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,  22.04.2020  
C(2020 ) 2642 final  
PUBLIC VERSION  
 
To the notifying parties  
Subject : Case M.9517 – Mylan/Upjohn  
Commission decision pursuant to Article 6(1)(b) in conjunction with 
Article 6(2) of Council Regulation No  139/200 41 and Article 57 of the 
Agreement on the European Economic Area2 
 
  
                                                 
1  OJ L 24, 29.1.2004, p. 1 (the "Merger Regulation"). With effect from 1 December 2009,  the Tr eaty 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 secret s 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information omitted has been replaced by 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 
 
 TABLE OF CONTENTS  
1. THE PARTIES  ................................ ................................ ................................ .............  4 
2. THE OPERATION  ................................ ................................ ................................ ....... 4 
3. UNION DIMENSION  ................................ ................................ ................................ .. 5 
4. OVERVIEW OF THE OVER LAPS AND VERTICAL RE LATIONSHIPS  ...................  5 
5. FINISHED DOSE PHARMA CEUTICALS  ................................ ................................ .. 6 
5.1. Market definiti on ................................ ................................ ...............................  6 
5.1.1.  Product market definition  ................................ ................................ .... 6 
5.1.2.  Geographic market definition  ................................ ..............................  9 
5.2. Methodology for the identification and the assessment of affected markets  ..... 9 
5.3. Competitive assessment  ................................ ................................ ...................  11 
5.3.1.  Cardiovascular system treatment FDPs  ................................ ............  14 
5.3.2.  Genito -urina ry system treatment FDPs  ................................ .............  39 
5.3.3.  Musculoskeletal system treatment FDPs  ................................ ...........  43 
5.3.4.  Nervous system treatment FDPs  ................................ .......................  46 
5.3.5.  Sensory organs system treatment FDPs  ................................ ............  99 
5.4. Conclusion  ................................ ................................ ................................ ..... 114 
6. ACTIVE PHARMACEUTICA L INGREDIENTS  ................................ .....................  115 
6.1. Relevant market  ................................ ................................ .............................  115 
6.1.1.  Product market  ................................ ................................ ................  115 
6.1.2.  Geographic market  ................................ ................................ ..........  116 
6.2. Competitive assessment  ................................ ................................ .................  117 
 6.2.1.  Alprazolam  ................................ ................................ ......................  117 
 6.2.2.  Celecoxib  ................................ ................................ .........................  119 
 6.2.3.  Eletriptan  ................................ ................................ .........................  121 
 6.2.4.  Sertraline  ................................ ................................ .........................  122 
 6.2.5.  Sildenafil  ................................ ................................ ..........................  124 
 6.2.6.  General considerations  ................................ ................................ ... 125 
6.3. Conclusion  ................................ ................................ ................................ ..... 127 
7. OUTL ICENSING  ................................ ................................ ................................ ..... 127 
 
 
 
3 
 
 7.1. Relevant market  ................................ ................................ .............................  127 
7.1.1.  Product market definition  ................................ ................................  127 
7.1.2.  Geographic market definition  ................................ ..........................  127 
7.2. Competitive assessment  ................................ ................................ .................  128 
Commission’s assessment  ................................ ................................ ..............  129 
7.3. Conclusion  ................................ ................................ ................................ ..... 131 
8. COMMITMENTS  ................................ ................................ ................................ ..... 131 
8.1. Framework for the assessment of the C ommitments  ................................ ..... 131 
8.2. Procedure  ................................ ................................ ................................ ...... 132 
8.3. The Initial Commitments  ................................ ................................ ...............  133 
8.4. Assessment of the Initial Commitments  ................................ .........................  135 
8.5. The Final Commitments  ................................ ................................ ................  137 
8.6. Assessment of the Final Commitments  ................................ ..........................  138 
8.7. Conditions and obligations  ................................ ................................ ............  139 
9. CONCLUSION  ................................ ................................ ................................ ........  139 
 
  
 
 
 
4 
 
 Dear Sir or Madam,  
(1) On 28 February 2020 , the European Commission (the “Commission”) received 
notification of a proposed concentration pursuant to Article 4 of the Merger 
Regulation by which Mylan N.V. (“Mylan”, the Netherlands) and Upjohn, a 
business division of Pfi zer Inc. (“Pfizer”, the United States of America) intend to 
merge (the “Transaction”).3 Mylan and Upjohn are designated hereinafter as the 
“Notifying Parties” or “Parties” to the Transaction.  
1. THE PARTIES  
(2) Mylan  is a publicly listed global pharmaceutical co mpany, which develops, licenses, 
manufactures, markets, and distributes (i) generic, (ii) branded generic and (iii) 
specialty pharmaceuticals. Mylan offers a broad product portfolio of medicines, 
including more than 1  500 products ( generics, branded  generi cs, prescription, and 
non-prescription). Mylan has a vertically integrated global supply chain that includes 
over 40 manufacturing facilities.  
(3) Upjohn  is a global business division of Pfizer. It operates a portfolio of  20 off -patent 
branded and generic mol ecules under 21 brands in five therapeutic areas: (i) 
cardiovascular, (ii) central nervous system/psychiatry, (iii) pain/neurology, (iv) 
urology, and (v) ophthalmology. In addition, Upjohn includes the generic business of 
Greenstone LLC, a generic business  exclusively active in the United States of 
America .  
2. THE OPERATION  
(4) On 29 July 2019, the Parties and Pfizer entered into a business combination 
agreement pursuant to which the businesses of the Parties will be combined. The 
Transaction will take place in t hree steps.  
(a) First, Pfizer will contribute and transfer Upjohn’s assets and liabilities to 
Spinco, a special -purpose vehicle wholly  owned by Pfizer.  
(b) Second, Pfizer will distribute Spinco’s common stock to its stockholders.4 
(c) Third, Spinco and Mylan will co mbine, by a merger or an asset sale, resulting 
in the transfer of Mylan’s assets and liabilities to Spinco.  
                                                 
3  Publication in the Official Journal of the European Union No C 72 , 5.3.2020 , p. 13.  
4  Pursuant to the Transaction’s agreements, Pfizer will distribute Spinco common stock to its stockholders, 
either through a pro rata distribution as a stock dividend or an offer of Spinco common stock to Pfizer’s 
stockholders as a non -pro rata  exchange offer  
 
 
 
5 
 
 (5) Upon completion of the Transaction, the merged entity (comprising Upjohn and 
Mylan ) will be wholly  owned by Spinco, which will be renamed “Viatris” . Former 
Mylan shareholders will hold 43% and Pfizer’s  shareholders will hold 57% of 
Viatris. None of the individual shareholders of Mylan or Pfizer will exercise control 
over Viatris, which will be an independent undertaking.  
(6) The Transaction therefore con stitutes a merger between Mylan and Upjohn within 
the meaning of Article 3(1)(a) of the Merger Regulation.  
3. UNION DIMENSION  
(7) The undertakings concerned have a combined aggregate worldwide turnover of more 
than EUR 5  000 million (Mylan: EUR 9  551 million; Upj ohn: EUR 10  582 million).5 
Each of them has a Union -wide turnover in excess of EUR 250 million (Mylan: EUR 
[…] million; Upjohn: EUR […] million), but each does not achieve more than two -
thirds of its aggregate Union -wide turnover within one and the same Me mber State. 
The notified operation therefore has a Union dimension.  
4. OVERVIEW OF THE OVERL APS AND VERTICAL REL ATIONSHIPS  
(8) The Transaction will combine one of the top five generic suppliers in the EEA6 
(Mylan) with an originator,7 whose products were the firs t launched on the market 
for a specific molecule but that have lost exclusivity following patent expiries 
(Upjohn).  
(9) The Transaction gives rise to horizontally affected markets in the supply of finished 
dose pharmaceuticals (“FDPs”), which are assessed in S ection 5 of this Decision.8 
(10) In addition, the Transaction leads to vertically affected markets for (i) the supply of 
active pharmaceutical ingredients (“APIs”) , upstream, and the supply of FDPs, 
downstream,  and (ii) the outlicensing of rights to FDPs , upstr eam and the supply of 
FDPs, downstream . These vertical links are respectively assessed in Sections 6 
                                                 
5  Turnover calculated in accordance with Article 5(1) of the Merger Regulation and the Commission 
Consolidated Jurisdictiona l Notice (OJ C95, 16.4.2008, p. 1).  
6  For the purpose of this Decision, although the United Kingdom withdrew from the European Union as of 
1 February 2020, according to the Withdrawal Agreement, Union law continues to apply to the United 
Kingdom during th e transition period. Accordingly, any references made to the EEA in this Decision are 
meant to also include the United Kingdom.  
7  In the pharmaceutical space, while an “originator” refers to the first product that was launched on the 
market for a specifi c molecule, “generics” refer to products that were launched after the loss of exclusivity 
of the originator.  
8  The Commission notes that the Parties’ activities also overlap for (i) the supply of active pharmaceutical 
ingredients, (ii) the outlicensing of  rights to FDPs, and (iii) the contract manufacturing of FDPs. However, 
the Transaction does not give rise to any affected market for these horizontal overlaps, regardless of 
market definition.  
 
 
 
6 
 
 (regarding the supply of APIs) and 7 (regarding the outlicensing of rights to FDPs) 
of this Decision.9  
5. FINISHED DOSE PHARMACEUTICALS  
(11) FDPs are pharmaceutic al products that have undergone all stages of production 
(including packaging in the final container and labelling). They are the final 
pharmaceutical product s received by pharmacies and other healthcare professionals, 
and ready to use by patients.  
(12) Both P arties supply genericized FDPs in the EEA, but have a slightly different 
business focus . While Mylan offers mostly unbranded generics  (among its offering 
of more than 1  500 FDPs) , Upjohn  is an originator supplier, whose portfolio 
comprises 21 brands based on 20 molecules that were the first launched on the 
market for a specific molecule but most of which lost exclusivity following patent 
expiry more than five years ago.  
5.1. Market definition  
5.1.1.  Product market definition  
5.1.1.1.  Product market definition in the pharmaceut ical sector  
(13) FDPs  may be subdivided into therapeutic classes by reference to the Anatomical 
Therapeutic Classification (“ATC”), devised by the European Pharmaceutical 
Marketing Research Association (“EphMRA”) and maintained by EphMRA and 
IQVIA, formerly kn own as Intercontinental Medical Statistics (“IMS”).  
(14) The ATC system is a hierarchical and coded four -level system , which classifies 
medicinal products according to their indication, therapeutic use, composition, and 
mode of action. In the first and broadest  level (ATC1), medicinal products are 
divided into the 16 anatomical main groups. The second level (ATC2) is either a 
pharmacological or a therapeutic  group. The third level (ATC3) further groups 
medicinal products by their specific therapeutic indications . Finally, the ATC4 level 
is generally the most detailed one (not available for all ATC3 classes) and refers for 
instance to the mode of action or any other subdivision of the relevant products.  
(15) When defining relevant markets in past decisions dealing wit h FDPs, the 
Commission often referred to the third level (ATC3) as the starting point for 
defining the relevant product market.10 However, in a number of cases, the 
Commission found that the ATC3 level classification did not yield the appropriate 
                                                 
9  The Commission notes the Transaction also gives rise to a v ertical relationship between the Parties’ 
activities in the contract manufacturing of FDPs (upstream) and the supply of FDPs (downstream). 
However, the Transaction does not give rise to any affected market for this vertical relationship, 
regardless of mark et definition.  
10  See, for example M.9274 – GlaxoSmithKline/Pfizer Consumer Healthcare Business ; M.8889  – Teva/PGT 
OTC.  
 
 
 
7 
 
 market def inition within the meaning of the Commission Notice on the Definition of 
the Relevant Market.11  
(16) In decisions  involving genericized FDP markets , the Commission generally defined  
the relevant product market at the level of the relevant molecule (i.e. based o n the 
same active pharmaceutical ingredient) or group of molecules (for instance all 
benzodiazepines  or all  anticholinergics )12 that are considered interchangeable.13 
(17) In previous decisions, the Commission found that, at molecule level, the originator 
(i.e. t he first product that was launched on the market for a specific molecule) and 
generics (i.e. products that were launched after the originator’s loss of exclusivity)14 
generally form part of the same market . This is bec ause generics are versions of 
originato r medicines , which are specifically designed to compete with those 
medicines and normally represent the closest substitute to them.15  
(18) The Commission has  acknowledged in previous decisions  that additional 
segmentations may also apply.16 FDPs may be different iated not only by their active 
ingredient(s), but also by  galenic  form and route of administration, which  may limit 
their substitutability. The Commission also considered separate markets for FDPs , 
which can be dispensed only against a prescription and tho se which can be sold over 
the counter (or "OTC").17 
5.1.1.2.  The Notifying Parties' views  
(19) The Notifying Parties did not provide any indications that the Commission should 
depart from the more recent approach to define the product market for genericized 
FDPs at the l evel of molecules within the same ATC3 class, and considered all 
alternative market definitions (at ATC3, ATC4, and multi -molecule levels , based on 
galenic form, as well as between prescription and OTC products ) in line with 
applicable precedents.18  
5.1.1.3.  The Co mmission's assessment  
(20) For the purpose of this Decision, the Commission considers that the relevant product 
markets for FDPs should be defined at molecule level.  
                                                 
11  OJ C 372, 9.12.1997, pages 5 to 13.  
12  In past decisions, the Commission considered that anticholinergics could form a separate rel evant product 
market. See M.7379 – Mylan/Abbott EPD -DM, para. 444 and M.7975 – Mylan/Meda , paras. 404 -409. 
13  See for example M.7975 – Mylan/Meda , para. 13 and M.7746 – Teva/Allergan , para. 13.  
14  Generics are in general less expensive, bioequivalent versi ons of originator drugs. In regulatory approval 
procedures, a generic drug manufacturer has to demonstrate that the generic version of the originator drug 
has the same qualitative and quantitative composition in terms of active substance and the same 
pharm aceutical form and is bioequivalent to the originator drug.  
15  See M.7975 – Mylan/Meda , M.5253 - Sanofi -Aventis/Zentiva . 
16  See M.5778 - Novartis/Alcon , M.5865 - Teva/Ratiopharm , and M.5253 - Sanofi -Aventis/Zentiva . 
17  See M.9274 - GlaxoSmithKline / Pfizer  Consumer Healthcare Business . In the present case, drugs giving 
rise to (Group 1) affected markets are only prescription drugs and this distinction is thus not relevant.  
18  Form CO, paras. 86 -89. 
 
 
 
8 
 
 (21) In the present case,  the responses to the market investigation suggest that, for the 
molecules  involved in this case, different genericized molecules, including from the 
same ATC3 class, do not form part of the same product market, in particular since 
they are not interchangeable for patients and pharmacies,19 and their price -setting 
modalities diff er.20 Relatedly, respondents to the market investigation also indicated 
that certain genericized molecules belonging to wider groups of molecules with the 
same or similar mode of actions, such benzodiazepines , are generally not 
interchangeable.21 However, w ith regard to anticholinergics specifically, while the 
majority of respondents also consider that different molecules  generally do not form 
part of the same product market, 22 the Commission notes that the answers received 
in the market investigation to this  question were mixed regarding the Lithuanian 
market .23 These elements indicate  that, with the possible exception of 
anticholinergics ,24 the molecules  offered by the Parties and analysed in the present 
case each form  a separate  product market.   
(22) Respondents t o the market investigation also took the view that, for the same 
genericized molecule, originator and generics form part of the same market , as they 
are generally perceived as substitutes to each other and interchangeable.25 This 
indicates that, concerning the products offered by the Parties and therefore analysed 
in the present case, products based on the  same  molecule(s) that fall within the s ame 
therapeutic indication (namely  within a same ATC3 class) belong to the same 
product market.  
(23) The market investig ation was inconclusive regarding whether products with different 
galenic forms are substitutable.26 A large majority of responding pharmacies 
indicated that different form factors might  not be interchangeable to treat the same 
symptoms or illness , especiall y for nervous system tr eatments ,27 while an 
                                                 
19  Questionnaire Q2 to retailers, non -confidential replies to question 14.  
20  Questionnaire Q1 to competitors, non -confidential replies to question 13.  
21  Questionnaire Q2 to retailers, non -confidential replies to questions 14.2 and 14.3 and questionnaire Q1 to 
competitors, non -confidential replies to question 43.  
22  Questionnaire Q2 to retailers, non -confidential replies to questions 14.2 and 14.3 and questionnaire Q1 to 
competitors, non -confidential replies to question 43.  
23  Questionnaire Q1 to competitors, non -confidential replies to question 43.  Significant  competitors active in 
the supply of a nticholinergics in Lithuania indeed consider that these molecules are interchangeable, 
especially because they are reimbursed for the same diagnosis (i.e. overactive bladder).  
24  With regard to anticholinergics,  the Commi ssion considers that the precise relevant product market, 
whether it includes (i) all anticholinergic agents combined or (i) each separate anticholinergic agent 
separately, can be left open. Indeed, the  competitive assessment of the Transaction does not ra ise serious 
doubts regardless of whether the relevant product market  comprises (i) all anticholinergic agents 
combined or (i) each separate anticholinergic agent separately.  
25  Questionnaire Q2 to retailers, non -confidential replies to question 13. Questi onnaire Q3 to wholesalers, 
non-confidential replies to question 8.   
26  For the purpose of this Decision, the Commission has looked at “galenic form” with reference to the first 
letter of the typology of form codes (the so -called “New Form Code” or NFC) use d by IMS/EphMRA. In 
general, the first letter ("NFC -1") differentiates between forms for systemic and topical effect, site of 
application (e.g. oral, nasal, parenteral or rectal), and long -acting and ordinary forms.  
27  Questionnaire Q2 to retailers, non -confidential replies to question 15.  
 
 
 
9 
 
 overwhelming majority of competitors consider that different galenic forms do 
compete with each other.28 The Commission notes that the Commission’s 
assessment does not significantly differ in the present case shoul d the relevant 
product markets be sub -segmented at the galenic form level or comprise all galenic 
forms. Moreover,  no additional  Group 1 (+) or 2 markets arise from the Transaction 
if the relevant product markets were defined based on different galenic for ms, except 
where this is explicitly mentioned in Section 5, and in none of those cases the 
competitive assessment change s. Therefore, t he question of whether the relevant 
molecule markets should be further segmented based on the galenic form of FDPs  
can be left open, as it has no impact on the competitive  assessment of the 
Transaction .  
(24) In summary, based on the results of the market investigation and any other evidence 
available to it , the Commission has no reason to depart from its decisional 
precedents in the area of genericized FDPs (see paras. 15 to 18 above) , and 
concludes that the relevant product markets should be defined at molecule level, 
while the question of the sub -segmentation based on the galenic form can be left 
open.  
5.1.2.  Geographic market definiti on 
(25) The Commission has consistently defined the geographic markets for FDPs as being 
national in scope.29  
(26) The Notifying Parties , in line with the Commission’s decisional practice, provided 
market share data at national level for FDP overlaps.  
(27) The market inv estigation in this case confirmed the national dimension of the 
markets for FDPs, in particular in view of the differing national regulatory and 
reimbursement schemes, and the fact that competition between pharmaceutical 
suppliers still predominantly takes  place at a national level.30  
(28) Therefore, for the purpose of this Decision, the Commission considers that the 
geographic scope of all relevant FDP product markets is national . 
5.2. Methodology for the identification and the assessment of affected markets  
(29) In line with Commission  precedents ,31 the Notifying Parties primarily used sales data  
of pharmaceutical products compiled by IQVIA to identify the affected markets that 
the Transaction gives rise to.32  
                                                 
28  Questionnaire Q1 to competitors, non -confidential replies to question 5.  
29  See M.9274 – GlaxoSmithKline / Pfizer Consumer Healthcare Business , paras. 23 -26. See also, e.g., 
M.7975 – Mylan/Meda , para. 24, and M.7746 – Teva/Allergan, para. 19.  
30  See Questionnaire Q4 to national authorities, non -confidential replies, as well as Questionnaire Q1 to 
competitors, non -confidential replies, Questionnaire Q2 to retailers, non -confidential replies, and 
Questionnaire Q3 to whol esalers, non -confidential replies.  
31  See M.7746 – Teva/Allergan , e.g. paras 47, 126, 168; M.7975 – Mylan/Meda , para 67. In those decisions, 
IQVIA’s former name, “IMS”, is mentioned as source of market share data.  
 
 
 
10 
 
 (30) In addition , given a large number of affected markets in pharm aceutical mergers 
(involving numerous product and geographic markets), the Commission has applied 
a system of filters aimed at determining the group of markets where concerns are 
most likely and on which it focuses its analysis.  In line with Commission pre cedents 
in the pharmaceutical sector,33 affected markets can be classified in four categories:  
 Group 1, where the Parties' combined market share exceeds 35% and the 
increment exceeds 1%;  
 Group  1+, where either (i) the combined market share is below 35% (bu t 
above 20%), and only one other competitor remains on the market, or where 
(ii) the combined market share exceeds 35% and the increment is below 1%, 
but the party with the small increment is a recent entrant.34 
 Group 2, where the Parties' combined market s hare exceeds 35% but the 
increment is below 1%; and  
 Group 3, where the Parties' combined market share is between 20% and 35%.  
(31) The Commission has analysed all markets affected by the Transaction. Regarding 
Group 1(+) markets (comprising Group 1 and Group 1+ markets),  the Commission 
assessed the markets under the narrowest plausible market definition, namely  at the 
molecule level (with potential sub -segmentation by galenic form where relevant).  
Depending  on the results of the market investigation on the sco pe of the relevant 
market in relation to these molecules, the Commission also assessed these markets at 
"multi -molecule" level ( namely  a combination of potentially interchangeable 
molecules within the same ATC4 or ATC3 class).  
(32) The Commission's assessment focused primarily on volume -based market shares . As 
generics are in general less expensive than the originator drugs, the competitive 
interactions between Mylan (and other generic players) and Upjohn, are more 
accurately reflected in volume -based market sh ares. In addition, the products 
concerned by the Transaction have typically been genericised over five years ago, 
thus mitigating any first -mover advantage that a specific generic player may have in 
                                                                                                                                                      
32  The Notifying Parties relied on IQVIA data for most EEA countries, except those that are not fully 
covered by IQVIA, namely Cyprus, Iceland, Malta, and the United Kingdom (as well as the Netherlands 
for which the Notifying Parties relied on, the Farminform database ). With regard to the years c overed, t he 
Notifying Parties did not provide full year 2019 market share because such data was not available at the 
time of notification  from the relevant databases . As year -to-date market share data was however available 
from the relevant databases, a t the request of the Commission, the Notifying Parties identified the 
additional affected markets arising from the Transaction based on 2019 year -to-date (January -November 
2019) market share data. The Notifying Parties provided  2019 year -to-date (January -Nove mber 2019) 
market share data for these additional affected markets  and for those where Mylan is a recent entrant (i.e. 
where it entered in the last three years) . This Decision therefore contains 2019 market share data for the 
period January -November 2019 i n the individual assessment of these markets  where relevant . 
33  See M.8889 – Teva / PGT OTC Assets , para. 35.  
34  See M.5778 – Novartis/Alcon , para. 25. 
 
