Commission européenne, DG COMP MERGER REGISTRY, 1049 Bruxelles, BELGIQUE  
Europese Commissie, DG COMP MERGER REGISTRY, 1049 Brussel,  BELGIË 
 
Tel: +32 229- 91111. Fax: +32 229 -64301. E -mail: COMP -MERGER -REGISTRY@ec.europa.eu.   EUROPEAN COMMISSION  
Brussels, 10.1.2020  
C(2020)  139 final  
PUBLIC VERSION 
 
To the notifying p arty 
Subject : Case M.9461 – ABBVIE / ALLERGAN  
Commission decision pursuant to Article 6(1)(b) in conjunction with 
Article 6(2) of Council Regulation No 139/20041 and Article 57 of the 
Agreement on the European Economic Area2 
Dear Sir or Madam,  
(1) On 12 November 2019, the European Commission received notification of a 
proposed concentration pursuant to Article 4 of the Merger Regulation 
(the “Transaction”) by which AbbVie Inc.  (“AbbVie”, United States), acquires 
within the meaning of Article 3(1)(b) of the Merger Regulation control of the whole 
of Allergan plc (“Allergan”, Ireland, and together with AbbVie the “Parties”).   
1. THE PARTIES  AND THE OPERATION  
(2) AbbVie  is a global pharmaceutical company listed on the New York Stock 
Exchange and headquartered in the United States. AbbVie is engaged in the 
development and commercialisation of innovative medicines in six main therapeutic 
areas: immunology (including autoimmune diseases), oncology, virology, 
                                                 
1  OJ L 24, 29.1.2004, p. 1 (the “ Merger Regulation”). With effect from 1 December 2009,  the Treaty  on 
the Functioning of the European Union (“ TFEU”) has introduced certain changes, such as the 
replacement of “Community” by “Union” and “common market” by “internal market”. The terminology 
of the TFEU will be used throughout this decision.  
2  OJ L 1, 3.1.1994, p. 3 (the “EEA Agreement ”). 
In the published version of this decision, 
some information has been omitted 
pursuant to Article 17(2) of Council 
Regulation (EC) No 139/2004 concerning 
non-disclosure of business secrets and other  
confidential information. The omissions are 
shown thus […] . Where possible the 
information omitted has been replaced by 
ranges of figures or a general description.  
 
 
2 neuroscience/central nervous system disorders, metabolic diseases and pain 
associated with endometriosis.  
(3) Allergan  is a global pharmaceutical company listed on the New York Stock 
Exchange and headqua rtered in Ireland. Allergan is engaged in the development and 
commercialisation of medicines in four main therapeutic areas: medical aesthetics, 
eye care, neuroscience/central nervous system disorders and gastroenterology.  
(4) On 25 June 2019, AbbVie and Aller gan signed an agreement (the “Transaction 
Agreement”). Under the terms of the Transaction Agreement, upon closing of the 
proposed Transaction, AbbVie will acquire 100% of the shares and therefore sole 
control of Allergan, in a cash and stock transaction. T he Transaction would therefore 
give rise to a concentration within the meaning of Article 3(1)(b) of the Merger 
Regulation.  
2. EU DIMENSION  
(5) The undertakings concerned have a combined aggregate world- wide turnover of 
more than EUR 5 000 million3. Each of them has an EU -wide turnov er in excess of 
EUR 250 million, but each of them does not achieve more than two- thirds of its 
aggregate EU-wide turnover within one and the same Member State. The notified 
operation therefore has an EU dimension. 
3. FRAMEWORK FOR THE COMMISSION ’S COMPETITIVE ASSESS MENT  
3.1. General considerations on market definition in the pharmaceutical sector  
3.1.1. Relevant product market  
(6) When defining relevant markets in past decisions dealing with finished dose 
pharmaceutical products  (“FDPs”),4 the Commission based its assessment on the 
following general approach.5  
(7) The ATC system is a hierarchical and coded four -level system, which classifies 
medicinal products  by class according to their indication, therapeutic use, 
composition, and mode of ac tion (“MoA”). In the first and broadest level (ATC 1), 
medicinal products are divided into the 16 anatomical main groups. The second level 
(ATC 2) is either a pharmacological or therapeutic group. The third level (ATC 3) 
further groups medicinal products b y their specific therapeutic indications. Finally, 
                                                 
3  Turnover calculated in accordance wi th Article 5(1) of the Merger Regulation and the Commission 
Consolidated Jurisdictional Notice (OJ C95, 16.4.2008, p. 1).  
4  FDPs refer to the fi nished dosage form of pharmaceutical products, which, in other words, are ready to be 
used by customers. FDPs c ontain (i) an active pharmaceutical ingredient (or “API”, which correspond to 
the component present within the product that provides the pharmacological action in the body, 
e.g. acetyl salicylic  acid in an aspirin tablet), or a combination of APIs and (ii)  other excipients.  
5  See, for example, cases M.8974 – Procter & Gamble / Merck Consumer Health Business, decision of 
27.8.2018; M.7919 –  Sanofi/Boehringer Ingelheim Consumer healthcare Business, decision of 4.8.2016; 
M.6969 – Valeant Pharmaceuticals Inter national/Bausch & Lomb Holdings, decision of 5.8.2013; 
M.5778 – Novartis/Alcon, decision of 9.8.2010; M.7276 – GlaxoSmithKline/ Novartis Vaccines Business 
(Excl. Influenza) / Novartis Consumer Health Business, decision of 28.1.2015;  M.5865 – Teva / 
Ratiopharm, decision of 3.8.2010; and M.8889 – Teva / PGT OTC , decision of 29.1.2010.  
 
 
3 the ATC 4 level is generally the most detailed one (not available for all ATC 3) and 
refers for instance to the MoA or any other subdivision of the relevant products.  
(8) The Commission has referred to the third level (ATC 3) as the starting point for 
defining the relevant product market. However, in several  cases, the Commission  
found that the ATC 3 level classification did not yield the appropriate market 
definition within the meaning of the Commission Notic e on the Definition of the 
Relevant Market.6 In particular, the Commission has considered in previous 
decisions plausible product markets  at the ATC 4 level, at a level of a molecule or a 
group of molecules considered interchangeable and exercising competi tive pressure 
on one another.7 
(9) The Commission has also envisaged the possibility of defining the market by 
reference to the disease treated (and its degree of severity). For instance, in 
oncology, the Commission took into  consideration the type of cancer, its location 
and whether the cancer is in an initial or an advanced stage.8 Similarly, in 
autoimmune diseases, the Commission has typically identified relevant product 
markets by reference to indications.9  
(10) In its past decisional practice, the Commissio n has also considered relevant market 
segmentations  based on (i) the types of treatment ( e.g. chemotherapy, targeted 
therapies and immunotherapies in oncology;10 conventional and biologic treatments 
in autoimmune diseases),11 (ii) the line of treatment,12 (iii) the MoA,13 and (iv) the 
mode of delivery (“MoD”, e.g. oral, intravenous, intramuscular, and subcutaneous 
injections).14  
(11) As regards pharmaceutical products in development (also called pipeline products ), 
the Commission has in previous decisions considered market definitions based on 
the indication, the MoA , and, where relevant, the line of treatment, but ultimately 
left open the exact delineation of the market.15 The Commission added that when 
                                                 
6  OJ C 372, 9.12.1997, p. 5.  
7  See case M.9274 –  GSK/Pfizer Consumer Healthcare Business, decision of 10. 7.2019, recital 15 and case 
M.7275 - Novartis/GSK Oncology , decision of 28.1.2015, recitals 207 and 216.  
8  See case M.5476 -  Pfizer/Wyeth , decision of 17.7. 2009, recitals 21- 26 (renal cell carcinoma).  
9  See case M.8955 -  Takeda/Shire , decision of 20.11.2018, recital s 9-49 (inflammatory bowel diseases).  
10  See case M.7275 -  Novartis/GSK Oncology , decision of 28.11.2015, recital 31. The Commission found 
that, given the different ways in which they treat cancer, chemotherapies, targeted therapies, and 
immunotherapies may not be substitutable and they are most often used as complementary treatments. 
For instance, chemotherapies and targeted therapies attack cancerous cells directly, whereas 
immunotherapies work to enable the patient’s own immune system to attack the cancer. Targeted 
therapies are designed to int eract with a specific target associated with cancer, whereas chemotherapies 
are typically identified because they kill rapidly dividing cells. Targeted therapies and immunotherapies 
are also typically more expensive than chemotherapies. Given their novelty, targeted therapies and 
immunotherapies are generally still under patent, while many chemotherapy drugs are off patent.  
11  See case M.8955 -  Takeda/Shire , decision of 20.11.2018, recitals 17- 25. 
12  See case M.7275 -  Novartis/GSK Oncology , decision of 28. 1.2015, recitals 33 and 143. Line of treatment 
refers to the setting for which a specific drug is indicated.  For example, a drug indicated for second -line of 
treatment should be used only after another therapy (the first -line of treatment) has proven  ineffective or if 
this other therapy cannot be prescribed altogether to a specific patient.  
13  See case M.8955 -  Takeda/Shire , decision of 20.11.2018, recitals 31- 49. 
14  See case M.8401 -  J&J/Actelion , decision of 9.06.2017, recital 60.  
15  See cases M.335 4 - Sanofi -Synthelabo/Aventis , decision of 26.4.2004, recital 57;  and M.7275 - 
Novartis/GSK Oncology , decision of 28.1.2015, recitals 85- 94. 
 
 
4 research and development (“R&D”) activities are assessed in terms of importance for 
future markets, the product market definition can be less clearly defined than for 
marketed products , reflecting the intrinsic uncertainty in  analysing products that do 
not exist yet.16  
(12) The Commission will analyse in Section 4 below the relevance of these distinctions 
for the relevant product market definition in the present case.  
3.1.2. Relevant geographic market  
(13) The Commission has consistently considered that the markets for FDP s are national 
in scope, in particular in view of the  national regulatory and reimbursement schemes 
and the fact that competition between pharmaceutical firms still predominantly takes 
place at a national level.17 For pipeline products, the Commission has considered the 
geographic scope of the market to be at  least EEA -wide.18  
(14) The Commission will analyse in Section 4 below the relevance of these precedents 
for the relevant geographic market definition in the present case.  
3.2. General approach to competitive assessment of horizontal effects of the 
Transaction  
(15) Article 2 of the Merger Regulation requires the Commission to examine whether 
notified concentrations are compatible with the internal market, by assessing whether 
they would significantly impede effective competition in the internal market or in a 
substantial part of it, in particular, as a result of the creation or strengthening of a 
dominant position or the removal of a significant competitive constraint.  
(16) In addition, Article 57(1) of the EEA Agreement requires the Commission to 
examine whether notified  concentrations are compatible with the functioning of the 
EEA Agreement, by assessing whether they would create or strengthen a dominant 
position as a result of which effective competition would be significantly impeded 
within the EEA territory or a subst antial part of it.  
(17) In this framework, “competition” is understood to mean product and price 
competition (actual or potential), as well as innovation competition, where the 
Commission assesses in particular potential horizontal non- coordinated effects.19 The 
Commission considers that a concentration may not only affect competition in 
existing markets, but also competition in innovation and new product markets.20 This 
may be the case when a concentration concerns entities currently developing new 
products or te chnologies which may  one day replace existing ones or which are 
                                                 
16  Case M.7275 -  Novartis/GSK Oncology , decision of 28.1.2015, recital 26.  
17  See cases M.8955 -  Takeda/Shire , decision of 20.11.2018, recital 56 and M.8401 -  J&J/Actelion , decision 
of 9.06.2017, recital 66.  
18  See most recently, case M.8955 -  Takeda/Shire , decision of 20.11.2018, recital 56.  
19  See case M.8084 -  Bayer/Monsanto,  decision of 21.3. 2018, recital 48. The remainder of this decision 
focuses on horizontal, non- coordinated effects, as the Transaction does not give rise to non -horizontal 
overlaps or coordinated effects. Regarding the framework of assessment of horizontal non -coordinated 
effects, see the Commission Guidelines on the assessment of horizontal mergers under the Merger 
Regulation (the “Horizontal Merger Guidelines”) OJ C 31, 5.2.2004, p. 5, paragraphs 24- 38.  
20  Horizontal Merger Guidelines, paragraph 8.  
 
 
5 being developed for a new intended use and will therefore not replace existing 
products but crea te a completely new demand.21  
(18) In the pharmaceutical industry, the process of innovation is struc tured in such a way 
that it is typically possible to identify competing research programmes (or “pipeline” 
programmes)  at an early stage of clinical trials .22 Competing pipeline programmes 
can be defined as R&D efforts aimed at developing substitutable products and 
having similar timing. The timing of a research programme should be assessed by 
reference to the stage of the on -going preclinical or clinical trials.23  
(19) In line with the past decisional practice in the pharmaceutical sector24 and the 
Commission’s d ecisions in Dow/Dupont  and Bayer/Monsanto,25 the Commission has 
taken into account a four -layer competitive assessment framework, which 
corresponds to the overlaps between the Parties’ activities in terms of:  
(a) Actual (product and price) competition, assessi ng the overlaps between the 
Parties' existing (marketed) products;  
(b) Potential (product and price) competition, assessing the overlaps (i) between 
the parties’ existing (marketed) and pipeline products at advanced stages of 
development  and (ii) between the parties’ pipeline products at advanced stages 
of development. For pharmaceutical products, the Commission in principle 
considers programmes in Phase II and III clinical trials as being at an advanced 
stage of development;26 
                                                 
21  Horizontal Merger Gu idelines, paragraph 38.  
22  In the pharmaceutical industry, pipeline drugs go through several development stages, start ing with 
preclinical trials in laboratories and on animals, and later moving on to clinical trials in humans (so called 
“Phase I”, “Phase II” and “Phase III” clinical trials).  Clinical trials in humans are strictly regulated in 
order to ensure the protection of trial subjects and the credibility of the results. In most jurisdictions, 
before a clinical trial can start, the sponsor must typic ally apply for and receive clinical trial authorisation 
from the competent authorities. The clinical trial is also typ ically registered on public databases. All 
clinical trial protocols conducted in Europe are identified at European level with a unique num ber and 
registered in the European Clinical Trials Database (EudraCT database). ClinicalTrials.gov is a web -
based resource that provides easy access to information on publicly and privately supported clinical 
studies conducted worldwide. Unlike clinical tr ials, preclinical trials are not registered in public databases 
and their existence is not always disclosed to the public.   
23  See case M.7275 -  Novartis/GSK Oncology , decision of 28.1.2015, recital 90 and M.9294 – 
BMS/Celgene , decision of 29.7.2019, recit al 21.  
24  See case M.7275 -  Novartis/GSK Oncology , decision of 28.1.2015, recitals 89- 90 and M.9294 –  
BMS/Celgene , decision of 29.7.2019, recital 22.  
25  See cases M.7932 -  Dow/Dupont , decision of  27.3. 2017, recitals 272- 302 and M.8084 -  Bayer/Monsanto,  
decision of 21.3.2018, recitals 48- 54. 
26  The phases of clinical development for pipeline products can be described as follows.  Phase I  starts with 
the initial administration of a new drug into humans, with trials carried out on a small number of people 
(e.g. in oncology, the sample size is usually in the low tens). The focus of Phase I trials is to confirm that 
the drug is safe to use in humans and to identify the appropriate dosage and exposure -response 
relationship. They typically involve one or a combinati on of the following aspects: estimation of initial 
safety and tolerability, characterisation of a drug's absorption, distribution, metabolism, and excretion, 
and early measurement of drug activity. Phase II  usually starts with the initiation of studies to explore 
therapeutic efficacy in patients. Studies in Phase II are typically conducted on a small group of patients 
(generally around 20 to 50 up to some hundreds per cohort or treatment arm) that are selected based on 
stricter criteria for indications. Pha se III  trials aim to demonstrate or confirm therapeutic benefit in a 
larger group of patients (Phase III trials will typically have hundreds of patients and may have over a 
thousand, for example for autoimmune diseases). Studies in Phase III are designed t o confirm the 
 
 
 
6 (c) Innovation competition in relation to the parties’ ongoing pipeline products, 
assessing the risk of significant loss of innovation competition resulting from 
the discontinuation, delay or redirection of the overlapping pipelines 
(including early stage pipelines); and  
(d) Innovation competition in relation to the capability to innovate in certain 
innovation spaces, ass essing the risk of a significant loss of innovation 
competition resulting from a structural reduction of the overall level of 
innovation.27 
(20) The Commission will analyse the overlaps between the activities of the Parties 
against this framework  in Section 4 below. 
4. COMPETITIVE ASSESSMEN T 
(21) AbbVie and Allergan are both active in the development and commercialisation of 
pharmaceutical products. The Parties’ activities are highly complementar y and only 
give rise to limited actual horizontal overlap in the EEA in relation to marketed 
and/or pipeline treatments in (i) inflammatory bowel diseases (“IBD”), covering 
ulcerative colitis (“UC”) and Crohn’s disease (“CD”), as well as (ii) uveitis.28  
                                                                                                                                                      
preliminary evidence accumulated in Phase II that a drug is safe and effective for use in the intended 
indication and recipient population. Usually, Phase III trials will involve a comparison of the 
investigational agent with a placebo or the  standard of care therapy. These studies are also intended to 
provide an adequate basis for marketing approval. Phase IV  begins after drug approval to monitor 
possible adverse reactions and/or new side effects over time.  See Case M.8401 -  J&J/Actelion , decision 
of 9.06.2017, footnote 6 and M.9294 –  BMS/Celgene , decision of 29.7.2019, footnote 27.  
27  The Transaction do es not raise competition concerns in this respect given the very large number of R&D 
organisations competing at global level ( e.g., pharmaceut ical and biotechnology companies, university 
research programmes) in autoimmune diseases, where the Parties’ activities mainly overlap . A report of 
the Pharmaceutical Research and Manufacturers of America (“PhRMA”) indicated that in 2016, there 
were 311 me dicines and vaccines in development by more than 150 companies for patients with 
autoimmune diseases (see http://phrma -docs.phrma.or g/sites/default/files/pdf/medicines -in-development -
report -autoi mmune -diseases.pdf ).  
28  The Transaction also gives rise to potential minor horizontal overlaps in relation to (i) Parkinson’s 
disease, (ii) Alzheimer’s disease, (iii) cystic fibrosis and (iv) oncology […], where it is unlikely to raise 
serious doubts as to its compatibility with the internal market for the following reasons.  
 
