared by PBI's finance team for proposed market entries, incorporating product-specific pricing assumptions, volume forecasts, expected reimbursement levels, and anticipated costs of market entry, including regulatory submission fees, distribution infrastructure costs, and local marketing expenditures.
These memoranda document PBI's independent decision-making regarding which non-Americas markets to enter and the sequencing and timing of product launches. The documents reflect that PBI's commercial strategy team conducted independent analyses and made recommendations to PBI's senior management and, in certain cases, to the PBI Board of Directors for approval. The memoranda demonstrate that market entry decisions were driven by PBI's assessment of market opportunities and PBI's own strategic priorities, rather than by direction from PPC's U.S.-based personnel.
The documents further evidence PBI's risk-bearing role in non-Americas territories. PBI bore the market risk associated with its commercialization activities, including the risk that market entry efforts would not yield anticipated returns, the risk of adverse regulatory outcomes, and the risk of competitive pressures eroding anticipated pricing and volume. To that end, the memoranda reflect that PBI made cumulative capital expenditures of approximately €47.2 million on regulatory submissions across 68 country markets during the period 2017 through 2020, funds that were deployed at PBI's own risk and pursuant to PBI's independent commercial judgment.
These documents are responsive to category (b) of IDR No. 35.
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 country market was documented on a country-level pricing approval form. Each form sets forth the following information:
• The product name, dosage form, and presentation;
• The proposed ex-factory price and estimated net price after applicable discounts, rebates, and statutory pricing adjustments;
• Supporting analysis, including local reimbursement data, health technology assessment outcomes (where applicable), competitor pricing benchmarks, volume projections, and gross-to-net adjustments;
• The recommended pricing tier and the rationale for the recommended price point;
• The signature of the PBI employee preparing the recommendation, typically a member of PBI's market access or commercial strategy team in Dublin;
• The approval signature of the authorized PBI decision-maker, typically the Vice President, Commercial Strategy (EMEA or APAC, as applicable), or, for pricing decisions above a specified threshold, the Managing Director of PBI.
Each pricing approval form was executed by PBI employees based in Dublin. The forms do not bear the signatures of, nor do they reflect approval by, PPC U.S.-based personnel. This is consistent with PBI's pricing authority as the principal for non-Americas commercialization and with the delegation of pricing authority documented in PBI's corporate governance framework (see Attachment E below).
PPC is producing representative samples of completed pricing approval forms for major markets across the EMEA and APAC regions for each of the four examination years. The major markets for which representative samples are included in this production encompass, among others, Germany, the United Kingdom, France, Italy, Spain, the Netherlands, Sweden, Japan, Australia, South Korea, and select markets in the Middle East and Southeast Asia. The representative samples are sufficient to demonstrate the consistent application of PBI's pricing approval process across the relevant territories and time periods.
The pricing approval forms further reinforce the scope and substance of PBI's operations. As of December 31, 2020, PBI employed approximately 185 full-time employees at its Dublin offices, a significant increase from the 52 employees at PBI's establishment in 2012. PBI's workforce spanned multiple functional areas critical to the commercialization of pharmaceutical products, including regulatory affairs, medical affairs, commercial strategy, market access and pricing, supply-chain management, and finance. The pricing approval forms reflect the work product of these substantive functional teams and their exercise of commercial judgment in each territory.
These documents are responsive to categories (a) and (b) of IDR No. 35 and cover all four examination years.
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 distribution partners in markets where PBI did not maintain a direct commercial presence. The selection and management of these distribution partners was a key commercial function performed by PBI's Dublin-based team. The documents produced in Attachment D include the following:
• Requests for proposals ("RFPs"): Formal RFP packages issued by PBI to prospective distribution partners, setting forth PBI's requirements for distribution services, including geographic scope, product handling and storage requirements, regulatory compliance expectations, and commercial performance targets.
• Evaluation scorecards: Internal PBI scoring matrices used to evaluate competing distribution partner candidates based on defined criteria, including distribution capability, geographic coverage, regulatory track record, financial stability, existing customer relationships, and proposed commercial terms.
• Negotiation correspondence: Selected correspondence between PBI's Dublin-based commercial and legal teams and prospective distribution partners, documenting the negotiation of key commercial terms, including pricing, volume commitments, exclusivity provisions, and performance milestones.
• Final selection memoranda: Internal PBI memoranda recommending the selection of a preferred distribution partner for each relevant market, setting forth the rationale for the selection, the results of the evaluation process, and the key terms of the proposed engagement.
These documents demonstrate that PBI exercised independent authority over distribution channel decisions in non-Americas territories. The selection of distribution partners was managed by PBI's commercial strategy and business development teams in Dublin, and final selection decisions were made by PBI management without requiring PPC U.S. approval. The documents reflect PBI's analysis of local market conditions, competitive factors, and commercial considerations specific to each territory.
PPC notes that certain executed third-party distribution agreements between PBI and its distribution partners were previously produced in response to IDR No. 18, issued by the Exam Team and dated December 5, 2022. Those agreements, which were Bates-stamped as part of the IDR No. 18 production, provide additional context for the distribution partner selection documentation produced herein. PPC provides this cross-reference for the convenience of the Exam Team and to avoid duplicative production.