 
 
11 
 
 particular on pricing . Under these circumstances, the com petiti ve pressure that 
generics  exert on the originator largely depend s on the volumes that they can divert  
from the originator , and the competitive position of each company is  therefore better 
captured  with volume market shares.  However, the Commission al so reviewed the 
value -based market shares of the Parties and their competitors for the affected 
markets. In the present case, the combined value -based market share of the Parties is 
generally higher than their volume -based combined market share, as the for mer 
originator product of Upjohn is generally sold at a higher price point  than its generic 
competitors . In any event, t he Commission notes  that the competitive assessment  
does not differ substantially when  considering value market shares for any  affected  
market , in particular because the number of competitors and their ability to exert a 
credible competitive pressure on the merged entity does not change.    
5.3. Competitive assessment  
(33) In line with precedents,35 Group 3 markets are not discussed individually in th is 
Decision.36 The Commission assessed the competitive situation in these markets by 
considering the combined market shares of the Parties and their competitors over the 
last three years, other factors including the presence of competitors with a significan t 
presence in the generics markets, the date of patent expiry, the recent evolution of 
prices, the level of complexity of the Parties’ products,37 the Parties’ pipeline 
products , as well as the results of the market investigation. The Commission reached 
the conclusion that the Transaction does not raise serious doubts as to its 
compatibility with the internal market in relation to the Group 3 markets arising 
from the Transaction , due to the limited market shares of the Parties and the presence 
of significant  competitors remaining on the market post -Transaction  that will likely 
sufficiently constrain the merged entity .  
(34) The Commission has assessed all Group 1(+) and 2 markets individually, but does 
not discuss individually in this Decision the Group 1(+) and 2  markets which fall 
within one of the two following sets of criteria . These markets (for which the 
                                                 
35  See M.8889 – Teva / PGT OTC Assets , para.  36. 
36  Based on 2018 market shares provided by the Parties , Group 3 markets arise in the following molecules 
(or combination of molecules)/country pairs: Nitroglycerin (C1E) in Spain; Doxazosin (C2A) in Poland 
and Spain; Doxazo sin/Prazosin (C2A) in Spain; Sildenafil (C6B) in Germany and Sweden; Amlodipine 
(C8A) i n Ireland and Portugal; atorvastatin (C10A) in Bulgaria, Croatia, Czechia, Greece, the 
Netherlands, Portugal, Slovakia, and the United Kingdom; anticholinergics (G4D) in Finland and Italy; 
sildenafil (G4E) in Czechia, Denmark,  Hungary, Iceland, Ireland, Po rtugal, Slovakia, and the United 
Kingdom; celecoxib (M1A) in Germany; gabapentin (N3A) in Belgium, Iceland, and Italy; pregabalin 
(N3A) in Bulgaria, Germany, Iceland, and the Netherlands; ziprasidone (N5A) in Slovakia; alprazolam 
(N5C) in Belgium; benzodia zepines (N5C) in France and Portugal; sertraline (N6A) in Belgium, Czechia, 
Ireland, and Sweden; venlafaxine (N6A) in Czechia, Ireland, the Netherlands, Portugal, and Spain; 
latanoprost (S1E) in France (see Form CO, Annexes 10a -b). 
37  Complex generics comm only refer to products , which require comparably higher investment before they 
may be launched on the market, because they are more difficult to manufacture or formulate, or require a 
drug/device combination.  

 
 
 
13 
 
 (36) In the se markets, the Parties' combined market share gen erally remains below [50-
60]%,39 under any plausible market definition.40 In this case, which involv es a 
merger between an originator and a generic company, high market shares alone do 
not equate to market power . Genericised FDPs are typically heavily regula ted, which 
limit the opportunity to engage in price increases and favours the entry of new and 
lower cost generic players. In addition, Mylan, as a generic player, competes more 
closely with other generic players. I f a sufficient number of credible competi tors 
remain in the market , combining  the market shares of Mylan and Upjohn thus does 
not automatically translate into increased market power .  
(37) Moreover, the overwhelming majority of respondents to the market investigation 
considered that the Transaction would have a neutral or positive impact on these 
markets.  
(38) In light of the foregoing, the Commission finds that the Transaction does not raise 
serious doubts as to its compatibility with the internal market in relation to the 
markets listed in Table 1.  
(39) In th e following, the Commission individually assesses  all Group 1(+) and Group 2 
markets, which do not fall under one of the two categories referred to in paragraph 
(34). For the reasons detailed in paragraph (32) above, the Commission relied as a 
starting point on volume -based market shares to assess the competitive dynamics of 
the affected markets. However, as noted above, the Commission considered the  
value market shares for the markets affected by the Transaction and notes that the 
competitive assessment does  not differ substantially when  considering value market 
shares for any  affected mark et.  
                                                 
39  However, in some instances the Parties’ combined market share  may reach [60-70] or [60-70]%. The 
molecule/country markets in which the Parties’ combined market shares  are between [50-60]% and [60-
70]% (based on volume shares)  in 2018 are the followin g: amlodipine  in Italy (Upjohn: [40-50]%, Mylan: 
[5-10]%, combined: [50-60]%, competitors Teva: [5-10]%, Doc Generici: [5-10]%, Novartis: [5-10]%); 
alprazolam in the Netherlands (Upjohn: [40-50]%, Mylan: [10-20]%, combined: [50-60]%, competitors 
Novartis: [20-30]%, Stada: [10-20]%, Teva: [5-10]%); alprazolam  in Spain (Upjohn: [5-10]%, Mylan: [40-
50]%, combined: [50-60]%, competitors Infarco: [10-20]%, Normon: [5-10]%, Stada: [5-10]%, Aristo 
Pharma [5-10]%, Sun Pharma: [5-10]%); doxazosin  in Italy (Upjohn: [50-60]%, Mylan: [5-10]%, 
combined: [60-70]%, competitors Stada: [5-10]%, Teva; [5-10]%, Doc Generici; [5-10]%); eplerenone  in 
the United Kingdom (Upjohn: [40-50]%, Mylan: [10-20]%, combined: [60-70]%, competitors: Accord: ca. 
[10-20]%, Zentiva: ca. [10-20]%, Aspire Pharma: ca. [5-10]% based on the Parties’ estimates) ; pregabalin  
in Ireland (Upjohn: [50-60]%, Mylan: [0-5]%, combined: [50-60]%, competitors Krka: [10-20]%, Intas:  
[10-20]%, Teva: [5-10]%); pregabalin  in Slovakia (Upjohn : [20-30]%, Mylan: [30-40]%, combined: [50-
60]%, competitors Krka: [10-20]%, Novartis: [5-10]%, Stada: [5-10]%, Glenmark Pharma: [5-10]%); 
sertraline  in Italy (Upjohn: [10-20]%, Mylan: [40-50]%, combined: [50-60]%, competitors Doc Generici: 
[10-20]%, Novartis: [10-20],% Teva: [5-10]%, Stada: [5-10]%). 
40  See Form CO, Section 7A.  


 
 
 
16 
 
 Commission’s assessment  
(47) The combined market share of the Parties at molecule level amounts to nearly [40-
50]% in 2018 . In addition, only one signifi cant competitor would remain post -
Transaction , namely Zentiva with a volume -based market share of [40-50]% in 2018 
and hence, the combined entity would face limited competitive constraints post -
Transaction.  
(48) Moreover,  if the market was further segmented bas ed on galenic form, the Parties are 
the only two manufacturers supplying extended release tablets of doxazosin  in 
Czechia . Therefore, the Transaction would lead to a monopoly if a market 
segmented by galenic form at molecule level were  considered.  
Conclusi on 
(49) In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission concludes that the Transaction raises 
serious doubts as to its compatibility with the internal market due to its likel y 
horizontal non -coordinated effects (i) in the market for doxazosin in Czechia given 
the high combined market share post -Transaction and the reduced number of 
significant competitors in the market,  as well as (ii) in a possible market for extended 
release  tablets of doxazosin in Czechia given that no competitor would remain on 
this possible market.   
(b) Doxazosin  in France  
(50) Both Parties supply doxazosin (ATC3 class C2A) in France. This molecule is 
genericized in France since 2009. While Upjohn markets doxazosin  under the brand 
name Zoxan, Mylan supplies an unbranded version of doxazosin.    
Market shares  
(51) A Group 1 market arises at the molecule level for doxazosin in France.44 
(52) The volume market shares of the Parties and their competitors for the supply of 
doxazosin  in France  are provided below in Table 3. 
 
 
 
 
                                                 
44  A Group 1 market also arises at the multi -molecule level (doxazosin and prazosin) in France.  


 
 
 
19 
 
 Notifying Parties’ views  
(63) The Parties did not submit any views in relation to this market. To expedite the 
clearance of the Transaction, the Parties offered to divest Mylan’s eplerenone 
product in Belgium to a suitable purch aser.47 
Commission’s assessment  
(64) The combined market share of the Parties is [90-100]% at molecule level, with a 
significant increment from Upjohn (of [20-30]% based on 2018 figures ). As a result,  
no competitor would remain post -Transaction and the Transacti on would therefore 
lead to a monopoly for the supply of eplerenone in Belgium.  
(65) The market investigation did not provide any elements to dispel the serious doubts 
arising from the fact that the merged entity would have a monopoly on the market 
post-Transact ion and there would be no competitor present . 
Conclusion  
(66) In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission considers that the Transaction raises 
serious doubts as to its c ompatibility with the internal market as regards the supply 
of eplerenone in Belgium  due to its likely horizontal non -coordinated effects in the 
market for eplerenone in Belgium given the high combined market share and the fact 
that no competitors will rem ain on the market post -Transaction.   
(b) Eplerenone in Hungary  
(67) Both Parties supply eplerenone (ATC3 class C3A) in Hungary. This molecule is 
genericized in Hungary since 2010. In this country, while Upjohn markets 
eplerenone under the brand name Inspra, Mylan s ells an unbranded version of 
eplerenone.    
Market shares  
(68) The Transaction gives rise to a Group 1 market at the molecule level for eplerenone 
in Hungary.  
                                                 
47  See Section 8 of this Decision.  

 
 
 
21 
 
 Commission’s assessment  
(72) Structurally, the Tra nsaction leads to an important change in the market. Post -
Transaction, the merged entity’s market share would be very high (reaching [80-
90]% based on 2018 figures) with a material increment from Mylan (of [5-10]% 
based on 2018 figures). Such market shares  may in themselves be indicative of a 
dominant position of the merged entity post -Transaction.49  
(73) In addition, the market investigation conducted by the Commission does not fully 
support the Notifying Parties’ arguments.50  
(74) First, the Transaction will result  in a reduction in the number of players from four to 
three. Between  the two other players active in the supply of eplerenone in Hungary, 
only one competitor has a  significant presence in Hungary overall and in diuretics 
(ATC 2 class C3) more specifically, namely Krka, which is a recent entrant with a 
market share remaining below [0-5]% in 2018 . Alvogen, the only other supplier of 
eplerenone in Hungary, has consistently had a higher market share than Mylan in the 
last 3 years. However, this player does not h ave a  strong presence in Hungary in 
general, nor in the therapeutic area (ATC2 level). As a result, the constraints 
exercised by competitors on the merged entity for the supply of eplerenone in 
Hungary are likely to remain limited post -Transaction.  
(75) Second , the Parties’ claim that generics/unbranded products do not compete closely 
with originators/branded products was not supported by the market investigation. 
Replies to the market investigation were inconclusive as to whether originator and 
generic product s are considered interchangeable.51 In addition, the Hungarian 
national authority states that pharmacies have incentives to substitute originator 
products with generics.52 
(76) In addition, wholesalers in Hungary indicated that they carry both the originator and 
generic versions of genericized molecule, and try to offer as many generics as 
possible,53 evidencing as well the importance of a sufficient number of generic 
suppliers to maintain effective competition.  
                                                 
49  Horizontal Merger Guidelines, para 17.  
50  No Hungary -based retailers responded to the market investigation.  
51  Questionnaire Q3 to whol esalers, non -confidential replies to question 8. As indicated in footnote 50, no 
Hungary -based retailers responded to the market investigation.  
52  Questionnaire Q4 to national authorities, non -confidential replies to question 5 . 
53  Questionnaire Q3 to wholesalers, non -confidential replies to questions 6 and 7.  


 
 
 
24 
 
 (86) Mylan’s limited increment and the constraints exercised by competitors suggest that 
the Transaction will not alter significantly the structure of the market for the supply 
of eplerenone in Ireland. This was confirmed by the market investigation. The 
majority of respondents consider  that the Transaction will not have a negative impact 
on th e market for eplerenone in Ireland, either on prices or on product availability.57 
(87) Finally, the results of the market investigation did not reveal any substantiated 
concerns as regards the impact of the Transaction in the eplerenone market in 
Ireland.  
  Conclusion  
(88) In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission considers that the Transaction does 
not raise serious doubts as to its compatibility with the internal market wit h respect 
to the supply of eplerenone in Ireland.  
5.3.1.3.  Pulmonary arterial hypertension (ATC3 class C6B)  
(89) In the EEA, both Parties market sildenafil, which is a so -called PDE -5 inhibitor. This 
molecule is used to treat pulmonary arterial hypertension (“PAH”) and  is indicated 
for the prevention of cardiovascular disease in adults and for the treatment of 
hyperlipidemia. The Transaction gives rise to the following Group 1(+)/2 markets 
(which do not fall within one of the two categories  referred to in paragraph (34)) for 
sildenafil (PAH).   
(a) Sildenafil in Estonia  
(90) Both Parties supply sildenafil for the treatment of PAH (ATC3 class C6B) in 
Estonia.58 
(91) This molecule is genericized in Estonia since 2015 for the treatment of PAH. Bot h 
Parties market a branded version of sildenafil for the treatment of PAH in Estonia. 
While Upjohn markets sildenafil (C6B) under the brand name Revatio, Mylan 
markets this product under the name Mysildecard.  
Market shares  
(92) The Transaction gives rise to a Group 1 + market at the molecule level for the supply 
of sildenafil (C6B) in Estonia.  
                                                 
57  Questionnaire Q2 to retailers, non -confidential replies, non -confidential replies to question 28.  
58  Sildenafil is a molecule falling within both (i) the ATC3 class C6B, for the treatment  of PAH and (ii) the 
ATC3 class G4E, for the treatment of erectile dysfunctions. In this Decision, the Commission refers to 
“sildenafil (C6B)” for sildenafil products marketed for the treatment of PAH, and to “sildenafil (G4E)” for 
sildenafil products mark eted for the treatment of erectile dysfunction.  


 
 
 
27 
 
 Notifying Parties’ views  
(103)  The Parties did not submit any views in relation to this market. To expedite the 
clearance of the Transaction, the Parties offered to d ivest Mylan’s sildenafil product 
(C6B) in France to a suitable purchaser.60 
Commission’s assessment  
(104)  Structurally, for the supply of sildenafil (C6B) in France, the combined market share 
of the Parties is extremely high (namely [90-100]%). Besides the Partie s, no other 
competitor is active for the supply of sildenafil (C6B) in France and thus no 
competitor would remain post -Transaction on the market. Therefore, the Transaction 
would lead to a monopoly for the supply of sildenafil (C6B)  in France.  
(105)  The market i nvestigation did not provide any elements to dispel the serious doubts 
arising from the fact that the merged entity would have a monopoly on the market 
post-Transaction and there would be no  competitor present.  
Conclusion  
(106)  In view of the above consideration s, taking into account the market investigation and 
all the evidence available to it , the Commission concludes that the Transaction raises 
serious doubts as to its compatibility with the internal market  as regards the supply 
of sildenafil for the treatment  of PAH (ATC3 class C6B) in France, due to its 
horizontal non -coordinated effects in the market for sildenafil in France given the 
high combined market share and the fact that no competitors  will remain in the 
market post -Transaction.  
(c) Sildenafil in Ireland  
(107)  Both Parties supply sildenafil (ATC3 class C6B) in Ireland for the treatment of PAH. 
This molecule is genericized in Ireland since 2015 for the treatment of PAH. In this 
country, both Parties market a branded version of sildenafil (C6B) under the brand 
names Revatio concerning Upjohn and Mysildecard concerning Mylan.  
Market shares  
(108)  The Transaction gives rise to a Group 1 + market at the molecule level for sildenafil 
(C6B) in Ireland.  
                                                 
60  See Section 8 of this Decision.  

 
 
 
29 
 
 [5-10]% and [5-10]% respectively) and have a strong presence in the therapeutic 
area as well (namely a market share of [5-10]% and [5-10]% respectively at ATC 2 
level in Ireland) . 
(114)  In addition, the results of the market investigation indicate that there will remain a 
sufficient number of supplie rs of sildenafil (C6B) in Ireland. All responding Irish 
wholesalers indicated that a sufficient number of suppliers of sildenafil (C6B) would  
remain in the market post -Transaction.61 
(115)  Finally, the results of the market investigation did not reveal any substa ntiated 
concerns as regards the impact of the Transaction regarding the supply of sildenafil 
(C6B) in Ireland.  
Conclusion  
(116)  In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commissio n considers that the Transaction does 
not raise serious doubts as to its compatibility with the internal market with respect 
to the supply of sildenafil for the treatment of PAH (C6B) in Ireland.  
(d) Sildenafil in Latvia  
(117)  Both Parties supply sildenafil (ATC3 cl ass C6B) in Latvia for the treatment of PAH. 
This molecule is genericized in Latvia since 2015 for this therapeutic indication. 
Both Parties market a branded version of sildenafil for the treatment of PAH in 
Latvia. While Upjohn markets sildenafil (C6B) un der the brand name Revatio, 
Mylan markets this product under the name Mysildecard.  
Market shares  
(118)  The Transaction gives rise to a Group 1 market at the molecule level for the supply 
of sildenafil (C6B) in Latvia.  
(119)  The volume market shares of the Parties and  their competitors for the supply of 
sildenafil in Latvia  are provided below in Table 10. 
                                                 
61  Questionnaire Q3 to wholesalers, non -confidential replies to question 25.  


 
 
 
32 
 
 Commission’s a ssessment  
(130)  Structurally, the combined market share of the Parties is very high at molecule level 
([90-100]% in 2018), with a significant market share from Upjohn ( [90-100 ] % in 
2018 ), and Mylan’s increment is small (below [0-5]% in 2018). Mylan is, however,  a 
recent entrant, which started supplying sildenafil for PAH in Lithuania in 2017. In 
addition, only two competitors are active in the supply of this product in Lithuania, 
namely Teva and Intas, one of which (Intas) does not rank among the top 10 
supplier s of generics in Lithuania. As a result, the Transaction would reduce the 
number of players from four to three. These elements are indicative of a likely 
dominant position of Upjohn pre -Transaction, which would be further strengthened 
by the Transaction . 
(131)  The market investigation did not provide any elements to dispel the serious doubts 
arising from the fact that Upjohn would likely have a dominant position  pre-
Transaction , which would be further strengthened by the Transaction and  that the 
merged entity  would only face limited competition  post-Transaction . 
Conclusion  
(132)  In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission concludes that the Transaction raises 
serious doubts as to its compatibility with the internal market as regards the supply 
of sildenafil in Lithuania for the treatment of PAH (ATC3 class C6B), due to its 
likely horizontal non -coordinated effects, in particular given the high combined 
market share and the limited number of significant suppliers.  
(f) Sildenafil in Romania  
(133)  Both Parties supply sildenafil (ATC3 class C6B) in Romania for the treatment of 
PAH. This molecule is genericized in Romania since 2015 for this therapeutic 
indication. Both Parties market a branded v ersion of sildenafil for the treatment of 
PAH in Romania. While Upjohn markets sildenafil (C6B) under the brand name 
Revatio, Mylan markets this product under the name Mysildecard.  
Market shares  
(134)  The Transaction gives rise to a Group 1 market at the molecu le level for the supply 
of sildenafil in Romania.  
(135)  The volume market shares of the Parties and their competitors for the supply of 
sildenafil in Romania  are provided below in Table 12. 


 
 
 
35 
 
 Notifying Parties’ views  
(145)  The Parties did not submit any views in relation to this market. To expedite the 
clearance of the Transaction, the Parties offered to divest Mylan’s sildenafil product 
(C6B) in the United Kingdom to a suitable purchaser.66 
Commission’s assessment  
(146)  Structurally, the combined market share o f the Parties is very high at molecule level 
([80-90]% in 2018), with a significant market share from Upjohn ( [50-60]% in 
2018), and Mylan’s increment is also high (namely [30-40]% in 2018). These 
elements are indicative of a likely dominant position of  Upjohn pre -Transaction, 
which would be further strengthened by the Transaction.  
(147)  The market investigation did not provide any elements to dispel the serious doubts 
arising from the fact Upjohn  would likely have a dominant position  pre-Transaction , 
which would  be further strengthened by the Transaction and that the merged entity 
would only face limited competition  post-Transaction . To the contrary , three 
wholesalers based in the United Kingdom believe that, for the supply of sildenafil, 
the Transaction will hav e a negative impact on prices or product availability in the 
United Kingdom.67 
Conclusion  
(148)  In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission concludes that the Transaction r aises 
serious doubts as to its compatibility with the internal market as regards the supply 
of sildenafil in the United Kingdom for the treatment of PAH (ATC3 class C6B), 
due to horizontal non -coordinated effects, in particular given the high combined 
mark et share and the limited number of significant suppliers.  
5.3.1.4.  Cholesterol and Triglyceride preparations (ATC3 class C10A)  
(149)  In the EEA, both Parties market atorvastatin, which is a molecule indicated for the 
prevention of cardiovascular disease in adults and for  the treatment of 
hyperlipidemia . The Transaction gives rise to the following Group 1(+)/2 markets 
(which do not fall within one of the two categories referred to in paragraph (34)) for 
atorvastatin.   
(a) Atorvastati n in Italy  
(150)  Both Parties supply atorvastatin  (ATC3 class C10A) in Italy. This molecule is 
genericized in Italy since 2012. In this country, Upjohn markets a branded version of 
                                                 
66  See Section 8 of this Decision.  
67  Questionnaire Q3 to wholesalers, non -confidential replies to question 22.  

 
 
 
37 
 
 Commission’s assessment  
(155)  Structurally, the Parties’ combined market share is high, but remained below [50-
60]% in the past three years. Mylan’s increment amounted to [5-10]% in 2018, and 
remained below [10-20]% in 2016 and 2017.  
(156)  In addition, a high number of players, namely nineteen, will remain active in the 
supply of atorvastatin in Italy post -Transaction. Importantly, two of the Parties’ 
competitors, Menarini and Teva, have a significant presence in this market. Menarini 
and Teva ’s market share exceeded [5-10]% in the past three years ( [20-30]% and [5-
10]% respectively in 2018). In addition, both Menarini and Teva have a significant 
presence at the level of the ATC1 class to which atorvastatin belongs.68 An 
additional player, Doc G enerici, which ranks among the top 10 suppliers of generics 
in Italy, is also active in the supply of atorvastatin in Italy, although with a market 
share slightly below [5-10]% ([0-5]% in 2018, but with a small increase in the past 
three years). These comp eting suppliers will thus likely be able to constrain the 
merged entity post -Transaction. This was confirmed by the market investigation. 
The Italy -based customers that responded to the market investigation indicated that 
there would  be no material change in terms of having a sufficient number of 
suppliers post -Transaction for this molecule.69  
(157)  Finally, the results of the market investigation did not reveal any substantiated 
concerns as regards the impact of the Transaction in the atorvastatin market in Ital y. 
None of the respondents to the market investigation considers  that the Transaction 
will have a negative impact on the market, either on prices or on product 
availability.70 
Conclusion  
(158)  In view of the above considerations, taking into account the market in vestigation and 
all the evidence available to it, the Commission considers that the Transaction does 
not raise serious doubts as to its compatibility with the internal market with respect 
to the supply of atorvastatin in Italy.  
(b) Atorvastatin in Norway  
(159)  Both Parties supply atorvastatin  (ATC3 class C10A) in Norway. This molecule is 
genericized in Norway since 2002. In this country, while Upjohn markets a branded 
                                                 
68  The Commission note s that Upjohn has an outlicensing arrangement with [Upjohn’s outlicensees]  for the 
supply of atorvastatin in Italy. However, this outlicensing relationship is very limited. It only relates to 
[details of the outlicensing agreement ] (with a market share at molecule level of [0-5]% in terms of 
volume and value). The licensee, [name of the licensee ], has its own independent marketing authorization 
for [galenic form ], which accounts for the majority of [the licensee ’s] sales in that molecule market.  
69  Questio nnaire Q3 to wholesalers, non -confidential replies to question 25.  
70  Questionnaire Q1 to competitors, non -confidential replies to question 22. Questionnaire Q2 to retailers, 
non-confidential replies to question 28.  



