| Item | Detail |
| Prepared By | Calderwood & Harkness LLP in coordination with Whitmore Valuation Group LLC |
| C&H Matter Number | 1018-00009 |
| Client | Penterra Pharmaceuticals Corp. (PPC), EIN 22-3741856 |
| Client HQ | 2200 Independence Boulevard, Princeton Junction, NJ 08550 |
| Subsidiary Analyzed | Penterra Biopharma International DAC (PBI), Irish Tax Ref. 3218764T |
| PBI Registered Office | 4th Floor, Claremont House, Sandyford Business Park, Dublin D18 K7T4, Ireland |
| Intermediate Holding Co. | Penterra Holdings Luxembourg S.à r.l. (PHL), RCS B 168452 — disregarded entity for U.S. federal tax purposes |
| Contract Manufacturer | Penterra Manufacturing Ireland Ltd. (PMI), CRO 512347, Unit 7, Ringaskiddy Industrial Estate, Co. Cork T12 PX29, Ireland |
| Tax Years | 2017, 2018, 2019, 2020 |
| IRS Exam Team | LB&I-NE-TP-2022-00641; SRA Gerald Meskill, RA Patricia Dunleavy, Economist Dr. Alan Washburne |
| DEMPE Framework | Development, Enhancement, Maintenance, Protection, Exploitation — per OECD Transfer Pricing Guidelines (2017, 2022 revisions), Chapter VI |
| Applicable Regulations | IRC § 482; Treas. Reg. §§ 1.482-4, 1.482-7; IRC § 6662(e) |
| Purpose | Document allocation of DEMPE functions between PPC (U.S.) and PBI (Ireland) to rebut IRS economic substance challenge and support arm's-length transfer pricing positions |
| Key Products | Veritaxol (oncology), Imvara (immunology), Cerulon (rare disease) |
| CSA Effective Date | July 1, 2012 |
| PCT Payment | $312,000,000 (lump sum paid by PBI to PPC on July 1, 2012) |
| PBI Incorporation | March 15, 2012 |
| C&H Lead Partner | Leonard Cross, Responsible Partner, Tax |
| WVG Lead Economist | Dr. Helena Vasquez, Managing Director |
| Crestfield & Associates | Original transfer pricing documentation preparer (Susan Lam, TP Partner; Martin Ogilvy, Engagement Partner) |
| Irish Tax Advisor | Thornbury & Keogh (Ciarán Thornbury, Lead Partner), 22 Fitzwilliam Square, Dublin 2, D02 YH68, Ireland |
| Date Prepared | October 2022 (updated March 2023) |
| Product Line | Tax Year | DEMPE Function | Sub-Function / Activity | PPC (U.S.) — Description of Activities | PPC Headcount Allocated | PPC Expenditure ($M) | PBI (Ireland) — Description of Activities | PBI Headcount Allocated | PBI Expenditure (€M) | PMI (Ireland) — Description of Activities | PMI Headcount Allocated | Primary Decision-Maker | Risk Bearer | Notes / Supporting Evidence |
| Veritaxol | 2017 | Development | Drug discovery & Pre-Clinical Research | PPC conducts primary drug discovery, lead compound identification, and pre-clinical testing at Princeton Junction R&D center | 380 | 148.2 | PBI co-funds R&D costs per CSA (38.2% share in 2017); limited local clinical oversight for non-Americas regulatory submissions | 6 | 5.1 | N/A | 0 | PPC | Shared per CSA | CSA cost-sharing ratio: PBI 38.2% of $487.3M total qualified R&D |
| Veritaxol | 2017 | Development | Clinical Trials (Phase I–III) | PPC designs, manages, and sponsors global clinical trial protocols; U.S.-based clinical operations team | 240 | 112.5 | PBI manages non-Americas clinical site coordination, regulatory interactions with EMA and national agencies | 18 | 8.4 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA | PBI board approved non-Americas clinical strategy |
| Veritaxol | 2017 | Development | Regulatory Science (Development Phase) | PPC prepares and files U.S. FDA submissions | 40 | 14.8 | PBI prepares and files non-Americas regulatory submissions (EMA, national agencies) | 6 | 3.2 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) | PBI regulatory expenditure included in cumulative €47.2M total 2017–2020 |
| Veritaxol | 2018 | Development | Drug discovery & Pre-Clinical Research | PPC conducts primary drug discovery and pre-clinical testing at Princeton Junction R&D center | 395 | 158.6 | PBI co-funds R&D costs per CSA (39.6% share in 2018); growing local clinical oversight | 8 | 6.2 | N/A | 0 | PPC | Shared per CSA | CSA cost-sharing ratio: PBI 39.6% of $523.8M |
| Veritaxol | 2018 | Development | Clinical Trials (Phase I–III) | PPC designs and manages global clinical trial protocols | 255 | 122.0 | PBI manages non-Americas clinical site coordination in EMEA/APAC; regulatory interactions with EMA | 22 | 10.5 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA |
| Veritaxol | 2018 | Development | Regulatory Science (Development Phase) | PPC prepares and files U.S. FDA submissions | 42 | 15.8 | PBI prepares and files non-Americas regulatory submissions | 7 | 3.8 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Veritaxol | 2019 | Development | Drug discovery & Pre-Clinical Research | PPC conducts primary drug discovery, lead compound identification, and pre-clinical testing | 410 | 172.4 | PBI co-funds R&D costs per CSA (41.1% share in 2019); expanding local clinical oversight | 10 | 7.2 | N/A | 0 | PPC | Shared per CSA | CSA cost-sharing ratio: PBI 41.1% of $561.2M |
| Veritaxol | 2019 | Development | Clinical Trials (Phase I–III) | PPC designs, manages, and sponsors global clinical trial protocols | 268 | 132.0 | PBI manages non-Americas clinical site coordination; PBI regulatory team expands to cover additional APAC markets | 25 | 12.8 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA |
| Veritaxol | 2019 | Development | Regulatory Science (Development Phase) | PPC prepares and files U.S. FDA submissions | 44 | 16.2 | PBI prepares and files non-Americas regulatory submissions for 66 markets | 8 | 4.1 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Veritaxol | 2020 | Development | Drug discovery & Pre-Clinical Research | PPC conducts primary drug discovery, lead compound identification, and pre-clinical testing at Princeton Junction R&D center | 420 | 185.5 | PBI co-funds R&D costs per CSA (42.7% share in 2020); limited local clinical oversight for non-Americas regulatory submissions | 12 | 8.2 | N/A | 0 | PPC | Shared per CSA | CSA cost-sharing ratio: PBI 42.7% of $598.4M total qualified R&D = $255.52M |
| Veritaxol | 2020 | Development | Clinical Trials (Phase I–III) | PPC designs, manages, and sponsors global clinical trial protocols; U.S.-based clinical operations team | 280 | 142.0 | PBI manages non-Americas clinical site coordination, regulatory interactions with EMA and national agencies; PBI personnel conduct site selection and monitoring in EMEA/APAC | 28 | 14.6 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA | PBI board approved non-Americas clinical strategy at 42 board meetings (2017–2020) |
| Veritaxol | 2020 | Development | Regulatory Science (Development Phase) | PPC prepares and files U.S. FDA submissions | 48 | 18.2 | PBI prepares and files non-Americas regulatory submissions for 68 markets | 9 | 4.5 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) | PBI cumulative regulatory spend €47.2M 2017–2020 |
| Imvara | 2017 | Development | Drug discovery & Pre-Clinical Research | PPC conducts drug discovery and pre-clinical research for immunology pipeline at Princeton Junction | 180 | 72.5 | PBI co-funds R&D costs per CSA; limited local oversight for non-Americas | 4 | 2.8 | N/A | 0 | PPC | Shared per CSA |