In cystic fibrotic and oncology, the overlaps arising from the Transaction only relate to marketed or 
pipeline products  for which Allergan has no development, marketing and distribution rights […] . 
Moreover, the Parties’ products are differentiated (with different MoAs, therapeutic uses and targeted 
patient populations). Furthermore, the Parties face several competing prod ucts for the same indications. 
Also, some of the Parties’ drugs are pipelines in early stages of development (Phase I), i.e. many years 
away from a hypothetical launch on the market, which remains highly uncertain.  
 
In Alzheimer’s disease, AbbVie has one pipeline product (in Phase II) and options on two other 
pipelines  (in Phase I); Allergan has two pipeline products (in […] ). The Parties’ drugs are 
complementary rather than substitutes since AbbVie’s products are […]  treatments, while Allergan’s 
products are […]. Also, the Parties’ products have different MoAs, face a large number of competitors . 
Moreover, Allergan’s product  and the two products on which AbbVie  has an option are pipeline drugs in 
early stages of development.   
 
In Parkinson’s disease , AbbVie has one marketed product in the EEA (Duopdopa) and two pipeline 
drugs (in Phase I and III). […] , in some limited instances , its Botox drug can be used to treat a number of 
symptoms associated with this disease ( e.g. movement problems, drooling and incontinence), However, 
 
 
 
7 4.1. Treatments for UC and CD 
4.1.1. Introduction 
4.1.1.1. Overview of the diseases  
(22) UC is a chronic autoimmune disease that causes inflammation and ulceration of the 
inner superficial lining of the large intestine. Inflammation usually begins in the 
rectum and lower colon, but m ay affect the entire colon.  
(23) CD is a chronic autoimmune disease that affects any part of the gastrointestinal tract 
from the mouth to the rectum, affecting the full thickness of the intestinal wall (the 
superficial lining as well as deeper within the bowel  wall). Most commonly, CD 
affects the last part of the small intestines, or the colon. The area of inflammation 
may be small (only a few centimetres) or may extend quite a distance along part of 
the bowels.  
(24) The main difference between UC and CD is the areas affected by each disease. A 
schematic overview of the areas affected by UC and CD is provided below:  
Figure 1  – UC and CD inflammation areas  
UC CD 
 
 
Source : Form CO  
(25) Symptoms experienced by patients suffering from UC and CD are similar and 
include abdominal pain, severe diarrhoea, fatigue, malnutrition, severe weight loss 
and frequent bowel movements.  
(26) The European Crohn’s and Colitis Organisation (“ECCO”) sets out (se parate) 
guidelines for the treatment of UC and CD. The ECCO guidelines distinguish 
between mild, moderate or severe UC and CD based on a number of factors 
including (i) number of bowel movements and the presence of blood in stools, as 
well as temperature, pulse, haemoglobin, and C -reactive protein (“CRP”) levels for 
UC; (ii) a Crohn’s Disease Activity Index (“CDAI”), weight loss, fever, and CRP 
levels for CD.  
                                                                                                                                                      
Botox does not act on cerebral pathways and, therefore, does not constitute a substitute for Parkinson’s 
disease treatments but a complement, which is only prescribed in conjunction with other therapies.  

 
 
8 4.1.1.2. Treatment algorithm  
(27) The treatment for UC and CD follow sequences (or “algorithms”), meaning that the 
patient is initially treated with one type of drugs and moves on to another type if the 
initial drug does not work or stops working after a certain period of time. The 
algorithms for UC and CD are to a large extent similar and consist of:  
- Conventional treatments,  including aminosalicylates (“5 -ASA”, typically 
mesalazine), corticosteroids and immunosuppressants ;  
- Post-conventional treatments  (prescribed after the failure of conventional 
therapies or in case of contraindication), including biologic drugs and innovative 
small molecules. Biologic drugs include drugs with different MoAs, namely  anti- 
Tumour Necrosis Factor (“anti -TNFs”), anti -integrins, interleurkin (“IL”) -12/23 
inhibitors, and IL -23 inhibitors (currently under development). There is currentl y 
only one innovative small molecule approved and marketed in the EEA for the 
treatment of UC (not CD), marketed by Pfizer (Xeljanz), which was launched in 
the EEA in late 2018.  
(28) UC and CD are both characterised by phases of remission and relapse. Patients may 
be switched back from post -conventional treatments to conventional treatments to 
maintain remission. Within post -conventional treatments, patients are also typically 
prescribed treatments in succession over the course of the disease. This is because a 
substantial proportion of UC and CD patients have an inadequate response or 
progressively lose response to a drug and need to switch to another treatment. As a 
result , there are also first, second, and/or third line post -conventional treatments.  
4.1.2. The Parti es’ activities  
(29) The Parties’ marketed and pipeline drugs for the treatment of UC and/or CD are 
detailed in Table 1 below. 
TABLE 1  - Parties’ marketed and pipeline drugs for the treatment of UC and/or CD  
Product  Indication  Line of 
treatment  MoA  Status  
ABBVIE  
Humira (adalimumab)  UC / CD  post-conv.  anti-TNF ( biologic s)  Marketed ( […]) 
Skyrizy (risankizumab)  UC / CD  post-conv.  IL-23 inhibitor ( biologics ) Phase III  
Upadacitinib  UC / CD  post-conv.  JAK inhibitor ( innovative  small molecule ) Phase III  
ABBV -323 UC post-conv.  CD40 antagonist ( innovative  small molecule ) Phase II  
ALLERGAN  
Asacol (mesalazine)  UC / CD  conv.  5-ASA  Marketed ( […]) 
Brazikumab  UC / CD  post-conv.  IL-23 inhibitor ( biologics ) Ph. II (UC)  
Ph. II/III (CD)  
ABI-M201  UC post-conv.  Microbiome biologic drug  Phase I  
Source : Form CO  
(30) […]. AbbVie markets a post -conventional treatment indicated for moderate -to-
severe UC and CD in the EEA, namely Humira (adalimumab), an anti -TNF. AbbVie 
is also currently developing Skyrizi (risankizumab), an IL -23 inhibitor currently in 
Phase III clinical trials for both UC and CD (and approved for the treatment of 
psoriasis). In addition, AbbVie is also developing a JAK inhibitor (upadacitinib), 
which is in Phase III for both UC and CD, and a CD -40 antagonist, which is 
currently in Phase II for UC.  
 
 
9 (31) Allergan markets a conventional treatment for mild -to-moderate UC and (to a lesser 
extent) CD […] , namely Asacol -HD (mesalazine). Allergan does not currently 
market post -conventional treatments for UC or CD in the EEA. However, Allergan 
is developing brazikumab, an IL -23 inhibitor currently in Phase II clinical trial for 
UC and Phase II/III clinical t rial for CD. Allergan is also developing ABI -M201, an 
early -stage (Phase I) pipeline for an orally administered microbiome biologic drug 
for the treatment of UC.  
4.1.3. Market definition  
4.1.3.1. Commission’s precedents  
(32) The Commission has previously assessed the market f or UC and CD treatments in 
several cases, including in particular in cases M.7379 – AbbVie/Shire and M.8955 – 
Takeda/Shire.29 In these decisions, the Commission considered a segmentation based 
on the line of treatment and found that conventional treatments (such as mesalazine) 
and post -conventional treatment s (such as anti -TNFs) do not belong to the same 
product market.30  
(33) Within post -conventional treatments, the Commission envisaged a segmentation 
based on MoA ( e.g. anti-TNFs, anti -integrins, IL -12/23 inhibi tors). In Takeda/Shire , 
the Commission found that anti -integrin biologics had a better safety profile than 
anti-TNFs and IL -12/23 inhibitors (which have a general immunosuppressant effect) 
and concluded, on this basis, and for the purpose of that  decision, that anti- integrins 
constituted a distinct product market.31 Most recently, in case M.9294 -  
BMS/Celgene , the Commission considered potential segmentations of the IBD 
treatments market by line of treatment, MoA or MoD, but ultimately left the relevant 
product market definition open.32  
4.1.3.2. The Parties’ views  
(34) The Parties submit it is appropriate to consider a market for post -conventional 
treatments of moderate -to-severe UC and CD distinct from that of conventional 
therapies.  
(35) In light of the Takeda/Shire  decision, the Parties submit that a relevant market for 
post-conventional treatments of moderate to severe UC and CD would include all 
such treatments excluding anti -integrins, which the Commission held to be a 
separate market. This market would thus cover anti -TNF s, IL -inhibitors (including 
both IL -12/23 and IL -23 inhibitors), and innovative small molecule treatments 
(including JAK inhibitors and other products under development such as S1P 
receptor agonists).  
                                                 
29  See cases M. 7339 – AbbVi e/Shire , decision of 16.10.2014 (this transaction ultimately did not materialise) 
and M.8955 – Takeda/Shire , decision of 20.11.2018.  
30  See cases M.7339  – AbbVie/Shire , decision of 16.10.2014, recital 27 and M.8955 – Takeda/Shire , decision 
of 20.11.2018, recital s 25 and 30.  
31  See case M.8955 –  Takeda/Shire , decision of 20.11.2018, recitals 31- 49. 
32  See case M.9294 –  BMS/Celgene , decision of 29.7.2019, recital 120.  
 
 
10 4.1.3.3. The Commission’s assessment  
(36) In line with the Commissio n’s precedents, the market investigation indicated that the  
treatments and the competitive dynamics are similar in UC and CD.33 Treatments for 
these two diseases are thus assessed jointly, and specificities are flagged where 
relevant.  
(37) The market investigation confirmed that (i) conventional and (ii) post -conventional 
treatments for UC and CD  belong to separate markets. This is due to the fact that 
conventional treatments are used to treat patients suffering from less severe forms of 
UC and CD,34 before the us e of post -conventional biologics and innovative small 
molecule  drug s.35 
(38) The remainder of this Section focuses on the potential segmentations of the post -
conventional treatments for UC and CD. In this respect, the market investigation was 
not conclusive , in part because some of the drugs analysed (notably IL -23 inhibitor s) 
are still at the development stage and there is an intrinsic level of uncertainty in 
assessing their future characteristics and market positioning . 
 
(A) Potential segmentation of the post -conventional treatments market based on 
the line of treatment 
(39) Based on the results of the market investigation, it is not clear whether a 
segmentation based on the line of treatment is warranted.  
(40) On the one hand, the results of the market investigation con firmed that biologics and 
innovative small molecules are often prescribed in succession with anti -TNFs (first 
generation biologics) .36  
(41) The use of anti -TNFs as first -line post -conventional treatment s is a requirement in 
some countries such as Austria and Fr ance due to reimbursement restrictions  but also 
applies to other countries, where anti -TNFs are used in practice as first -line post -
conventional treatment s for cost reasons (as anti -TNFs are cheaper in particular due 
to the availability of biosimilars).37 One competitor noted for instance that “ [t]here 
are several EEA countries where the use of anti -TNF as a first –line post -
conventional treatment for UC/CD is encouraged and certain measures are in place. 
The level of these measures may vary however from obli gatory use of anti -TNF to 
strong recommendation / incentivization of the use of the cheapest treatment in first -
line post conventional UC/CD treatment populations. Different guidance may apply 
on national and regional (or hospital) level” . One Key Opinion Leader (“ KOL ”) 
also noted that “ [g]enerally the first line biologic is anti- TNF – other biologics are 
                                                 
33  Questionnaire Q1  to customers , replies to questions 16 and 28. Questionnaire Q2 to comp etitors, replies 
to questions 4.2, 5.2, 6.2, 10.1, 12.1, 14.1, 15.1, 19.1, 22.1.1, 22.2.1, 23.1, 25.1, 26.1, 27.1.1, 27.1.1, 
27.1.1, 27.1.1, 27.1.1, 27.1.1, 27.1.1, 28.1, 31.1, 34.2 and 35.2.  
34  Questionnaire Q1  to customers , replies to question 7. Questionnaire Q2 to competitors, replies to 
question 9. Questionnaire to Key Opinion Leaders (“KOLs”), replies to question 3(a).  
35  As a result, Al lergan’s Asacol is not substitutable with AbbVie’s Humira or any other post -conventional 
treatment s. This is confirmed by all KOLs who responded to the market investigation. See Questionnaire 
to KOLs, replies to question 3(b). Therefore, Allergan’s Asacol does not overlap with AbbVie’s 
treatments for UC and CD and will not be discussed  further in the Decision.  
36  Questionnaire Q2 to competitors, replies to questions 7.1 and 7.2.  
37  Questionnaire Q2 to competitors, replies to question 8. Questionnaire to KOLs, replies to question 6.  
 
 
11 used in specific instances. Failure of anti - TNF leads to initiation of other biologics 
or oral synthetic drug Tofacitinib”. 38 
(42) This is also illustrated by the fact that a majority of customers expects that the 
launch of IL -23 inhibitors will have a more limited impact on the sale of anti -TNFs 
than on the sales of anti -integrins, IL -12/23 and JAK inhibitors, which are currently 
still mainly prescribed after the use of anti -TNFs.39 This is due to the fact that IL -23 
inhibitors are also expected to be used as second or further line post -conventional 
treatment s, at least at the time of their launch.40 
(43) On the other hand, the market invest igation revealed a certain degree of 
substitutability between post -conventional treatments for UC and CD.  
(44) While  anti-TNFs are currently the standard first -line post -conventional treatment for 
UC and CD, they are subject to competition from other treatments. A majority of 
responding competitors and KOLs consider that all post -conventi onal treatment s 
compete with each other.41 One competitor noted for instance that “ [i]n Immunology 
in general, and in GI  [gastroenterology ] specifically, [TNF inhibitors, IL -12/23 
inhibitors, anti -integrin, and JAK inhibitors] compete with one another to a large 
extent ”. Another one confirmed that “ [d]ifferent modes of action compete against 
each other to a certain extent. Physicians will select the appropriate treatment based 
on patient characteristics ”. Notably, the clinical trial for brazikumab (Allergan’s IL -
23 inhibitor  pipeline) for CD aims at demonstrating its superiority versus AbbVie’s 
Humira, indicating that the two drugs can be used for the same groups of patients. In 
line with the above, respondents to the market investigation expect IL -23 inhibitors 
to compete with all other post- conventional treatments for UC and CD  currently 
available on the market.42  
(45) In addition, there is some fluidity across the various lines of tr eatments for post -
conventional drugs. While some EEA countries require (or encourage) the use of 
anti-TNFs as first -line post -conventional treatment s of UC and CD for cost reasons, 
this is not the case in all EEA countries.  
(46) In fact, the use of anti-integr ins and IL -12/23 inhibitors as first -line post -
conventional treatment s is increasing (although it is currently rather limited). This is 
particularly the case in UC, where Takeda’s anti -integrin Entyvio is increasingly 
used as a first -line post -conventional  treatment.43 One KOL noted for instance that 
“[a]ll biologics can be prescribed as first line biologic treatment ”, another one that 
“currently, the choice of biologic in UC or CD after conventional therapy failure is 
                                                 
38  Questionnaire to KOLs, replies to question 2.  
39  Questionnaire Q1 to customers, replies to questions 27.2, 27.3, and 27.4.  
40  Questionnaire Q1 to customers, replies to question 27.1. In this respect, one competitor also explained 
that “ IL-23 products are expected to compete initially with Stelara (Il -12/23), and other mechanism of 
actions such as Entyvio, Xeljanz, Upadacitinib and Ozanimod as 2nd or 3rd initially. Later, with the 
physician gaining clinical experience with IL -23, these products could be expected to compete as 1st line 
therapy with anti -TNFs ”, questionnaire Q2 to competi tors, reply to question 18.  
41  Questionnaire Q2 to competitors, replies to question 25. Questionnaire to KOLs, replies to question 4.  
42  Questionnaire Q2 to competitors, replies to question 18.  
43  Questionnaire Q1 to customers, replies to question 27.2. For instance, one customer expects “ anti-
integrin market share to increase slightly or stagnate overall, there will be increased use as first line but 
decreased in the second and third line space ”. Questionnaire Q2 to competitors, replies to question 26. 
See non-confidential minutes of call with KOL dated 18 September 2019.  
 