 
 
 
41 
 
 Commission’s assessment  
(175)  Post-Transaction, the Parties will face competition from a number of established 
generic manufacturers, with a significant market presence in Austria  (Sanofi is 
among the top 10 competitors in generi cs in Austria) , with a significant presence in 
urinary incontinence products  (Montavit has a market share of [5-10]% at ATC 2 
level) , as well as Astellas Pharma ( market share of [10-20]% in anticholinergics ). 
Furthermore, Upjohn faces competition from two a dditional competitors (namely 
Intas with a market share of [5-10]% and Easypharm Generika with a market share 
of [5-10]%) at the molecule level (tolterodine).  
(176)  Furthermore , the market investigation confirmed the argument of the Parties that the 
Parties’ pro ducts are not close substitutes, as the Parties do not market the same 
genericized molecule .72.  
(177)  In addition, the results of the market investigation indicate that there will remain a 
sufficient number of suppliers of anticholinergics in Austria. All respon ding 
Austrian wholesalers indicated that a sufficient number of suppliers of 
anticholinergics would remain on the market post -Transaction.73 
(178)  Finally, the results of the market investigation did not reveal any substantiated 
concerns as regards the impact of the Transaction in the anticholinergics market in 
Austria.  
Conclusion  
(179)  In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission considers that the Transaction does 
not raise serio us doubts as to its compatibility with the internal market with respect 
to the supply of anticholinergics in Austria.  
(b) Anticholinergic agents  in Lithuania  
(180)  The Transaction does not give rise to Group 1(+) or 2 market at molecule level for 
the treatment of ur inary incontinence (ATC3 G4D) in Lithuania. However, the 
Transaction gives rise to a Group 1 market if the relevant market were defined at the 
multi -molecule level for the supply of anticholinergics in Lithuania.  
(181)  With regard to anticholinergics in Lithuan ia, Upjohn sells the molecule tolterodine, 
under the brand name Detrusitol, while Mylan markets a branded version of 
oxybutynin, under the brand name Driptane.  
                                                 
72  Questionnaire Q2 to retailers, non -confidential replies to question 14.3 and questionnaire Q1 to 
competitors, non -confidential replies to question 43.  
73   Questionnaire Q3 to wholesalers, non -confidential replies to question 25.  

 
 
 
43 
 
 respectively [30-40]% and [10-20]%). Respondents to the market investigation based  
in Lithuania indicated that these two companies are among the ten leading suppliers 
of generics in Lithuania.74 This indicates that Zentiva and Teva could exert 
constraints on the behaviour of the merged entity, including in terms of pricing.  
(187)  Second, the market investigation confirmed the argument of the Parties that the 
Parties’ products are not close substitutes , as the Parties do not market the same 
genericized molecule.75  
(188)  In addition, the results of the market investigation indicate that there will rem ain a 
sufficient number of suppliers of anticholinergics in Lithuania. All responding 
Lithuanian wholesalers indicated that a sufficient number of suppliers of 
anticholinergics would remain on the market post -Transaction.76 
(189)  Finally, the results of the marke t investigation did not reveal any substantiated 
concerns as regards the impact of the Transaction in the anticholinergics market in 
Lithuania.  
Conclusion  
(190)  In view of the above considerations, taking into account the market investigation and 
all the evidenc e available to it, the Commission considers that the Transaction does 
not raise serious doubts as to its compatibility with the internal market with respect 
to the supply of anticholinergics in Lithuania.  
5.3.3.  Musculoskeletal system treatment FDPs  
(191)  Regarding tre atments for the musculoskeletal system, the Transaction also gives rise 
to a Group 1 affected market (which does not fall within one of the two categories  
referred to in paragraph (34)) in the market for the supply of celecoxib in Italy.   
(192)  In the EEA, both Parties market celecoxib, which is a molecule  indicated for the 
treatment of musculoskeletal inflammation. A Group 1 affected market arises in 
Italy.   
(193)  Both Parties supply celecoxib (ATC3 class M1A) in Italy. This molecule  is 
genericized in Italy since 2014. In this country, Upjohn sells both an unbranded and 
a branded version (Celebrex) of celecoxib, and Mylan supplies an unbranded version 
of celecoxib.    
                                                 
74  Questionnaire Q3 to wholes alers, non -confidential replies to question 15.  
75  Questionnaire Q2 to retailers, non -confidential replies to question 14.3 and questionnaire Q1 to 
competitors, non -confidential replies to question 43.  
76  Questionnaire Q3 to wholesalers, non -confidential r eplies to question 25.  

 
 
 
45 
 
 (199)  Second, a suf ficient number of competitors remain in the market post -Transaction. 
11 generic suppliers of celecoxib will remain active post -Transaction, five of which 
had market shares exceeding the increment contributed by Mylan, namely: S.F. 
Group ( [5-10]%), Teva ( [5-10]%), Doc Generici ( [0-5]%), Novartis ( [0-5]%) and 
Stada ( [0-5]%). Importantly, these five suppliers have a significant presence in Italy 
in the generic space. These five suppliers will thus likely be able to constrain the 
merged entity post -Transaction.  Another  six competitors offer the same molecule. 
Therefore, a sufficient number of competitors will remain in the market post -
Transaction. This was confirmed by the market investigation. Indeed, Italian -based 
wholesalers indicated unanimously that they would have a sufficient number of 
suppliers post -Transaction for this molecule.77  
(200)  In addition, the presence of five suppliers with market shares larger than Mylan 
suggests that the Transaction will not alter significantly the structure of supply and 
will not  lead to a negative impact in terms of product availability or frequency of 
price reductions. This was confirmed by the market investigation. Respondents to 
the market investigation unanimously confirmed that the Transaction would  not have 
a negative impac t on the market for celecoxib  in Italy, either on prices or on product 
availability.78 
(201)  Third, the market investigation did not indicate that the Transaction could 
meaningfully alter the competitive dynamics in the market. S.F. Group, the second 
largest supp lier of celecoxib in Italy following Upjohn (in terms of market shares), is 
the only competing supplier besides Upjohn offering branded celecoxib  in Italy. All 
other suppliers, including Mylan, offer undifferentiated generic products.79  
(202)  Finally, the result s of the market investigation did not reveal any substantiated 
concerns as regards the impact of the Transaction in the celecoxib market in Italy.  
Conclusion  
(203)  In view of the above considerations, taking into account the market investigation and 
all the evid ence available to it, the Commission considers that the Transaction does 
not raise serious doubts as to its compatibility with the internal market with respect 
to the supply of celecoxib in Italy.  
                                                 
77  Questionnaire Q3 to wholesalers, non -confidential replies to quest ion 25.  
78  Questionnaire Q3 to wholesalers, non -confidential replies to question 22.  Questionnaire Q2 to retailers, 
non-confidential replies to question 28.  
79  Ques tionnaire Q3 to wholesalers, non -confidential replies to question 19.  Questionnaire Q2 to Retailers, 
non-confidential replies to question 22.  


 
 
 
48 
 
 competitive constraint, as they can enter or re -enter the market very easily from 
neighbouring countries.  
Commission’s assessment  
(211)  The market investigation conducted by the Commission does not fully support the 
Notifying Parties' arguments.  
(212)  First, the combined market share of the Parties is very high ( [70-80]%) with a very 
significant increment brought by Mylan ( [20-30]%). The Parties  were the two largest 
suppliers of Eletriptan in Denmark in 2018. The combined market share of [70-80]% 
may in itself be evidence of a dominant position of the merged entity post -
Transaction.80  
(213)  Moreover, only one competitor with a significan t presence woul d remain in the 
market post -Transaction, namely Orifarm, a parallel importer81 of Upjohn’s 
eletriptan product with a [20-30]% market share. Although market shares fluctuate 
significantly in Denmark, only three suppliers have gained market shares above 10% 
in the last three years, showing clearly that the Parties are among the top three 
suppliers of eletriptan in Denmark.  
(214)  While the market investigation confirms the Notifying Parties' claims that barriers to 
entry are not particularly high in Denmark, the Comm ission was not able to confirm 
entry plans for this market in Denmark before 2023.82 Moreover, the market 
investigation was inconclusive as to whether parallel importers are effective 
competitors. While the views of competitors are mixed, the retailer respo nding to the 
market investigation does not consider parallel importers as effective competitors.83  
(215)  Second, the Commission observes that while the tenders system in Denmark fosters 
competition, it is important to have a sufficient number of credible supplie rs 
participating in such tenders in order to keep downward pressure on prices and to 
ensure product availability. The Transaction would reduce the number of suppliers 
who have achieved market shares above [10-20]% in the last years from three to two. 
Moreo ver, over the period between 2016 and 2018, only one additional supplier 
achieved market shares above [5-10]% and only in 2016.  
(216)  Moreover, wholesalers in Denmark indicated that they carry both the originator and 
generic versions, and try to offer as m any generics as possible,84 evidencing as well 
                                                 
80  Horizontal Merger Guidelines, para. 17.  
81  Based on IQVIA, Orifarm also supplied its own unbranded product (ele triptan Orifarm).  
82  Questionnaire Q1 to competitors, non -confidential replies to question 40.  
83  Questionnaire Q1 to competitors, non -confidential replies to question 47. Questionnaire Q2 to retailers, 
non-confidential replies to question 35.  
84  Questionn aire Q3 to wholesalers, non -confidential replies to questions 6 and 7.  

 
 
 
50 
 
 Orion, one of the largest pharmaceutical suppliers in Finland, obtained a market ing 
authorization for eletriptan in October 2018. Second, the Parties submit that the main 
reason for the limited generic uptake in this segment is Upjohn’s decision to price 
Relpax (eletriptan) within the price corridor applied under the Finnish generic 
substitution policy. Upjohn’s strategy to price within it generally limits the incentive 
for patients to switch to a generic. In Finland, pharmacies may dispense not just the 
lowest priced generic alternative for a prescribed medicinal product, but all prod ucts 
priced within the acceptable price range (referred to as the "price corridor"). In many 
instances where the originator prices within the price corridor, which is what Upjohn 
does for Relpax, patients tend to prefer the originator product and pharmacie s tend to 
dispense it.  
Commission’s assessment  
(223)  The market investigation conducted by the Commission does not validate the 
Notifying Parties' arguments.  
(224)  First, the combined market shares of the Parties are very high ( [90-100]%). Although 
the increment is v ery limited, only one additional supplier (Orifarm) achieved sales 
of eletriptan in Finland in 2018.  
(225)  Orifarm is a parallel importer of Upjohn’s own eletriptan, Relpax, and does not offer 
a generic version of eletriptan. Therefore, the Transaction would re move from the 
market the only generic supplier of eletriptan in 2018. Even if Orion were to enter 
the market, as suggested by the Parties, the number of generic competitors would 
remain very limited.  
(226)  Second, despite the decision of some suppliers to price  their originator drugs within 
the price corridor, it is important to have generic suppliers to maintain price 
competition. The vast majority of competitors who responded to the market 
investigation indicated that generics exert a competitive constraint on  originators in 
Finland.85 Removing the only generic eletriptan player would limit the competitive 
constraint exerted on Upjohn's Relpax, the only other molecule sold in Finland.  
Conclusion  
(227)  In view of the above considerations and taking account of the resul ts of the market 
investigation and all of the evidence available to it, the Commission considers that 
the Transaction raises serious doubts as to its compatibility with the internal market, 
due to its likely horizontal non -coordinated effects in the market  for eletriptan in 
Finland, in particular given the high combined market shares of the Parties and the 
limited number of suppliers.  
                                                 
85  Questionnaire Q1 to competitors, non -confidential replies to question 56. 








 
 
 
59 
 
 market post -Transaction. Among those, both Novartis ( [0-5]%) and Stada ( [0-5]%) 
achie ve market shares higher than Mylan.  
(270)  However, the Parties submitted remedies for Luxembourg for pregabalin and 
explained that, for the purpose of marketing pregabalin, [Information relating to the 
promotion and distribution of pregabalin in Luxembourg ]. Therefore, to expedite the 
clearance of the Transaction, the Parties offered to divest Mylan’s pregabalin 
product in Belgium and Luxembourg to a suitable purchaser. 93 
Commission’s assessment  
(271)  The combined market shares of the Parties are very high ( [90-100]% in 2018 ), with 
an increment brought by Mylan of [0-5]% on top of Upjohn’s significant market 
share ( [80-90]% in 2018).  Moreover, only two competitors with market shares above 
the increment would remain in the market. No competitor achieves market shares 
above [5-10]%. These elements are indicative of a likely dominant position of 
Upjohn pre -Transaction that would be further strengthened by the Transaction . 
(272)  The market investigation did not provide enough elements to dispel the serious 
doubts arising from the  fact that Upjohn likely has a dominant position pre -
Transaction, which would be strengthened by the Transaction , and given that  the 
merged entity would  only face limited competition.  
Conclusion  
(273)  In view of the above considerations and taking account of the  results of the market 
investigation and all of the evidence available to it, the Commission considers that 
the Transaction raises serious doubts as to its compatibility with the internal market 
due to its likely horizontal non -coordinated effects in the market for pregabalin in 
Belgium, in particular given the high combined market share and the limited number 
of significant suppliers.  
(b) Pregabalin in Czechia  
(274)  Both Parties supply pregabalin (ATC3 class N3A) in Czechia. This molecule  is 
genericized in Czechia since 2014. In this country, while Upjohn sells a branded 
version (Lyrica) of pregabalin, Mylan supplies an unbranded version of pregabalin.    
                                                 
93  See S ection 8 of this Decision.  

 
 
 
61 
 
 Commission’s assessment  
(279)  The market investigation conducted by the Commission does not fully support the 
Notifying Parties'  arguments.  
(280)  First, the combined market share of the Parties is high ( [50-60]%) with a significant 
increment brought by Mylan ( [5-10]%). Although, Upjohn has lost market shares 
over the last three years, it remains the clear market leader. The increment br ought 
by Mylan would lead to market shares above [50-60]%.  
(281)  Second, while a large number of competitors are active in the market, only two 
competitors with a significan t presence would remain in the market post -
Transaction, namely Krka with a [10-20]% mark et share and Novartis with a [5-
10]% market share. All the other competitors would have markets shares below [5-
10]% and below the increment created by the Transaction.  
(282)  Regardless of the fact that the regulatory framework would constrain potential price 
increases, it cannot be excluded that the removal of one of the few significant 
competitors to Upjohn would lead to less frequent  price decreases or less product 
availability.  
(283)  The market investigation did not provide any elements to dispel the serious doubt s 
arising from the fact that the merged entity would have a strong position on the 
market post Transaction and only face limited competition.  
Conclusion  
(284)  In view of the above, the Commission considers that the Transaction raises serious 
doubts as to its com patibility with the internal market, due to its likely horizontal 
non-coordinated effects in the market for pregabalin in Czechia, in particular given 
the high combined market shares and the limited number of significant suppliers.  
(c) Pregabalin in Greece  
(285)  Both Parties supply pregabalin (ATC3 class N3A) in Greece. This molecule  is 
genericized in Greece since 2014. In this country, while Upjohn sells a branded 
version (Lyrica) of pregabalin, Mylan supplies an unbranded version of pregabalin.    

 
 
 
63 
 
 Commission’s assessment  
(290)  First, the Commission notes that Mylan contributes a limited increment of [0-5]% 
for the s upply of pregabalin in Greece. The Parties' combined market share therefore 
primarily reflects the market position of Upjohn.  
(291)  Second, a sufficient number of competitors would remain in the market post -
Transaction. Six generic suppliers of pregabalin will r emain active post -Transaction 
in addition to the Parties, four of which with market shares exceeding the increment 
contributed by Mylan, namely: Novartis ( [0-5]%), Teva ( [0-5]%), Medochemie ( [0-
5]%) and Elpen ( [0-5]%). Another two competitors offer the sam e molecule and two 
additional suppliers have entered in 2019. Therefore, a sufficient number of 
competitors remain in the market post -Transaction. This was confirmed by the 
market investigation. Indeed,  wholesalers active in Greece unanimously indicated 
that they would  have a sufficient number of suppliers for this molecule post -
Transaction.96  
(292)  In addition, the presence of four suppliers with market shares larger than Mylan 
suggests that the Transaction will not alter significantly the structure of supply an d 
will not lead to a negative impact in terms of product availability or frequency of 
price reductions. This was confirmed by the market investigation.97  
(293)  Respondents to the market investigation generally consider  that the Transaction will 
not have a negati ve impact on the market for pregabalin  in Greece.98  
Conclusion  
(294)  In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission considers that the Transaction does 
not raise serious doub ts as to its compatibility with the internal market with respect 
to the supply of pregabalin in Greece.  
(d) Gabapentin in Ireland  
(295)  Both Parties supply gabapentin (ATC3 class N3A) in Ireland. This molecule  is 
genericized in Ireland since 1999. In this country, w hile Upjohn sells a branded 
version (Neurontin) of gabapentin, Mylan supplies an unbranded version of 
gabapentin.    
                                                 
96  Questionnaire Q3 to wholesalers, non -confidential replies to question 25.  
97  Questionnaire Q3 to wholesalers, non -confidential replies to question 22. Questionnaire Q2 to retailers, 
non-confidential replies to question 28.  
98  Questionnaire Q3 to wholesalers, non -confidential replies to question 22.  Questionnaire Q2 to retailers, 
non-confidential replies to question 28.  

 
 
 
65 
 
 recently become substitutable at pharmacy level and that consequently Upjohn 
would face more competition from generic players, and that given the number of 
remaining suppliers the Transaction cannot have a negati ve impact on product 
availability. Finally, the Notifying  Parties submit that the merged entity will be 
constrained in its pricing behaviour by the regulatory framework in Ireland.  
Commission’s assessment  
(301)  The market investigation conducted by the Commissi on does not fully support the 
Notifying Parties' arguments.  
(302)  First, the combined market share of the Parties is high ( [50-60]%) with a material 
increment brought by Mylan ( [5-10]%). The increment brought by Mylan would 
lead to market shares above [50-60]%. Market shares for the first two months of 
2020 are still not sufficiently meaningful, as the period of two months is too short to 
be indicative of the market position of the Parties. In any event, market shares do not 
change significantly ( [40-50]% combin ed for the first two months of 2020) and there 
is only one competitor with a market share  above [5-10]% or the increment, namely 
Teva.  
(303)  Second, while four competitors are active in the market, only one competitor with a 
significant presence would remain in  the market post -Transaction, namely Teva with 
a [30-40]% market share. All the other competitors would have markets shares 
below [5-10]% and below the increment created by the Transaction.  
(304)  Third, as recognized by the Notifying Parties  and confirmed by the  market 
investigation,100 gabapentin is substitutable at pharmacy level. This  increases 
competition between the originator and generics. Mylan is the second largest generic 
supplier of gabapentin in Ireland and thus it is well positioned to compete closely 
with Upjohn to gain market shares.  
(305)  Fourth, respondents to the market investigation indicate that the Transaction would 
likely have a negative impact, in particular on product availability.101 
Conclusion  
(306)  In view of the above, the Commission considers that the Transaction raises serious 
doubts as to its compatibility with the internal market, due to its likely horizontal 
non-coordinated effects in the market for gabapentin in Ireland, in particular given 
the high combined market shares of the Parties and the lim ited number of significant 
suppliers.  
                                                 
100  Questionnaire Q2 to retailers, non -confidential replies to question 50.  
101  Questionnaire Q3 to wholesaler s, non -confidential replies to question 22.  Questionnaire Q2 to retailers, 
non-confidential replies to question 28.  

 
 
 
67 
 
 Notifying Parties' view  
(311)  The Parties submit that the Transaction does not give rise to competition concerns 
regarding the supply of pregabalin in Italy  because (i) a sufficient numb er of 
supplier s (namely 16) will remain in the market post -Transaction, (ii) Upjohn lost 
significant market share since generic entry in 2015 ( -[30-40]% in volume) and (iii) 
the merged entity will post -Transaction be constrained in its pricing behaviour by  the 
regulatory framework.  
Commission’s assessment  
(312)  First, a sufficient number of competitors remain in the market post -Transaction. 16 
generic suppliers of pregabalin will remain active post -Transaction, three of which 
have market shares exceeding the incr ement contributed by Mylan and above [5-
10]%, namely: Teva ( [10-20]%), Doc Generici ( [5-10]%) and Novartis ( [5-10]%). 
Importantly, these three suppliers also have a significant presence in in Italy in the 
generic space. Another 13 competitors offer the sam e molecule. Therefore, a 
sufficient number of competitors remain in the market post -Transaction which will 
be able to exert a meaningful competitive constraint for the supply of pregabalin in 
Italy. This was confirmed by the market investigation. Indeed, I talian -based 
wholesalers indicated unanimously that they would  have a sufficient number of 
suppliers post -Transaction for this molecule.102  
(313)  In addition, the presence of three suppliers with market shares larger than Mylan 
suggests that the Transaction will not alter significantly the structure of supply and 
will not lead to a negative impact in terms of product availability or frequency of 
price reductions. This was confirmed by the market investigation. Respondents to 
the market investigation unanimously co nfirmed that the Transaction would  not have 
a negative impact on the market for pregabalin  in Italy, either on prices or on product 
availability.103 
(314)  Second, Upjohn has lost market shares very rapidly in the last years  ([20-30] 
percent age points between 2016 and 2018) , since the loss of exclusivity for 
pregabalin in Italy in 2014, while the market shares of Mylan have grown modestly  
([0-5] percent age points between 2016 and 2018) . Other suppliers such as Teva or 
Novartis have gained market shares faster than M ylan. Suppliers such as Stada or 
Ecupharma have also gained market shares in the last three years. This suggests that 
other suppliers compete more closely with Upjohn than Mylan and exert a 
competitive pressure on Upjohn.  
                                                 
102  Questionnaire Q3 to wholesalers, non -confidential replies to question 25.  
103  Questionnaire Q3 to wholesalers, non -confidential replies to  question 22. Questionnaire Q2 to retailers, 
non-confidential replies to question 28.  