| Imvara | 2017 | Development | Clinical Trials (Phase I–III) | PPC designs and manages global clinical trial protocols for Imvara | 140 | 65.0 | PBI manages non-Americas clinical site coordination | 10 | 4.5 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA |
| Imvara | 2017 | Development | Formulation & Process Development | PPC leads formulation science and process development at U.S. facilities | 80 | 38.2 | PBI provides input on non-Americas formulation requirements | 3 | 1.2 | PMI supports scale-up manufacturing process development | 35 | PPC | Shared per CSA |
| Imvara | 2018 | Development | Drug discovery & Pre-Clinical Research | PPC conducts ongoing pre-clinical research for Imvara | 190 | 78.4 | PBI co-funds R&D costs per CSA; growing local oversight capabilities | 5 | 3.2 | N/A | 0 | PPC | Shared per CSA |
| Imvara | 2018 | Development | Clinical Trials (Phase I–III) | PPC designs and manages global clinical trial protocols | 150 | 72.0 | PBI manages non-Americas clinical site coordination and regulatory interactions | 12 | 5.4 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA |
| Imvara | 2018 | Development | Formulation & Process Development | PPC leads formulation science and process development | 85 | 41.5 | PBI provides input on non-Americas formulation requirements (packaging, labeling) | 4 | 1.5 | PMI supports scale-up manufacturing process development | 38 | PPC | Shared per CSA |
| Imvara | 2019 | Development | Drug discovery & Pre-Clinical Research | PPC conducts ongoing pre-clinical research | 200 | 84.6 | PBI co-funds R&D costs per CSA; expanded local clinical oversight | 6 | 3.6 | N/A | 0 | PPC | Shared per CSA |
| Imvara | 2019 | Development | Clinical Trials (Phase I–III) | PPC designs and manages global clinical trial protocols | 160 | 78.5 | PBI manages non-Americas clinical site coordination in expanded markets | 14 | 6.2 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA |
| Imvara | 2019 | Development | Formulation & Process Development | PPC leads formulation science and process development at U.S. facilities | 95 | 48.3 | PBI provides input on non-Americas formulation requirements (packaging, labeling for 68 country markets) | 5 | 1.8 | PMI supports scale-up manufacturing process development | 45 | PPC | Shared per CSA |
| Imvara | 2020 | Development | Drug discovery & Pre-Clinical Research | PPC conducts ongoing pre-clinical and translational research | 210 | 92.4 | PBI co-funds R&D costs per CSA (42.7% share); expanded local clinical oversight | 7 | 4.2 | N/A | 0 | PPC | Shared per CSA |
| Imvara | 2020 | Development | Clinical Trials (Phase I–III) | PPC designs and manages global clinical trial protocols | 170 | 85.0 | PBI manages non-Americas clinical site coordination across EMEA/APAC | 16 | 7.4 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA |
| Imvara | 2020 | Development | Formulation & Process Development | PPC leads formulation science and process development at U.S. facilities | 100 | 52.8 | PBI provides input on non-Americas formulation requirements for 68 markets | 6 | 2.1 | PMI supports scale-up manufacturing process development | 50 | PPC | Shared per CSA |
| Cerulon | 2017 | Development | Drug discovery & Pre-Clinical Research | PPC conducts rare disease drug discovery and pre-clinical research | 60 | 22.4 | PBI co-funds R&D costs per CSA; assists with non-Americas orphan drug regulatory strategy | 2 | 1.1 | N/A | 0 | PPC | Shared per CSA |
| Cerulon | 2017 | Development | Clinical Trials (Phase I–III) | PPC designs and manages global clinical trial protocols for rare disease | 45 | 18.6 | PBI manages non-Americas clinical site coordination for rare disease trials | 4 | 1.8 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA |
| Cerulon | 2017 | Development | Regulatory Science (Development Phase) | PPC prepares and files U.S. FDA submissions | 35 | 12.1 | PBI prepares and files non-Americas regulatory submissions (EMA, national agencies); €47.2M cumulative regulatory spend 2017–2020 | 8 | 3.4 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) | PBI's regulatory capital expenditure: €47.2M cumulative across all products 2017–2020 |
| Cerulon | 2018 | Development | Drug discovery & Pre-Clinical Research | PPC conducts rare disease pre-clinical research | 65 | 24.8 | PBI co-funds R&D costs per CSA; expanded orphan drug regulatory work | 3 | 1.4 | N/A | 0 | PPC | Shared per CSA |
| Cerulon | 2018 | Development | Clinical Trials (Phase I–III) | PPC designs and manages global clinical trial protocols for rare disease | 48 | 20.2 | PBI manages non-Americas clinical site coordination for rare disease trials in EMEA/APAC | 5 | 2.2 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA |
| Cerulon | 2018 | Development | Regulatory Science (Development Phase) | PPC prepares and files U.S. FDA submissions for pediatric and rare disease indications | 38 | 13.5 | PBI prepares and files non-Americas regulatory submissions for pediatric and orphan indications | 8 | 3.8 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Cerulon | 2019 | Development | Drug discovery & Pre-Clinical Research | PPC conducts ongoing rare disease research | 70 | 28.2 | PBI co-funds R&D costs per CSA; supports non-Americas regulatory strategy | 3 | 1.6 | N/A | 0 | PPC | Shared per CSA |
| Cerulon | 2019 | Development | Clinical Trials (Phase I–III) | PPC designs and manages global clinical trial protocols | 52 | 22.8 | PBI manages non-Americas clinical site coordination | 6 | 2.6 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA |
| Cerulon | 2019 | Development | Regulatory Science (Development Phase) | PPC prepares and files U.S. FDA submissions | 40 | 14.5 | PBI prepares and files non-Americas regulatory submissions across expanded markets | 9 | 4.2 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Cerulon | 2020 | Development | Drug discovery & Pre-Clinical Research | PPC conducts ongoing rare disease research and next-generation compound identification | 75 | 32.0 | PBI co-funds R&D costs per CSA (42.7% share); supports non-Americas regulatory and clinical strategy | 4 | 1.9 | N/A | 0 | PPC | Shared per CSA |
| Cerulon | 2020 | Development | Clinical Trials (Phase I–III) | PPC designs and manages global clinical trial protocols for rare disease | 55 | 25.4 | PBI manages non-Americas clinical site coordination for rare disease trials | 7 | 3.0 | N/A | 0 | PPC (protocol design); PBI (non-Americas site management) | Shared per CSA |
| Cerulon | 2020 | Development | Regulatory Science (Development Phase) | PPC prepares and files U.S. FDA submissions | 42 | 15.8 | PBI prepares and files non-Americas regulatory submissions for 68 markets | 9 | 4.5 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Cross-Product / Platform | 2017 | Development | Total Qualified R&D Cost Pool | PPC bears 61.8% of total qualified R&D costs ($487.3M × 61.8% = $301.15M) | 301.15 | PBI bears 38.2% of total qualified R&D costs ($487.3M × 38.2% = $186.15M) | N/A | Shared | Shared per CSA | IRS proposed increasing PBI share to 48.2% (+10.0pp) |