These documents are responsive to category (c) of IDR No. 35.
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 meetings in Dublin, consisting of regularly scheduled quarterly meetings and additional special sessions convened to address significant commercial, regulatory, and strategic matters. Board meetings were held at PBI's registered office or at other locations in Dublin and were attended by PBI's directors, including Managing Director Aidan Naughton and other members of PBI's senior management team.
The extracts produced in Attachment E include the following categories of board actions:
• Resolutions delegating pricing authority: Board resolutions formally delegating pricing authority to PBI's Pricing Committee and to designated members of PBI's senior management, including the parameters within which such authority was to be exercised and any thresholds requiring escalation to the Board.
• Ratification of key commercial strategy decisions: Board resolutions ratifying significant commercial decisions, including new market entry approvals, product launch timelines, pricing strategy frameworks for major markets, and the approval of annual commercial budgets.
• Board discussion of pricing and commercial performance: Extracts reflecting the Board's discussion and oversight of PBI's pricing performance, market share trends, competitive dynamics, and commercial strategy execution.
These board extracts demonstrate the corporate governance structure supporting PBI's independent decision-making authority. The PBI Board maintained active oversight of PBI's commercial activities and exercised its governance responsibilities through regular meetings held in Dublin. The resolutions and discussions reflected in these extracts are consistent with PBI's role as the principal for non-Americas commercialization and with the allocation of decision-making authority under PBI's corporate charter, the intercompany cost-sharing arrangement, and the related intercompany agreements.
PPC notes that the full, unredacted minutes of all PBI Board of Directors meetings during the examination period were previously produced in response to IDR No. 9, issued by the Exam Team and dated September 12, 2022. The extracts produced in Attachment E are drawn from those previously produced minutes and are provided here for the convenience of the Exam Team, as they are directly responsive to the specific subject matter of IDR No. 35. To the extent the Exam Team wishes to review the full board minutes for additional context, PPC respectfully refers the Exam Team to the IDR No. 9 production.
These documents are responsive to categories (a) and (b) of IDR No. 35.
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 regarding pricing is directed at evaluating whether PPC U.S.-based personnel directed, controlled, or otherwise exercised decision-making authority over PBI's pricing determinations for non-Americas territories. PPC is producing these communications because they demonstrate the nature of the relationship between PBI and PPC with respect to pricing matters and support PPC's position that PBI exercised independent commercial judgment over pricing in non-Americas territories.
The communications produced in Attachment F include the following types of documents:
• Informational reports: Periodic reports prepared by PBI and provided to PPC's corporate headquarters, including quarterly commercial performance summaries, revenue updates, and market trend analyses. These reports were provided by PBI to PPC in the ordinary course of PPC's corporate governance and financial reporting processes, consistent with the parent-subsidiary relationship between PPC and PBI. The reports are informational in nature and do not reflect PPC's exercise of pricing authority over PBI's non-Americas markets.
• Cross-functional coordination emails: Communications between PBI and PPC personnel relating to cross-functional matters such as global supply chain coordination, product availability, and manufacturing scheduling. While these communications occasionally reference pricing in the context of supply and demand planning, they do not reflect PPC's exercise of pricing decision-making authority over PBI's territories.
• Corporate governance communications: Communications in which PBI informed PPC's corporate management of significant commercial developments in non-Americas territories, consistent with PBI's obligations under PPC's corporate governance framework. These communications demonstrate that PBI provided updates to its parent company as part of normal corporate reporting but that PPC did not direct or control PBI's pricing decisions.
The communications produced in Attachment F consistently show that PBI exercised independent commercial judgment over pricing in non-Americas territories. Where PPC personnel provided input or feedback on pricing matters, such input was in the nature of informational exchange between a parent company and its subsidiary, rather than directive or controlling in character. PBI's pricing decisions were made by PBI's Dublin-based personnel through PBI's established pricing governance processes, as documented in Attachments A, C, and E. The communications produced herein are consistent with an arm's-length, principal-subsidiary relationship in which PBI controlled its own pricing and commercialization functions while reporting to its parent in the ordinary course of corporate governance.
These documents are responsive to category (d) of IDR No. 35.
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 includes the following subject areas:
• Product launch sequencing and market expansion plans, including prioritization of target markets based on PBI's independent commercial analysis;
• Pricing strategies by region, including proposed pricing frameworks for EMEA and APAC markets, anticipated pricing actions in response to regulatory developments or competitive dynamics, and planned pricing negotiations with national health authorities;
• Competitive positioning, including analyses of competitive threats, biosimilar entry timelines, and strategies for maintaining or expanding market share;
• Revenue targets and financial projections for the non-Americas business, including product-level and regional-level revenue forecasts;
• Key risk factors and mitigation strategies, including regulatory risks, reimbursement risks, and competitive risks specific to non-Americas territories.