 
 
 
71 
 
 (333)  The market investigation indicated that parallel importers sell branded products and 
do not price at generic level.106 Wholesalers also indicated that parallel importers are 
less reliable suppliers.107 Therefore, they do not exert a strong competition constraint 
on originator products.  
(334)  Third, the Commission was not able to verify the entry plans of other suppliers 
before 2023 in the pregabalin market in Norway.108 The Transaction would eliminate 
Mylan as the only potential competitor for a generic product in Norway.  
(335)  Finally, the Commission does not find that it is appropriate to consider as the most 
likely counterfactual scenario a lack of entry by Mylan in the market. [information 
about Mylan’s commercialization of pregabalin in Norway ].  
Conclusion  
(336)  In view of the above, the Commission considers that the Transaction raises serious 
doubts as to its compatibility with the internal market, due to its likely horizontal 
non-coordinated effects in the market for pregabalin in Norway given the  removal of 
the only potential generic competitor.  
5.3.4.3.  Antipsychotics (ATC3 class N5A)  
(337)  In the EEA, both Parties market ziprasidone, a molecule indicated for the treatment 
of mental disorders including schizophrenia and mania. The Transaction gives rise to 
the following Group 1(+)/2 affected markets (which do not fall within one of the two 
categories  referred to in paragraph (33)) for ziprasidone.  
(a) Ziprasidone in Czechia  
(338)  Both Parties supply ziprasidone (ATC3 class N5A) in Czechia . This molecule is 
genericized in Czechia  since 2013. In this country, while Upjohn markets 
ziprasidone under the brand name Zeldox, Mylan supplies an unbranded version of 
ziprasidone.  
Market shares  
(339)  The Transaction gives rise to a Group 1 market at the molecule level for ziprasidone 
in Czechia .109 
                                                 
106  Questionnaire Q3 to wholesaler s, non -confidential replies to question 45.  Questionnaire Q2 to retailers, 
non-confidential replies to question 51.  
107  Questionnaire Q3 to wholesalers, non -confidential replies to question 45.  
108  Questionnaire Q1 to competitors, non -confidential replies to  question 41  
109  The Transaction also gives rise to a Group 1 affected market, when looking only at oral solid immediate 
release products (NFC1 class A). However, the competitive dynamics do not differ compared to those at 
 


 
 
 
74 
 
 (350)  For the molecule ziprasidone (ATC3 class N5A) in Portugal, the Parties' combined 
market share amounted to [40-50]% in 2018, with an increment of [10-20]% from 
Upjohn.  
Notifying Parties' view  
(351)  The Parties submit that competition concerns can be excluded for the supply of 
ziprasidone (ATC3 class N5A) in Portugal, in particular due to the actual and 
potential competitors on the market (including holders of do rmant market 
authorisations), the lack of closeness of competition between the Parties, and 
constraints due to the applicable regulatory framework which would limit the 
possibility to increase prices.  
Commission’s assessment  
(352)  The combined market shares of t he Parties would remain below [40-50]% post -
Transaction. The increment is brought about by Upjohn, evidencing the largely 
genericized nature of the ziprasidone market in Portugal.  
(353)  Post-Transaction, at least two other significant generic players will remai n on the 
market, namely Stada and Aurobindo , with market shares of [20-30]% and [20-30]% 
respectively . In addition, the responding Portuguese national health authorities 
indicate that entry in the market is easy, and in particular,  that generic companies 
holding dormant marketing authorisations are credible entrants which could enter 
within a short period .112 
(354)  The market investigation also indicates that, in Portugal, generics compete with 
originators primarily on prices. However, the market investigation also  indicates that 
Mylan is perceived as not being a particularly price -aggressive player by some 
pharmacies and wholesalers. Respondents note in particular [Information relating to 
the commercialization of ziprasidone in Portugal ].113 
(355)  In addition, virtually al l responding wholesalers indicated that a sufficient number of 
suppliers of ziprasidone would remain on the market post Transaction.114 
(356)  Finally, the results of the market investigation did not reveal any substantiated 
concerns as regards the impact of the Tr ansaction in the ziprasidone market in 
Portugal.  
                                                 
112  Questionnaire Q4 to national authorities, non -confide ntial replies to question 11.  
113  Questionnaire Q2 to retailers, non -confidential replies to question 17. Questionnaire Q3 to wholesalers, 
non-confidential replies to question 16.  
114  Questionnaire Q3 to wholesalers, non -confidential replies to question 25.  

 
 
 
76 
 
 (361)  For the molecule ziprasidone (ATC3 class N5A) in Spain, the Parties' combined 
market share amounted to [80-90]% in 2018,  with an increment of [0-5]% from 
Mylan.  
Notifying Parties’ view  
(362)  The Parties submit that competition concerns can be excluded for the supply of 
ziprasidone (ATC3 class N5A) in Spain, in particular due to the limited increment 
brought about by Mylan, the n umber of competitors remaining on the market, the 
lack of closeness of competition between the Parties, and constraints due to the 
applicable regulatory framework, which would limit the possibility to increase 
prices.  
Commission’s assessment  
(363)  The Commission  notes that the increment brought about by Mylan (less than [0-5]%) 
is particularly limited. The merged entity’s significant market share thus mainly 
reflects Upjohn’s position and is largely not merger -specific.  
(364)  Importantly, substitutability between orig inators and generics for ziprasidone may be 
limited in Spain. In the area of anti -psychotics, such as ziprasidone, doctors would 
normally not switch a patient’s prescription when one specific product is found to be 
effective, as switching can be counterpro ductive or even lead to side effects. 
Responding Spanish pharmacies confirmed that for antipsychotics, pharmacies 
would not switch a patient’s prescription from a branded product to a generic , while 
they generally have the ability to do convert prescriptio n towards generics under the 
applicable rules .116 This situation may explain the relative stability of Upjohn’s 
market share over the years.  
(365)  In addition, responding pharmacies and wholesalers do not consider Mylan’s 
ziprasidone as a must -have product , i.e. a product that they need to have in stock to 
meet patients' demand,  in Spain.117  
(366)  Competitors to the Parties, with a more significant footprint than Mylan will remain 
on the market post -Transaction. At least three players, including large generic 
companies s uch as Krka (with a [5-10]% market share) and Stada  ([0-5]%), as well 
as Infarco ( [0-5]%), which have a market share exceeding the increment  ([0-5]%), 
will remain active on the market.  
(367)  Furthermore, virtually all responding wholesalers also indicated that a  sufficient 
number of suppliers of ziprasidone would remain on the market post Transaction.118 
                                                 
116  Questionnaire Q2 to retailers, non -confidential replies to questions 4 and 6.  
117  Questionnaire Q2 to retailers, non -confidential replies to question 22. Questionnaire Q3 to whol esalers, 
non-confidential replies to question 19.  
 
 
 
77 
 
 (368)  Finally, the results of the market investigation did not reveal any substantiated 
concerns as regards the impact of the Transaction in the ziprasidone market in Sp ain.  
Conclusion  
(369)  In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission considers that the Transaction does 
not raise serious doubts as to its compatibility with the internal m arket with respect 
to the supply of ziprasidone in Spain.  
5.3.4.4.  Tranquilisers (ATC3 class N5C)  
(370)  In the EEA, both Parties market alprazolam, a molecule indicated for the treatment 
of anxiety, panic disorders, alcohol withdrawal syndrome, depression, and anxiety.   
(371)  Alprazolam belongs to the category of benzodiazepines, which are molecules 
affecting a key neurotransmitter, effectively slowing nerve impulses throughout the 
body. While Mylan markets other benzodiazepines (including for instance 
oxazepam, lorazepam, brom azepam, hydroxyzine and buspirone), Upjohn only 
markets alprazolam.  
(372)  The Transaction gives rise to the following Group 1(+)/2 markets (which do not fall 
within one of the two categories  referred to in paragraph (34)) for alprazolam.119 
(a) Alprazolam in Greece  
(373)  Both Parties supply alprazolam (ATC3 class N5C) in Greece. This molecule is 
genericized in Greece for at least 20 years . In this country, while Upjohn markets 
alprazolam under the brand name Xanax, Mylan supplies an unbranded version of 
alprazolam.  
Market shares  
(374)  The Transaction gives rise to a Group 2 market at the molecule level for alprazolam 
in Greece.  
                                                                                                                                                      
118  Questionnaire Q3 to wholesalers, non -confidential replies to question 25.  
119  No additional affected Group 1(+) or 2 market would arise, considering benzodiazepines as a whole, with 
the exception of Austr ia. In Austria, Upjohn sells alprazolam (under the brand Xanor) and Mylan sells a 
different molecule, namely oxazepam. Regardless of market definitions, competition concerns can be 
excluded as the Parties’ combined market share is [40-50]% and there remain  at least three providers with 
each, a market share of at least [5-10]% and a substantial presence in the country concerned and/or in 
terms of a portfolio of products in the same therapeutic area in the country.  

 
 
 
79 
 
 (381)  First, Upjohn’s Xanax is by far the primary alprazolam product sold in Greece, and 
only faces limited competition to date. Most respondents, including virtually all 
responding pharmacies/hospi tals and a majority of wholesalers consider Upjohn’s 
products including Xanax as a must -have.120 In addition, […].  
(382)  Competition from all third parties, including Mylan, is important to guarantee supply 
of alprazolam to Greek patients and hospitals. Pfizer su ffered out of stock situations 
for alprazolam in Greece over the last three years.121 In addition, supply is further 
limited due to parallel exports from Greece.122 As a result, product availability from 
smaller players, including Mylan, is likely to be partic ularly critical for patients and 
health systems.  
(383)  Only one player, namely Adelco, would remain active in the market post -
Transaction  with a market share of [0-5]%. Adelco and Mylan hold a similar market 
share for the supply of alprazolam in Greece . Contrar y to Mylan, Adelco is not 
among the top 10 generic players in Greece. Adelco thus  presumably exert s a similar 
or lesser level of competitive constraint on Upjohn pre -Transaction  than Mylan .  
(384)  Regardless of any price increase, the removal of one of only two competitors to 
Upjohn’s Xanax could potentially  lead to less frequent price decreases or less 
product availability.  
(385)  A majority of responding customers expect a negative impact of the Transaction on 
prices and/or product availability, in relation to the su pply of alprazolam in 
Greece.123 One customer notes for instance that “" Xanax of Pfizer & alprazolame 
(sic) of Mylan cover almost [90-100] % of patient needs ”.124 
(386)  Lastly, documents provided by the Parties [[Information relating to Mylan’s 
commercial activities in Greece ]. As a result, it is not clear that the correct 
counterfactual scenario, absent the Transaction, would be [[Information relating to 
Mylan’s commercial activities in Greece ]. 
Conclusion  
(387)  In view of the above considerations and taking account of the  results of the market 
investigation and all of the evidence available to it, the Commission considers that 
the Transaction raises serious doubts as to its compatibility with the internal market, 
due to its likely horizontal non -coordinated effects in the market for alprazolam in 
                                                 
120  Questionnaire Q2 to retailers, non -confid ential replies to question 21. Questionnaire Q3 to wholesalers, 
non-confidential replies to question 18.  
121  Questionnaire Q2 to retailers, non -confidential replies to question 27.  
122  Questionnaire Q4 to national authorities, non -confidential replies to que stion 11.  
123  Questionnaire Q2 to retailers, non -confidential replies to questions 28 and 29. Questionnaire Q3 to 
wholesalers, non -confidential replies to questions 22 and 23.  
124  Questionnaire Q3 to wholesalers, non -confidential replies to question 26.  

 
 
 
81 
 
 Commission’s assessment  
(393)  The Parties’ combined market shares are very hi gh, exceeding [80-90]%, with a 
significant increment, approaching [20-30]%, from Upjohn , on top of Mylan’s 
significant market share ( [50-60]% in 2018)  These elements are indicative of a likely 
dominant position of Mylan  pre-Transaction, which would be furt her strengthened 
by the Transaction.  
(394)  On such market, the Parties only face one competitor, namely Krka. As a result, the 
Transaction essentially amounts to a reduction in the number of players active on the 
market from three to two.  
(395)  Furthermore, when look ing only at oral solid immediate release alprazolam products 
(NFC1 class A) in Iceland, the situation is even more problematic, as Mylan's market 
share would be [80-90]% and Upjohn's [10-20]%. On this market, the merger would 
essential ly amount to a merger  to monopoly.  
(396)  The market investigation did not provide any elements to dispel the serious doubts 
arising from the fact that Mylan likely has a dominant position pre -Transaction, 
which would be further strengthened by the Transaction , and given that the me rged 
entity would only face limited competition post -Transaction . 
Conclusion  
(397)  In view of the above considerations and taking account of the results of the market 
investigation and all of the evidence available to it, the Commission considers that 
the Transa ction raises serious doubts as to its compatibility with the internal market, 
due to its likely horizontal non -coordinated effects in the market for alprazolam in 
Iceland, in particular given the high combined market shares and the limited number 
of suppli ers. 
(c) Alprazolam in Ireland  
(398)  Both Parties supply alprazolam (ATC3 class N5C) in Ireland. This molecule is 
genericized in Ireland since at least 20 years. In this country, Upjohn markets 
alprazolam under the brand name Xanax, Mylan markets alprazolam under t he brand 
name Gerax.  
Market shares  
(399)  The Transaction gives rise to a Group 1 market at the molecule level for alprazolam 
in Ireland.  
                                                                                                                                                      
126  See Section 8 of this Decision.  

 
 
 
83 
 
 (404)  The market investigation did not provide any elements to dispel the serious doubts 
arising from the fact that Upjohn likely has  a dominant position  pre-Transaction , 
which would be further strengthened by the Transaction , and given that the merged 
entity would only face limited competition post -Transaction . In fact, half of 
responding customers (pharmacies and wholesalers) considered t hat the Transaction 
would have a negative impact on prices or product availability with regards to 
alprazolam in Ireland.128 
Conclusion  
(405)  In view of the above considerations and taking account of the results of the market 
investigation and all of the evidence available to it, the Commission concludes 
considers that the Transaction raises serious doubts as to its compatibility with the 
internal market, due to its likely horizontal non -coordinated effects in the market for 
alprazolam in Ireland, in particular giv en the high combined market shares and the 
limited number of significant suppliers.  
(d) Alprazolam in Italy  
(406)  Both Parties supply alprazolam (ATC3 class N5C) in  Italy. This molecule is 
genericized in Italy since at least 20 years. In this country, while Upjohn m arkets 
alprazolam under the brand name Xanax, Mylan supplies both an unbranded version 
of alprazolam and a branded version, under the brand name Frontal.  
Market shares  
(407)  The Transaction gives rise to a Group 1 market at the molecule level for alprazolam 
in Italy.129 
(408)  The volume market shares of the Parties and their competitors for the supply of 
alprazolam in Italy are provided below in Table 39. 
 
 
 
                                                 
128  Questionnaire Q2 to retailers, non -confidentia l replies to question 28 Questionnaire Q3 to wholesalers, 
non-confidential replies to question 22.  
129  The Transaction also gives rise to a Group 1 affected market, when looking only at oral solid immediate 
release products (NFC1 class A) or oral liquid ord inary products (NFC1 class D). However, the 
competitive dynamics do not differ significantly compared to those at molecule level, as the Parties' 
combined market share remains similar (between [70-80]% and [70-80]% at NFCA1 A and D level 
respectively, with  similar increments of [10-20]% and [10-20]% respectively) and the same competitors 
are generally active in both format, and will thus not be assessed separately.  

 
 
 
85 
 
 share ( [60-70]%). These elements are indicative of a likely dominant position of 
Upjohn pre -Transaction, which would be further strengthened by the Transaction.  In 
addition, the market investigation conducted by the Commission does not fully 
support the Notifying Parties’ arguments.  
(413)  First, the market investigation indicates that generic penetration remains quite low 
for alprazolam in Italy (below one third of the total market ).130 This is confirmed by 
Upjohn’s consistently high market shares over the last three years, in spite of 
Xanax’s loss of exclusivity occurring over 20 years ago.  
(414)  A majority of responding Italian customers (pharmacies and wholesalers) consider 
that the pri ce of generic products in Italy generally affects  the price level of 
originators. For instance, prices of originators would likely decrease if all generic 
players reduced their prices by 5 -10%.131 Respondents to the market investigation 
also took specificall y the view that the price of generic alprazolam constrains the 
pricing of Upjohn’s Xanax.132  
(415)  Second, Mylan exerts a competitive constraint on Upjohn. The market investigation 
confirms that brand loyalty is very high in Italy and is a key parameter of 
compet ition in the supply of pharmaceutical products in Italy.133 However, as 
mentioned in paragraph [ 414], generic alprazolam exerts a competitive constraint on 
Xanax, in particular in terms of pricing. As a result, removing the largest provider of 
generic alpraz olam is likely to strengthen Xanax’s already strong market position.  
(416)  Third, independently from any kind of product differentiation, Mylan can be set 
apart from other generic players on the alprazolam market in Italy. Mylan is the 
largest generic player in the alprazolam market, with a market share nearly three 
times as large as the second generic player, Stada, whose market shares does not 
exceed [5-10]%. One responding competitor even considers the Parties to be close 
competitors in Italy because  they both  have high market shares.134 The respondents 
to the market investigation indicate that companies with low market shares (that is to 
say below 5%) do not exert a strong competitive constraint on an originator.135 
Combined, all other generic suppliers besides St ada have a market share lower than 
Mylan’s. As a result, Mylan is among one of the only two generic players able to 
exert an effective competitive constraint on Upjohn’s Xanax.  
                                                 
130  Questionnaire Q1 to competitors, non -confidential replies to question 51.2.  
131  Questionnai re Q1 to competitors, non -confidential replies to question 51.3.  
132  Questionnaire Q2 to retailers, non -confidential replies to question 43.2. Questionnaire Q3 to wholesalers, 
non-confidential replies to question 38.2.  
133  Questionnaire Q1 to competitors, no n-confidential replies to question 50. Questionnaire Q2 to retailers, 
non-confidential replies to question 43. Questionnaire Q3 to wholesalers, non -confidential replies to 
question 38.  
134  Questionnaire Q1 to competitors, non -confidential replies to questio n 57.  
135  Questionnaire Q1 to competitors, non -confidential replies to question 51.3.  
 
 
 
86 
 
 (417)  In addition, part of Mylan’s sales (accounting for around [0-5]% of the sales in the 
Italian alprazolam market) result from the sale of its branded product Frontal, 
[Information concerning alprazolam in Italy ].136 This product is priced at a premium, 
closer to Upjohn’s than Mylan’s unbranded generic alprazolam.  
(418)  Lastly, alprazolam is not a reimbursed product in Italy. It belongs to the so -called 
“class C” of pharmaceutical products. The pricing of class C products, such as 
alprazolam is set freely by the manufacturers, and can be increased every odd year, 
in line with anticipated infla tion, under the monitoring of the Italian public health 
authorities. Information provided by the Notifying Parties shows that both Upjohn, 
Mylan, as well as other generic suppliers have used this possibility in 2017 and 
2019.  
(419)  In addition to potential pric e increases, the Transaction could potentially  lead to less 
frequent price reductions, as a result of the more limited competitive interactions 
between Xanax and generic alprazolam.  
Conclusion  
(420)  In view of the above considerations and taking account of the r esults of the market 
investigation and all of the evidence available to it, the Commission considers that 
the Transaction raises serious doubts as to its compatibility with the internal market, 
due to its likely horizontal non -coordinated effects in the ma rket for alprazolam in 
Italy, in particular given the high combined market shares and the limited number of 
significant suppliers.  
(e) Alprazolam in Poland  
(421)  Both Parties supply alprazolam (ATC3 class N5C) in Poland. This molecule is 
genericized in Poland since at least 20 years. In this country, while Upjohn markets 
alprazolam under the brand name Xanax, Mylan supplies an unbranded version of 
alprazolam.  
Market shares  
(422)  The Transaction gives rise to a Group 1 market at the molecule level for alprazolam 
in Poland.137 
                                                 
136  [Information concerning alprazolam in Italy ]  
137  The Transaction also gives rise to a Group 1 affected market, when looking only at oral solid immediate 
release product s (NFC1 class A). However, the competitive dynamics do not differ compared to those at 
molecule level, as the Parties and their competitors' market shares are similar, and will thus not be 
assessed separately.  

 
 
 
88 
 
 (427)  Post-Transaction, the Parties will face competition from a number of established 
generic purchasers, with a significant market presence, including Orion  (with a [10-
20]% market share) , Servier  ([10-20]%), Krka  ([10-20]%), and Delfarma  ([5-10]%), 
all with market shares exceeding [5-10]% and even exceeding [10-20]% for the 
former three.   
(428)  In addition, virtually all responding Polish wholesalers indicated that a sufficient 
number of suppliers of alprazolam would remain on the market post -Transaction.138 
Conclusion  
(429)  In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission considers that the Transaction does 
not raise serious doubts as to its compatibility with the int ernal market with respect 
to the supply of alprazolam in Poland.  
(f) Alprazolam in Portugal  
(430)  Both Parties supply alprazolam (ATC3 class N5C) in Portugal. This molecule is 
genericized in Portugal since at least 20 years. In this country, while Upjohn markets 
alprazolam under the brand name Xanax, Mylan supplies an unbranded version of 
alprazolam.  
Market shares  
(431)  The Transaction gives rise to a Group 1 market at the molecule level for alprazolam 
in Portugal.139 
(432)  The volume market shares of the Parties and their compet itors for the supply of 
alprazolam in Portugal are provided below in Table 41. 
 
 
 
 
                                                 
138  Questionnaire Q3 to wholesalers, non -confid ential replies to question 25.  
139  The Transaction also gives rise to a Group 1 affected market, when looking only at oral solid immediate 
release products (NFC1 class A) or only oral solid extended release formulations (NFC class B). 
However, the competiti ve dynamics do not differ significantly compared to those at molecule level, and 
will thus not be assessed separately. As the Parties' combined market share remains similar (between [50-
60]% and [60-70]% at NFCA1 A and B level respectively, with similar in crements of [20-30]% and [30-
40]% respectively) and the same competitors are generally active in both format.  