| Cross-Product / Platform | 2018 | Development | Total Qualified R&D Cost Pool | PPC bears 60.4% ($523.8M × 60.4% = $316.38M) | 316.38 | PBI bears 39.6% ($523.8M × 39.6% = $207.42M) | N/A | Shared | Shared per CSA | IRS proposed PBI share at 50.6% (+11.0pp) |
| Cross-Product / Platform | 2019 | Development | Total Qualified R&D Cost Pool | PPC bears 58.9% ($561.2M × 58.9% = $330.55M) | 330.55 | PBI bears 41.1% ($561.2M × 41.1% = $230.65M) | N/A | Shared | Shared per CSA | IRS proposed PBI share at 52.3% (+11.2pp) |
| Cross-Product / Platform | 2020 | Development | Total Qualified R&D Cost Pool | PPC bears 57.3% ($598.4M × 57.3% = $342.88M) | 342.88 | PBI bears 42.7% ($598.4M × 42.7% = $255.52M) | N/A | Shared | Shared per CSA | IRS proposed PBI share at 53.7% (+11.0pp) |
| Cross-Product / Platform | 2017 | Development | Platform Technology & Shared R&D Infrastructure | PPC maintains shared R&D platform, laboratory facilities, and computational infrastructure at Princeton Junction | 120 | 28.5 | PBI contributes to shared platform costs per CSA allocation | 2 | 0.8 | N/A | 0 | PPC | Shared per CSA | Included in total qualified R&D cost pool |
| Cross-Product / Platform | 2018 | Development | Platform Technology & Shared R&D Infrastructure | PPC maintains shared R&D platform and computational infrastructure | 125 | 30.2 | PBI contributes to shared platform costs per CSA allocation | 2 | 0.9 | N/A | 0 | PPC | Shared per CSA |
| Cross-Product / Platform | 2019 | Development | Platform Technology & Shared R&D Infrastructure | PPC maintains shared R&D platform and infrastructure | 130 | 32.8 | PBI contributes to shared platform costs per CSA allocation | 3 | 1.0 | N/A | 0 | PPC | Shared per CSA |
| Cross-Product / Platform | 2020 | Development | Platform Technology & Shared R&D Infrastructure | PPC maintains shared R&D platform and infrastructure | 135 | 35.4 | PBI contributes to shared platform costs per CSA allocation | 3 | 1.1 | N/A | 0 | PPC | Shared per CSA |
| All Products | 2017 | Development | TOTAL — Development Function (2017) | PPC total Development expenditure for 2017 | 1380 | 301.15 | PBI total Development expenditure (CSA share) for 2017 | 63 | 32.3 | PMI Development support | 35 | Shared | Shared per CSA | Total qualified R&D pool: $487.3M |
| All Products | 2018 | Development | TOTAL — Development Function (2018) | PPC total Development expenditure for 2018 | 1458 | 316.38 | PBI total Development expenditure (CSA share) for 2018 | 77 | 38.9 | PMI Development support | 38 | Shared | Shared per CSA | Total qualified R&D pool: $523.8M |
| All Products | 2019 | Development | TOTAL — Development Function (2019) | PPC total Development expenditure for 2019 | 1544 | 330.55 | PBI total Development expenditure (CSA share) for 2019 | 89 | 45.1 | PMI Development support | 45 | Shared | Shared per CSA | Total qualified R&D pool: $561.2M |
| All Products | 2020 | Development | TOTAL — Development Function (2020) | PPC total Development expenditure for 2020 | 1620 | 342.88 | PBI total Development expenditure (CSA share) for 2020 | 101 | 51.5 | PMI Development support | 50 | Shared | Shared per CSA | Total qualified R&D pool: $598.4M |
| Product Line | Tax Year | DEMPE Function | Sub-Function / Activity | PPC (U.S.) — Description of Activities | PPC Headcount Allocated | PPC Expenditure ($M) | PBI (Ireland) — Description of Activities | PBI Headcount Allocated | PBI Expenditure (€M) | Primary Decision-Maker | Risk Bearer | Notes / Supporting Evidence |
| Veritaxol | 2017 | Enhancement | New Indication Development (Adjuvant Therapy) | PPC leads early-stage clinical program for potential adjuvant indication; U.S. R&D team initiates trial design | 65 | 42.0 | PBI co-funds per CSA and supports non-Americas regulatory strategy for new indication | 8 | 3.4 | PPC (trial design); PBI (non-Americas regulatory) | Shared per CSA | Enhancement costs included in qualified R&D cost pool |
| Veritaxol | 2017 | Enhancement | Lifecycle Management / Dosing Optimization | PPC manages dosing optimization studies for existing indication | 30 | 14.5 | PBI assesses non-Americas market need for dosing modifications; engages with EMA | 3 | 1.2 | PPC (clinical); PBI (non-Americas market assessment) | Shared per CSA |
| Veritaxol | 2017 | Enhancement | Post-Approval Commitments | PPC manages FDA post-approval study commitments | 20 | 8.8 | PBI manages EMA and national authority post-approval commitments for non-Americas markets | 4 | 1.5 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Veritaxol | 2018 | Enhancement | New Indication Development (Adjuvant Therapy) | PPC continues clinical program for adjuvant indication; Phase II trial initiated | 72 | 48.5 | PBI co-funds per CSA and manages non-Americas regulatory strategy; prepares EMA scientific advice request | 10 | 4.2 | PPC (trial design); PBI (non-Americas regulatory) | Shared per CSA |
| Veritaxol | 2018 | Enhancement | Lifecycle Management / Dosing Optimization | PPC manages dosing optimization studies | 32 | 15.8 | PBI assesses non-Americas market demand for dosing modifications | 3 | 1.3 | PPC (clinical); PBI (non-Americas market assessment) | Shared per CSA |
| Veritaxol | 2018 | Enhancement | Post-Approval Commitments | PPC manages FDA post-approval study commitments | 22 | 9.5 | PBI manages EMA and national authority post-approval commitments | 5 | 1.8 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Veritaxol | 2019 | Enhancement | New Indication Development (Adjuvant Therapy) | PPC leads Phase III trial for adjuvant indication | 78 | 55.0 | PBI co-funds per CSA and manages non-Americas site coordination for Phase III; prepares EMA Type II variation applications | 12 | 5.5 | PPC (trial design); PBI (non-Americas regulatory) | Shared per CSA |
| Veritaxol | 2019 | Enhancement | Lifecycle Management / Dosing Optimization | PPC completes dosing optimization studies | 34 | 16.2 | PBI implements dosing changes across non-Americas markets | 4 | 1.5 | PPC (clinical); PBI (non-Americas implementation) | Shared per CSA |
| Veritaxol | 2019 | Enhancement | Post-Approval Commitments | PPC manages FDA post-approval study commitments | 24 | 10.2 | PBI manages EMA and national authority post-approval commitments across 66 markets | 5 | 2.0 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Veritaxol | 2020 | Enhancement | New Indication Development (Adjuvant Therapy) | PPC leads clinical program for new adjuvant indication; U.S. R&D team designs trial protocol | 85 | 62.0 | PBI co-funds per CSA and manages non-Americas regulatory strategy for new indication; PBI regulatory team prepares EMA Type II variation applications | 15 | 6.8 | PPC (trial design); PBI (non-Americas regulatory) | Shared per CSA | Enhancement costs included in qualified R&D cost pool |
| Veritaxol | 2020 | Enhancement | Lifecycle Management / Dosing Optimization | PPC manages additional dosing studies for new patient populations | 36 | 17.5 | PBI manages non-Americas regulatory submissions for dosing changes across 68 markets | 4 | 1.6 | PPC (clinical); PBI (non-Americas regulatory) | Shared per CSA |