 
12 very open. Any biologics could be used. They all have advantages and limitations. 
Clinicians try to adapt the choice of the biologics to the profile of the patient. As 
there is no strong biological predictor, the clinicians  rely more on the demographic 
and clinical characteristics of the patients ”, a third that “ [w]hile use of anti -TNF as 
first line is encouraged (biosimilar use), there is no prohibition to use of other 
classes in specific situations decided by most responsible physician or 
multidisciplinary team ”.44  
(47) Separately, the market investigation indicates that a nti-TNFs, in addition to being 
used as first -line post -conventional treatmen ts, are also largely used as second line 
treatment (including when a different anti- TNF was prescribed in first line), where 
they compete more directl y with other drugs, including anti -integrins and JAK 
inhibitors.45 
(B) Potential segmentation of the post -conv entional treatments market based on 
the MoA  
(48) Based on the results of the market investigation, it is not clear whether a 
segmentation based on MoA is warranted.  
(49) On the one hand, the results of the market investigation revealed that all post -
conventional treatment s compete with each other, regardless  of their MoA (see 
recital 44 above).  
(50) On the other hand, the Commission also found that post -conventional treatments f or 
UC and CD  based on different MoAs may  not be fully substitutable. The Parties’ 
activities overlap in relation to IL -23 inhibitors for U C and CD, as each of AbbVie 
and Allergan is currently developing an IL -23 inhibitor.  
(51) Drugs with different MoAs  have distinct efficacy and safety profile, which are key 
factors for physicians when prescribing drug.46 For instance, respondents to the 
market investigation highlighted the promising nature of IL -23 inhibitors. 
Competitors rank IL -23 inhibitors consistently higher than all other available post -
conventional treatments, in terms of efficacy, sustainability of effects and safety, as 
well as in terms  of speed of onset.47 Similarly, some customers and KOLs view IL -
23 inhibitors as particularly “ promising” or even as products that “ will change the 
market ” due to their expected better profile.48 The distinct efficacy and safety profile 
of IL -23 inhibitors compared to other post -conventional drugs is further illustrated 
                                                 
44  Questionnaire Q2 to competitors, replies to question 8. Questionnaire to KOLs, replies to question 6.  
45  Questionnaire Q2 to competitors , replies to questions 7.1 and 7.2.  
46  Questionnaire Q2 to competitors, replies to question 6.   
47  Questionnaire Q2 to competitors, replies to questions 27.1 to 27.8.  
48  Questionnaire Q1 to customers, replies to question 15 . Non -confidential minutes of call with KOL dated 
16 September 2019, par a. 20. Non -confidential minutes of call with KOL  dated 17 September 2019, 
para.  15. Non -confidential minutes of call with KOL dated 18 September 2019, para. 18: “ IL-23 
inhibitors are very promising and have the potential to be a game -changer for the treatm ent of IBD, with 
a high level of patients achieving clinical remission (40- 50%) ”. 
 
 
13 by the Parties ’ internal documents […].49 Consequently, post -conventional 
treatment s with the same MoA compete more closely with each other.50 
(52) Moreover, the Commission found t hat, in order to be able to cover all patients’ 
needs, customers usually procure all different classes of post -conventional 
treatments  available on the market ( i.e. anti-TNFs, anti -integrins, IL -12/23 inhibitors  
and JAK inhibitors ),51 which shows that drugs with different M oAs are not fully 
substitutable.  
4.1.3.4. Conclusion 
(53) Based on the above information, three alternative product market definitions giving 
rise to overlaps between the Parties can be envisaged, namely: (i) the market for 
post-conventional treatments for UC and CD, including all biologics and innovative 
small molecules; (ii) the market for post- conventional treatments for UC and/or CD 
excluding anti -TNFs; and (iii) the market for IL -23 inhibitors for UC and CD.  
(54) In any event, the exact relevant product market definitio n for treatments of moderate 
to severe UC and CD can be left open. The Transaction gives rise to serious doubts 
as to its compatibility with the internal market regardless of whether the relev ant 
markets are defined as: (i) all post -conventional treatments  for UC and CD; (ii) all 
post-conventional treatments for UC and CD excluding anti -TNFs; or (iii) IL -23 
inhibitors.  
4.1.4. Competitive assessment  
4.1.4.1. The Parties’ views  
(55) The Parties submit that the Transaction does not give rise to competition concerns 
regardless of the exact scope of the market, in particular due to: (i) the crowded 
competitive landscape and pipeline for post -conventional treatments of UC and CD 
(including regarding IL -inhibitors); (ii) differences between the Parties’ timing in 
terms of clinical trials and market entry of pipeline products, and the uncertainty 
related thereto; as well as (iii) a lack of closeness of competition between the Parties’ 
products. 
4.1.4.2. The Commission’s assessment  
(A) Potential market for IL -23 inhibitors  
(56) In the potential (narrowes t) market for IL -23 inhibitors for the treatment of UC and 
CD, the Transaction gives rise to a pipeline -to-pipeline overlap between two 
advanced -stage pipelines of the Parties.  
                                                 
49  See for instance Annex 7.4 to Form CO.  
50  Conversely, respondents to the market investigation generally do not expect a significant level of 
differentiation among IL -23 in hibitors, although noting that the products are not yet marketed and that 
additional studies may highlight differentiating features. As a result, no sub -segmentation of the potential 
market for IL -23 inhibitors will be considered in the present Decision. S ee Questionnaire to KOLs, 
replies to question 8.  
51  Questionnaire Q1 to customers, replies to question 20.   
 
 
14 (57) As explained, AbbVie develops Skyrizi (risankizumab), currently in Phase III f or 
UC and CD  and expects to launch the drug in the EEA at the earliest after […] . 
Allergan develops brazikumab, currently in Phase II for UC and Phase II/III for CD  
and expects  to launch the drug in the EEA at the earliest after […] .  
(58) A material number of respondents to the market investigation, and in particular the 
overwhelming majority of responding KOLs, raised concerns linked to the 
discontinuation of one of the Parties’ IL -23 inhibitors development programme 
(most likely brazikuma b), as a result of the Transaction, the new entity having 
limited incentives to develop in parallel two drugs with the same MoA .52  
(59) Concerns relating to the discontinuation of brazikumab by  AbbVie are warranted, 
[…].53 
(60) Besides the Parties, only two other com panies are currently developing IL -23 
inhibitors pipelines for UC and CD, namely:  
• Eli Lilly which is developing mirikizumab , currently in Phase III for UC and 
CD and expected to be launched in the EEA at the earliest after […] ; and  
• Johnson & Johnson (“J& J”), which is developing guselkumab, currently in 
Phase II for UC and Phase II/III for CD and expected to be launched in the 
EEA at the earliest after […] .54 
(61) As a result, the Transaction would lead to a  reduction in the already limited number 
of players act ive on the market for IL -23 inhibitors from four to three, assuming that 
all IL -23 inhibitor pipelines reach the (EEA) market, which remains highly uncertain 
at this stage.55 
(62) In this respect, a large number of  respondents to the market investigation, including 
all KOLs, highlighted that it is important to have several options within the same 
class of post -conventional treatments ( e.g. several IL -23 inhibitors).56 Reasons cited 
by KOLs include the possibility to obtain lower prices for the drug, supply 
disrupt ion management, and better clinical data (including head- to-head 
comparisons ), as well as a broader choice of products (including different modes of 
deliveries, dose intervals etc.), allowing patients to benefit from the most appropriate 
form of treatment at the best conditions.57 
                                                 
52  Questionnaire Q1 to customers, replies to questions 12 and 31.  Questionnaire Q2 to competitors, replies 
to question 36.1. Questionnaire to KOLs, replies to question 9.  
53  Annex 7.8 to Form CO.  
54  J&J is also developing an oral IL -23R antagonist ( JNJ-67864238) which recently started  Phase II trials 
(in September 2019) . 
55  The fact that all pipelines may not reach the market is illustrated by the Parties’ internal documents , […]. 
56  Questionnaire Q1 to customers, replies to question 14.2.   
57  Questionnaire to KOLs, replies to question 5. For instance, one KOL noted that “it is important as drugs 
hits an identical target and with biological resistance due to immunogenicity could arise, best example 
the efficacy of adalimumab in infliximab failures ”, another one that “ patients who initially respond to a 
medication may lose  response due to antidrug antibody formation and hence have undetectable trough 
drug levels. an alternative drug in the same class is ideal, as you know that the patient will respond (from 
previous experience) and that antidrug antibodies do not cross reac t with agents of the same class 
(excluding biosimilars of course) ”, and an additional KOL “[believes] that it is highly important to have 
 
 
 
15 (63) As a result  of potential horizontal non- coordinated e ffects in the plausible market for 
IL-23 inhibitors, in particular the potential discontinuation of Allergan’s 
brazikumab, leading to potentially less choice and higher prices for patients and 
health systems in the EEA, the Transaction raises serious doubt s as to its 
compatibility with the internal market and the functioning of the EEA Agreement.   
(B) Potential market for post -conventional treatments excluding anti -TNFs  
(64) In a potential market for post -conventional treatments of UC and CD excluding anti -
TNFs, the  Transaction gives rise to several pipeline -to-pipeline overlaps, the main 
one being the overlap between the Parties’ IL -23 inhibitors.58 
(65) The risk of discontinuation of brazikumab (see recitals 58 -59 above ) would also 
have a detrimental impact on this poten tial market for several reasons . 
(66) First , the market investigation revealed the nee d for new alternative treatments . Most 
respondents  confirmed the importance of having several MoA options in order to be 
able to cover all patients’ needs.59 There are currentl y only three drugs with different 
MoA available on this potential market, namely (i) Entyvio (vedolizumab), an anti -
integrin biologic drug marketed by Takeda (for both UC and CD), (ii) Stelara 
(ustekinumab), an IL -12/23 inhibitor marketed by J&J (for CD and (recently) UC), 
and (iii) Xeljanz (tofacitinib), a n innovative small molecule JAK inhibitor recently 
launched in the EEA by Pfizer (for UC only).  
(67) According to the market investigation, these three drugs have an overall similar 
efficacy but different s afety profiles.60 Anti-integrins (Entyvio) are considered to be 
the safest drug currently available on the market ( i.e. it leads to less adverse effects  
and a lower risk of infection) , due to a more targeted (gut -specific) MoA . IL-12/23 
inhibitors (Stelara)  are associated with a risk of immunosuppression. JAK inhibitors 
                                                                                                                                                      
more than one drug within a same class, since this push the competition and differentiation at many 
levels. This inclu des, but is not restricted to, aspects such as price, push for RWD (to demonstrate 
clinical effectiveness and safety beyond the subgroup of patients who goes into a randomized controlled 
phase III trial) and development of phase IV trials to further differ entiate the drug and demonstrate 
strengths and weaknesses of the drug (including possible head- to-head comparisons) ”.  
58  On this potential market, the Transaction notably  gives rise to other pipeline -to-pipeline overlaps 
involving upadacitinib (AbbVie), A BBV -323 (AbbVie) and ABI -M201 (Allergan), described in Table 1 . 
KOLs indicated that these  three pipeline  drugs have very different MoAs ( i.e. JAK inhibitor, CD -40 
antagonist, and microbiome biologics) compared to the Parties’ other marketed and pipeline dr ugs for UC 
and CD. Moreover, Allergan’s ABI -M201 is at an early -stage of development (in Phase I), and thus many 
years from a hypothetical launch on the market. At this point in time, and based on the available 
information, there is no indication that the efficacy and safety profiles of these drugs would be similar to 
other marketed and pipeline drugs of the Parties.  See non -confidential minutes of call with KOL dated 18 
September 2019, and 16 September 2019. The Transaction is therefore unlikely to raise concerns in 
relation to these products.  
59  Questionnaire Q1 to customers, replies to question 14.1.  
60  Questionnaire Q2 to competitors, replies to questions 27.1 to 27.8.  Non-confidential minutes of call with 
KOL dated 16 September 2019, paras. 11 to 15. Non -confidential minutes of call with KOL dated 17 
September 2019, paras. 11 to 14. Non -confidential minutes of call with KOL dated 18 September 2019, 
paras. 14 to 16.  
 
 
16 (Xeljanz) are characterized by a particularly poor safety profile61 and safety 
warnings.62 
(68) In addition, there are a number of post -conventional treatments for  UC and/or CD 
currently under devel opment  but, as illustrated in the table below, most of them 
relate to existing MoAs.  
TABLE 2 – MAIN COMPETING PIPELINE PRODUCTS  
MoA  Company  Product  Phase  UC/CD  
Marketed MoAs  
Anti-integrins  Roch e Etrolizumab  Phase III  UC / CD  
Takeda (ex Shire)  SHP-647 Phase III  UC / CD  
IL 12/23 inhibitors  Various  Biosimilars  n.a. UC / CD  
JAK inhibitors  Gilead / Galapagos  Filgotinib  Phase III  UC 
AbbVie  Upadacitinib  Phase III  UC 
BMS  BMS -986165  Phase II  UC / CD  
Novel MoAs  
S1P1 receptor modulator  Celgene  Ozanimod  Phase III  UC / CD  
CD40 antagonist  AbbVie  ABBV -323 Phase II  UC 
IL-23 inhibitors  
  AbbVie  Skyrizi  Phase III  UC / CD  
Allergan  Brazikumab  Phase II/III  UC / CD  
Eli Lilly  Mirikizumab  Phase II/III  UC / CD  
J&J Guselkumab  Phase II/III  UC / CD  
Source : Form CO  
(69) Second, IL -23 inhibitors are expected to have a better efficacy and safety profile than 
(marketed and pipeline) drugs with other MoA s. In particular, KOLs and 
competitors expect IL -23 inhibitors to have a better safety profile  than existing post -
conventional treatments, including anti -integrins, which is a key consideration for 
prescribing practitioners. For instance, some customers and KOLs view IL -23 
inhibitors as particularly “ promising” or even as products that “ will change the 
market ” due to their expected better profile.63 This is also corroborated by the 
Parties ’ internal documents , […].64 Therefore, within the potential market for post -
conventional treatments for UC and/or CD excluding anti -TNFs, the Parties’ IL -23 
inhibitors are expected to be close competitors.65 
                                                 
61  Questionnaire Q2 to competitors, replies to question 27.5.  
62  A post -marketing study s howed an increased risk of pulmonary embolism, malignancy, and overall 
mortality in rheumatoid arthritis patients. As a result of this safety signal, in July 2019, the FDA 
approved new warnings about an increased risk of blood clots and death with certain dosages of Xelianz. 
The implications of this safety signal are currently being discussed by the EMA.  
63  Questionnaire Q1 to customers, replies to question 15 . Questionnaire Q2 to competitors, replies to 
questions 27.1 to 27.8. Non -confidential minutes of call with KOL dated 16 September 2019, para. 20. 
Non-confidential minutes of call with KOL dated 17 September 2019, para. 15. Non -confidential minutes 
of call with KOL dated 18 September 2019, para. 18: “ IL-23 inhibitors are very promising and have the 
potential to be a game -changer for the treatment of IBD, with a high level of patients achieving clinical 
remission (40- 50%) ”. 
64  See for instance Annex 7.4 to Form CO.  
65  See for instance Questionnaire Q2 to competitors, replies to question 13.   
 