 
 
 
90 
 
 Commission’s assessment  
(436)  Structurally, the Transaction leads to an important change in market dynamics. 
Based on 2018 figures, t he merged entity’s market share would reach nearly [50-
60]%, with a significant increment from Upjohn ( [20-30]%). 
(437)  In addition, the market investigation conducted by the Commission does not fully 
support the Notifying Parties’ arguments.  
(438)  First, while there is a signi ficant number of companies offering alprazolam in 
Portugal, only few have a significant market presence. Indeed, only four, including 
Upjohn and Mylan (who is the market leader), have a market share exceeding [5-
10]%, including Teva ( with an [10-20]% marke t share) and Atral (around [10-20]%). 
Out of these, only Teva is perceived by responding pharmacies as having a 
salesforce matching Mylan’s in the country.140 
(439)  In addition, Portugal is pharmacy -driven market, where discounts and broad 
portfolio offering regar ding or regardless of the therapeutic are key advantages. A 
large majority of responding pharmacies indicated receiving multi -product discounts 
from pharmaceutical companies, including from those offering both generics and 
originators.141 One Portuguese whol esaler states for instance that “ […] when there 
are rebates, these are applied to all portfolio, and not to a specific range of 
products. We don't have rebates that favor generics against branded products” .142 
The market investigation indicates that Upjohn’s  Xanax is considered as must -have 
by a majority of responding customers. The results of the market investigation are 
more mixed as to whether Mylan’s alprazolam is also a must -have product. While a 
large majority of wholesalers consider it to be the case ( but also list other suppliers 
of must -have alprazolam including for instance Teva), pharmacies are more split.143 
As a result, the market position of the merged entity post Transaction may be even 
stronger than the combination of Mylan and Upjohn’s position pre Transaction.  
(440)  Second, regardless of any consideration relating to closeness of competition, the 
Parties can be considered as exerting a competitive constraint on each other. A 
majority of respondents to the market investigation consider generics exert 
competitive constraints  on originators (and vice versa) in Portugal, proportionally 
more than on average in the EEA.144 The pricing of generics also move in parallel to 
the pricing of the originator based on information provided by the Notifying Parties. 
As the leading generic supplier for alprazolam in Portugal, Mylan is thus a primary 
competitor to Upjohn.  
                                                 
140  Questionnaire Q2 to retailers, non -confidential replies to question 26.  
141  Questionnaire Q2 to retailers, non -confidential replies to question 19. 
142  Questionnaire Q3 to wholesalers, non -confidential replies to question 13.  
143  Questionnaire Q2 to retailers, non -confidential replies to question 54. Questionnaire Q3 to wholesalers, 
non-confidential replies to questions 20.1 and 48.  
144  Questionnaire  Q1 to competitors, non -confidential replies to question 55.  
 
 
 
91 
 
 (441)  Finally, the market investigation confirms price increases of generics in Portugal are 
infrequent.145 However, the transaction may lead to less frequent p rice decreases in 
relation to alprazolam in Portugal , as prices of generics tend to decrease over time . 
While information provided by the Notifying Parties indicates that no voluntary 
price reduction occurred over the last six years, there are no indicatio ns that future 
price reductions would not take place absent the Transaction . 
Conclusion  
(442)  In view of the above considerations and taking account of the results of the market 
investigation and all of the evidence available to it, the Commission considers that  
the Transaction raises serious doubts as to its compatibility with the internal market, 
due to its likely horizontal non -coordinated effects in the market for alprazolam in 
Portugal, in particular given the high combined market shares and the limited 
numb er of significant suppliers.  
5.3.4.5.  Anti-depressants and mood stabilisers (ATC3 class N6A)  
(443)  In the EEA, both Parties market venlafaxine and sertraline, which are molecules 
used t o treat depression and anxiety disorders . In the EEA, their only common 
indication is for the treatment and prevention of the recurrence of major depressive 
episodes. In addition, sertraline is also indicated for the treatment of panic, 
obsessive -compulsive, social anxiety and post -traumatic stress disorders. The 
Transaction gives rise to t he following Group 1(+)/2 markets (which do not fall 
within one of the two categories  referred to in paragraph (34)) for venlafaxine and 
sertraline.   
(a) Venlafaxine in Belgium  
(444)  Both Parties supply venlafaxine (ATC3 c lass N6A) in Belgium. This molecule is 
genericized in Belgium since 2008. In this country, while Upjohn markets 
venlafaxine under the brand name Effexor -Exel, Mylan supplies an unbranded 
version of venlafaxine.  
Market shares  
(445)  The Transaction gives rise to a Group 1 market at the molecule level for venlafaxine 
in Belgium.146 
                                                 
145  Questionnaire Q4 to national authorities, non -confidential replies to question 5.  
146  The Transaction also gives rise to a Group 1 affected market, when looking only at oral solid extended 
release formulations (NFC class B). However, the competitive dynamics do not differ compared to those 
at molecule level, as the Parties and their competitors' market shares are similar, and will thus not be 
assessed separately.  

 
 
 
93 
 
 (451)  First, there are only two significant suppliers of venlafaxine in Belgium besides the 
Parties, namely Novartis  and Stada, with market shares around half or less compared 
to the merged entity’s. The Transaction would thus largely result in a reduction in 
the number of significant players from four to three.  
(452)  In addition, the market investigation provided some indica tion that, among generic 
players, Mylan was perceived as having a more aggressive price policy, or as 
initiating price decreases, compared to other generic players. Half of the responding 
pharmacies flagged this.147 
(453)  Second, regarding out of stock situations in relation to venlafaxine, the market 
investigation results are more mixed. A majority of responding customers as well as 
the national authority indicate that these situations are not frequent in relation to the 
molecule in Belgium.148 However, the market i nvestigation did not indicate that the 
recent supply issues experienced by the Parties’ competitors have been resolved. 
One customer also expressed concerns that the Transaction could lead to further 
issues in terms of product availability, including for t he provision of venlafaxine.149  
(454)  Finally, the market investigation confirms that prices are fixed by law including for 
venlafaxine. However, the market investigation, and in particular the national health 
authority , confirms that significant price reductions  are also common several years 
after first generic entry.150 As a result, the Transaction, which involves the merger 
between the originator manufacturer, and an established generic player, potentially 
aggressive in terms of pricing, could lead to less freque nt price reductions for 
venlafaxine in Belgium.   
Conclusion  
(455)  In view of the above considerations and taking account of the results of the market 
investigation and all of the evidence available to it, the Commission considers that 
the Transaction raises seri ous doubts as to its compatibility with the internal market, 
due to its likely horizontal non -coordinated effects in the market for venlafaxine in 
Belgium, in particular given the high combined market shares and the limited 
number of significant suppliers.  
                                                 
147  Questionnaire Q2 to retailers , non -confidential replies to question 17. Questionnaire Q3 to wholesalers, 
non-confidential replies to question 16.  
148  Questionnaire Q2 to retailers, non -confidential replies to question 33.1. Questionnaire Q3 to wholesalers, 
non-confidential replies to q uestion 28.  
149  Questionnaire Q3 to wholesalers, non -confidential replies to question 22.  
150 Questionnaire Q4 to national authorities, non -confidential replies to question 4.  

 
 
 
95 
 
 increment brought about by Mylan, [information concerning the commercialization 
of venlafaxine in Greece ].  
Commission’s assessment  
(461)  The Commission notes that the increment brought about by Mylan is minimal (less 
than [0-5]%). Mylan’s li mited market share has been consistent over the last three 
years. The merged entity’s strong market share thus mainly reflects Upjohn’s and is 
largely not merger -specific.  
(462)  The Parties will face competition from a number of established generic purchasers, 
with a significant and stable market presence, including Innovis  (with a [10-20]% 
market share) , Gap  ([5-10]%), Medochemie  ([5-10]%), all with market shares 
exceeding [5-10]%, and other players including Qualia or SJA, whose share are 
much higher (around o r nearly tenfold) than the increment brought about by Mylan. 
In total, the Parties will continue facing competition from 14 generic suppliers active 
in the market.   
(463)  In addition, virtually all responding Greek wholesalers indicated that a sufficient 
number of suppliers of venlafaxine would remain on the market post Transaction.151 
(464)  Finally , the results of the market investigation did not reveal any substantiated 
concerns as regards the impact of the Transaction in the venlafaxine market in 
Greece.  
Conclusion  
(465)  In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission considers that the Transaction does 
not raise serious doubts as to its compatibility with the internal market with respect 
to the supply of venlafaxine in Greece.  
(c) Sertraline in Greece  
(466)  Both Parties supply sertraline (ATC3 class N6A) in Greece. This molecule is 
genericized in Greece since 1996. In this country, while Upjohn markets sertraline 
under the brand name Zoloft, Mylan s upplies an unbranded version of sertraline.  
                                                 
151  Questionnaire Q3 to wholesalers, non -confidential replies to question 25.  

 
 
 
97 
 
 over the last three years. The merged ent ity’s market share thus mainly reflects 
Upjohn’s and is largely not merger -specific.  
(472)  The Parties will face competition from a number of established generic purchasers, 
with a significant and stable market presence, including in particular Teva, with a 
market share nearing [20-30]% (at [20-30]%), followed by Novartis ( [5-10]%), and 
other players including Vianex  ([0-5]%), whose share s are higher than the increment 
brought about by Mylan. In total, the Parties will continue facing competition from 
nine gener ic suppliers active in the market.   
(473)  In addition, virtually all responding Greek wholesalers indicated that a sufficient 
number of suppliers of venlafaxine would remain on the market post Transaction.152 
(474)  Finally , the results of the market investigation did no t reveal any substantiated 
concerns as regards the impact of the Transaction in the sertraline in Greece.  
Conclusion  
(475)  In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission cons iders that the Transaction does 
not raise serious doubts as to its compatibility with the internal market with respect 
to the supply of sertraline in Greece.  
(d) Venlafaxine in Italy  
(476)  Both Parties supply venlafaxine (ATC3 class N6A) in Italy. This molecule is 
genericized in Italy since 2008. In this country, Upjohn markets both an unbranded 
version of venlafaxine as well as branded venlafaxine under the name Effexor, while 
Mylan only supplies an unbranded version of venlafaxine.  
Market shares  
(477)  The Transaction g ives rise to a Group 1 market at the molecule level for venlafaxine 
in Italy.153 
(478)  The volume market shares of the Parties and their competitors for the supply of 
venlafaxine in Italy are provided below in Table 45. 
                                                 
152  Questionnaire Q3 to wholesalers, non -confidential replies to question 25.  
153  The Transaction also gives rise to a Group 1 affected market, when looking only at oral solid extended 
release formulations (NFC class B). However, the competitive dynamics do not di ffer compared to those 
at molecule level, as the Parties and their competitors' market shares are similar, and will thus not be 
assessed separately.  







 
 
 
105 
 
 with generic players such as Stada, Teva, and Zentiva, and less so with branded 
products.158 Third, the Parties claim that the applicable regulatory framework 
constrains the pricing of l atanoprost/timol ol in Italy, including the merged entity.159 
(508)  In a separate submission following the State of Play meeting, the Notifying Parties 
additionally submit pricing analyses evidencing [information concerning Mylan’s 
pricing strategy of latanoprost/timolol in Italy] .  
Commission’s assessment  
(509)  Structurally, the Transaction leads to an important change in market dynamics. The 
combined market share of the Parties is very high at molecule combination level 
([60-70]% in 2018), and Mylan’s increment is material ( [5-10]% in 2018) , on top of 
Upjohn’s significant market share ( [60-70]% in 2018) .  
(510)  In addition, the market investigation conducted by the Commission does not fully 
confirm the Notifying Parties’ arguments.  
(511)  First, while eight additional competitors are also active in the supply of 
latanoprost/timolol in Italy, only two of them have market shares exceeding [5-10]% 
and/or the increment brought by Mylan (namely Visufarma and Novartis) . While 
Novartis is a well -established generic player in Italy, Visufarma does not rank 
among the top ten generic suppliers in Italy. The results of the market investigation 
further indicate that Visufarma is not a leading generic player in Italy160 and is not 
perceived by responding pharmacies as having a salesforce matching Mylan’s in the 
coun try.161  
(512)  Second, the results of the market investigation did not confirm the Parties’ claim that 
Mylan does not exert a material competitive constraint on Upjohn. The market 
investigation confirms that in Italy, while brand loyalty is very high and constitut es a 
key parameter of competition in the supply of pharmaceuticals,162 generics do exert a 
competitive constraint on originators, and in particular that the price of generic 
products in Italy impacts the price level of originators. These elements are indicat ive 
of a likely dominant position of Upjohn pre -Transaction, which would be further 
strengthened by the Transaction.  
                                                 
158  Besides Upjohn, in Italy, latanoprost/timolol is marketed as branded generic by Bausch (with 
Ocuprostim), Doc Generici (with Latafix), Visufarma (w ith Imolast) and Angelini (with Droplacomb).  
159  The Parties state that the Italian authorities do not allow for price increases of reimbursed products 
(latanoprost/timolol is a reimbursed product).  
160 Questionnaire Q3 to wholesalers, non -confidential replie s to question 15.  
161  Questionnaire Q2 to retailers, non -confidential replies to question 26.  
162  Questionnaire Q1 to competitors, non -confidential replies to question 50. Questionnaire Q2 to retailers, 
non-confidential replies to question 43. Questionnaire Q3 to wholesalers, non -confidential replies to 
question 38.  
 
 
 
106 
 
 (513)  In addition, the market investigation revealed that the latanoprost/timolol molecule 
combination faced out of stock incidents in Italy in t he past years.163 
(514)  Finally, neither the market investigation nor the additional submission of the Parties 
provided sufficient elements to dispel the serious doubts arising from the fact that 
the merged entity would have a dominant position on the market post -Transaction 
and would only face limited competition. To the contrary, for example, a leading 
generic supplier specifically mentioned that the Transaction would  have a negative 
impact on prices for the supply of latanoprost/timolol in Italy.164 
Conclusion  
(515)  In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission concludes that the Transaction raises 
serious doubts as to its compatibility with the internal market due to horizontal non -
coordinated effects as regards the supply of latanoprost/timolol in Italy, as the 
Transaction would likely lead to the creation or strengthening of dominance in this 
market.  
(d) Latanoprost and latanoprost/timolol in Luxembourg  
(516)  Both Parties supply latanopros t and latanoprost/timolol (both ATC3 class S1E) in 
Luxembourg. This molecule and molecule -combination are genericized in 
Luxembourg since 2012. Both Parties market latanoprost as branded products. 
Upjohn’s latanoprost and latanoprost/timolol products are b randed under the 
respective names Xalatan and Xalacom while Mylan’s products are branded under 
the names Latanotears for latanoprost and Timolatears for latanoprost/timolol. In 
addition, […]. 
Market shares  
(517)  The Transaction gives rise to a Group 1 market at the molecule level for latanoprost, 
as well as at the molecule combination level for latanoprost/timolol in Luxembourg.  
(518)  The volume market shares of the Parties and their competitors for the supply of 
latanoprost and of latanoprost/timolol in Luxembourg are  provided below in Table s 
50 and 51. 
 
 
                                                 
163  Questionnaire Q2 to retailers, non -confidential replies to question 27.  
164  Questionnaire Q1 to competitors, non -confidential replies to question 57.  

 
 
 
108 
 
 Commission’s assessment  
(521)  Structurally, for the supply of latanoprost, the combined market share of the Parties 
is very high (reaching [70-80]% in 2018), with a significant increment from Mylan 
(of [10-20]% in 2018). Moreover, only one competitor, Thea, would remain active 
post-Transaction with a market share higher than [0-5]%.  
(522)  Regarding the supply of latanoprost/timolol, the combined market share of the 
Parties is even higher (namely [90-100]%), with an incre ment from Mylan of [0-
5]%. As a result, no competitor would remain active post -Transaction for the supply 
of latanoprost/timolol. Therefore, the Transaction would reduce the number of 
significant competitors from three to two for latanoprost and from two t o one for 
latanoprost/timolol. As a result, the Transaction will lead to a significant change in 
the structure of the market, both at molecule level for latanoprost, and even more so 
at molecule -combination level for latanoprost/timolol. These elements are  indicative 
of a likely dominant position of Upjohn pre -Transaction for the markets of 
latanoprost and latanoprost/timolol, which would be further strengthened by the 
Transaction.  
(523)  The market investigation did not provide any elements to dispel the serious doubts 
arising from the fact that the merged entity would have a dominant position on the 
markets for latanoprost and latanoprost/timolol in Luxembourg post -Transaction and 
would only face limited  effective competition (if any for latanoprost/timolol) as a  
result of the Transaction.  
Conclusion  
(524)  In view of the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission considers that the Transaction raises 
serious doubts as to its compatibility with the internal market as regards the supply 
of latanoprost and of latanoprost/timolol in Luxembourg, due  to hori zontal non -
coordinated effects, in particular given the high combined market share and the 
limited number of competitors remaining post -Transactio n. 
(e) Latanoprost/timolol in Netherlands  
(525)  Both Parties supply latanoprost /timolol (ATC3 class S1E) in the Netherlands . This 
molecule combination is genericized in the Netherlands since 2012. In this country, 
while Upjohn markets a branded version of latanopros t/timolol , under the name 
Xalacom, Mylan markets an unbranded version of latanoprost /timolol .  
Market shares  
(526)  The Transaction gives rise to a Group 1 market at the molecule combination level for 
the supply of latanoprost/timolol in the Netherlands.  


 
 
 
111 
 
 (536)  For the molecule combination latanoprost/timolol  in Portugal, the Parties' 2018 
combined market  share amounted to [90-100]%, with an increment of [0-5]% from 
Mylan.  
Notifying Parties’ views  
(537)  The Notifying Parties submit that the Transaction will not raise competitive concerns 
regarding the supply of l atanoprost/timolol  (ATC3 class S1E) in Portugal f or the 
following reasons. First, the Parties consider that, because Mylan’s increment is 
small, the Transaction will neither (meaningfully) strengthen the pre -merger position 
of Upjohn, nor alter the structure of supply in the market. Second, the Parties a rgue 
that post -Transaction the merged entity will face competition constraints from four 
generic players active on this market, namely Edol, Teva, Aurobindo and Novartis, 
and three additional competitors (Stada, Bruschettini and Thea, which have a 
register ed latanoprost/timolol product in Portugal and could easily enter the market. 
Third, the Parties claim that the applicable regulatory framework constrains the 
pricing of l atanoprost/timolol in Portugal.168 
Commission’s assessment  
(538)  Structurally, the combined m arket share of the Parties is very high at molecule 
combination level ( [90-100]% in 2018), and Mylan’s increment remains small ( [0-
5]% in 2018).  
(539)  In addition, the market investigation conducted by the Commission does not fully 
support the Notifying Parties ’ arguments.  
(540)  Besides the Parties, four  players are active in Portugal for the supply of 
latanoprost/timolol but none of the Parties’ competitors have a market share 
exceeding [5-10]% and only two have a market share slightly exceeding Mylan’s 
increment, n amely Edol and Teva  (with respective 2018 market shares of [0-5]% and 
[0-5]%). While Teva is a well -established generic player in Portugal, Edol does not 
rank among the top ten generic suppliers in Portugal. The results of the market 
investigation further indicate that Edol is not a leading generic player in Portugal169 
and is not perceived by responding pharmacies as having a salesforce matching 
Mylan’s in the country.170  
(541)  The results of the market investigation also indicate that post -Transaction there will 
not remain a sufficient number of suppliers for latanoprost/timolol in Portugal. A 
Portuguese -based competitor indicated that the Parties are among the few suppliers 
                                                 
168  The Parties explain that in Portugal, for prescription products, (i) public authorities establish a maximum 
ex-factory price and regulate the wholesale  and pharmacy margins, which would cap the public price paid 
by patients in the pharmacy and (ii) price increases require a request which would occur rarely and be only 
exceptionally granted.  
169  Questionnaire Q3 to wholesalers, non -confidential replies to question 15.  
170  Questionnaire Q2 to retailers, non -confidential replies to question 26.  
 
 
 
112 
 
 for this eye drop product in Portugal171 and a Portuguese -based wholesaler indicated 
that the re would  not be a sufficient number of suppliers for this combination of 
molecules.172 In addition, the market investigation did not reveal that the companies 
that have  a registered latanoprost/timolol product in Portugal have plans to enter the 
market in th e next three years .173 
(542)  The market investigation further indicates that Upjohn’s Xalacom is considered as 
must -have by some responding customers, which is indicative of market power. In 
addition, Portugal is a “pharmacy -driven” market, where discounts and bro ad 
portfolio offering regarding or regardless of the therapeutic are key advantages. A 
large majority of responding pharmacies indicated receiving multi -product discounts 
from pharmaceutical companies, including from those offering both generics and 
origin ators.174 One Portuguese wholesaler states for instance that “ […] when there 
are rebates, these are applied to all portfolio, and not to a specific range of 
products. We don't have rebates that favor generics against branded products” .175 
Therefore, despite My lan’s small increment, the Transaction will likely strengthen 
the merged entity’s dominance in this market.  
(543)  In addition, the market investigation revealed that suppliers of latanoprost/timolol 
faced out of stock incidents in Portugal in the past years.176 
(544)  Finally, the market investigation confirms that price increases of generics in Portugal 
are infrequent.177 However, the Transaction may lead to less frequent price decreases 
in relation to l atanoprost/timolol  in Portugal. While information provided by the 
Notifying Parties indicates that no voluntary price reduction occurred over the last 
six years, there are no indications that future price reductions would not take place 
absent the Transaction.  
Conclusion  
(545)  In view of the above considerations, taking into acco unt the market investigation and 
all the evidence available to it, the Commission concludes that the Transaction raises 
serious doubts as to its compatibility with the internal market due to horizontal non -
coordinated effects as regards the supply of latan oprost/timolol in Portugal, in 
particular given the high combined market share and the limited number of 
competitors remaining post -Transaction.  
                                                 
171  Questionnaire Q1 to competitors, non -confidential replies to question 61.  
172  Questionnaire Q3 to wholesalers, non -confidential replies to question 25.  
173  Questionnai re Q1 to competitors, non -confidential replies to question 23.  
174  Questionnaire Q2 to retailers, non -confidential replies to question 19.  
175  Questionnaire Q3 to wholesalers, non -confidential replies to question 13.  
176  Questionnaire Q2 to retailers, non -confidential replies to question 27.  
177  Questionnaire Q4 to national authorities, non -confidential replies to question 5.  