| Veritaxol | 2020 | Enhancement | Post-Approval Commitments | PPC manages FDA post-approval study commitments | 25 | 10.8 | PBI manages EMA and national authority post-approval commitments across 68 markets | 6 | 2.2 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Imvara | 2017 | Enhancement | Lifecycle Management / Reformulation | PPC initiates reformulation efforts for extended-release version | 30 | 12.5 | PBI assesses non-Americas market demand for reformulation | 4 | 1.2 | PPC (formulation); PBI (market assessment) | Shared per CSA |
| Imvara | 2017 | Enhancement | New Indication Screening | PPC screens potential new indications in immunology pipeline | 25 | 10.0 | PBI provides non-Americas market intelligence on unmet medical needs | 3 | 0.8 | PPC | Shared per CSA |
| Imvara | 2017 | Enhancement | Post-Approval Commitments | PPC manages FDA post-approval commitments for Imvara | 15 | 6.5 | PBI manages EMA post-approval commitments | 3 | 1.0 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Imvara | 2018 | Enhancement | Lifecycle Management / Reformulation | PPC continues reformulation efforts for extended-release version | 34 | 14.8 | PBI assesses non-Americas market demand and regulatory pathway for reformulation | 5 | 1.5 | PPC (formulation); PBI (market assessment, non-Americas regulatory) | Shared per CSA |
| Imvara | 2018 | Enhancement | New Indication Development | PPC initiates clinical studies for potential new indication in dermatology | 28 | 11.5 | PBI provides non-Americas market assessment and regulatory intelligence | 4 | 1.0 | PPC | Shared per CSA |
| Imvara | 2018 | Enhancement | Post-Approval Commitments | PPC manages FDA post-approval commitments | 16 | 7.0 | PBI manages EMA post-approval commitments across EMEA markets | 3 | 1.1 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Imvara | 2019 | Enhancement | Lifecycle Management / Reformulation | PPC manages reformulation efforts for extended-release version | 40 | 18.5 | PBI assesses non-Americas market demand for reformulation; engages with local regulatory authorities in 68 markets | 8 | 2.1 | PPC (formulation); PBI (market assessment, non-Americas regulatory) | Shared per CSA |
| Imvara | 2019 | Enhancement | New Indication Development | PPC conducts Phase II studies for dermatology indication | 32 | 14.2 | PBI manages non-Americas clinical site coordination for new indication studies | 5 | 1.4 | PPC (clinical); PBI (non-Americas site management) | Shared per CSA |
| Imvara | 2019 | Enhancement | Post-Approval Commitments | PPC manages FDA post-approval commitments | 18 | 7.8 | PBI manages EMA post-approval commitments | 4 | 1.2 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Imvara | 2020 | Enhancement | Lifecycle Management / Reformulation | PPC completes reformulation for extended-release version; files sNDA with FDA | 45 | 22.0 | PBI prepares non-Americas regulatory filings for reformulated product across 68 markets | 9 | 2.8 | PPC (formulation); PBI (non-Americas regulatory) | Shared per CSA |
| Imvara | 2020 | Enhancement | New Indication Development | PPC continues Phase II/III studies for dermatology indication | 35 | 16.5 | PBI manages non-Americas clinical coordination and regulatory strategy for new indication | 6 | 1.8 | PPC (clinical); PBI (non-Americas regulatory) | Shared per CSA |
| Imvara | 2020 | Enhancement | Post-Approval Commitments | PPC manages FDA post-approval commitments | 20 | 8.5 | PBI manages EMA and national authority post-approval commitments | 4 | 1.4 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Cerulon | 2017 | Enhancement | Label Extension — Pediatric Indication | PPC initiates pediatric studies per FDA requirements | 18 | 7.5 | PBI coordinates pediatric indication applications with EMA and national agencies | 3 | 1.0 | PPC (clinical); PBI (non-Americas regulatory) | Shared per CSA |
| Cerulon | 2017 | Enhancement | New Formulation Development | PPC explores alternative formulations for rare disease patient population | 12 | 5.2 | PBI provides non-Americas market input on formulation needs | 2 | 0.6 | PPC | Shared per CSA |
| Cerulon | 2017 | Enhancement | Post-Approval Commitments | PPC manages FDA orphan drug post-approval commitments | 10 | 4.0 | PBI manages EMA orphan drug post-approval commitments | 2 | 0.8 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Cerulon | 2018 | Enhancement | Label Extension — Pediatric Indication | PPC conducts pediatric studies per FDA requirements | 22 | 9.8 | PBI coordinates pediatric indication applications with EMA and national agencies | 4 | 1.5 | PPC (clinical); PBI (non-Americas regulatory) | Shared per CSA |
| Cerulon | 2018 | Enhancement | New Formulation Development | PPC continues alternative formulation development | 14 | 6.0 | PBI provides non-Americas market input | 2 | 0.7 | PPC | Shared per CSA |
| Cerulon | 2018 | Enhancement | Post-Approval Commitments | PPC manages FDA post-approval commitments | 12 | 4.8 | PBI manages EMA orphan drug post-approval commitments across EMEA | 3 | 1.0 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Cerulon | 2019 | Enhancement | Label Extension — Pediatric Indication | PPC completes pediatric studies; files pediatric sNDA with FDA | 24 | 11.0 | PBI files pediatric indication submissions with EMA and national agencies | 5 | 1.8 | PPC (clinical); PBI (non-Americas regulatory) | Shared per CSA |
| Cerulon | 2019 | Enhancement | New Formulation Development | PPC advances oral formulation for rare disease | 15 | 6.8 | PBI provides non-Americas regulatory pathway assessment | 3 | 0.9 | PPC | Shared per CSA |
| Cerulon | 2019 | Enhancement | Post-Approval Commitments | PPC manages FDA post-approval commitments | 13 | 5.2 | PBI manages EMA post-approval commitments | 3 | 1.1 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Cerulon | 2020 | Enhancement | Label Extension — Pediatric Indication | PPC manages ongoing pediatric post-marketing studies | 26 | 12.5 | PBI manages pediatric indication across non-Americas markets; coordinates with national agencies | 6 | 2.2 | PPC (clinical); PBI (non-Americas regulatory) | Shared per CSA |
| Cerulon | 2020 | Enhancement | New Formulation Development | PPC continues oral formulation development for rare disease | 16 | 7.5 | PBI provides non-Americas regulatory and market assessment | 3 | 1.0 | PPC | Shared per CSA |
| Cerulon | 2020 | Enhancement | Post-Approval Commitments | PPC manages FDA post-approval commitments | 14 | 5.8 | PBI manages EMA orphan drug post-approval commitments across 68 markets | 3 | 1.2 | PPC (U.S.); PBI (non-Americas) | Shared per CSA |
| Product Line | Tax Year | DEMPE Function | Sub-Function / Activity | PPC (U.S.) — Description of Activities | PPC Headcount Allocated | PPC Expenditure ($M) | PBI (Ireland) — Description of Activities | PBI Headcount Allocated | PBI Expenditure (€M) | PMI (Ireland) — Description of Activities | PMI Headcount Allocated | PMI Expenditure (€M) | Primary Decision-Maker | Risk Bearer | Notes / Supporting Evidence |