 
17 (70) Third, the discontinuation of Allergan’s brazikumab would remove a promising 
competitive constraint on the market for UC and CD post -conventional treatments 
excluding anti -TNFs, compared to the situation absent the Transaction.  
(71) Indeed, Allergan implemented a strategy to differentiate brazikumab from competing 
products , including in particular head- to-head trials comparing the efficacy and 
safety of its IL -23 inhibitor pipeline drug with Takeda’s anti -integrin (Entyvio) in 
UC, i.e. the leading post -conventional treatment for UC and CD excluding anti -
TNFs. Allergan’s head -to-head trial against Entyvio aims at establishing a clinical 
superiority of brazikumab over Entyvio, as evidenced by Allergan’s internal 
documents.66 Moreover, All ergan is also testing brazikumab with an IL -22 
companion diagnostics in order to assess whether the compound is more effective in 
patients expressing higher levels of the IL -22 biomarker.  
(72) The Commission found that, if successful, brazikumab’s head -to-head  trials against 
Entyvio in UC and Humira in CD  and IL -22 biomarker indication would give 
Allergan a competitive advantage compared to competitors. Discontinuing such 
head -to-head trial s and biomarker indication would potentially deprive practitioners 
from useful clinical data, ultimately resulting in a lower quality of patient treatment. 
For instance, one KOL noted that “ the head- to-head comparisons may be used as 
one of the strongest arguments (if not the strongest) for positioning of brazikumab” 
and that “ if the use of IL22 as a companion diagnostic holds true it would probably 
be rapidly picked up and implemented at IBD -specialised centres  […]”; another one 
that “[i] t is imperative to have head- to-head comparisons in order to identify the 
efficacy, safety, sustainability long- term of a new agent and position this new drug in 
the therapeutic algorithms of IBD ”.67  
(73) As a result  of potential horizontal non- coordinated effects in the plausible market for 
post-conventional treatments for UC and CD excluding anti -TNF s in the EEA, in 
particular the potential discontinuation of Allergan’s IL -23 inhibitor, leading to 
potentially less choice, lower quality treatments, and higher prices for patients and 
health systems in the EEA, the Transaction raises serious doubts as  to its 
compatibility with the internal market and the functioning of the EEA Agreement.   
                                                 
66  See Form CO, Annex 7. 6, p. 23: “ […]”. In CD, Allergan is comparing the efficacy and safety of 
brazikumab with AbbVie’ anti -TNF (Humira) (s ee Form CO, Annex 7.6, p. 21: “ […]”). 
67  Questionnaire R1 to KOLs, replies to question 3.1. See also Questionnaire R2 to Custom ers, replies to 
question 3 (a customer stated that “ head- to-head trials against existing biologics may allow positioning 
of brazikumab in the treatment armatorium which is very important information and may give the drug 
an advantage against other il -23 inhibitors  in the case it is found to be superior regarding effect or 
safety. […] Biomarkers predictive of drug response are important to use drug more selectively and 
effectively […] This may therefore also give brazikumab a market advantage when it is intr oduced”); and 
Questionnaire R3 to Competitors, replies to question 6 (a competitor stated that “ it will be very important 
to show superiority on head- to-head basis for reimbursement purposes  […]”; another one indicated that 
“the comparator studies and a potential indication for a biomarker -defined population would provide 
differentiation and guidance to prescribers and be positive for market access ”). 
 
 
18 (C) Potential market including all post- conventional treatments  
(74) In a potential market for all post -conventional treatments of UC and CD, the 
Transaction gives rise to sev eral market -to-pipeline68 and pipeline -to-pipeline 
overlaps,69 the most relevant ones being (i) the market- to-pipeline overlap between 
AbbVie’s Humira (anti -TNF) and Allergan’s brazikumab (IL -23 inhibitor); as well 
as (ii) the pipeline -to-pipeline overlap between the Parties’ IL -23 inhibitors.  
(75) On this potential mark et, the Transaction also raises serious doubts as to the 
compatibility of the Transaction with the internal market and the functioning of the 
EEA Agreement for several reasons.  
(76) First , the market investigation revealed Humira’s leadership on the market of post -
conventional treatments.  
(77) Anti-TNFs are the first generation of biologics used in UC/CD. There are a number 
of marketed anti -TNFs in the EEA, besides AbbVie’s Humira (adalimumab), which 
are indicated for the treatment of UC and CD, including J&J’s Remi cade 
(infliximab) and Simponi (golimumab), as well as adalimumab and infliximab 
biosimilars  following Humira ’s loss of exclusivity in 2018,70 and Remicade’s loss of 
exclusivity between 2013 and 2015. Simponi is schedule d to lose exclusivity in 
2024.  
(78) AbbVie currently markets its anti -TNF Humira, the first post- conventional treatment 
for UC and CD, in […] . 
(79) Table 3 below  provides an estimate of AbbVie’s market share  in the EEA member 
states for the treatment of moderate to severe UC, based on the number of patients 
treated, where such share exceeds 20%.   
Table 3 - UC MARKET SHARES (volume, 2018)  
EEA countries71 AbbVie (Humira)  Competitors with market shares > 10%  
Austria  [30-40]% J&J ( [20-30]%) / Celltrion ( [10-20]%) 
Belgium  [20-30]% J&J ( [30-40]%) / Takeda ( [20-30]%) 
Bulgaria  [70-80]% Celltrion ( [10-20]%) 
Czechia  [30-40]% J&J ( [30-40]%) 
Estonia  [20-30]% J&J ( [20-30]%) / Takeda ( [10-20]%) 
France  [30-40]% J&J ( [30-40]%) / Pfizer ( [10-20]%)  
Germany  [20-30]% J&J ( [20-30]%) / Takeda ( [20-30]%) / Pfizer ( [10-
20]%) 
Greece  [40-50]% J&J ( [20-30]%) / Pfizer ( [10-20]%) / Takeda ( [10-
20]%) 
Hungary  [50-60]% J&J ( [40-50]%) 
Ireland  [40-50]% J&J ( [30-40]%)  
Italy [20-30]% J&J ( [20-30]%) / Takeda ( [10-20]%) 
Latvia  [40-50]% Celltrion ( [50-60]%) 
                                                 
68  The market -to-pipeline overlap between AbbVie’s Humira and Allergan’s pipeline product ABI -M201 is 
unlikely to raise concerns given the different MoAs  of these products and the very early stage of 
development of ABI -M201 (Phase I) . 
69  The pipeline -to-pipeline overlaps involving upadacitinib (AbbVie), ABBV -323 (AbbVie) and ABI -M201 
(Allergan) are unlikely to raise concerns, as explained in footnote 58.  
70  Biosimilars of adalimumab were approved in the EEA in 2017 and entered the market in  2018.  
71  The Parties submit that no reliable market share data is available for Croatia.  
 
 
19 Table 3 - UC MARKET SHARES (volume, 2018)  
EEA countries71 AbbVie (Humira)  Competitors with market shares > 10%  
Lithuania  [20-30]% Celltrion ( [40-50]%) / J&J ( [10-20]%) / Pfizer ( [10-
20]%) 
Netherlands  [20-30]% Celltrion ( [20-30]%) / Pfizer ( [20-30]%) / J&J ( [10-
20]%) / Takeda ( [10-20]%) 
Portugal  [30-40]% J&J ( [40-50]%) / Pfizer ( [10-20]%) 
Romania  [50-60]% J&J ( [40-50]%) 
Slovakia  [20-30]% J&J ( [30-40]%) / Takeda ( [10-20]%) / Celltrion ( [10-
20]%)  
Slovenia  [30-40]% Celltrion ( [20-30]%) / Takeda ( [20-30]%) / J&J ( [10-
20]%) 
Spain  [30-40]% J&J ( [30-40]%) 
Sweden  [30-40]% Pfizer ( [30-40]%) / Celltrion ( [10-20]%) / Takeda 
([10-20]%)  
UK [30-40]% Takeda ( [20-30]%) / Celltrion ( [20-30]%) / Pfizer  
([10-20]%) 
Source : Form CO, Annex 7.1  
 
(80) Table 4 below  provides an estimate of AbbVie’s market share in the EEA member 
states for the treatment of moderate to severe CD, based on the number of patients 
treated, where such share exceeds 20%.  
Table 4 - CD MARKET SHARES (volume, 2018)  
EEA countries72 AbbVie (Humira)  Competitors with market shares > 10%  
Austria  [50-60]% Celltrion ( [10-20]%) / J&J ( [10-20]%) 
Belgium  [30-40]% J&J ( [30-40]%) / Takeda ( [10-20]%) 
Bulgaria  [80-90]% Celltrion ( [10-20]%) 
Czechia  [40-50]% J&J ( [10-20]%) 
Denmark  [30-40]% Pfizer ( [50-60]%)  
Estonia  [30-40]% J&J ( [30-40]%) 
Finland  [30-40]% J&J ( [40-50]%) 
France  [40-50]% J&J ( [20-30]%) / Pfizer ( [10-20]%) 
Germany  [30-40]% J&J ( [20-30]%) / Takeda ( [10-20]%) 
Greece  [50-60]% J&J ( [30-40]%) / Pfizer ( [10-20]%) 
Hungary  [60-70]% J&J ( [30-40]%) 
Irelan d [60-70]% J&J ( [30-40]%) 
Italy [40-50]% Takeda ( [10-20]%) / J&J ( [10-20]%) 
Latvia  [50-60]% Pfizer ( [40-50]%) 
Lithuania  [30-40]% Celltrion ( [40-50]%) / Pfizer ( [10-20]%) 
Netherlands  [30-40]% Celltrion ( [20-30]%) / Pfizer ( [20-30]%) / J&J ( [10-
20]%) 
Norway  [20-30]% Pfizer ( [30-40]%) / Celltrion ( [10-20]%) / Takeda 
([10-20]%) 
Poland  [40-50]% Pfizer ( [30-40]%) / Celltrion ( [20-30]%)  
Portugal  [40-50]% J&J ( [30-40]%) / Pfizer ( [10-20]%) 
Romania  [60-70]% J&J ( [30-40]%) 
Slovakia  [60-70]% J&J ( [20-30]%) 
Slovenia  [60-70]% Celltrion ( [20-30]%) / J&J ( [10-20]%) 
Spain  [40-50]% J&J ( [20-30]%) 
Sweden  [40-50]% Pfizer ( [20-30]%) / J&J ( [10-20]%) 
UK [40-50]% Celltrion ( [20-30]%) / Pfizer ( [10-20]%) / Takeda 
([10-20]%) 
Source : Form CO, Annex 7.1  
                                                 
72  The Parties submit that no reliable market share data is available for Croatia.  
 
 
20 (81) Humira is a blockbuster drug ( […] sales in the EEA in 2018), which accounts for 
over 60% of AbbVie’s worldwide revenues. Since the loss of its exclusivity in 2018 
and the launch of several biosimilars, Humira’s market shares have generally 
declined in Europe, […] . Humira’s market shares are expected to decrease further 
over the next few years, due to the health authorities’ incentives to increase the use 
of biosimilars, priced lower than Humira.  
(82) However, AbbVie still retains a significant market presence in numerous EEA 
countries (see Tab les 3 and 4 above). In particular, its market share exceeds 50% in 
Austria (in CD), Bulgaria (in UC and CD), Greece (in CD), Hungary (in UC and 
CD), Ireland (in CD), Latvia (in CD), Romania (in UC and CD), Slovakia (in CD) 
and Slovenia (in CD) in 2018. AbbVie’s market share has even increased in a 
number of EEA countries between 2018 and 2019, in spite of biosimilar entry in the 
EEA, including in [seven EEA countries in UC and four EEA countries in CD] .73 
According to well -established case law, such large market shares may in themselves 
be evidence of the existence of a dominant position.74 
(83) The market investigation also revealed that Humira benefits from a long -lasting and 
strong track -record  in the treatment of  UC and CD. Such track -record is an important 
criterion for physicians prescribing post -conventional treatments to patients.75 
According to a large majority of customers, AbbVie’s track -record in selling Humira 
provides the company with a strong competitive advantage since competing products 
do not benefi t from a similar track record. This advantage is linked in particular to 
the company’s long -term experience with biologics in the IBD field, established 
customer base, contacts with phys icians, KOLs and public health authorities.76  
(84) Several competitors also  share this view, with one stating for instance that “ AbbVie 
has a long track record in the disease area and strong commercial presence. It has 
the #1 selling biologic across all indicat ions and also specifically in IBD” .77 
Another competitor also indicated that “ Humira has solid long- term safety data as 
well as real -world evidence, compared to the other post -conventional treatments for 
UC and CD (which have been on the market for a shorte r period of time) ”.78 
(85) Second, the number of competitors active at natio nal level is limited in several EEA 
countries (e.g. duopoly or quasi duopoly in Hungary, Ireland and Romania) (see 
Tables 3 and 4 above).  
                                                 
73  Based on data provided until April 2019, Form CO, Annex 7.1.  
74   Horizontal Merger Guidelines, paragraph 17.  
75  Questionnaire Q 2 to competitors, replies to question 6.  
76 See Questionnaire Q1  to customers, replies to question 13. One customer notes for instance that “ over 
many years AbbVie has build up experience and have done a good job in building networks and contacts 
to KOL ”, another one that “ [l]ong experience with the  disease entities, established contact to key opinion 
leaders, established brand within the field […] would give [AbbVie] some advantages compared to 
companies with no prior track record”, an additional customer confirms that “ [o]ver the years, Abbvie 
has developed a huge network of contacts in IBD centers over the Europe. IBD specialists have become 
overly familiar with Abbvie brand and products. For these reasons, Abbvie will have a competitive 
advantage over all other companies ”, similarly another custom er considers that “ [a]s a company with an 
esteemed track record in the portfolio of products to treat IBD, any new product with the AbbVie brand 
must has an advantage in competitive marketing. Probably, the network of the company comprises many 
peers in th e IBD -world, which may also be a competitive ad vantage ”. 
77  Questionnaire Q 2 to competitors, replies to question 32.1.1.  
78  Questionnaire Q 2 to competitors, replies to question 15.  
 
 
21 (86) Third, as previously mentioned, the market investigation also confirmed the 
closeness of competition between the Parti es’ IL -23 inhibitors and the risk of 
discontinuation of brazikumab. The Transaction may therefore lead to the 
elimination of a potentially importan t competitive constraint.  
(87) Indeed, the market investigation confirmed that IL -23 inhibitors are a promising 
class, especially brazikumab, which is currently undergoing several head- to-head 
trials against existing treatments, namely Entyvio in UC and Humira in CD with a 
view of proving superiority of brazikumab over these products, as evidenced by 
Allergan’s intern al documents.79 As illustrated in Table 5 below, only Allergan 
conducts head- to-head trials to show superiority of brazikumab with the current 
standard of care in UC (Takeda’s Entyvio) and CD (AbbVie’s Humira). If 
successful, these trials would constitute a  competitive advantage  for brazikumab. 
TABLE 5 -  Active comparators in UC and CD clinical trials  
Product  Company  Comparator in UC  Comparator in CD  
Risankizumab  AbbVie  • Placebo  • Placebo  
Brazikumab  Allergan  • Entyvio (anti -integrin)  • Humira (anti -TNF)  
Guselkumab  J&J • Placebo  • Placebo  
• Stelara (anti -IL 12/23)  
Mirikizumab  Eli Lilly  • Placebo  
• Simponi (anti -TNF)80  • Placebo  
• Stelara (anti -IL 12/23)  
Source : Form CO  
(88) As a result  of potential horizontal non- coordinated effects in the plausible market for 
post-conventional treatments for UC and CD in the EEA (in particular (i) the 
strengthening of AbbVie’s dominant position; and (ii) the potential discontinuation 
of Allergan’s IL -23 inhibitor, both leading to potentially less choice and higher 
prices for patients and health systems), the Transaction raises serious doubts as to its 
compatibility with the internal market and the functioning of the EEA Agreement.   
4.1.4.3. Conclusion 
(89) It derives from the above that the Transaction raises serious doubts as to its 
compatibility with the internal market and the functioning of the EEA Agreement as 
a result of the overlap of the Parties’ activities in post- conventional treatments for 
UC and CD, under a ll plausible market definitions . 
4.2. Treatments for Uveitis  
(90) Uveitis is a generic term covering inflammation of the interior part of the eye (as 
opposed to eye surface inflammations such as conjunctivitis), also referred to as 
uvea. Uveitis can cause eye pain, eye redness, sensitivity to light and can lead to 
blindness. 
                                                 
79  See Form CO, Annex 7.6, p. 21: “ […]”.  
80  J&J’s Simponi is an anti -TNF which is scheduled to lose exclusivity in the EEA in 2024.  
 