 
 
 
114 
 
 Commission’s assessment  
(551)  The Commission notes that Mylan’s i ncrement is small (consistently below [0-5]% 
during the last three years) and therefore, the market structure is unlikely to 
significantly change as a result of the Transaction.  
(552)  The Parties will face competition from a number of established generic 
manufa cturers including Thea  ([20-30]%), Bausch Health  ([0-5]%), Vir ([0-5]%) and 
Stada  ([0-5]%), all with market shares exceeding Mylan’s as regards latanoprost 
sales.  
(553)  Competitors did not raise any concerns regarding the impact of the transaction in 
relation to  latanoprost in Spain.178 In addition , a responding pharmacy confirmed 
that it expected a neutral impact of the transaction on prices for latanoprost in 
Spain.179 In addition, all responding Spanish wholesalers indicated that a sufficient 
number of suppliers o f latanoprost would remain on the market post Transaction.180 
(554)  In summary , the results of the market investigation did not reveal any substantiated 
concerns as regards the impact of the Transaction in the latanoprost market in Spain.  
Conclusion  
(555)  In view of the  above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission considers that the Transaction does 
not raise serious doubts as to its compatibility with the internal market with respect 
to the suppl y of latanoprost in Spain.  
5.4. Conclusion  
(556)  It derives from the assessment conducted in Section 5.3 that the Transaction raises 
serious doubts as to its compatibility with the internal market, due to its likely 
horizontal non -coordinated effects in the following  molecule/country pair markets:  
(a) Atorvastatin in Norway  
(b) Doxazosin in Czechia  
(c)  Doxazosin in France  
(d) Eplerenone in Belgium  
(e) Eplerenone in Hungary  
(f) Sildenafil (PAH) in Estonia  
(g) Sildenafil (PAH) in France  
(h) Sildenafil (PAH) in Latvia  
(i) Sildenafil (PAH) in Lithuania  
                                                 
178 Questionnaire 1 to competitors, non -confidential replies to question 57.  
179  Questionnaire 2 to retailers, non -confidential replies to q uestion 28.  
180  Questionnaire Q3 to wholesalers, non -confidential replies to question 25.  
 
 
 
115 
 
 (j) Sildenafil (PAH) in Romania  
(k) Sildenafil (PAH) in the United Kingdom  
(l) Eletriptan in Denmark  
(m) Eletriptan in Finland  
(n) Eletriptan in France  
(o) Eletriptan in Norway  
(p) Eletriptan in Sweden  
(q) Pregabalin in Czechia  
(r) Pregabalin in Belgium  
(s) Pregabalin in Luxembourg  
(t) Pregabalin in N orway  
(u) Gabapentin in Ireland  
(v) Ziprasidone in Czechia  
(w) Alprazolam in Greece  
(x) Alprazolam in Iceland  
(y) Alprazolam in Ireland  
(z) Alprazolam in Italy  
(aa) Alprazolam in Portugal  
(bb) Venlafaxine in Belgium  
(cc) Latanoprost in Belgium  
(dd) Latanoprost/timolol in Belgium  
(ee) Latanoprost/timol ol in France  
(ff) Latanoprost/timolol in Italy  
(gg) Latanoprost in Luxembourg  
(hh) Latanoprost/timolol in Luxembourg  
(ii) Latanoprost/timolol in the Netherlands  
(jj) Latanoprost/timolol in Portugal  
6. ACTIVE PHARMACEUTICAL INGREDIENTS  
(557)  An active pharmaceutical ingredient ("API") is t he substance in a FDP that is 
pharmaceutically active and is suspended in excipients (that is, inert substances 
taking the form, for instance, of a tablet or a solution), for the purposes of 
administration.  
(558)  Both Parties are active in the production of APIs  for pharmaceutical products.   
6.1. Relevant market  
6.1.1.  Product market  
(559)  In past decisions, the Commission considered that the supply of APIs for each 
individual molecule might  constitute a separate product market that is upstream to 
the markets for the supply of FDP s, whilst noting that it was not excluded that 
 
 
 
116 
 
 certain APIs may be substitutable with each other for all, or for a range of, 
applications.181 
(560)  The Notifying Parties agree with the previous practice of the Commission  and 
submit that  the competitive analysis of  the supply of API s does not have to be 
conducted at the ATC3 or ATC4 level if competition concerns can be excluded at 
the level of individual  APIs.  
(561)  The Commission's file does not contain any indication that would suggest departing 
from the previous practi ce and the views of the Notifying Parties.  
(562)  Therefore, for the purpose of this Decision, the product market definition proposed 
by the Notifying Parties is retained. For the purpose of this case, and for the 
molecules involved in this case, the Commission t herefore considers that the supply 
of the APIs for each molecule concerned by the Transaction constitutes a separate 
relevant product market.  
6.1.2.  Geographic market  
(563)  In past decisions, the Commission considered that API markets are, from a 
geographic perspectiv e, at least EEA -wide and possibly global in scope.182 The 
Notifying Parties submit that in this case the upstream API markets should be 
defined as global in scope.  
(564)  The Notifying Parties submit that API suppliers are active globally. The Parties 
indicate tha t only [30-40]% of the valid certificates awarded to control the quality of 
pharmaceutical substances183 were held by European manufacturers, while Chinese 
and Indian manufacturers held together [50-60]% of these certificates in 2017.184 
The Parties further su bmit that the share of Indian and Chinese manufacturers has 
steadily increased over recent years. In the Parties’ view, the fact that the majority of 
CEP holders are from outside of Europe shows that suppliers are able to compete in 
Europe regardless of th eir location.  
(565)  In view of the fact that the Transaction does not raise serious doubts as to its 
compatibility with the internal market in relation to the API markets under any 
plausible geographic market definition, the exact scope of the geographic market  
(i.e. whether it is at least EEA  wide or worldwide) can be left open for the purpose of 
the competitive assessment of the Transaction .185 
                                                 
181   See M.7645 Mylan/Perrigo  and M.5865 Teva/Ratiopharm , 
182   See M.7645 - Mylan/Perrigo  and M.5865 - Teva/Ratiopharm . 
183   Certificate(s) of suitability to the monograp hs of the European Pharmacopoeia, or "CEPs".  
184   See https://www.edqm.eu/sites/default/files/presentation -pheur -training -ppr g eneral presentation 
on cep -may2018.pdf  
185  See paragraph 605.  
 
 
 
117 
 
 (566)  For the purpose of this case, the Commission considers that for the supply of APIs 
the geographic market is at least EE A-wide and possibly global in scope.  
6.2. Competitive assessment  
(567)  Mylan generated total worldwide sales of approximately EUR […] million from the 
sale of APIs to third parties in 2018, of which only [20-30]% (i.e. EUR […] million) 
are sales achieved in the EEA. Upjohn does not generally supply APIs to third 
parties, with only very limited exceptions which do not give rise to any affected 
market in the EEA.  
(568)  Based on the Commission’s practice, the Commission has applied a system of filters 
aimed at determining the groups of markets where concerns are most likely and on 
which it focuses its analysis regarding the supply of APIs, namely:  
 Horizontally affected markets, where the parties have a combined market 
share exceeding 35% at the level of the supply of an indivi dual API;186  
 Downstream vertically affected markets where either party has a market 
share of more than 30% in the upstream API market and the other party has a 
market share that exceeds 5% in the downstream FDP market; and  
 Upstream vertically affected mark ets where either party has a market share of 
more than 5% in the upstream API market and the other party has a market 
share that exceeds 30% in the downstream FDP market .187 
(569)  In the present case, the Transaction does not result in any horizontal overlaps or 
downstream vertically relationships falling under the se criteria .  
(570)  The Transaction, however, gives rise to five upstream vertically affected markets 
falling under the se criteria, namely for the supply of alprazolam, celecoxib, 
eletriptan, sertraline and sil denafil, where Mylan has an estimated worldwide market 
share of [5-10]% or more on the upstream API market and Upjohn has a market 
share of [30-40]% or more at the downstream FDP market at the molecule level in 
various EEA countries.  
6.2.1.  Alprazolam  
(571)  While only  Mylan is active for the supply of the alprazolam  API (Upjohn is not  
active in this market ), both Parties supply alprazolam FDPs in the EEA.  
(572)  The Parties’ upstream market shares (stemming exclusively from Mylan) for the 
supply of alprazolam API are provided  in Table 55 below:  
                                                 
186  See M.5295 – Teva/Barr . 
187 See M.7746 – Teva/Allergan . 








 
 
 
126 
 
 investigation in the present case confirm ed that companies rely on  multi -sourcing 
strate gies and  do not have difficulties to purchase API s.189 
(595)  Second, the market shares of the merged entity for the supply of the r elevant APIs 
are not high. In fact, as detailed in Tables 55, 57, 59, and 61 , the market share s of the 
merged entity remain below [5-10]% (volume , 2018 ) for alprazolam, celecoxib, 
eletriptan and sertraline.  For the supply of sildenafil , the market share of the merged 
entity  is [20-30]% (volume , 2018 ). In all the relevant API markets  (namely  
alprazolam, celecoxib, eletriptan, sildenafil, and sertraline) , only Mylan is active and 
Upjohn does not contribute any increment.  Therefore, the merged entity does not 
have market power  upstream, and consequently does not have the ability to engage 
in input foreclosure . 
(596)  Third, the merged entity is unlikely to restrict access to APIs for alprazolam, 
celecoxib, eletriptan, sertraline or sildenafil  to downstream FDP competi tors because 
the merged entity will face competition from multiple companies active in the 
upstream markets with valid CEPs. The market investigation confirmed that there 
are a sufficient number of suppliers of APIs for alprazolam, celecoxib, eletriptan, 
sertraline and sildenafil .190 In particular for sildenafil, which is the only upstream 
market where the merged entity’s share will exceed [5-10]%, the majority of API 
suppliers who responded to the market investigation confirmed that they do not face 
any cons traint to increase the volumes of production and that they would be 
interested in supplying more volumes to existing or new customers.191  
(597)  Finally, competitors indicated almost unanimously that the Transaction would  not 
have any impact on their ability to pu rchase APIs, including for alprazolam, 
celecoxib, eletriptan, sertraline and  sildenafil.192 
(598)  On the other hand, customer foreclosure risks can also be excluded for the following 
reasons.  
(599)  [Information on the Parties’ API sourcing ]. Therefore, the Transaction d oes not 
remove an important customer from the market, and the merged entity will not have 
the ability or incentive to engage in customer foreclosure.  
(600)  In addition, competitors active upstream  indicated almost unanimously that the 
Transaction would  not have any impact on their ability to sell alprazolam, the APIs 
for celecoxib, eletriptan, sertraline or sildenafil .193  
                                                 
189  Questionnaire Q1 to competitors, non -confidential replies t o questions 72, 73 and 76.  
190  Questionnaire Q1 to competitors, non -confidential replies to questions 73 and 76.  
191  Questionnaire Q1 to competitors, non -confidential replies to question 72.  
192  Questionnaire Q1 to competitors, non -confidential replies to que stion 76.  
193  Questionnaire Q1 to competitors, non -confidential replies to question 76  
 
 
 
127 
 
 6.3. Conclusion  
(601)  Based on the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission concludes that the Transaction does 
not raise serious doubts as to its compatibility with the internal market in relation to 
any vertical links between the Parties’ activities for APIs and FDPs.  
7. OUTLICENSING  
(602)  Outlicensing in the pharmaceutical industry ref ers to a company (the licensor) 
licensing to another company (the licensee) rights to use a dossier to obtain a 
marketing authorization for a product in one or more countries and commercialize 
the licensed product in those countries.  
7.1. Relevant market  
7.1.1.  Produ ct market definition  
(603)  In past decisions, the Commission considered outlicensing for each individual 
molecule to potentially constitute a separate product market which is upstream of the 
market for the supply of FDPs.194  
(604)  Neither the Notifying Parties nor the market investigation provided any indications 
that the Commission should depart from this approach regarding product market 
definition.  
(605)  For the purpose of this case, the Commission therefore considers that individual 
molecules constitute the relevant prod uct market for outlicensing.  
7.1.2.  Geographic market definition  
(606)  In past decisions, the Commission considered the upstream outlicensing market(s) to 
be at least EEA -wide.195 
(607)  Neither the Notifying Parties nor the market investigation provided any indications 
that th e Commission should depart from this approach regarding geographic market 
definition.  
(608)  For the purpose of this case, the Commission considers that the market(s) of FDP 
outlicensing to be EEA -wide in geographic scope.  
                                                 
194  See e.g. M.7746 – Teva/Allergan , para. 596; M.7480 – Actavis/Allergan , para. 75 and M.6613 – 
Watson/Actavis , para. 120. In the past the Commission did not always disti nguish between contract 
manufacturing and outlicensing (see e.g., M.5865 – Teva/Ratiopharm , paras. 408 -420 and M.6258 – 
Teva/Cephalon , paras. 145 -151).  
195  M.7746 – Teva/Allergan , para. 599; and M.6613 – Watson/Actavis , para. 120.  


 
 
 
130 
 
 of harm seems however unlikely to materialize in practice due to the below 
considerations.  
(614)  Firstly, the merged entity lacks the ability to foreclose  FDP competitors,  as neither 
Party is a particularly important competitor in the EEA outlicensing markets 
upstream for the relevant molecules . In addition, competitors in the market 
investigation agreed that the merged entity has no competitive advantage i n relation 
to the outlicensing of generics post -Transaction.  
(615)  Numerous competitors remain on the upstream outlicensing markets for the relevant 
molecules, including (i) Esteve and Aurobindo for doxazosin; (ii) Teva, Esteve, 
Adamed, Grupo Tecnimede, Accord, Aurobindo for amlodipine; (iii) Teva, Esteve, 
and Aurobindo for atorvastatin; (iv) Adamed and Grupo Tecnimede for eplerenone 
and (v) Esteve and Aurobindo for venlafaxine.202 
(616)  Secondly, the merged entity would lack the incentive to foreclose FDP competitors. 
Its existing licensees only account  for a minor share of FDP sales downstream and 
thus the  licensees’ sales that could be diverted to the Parties as a result of a potential 
foreclosure would remain limited. Hence, it would likely not be profitable for the 
merged entity to forego license fees from those downstream competitors if it were to 
terminate their license agreements. In most instances, the market share of the Parties' 
licensee accounts for less than [5-10]% in the supply of the relevant FDP market at 
molecule level. For instance, [licensee]  presence in the Italian doxazosin and 
amlodipine  markets is limited (with respective shares of [0-5]% and [0-5]% in 
2018). Similarly, Mylan's [licensee] , has only a [0-5]% market share for venlafaxine 
in Belgium. Re garding atorvastatin in Italy, while Upjohn’s  licensee, [licensee] , has 
an important market share (of [5-10]% in 2018), [licensee]  share from the sale of the 
out-licensed product amounts to less than 1%.203 Regarding epler enone in Spain, 
Upjohn’s licensee, [licensee] , has a high share (of [40-50]% in 2018). However, the 
Commission notes in this respect that the merged entity would not necessarily 
recuperate [licensee]  market share if it were to terminate [licensee]  licensing 
contract. First, [licensee]  could switch to an alternative outlicensor (e.g. Adamed and 
Grupo Tecnimede). Second, e ven if [licensee]  would not switch to an alternative 
licensor, other competitors at the FDP level would compete with the merged entity to 
recuperate [licensee]  market share. I n particular, for the supply of epler enone in 
Spain (downstream), the Parties’ market share is limited (it amounted to [5-10]%) 
while the  merged entity will continue to face strong competition from a number of 
other competitors than [licensee]  with shares greater than [5-10]%, including Vir 
([10-20]%), Infarco ( [5-10]%), Teva ( [5-10]%), Stada ( [5-10]%), Normon ( [5-10]%) 
and Novartis ( [5-10]0%).  
                                                 
202  Questionnaire Q1 to competitors, non -confidential replies to question 63.  
203  In the case of atorvastatin in Italy, the outlicensing relationship is very limited. It only relates to [details of 
the outlicensing agreement ] (with a market share at molecule level of [0-5]% in terms of volume and 
value). The licensee, [name] , has its own independent marketing authorization for [product with a 
different galenic form ], which  accounts for the majority of [licensee] ’s sales in that molecule market.  
 
 
 
131 
 
 (617)  In addition, the market investigation did not reveal any substantiated concerns in 
relation to outlicensing activi ties. Competitors also generally confirm that in their 
view, the merger has no impact on the outlicensing markets in the EEA.204 
7.3. Conclusion  
(618)  Based on the above considerations, taking into account the market investigation and 
all the evidence available to it, the Commission concludes that the Transaction does 
not raise serious doubts as to its compatibility with the internal market in relation to 
the Parties' outlicensing activities in the EEA.  
8. COMMITMENTS  
8.1. Framework for the assessment of the Commitments   
(619)  Where a notified concentration raises serious doubts as to 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. Pursuant to Article 
6(2) of th e 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.  
(620)  As set out in the Commission's Remedies Notice,205 the commitments have to 
eliminate the competition concerns entirely, and have to be comprehensive and 
effective from all points of view.206  
(621)  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 the particular 
characteristics of the market in which the Transaction i s likely to significantly 
impede effective competition, including the position of the Parties and other 
participants on the market .207 
(622)  In order for the commitments to comply with those principles, they must be capable 
of being implemented effectively within a short period . Concerning the form of 
acceptable commitments, the Merger Regulation gives discretion to the Commission 
as long as the commitments meet the required standards. 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 
                                                 
204  Questionnaire Q1 to competitors, non -confidential replies to question 65.  
205  Commission Notice on remedies acceptable under Council Regulation (EC) No 139/2004 and under 
Commissi on Regulation (EC) No 802/2004 (OJ C 267, 22.10.2008, p. 1 -27), the "Remedies Notice".  
206  Remedies Notice, paras. 9 and 61.  
207  Remedies Notice, para. 12.  
 
 
 
132 
 
 be possible to implement them and that it will be likely that the new commercial 
structures resulting from them will be sufficiently workab le and lasting to ensure that 
effective competition will be maintained.208 Divestiture commitments are normally 
the best way to eliminate competition concerns resulting from horizontal overlaps.  
(623)  The divested activities must consist of a viable business that , if operated by a 
suitable purchaser, can compete effectively with the merged entity on a lasting basis 
and that is divested as a going concern. The business must include all the assets 
which contribute to its current operation or which are necessary to e nsure its viability 
and competitiveness and all personnel which are currently employed or which are 
necessary to ensure the business' viability and competitiveness.209  
(624)  The intended effect of the divestiture will only be achieved if and once the business 
is transferred to a suitable purchaser in whose hands it will become an active 
competitive force in the market. The potential of a business to attract a suitable 
purchaser is an important element of the Commission's assessment of the 
appropriateness of the pr oposed commitment.210  
(625)  Even though normally the divestiture of an existing viable stand -alone business is 
required, the Commission, taking into account the principle of proportionality, may 
also consider the divestiture of businesses which have existing stro ng links or are 
partially integrated with businesses retained by the parties and therefore need to be 
‘carved out’ in those respects. Commitments including a carve -out of a business can 
only be accepted by the Commission if it can be certain that, at least  at the time 
when the business is transferred to the purchaser, a viable business on a stand -alone 
basis will be divested and the risks for the viability and competitiveness caused by 
the carve -out will thereby be reduced to a minimum.  
(626)  It is against this background that the Commission analysed the proposed 
commitments in this case.   
8.2. Procedure  
(627)  In order to render the concentration compatible with the internal market, the Parties 
have submitted a set of commitments under Article 6(2) of the Merger Regulation on 
27 March 2020 (the "Initial Commitments"). The Commission market tested the 
Initial Commitments on 30 March 2020 in order to assess whether they were 
sufficient and suitable to remedy the serious doubts identified in Section 5.4 above. 
Following the fee dback received during the market test, the Initial Commitments 
were refined and improved, and amended commitments were submitted on 17 April 
2020 (the “Final Commitments”). The Final Commitments are annexed to this 
Decision and form an integral part thereo f. 
                                                 
208  Remedies Notice, para. 10.  
209  Remedies Notice, paras. 23 -25. 
210  Remedies Notice, para. 47.  
 
 
 
133 
 
 8.3. The Initial Commitments  
(628)  Under the Initial Commitments, the Parties offered to divest Mylan’s products, in 
markets where serious doubts were identified following the Commission's market 
investigation, to one or more suitable third party purchasers (“the Purchaser (s)”).  
(629)  The products that the Parties offered to divest under the Initial Commitments 
(hereafter referred to gether  as the “Divestment Businesses” , and each individually as 
a “Divestment Business ”) are listed below:  
(i) Mylan's atorvastatin in Norway;   
(ii) Mylan's doxazosin in Czechia;  
(iii) Mylan's doxazosin in France;  
(iv) Mylan's eplerenone in Belgium;  
(v) Mylan's eplerenone in Hungary;  
(vi) Mylan's sildenafil (PAH) in Estonia;  
(vii) Mylan's sildenafil (PAH) in France;  
(viii) Mylan's tadalafil in France;  
(ix) Mylan's sildenafil (PAH)  in Latvia;  
(x) Mylan's sildenafil (PAH) in Lithuania;  
(xi) Mylan's sildenafil (PAH) in Romania;  
(xii) Mylan's sildenafil (PAH) in the United Kingdom;  
(xiii) Mylan's eletriptan in Denmark;  
(xiv) Mylan's eletriptan in Finland;  
(xv) Mylan's eletriptan in France;  
(xvi) Mylan's eletriptan in  Norway;  
(xvii)  Mylan's eletriptan in Sweden;  
(xviii)  Mylan's pregabalin in Belgium;  
(xix) Mylan's pregabalin in Czechia;  
(xx) Mylan's pregabalin in Luxembourg;  
(xxi) Mylan's pregabalin in Norway;  
(xxii)  Mylan's gabapentin in Ireland;  
(xxiii)  Mylan's ziprasidone in Czechia;  
(xxiv)  Mylan's alprazolam i n Greece;  
(xxv)  Mylan's alprazolam in Iceland;  
(xxvi)  Mylan's alprazolam in Ireland;  
(xxvii)  Mylan's alprazolam in Italy;  
(xxviii)  Mylan's alprazolam in Portugal;  
(xxix)  Mylan's venlafaxine in Belgium;  
(xxx)  Mylan's latanoprost in Belgium;  
(xxxi)  Mylan's latanoprost in Luxembourg;  
(xxxii)  Mylan's latanopr ost/timolol in Belgium;  
(xxxiii)  Mylan's latanoprost/timolol in France;  
(xxxiv)  Mylan's latanoprost/timolol in Italy;  
(xxxv)  Mylan's latanoprost/timolol in Luxembourg;  
(xxxvi)  Mylan's latanoprost/timolol in the Netherlands; and  
(xxxvii)  Mylan's latanoprost/timolol in Portugal.  
 