| Veritaxol | 2017 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains global safety database; U.S. medical affairs team manages FDA adverse event reporting | 52 | 22.0 | PBI operates non-Americas pharmacovigilance function; medical affairs staff in Dublin monitor adverse events across EMEA/APAC | 8 | 2.8 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) | PBI medical affairs headcount grew from 8 (2012) to 22 (2020) |
| Veritaxol | 2017 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards and SOPs | 12 | 3.2 | PBI oversees contract manufacturing quality for non-Americas supply chain | 6 | 1.5 | PMI manufactures biologics for non-Americas markets under cost-plus arrangement (cost + 8%); maintains GMP compliance | 150 | 32.0 | PBI (non-Americas supply chain); PPC (global QA standards) | PBI (non-Americas); PPC (Americas) | PMI operates under cost + 8% markup with PBI |
| Veritaxol | 2017 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain and inventory management | 25 | 10.5 | PBI manages non-Americas supply chain, distributor relationships and inventory across 62 countries | 8 | 2.2 | PMI ensures manufacturing continuity for non-Americas supply | 80 | 18.5 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Veritaxol | 2017 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA annual reports, periodic safety updates | 18 | 5.8 | PBI manages non-Americas regulatory maintenance including annual renewals and periodic safety update reports across 62 markets | 6 | 1.8 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Veritaxol | 2018 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains global safety database; U.S. medical affairs manages FDA adverse event reporting | 55 | 23.5 | PBI non-Americas pharmacovigilance function expanding; monitors adverse events across EMEA/APAC | 12 | 3.5 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Veritaxol | 2018 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards and SOPs | 13 | 3.5 | PBI oversees contract manufacturing quality for non-Americas | 7 | 1.8 | PMI manufactures under cost + 8%; maintains GMP compliance | 155 | 34.5 | PBI (non-Americas supply chain); PPC (global QA standards) | PBI (non-Americas); PPC (Americas) |
| Veritaxol | 2018 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain | 26 | 11.0 | PBI manages non-Americas supply chain across 64 countries | 9 | 2.5 | PMI ensures manufacturing continuity | 85 | 20.0 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Veritaxol | 2018 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA annual reports and periodic safety updates | 19 | 6.2 | PBI manages non-Americas regulatory maintenance across 64 markets | 7 | 2.0 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Veritaxol | 2019 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains global safety database; U.S. medical affairs manages FDA adverse event reporting | 58 | 25.0 | PBI operates independent non-Americas pharmacovigilance function; expanded medical affairs staff | 16 | 4.5 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Veritaxol | 2019 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards and SOPs | 14 | 3.8 | PBI oversees contract manufacturing quality for non-Americas | 8 | 2.2 | PMI manufactures under cost + 8%; maintains GMP compliance | 165 | 38.0 | PBI (non-Americas supply chain); PPC (global QA standards) | PBI (non-Americas); PPC (Americas) |
| Veritaxol | 2019 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain | 28 | 11.5 | PBI manages non-Americas supply chain across 66 countries | 10 | 2.8 | PMI ensures manufacturing continuity | 90 | 21.5 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Veritaxol | 2019 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA annual reports and periodic safety updates | 20 | 6.5 | PBI manages non-Americas regulatory maintenance across 66 markets | 8 | 2.2 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Veritaxol | 2020 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains global safety database; U.S. medical affairs team manages FDA adverse event reporting | 65 | 28.4 | PBI operates independent non-Americas pharmacovigilance function; medical affairs staff in Dublin monitor adverse events across EMEA/APAC and file reports with EMA and national authorities | 22 | 5.9 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) | PBI's medical affairs headcount grew from 8 (2012) to 22 (2020) |
| Veritaxol | 2020 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards and SOPs | 15 | 4.2 | PBI oversees contract manufacturing quality; supply chain management for non-Americas | 10 | 2.8 | PMI manufactures biologics for non-Americas markets under cost-plus arrangement (cost + 8%); maintains GMP compliance | 180 | 42.0 | PBI (non-Americas supply chain); PPC (global QA standards) | PBI (non-Americas); PPC (Americas) | PMI operates under cost + 8% markup with PBI; 620 total PMI employees |
| Veritaxol | 2020 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain and inventory | 30 | 12.5 | PBI manages non-Americas supply chain, distributor relationships and inventory across 68 countries | 12 | 3.2 | PMI ensures manufacturing continuity for non-Americas supply | 95 | 23.0 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Veritaxol | 2020 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA annual reports and periodic safety updates | 22 | 7.0 | PBI manages non-Americas regulatory maintenance including annual renewals across 68 markets | 9 | 2.5 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Imvara | 2017 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains global safety database; U.S. medical affairs manages Imvara safety reporting | 35 | 14.5 | PBI operates non-Americas pharmacovigilance for Imvara | 5 | 1.6 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2017 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards and SOPs for Imvara | 10 | 2.8 | PBI oversees contract manufacturing quality for Imvara non-Americas supply | 5 | 1.2 | PMI manufactures Imvara for non-Americas under cost + 8% | 100 | 22.0 | PBI (non-Americas); PPC (global QA) | PBI (non-Americas); PPC (Americas) |
| Imvara | 2017 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain for Imvara | 22 | 9.0 | PBI manages non-Americas supply chain for Imvara across 62 countries | 8 | 2.0 | PMI ensures manufacturing continuity | 70 | 15.0 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2017 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA regulatory maintenance for Imvara | 14 | 4.5 | PBI manages non-Americas regulatory maintenance for Imvara | 4 | 1.2 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Imvara | 2018 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains safety database and FDA adverse event reporting for Imvara | 38 | 15.8 | PBI non-Americas pharmacovigilance for Imvara expanding | 7 | 2.0 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2018 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards for Imvara | 11 | 3.0 | PBI oversees contract manufacturing quality for Imvara non-Americas | 6 | 1.5 | PMI manufactures Imvara under cost + 8% | 105 | 24.0 | PBI (non-Americas); PPC (global QA) | PBI (non-Americas); PPC (Americas) |