 
22 (91) Uveitis can be classified as anterior, intermediate, or posterior depending on the part 
of the uvea affected by the inflammation (or as panuveitis when the entire uvea is 
affected). Uveitis may b e acute or chronic, and may be infectious or not.  
(92) Different  treatments are available depending on the type (infectious or non-
infectious) and location of the uveitis (anterior, intermediate, posterior uveitis, or 
panuveitis) . 
4.2.1. The Parties’ activities  
(93) The Parties’ drugs for the treatment of uveitis are detailed in Table 6 below. 
TABLE 6 - Parties’ drugs for the treatment of uveitis  
Product  Indication  Line of 
treatment  MoA  Status  
ABBVIE  
Humira  
(adalimumab)  Non-infectious intermediate, 
posterior and panuveitis  2nd and 3rd anti-TNF ( biologic s) Marketed81 
ALLERGAN82 
Ozurdex  
(dexamethasone)  Non-infectious posterior 
uveitis  1st unclear ( innovative small molecule ) Marketed83 
Source : Form CO  
(94) Allergan markets one product approved for the treatment of uveitis  in the EEA, 
Ozurdex, a corticosteroid that is indicated for the treatment of posterior non-
infectious uveitis.  […] . 
(95) AbbVie has one marketed product , its anti- TNF drug Humira, indicated for the 
treatment of posterior non- infectious uveitis only when a cort icosteroid treatment has 
had an inadequate response (or is inappropriate) . […] . 
4.2.2. Market definition  
(96) As regards product market definition, the Commission has not assessed the market 
for the treatment of uveitis in the past. In line with the Parties’ views, th e 
Commission considers that, for the purpose of this Decision, the exact scope of the 
market for uveitis treatments can be left open as the Transaction does not give rise to 
serious doubts as to its compatibility with the internal market even under the 
narrowest market definition giving rise to an overlap between the Parties’ drugs ( i.e. 
market for the treatment s of non- infectious posterior uveitis).  
(97) As regards the geographic market definition, the Commission has consistently 
considered the market for marketed drugs to be national in scope.84 The Parties do 
not contest this. Nothing in the market investigation suggests that the Commission 
should depart in the present case from its previous practice.  
                                                 
81  […]. 
82  For completeness, Allergan also markets Pred Forte, corticosteroid eye drops indicated for the short -term 
treatment of eye inflammation. Corticosteroid eye drops are usually the first treatment used for uveitis 
that affects the front of the eye only ( i.e. anterior uveitis). Pred Forte is not therefore substitutable with 
AbbVie’s H umira, which is not indicated for anterior uveitis.  
83  In 2018, Allergan sold Oz urdex in the following EEA countries: […] . 
84  See Section 3.1 above.  
 
 
23 4.2.3. Competitive assessment  
(98) The Parties argue that no compet ition concerns arise in the market for uveitis 
treatments or any of its plausible sub -segmentations, in particular because: (i) the 
products are not prescribed to patients as alternative treatments; (ii) the products 
have different ATC3 codes; (iii) the Pa rties compete more closely with other 
alternative treatments for uveitis.  
(99) The Commission considers that the Transaction does not raise serious doubts as to 
its compatibility with the internal market and the functioning of the EEA agreement.  
(100)  First , the Parties’ product s for the treatment of uveitis are very differentiated. They 
(i) rely on different active ingredient, (ii) involve different  MoAs (see Table 6 
above ), (iii) are used at different stages of a patient’s treatment (corticosteroids, such 
as All ergan’s Ozurdex , are used as first line treatments whereas AbbVie’s Humira is 
generally  used as second or third line treatment), and (iv) have different MoD 
(Allergan’s Ozurdex is administered directly in the eye85 whereas AbbVie’s Humira 
is injected subcut aneously). The products further differ in terms of potential side 
effects (local for Ozurdex, against immunosuppression for Humira) and treatment 
duration, a s corticosteroids such as Ozurdex typically cannot be prescribed over a 
prolonged period of time. A s a result, the Parties’ products are not close competitors 
in this space.  
(101)  The market investigation confirmed that steroids such as Ozurdex and biologics  such 
as Humira  are unlikely to be substitute s for the treatment of uveitis. In particular, one 
KOL  indicated that “Ozurdex and Humira are not alternatives to each other. These 
two products are used in a sequential fashion, in different cases, and are not 
substitutable ”.86  
(102)  Second, the Parties will continue to face the competition of many alternative 
product s, including from drugs competing more closely with each of the Parties’ 
products. There are various competing corticosteroids besides Ozurdex, including 
Iluvien, which is indicated for uveitis and has a longer durability compared to 
Ozurdex.87 While Humira  is the only  anti-TNF approved for the treatment of uveitis, 
there are biosimilars drugs available on the market. Furthermore, other anti -TNFs 
may be used off -labels. This is corroborated by the fact that […] .  
(103)  Finally , the results of the market investigat ion did not reveal any substantiated 
concerns as regards the overall impact of the Transaction in the markets for uveitis 
treatments in the EEA.  
4.2.4. Conclusion 
(104)  For all these reasons, the Commission concludes that the Transaction does not give 
rise to serious doubts as to its compatibility with the internal market and the 
functioning of the EEA Agreement as regards its impact on competition in the 
possible market s for uveitis treatments and its plausible sub -segmentations.  
                                                 
85  Ozurdex is given locally to limit systemic effects via intravitreal implants.  
86  See non -confidential minutes of call with KOL dated 26 September 2019 [original wording in French  
reads : “Humira ne constitue pas une alternative à Ozurdex. Ces deux produits sont utilisés de manière 
séquencée, dans des cas différents et ne sont pas substituables”] .  
87  See non -confidential minutes of call with KOL dated 26 September 2019.  
 
 
24 5. COMMITMENTS  
5.1. Framework for the assessment of the Commitments  
(105)  Where a concentration raises serious doubts as regards its compatibility with the 
internal market, the parties may undertake to modify the concentration to remove the 
grounds for the serious doubts identified by the Commission. Pursua nt to 
Article  6(2) of the Merger Regulation, where the Commission finds that, following 
modification by the undertakings concerned, a notified concentration no longer 
raises serious doubts, it shall declare the concentration compatible with the internal 
market pursuant to Article 6(1)(b) of the Merger Regulation.  
(106)  As set out in the Commission’s Remedies Notice,88 the commitments have to 
eliminate the competition concerns entirely, and have to be comprehensive and 
effective from all points of view.89  
(107)  In assessing whether commitments will maintain effective competition, the 
Commission considers all relevant factors, including the type, scale and scope of the 
proposed commitments, with reference to the structure and particular characteristics 
of the mark et in which the transaction is likely to significantly impede effective 
competition, including the position of the parties and othe r participants on the 
market.90 
(108)  In order for the commitments to comply with those principles, they must be capable 
of being im plemented effectively within a short period of time. Concerning the form 
of acceptable commitments, the Merger Regulation gives discretion to the 
Commission as long as the commitments meet the requisite standard. Structural 
commitments will meet the conditions set out above only in so far as the 
Commission is able to conclude with the requisite degree of certainty, at the time of 
its decision, that it will be possible to implement them, and that it will be likely that 
the new commercial structures resulting  from them will be sufficiently workable and 
lasting to ensure that the serious doubts are removed.91 Divestiture commitments are 
normally the best way to eliminate competition concerns resulting from horizontal 
overlaps.  
5.2. Proposed Commitments  
(109)  In order to r ender the concentration compatible with the internal market, the Parties 
submitted a set of commitments under Article 6(2) of the Merger Regulation on 
10 December 2019 (the “Commitments”).  
(110)  The Commission market tested the Commitments to assess whether the y are 
sufficient and suitable to remedy the serious doubts identified in Section 4 of this 
Decision. The feedback received during the market test confirmed that the 
Commitments eliminate the Commission’s competition concerns entirely .  
                                                 
88  Commission Notice on remedies acceptable under Council Regulation (EC) No 139/2004 and under 
Commission Regulation (EC) No 802/2004, the “Remedies Notice” (OJ C 267, 22.10.2008, p. 1- 27). 
89  Remedies Notice, paragraph 9.  
90  Remedies Notice, paragraph 12.  
91  Remedies Notice, paragraph 10.  
 
 
25 (111)  The Commitments are annexed to this Decision and form an integral part thereof.  
5.2.1. Description of the Commitments  
(112)  In order to dispel the serious doubts raised by the Commission, the Parties submitted 
commitments consisting of a full divestiture of the development, manufacturing  and 
marketing rights related to Allergan’s IL -23 inhibitor pipeline programme 
(brazikumab) at worldwide level (the “Divestment Business”) to a suitable purchaser 
(the “Purchaser”).  
(113)  Brazikumab is being developed by Allergan pursuant to a licence agreement  with 
AstraZeneca under which AstraZeneca granted Allergan an exclusive licence to 
develop and commercialise brazikumab worldwide. Brazikumab is currently in 
Phase II clinical trials for the treatment of UC and Phase II/III clinical trials for the 
treatmen t of CD. Brazikumab’s clinical trials include head -to-head trials to assess 
whether brazikumab is more effective than existing approved treatments (namely 
AbbVie’s Humira in CD and Takeda’s Entyvio in UC). Allergan is also testing 
brazikumab with an IL -22 companion diagnostics in order to assess whether the 
compound is more effective in patients expressing higher levels of the IL -22 
biomarker. Furthermore, Allergan is considering […]  in relation to brazikumab. 
(114)  The Divestment Business includes assets necessa ry to conduct and complete 
brazikumab’s global clinical trials, obtain the required marketing authorisation from 
regulatory authorities (if the trials are successful) and bring the product to the EEA 
and (potentially) non- EEA markets. In particular, the Di vestment Business includes 
the following main intangible and tangible assets: (i) rights to conduct the clinical 
trials, to manufacture and to market brazikumab globally; (ii) patents, copyrights, 
data and know -how related to brazikumab; (iii) the proposed  “brazikumab” 
international non- proprietary name; (iv) licences, permits and authorisations issued 
by third parties in relation to brazikumab; (v) the relevant reports related to the 
clinical trials, regulatory files, books and records, and the documentati on related to 
marketing plans and forecasts of brazikumab; (vi) contracts with third parties related 
to brazikumab, to the extent these are transferrable; (vii) all inventories of 
brazikumab; and (vii) certain Allergan employees working on the brazikumab 
programme.  
(115)  Furthermore, with the aim of ensuring a smooth transfer of the Divestment Business, 
the Parties committed to offer a number of transitional supply arrangements to the 
Purchaser, including: (i) the supply of any transitional support required by t he 
Purchaser to ensure the continuity of the clinical trials ( e.g. technical assistance, 
liaising with regulatory authorities), for up to […] ; (ii) the supply of all products and 
services currently provided by Allergan to the Divestment Business, for up to […]; 
and (iii) the supply of products and services provided to Allergan by third parties, 
through back- to-back arrangements, if the contracts in question cannot be 
transferred, for up to […] .  
(116)  In addition to the standard purchaser requirements contained i n the Commission’s 
template for divestiture remedies, the Commitments provide that the Purchaser must 
have: (i) the incentive to pursue the clinical trials for the EEA approval of 
brazikumab as they are currently designed; (ii) expertise and experience in the 
clinical development of medicinal products for EEA approval; (iii) expertise and 
experience in having interactions with relevant EEA -wide and national bodies that 
 
 
26 decide on approval of medicinal products in the EEA; and (iv) experience in the 
pricing a nd reimbursement, marketing, promotion, sales and distribution of 
medicinal products in the EEA, or the ability to develop such capabilities for the 
marketing of brazikumab. 
(117)  The Commitments also provide that the Parties should enter into commitments 
related to the divestiture, inter alia  regarding the separation of the Divestment 
Business from the Parties’ retained businesses, the preservation of the viability, 
marketability a nd competitiveness of the Divestment Business, as well as the 
appointment of a monitoring trustee and, if necessary, a divestiture trustee.  
(118)  Finally, the Commitments provide for an upfront buyer provision pursuant to which 
the Transaction cannot be impleme nted until the Commission has given its approval 
to the purchase of the Divestment Business by the Purchaser.  
(119)  The Parties argued that the Commitments remedy the Commission’s competition 
concerns since the pipeline- to-pipeline overlap between the Parties’ I L-23 inhibitor 
pipeline drugs will be removed entirely. The Parties further argued that the rights 
and assets to be transferred are sufficient for a Purchaser to continue the 
development and, depending on the outcome of the clinical trials, ultimately mark et 
brazikumab, thus allowing the Purchaser to operate the Divestment Business as a 
viable and independent business in the EEA. In addition, the Parties explained that 
the earliest date currently anticipated by Allergan for the launch of brazikumab in the 
EEA […], which gives the Purchaser […]  to prepare and establish the necessary 
operations needed for the commercialisation of brazikumab.92  
5.2.2. Results of the market test  
(120)  The market test was launched on 11  December 2019 and sought to assess the scope 
and effectiveness of the Commitments, the viability and attractiveness of the 
Divestment Business, and the appropriateness of the purchaser suitability criteria.  
(121)  The majority of competitors that responded to t he market test considered the 
Divestment Business to be an attractive asset, likely to appeal to suitable purchasers. 
In fact, several of the respondents expressed interests in acquiring brazikumab.93  
(122)  In terms of scope, market participants considered that the Divestment Business 
includes all the necessary assets, for a purchaser to be able to continue the clinical 
trials and ultimately bring the product to the EEA market.94 More specifically , 
market participants confirmed that the personnel transferred was s ufficient to 
continue the development of the programme and that the Key Personnel as identified 
in the Commitments covered all the necessary roles.95 
                                                 
92  Form RM, paragraphs 2.3 to 2.5.  
93 Questionnaire R3 to Competitors, replies to questions 4 and 5.  
94 Questionnaire R1 to KOLs, replies to question 1; Questionnaire R2 to Customers, replies to question 1; 
and Questionnaire R3 to Compe titors, replies to question 1 . 
95 Questionnaire R1 to KOLs, replies to question 2; Questionnaire R2 to Customers, replies to question 2; 
and Questionnaire R3 to Competitors, replies to questions 2 and 3.  
 
 
27 (123)  As concerns the Purchaser, the results of the market test confirmed the relevance of 
the p urchaser requirem ents included in the Commitments. In particular, most market 
participants indicated that the most suitable type of purchaser would be a company 
with (i) expertise and experience in dealing with national bodies in the EEA that 
decide on pricing and reimburs ement, and (ii) capabilities in the commercialisation 
and distribution of pharmaceutical products in the EEA.96 However, a majority of 
competitors also stated that, in the present case,  a pharmaceutical company could 
rely on third parties (including contrac t research organisations) based in the EEA to 
develop a pipeline product such as the Divestment Business.97 Furthermore, the vast 
majority of market participants consider that brazikumab’s head- to-head trials and 
IL-22 biomarker indication are particularly important,98 which confirms the need to 
pursue the clinical trials as they are currently designed.  
(124)  As regards potential implementation risks, market participants generally consider 
that the transfer of the Divestment Business and, in particular, the transfe r of third -
party supply contracts does not entail particular hurdles.99  
(125)  Finally, the respondents who expressed an opinion generally consider that the 
proposed transitional agreements provided for in the Commitments were sufficient, 
notably in terms of duration, to ensure a smooth transfer of the Divestment 
Business.100 
5.2.3. Commission’s assessment  
(126)  The Commitments remove the entire pipeline -to-pipeline and market -to-pipeline 
overlap s between the Parties’ activities for which the Commission raised serious 
doubts  following the results of the Phase I market investigation. In particular, the 
Commitments include the tangible and intangible assets necessary to conduct and 
complete the clinical trials at global level for brazikumab, and, if successful, obtain a 
marketi ng authorisation and bring brazikumab to the market.  
                                                 
96 Questionnaire R1 to KOLs, replies to question 6; Qu estionnaire R2 to Customers, replies to question 6; 
and Questionnaire R3 to Competitors, replies to question 10 . 
97 Questionnaire R3 to Competitors, replies to question 9.  
98 Questionnaire R1 to KOLs, replies to question 3 (a KOL stated that “ the head- to-head comparison may 
be used as one of the strongest argument (if not the strongest) for positioning brazikumab […] if the use 
of IL22 as a companion diagnostic holds true it would probably be rapidly picked up and implemented at 
IBD-specialised cen tres […]”); Questionnaire R2 to Customers, replies to question 3 (a customer stated 
that “ head- to-head trials against existing biologics may allow positioning of brazikumab in the treatment 
armatorium which is very important information and may give the dr ug an advantage against other il -23 
inhibitors  in the case it is found to be superior regarding effect or safety. […] Biomarkers predictive of 
drug response are important to use drug more selectively and effectively […] This may therefore also 
give braziku mab a market advantage when it is introduced”); and Questionnaire R3 to Competitors, 
replies to question 6 (a competitor stated that “ it will be very important to show superiority on head -to-
head basis for reimbursement purposes  […]”; another one indicated  that “ the comparator studies and a 
potential indication for a biomarker -defined population would provide differentiation and guidance to 
prescribers and be positive for market access ”). 
99 Questionnaire R1 to KOLs, replies to questions 9 and 10; Questionna ire R2 to Customers, replies to 
questions 9 and 10; and Questionnaire R3 to Competitors, replies to questions 14 and 15.  
100 Questionnaire R1 to KOLs, replies to question 8; Questionnaire R2 to Customers, replies to questions 7 
and 8; and Questionnaire R3 to Competitors, replies to question 12.  
 