 
 
134 
 
  
(630)  The Divestment  Businesses are structured as an asset carve -out; no legal entity of 
Mylan is to be divested. Specifically, under the Initial Commitments, the Parties 
committed that the  Divestment B usiness (es) include the following assets and rights:   
i. all tangible and intangible assets (including intellectual property rights, 
which contribute to the current operation and are necessary to ensure the 
viability, marketability and competitiveness of the Divestment Business);  
ii. all licences, permits and authorizations iss ued by any governmental 
organisation for the benefit of the Divestment Business ;  
iii. all contracts, commitments and customer orders of the Divestment 
Business, insofar they relate to the Divestment Business; all customer, credit 
and other records of the Divestment Business;  
iv. all advertising, marketing, sales, publicity and presentational materials 
related to the Divestment Business, as applicable;  
v. a best efforts obligation for the Parties to obtain the assignment (at the 
Purchaser’s option) of exi sting contract manufacturing contracts and/or API 
supply contracts, where applicable, or, in the event that consent for the 
assignment cannot be obtained, the benefit of a back -to-back arrangement for 
the supply of the product to the Purchaser for the dura tion of the relevant 
third party contract and, in any case, for no longer than three years;  
vi. a best efforts obligation for the Parties to obtain the assignment (at the 
Purchaser’s option) of existing licensing agreements and/or any other 
relevant contra ct currently in place including any awarded tender contracts 
(to the extent that national legislation allows for assignment), where 
applicable;  
vii. the benefit, for a period of up to 3 years after the closing of the 
divestment (the " Divestment Closing "), of (i) an at -cost transitory 
manufacturing or supply arrangement relating to the existing forms of the 
product in the Member State of the Divestment Business to be agreed with 
the Purchaser and overseen by the person (s) approved by the Commission , 
and ent rusted with the duty to monitor Mylan's compliance  to this Decision 
(the “M onitoring Trustee ”) (such transitory arrangement(s) shall include the 
appropriate provisions to ensure the continued supply of the product to the 
Purchaser, including prioritization  of the supply to the Purchaser in case of 
shortages); and/or (ii) reasonable technical assistance to the Purchaser or a 
third party manufacturer indicated by the Purchaser, provided on a no cost 
basis, to assume responsibility for the manufacture, sale an d marketing of the 
relevant Divestiture Business, to be agreed with the Purchaser and overseen 
by the Monitoring Trustee ; and  
 
 
 
135 
 
 viii. an option for the Purchaser to hire one or more Mylan personnel, who 
work for the relevant Divestment Business and would be considered 
necessary to maintain the viability, marketability and competitiveness of that 
Divestment Business to be supervised by the Monitoring Trustee . This option 
is to be exercised within a period of one year after Divestment Closing.  
(631)  In addition, the Parties have offered  related commitments, inter alia regarding the 
separation of the Divestment Businesses from their retained businesses, the 
preservation of the economic viability, marketability and competitiveness of the 
Divestment Businesses, including  the appointment of a Monitoring Trustee and, if 
necessary, the person(s) approved by the Commission with a  mandate to sell the 
Divestment Business to a Purchaser at no minimum price  (the “D ivestiture 
Trustee ”).  
(632)  The Initial Commitments also include specif ic purchaser requirements in particular 
the need for the Purchaser(s) to be either (i) an established generic supplier with 
presence in the EEA that can market the Divestment Businesses through its own 
commercial infrastructure or through distributors in t he relevant countries where 
each relevant Divestment Business is currently active, or (ii) an established generic 
supplier that is not yet present in the EEA but has an advanced plan to enter the EEA 
which existed prior and unrelated to the divestment tran saction and will persuade the 
Monitoring Trustee and the Commission that it can effectively start competing in the 
relevant markets within the required timeframe.   
8.4. Assessment of the Initial Commitments  
(633)  The Commission analysed the suitability of the Commitm ents to remedy the serious 
doubts raised by the Transaction, in particular under the principles set out in the 
Commission Remedies Notice. In its assessment, the Commission relied inter alia  
on the results of the market test launched on 30 March 2020.  
(634)  Respondents to the market test were generally positive about the Initial 
Commitments and confirmed that the y are suitable to eliminate the competition 
concerns identified by the Commission.211 In particular, the majority of respondents 
considered that, provided  they are divested to suitable purchasers, the Divestment 
Businesses include all the necessary assets to successfully market the specific 
molecules in the markets where the Commission identified competition concerns and 
to subsequently compete effectively with the merged entity on these markets.212 In 
addition , respondents highlighted that the transfer/assignment of existing contracts 
(licensing, manufacturing, tender contracts etc.) proposed in the Initial Commitments 
is crucial for the Divestment Businesses  to remain a viable and competitive force 
after the transfer to suitable purchasers.213 Moreover, some respondents highlighted 
                                                 
211  Marke t test of the commitments (R1, R2 and R3), non -confidential replies to question 2.  
212  Market test of the commitments (R1, R2 and R3), non -confidential replies to question 3.  
213  Market test of the commitments (R1, R2 and R3), non -confidential replies to que stion 3.  
 
 
 
136 
 
 that some individual molecule markets offered for divestment may not be viable 
when transferred on a standalone basis and hence, a certain grouping of Divestment 
Businesses could be required.214 For this reason, and the reasons described in 
paragraph  (636) ii, the Commission welcomes the requirement s et out in the Initial 
Commitments according to which, in the event that multiple Purchasers were 
proposed to acquire the Divestment Businesses, the Commission will approve the 
different Purchasers and correlated sale and purchase agreements at the same tim e. 
Such approach ensures that the transfer of each individual molecule  to a suitable 
purchaser  is carried out, regardless of the grouping ultimately adopted .  
(635)  However, the results of the market test also identified issues with the Initial 
Commitments requi ring further improvements.  
(636)  First, while the Initial Commitments allowed for the closing of the Transaction 
before completing the transfer of the Divestment Businesses, the Commission 
considers for the following reasons, based on the results of the market test and the 
evidence available to it, that an upfront buyer is necessary to ensure the viability and 
competitiveness of the Divestment Businesses:  
i. Only a limited number of companies with an existing presence in the EEA have 
expressed an interest in purch asing all Divestment Businesses together. A more 
significant number of respondents expressed interest in purchasing some 
Divestment Businesses (as opposed to all). However, even adding up these 
respondents would still leave some Divestment Businesses with no suitable 
Purchaser.215  
ii. While the responses to the market test were mixed as to whether the viability and 
competitiveness of the Divestment Businesses will be negatively affected if its 
transfer occurs after the closing of the Transaction,216 a significant number of 
respondents potentially interested in purchasing the Divestment Business(es) 
considered it necessary to sell the Divestment Business(es) before the closing of 
the Transaction in this case. The reasons expressed by the respondents included 
the fol lowing: (i) the merged entity has a strategic advantage vis-à-vis the 
Purchaser(s), being active with branded originator products that are considered 
“must -haves” and not having to deal with contract assignments, transfers and the 
uncertainty of robust sup ply, which is important for customers of generic 
manufacturers; and (ii) the “dispersed” composition of the Divestment Business 
in terms of molecules and countries led to limited interest in the market test of 
potential buyers to purchase the whole Divestm ent Business.  
                                                 
214  The responses were, however, inconclusive as to the criterion (by molecule, by country, or by therapeutic 
area) by which a grouping would be most effective . See Market test of the commitments (R1, R2 and R3, 
non-confidential replies to question  4. 
215  Market test of the commitments (R1, R2 and R3), non -confidential replies to question 18.  
216  Market test of the commitments (R1, R2 and R3), non -confidential replies to question 5.  
 
 
 
137 
 
 iii. In addition, the Commission notes that a number of divested molecules have 
declining sales and are not among the most sought after molecules, given that 
loss of exclusivity happened between  five to over twenty years ago, and may 
therefore fa ce difficulties to attract a suitable Purchaser.  
(637)  Second, with regard to the Purchaser requirements, the results of the market test 
indicated, that a Purchaser with no existing generic presence in the EEA is unlikely 
to be suitable. However, respondents to  the market test expressed the view that the 
presence could be direct or indirect via third party distributor/s, as the importance of 
a direct salesforce seems to vary from country to country.217 As a consequence, the 
Commission considers that the Purchaser criteria as set out in the Initial 
Commitments required further improvements so as to require the Purchaser(s) to be 
an established generic supplier with presence in the EEA that can market the 
products of the Divestment Businesses through its own commerci al infrastructure or 
through distributors in the relevant countries where each relevant Divestment 
Business is currently active.   
(638)  Third, with regard to the transitional supply agreements, the results of the market test 
indicated that the proposed duration of three years might  be insufficient to ensure the 
viability of the Divestment Businesses  and allow the Purchaser to be fully 
operational.218 Therefore , the Commission considers that the duration of the 
transitional supply agreements should be extendable bey ond three years (for at least 
an additional year) at the option of the Purchaser and under the supervision of the 
Monitoring Trustee.  
8.5. The Final Commitments  
(639)  On 17 April 2020, the Parties submitted a revised set of commitments (the "Final 
Commitments") taki ng into account the results of the market test of the Initial 
Commitments.  
(640)  First, the Parties included an upfront buyer clause in the Final Commitments. As a 
result, the Transaction shall not be implemented before Mylan (or the Divestiture 
Trustee) has en tered into a final binding sale and purchase agreement for the sale of 
the Divestment Businesses and the Commission has approved the Purchaser or 
Purchasers and the terms of sale. Upon the Parties’ reasoned request accompanied by 
a reasoned opinion by the Monitoring Trustee, the Commission may (i) approve the 
Purchaser(s) on the basis of (a) legally binding agreement(s) for the sale of the 
Divestment Business(es) setting out all material terms and conditions of such sale, 
but prior to the execution of final  sale and purchase agreement(s)  and (ii) approve 
the implementation of the Transaction . In that case , the final sale and purchase 
agreement(s) (including any ancillary agreement relevant for the purpose of the Final 
Commitments) shall be approved separatel y by the Commission.  
                                                 
217  Market test of the commitments (R1, R2 and R3), non -confidential r eplies to questions 13 -15. 
218  Market test of the commitments (R1, R2 and R3), non -confidential replies to question 8.  
 
 
 
138 
 
 (641)  Second, the Parties amended the Purchaser requirements to reflect the market test 
feedback. Under the Final Commitments, a Purchaser with no existing generic 
presence in the EEA would no longer be suitable. However, an established gen eric 
supplier with presence in the EEA that can market products of the Divestment 
Businesses through its own commercial infrastructure or through distributors in the 
relevant countries where each relevant Divestment Business is currently active, 
would be a  suitable Purchaser.  
(642)  Third, the Parties amended the duration of transitional supply agreements. Under the 
Final Commitments, these agreements would have an initial term of up to three 
years, and may be extended for an additional year, up to two times (for a total 
duration of five years) at the request of the Purchaser/s and subject to the approval of 
the Monitoring Trustee .  
8.6. Assessment  of the Final Commitments  
(643)  The Commission considers that these amendments adequately address the concerns 
raised by the marke t test respondents and the Commission itself in relation to the 
Initial Commitments. The Commission notes in particular that the introduction of an 
upfront purchaser requirement, in light of the limited interest from market 
participants and the s pecificiti es of the Divestment Businesses, contributes to the 
viability and competitiveness of the Divestment Businesses, by guaranteeing timely 
divestment to (a) suitable Purchaser(s).   
(644)  In addition, the Commission  may, if it considers it appropriate in the circumst ances,  
(i) approve the Purchaser(s) on the basis of (a) legally binding agreement(s) setting 
out all material terms and conditions of the sale of the Divestment Businesses but 
prior to Mylan (or the Divestiture Trustee) having entered into (a) final sale a nd 
purchase agreement(s) for the sale of the Divestment Businesses and (ii) approve the 
implementation of the Transaction, based on the Parties’ reasoned request 
accompanied by a reasoned opinion by the Monitoring or Divestiture Trustee. 
Indeed, the Final Commitments imply the negotiation of numerous ancillary 
agreements, including transitional supply agreements for the 37 Divestment 
Businesses across 20 different EEA countries. However, the exceptional 
circumstances brought about by the coronavirus outbrea k, and the disruptions caused 
by it to the usual course of business, notably in the pharmaceutical industry, may 
delay the finalis ation of these ancillary agreements. Moreover, even if the Parties 
request that the Commission uses  this possibility and the C ommission accepts it, the 
final sale and purchase agreement(s), including all ancillary agreement(s), will 
remain subject to the Commission’s approval .  
(645)  Based on  the above, the Commission concludes that the Divestment Businesses are 
viable businesses and t he modalities foreseen for their transfer under the Final 
Commitments will allow suitable Purchaser(s) to operate them in a competitive and 
viable manner.  
 
 
 
139 
 
 (646)  The Final Commitments fully address the competition concerns identified in th is 
Decision as they remo ve the overlap between Mylan and Upjohn in all markets 
where serious doubt arise, replacing Mylan with an alternative generic player.  
(647)  Moreover, the Commitments are comprehensive, effective, and are capable of being 
implemented effectively within a short period . 
(648)  The Commission therefore considers that the Final Commitments are sufficient to 
eliminate all serious doubts as to the compatibility of the Transaction with the 
internal market and the EEA Agreement.  
8.7. Conditions and obligations   
(649)  Under the first sente nce 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 th e Commission with a view to rendering a notified 
concentration compatible with the internal market.  
(650)  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.  
(651)  In accordance with the distinction described above, th is Decision in this case is 
conditioned on the full compliance with the requirements set out in Section B of the 
Final Commitments (including the Schedules), which constitute conditions. Th e 
remaining requirements set out in the other sections of the Final Commitments 
constitute obligations on the Parties.  
(652)  The detailed text of the Final Commitments is annexed to this Decision. The full text 
of the Final Commitments forms an integral part of  this Decision.  
9. CONCLUSION   
(653)  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 (including the Schedules) of the 
Commitments annexed to t his Decision and with the obligations contained in the 
other sections of the said Commitments. This Decision is adopted in application of 
 
 
 
140 
 
 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  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Case M.9517 | Commitments  
 
 
 
 17 April 2019  
 
2 
  
TABLE OF CONTENTS  
 
SECTION A – DEFINITIO NS ................................ ................................ ...........................  6 
SECTION B – THE COMM ITMENT TO DIVEST AND  THE DIVESTMENT 
BUSINESS  ................................ ................................ ................................ ..................  7 
SECTION C – RELATED COMMITMENTS  ................................ ................................ . 10 
SECTION D – THE PURC HASER  ................................ ................................ ..................  12 
SECTION E – TRUSTEE  ................................ ................................ ................................ . 13 
SECTION F – THE REVI EW CLAUSE  ................................ ................................ ..........  18 
SECTION G – ENTRY IN TO FORCE  ................................ ................................ ............  19 
PRODUCT: MYL AN'S EPLERENONE PROD UCTS  ................................ ....................  20 
Territory: Belgium  ................................ ................................ ................................ ..... 20 
PRODUCT: MYLAN'S LAT ANOPROST PRODUCTS  ................................ .................  21 
Territory: Belgium  ................................ ................................ ................................ ..... 21 
PRODUCT: MYLAN'S LAT ANOPROST/TIMOLOL PRO DUCTS  ..............................  24 
Territory: Belgium  ................................ ................................ ................................ ..... 24 
PRODUCT: MYLAN'S PRE GABALIN PRODUCTS  ................................ ....................  26 
Territory: Belgium  ................................ ................................ ................................ ..... 26 
PRODUCT: M YLAN'S VENLAFAXINE P RODUCTS  ................................ ..................  28 
Territory: Belgium  ................................ ................................ ................................ ..... 28 
PRODUCT: MYLAN'S DOX AZOSIN PRODUCTS  ................................ ......................  30 
Territory: the Czech Republic  ................................ ................................ ...................  30 
PRODUCT: MYLAN'S PRE GABALIN PRODUCTS  ................................ ....................  32 
Territory: Czech Republic  ................................ ................................ .........................  32 
PRODUCT: MYLAN'S ZIP RASIDONE PRODUCTS  ................................ ....................  34 
Territory: the Czech Republic  ................................ ................................ ...................  34 
PRODUCT: MYLAN'S ELE TRIPTAN PRODUCTS  ................................ ......................  36 
Territory: Denmark  ................................ ................................ ................................ .... 36 
PRODUCT: MYLAN'S SIL DENAFIL (PAH) PRODUC TS ................................ ...........  38 
 
3 
  
Territory: Estonia  ................................ ................................ ................................ ...... 38 
PRODUCT: MYLAN'S ELE TRIPTAN PRODUCTS  ................................ ......................  40 
Territory: Finland  ................................ ................................ ................................ ...... 40 
PRODUCT: MYLAN'S DOX AZOSIN PRODUCTS  ................................ ......................  42 
Territory: Fr ance ................................ ................................ ................................ ........  42 
PRODUCT: MYLAN'S ELE TRIPTAN PRODUCTS  ................................ ......................  44 
Territory: France  ................................ ................................ ................................ ........  44 
PRODUCT: MYLAN'S LAT ANOPROST/TIMOLOL PRO DUCTS  ..............................  46 
Territory: France  ................................ ................................ ................................ ........  46 
PRODUCT: MYLAN'S SIL DENAFIL (PAH) PRODUC TS ................................ ...........  48 
Territory: France  ................................ ................................ ................................ ........  48 
PRODUCT: MYLAN'S TAD ALAFIL (PAH) PRODUCT S ................................ ............  50 
Terri tory: France  ................................ ................................ ................................ ........  50 
PRODUCT: MYLAN'S ALP RAZOLAM PRODUCTS  ................................ ..................  53 
Territory: Greece  ................................ ................................ ................................ ....... 53 
PRODUCT: MYLAN'S EPL ERENONE PRODUCTS  ................................ ....................  54 
Territory: Hungary  ................................ ................................ ................................ .... 54 
PRODUCT: MYLAN'S ALP RAZOLAM PRODUCTS  ................................ ..................  56 
Territory: Iceland  ................................ ................................ ................................ ....... 56 
PRODUCT: MYLAN'S ALP RAZOLAM PRODUCTS  ................................ ..................  58 
Territory: Irel and ................................ ................................ ................................ ....... 58 
PRODUCT: MYLAN'S GAB APENTIN PRODUCTS  ................................ ....................  60 
Territory: Ireland  ................................ ................................ ................................ ....... 60 
PRODUCT: MYLAN'S ALP RAZOLAM PRODUCTS  ................................ ..................  62 
Territory: Italy  ................................ ................................ ................................ ...........  62 
PRODUCT: MYLAN'S LAT ANOPROST/TIMOLOL PRO DUCTS  ..............................  65 
Territory: Italy  ................................ ................................ ................................ ...........  65 
PRODUCT: MYLAN'S SIL DENAFIL (PAH) PRODUC TS ................................ ...........  67 
Territory: L atvia  ................................ ................................ ................................ ........  67 
PRODUCT: MYLAN'S SIL DENAFIL (PAH) PRODUC TS ................................ ...........  69 
 
4 
  
Territory: Lithuania  ................................ ................................ ................................ ... 69 
PRODUCT: MYLAN'S LAT ANOPROST PRODUCTS  ................................ .................  71 
Territory: Luxembourg  ................................ ................................ ..............................  71 
PRODUCT: MYLAN'S LAT ANOPROST/TIMOLOL PRO DUCTS  ..............................  73 
Territory: Luxembourg  ................................ ................................ ..............................  73 
PRODUCT: MYLAN'S PRE GABALIN PRODUCTS  ................................ ....................  75 
Territory: Luxembourg  ................................ ................................ ..............................  75 
PRODUCT: MYLAN'S LAT ANOPROST/TIMOLOL PRO DUCTS  ..............................  77 
Territory: the Netherlands  ................................ ................................ .........................  77 
PRODUCT: MYLAN'S ATO RVASTATIN PRODUCTS  ................................ ...............  80 
Territory: Norway  ................................ ................................ ................................ ...... 80 
PRODUCT: MYLAN'S ELE TRIPTAN PRODUCTS  ................................ ......................  82 
Territory: Norway  ................................ ................................ ................................ ...... 82 
PRODUCT: MYLAN'S PRE GABAL IN PRODUCTS  ................................ ....................  83 
Territory: Norway  ................................ ................................ ................................ ...... 83 
PRODUCT: MYLAN'S ALP RAZOLAM PRODUCTS  ................................ ..................  85 
Territory: Portugal  ................................ ................................ ................................ ..... 85 
PRODUCT: MYLAN'S LAT ANOPROST/TIMOLOL PRO DUCTS  ..............................  87 
Territory: Portugal  ................................ ................................ ................................ ..... 87 
PRODUCT: MYLAN'S SIL DENAFIL (PAH) PRODUC TS ................................ ...........  90 
Territory: Romania  ................................ ................................ ................................ .... 90 
PRODUCT: MYLAN'S ELETRIPTAN PRODUCTS  ................................ ......................  92 
Territory: Sweden  ................................ ................................ ................................ ...... 92 
PRODUCT: MYLAN'S SIL DENAFIL (PAH) PRODUC TS ................................ ...........  94 
Territory: United Kingdom  ................................ ................................ .......................  94 
 
 
  
 
5 
 COMMITMENTS TO THE EUROPEAN COMMISSION  
Pursuant to Article 6(2) of Council Regulation (EC) No 139/2004 (the " Merger 
Regulation "), My lan N.V. (" Mylan ") and Upjohn (“ Upjohn ”) hereby enter s into the 
following Commitments (the " Commitments ") vis -à-vis the European Commission (the 
"Commission ") with a view to rendering their merger  (the " Transaction ") 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 Transaction  compatible with the internal 
market and the functioning of the EEA A greement (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 Regu lation (EC) No 802/2004 (the " Remedies 
Notice ").   
 
6 
 SECTION A – DEFINITIONS  
(1) For the purpose of the Commitments, the following terms shall have the following meaning:  
Affiliated Undertakings : undertakings controlled by the Parties and/or by the ultimate 
parents of the Parties, whereby the 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 concentratio ns between 
undertakings (the " Consolidated Jurisdictional Notice ").  
Assets : the assets that contribute to the current operation or are necessary to ensure the 
viability and competitiveness of the Divestment Business as indicated in Section B, 
paragraph 6 (a), (b) and (c) and described more in detail in the Schedule.  
Divestment Closing : the transfer of the legal title to the Divestment Business to the 
Purchaser.  
Divestment Closing  Period : the period of […] months from the approval of the Purchaser 
and the  terms of sale by the Commission.  
Confidential Information : 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 imp airs the Trustee's objectivity and 
independence in discharging its duties under the Commitments.  
Divestment Business : each of the  businesses  that Mylan commits to divest as  defined in 
Section B and in the Schedule s. 
Divestiture Trustee : one or more natura l or legal person(s) who is/are approved by the 
Commission and appointed by Mylan and who has/have received fr om Mylan the exclusive 
Trustee m andate to sell the Divestment Business to a Purchaser at no minimum price.  
Effective Date : the date of adoption o f the Decision.  
First Divestiture Period : the period of […] months from the Effective Date.  
Hold Separate Manager : the person appointed by Mylan to manage the day -to-day 
operations of  the Divestment Business under the supervision of the Monitoring Truste e.  
Monitoring Trustee : one or more natural or legal person(s) approved by the Co mmission, 
appointed by Mylan,  and entrusted with  the duty to monitor Mylan's compliance with the 
conditions and obligations attached to the Decision.  
Mylan : Mylan N.V. a priva te limited liability company organized and existing under the 
laws of the Netherlands, with its corporate seat in Amsterdam, the Netherlands .  
Parties : Mylan and Upjohn or following the closing of the Transaction, Viatris .  
Personnel : the staff that could  be considered necessary to maintain the viability, 
marketability and competitiveness of the Divestment Business.  
Pfizer : Pfizer Inc. a pharmaceutical company active worldwide in the research, 
development, manufacturing and marketing of innovative medicine s with its corporate 
headquarters in 235 East 42nd Street , New York, NY 10017 , USA . 
 