| Imvara | 2018 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain for Imvara | 24 | 9.8 | PBI manages non-Americas supply chain for Imvara across 64 countries | 9 | 2.3 | PMI ensures continuity | 75 | 16.5 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2018 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA regulatory maintenance for Imvara | 15 | 4.8 | PBI manages non-Americas regulatory maintenance for Imvara across 64 markets | 5 | 1.4 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Imvara | 2019 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains safety database and FDA adverse event reporting for Imvara | 42 | 17.5 | PBI non-Americas pharmacovigilance for Imvara; expanded staff | 10 | 2.8 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2019 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards for Imvara | 12 | 3.2 | PBI oversees contract manufacturing quality for Imvara non-Americas | 7 | 1.8 | PMI manufactures Imvara under cost + 8% | 110 | 26.5 | PBI (non-Americas); PPC (global QA) | PBI (non-Americas); PPC (Americas) |
| Imvara | 2019 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain for Imvara | 30 | 12.6 | PBI manages non-Americas supply chain, including distributor relationships and inventory management across 68 countries | 14 | 3.5 | PMI manufactures product under PBI direction | 120 | 28.0 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2019 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA regulatory maintenance for Imvara | 16 | 5.2 | PBI manages non-Americas regulatory maintenance across 66 markets | 6 | 1.6 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Imvara | 2020 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains safety database and FDA adverse event reporting for Imvara | 45 | 19.2 | PBI non-Americas pharmacovigilance for Imvara; full independence | 12 | 3.4 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2020 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards for Imvara | 12 | 3.5 | PBI oversees contract manufacturing quality for Imvara non-Americas | 8 | 2.0 | PMI manufactures Imvara under cost + 8% | 115 | 28.0 | PBI (non-Americas); PPC (global QA) | PBI (non-Americas); PPC (Americas) |
| Imvara | 2020 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain for Imvara | 32 | 13.5 | PBI manages non-Americas supply chain across 68 countries | 15 | 3.8 | PMI ensures manufacturing continuity | 125 | 30.0 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2020 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA regulatory maintenance for Imvara | 18 | 5.8 | PBI manages non-Americas regulatory maintenance across 68 markets | 7 | 1.8 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Cerulon | 2017 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains safety database for Cerulon rare disease adverse events | 15 | 5.8 | PBI monitors non-Americas adverse events for Cerulon | 3 | 0.8 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2017 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards for Cerulon | 5 | 1.5 | PBI oversees Cerulon manufacturing quality for non-Americas | 3 | 0.6 | PMI manufactures Cerulon under cost + 8% | 40 | 8.5 | PBI (non-Americas); PPC (global QA) | PBI (non-Americas); PPC (Americas) |
| Cerulon | 2017 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain for Cerulon | 10 | 4.0 | PBI manages non-Americas supply chain for Cerulon across specialist distribution networks | 4 | 1.0 | PMI ensures manufacturing continuity for Cerulon | 30 | 6.5 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2017 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA orphan drug regulatory maintenance for Cerulon | 8 | 2.5 | PBI manages EMA orphan drug regulatory maintenance across non-Americas markets | 3 | 0.8 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Cerulon | 2018 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains safety database for Cerulon | 16 | 6.2 | PBI monitors non-Americas adverse events for Cerulon | 4 | 1.0 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2018 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards for Cerulon | 6 | 1.6 | PBI oversees Cerulon manufacturing quality for non-Americas | 3 | 0.7 | PMI manufactures Cerulon under cost + 8% | 42 | 9.2 | PBI (non-Americas); PPC (global QA) | PBI (non-Americas); PPC (Americas) |
| Cerulon | 2018 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain for Cerulon | 11 | 4.2 | PBI manages non-Americas supply chain for Cerulon | 4 | 1.1 | PMI ensures continuity | 32 | 7.0 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2018 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA orphan drug regulatory maintenance | 9 | 2.8 | PBI manages EMA orphan drug regulatory maintenance | 3 | 0.9 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Cerulon | 2019 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains safety database for Cerulon | 18 | 6.8 | PBI monitors non-Americas adverse events for Cerulon; expanded monitoring | 5 | 1.2 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2019 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards for Cerulon | 6 | 1.8 | PBI oversees Cerulon manufacturing quality for non-Americas | 4 | 0.8 | PMI manufactures Cerulon under cost + 8% | 45 | 10.0 | PBI (non-Americas); PPC (global QA) | PBI (non-Americas); PPC (Americas) |
| Cerulon | 2019 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain for Cerulon | 12 | 4.5 | PBI manages non-Americas supply chain for Cerulon across specialist networks | 5 | 1.2 | PMI ensures continuity | 35 | 7.5 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2019 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA orphan drug regulatory maintenance | 10 | 3.0 | PBI manages EMA orphan drug regulatory maintenance across 66 markets | 4 | 1.0 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Cerulon | 2020 | Maintenance | Pharmacovigilance / Post-Marketing Surveillance | PPC maintains safety database for Cerulon rare disease adverse events | 20 | 7.5 | PBI monitors non-Americas adverse events for Cerulon; independent pharmacovigilance | 6 | 1.5 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2020 | Maintenance | Manufacturing Quality Assurance (Non-Americas) | PPC provides quality standards for Cerulon | 7 | 2.0 | PBI oversees Cerulon manufacturing quality for non-Americas | 4 | 0.9 | PMI manufactures Cerulon under cost + 8% | 48 | 10.8 | PBI (non-Americas); PPC (global QA) | PBI (non-Americas); PPC (Americas) |
| Cerulon | 2020 | Maintenance | Product Supply Continuity | PPC manages Americas supply chain for Cerulon | 13 | 4.8 | PBI manages non-Americas supply chain for Cerulon across specialist rare-disease distribution networks | 5 | 1.3 | PMI ensures continuity | 38 | 8.2 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2020 | Maintenance | Ongoing Regulatory Maintenance | PPC manages FDA orphan drug regulatory maintenance for Cerulon | 11 | 3.2 | PBI manages EMA orphan drug regulatory maintenance across 68 markets | 5 | 1.2 | N/A | 0 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Product Line | Tax Year | DEMPE Function | Sub-Function / Activity | PPC (U.S.) — Description of Activities | PPC Headcount Allocated | PPC Expenditure ($M) | PBI (Ireland) — Description of Activities | PBI Headcount Allocated | PBI Expenditure (€M) | Primary Decision-Maker | Risk Bearer | Notes / Supporting Evidence |