 
28 (127)  The Commitments also include potential transitional agreements, which are 
sufficient, both in terms of scope and duration, to ensure a smooth transfer of the 
Divestment Business to the Purchaser. Furthe rmore, the Commitments include 
targeted purchaser criteria, such that the Divestment Business will be transferred to a 
suitable purchaser. Finally, the Commission considers that the upfront buyer clause 
mitigates implementation risks inherent to the develo pment of pipeline drugs.  
(128)  The results of the market test confirmed the suitability and viability of the 
Divestment Business and did not reveal any shortcomings of the Commitments.  
(129)  On this basis, and in view of the presence of a number of interested potenti al 
purchasers, the Commission considers that the Divestment Business is attractive and 
likely to be acquired by a suitable purchaser.  
(130)  For the reasons outlined above, the Commission concludes that the Commitments 
are sufficient in scope and suitable to eli minate the serious doubts as to the 
compatibility of the Transaction with the internal market on all plausible markets .  
6. CONDITIONS AND OBLIGA TION  
(131)  Under the first sentence of the second subparagraph of Article 6(2) of the Merger 
Regulation, the Commission may attach to its decision conditions and obligations 
intended to ensure that the undertakings concerned comply with the commitments 
they have entered into vis -à-vis the Commission with a view to rendering a notified 
concentration compatible with the inter nal market.  
(132)  The achievement of the measure that gives rise to the structural change of the market 
is a condition, whereas the implementing steps which are necessary to achieve this 
result are generally obligations on the Parties. Where a condition is not fulfilled, the 
Commission’s decision declaring the concentration compatible with the internal 
market no longer stands. Where the undertakings concerned commit a breach of an 
obligation, the Commission may revoke the clearance decision in accordance with 
Article 8(6) of the Merger Regulation. The undertakings concerned may also be 
subject to fines and periodic penalty payments under Articles 14(2) and 15(1) of the 
Merger Regulation.  
(133)  In accordance with the distinction described above, the Decision in this ca se is 
conditioned on the full compliance with the requirements set out in Section B of the 
Commitments (including the Schedule), which constitute conditions. The remaining 
requirements set out in the other s ection of the Commitments constitute obligations 
on the Parties.  
(134)  The detailed text of the Commitments is annexed to this Decision. The full text of 
the Commitments forms an integral part of this Decision.  
7. CONCLUSION  
(135)  For the above reasons, the Commission has decided not to oppose the notified 
operation as modified by the commitments and to declare it compatible with the 
internal market and with the functioning of the EEA Agreement, subject to full 
compliance with the conditions in Section B of the Commitments annexed to the 
 
 
29 present decision and with the obligations contained in the other sections of the said 
Commitments. This decision is adopted in application of Article 6(1)(b) in 
conjunction with Article 6(2) of the Merger Regulation and Article 57 of the EEA 
Agreement.  
For the Commission 
 
 
(Signed)  
Margrethe VESTAGER  
Executive Vice -President  
M.9461 – ABBVIE / ALLERGAN  
 
  
 
  
 
Dated 10 December  2019 
 
 
 
 
 
 
Case No COMP/M.9461 –  AbbVie/Allergan  
Commitments to the European Commission  
 
 
 
 
 
 
 
 
 
 
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
2 
 
 CASE NO. COMP/M.9461 – ABBVIE/ALLERGAN 
Commitments to the European  Commission  
Pursuant  to Article  6(2) of Council  Regulation  (EC) No.  139/2004 (the  “Merger Regulation ”), 
AbbVie Inc. (“AbbVie ”) and Allergan plc  (“Allergan ”) hereby enter into the following 
Commitments (the “ Commitments ”) vis -à-vis the European Commission (the “ Commission ”) 
with a view to rendering the acquisition by AbbVie of sole control over  Allergan  (the 
“Concentration ”) compatible  with the internal  market  and the functioning of the EEA  
Agreement.  
This text shall be interpreted in light of the Commission’s decision pursuant to Article 6(1)(b) 
of the Merger  Regulation  to declare the Concentration compatible  with the internal  market  and 
the functioning  of the EEA  Agreement  (the “Decision ”), in the general  framework  of European  
Union law, in particular in light of the Merger Regulation, and by reference to the Commission 
Notice on remedies acceptable under Council Regulation (EC) No 139/2004 and under 
Commission Regulation (EC) No 802/2004 (the “ Remedies  Notice ”). 
SECTION A:  DEFINITIONS  
1. For the purpose of the Commitments, the following terms shall have the following 
meaning  
AbbVie: AbbVie Inc. , a Delaware incorporated company with its registered office at 1 North 
Waukegan Road, North Chicago, Illinois, 60064- 6400. 
Affiliated Undertakings : undertakings controlled by the Parties and/or by the ultimate parents 
of the Parties, whereby th e notion of control shall be interpreted pursuant to Article 3 of the 
Merger Regulation and in light of the Commission Consolidated Jurisdictional Notice under 
Council Regulation (EC) No 139/2004 on the control of concentrations between undertakings 
(the “Consolidated Jurisdictional  Notice”).  
Allergan : Allergan plc, a company incorporated under the laws of Ireland, with its registered 
office at Clonshaugh Business and Technology Park, Coolock, Dublin, D17 E400, Ireland.   
Assets: the assets that contribute to the current operation or are necessary to ensure the 
viability  and competitiveness  of the Divestment Business  (including those  indicated  in Section  
C, paragraph 10 (i), (ii) and (iii)) and described in more detail in the  Schedule.  
AstraZeneca : AstraZeneca plc, a company incorporated under the laws of England and Wales, 
with its  registered office at 1 Francis Crick Avenue, Cambridge Biomedical Campus , 
Cambridge, CB2 0AA.  
AstraZeneca Agreement : the Licence Agreement between AstraZeneca and Allergan, dated 
[…], and modifications thereto, whereby AstraZeneca grants to Allergan exclusive  worldwide  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
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 patent  and know -how rights  to develop, manufacture,  commercialise and otherwise exploit 
Brazikumab. These rights are granted by […] . 
AstraZeneca/Amgen Collaboration: agreement for the joint development, manufacture and 
commercialisation of various products, including Brazikumab.  
Best Efforts : Best effort ob ligations shall be interpreted in light of the Commission's decision 
pursuant to Article 6(1)(b) of the Merger Regulation to declare the Concentration compatible 
with the internal market and the functioning of the EEA Agreement, the Merger Regulation 
and t he general principles of EU law.  Any interpretation that may be given to this term under 
the law of other jurisdictions is not relevant solely for the purpose of interpreting and/or 
implementing the Commitments.  
Brazikumab : Allergan’s in -licensed pipeline  IL-23 p19 biologic, previously known as 
MEDI2070 and AMG139, which is currently in Phase II clinical trials for the treatment of 
ulcerative colitis ("UC ") and Phase IIb / III clinical trials for the treatment of Crohn’s disease 
("CD"). 
Brazikumab drug substance:  the active ingredient of Brazikumab.  
Closing : the transfer of the legal title to the Divestment Business to the  Purchaser.  
Closing Period : the period of […] from the approval of the Purchaser and the terms of sale by 
the Commission.  
Confidential I nformation : any business secrets, know -how, commercial information, or any 
other information of a proprietary nature that is not in the public  domain. 
Conflict of Interest : any conflict of interest that impairs the Trustee's objectivity and 
independence in discharging its duties under the  Commitments.  
Divestment Business : the development programme and all relevant assets related to 
Brazikumab as defined in Section B and in the Schedule which the Parties commit to divest.  
Divestiture Trustee: one or more natural or legal person(s) who is/are approved by the 
Commission  and appointed by the Parties and  who has/have  received  from the Parties the  
exclusive Trustee Mandate to sell the Divestment Business to a Purchaser at no minimum 
price.  
Effective Date: the d ate of adoption of the  Decision.  
First  Divestiture  Period : the period of […]  from  the Effective Date.  
Hold Separate Manager : the person appointed by the Parties for the Divestment Business to 
manage the day -to-day business under the supervision of the Monitoring  Trustee.  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
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 Key Personnel: all personnel necessary to maintain the viability and competitiveness of the 
Divestment Business, as listed in Annex  4 to the Commitments , including the Hold Separate 
Manager.  
Monitoring Trustee: one or more natural or l egal person(s), who is/are approved by the 
Commission and appointed by the Parties , and who has/have the duty to monitor the Parties’ 
compliance with the conditions and obligations attached to the  Decision.  
Parties: Allergan and AbbVie. 
Personnel : all staf f currently involved in the development of Brazikumab, as listed in Annex  5 
to the Commitments.  
Purchaser: entity  approved by the Commission  as acquirer of the Divestment Business in 
accordance with the criteria set out in Section D.  
Purchaser Agreement: the asset purchase agreement for the sale of the Divestment Business, 
or other relevant and legally binding agreement(s) required to effect the transfer of the 
Divestment Business to the Purchaser.  
Purchaser Criteria : the criteria laid down in paragraph 18 of these Commitments that the 
Purchaser must fulfil in order to be approved by the  Commission.  
Schedule : the schedule to these Commitments describing in more detail the Divestment 
Business.  
Trustee(s) : the Monitoring  Trustee  and/or  the Divestiture  Trustee as the case may be. 
Trustee Divestiture Period : the period of […]  from  the end of the First Divestiture Period.  
SECTION  B: THE COMMITMENT TO DIVEST AND THE DIVESTMENT 
BUSINESS  
Commitment to  divest  
2. In order to maintain effective competition, the Parties commit to divest, or procure the 
divestiture of, the Divestment Business by the end of the Trustee Divestiture Period as a 
going concern to a purchaser and on terms of sale approved by the Commission in 
accordance with the procedure described in paragraphs 19 and 20 of these 
Commitments.  To carry out the divestiture, the Parties commit to find a purchaser and 
to enter into a final binding Purchaser Agreement within the First Divestiture Period.  If 
the Parties have not entered into such an agreement at the end of the First Divestiture 
Period, the Parties shall grant the Divestiture Trustee an exclusive mandate to sell the 
Divestment Business in accordance with the procedure described in paragraph 32 in the 
Trustee Divestiture Period.  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
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 3. The Concentrati on shall not be implemented before the Parties or the Divestiture 
Trustee has entered into a final binding Purchaser Agreement (as well as ancillary 
agreements) and the Commission has approved the Purchaser and the terms of sale in 
accordance with paragrap hs 19 and 20. 
4. The Parties shall be deemed t o have complied with this commitment if:  
(i) by the end of the Trustee  Divestiture  Period, AbbVie,  Allergan,  or the Divesture  
Trustee has entered into a final binding Purchaser Agreement (as well as 
ancillary agreements), and the Commission approves  the proposed purchaser  and 
the terms  of transfer  or sale as being consistent with the Commitments in 
accordance with the procedure described in paragraphs 19 and 20;  and 
(ii) the Closing of the sale of the Divestment Business to the Purchaser takes place 
within the Closing  Period. 
5. In order to maintain the structural effect of the Commitments, AbbVie shall, for a 
period of 10 years after Closing, not acquire, whether directly or indirectly, the 
possibility of exercising influence (as defined in paragraph 43 of the Remedies Notice, 
footnote 3) over the whole or part of the Divestment Business, unless, following the 
submission of a reasoned request from AbbVie showing good cause and accompanied 
by a report from the Monitoring Trustee (as provided in paragraph 46 of these 
Commitments), the Commission finds that the structure of the market has changed to 
such an extent that the absence of influence over the Divestment Business is no longer 
necessary to render the proposed Concentration compatible with the internal market.  
Structure and definition of the Divestment  Business  
6. The Divestment Business consists of all relevant rights, title and interests in 
Brazikumab worldwide, including in particular the assignment or transfer to the 
Purchaser or, (if relevant) termination, of Allergan’s exclusive licence to develop and 
commercialise Brazikumab in terms of the AstraZeneca Agreement, as well as certain 
ancillary assets and the rights to, or l icence for, certain technologies needed to 
successfully develop Brazikumab.  The legal and functional structure of the Divestment 
Business as operated to date is described in the Schedule.  The Divestment Business, 
described in more detail in the Schedule,  includes all assets and staff that contribute to 
the current operation of the Divestment Business or that are necessary to ensure the 
viability and competitiveness of the Divestment Business, in particular:  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
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 (i) all tangible and intangible assets (including in tellectual property rights);  
(ii) all licences, permits and authorisations issued by any governmental organisation 
for the benefit of the Divestment Business; 
(iii) all contracts, and commitments of the Divestment Business and all credit and 
other records of the Divestment Business;  
(iv) the Key Personnel.  Allergan will use its Best Efforts to obtain the consent of 
the Key Personnel to transfer with the Divestment Business.  For a period of 
[…] after Closing, the Purchaser shall also have the opportunity to interview the  
Personnel and to enter into employment contracts with any Personnel.  
7. The Divestment Business shall not include any physical production assets owned or 
operated by the Parties.  It will include a small volume of inventory (including samples, 
work -in-proces s and pharmaceutical ingredients inventory).   
8. The Parties commit to use Best Efforts to ensure an effective transfer of the clinical 
trials to the Purchaser, as well as reasonable support relating inter alia to regulatory 
interactions (as reasonably requested by the Purchaser) and assignment of contracts, 
regulatory permits and licences.  Furthermore, the Parties commit to continue to act as a 
sponsor for all clinical trials underway for the period between the Effective Date until 
Closing.  At the Pur chaser’s request, and subject to the Commission’s approval, with 
respect to any clinical trial, this period can be extended for a mutually agreed period, 
[…].  
9. In addition, the Divestment Business includes the benefit, for a transitional period of up 
to […]  after Closing and on terms and conditions equivalent to those at present afforded 
to the Divestment Business, of all current arrangements under which Allergan or its 
Affiliated Undertakings supply products or services to the Divestment Business, as 
detail ed in the Schedule, unless otherwise agreed with the Purchaser.  Strict firewall 
procedures will be adopted so as to ensure that any competitively sensitive information 
related to, or arising from such supply arrangements (for example, product roadmaps) 
will not be shared with, or passed on to, anyone outside the Parties’ entity(ies) 
providing such services.   
SECTION  C: RELATED  COMMITMENTS  
Preservation of viability, marketability and  competitiveness  
10. From the Effective Date until Closing, the Parties shall preserve, or procure the 
preservation of the economic viability, marketability and competitiveness of the 
Divestment Business, in accordance with good business practice, and shall minimise as 
far as possible any risk of loss of competitive potential of the  Divestment Business. In 
particular, the Parties undertake:  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
7 
 
 (i) not to carry  out any action  that might have  a significant  adverse impact on the 
value, management or competitiveness of the Divestment Business or that might 
alter the nature and scope of activity , or the industrial or commercial strategy or 
the investment policy of the Divestment Business;  
(ii) to make available, or procure to make available, sufficient resources for the 
development of the Divestment Business, on the basis and continuation of the 
existing business  plans;  
(iii) to use Best Efforts, including appropriate incentive schemes (based on industry 
practice), to  encourage all  Key Personnel to  remain  with the Divestment 
Business,  and not to solicit or move any  Key Personnel  to the Parties’  remainin g 
businesses.   Where,  nevertheless,  individual members of the Key Personnel 
exceptionally leave the Divestment Business, the Parties shall provide a 
reasoned proposal to replace the person or persons concerned  to the Commission  
and the Monitoring  Trustee.  The Parties  must  be able to demonstrate to the 
Commission that the replacement is well suited to carry out the functions 
exercised by those individual members of the Key Personnel.  The replacement 
shall take place under the supervision of the Monitoring Trustee, who shall 
report to the Commission.   
Hold -separate obligations  
11. The Parties commit from the Effective Date until Closing to procure that the 
Divestment Business is kept separate from the business(es) they will be retaining and, 
after closing of th e Concentration, to keep the Divestment Business separate from the 
business(es) they are retaining and to ensure that unless explicitly permitted under these 
Commitments:  
(i) Management and staff of the business(es) retained by the Parties have no 
involvement in the Divestment Business;  
(ii) Key Personnel of the Divestment Business have no involvement in any business 
retained by the Parties and do not report to any individual outside the 
Divestment Business, except for certain Key Personnel to the extent indicated i n 
Annex 4 to the Commitments;  
(iii) Personnel of the Divestment Business and the Key Personnel identified in 
Annex 4 can be involved in businesses retained by the Parties only to the extent 
that (a) they are bound by the terms of non- disclosure agreements or sim ilar 
arrangements preventing the disclosure of any information; (b) they are not 
involved in any UC/CD businesses retained by the Parties; and (c) their 
involvement in other businesses retained by the Parties is compatible with the 
required involvement in the Divestment Business.  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
8 
 