These presentations were prepared by PBI's commercial strategy team in Dublin and were presented at PBI Board of Directors meetings held in Dublin. The presentations reflect PBI's independent strategic planning process and PBI's role as the principal for non-Americas commercialization. They include references to PBI's independent pricing authority across 68 country markets and to PBI's functional and risk profile as the entity responsible for the commercial exploitation of PPC's products outside the Americas.
These documents are responsive to categories (a) and (b) of IDR No. 35 and cover all four examination years.
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 Ireland. PBI's registered office is located at 4th Floor, Claremont House, Sandyford Business Park, Dublin D18 K7T4, Ireland, where PBI has maintained approximately 18,000 square feet of dedicated office space throughout the examination period. PBI has operated as the principal for non-Americas commercialization of PPC products since the qualified cost-sharing arrangement (the "CSA") became effective on July 1, 2012.
Since its establishment, PBI has built substantial operational capability to support its role as the non-Americas commercial principal. PBI's headcount grew from 52 employees at its founding in 2012 to approximately 185 employees by the end of Tax Year 2020. These employees spanned multiple functional disciplines critical to the commercialization of pharmaceutical products in international markets, including regulatory affairs, medical affairs, commercial strategy, market access and pricing, supply-chain management, quality assurance, and finance and accounting. PBI's workforce included individuals with deep expertise in the regulatory and reimbursement frameworks of the jurisdictions in which PBI operated, and many of PBI's employees were recruited from other pharmaceutical and biopharmaceutical companies with significant experience in European and Asia-Pacific markets.
Throughout the examination period, PBI made independent pricing decisions across 68 country markets in the EMEA and APAC regions, supported by dedicated local market expertise and a formal pricing governance structure. PBI's independent pricing authority was consistent with PBI's role as the non-Americas commercial principal under the CSA and the legacy IP license agreement between PPC and PBI, under which PBI paid a royalty rate of 4.5% of net sales for the right to commercialize PPC's products in the non-Americas territory.
PBI bore market risk for the non-Americas territories, including the risk of adverse pricing and reimbursement outcomes, competitive pressures, regulatory delays, and fluctuations in demand. PBI made key commercial decisions regarding pricing, market entry, distribution partner selection, and commercial strategy in the exercise of its independent business judgment and through its Dublin-based management and governance structures.
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 regarding pricing, regulatory, commercial, and tax matters, as well as documents prepared in anticipation of litigation or in connection with legal proceedings.
Each withheld document is identified on the Master IDR Privilege Log that PPC is maintaining in connection with this examination. The privilege log has been supplemented to include the entries for documents withheld in connection with IDR No. 35, and the supplemented privilege log is being provided concurrently with this response. The privilege log identifies each withheld document by date, author, recipient, general subject matter, and the privilege or protection asserted.
PPC reserves all rights to assert the attorney-client privilege, the work-product doctrine, or any other applicable privilege or protection over any documents that may have been produced inadvertently in connection with this or any other IDR response. The production of any document in connection with this response does not constitute a waiver of any privilege or protection with respect to such document or any other document, in whole or in part, and PPC expressly invokes the protections of Federal Rule of Evidence 502(b) and any analogous state or federal provisions with respect to any inadvertent production.
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 of PBI, the characterization of PBI's functions, assets, or risks, the arm's-length nature of any intercompany transaction, the validity or enforceability of the CSA or any related intercompany agreement, or the application of any provision of the Internal Revenue Code or Treasury Regulations to PPC or PBI.
PPC further reserves the right to supplement this response if additional documents responsive to IDR No. 35 are identified in the course of PPC's and PBI's ongoing document collection and review efforts. PPC will notify the Exam Team promptly if any supplemental production is made.
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 lcross@calderwoodharkness.com.
We appreciate the Exam Team's continued professionalism in conducting this examination and look forward to working cooperatively with you as the examination proceeds.
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Garrett Simmons Lead Associate, Tax Department Calderwood & Harkness LLP 1735 Market Street, Suite 3100 Philadelphia, PA 19103 Tel: (215) 448-7264
Email: gsimmons@calderwoodharkness.com
cc (via email):
Leonard Cross, Partner, Calderwood & Harkness LLP Sylvia Hartwell, Partner, Calderwood & Harkness LLP Leila Nazari, Associate, Calderwood & Harkness LLP Marcus Whitfield, Vice President, Global Tax, Penterra Pharmaceuticals Corp. Deborah Staines, General Counsel, Penterra Pharmaceuticals Corp.
Enclosures:
Attachment A — PBI Pricing Committee Meeting Minutes (2017–2020) Attachment B — Market Entry Strategy Memoranda Attachment C — Country-Level Pricing Approval Forms Attachment D — Distribution Partner Selection Documentation Attachment E — PBI Board Resolutions on Pricing and Commercial Strategy Attachment F — Communications Between PBI and PPC Regarding Pricing Attachment G — Market Strategy Presentations (Annual Strategic Plans)
Documents Bates-stamped PPC-IDR35-000001 through PPC-IDR35-004837
Reference: IDR No. 35