| Veritaxol | 2017 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC legal team manages global patent strategy; coordinates with outside patent counsel | 14 | 10.5 | PBI manages non-Americas patent prosecution and enforcement through local counsel in key markets | 4 | 3.0 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) | PBI board meetings documented patent strategy decisions |
| Veritaxol | 2017 | Protection | Trademark Management (Non-Americas) | PPC maintains global trademark registrations | 4 | 1.5 | PBI manages trademark registrations and enforcement in 62 non-Americas markets | 2 | 0.8 | PBI (non-Americas) | PBI (non-Americas) |
| Veritaxol | 2017 | Protection | Trade Secret / Data Protection | PPC maintains U.S. trade secret protections, data security protocols | 10 | 4.2 | PBI implements data protection safeguards in compliance with local requirements across EMEA/APAC | 3 | 1.0 | PPC (U.S.); PBI (non-Americas) | Shared |
| Veritaxol | 2018 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC legal team manages global patent strategy; coordinates with outside counsel | 15 | 11.2 | PBI manages non-Americas patent prosecution and enforcement through local counsel | 4 | 3.5 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) |
| Veritaxol | 2018 | Protection | Trademark Management (Non-Americas) | PPC maintains global trademark registrations | 4 | 1.6 | PBI manages trademark registrations and enforcement in 64 non-Americas markets | 2 | 0.9 | PBI (non-Americas) | PBI (non-Americas) |
| Veritaxol | 2018 | Protection | Trade Secret / Data Protection | PPC maintains U.S. trade secret protections | 10 | 4.5 | PBI implements data protection safeguards; GDPR compliance preparation | 3 | 1.2 | PPC (U.S.); PBI (non-Americas) | Shared | GDPR effective May 2018 |
| Veritaxol | 2019 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC legal team manages global patent strategy | 16 | 12.8 | PBI manages non-Americas patent prosecution and enforcement; PBI board approves litigation strategy | 5 | 4.2 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) |
| Veritaxol | 2019 | Protection | Trademark Management (Non-Americas) | PPC maintains global trademark registrations | 5 | 1.8 | PBI manages trademark registrations and enforcement in 66 non-Americas markets | 3 | 1.0 | PBI (non-Americas) | PBI (non-Americas) |
| Veritaxol | 2019 | Protection | Trade Secret / Data Protection | PPC maintains U.S. trade secret protections, data security protocols | 11 | 5.0 | PBI implements GDPR-compliant data protection and trade secret safeguards across EMEA/APAC | 4 | 1.4 | PPC (U.S.); PBI (non-Americas) | Shared |
| Veritaxol | 2020 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC legal team manages global patent strategy; coordinates with outside patent counsel | 18 | 14.2 | PBI manages non-Americas patent prosecution and enforcement through local counsel in key markets; PBI board approves patent litigation strategy for non-Americas territories | 6 | 4.8 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) | PBI board meetings documented patent strategy decisions; 42 board meetings total 2017–2020 |
| Veritaxol | 2020 | Protection | Trademark Management (Non-Americas) | PPC maintains global trademark registrations | 5 | 2.1 | PBI manages trademark registrations and enforcement in 68 non-Americas markets | 3 | 1.2 | PBI (non-Americas) | PBI (non-Americas) |
| Veritaxol | 2020 | Protection | Trade Secret / Data Protection | PPC maintains U.S. trade secret protections, data security protocols | 12 | 5.5 | PBI implements data protection and trade secret safeguards in compliance with GDPR and local requirements across EMEA/APAC | 4 | 1.6 | PPC (U.S.); PBI (non-Americas) | Shared |
| Imvara | 2017 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC legal team manages global patent strategy for Imvara | 10 | 7.0 | PBI manages non-Americas patent prosecution for Imvara through local counsel | 3 | 2.0 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2017 | Protection | Trademark Management (Non-Americas) | PPC maintains global Imvara trademark registrations | 3 | 1.2 | PBI manages Imvara trademark registrations in 62 non-Americas markets | 1 | 0.5 | PBI (non-Americas) | PBI (non-Americas) |
| Imvara | 2017 | Protection | Trade Secret / Data Protection | PPC maintains Imvara trade secret protections | 5 | 2.0 | PBI implements data protection for Imvara IP in non-Americas | 2 | 0.6 | PPC (U.S.); PBI (non-Americas) | Shared |
| Imvara | 2018 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC manages global patent strategy for Imvara | 11 | 7.5 | PBI manages non-Americas patent prosecution for Imvara | 3 | 2.2 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2018 | Protection | Trademark Management (Non-Americas) | PPC maintains global Imvara trademark registrations | 3 | 1.3 | PBI manages Imvara trademark registrations in 64 non-Americas markets | 2 | 0.6 | PBI (non-Americas) | PBI (non-Americas) |
| Imvara | 2018 | Protection | Trade Secret / Data Protection | PPC maintains Imvara trade secret protections | 5 | 2.2 | PBI implements GDPR-compliant data protection for Imvara IP | 2 | 0.7 | PPC (U.S.); PBI (non-Americas) | Shared |
| Imvara | 2019 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC manages global patent strategy for Imvara | 12 | 8.5 | PBI manages non-Americas patent prosecution and enforcement for Imvara | 4 | 2.5 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2019 | Protection | Trademark Management (Non-Americas) | PPC maintains global Imvara trademark registrations | 4 | 1.5 | PBI manages Imvara trademark registrations in 66 non-Americas markets | 2 | 0.7 | PBI (non-Americas) | PBI (non-Americas) |
| Imvara | 2019 | Protection | Trade Secret / Data Protection | PPC maintains Imvara trade secret protections and data security | 6 | 2.5 | PBI implements GDPR-compliant data protection for Imvara IP across EMEA/APAC | 2 | 0.8 | PPC (U.S.); PBI (non-Americas) | Shared |
| Imvara | 2020 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC manages global patent strategy for Imvara | 13 | 9.5 | PBI manages non-Americas patent prosecution and enforcement for Imvara; board-approved strategy | 5 | 3.0 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) |
| Imvara | 2020 | Protection | Trademark Management (Non-Americas) | PPC maintains global Imvara trademark registrations | 4 | 1.6 | PBI manages Imvara trademark registrations in 68 non-Americas markets | 2 | 0.8 | PBI (non-Americas) | PBI (non-Americas) |
| Imvara | 2020 | Protection | Trade Secret / Data Protection | PPC maintains Imvara trade secret protections | 6 | 2.8 | PBI implements GDPR-compliant data protection for Imvara IP | 3 | 0.9 | PPC (U.S.); PBI (non-Americas) | Shared |