 12. Until Closing, the Parties shall assist the Monitoring Trustee in ensuring that the 
Divestment Business is managed as a distinct and saleable entity separate from the 
businesses which the Parties are retaining. Immediately after th e adoption of the 
Decision, the Parties shall appoint a Hold Separate Manager.  The Hold Separate 
Manager, who shall be part of the Key Personnel shall manage the Divestment Business 
independently and in the best interest of the business with a view to ens uring its 
continued economic viability, marketability and competitiveness and its independence 
from the businesses retained by the Parties.  The Hold Separate Manager shall closely 
cooperate with and report to the Monitoring Trustee, and, if applicable, the Divestiture 
Trustee.  Any replacement of the Hold Separate Manager shall be subject to the 
procedure laid down in paragraph 10(iii)  of these Commitments.  The Commission 
may, after having heard the Parties, require the Parties to replace the Hold Separate 
Manager.  
Ring -fencing  
13. The Parties shall implement, or procure to implement, all necessary measures to ensure 
that the Parties do not, after the Effe ctive Date, obtain any Confidential Information 
relating to the Divestment Business and that any such Confidential Information 
obtained by the Parties before the Effective Date will be eliminated and not be used by 
the Parties. In particular, the participa tion of the Divestment Business in any central 
information technology network shall be severed to the extent possible, without 
compromising the viability of the Divestment Business. The Parties may obtain or keep 
information relating to the Divestment Business which is reasonably necessary for the 
divestiture of the Divestment Business or the disclosure of which to the Parties is 
required by law.   
Non-solicitation  clause 
14. The Parties undertake, subject to customary limitations, not to solicit, and to procure  
that Affiliated Undertakings do not solicit, the Key Personnel and Personnel transferred 
with the Divestment Business for a period of […] after Closing.  
Due diligence  
15. In order to enable potential purchasers to carry out a reasonable due diligence of the 
Divestment Business, the Parties shall, subject to customary confidentiality assurances 
and dependent on the stage of the divestiture process:  
(i) provide to potential purchasers sufficient information as regards the Divestment 
Business;  
(ii) provide to potential purchasers after the Effective Date, a version of the 
Commitments (including the Schedule and its Annexes) without undue delay 
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
9 
 
 and no later than at the signing of a Non- Disclosure Agreement by the potential 
purchaser, or at the opening a data -room, whicheve r is earlier.  Any redaction to 
the Commitments should be agreed in advance with the Commission.  
(iii) provide to potential purchasers sufficient information relating to the Personnel 
and allow them reasonable access to the Personnel. 
Reporting  
16. The Parties shall  submit written reports in English on potential purchasers of the 
Divestment Business and developments in the negotiations with such potential 
purchasers to the Commission and the Monitoring Trustee no later than 10 days after 
the end of every month follow ing the Effective Date (or otherwise at the Commission’s 
request).  The Parties shall submit a list of all potential purchasers having expressed 
interest in acquiring the Divestment Business to the Commission at each and every 
stage of the divestiture proc ess, as well as a copy of all the offers made by potential 
purchasers within five days of their receipt.  
17. The Parties shall inform the Commission and the Monitoring Trustee on the preparation 
of the data room documentation and the due diligence procedure and shall submit a 
copy of any information memorandum to the Commission and the Monitoring Trustee 
before sending the memorandum out to potential purchasers.  
SECTION  D: THE  PURCHASER  
18. In order to be approved by the Commission, the Purchaser must fulfil the following 
criteria:  
(i) The Purchaser  shall  be independent  of and unconnected  to the Parties  and their 
Affiliated Undertakings (this being assessed having regard to the situation 
following the divestiture); 
(ii) The Purchaser shall have the financial resources, proven expertise and incentive  
to maintain and develop the Divestment Business as a viable and active 
competitive force in competition with the Parties and other  competitors.  The 
Purchaser should in particular have the incentive to pursue the clinical tri als for 
the EEA approval of Brazikumab as they are designed as of the Effective Date;  
(iii) The acquisition of the Divestment Business by the Purchaser must neither be 
likely to create, in light of the information available to the Commission, prima 
facie competi tion concerns nor give rise to a risk that the implementation of the 
Commitments will be delayed. In particular, the Purchaser must reasonably be 
expected to obtain all necessary approvals from the relevant regulatory 
authorities for the acquisition of the  Divestment Business;  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
10 
 
 (iv) The Purchaser shall have expertise and experience in the clinical development 
of medicinal products for EEA approval;  
(v) The Purchaser shall have expertise and experience in having relevant 
interactions with relevant EEA -wide and nationa l bodies that decide on approval 
of medicinal products in the EEA;  
(vi) The Purchaser shall have experience in the pricing and reimbursement, 
marketing, promotion, sales and distribution of medicinal products in the EEA, 
or the ability to develop such capabilit ies for the marketing of Brazikumab.  
19. The final binding Purchaser Agreement (as well as ancillary agreements) shall be 
conditional on the Commission’s approval.  
20. When Allergan has reached an agreement with a purchaser, the Parties shall submit a 
fully docum ented and reasoned proposal, including a copy of the final agreement(s), 
within one week to the Commission and the Monitoring Trustee. The Parties must be 
able to demonstrate to the Commission that the Purchaser fulfils the Purchaser Criteria 
and that the Divestment Business is being sold in a manner consistent with the 
Commission’s Decision and the Commitments.  For the approval, the Commission shall 
verify that the Purchaser fulfils the Purchaser Criteria and that the Divestment Business 
is being sold in a manner consistent with the Commitments including their objective to 
bring about a lasting structural change in the market. The Commission may approve the 
sale of the Divestment Business without one or more Assets, or parts of the Key 
Personnel, or by substituting one or more Assets or parts of the Key Personnel with one 
or more different assets or different personnel, if this does not affect the viability and 
competitiveness of the Divestment Business after the sale, taking account of the 
proposed purchas er. 
SECTION  E  TRUSTEE  
I. Appointment procedure  
21. The Parties shall appoint a Monitoring Trustee to carry out the functions specified in 
these Commitments for a Monitoring Trustee.  The Parties commit not to close the 
Concentration before the appointment of a Monitoring Trustee.  
22. If Allergan has not entered into a binding Purchaser Agreement […] before the end of 
the First Divestiture Period or if the Commission has rejected a purchaser proposed by 
the Parties at that time or thereafter, the Parties shall appoin t a Divestiture Trustee.  The 
appointment of the Divestiture Trustee shall take effect upon the commencement of the 
Trustee Divestiture Period.  
 
 
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11 
 
 23. The Trustee shall:  
(i) At the time of appointment, be independent  of the Parties  and their Affiliated  
Undertakings;  
(ii) Possess the necessary qualifications to carry out its mandate, for example have 
sufficient relevant experience as an investment banker or consultant or auditor;  
and 
(iii) Neither have nor become exposed to a Conflict of  Interest.  
24. The Trustee shall be remunerated  by the Parties in a way that does not impede the 
independent and effective fulfilment of its mandate. In particular, where the 
remuneration package of a Divestiture Trustee includes a success premium linked to the 
final sale value of the Divestment Busine ss, such success premium may only be earned 
if the divestiture takes place within the Trustee Divestiture Period.  
Proposal by the Parties  
25. No later than two weeks after the Effective Date, the Parties shall submit the name or 
names of one or more natural or  legal persons whom the Parties propose to appoint as 
the Monitoring Trustee to the Commission for approval. No later than one month 
before the end of the First Divestiture Period or on request by the Commission, the 
Parties shall submit a list of one or more persons whom the Parties propose to appoint 
as Divestiture Trustee to the Commission for approval. The proposal shall contain 
sufficient information for the Commission to verify that the person or persons proposed 
as Trustee fulfil the requirements set  out in paragraph 23 and shall include:  
(i) the full terms of the proposed mandate, which shall include all provisions  
necessary to enable the Trustee to  fulfil its duties under these  Commitments; 
(ii) the outline of a work plan which describes how the Trustee intends to carry out 
its assigned  tasks;  
(iii) an indication  whether  the proposed Trustee  is to act as both Monitoring Trustee 
and Divestiture Trustee or whether different trustees are proposed for the two  
functions. 
Approval or rejection by the Commission  
26. The Commission shall have the discretion to approve or reject the proposed Trustee(s) 
and to approve the proposed mandate subject to any modifications it  deems necessary 
for the Trustee to fulfil its obligations.  If only one name is approved, the Parties shall 
appoint or cause to be appointed the person or persons concerned as Trustee, in 
accordance with the mandate approved by the Commission.  If more than one name is 
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
12 
 
 approved, the Parties shall be free to choose the Trustee to be appointed from among 
the names approved.  The Trustee shall be appointed within one week of the 
Commission’s approval, in accordance with the mandate approved by the Commission.  
New proposal by  the Parties  
27. If all the proposed Trustees are rejected, the Parties shall submit the names of at least 
two more natural or legal persons within one week of being informed of the rejection, 
in accordance with paragraphs 21 and 26 of these Commitments.  
Trustee no minated by the  Commission  
28. If all further proposed Trustees are rejected by the Commission, the Commission shall 
nominate a Trustee, whom the Parties shall appoint, or cause to be appointed, in 
accordance with a trustee mandate approved by the Commission.  
II. Functions of the  Trustee  
29. The Trustee shall assume its specified duties and obligations in order to ensure 
compliance with the Commitments. The Commission may, on its own initiative or at 
the request of the Trustee or the Parties, give any orders or instruct ions to the Trustee in 
order to ensure compliance with the conditions and obligations attached to the 
Decision.  
Duties and obligations of the Monitoring  Trustee  
30. The Monitoring Trustee shall:  
(i) propose in its first report to the Commission a detailed work plan describing 
how it intends to monitor compliance with the obligations and conditions 
attached to the Decision;  
(ii) oversee, in close co -operation with the Hold Separate Manager, the on- going 
management of the Divestment Business with a view to ensuring its  continued 
economic viability, marketability and competitiveness and monitor compliance 
by the Parties with the conditions and obligations attached to the Decision.  To 
that end the Monitoring Trustee  shall: 
(a) monitor the preservation of the economic viability, marketability and 
competitiveness of the Divestment Business, and the keeping separate of 
the Divestment Business from the businesses retained by the Parties, in 
accordance with paragraphs 10 and 11 of these  Commitments;  
(b) supervise the management of the Divestment Business as a distinct and 
saleable entity, in accordance with paragraph 12 of these  Commitments;  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
13 
 
 (c)  with respect to Confidential Information:  
(I) determine all necessary measures to ensure that the Parties do not 
after the Effective Date obtain any Confidential Information 
relating to the Divestment Business;  
(II) in particular strive for the severing of the Divestment Business’ 
participation in  a central information technology network to the 
extent possible, without compromising the viability of the 
Divestment Business;  
(III) make sure that any Confidential  Information  relating  to the 
Divestment Business obtained by the Parties before the Effective 
Date is eliminated and will not be used by the Parties;  and 
(IV) decide whether such information may be disclosed to or kept by 
the Parties as the disclosure is reasonably necessary to allow the 
Parties to carry out the divestiture or as th e disclosure is required 
by law;  
(d) monitor the splitting of assets and the allocation of Personnel between 
the Divestment Business and the Parties or Affiliated  Undertakings;  
(iii) propose to the Parties such measures as the Monitoring Trustee considers 
necessary to ensure the Parties’ compliance with the conditions and obligations 
attached to the Decision, in particular the maintenance of the full economic 
viability, marketability o r competitiveness of the Divestment Business, the 
holding separate of the Divestment Business and the non- disclosure of 
competitively sensitive information; 
(iv) review and assess potential purchasers as well as the progress of the divestiture 
process and verif y that, dependent on the stage of the divestiture  process:  
(a) potential  purchasers  receive sufficient  and correct  information  relating  to 
the Divestment Business and the Personnel in particular by reviewing, if 
available, the data room documentation, the info rmation memorandum 
and the due diligence process, and 
(b) potential purchasers are granted reasonable access to the Personnel;  
(v) act as a contact point for any requests by third parties, in particular potential 
purchasers, in relation to the  Commitments;  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
14 
 
 (vi) provide  to the Commission, sending  the Parties  a non-confidential  copy  at the 
same time,  a written  report  within  15 days after the end of every  month that shall  
cover  the operation and management of the Divestment Business as well as the 
splitting of assets and the allocation of Personnel so that the Commission can 
assess whether the  business  is held in a manner  consistent  with the 
Commitments  and the progress of the divestiture process as well as potential  
purchasers;  
(vii) promptly report in writing to the Commission, sending the Parties a non-
confidential copy at the same time, if it concludes on reasonable grounds that 
the Parties are failing to comply with these  Commitments;  
(viii) within one week after receipt of the documented proposal referred to in 
paragraph  20 of these Commitments,  submit to the Commission,  sending  the 
Parties  a non-confidential copy at the same time, a reasoned opinion as to the 
suitability and independence of the proposed purchaser and the viability of the 
Divestment Business after the sale and as to whether the Divestment Business is 
sold in a manner consistent with the conditions and obligations attached to the 
Decision, in par ticular, if relevant, whether the sale of the Divestment Business 
without one or more Assets or not all of the Personnel affects the viability of the 
Divestment Business after the sale, taking account of the proposed purchaser;  
and 
(ix) assume the other functions assigned to the Monitoring  Trustee under the 
conditions and obligations attached to the  Decision. 
31. If the Monitoring and Divestiture Trustee are not the same legal or natural persons, the 
Monitoring Trustee and the Divestiture Trustee shall cooper ate closely with each other 
during and for the purpose of the preparation of the Trustee Divestiture Period in order 
to facilitate each other's tasks.  
Duties and obligations of the Divestiture  Trustee  
32. Within the Trustee Divestiture Period, the Divestiture Trustee shall sell at no minimum 
price the Divestment Business to a purchaser, provided that the Commission has 
approved both the purchaser and the final binding Purchaser Agreement (and ancillary 
agreements) as in line with the Decision and the Commitments in accordance with 
paragraphs 18, 19 and 20 of these Commitments.  The Divestiture Trustee shall include 
in the Purchaser Agreement (as well as in any ancillary agreements) such terms and 
conditions as it considers appropriate for an expedient sale in the Trustee Divestiture 
Period.  In particular, the Divestiture Trustee may include in the Purchaser Agreement 
such customary representations and warranties and indemnities as are reasonably 
required to effect the sale.  The Divestiture Trustee shall protect the legitimate financial 
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
15 
 
 interests of the Parties, subject to AbbVie’s unconditional obligation to divest at no 
minimum price in the Trustee Divestiture Period.  
33. In the Trustee Divestiture Per iod (or otherwise at the Commission’s request), the 
Divestiture Trustee shall provide the Commission with a comprehensive monthly report 
written in English on the progress of the divestiture process.  Such reports shall be 
submitted within 15 days after th e end of every month with a simultaneous copy to the 
Monitoring Trustee and a non- confidential copy to the Parties.  
III. Duties and obligations of the  Parties  
34. The Parties shall provide and shall cause their advisors to provide the Trustee with all 
such co -operation, assistance and information as the Trustee may reasonably require to 
perform its tasks. The Trustee shall have full and complete access to any of the Parties 
or the Divestment Business’s books, records, documents, management or other 
personnel, facili ties, sites and technical information necessary for fulfilling its duties 
under the Commitments and the Parties and the Divestment Business shall provide the 
Trustee upon request with copies of any document.  The Parties and the Divestment 
Business shall m ake available to the Trustee one or more offices on their premises and 
shall be available for meetings in order to provide the Trustee with all information 
necessary for the performance of its tasks.  
35. The Parties shall provide the Monitoring Trustee with al l managerial and administrative 
support that it may reasonably request on behalf of the management of the Divestment 
Business.  This shall include all administrative support functions relating to the 
Divestment Business which are currently carried out at h eadquarters level.  The Parties 
shall provide and shall cause their advisors to provide the Monitoring Trustee, on 
request, with the information submitted to potential Purchasers, in particular give the 
Monitoring Trustee access to the data room documentat ion and all other information 
granted to potential purchasers in the due diligence procedure.  The Parties shall inform 
the Monitoring Trustee on possible purchasers, submit lists of potential purchasers at 
each stage of the selection process, including th e offers made by potential purchasers at 
those stages, and keep the Monitoring Trustee informed of all developments in the 
divestiture process.  
36. The Parties shall grant or procure Affiliated Undertakings to grant comprehensive 
powers of attorney, duly executed, to the Divestiture Trustee to effect the sale 
(including ancillary agreements), the Closing and all actions and declarations which the 
Divestiture Trustee considers necessary or appropriate to achieve the sale and the 
Closing, including the appointment of advisors to assist with the sale process.  Upon 
request of the Divestiture Trustee, the Parties shall cause the documents required for 
effecting the sale and the Closing  to be duly executed.  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
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 37. The Parties shall indemnify the Trustee and its employees a nd agents (each an 
“Indemnified Party”) and hold each Indemnified Party harmless against, and hereby 
agrees that an Indemnified Party shall have no liability to the Parties for, any liabilities 
arising out of the performance of the Trustee’s duties under t he Commitments, except 
to the extent that such liabilities result from the wilful default, recklessness, gross 
negligence or bad faith of the Trustee, its employees, agents or advisors. 
38. At the expense of the Parties, the Trustee may appoint advisors (in pa rticular for 
corporate finance or legal advice), subject to the Parties’ approval (this approval not to 
be unreasonably withheld or delayed) if the Trustee considers the appointment of such 
advisors necessary or appropriate for the performance of its dutie s and obligations 
under the Mandate, provided that any fees and other expenses incurred by the Trustee 
are reasonable.  Should the Parties refuse to approve the advisors proposed by the 
Trustee the Commission may approve the appointment of such advisors instead, after 
having heard the Parties.  Only the Trustee shall be entitled to issue instructions to the 
advisors. Paragraph 37 of these Commitments s hall apply mutatis mutandis. In the 
Trustee Divestiture Period, the Divestiture Trustee may use advisors who served the 
Parties during the Divestiture Period if the Divestiture Trustee considers this in the best 
interest of an expedient sale.  
39. The Parties a gree that the Commission may share Confidential Information proprietary 
to the Parties with the Trustee.  The Trustee shall not disclose such information and the 
principles contained in Article 17 (1) and (2) of the Merger Regulation apply mutatis 
mutandis . 
40. The Parties agree that the contact details of the Monitoring Trustee are published on the 
website of the Commission's Directorate -General for Competition and they shall inform 
interested third parties, in particular any potential purchasers, of the ident ity and the 
tasks of the Monitoring Trustee.  
41. For a period of 10 years from the Effective Date the Commission may request all 
information from the Parties that is reasonably necessary to monitor the effective 
implementation of these Commitments.  
IV. Replacement , discharge and reappointment of the  Trustee 
42. If the Trustee ceases to perform its functions under the Commitments or for any other 
good cause, including the exposure of the Trustee to a Conflict of Interest:  
(i) the Commission may, after hearing the Trustee and the Parties, require the 
Parties to replace the Trustee;  or 
(ii) the Parties may, with the prior approval of the Commission, replace the  Trustee.  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
17 
 
 43. If the Trustee is removed according to paragraph 42 of these Commitments, the Trustee 
may be required to continue in its function until a new Trustee is in place to whom the 
Trustee has effected a full hand over of all relevant inform ation.  The new Trustee shall be 
appointed in accordance with the procedure referred to in paragraphs 21- 28 of these 
Commitments.  
44. Unless removed according to paragraph 42 of these Commitments, the Trustee shall cease 
to act as Trustee only after the Commission has discharged it from its duties after all the 
Commitments with which the Trustee has been entrusted have been implemented.  
However, the Commission may at any time  require the reappointment of the Monitoring 
Trustee if it subsequently appears that the relevant remedies might not have been fully and 
properly implemented.  
SECTION  F: THE REVIEW  CLAUSE  
45. The Commission may extend the time periods foreseen in the Commitmen ts in response to 
a request from the Parties or, in appropriate cases, on its own initiative.  Where the Parties 
request an extension of a time period, they shall submit a reasoned request to the 
Commission no later than one month before the expiry of that  period, showing good cause.  
This request shall be accompanied by a report from the Monitoring Trustee, who shall, at 
the same time send a non -confidential copy of the report to the Parties.  Only in exceptional 
circumstances shall the Parties be entitled  to request an extension within the last month of 
any period.  
46. The Commission may further, in response to a reasoned request from the Parties showing 
good cause waive, modify or substitute, in exceptional circumstances, one or more of the 
undertakings in these Commitments.  This request shall be accompanied by a report from 
the Monitoring Trustee, who shall, at the same time send a non- confidential copy of the 
report to the Parties.  The request shall not have the effect of suspending the application of 
the undertaking and, in particular, of suspending the expiry of any time period in which the 
undertaking has to be complied with.  
SECTION  G:  ENTRY INTO  FORCE  
47. The Commitments shall take effect upon the date of adoption of the Decision.  
(Signed)  
Duly authoris ed for and on behalf of:  AbbVie Inc.  
Duly authorised for and on behalf of:  Allergan plc  
  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
18 
 
 Schedule  
1. The Divestment Business consists of all relevant rights, title and interests in 
Brazikumab worldwide including in particular the assignment or transfer to the 
Purchaser or, (if relevant) termination, of Allergan’s exclusive licence to develop and 
commercialise Brazikumab in terms of the AstraZeneca Agreement, as well as certain 
ancillary assets and the rights to or licence for certain technologies needed to 
successfully develop Brazikumab.  The current development programme and ongoing 
clinical trials for Brazikumab are described in Annex 6.  
2. In accordance with Section B, paragraph 6  of these Commitments, the Divestment 
Business includes but is not limited to:  
(i) The following main tangible assets (together with the intangible assets listed 
below the “ Transferred  Assets”):  
(a) All finished goods inventory, together with any other inventory 
(including work -in-process, samples and active pharmaceutical 
ingredients inventory) of Brazikumab that is owned by and in the 
possession  or control, or otherwise held by or on behalf  of Allergan  or 
Affiliated Undertakings; 
(b) All relevant reports, databases and analysis related to Brazikumab, 
including all technical, preclinical, clinical and marketing files, 
protocols, clinical data and studies, reports, plans, books and records 
relating to Brazikumab.  The reports, databases and analysis relating to 
Brazikumab that also relate to other products developed or to be 
developed by Allergan shall only be transferred to the extent that they 
relate to Brazikumab, it being understood that the other sections shall be 
redacted prior to the t ransfer to the Purchaser.  If required by law, any 
individual patient data contained in such reports, databases and analysis 
shall be redacted prior to transfer to the Purchaser;  
(c) All original documents or, to the extent original documents are not 
reasonably available, copies thereof, in any format in the possession or 
control of Allergan or Affiliated Undertakings as at Closing, (i) relating 
to all relevant regulatory files, including all Regulatory Approvals 
(defined below); (ii) of all data that resulted from any research or 
development activities related to Brazikumab and conducted by or on 
behalf of Allergan or Affiliated Undertakings or a previous sponsor of an 
investigational new drug application (“ IND”) for Brazikumab; and (iii) 
correspondence with relevant regulatory bodies relating to the research, 
development, manufacture, testing, storage, import, export, use, 
labelling, distribution, sale, offer for sale, commercialisation, licensing, 
advertising, marketing and promotion (“ exploitation ”) of Brazikumab 
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
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 (including all INDs and foreign counterparts thereof, periodic safety 
reports and adverse drug experience reports for Brazikumab);  
(d) All documents related to marketing plans and forecasts which are 
specific to Brazikumab.  The mark eting plans and forecasts that also 
relate to other products developed or to be developed by Allergan or its 
Affiliates shall be transferred only to the extent that they relate to 
Brazikumab, it being understood that the other sections shall be redacted 
prior to the transfer to the Purchaser.  
(ii) The following main intangible assets: 
(a) All intellectual property rights licensed to Allergan under and in 
accordance with the terms of the AstraZeneca Agreement;  
(b) […] pending patent applications and […]  application liste d in Annex 1;  
(c) The rights to conduct the clinical trials sponsored by Allergan or its 
Affiliated Undertakings and related to Brazikumab globally;  
(d) The rights to manufacture (or have manufactured) and market 
Brazikumab globally;  
(e) All other intellectual propert y rights (including know -how and patents) 
existing as at the Closing Date that relate exclusively or predominantly 
to the development, manufacture and/or sale of Brazikumab worldwide, 
subject to a non- exclusive, perpetual, irrevocable, royalty -free licence-
back to the Parties of any such intellectual property rights that are shared 
with any of Allergan’s retained businesses.  Intellectual property rights 
that are used by or relevant for the Divestment Business, but that are not 
predominantly related to the development, manufacture and/or sale of 
Brazikumab, will be subject to a non- exclusive, perpetual, irrevocable, 
royalty- free licence to the benefit of the Purchaser;  
(f) The proposed “brazikumab” International Nonproprietary Name 
(“INN”), including any relevan t registered domain names.  
(iii) The following main licences, permits and  authorisations (“ Regulatory 
Approvals ”):  Brazikumab IND number […] and any new INDs, clinical trial 
authorisations (“ CTAs ”) or any other authorisations, permits or regulatory 
approvals (i ncluding any pending regulatory approvals) necessary for the 
exploitation of Brazikumab and held by Allergan or Affiliated Undertakings (as 
listed in Annex 2) .   
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
20 
 
 (iv) All contracts  with third parties to which Allergan or Affiliated Undertakings are 
bound that a re primarily related to the exploitation of Brazikumab.  A list of the 
third party contracts is provided in Annex 3.  These contracts will transfer to the 
Purchaser subject to any required consents being obtained.  The Parties 
undertake to use Best Efforts  to obtain all necessary third -party consents where 
applicable.  To the extent any such third -party consent could not be obtained, or 
any contract could not be otherwise transferred, the Parties will, as appropriate, 
either: (i) assist the Purchaser and th e relevant third party to put in place 
arrangements to transfer any work product and work in progress, and support 
the Purchaser to put in place alternative arrangements; or (ii) enter into back -to-
back agreements with the Purchaser under the same terms an d conditions as the 
relevant contract for a transitional period of up to […].  
(v) The Key Personnel listed in Annex  4.  The Key Personnel will transfer to the 
Purchaser with the Divestment Business subject to their consent, which the 
Parties shall use Best Efforts to obtain.  
(vi) In respect of the Personnel listed in Annex  5, for a period of […] after Closing, 
the Purchaser shall have the opportunity to interview, and enter into 
employment contracts with, any Personnel.  
(vii) At the Purchaser’s request, for a period of up to […] from the Closing Date, the 
Parties will provide, on terms and conditions equivalent to those at present  
afforded to the Divestment Business, all products or services currently supplied 
by Allergan or its Affiliated Undertakings to the Divestment Business.  
(viii) For a period of up to […] from the Closing Date, the Parties will provide, […], 
any transitional suppor t required by the Purchaser to enable the continuity of the 
clinical trials, including providing technical support, liaising with regulatory 
authorities and the transfer of relevant contracts, licences and CTAs .    
3. In the event that materials to be transfe rred contain information that is confidential to 
the Parties’ retained businesses and not relevant for the Divestment Business, the 
information shall be redacted as appropriate.   
4. The Divestment Business shall not include the following assets, to the exten t that they 
do not contribute to the current operation or are not necessary to ensure the viability 
and competitiveness of the Divestment Business:  
(i) any trademarks that Allergan or its Affiliated Undertakings own or have the 
right to use and licence, other than as described in paragraph 2 of this Schedule;  
(ii) any contracts with third parties to which Allergan or Affiliated Und ertakings are 
bound, other than those listed in Annex 3;  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
21 
 
 (iii) any intellectual property (including patents, trademarks and trade names, 
domain name registrations, copyrights and trade secrets and know how) owned 
by Allergan or its Affiliated Undertakings, other  than as described in paragraph 
2 of this Schedule;  
(iv) the corporate books and records of Allergan or its Affiliated Undertakings other 
than as described in paragraph 2 of this Schedule;  
(v) any right to manufacture, market or sell any product other than Brazikumab or 
any licence to use any asset of Allergan in connection with any product other 
than Brazikumab;  
(vi) any current and prior insurance policies and all related rights, including all 
insurance recoveries and related rights.  
5. If there is any asset or personnel which is not covered by paragraph 2 of this Schedule 
but which is both used (exclusively or not) for the Divestment Business and necessary 
for the continued viability and competitiveness of the Divestment Business, that asset 
or adequate substitute will be offered to potential purchasers by  transfer or (non -
exclusive, perpetual, irrevocable, and royalty -free) licence, as appropriate, as overseen 
by the Monitoring Trustee.   
  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
22 
 
 Annex 1  
Patent applications  
[...]  
 
  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
23 
 
 Annex 2  
Regulatory Approvals  
 
Table 1  
Clinical trial authorisations  
[...] 
 
Tabl e 2 
[…] investigational new drug applications  
[…] 
 
 
 
  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
24 
 
 Annex 3  
Transferring contracts  
[...] 
 
 
 
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
25 
 
 Annex 4  
Key Personnel  
[...] 
 
  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
26 
 
 Annex 5  
Personnel  
[...] 
 
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
27 
 
 Annex 6  
Brazikumab current development programme and ongoing clinical trials  
1. The Divestment Business currently forms part of Allergan’ s GI business.  Brazikumab was initially 
developed by Amgen Inc. (“Amgen ”).  In 2012, Amgen and AstraZeneca entered into the 
AstraZeneca/Amgen Collaboration to jointly develop, manufacture and commercialise various 
products, including Brazikumab.  […].  Following the conclusion of the AstraZeneca Agreement in 
[…], Allergan now holds the exclusive licence to develop and commercialise brazikumab 
worldwide at its own cost.  […] .   
2. Brazikumab is currently in Phase II clinical trials for the treatment of moderate to severe ulcerative 
colitis (“UC”) and in Phase IIb/III trials for the treatment of moderate to severe Crohn ’s disease 
(“CD”).  There is also an ongoing 52 week open label study for the treatment of moderate to 
severe CD.  
3. The clinical trials are carried out on at third party locations in the United States, and will be carried 
out at third party locations on a global basis including in Canada and the EEA.  Allergan’ s role is 
to act as a sponsor .  […].  Allergan has appointed […] to conduct recruitment and site 
management services for […].  Allergan also contracts with […] to perform activities such as site 
selection, site visits and site management for the Brazikumab studies in India and China.   
4. With the exception of some packaging and labelling services […], Allergan outsources all other 
services connected with the running of the clinical trials.  
5. […] third party manufacturers –  […] –- currently manufacture the Brazikumab drug substance.  
[…]. 
6. Allergan currently tests brazikumab with an IL- 22 companion diagnostic in order to assess 
whether brazikumab is more effective than existing approved products in treating UC and CD in 
patients expressing higher levels of the IL- 22 biomarker .  Any agreements with third parties 
entered into in relation to companion diagnostics in advance of Closing will be assigned to the 
Purchaser.     
7. […].   Any agreements with third parties entered into in relation to […] in advance of Closing will 
be assigned to the Purchaser .   
8. The table below lists the current ongoing and planned clinical trials for brazikumab.  
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
28 
 
 Annex 6, Table 1  
Ongoing/planned clinical trials  
Study 
num ber Condition  Phase  Details  Status  
3150 -
301-008 CD Phase IIb / 
Phase III 
Pivotal Study 
1 Global, Phase IIb/III, multicentre, randomised, double -blind, double -
dummy, active and placebo controlled, parallel -group, operationally 
seamless, 52 -week treat -through study.  
Comparator study designed to demonstrate […] in clinical symptom 
remission and endoscopic response of brazikumab over adalimumab 
(Humira) in biomarker positive patients . 
[…]   Ongoing 
Allergan is currently 
recruiting for Phase 
IIb (Stage I).   
[…].  Stage I is 
expected to be 
completed in […].  
Phase III (Stage II) 
will likely begin in 
[…]. 
Estimated completion 
date for  Stage II is 
[…]. 
[…]  […] […] […] 
 
 
M.9461 – ABBVIE / ALLERGAN  
 
 
 
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 Study 
num ber Condition  Phase  Details  Status  
3150 -
303-008  
 Phase III  52 week open -label extension study for patients who completed both 
double -blind studies (or discontinued from Study 3150- 301-008 at or after 
Week 12 due to lack of efficacy) to confirm the long -term safety of 
brazikumab in CD. Ongoing 
Estimated completion 
date is […] .  
[…] […] • […] […]  
3151-
201-008 UC Phase II  Global, multicentre, randomised, double -blind, double -dummy, active - 
and placebo -controlled, parallel -group 54- week treat -through design 
study.  
To compare the efficacy of brazikumab with that of placebo to achieve 
clinical remission at Week 10.    Ongoing  
[…]   
[…] […] […] […] 
[…] […] […] […] 
[…] […] […] […]