| Cerulon | 2017 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC manages global patent strategy for Cerulon rare disease compounds | 5 | 2.8 | PBI manages non-Americas patent prosecution for Cerulon | 2 | 0.8 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2017 | Protection | Regulatory Exclusivity (Orphan Drug Status) | PPC maintains FDA orphan drug designation for Cerulon | 3 | 1.2 | PBI maintains EMA orphan drug designation and manages orphan exclusivity in non-Americas markets | 1 | 0.5 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Cerulon | 2017 | Protection | Trade Secret / Data Protection | PPC maintains Cerulon trade secret protections | 3 | 1.0 | PBI implements data protection for Cerulon IP in non-Americas | 1 | 0.3 | PPC (U.S.); PBI (non-Americas) | Shared |
| Cerulon | 2018 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC manages global patent strategy for Cerulon | 6 | 3.2 | PBI manages non-Americas patent prosecution for Cerulon | 2 | 1.0 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2018 | Protection | Regulatory Exclusivity (Orphan Drug Status) | PPC obtained FDA orphan drug designation | 4 | 1.8 | PBI obtained EMA orphan drug designation and manages orphan exclusivity in non-Americas markets | 2 | 0.9 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) | Part of PBI's cumulative €47.2M regulatory spend |
| Cerulon | 2018 | Protection | Trade Secret / Data Protection | PPC maintains Cerulon trade secret protections | 3 | 1.1 | PBI implements data protection for Cerulon IP | 1 | 0.4 | PPC (U.S.); PBI (non-Americas) | Shared |
| Cerulon | 2019 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC manages global patent strategy for Cerulon | 6 | 3.5 | PBI manages non-Americas patent prosecution for Cerulon; board-approved litigation strategy | 3 | 1.2 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2019 | Protection | Regulatory Exclusivity (Orphan Drug Status) | PPC maintains FDA orphan drug designation | 4 | 1.9 | PBI maintains EMA orphan drug designation and manages orphan exclusivity | 2 | 0.8 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Cerulon | 2019 | Protection | Trade Secret / Data Protection | PPC maintains Cerulon trade secret protections | 4 | 1.2 | PBI implements GDPR-compliant data protection for Cerulon IP across EMEA/APAC | 2 | 0.5 | PPC (U.S.); PBI (non-Americas) | Shared |
| Cerulon | 2020 | Protection | Patent Prosecution & Defense (Non-Americas) | PPC manages global patent strategy for Cerulon | 7 | 4.0 | PBI manages non-Americas patent prosecution and enforcement for Cerulon; board-approved strategy | 3 | 1.4 | PPC (global strategy); PBI (non-Americas execution) | PPC (Americas); PBI (non-Americas) |
| Cerulon | 2020 | Protection | Regulatory Exclusivity (Orphan Drug Status) | PPC maintains FDA orphan drug designation for Cerulon | 4 | 2.0 | PBI maintains EMA orphan drug designation and manages orphan exclusivity in non-Americas | 2 | 0.9 | PPC (U.S.); PBI (non-Americas) | PPC (U.S.); PBI (non-Americas) |
| Cerulon | 2020 | Protection | Trade Secret / Data Protection | PPC maintains Cerulon trade secret protections and data security | 4 | 1.3 | PBI implements GDPR-compliant data protection for Cerulon IP | 2 | 0.6 | PPC (U.S.); PBI (non-Americas) | Shared |
| All Products | 2019 | Protection | Trade Secret / Data Protection (All Products) | PPC maintains U.S. trade secret protections, data security protocols | 12 | 5.5 | PBI implements data protection and trade secret safeguards in compliance with GDPR and local requirements across EMEA/APAC | 4 | 1.6 | PPC (U.S.); PBI (non-Americas) | Shared | Aggregate Protection expenditure across all products |
| Product Line | Tax Year | DEMPE Function | Sub-Function / Activity | PPC (U.S.) — Description of Activities | PPC Headcount Allocated | PPC Revenue — Americas ($M) | PBI (Ireland) — Description of Activities | PBI Headcount Allocated | PBI Revenue — Non-Americas ($M) | Primary Decision-Maker | Risk Bearer | Notes / Supporting Evidence |
| Veritaxol | 2017 | Exploitation | Commercial Strategy & Pricing | PPC sets Americas pricing strategy and market access programs | 100 | PBI independently sets pricing across 62 non-Americas country markets; PBI commercial-strategy team analyzes local market dynamics | 22 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) | PBI pricing decisions documented in board minutes |
| Veritaxol | 2017 | Exploitation | Sales & Marketing | PPC manages Americas sales force and marketing campaigns | 290 | 1280.0 | PBI manages non-Americas commercialization through distribution partner agreements | 18 | 880.0 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) | Veritaxol global net sales $2,160M (2017); non-Americas $880M (~40.7% of global) |
| Veritaxol | 2017 | Exploitation | Distribution & Supply Chain | PPC manages Americas distribution | 32 | PBI selects distribution partners, negotiates terms for non-Americas territories | 8 | PBI (non-Americas) | PBI (non-Americas) |
| Veritaxol | 2017 | Exploitation | Market Access & Reimbursement | PPC negotiates with U.S. payers and manages patient access programs | 42 | PBI negotiates reimbursement and market access in non-Americas markets; manages HTA submissions | 6 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) | PBI bears non-Americas market risk |
| Veritaxol | 2018 | Exploitation | Commercial Strategy & Pricing | PPC sets Americas pricing strategy | 105 | PBI independently sets pricing across 64 non-Americas country markets | 25 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Veritaxol | 2018 | Exploitation | Sales & Marketing | PPC manages Americas sales force and marketing campaigns | 310 | 1420.0 | PBI manages non-Americas commercialization through distribution partner agreements | 22 | 1020.0 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) | Veritaxol global net sales $2,440M (2018); non-Americas $1,020M (~41.8% of global) |
| Veritaxol | 2018 | Exploitation | Distribution & Supply Chain | PPC manages Americas distribution | 35 | PBI selects distribution partners and manages logistics for non-Americas | 9 | PBI (non-Americas) | PBI (non-Americas) |
| Veritaxol | 2018 | Exploitation | Market Access & Reimbursement | PPC negotiates with U.S. payers | 45 | PBI negotiates reimbursement in non-Americas markets; HTA submissions in key markets | 8 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Veritaxol | 2019 | Exploitation | Commercial Strategy & Pricing | PPC sets Americas pricing strategy | 112 | PBI independently sets pricing across 66 non-Americas country markets | 30 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) |
| Veritaxol | 2019 | Exploitation | Sales & Marketing | PPC manages Americas sales force and marketing campaigns | 330 | 1600.0 | PBI manages non-Americas commercialization through distribution partner agreements | 25 | 1180.0 | PPC (Americas); PBI (non-Americas) | PPC (Americas); PBI (non-Americas) | Veritaxol global net sales $2,780M (2019); non-Americas $1,180M (~42.4% of global) |
| Veritaxol | 2019 | Exploitation | Distribution & Supply Chain | PPC manages Americas distribution | 38 | PBI selects distribution partners and manages supply chain logistics |