7 
 Purchaser : the entity approved by the Commission as acquirer of the Divestment Business 
in accordance with the criteria set out in Section D.  
Purchaser Criteria : the crite ria laid down in paragraph 17 of these Commitments that the 
Purchaser must fulfil to be approved by the Commission.  
Retained Business(es) : Upjohn’s overlapping products in the relevant markets, 
which give rise to the need for a divestment and which are no t part of the 
Commitments.  
Schedule : the schedule to these Commitments describing the Divestment Business  in more 
detail .  
Trustee(s) : the Monitoring Trustee and/or the Divestiture Trustee as the case may be.  
Trustee Divestiture Period : the period of […] months from the end of the First Divestiture 
Period.  
Upjohn: the Upjohn business  being spun -off and combined with Mylan. Upjohn  is made up 
of (a) a portfolio of 21 established brands organised across the following key therapeutic 
areas: (i) Cardiovascular , (ii) Central Nervous System/Psychiatry, (iii) Pain/Neurology, (iv) 
Urology and  (v) O phthalmology; and (b) Greenstone LLC ( Greenstone ), a US -focused 
generics business. Greenstone sells non -branded authorized generic versions of Pfizer 
branded products (an d a very small number of authorized generics from Alle rgan) 
exclusively in the US.  
SECTION B – THE COMMITMENT TO DIV EST AND THE DIVESTMENT BUSINESS  
Commitment to divest  
(2) To maintain effective compe tition, Mylan commits to divest,  or procure the divestiture of, 
the Divestment Business by the end of the Trustee Divestiture Period to one or more  
purchaser s and on terms of sale approved by the Commission in accordance with the 
procedure described in paragraph 18 of these Commitments. To carry out the divestiture , 
Mylan commits to find ing a purchaser /purchasers and entering into one or more  final 
binding sale and purchase agreement s for the sale of the Divestment Business within the 
First Divestiture Period.  In the event that Mylan proposes to divest the Divestmen t Business 
to multiple purchasers, Mylan commits to submitting the reasoned proposals and the 
relevant sale and purchase agreements to the Commission for approval at the same time. If 
Mylan has not entered into such an agreement (or agreements) at the end of the First 
Divestiture Period, Mylan shall grant the Divestiture Trustee an exclusive mandate to sell 
the Divestment Business in the Trustee Divestiture Period in accordance with the procedure 
described in paragraph 30.  
(3) The Transaction shall not be imple mented before Mylan or the Divestiture Trustee has 
entered into (a) final binding sale and purchase agreement(s) for the sale of the Divestment 
Businesses and the Commission has approved the purchaser or purchasers and the terms of 
sale in accordance with paragraph 19.  Upon the Parties’ reasoned request accompanied by a 
reasoned opinion by the Trustee and the previous sentence notwithstanding, the Commission 
may (i) approve the purchaser or purchasers on the basis of (a) legally binding agreement(s) 
between  Mylan or the Divestiture Trustee and the purchaser(s) for the sale of the Divestment 
Business(es) setting out all material terms and conditions of such sale but prior to Mylan or 
the Divestiture Trustee having entered into (a) final sale and purchase agre ement(s) for the 
sale of the Divestment Businesses and (ii) approve the implementation of the Transaction. 
The final sale and purchase agreement(s) (including any ancillary agreement relevant for the 
purpose of these Commitments) shall be subject to approv al in line with paragraph 19 . 


 
10 
 no longer than three years;  
(f) if such contract exists, a best efforts obligation to obtain the assignment (at the 
purchaser’s option) of existing licen sing agreement s and/or any other relevant 
contract currently in place  including any awarded tender contracts (to the extent 
that national legislation allows for assignment);  
(g) the benefit, for a period of up to  3 years after Divestment Closing , which period  
may be extended by one year, and an additional year thereafter, upon request by 
the Purchaser and subject to the approval of the Monitoring Trustee on the basis 
that such extension is necessary for the Purchaser to continue commercializing the 
Divestment Business, of  (i) an at -cost transitory manufacturing or supply 
arrangement relating to the existing forms of the product  in the Member State of 
the Divestment Business  to be agreed with the Purchaser and overseen by the 
Monitoring Trustee in accordance wit h paragraph (29)(i)(iii)  (such transitory 
arrangement(s) shall include the appropriate provisions to ensure the continued 
supply of the product to the Purchaser, includ ing prioritization of the supply to the 
Purchaser in case of shortages); and/or (ii) reasonable technical assistance to the 
Purchaser  or a third party manufacturer indicated by the Purchaser, provided  on a 
no cost basis, to assume responsibility for the ma nufacture, sale and marketing of 
the relevant Divestiture Business, as detailed in the Schedules  to be  agreed with 
the Purchaser and overseen by the Monitoring Trustee in accordance with 
paragraph (29)(i)(iii) ; and  
(h) in relation to the Divestment Businesses set out in the Schedules, subject to 
applicable local employment legislation, an option for the Purchaser to hire one or 
more Mylan Personnel, who work for the relevant  Divestment Business and who 
would be  considered necessary to maintain the viability, marketability and 
competitiveness of that Divestment Business to be supervised by the Monitoring 
Trustee.  This option is to be exercised within a period of one year  after Divestment 
Closing .6 
(8) The Divestment Business is structured as an asset carve -out; no legal entity of Mylan is to be 
divested.  
SECTION C – RELATED COMMITMENTS  
Preservation of viability, marketability and competitiveness  
(9) From the Effective Date until Divest ment Closing , the Parties  shall preserve or procure the 
preservation of the economic viability, marketability and competitiveness of the Divestment 
Business es, in accordance with good business practice, and shall minimize as far as possible 
any risk of los s of competitive potential of the Divestment Business es. In particular , Mylan  
undertake s: 
(a) not to carry out any action that might have a significant adverse impact on the 
value, management or competitiveness of the Divestment Business es or that might 
alter the nature and scope of activity, or the industrial or commercial strategy or 
the investment policy of the Divestment Business es; 
                                                 
6  This entails that Purchaser(s) would have to adduce specific circumstances based on which it can demonstrate objectively that  in 
order to be able to competitively commercialize the relevant products it needs certain Mylan Personnel . Mylan will cooperate with 
the Monitoring Trustee to provide information necessary for the Purchaser to conduct this assessment.  
 
11 
 (b) to make available, or procure to make available, sufficient resources for the 
development of the Divestment Business es, on the  basis and continuation of the 
existing business plans.  
Hold -separate obligations  
(10) The Parties  commit  from the Effective Date until Divestment Closing , to the extent 
reasonably practica ble, to keep the Divestment Businesses separate from the Retained 
Busin ess. The Parties  also commit to ensuring  that the Personnel of the Divestment 
Business es – including the Hold Separate Manager – will not be involved  in the Retained 
Business . The Parties  likewise commit to ensuring  that the personnel of the Retained 
Busin ess will not be involved  in the Divestment Business es. 
(11) Until Divestment Closing , Mylan shall assist the Monitoring Trustee in ensuring that the 
Divestment Business es are  managed separately and as saleable businesses from the Retained 
Business . Immediately after the adoption of the Decision, Mylan shall appoint a Hold 
Separate Manager. The Hold Separate Manager shall manage the Divestment Business es 
independently of the Retained Business  and in the best interest of  each Divestment B usiness 
with a view to ens uring its continued economic viability, marketability and competitiveness. 
The Hold Separate Manager shall closely cooperate with and report to the Monitoring 
Trustee and, if applicable, the Divestiture Trustee. In case of any replacement of the Hold 
Separ ate Manager, Mylan shall provide a reasoned  proposal to replace the person(s) 
concerned to the Commission and the Monitoring Trustee. Mylan must be able to 
demonstrate to the Commission that the replacement is well -suited to carry out the functions 
exercis ed by the Hold Separate Manager. The replacement shall take place under the 
supervision of the Monitoring Trustee, who shall report to the Commission. The 
Commission may require Mylan to replace the Hold Separate Manager , after having heard 
Mylan.  
Ring -fencing 
(12) Mylan shall implement, or procure to implement, all necessary measures to ensure that its 
personnel that manages the Divestment Businesses shall not obtain commercially sen sitive 
and/or product specific Confidential I nformation relating to the Retaine d Business . 
(13) Mylan shall implement, or procure to implement, all necessary measures to ensure that its 
personnel that manages the Retained Business  shall not obtain commercially sensitive and/or 
product specific Confidential I nformation relating to the Dive stment Businesses.  
Non-Solicitation clause  
(14) In the instance that the Purchaser exercises the option as described in paragraph 6(g), the 
Parties  undertake, subject to customary limitations, not to solicit, and to procure that 
Affiliated Undertakings do not s olicit Personnel hired by (as opposed to seconded to) the 
Purchaser according to paragraph 6(g) for a period of 24 months after Divestment Closing . 
Due diligence  
(15) In order to enable potential purchasers to carry out a reasonable due diligence of the 
Divestm ent Business es, Mylan shall, subject to customary confidentiality assurances and 
subject to confidentiality obligations vis -à-vis third parties and dependent on the stage of the 
divestiture process:  
(a) provide to potential purchasers sufficient information as  regards the Divestment 
Business es; 
 
12 
 (b) provide to potential purchasers sufficient information relating to the Personnel and 
allow them reasonable access to the Personnel.  
Reporting  
(16) Mylan shall submit written reports in English on potential purchasers of the D ivestment 
Business es 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 
following the Effective Date (or otherwise at the Commission’s request) . Mylan shall submit 
a list of all potential purchasers having expressed interest in acquiring the Divestment 
Business es to the Commission at each and every stage of the divestiture process, as well as a 
copy of all the offers made by potential purchasers within five days of their receipt.  
(17) Mylan  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 t he 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:  
(a) 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) ;  
(b) The Purchaser shall have the financial resources, proven expertise and incentive to 
maintain and develop the relevant Divestment  Business (or Divestment 
Businesses) as a viable and active competitive force in competition with the Parties 
and other competitors;  
(c) The Purchaser shall be an established generic supplier with presence in the EEA 
that can market the relevant Divestment Bu siness (or Divestment Businesses) 
through its own commercial infrastructure or through distributors in the relevant 
countries where each relevant Divestment Business is currently active ; and  
(d) The acquisition of the relevant Divestment Business (or Divestmen t Businesses) 
by the Purchaser must neither be likely to create, in light of the information 
available to the Commission, prima facie  competition concerns nor give rise to a 
risk that the implementation of the Commitments will be delayed. In particular, th e 
Purchaser must reasonably be expected to obtain all necessary approvals from the 
relevant regulatory authorities for the acquisition of the Divestment Business (es). 
(19) Subject to paragraph 3, the  final binding sale and purchase agreement (s) (as well as anci llary 
agreements) r elating to the divestment of the  Divestment Business es shall be conditional on 
the Commission’s approval. When Mylan has reached an agreement with a purchaser, it 
shall submit a fully documented and reasoned proposal, including a copy of  the final 
agreement(s), within one week to the Commission and the Monitoring Trustee. Mylan must 
be able to demonstrate to the Commission that the purchaser fulfils the Purchaser Criteria 
and that the relevant 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 inclu ding their objective to bring 
about a lasting structural change in the market. The Commission may approve the sale of the 
 
13 
 Divestment Business es without one or more Assets or parts of the Personnel, or by 
substituting one or more Assets or parts of the Pers onnel with one or more different assets or 
different personnel, if this does not affect the viability and competitiveness of the 
Divestment Business es after the sale, taking account of the proposed purchaser (s). 
SECTION E – TRUSTEE  
I. Appointment procedure  
(20) Mylan shall appoint a Monitoring Trustee to carry out the functions specified in these 
Commitments for a Monitoring Trustee. Mylan commits not to close the Transaction  before 
the appointment of a Monitoring Trustee.  
(21) If Mylan has not entered into  binding s ale and purchase agreement s regarding the 
Divestment Business es one month before the end of the First Divestiture Period or if the 
Commission has rejected a purchaser proposed by Mylan at that time or thereafter, Mylan 
shall appoint a Divestiture Trustee. The appointment of the Divestiture Trustee shall take 
effect upon the commencement of the Trustee Divestiture Period.  
(22) The Trustee shall:  
(i) at the time of appointment, be independent of the Parties and their Affiliated 
Undertakings;  
(ii) possess the necessary qual ifications 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.  
(23) The Tru stee shall be remunerated by  Mylan in a way that do es 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 Business, such success premium may onl y be earned if the divestiture takes 
place within the Trustee Divestiture Period.  
Proposal by Mylan  
(24) No later than two weeks after the Effective Date, Mylan shall submit the name or names of 
one or more natural or legal persons whom Mylan proposes to appoin t 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, Mylan shall submit a list of one or 
more persons whom Mylan proposes to appoint as Divestitu re 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 above and shall 
include:  
(a) the full terms of the proposed  mandate, which shall include all provisions 
necessary to enable the Trustee to fulfil its duties under these Commitments;  
(b) the outline of a work plan which describes how the Trustee intends to carry out its 
assigned tasks;  
 
14 
 (c) an indication whether the propose d 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  
(25) The Commission shall have the discretion to approve or reject the proposed Trus tee(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, Mylan 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 approved, Mylan 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 Mylan  
(26) If all the proposed Trustees are rejected, Mylan shall submit the names of at least two more 
natural or legal persons within one week of being informed of the rejection, in a ccordance 
with paragraphs (20) and (25) of these Commitments.  
Trustee nominated by the Commission  
(27) If all further proposed Trustees are rejected by the Commission, the Com mission shall 
nominate a Trustee, whom Mylan shall appoint, or cause to be appointed, in accordance with 
a trustee mandate approved by the Commission.  
II. Functions of the Trustee  
(28) The Trustee shall assume its specified duties and obligations in order to en sure compliance 
with the se Commitments. The Commission may, on its own initiative or at the request of the 
Trustee or Mylan, give any orders or instructions to the Trustee in order to ensure 
compliance with the conditions and obligations attached to the De cision.  
Duties and obligations of the Monitoring Trustee  
(29) 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 es with a view to ensuring their continued 
economic viability, marketability and competitiveness and monitor compliance by 
Mylan with t he 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 es, and the keeping separate of 
the Divestment  Business es from the Retained Business , in accordance with 
paragraphs 8 and 9 of these Commitments;  
 
15 
 (b) supervise the management of the Divestment Business es as distinct and 
saleable entities , in accordance with paragraph 10 of these Commitments;  
(c) with respect to Confidential Information:  
- determine all necessary measures to ensure that Mylan does not 
after the Effective Date obtain any Confidential Information 
relating to the Divestment Business es, 
- in particular strive for the severing of the Divestment Business es’ 
participation in a central information technology network to the 
extent possible, without compromising the viability of the 
Divestment Business es, 
- make sure that any Confidential Information relating to the 
Divestment Business es obtained by Mylan befor e the Effective 
Date is eliminated and will not be used by Mylan and  
- decide whether such information may be disclosed to or kept by 
Mylan as the disclosure is reasonably necessary to allow Mylan to 
carry out the divestiture or as the disclosure is required  by law;  
(d) monitor the splitting of assets and the allocation of Personnel between the 
Divestment Business es and Mylan or Affiliated Undertakings  (should the 
Purchaser make use of the option in paragraph 6(g)) ; 
(iii) oversee  the determination of the reasonable cos t basis for the transitory 
manufacturing or supply arrangements and/or for the provision of technical 
assistance to the Purchaser (see paragraph 00 above) , which wi ll be provided by 
Mylan to the Purchaser at no cost ; 
(iv) propose to Mylan such measures as the Monitoring Trustee considers necessary to 
ensure Mylan's compliance with the conditions and obligations attached to the 
Decision, in particular the maintenance of th e full economic viability, 
marketability or competitiveness of the Divestment Business es, the holding 
separate of the Divestment Business es and the nondisclosure of competitively 
sensitive information;  
(v) review and assess potential purchasers as well as the progress of the divestiture 
process and verify 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 information memorandum and 
the due diligence process, and  
(b) potential purchasers are granted reasonable access to the Personnel;  
(vi) act as a contact point for any requests by third parties, in particular potential 
purcha sers, in relation to the se Commitments;  
(vii) provide to the Commission, sending Mylan 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 es as well as the 
splitting of assets and the allocation of Personnel so that the Commission can 
 
16 
 assess whether the business is held in a manner consistent with the se 
Commitments and the progress of the divestiture process as well as potential 
purchasers;  
(viii) promptly report in writing to the Commission, sending Mylan a non -confidential 
copy at the same time, if it concludes on reasonable grounds that Mylan is failing 
to comply with these Commitments;  
(ix) within one week after receipt of the documented proposal ref erred to in paragraph 
18 of these Commitments, submit to the Commission, sending Mylan 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 
Busines ses after the Sale and as to whether the Divestment Business es are  sold in a 
manner consistent with the conditions and obligations attached to the Decision, in 
partic ular, if relevant, whether the s ale of the Divestment Business es without one 
or more Asset s or not all of the Personnel affects the viability of the Divestment 
Business es after the sale, taking account of the proposed purchaser;  
(x) assume the other functions assigned to the Monitoring Trustee under the conditions 
and obligations attached to the De cision.  
(30) If the Monitoring and Divestiture Trustee are not the same legal or natural persons, the 
Monitoring Trustee and the Divestiture Trustee shall cooperate 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  
(31) Within the Trustee Divestiture Period, the Divestiture Trustee shall sell at no minimum price 
the Divestment Business es to a purchaser, provided that the C ommission has approved both 
the purchaser (s) and the final binding sale and purchase agreement (s) (and ancillary 
agreements) as in line with the Decision and paragraphs (16) and (17) of these 
Commitments. The Divestiture Trustee shall include in the sale and purchase agreement (as 
well as in any ancillary agreements) such terms and conditions as it considers appropriate for 
an expedient sale in the Trustee Divestiture Peri od. In particular, the Divestiture Trustee 
may include in the sale and purchase agreement such customary representations and 
warranties and indemnities as are reasonably required to effect the sale. The Divestiture 
Trustee shall protect the legitimate fina ncial interests of Mylan, subject to the Parties' 
unconditional obligation to divest at no minimum price in the Trustee Divestiture Period.  
(32) In the Trustee Divestiture Period (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 the end of every month with a simultaneous copy to the Monitoring Trustee and a 
non-confi dential copy to the Parties.  
III. Duties and obligations of the Parties  
(33) Mylan shall provide and shall cause its 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 Mylan's or the Divestment 
Business’ books, records, documents, management or other personnel, facilities, sites and 
technical information necessary for fulfilling its duties under the Commitments  and Mylan 
and the Divestment Business shall provide the Trustee upon request with copies of any 
document. Mylan and the Divestment Business shall make available to the Trustee one or 
 
17 
 more offices on their premises and shall be available for meetings in or der to provide the 
Trustee with all information necessary for the performance of its tasks.  
(34) Mylan shall provide the Monitoring Trustee with all managerial and administrative support 
that it may reasonably request on behalf of the management of the Divestme nt Business es. 
This shall include all administrative support functions relating to the Divestment Business es 
which are currently carried out at headquarters level. Mylan shall provide and shall cause its 
advisors to provide the Monitoring Trustee, on reque st, with the information submitted to 
potential purchasers, in particular give the Monitoring Trustee access to the data room 
documentation and all other information granted to potential purchasers in the due diligence 
procedure. Mylan shall inform the Mon itoring Trustee on possible purchasers, submit lists of 
potential purchasers at each stage of the selection process, including the offers made by 
potential purchasers at those stages, and keep the Monitoring Trustee informed of all 
developments in the dive stiture process.  
(35) Mylan 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 Divestment Closing  and all actions and decla rations which the Divestiture 
Trustee considers necessary or appropriate to achieve the sale and the Divestment Closing , 
including the appointment of advisors to assist with the sale process. Upon request of the 
Divestiture Trustee, Mylan shall cause the d ocuments required for effecting the sale and the 
Divestment Closing  to be duly executed.  
(36) Mylan shall indemnify the Trustee and its employees and agents (each an " Indemnified 
Party ") and hold each Indemnified Party harmless against, and hereby agrees that a n 
Indemnified Party shall have no liability to Mylan for, any liabilities arising out of the 
performance of the Trustee’s duties under the se Commitments, except to the extent that such 
liabilities result from the wilful default, recklessness, gross neglige nce or bad faith of the 
Trustee, its employees, agents or advisors.  
(37) At the expense of Mylan, the Trustee may appoint advisors (in particular for corporate 
finance or legal advice), subject to Mylan's 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 duties and obligations under the Trustee m andate, 
provided that any fees and other expenses incurred by the Trustee are reasonable. Sh ould 
Mylan refuse to approve the advisors proposed by the Trustee the Commission may approve 
the appointment of such advisors instead, after having heard Mylan. Only the Trustee shall 
be entitled to issue instructions to the advisors. Paragraph 35 of these  Commitments shall 
apply mutatis mutandis . In the Trustee Divestiture Period, the Divestiture Trustee may use 
advisors who served Mylan during the Divestiture Period if the Divestiture Trustee considers 
this in the best interest of an expedient sale.  
(38) Mylan  agrees that the Commission may share Confidential Information proprietary to Mylan 
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 . 
(39) Mylan agrees 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 identity and th e tasks of the 
Monitoring Trustee.  
(40) 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.  
 
18 
 IV. Replacement, disc harge and reappointment of the Trustee  
(41) 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:  
(a) the Commission may, after hearing the Trustee and Myla n, require Mylan to 
replace the Trustee; or  
(b) Mylan may, with the prior approval of the Commission, replace the Trustee.  
(42) If the Trustee is removed according to paragraph 40 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 information. The new Trustee shall be appointed 
in accordance with the procedure referred to in paragraphs 19 -26 of these Commitments.  
(43) Unless removed according to pa ragraph 40 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  
(44) The Commission may extend the time periods foreseen in the se Commitments in response to 
a request from Mylan or, in appropriate cases, on its own initiative. Where Mylan requests 
an extension of a time period, it shall submit a reasoned request to the Commission no later 
than one month before the expiry of that p eriod, 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 Mylan. Only in exceptional circumstances shall Mylan 
be entitled to request an e xtension within the last month of any period.  
(45) 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 Mylan. The request shall not have the effect of suspending the application of the 
undertaking and, in part icular, of suspending the expiry of any time period in which the 
undertaking has to be complied with.  
  
 
19 
 SECTION G – ENTRY INTO FORCE  
(46) The Commitments shall take effect upon the date of adoption of the Decision.  
 
…………………………………….  
duly authorized for and on be half of Mylan  
 
 
…………………………………….  
duly autho rized for and on behalf of Upjohn  
  
 
20 
 PRODUCT : MYLAN 'S EPLERENONE  PRODUCTS  
Territory: Belgium  
(1) The Divestment Business consists of Mylan's rights, title and interests in eplerenone  in 
Belgium (currently marketed unde r the name Eplerenone Mylan ) including the right to 
develop, manufacture and use eplerenone  with a view to its sale and marketing in any form 
in Belgium. Eplerenone is no longer under exclusivity and  is used to treat hypertension and 
specific types of hear t failure .  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  eplerenone  in Belgium . It includes in particular : 
(a) the sale of existing eplerenone finished product inventory, sales and promotional 
material in Belgium to the extent available;  
(b) all eplerenone -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to eplerenone in Belgium  specifically will be 
provided; 7  
(c) the transfer of the marketing authorization for eplerenone in Belgium including all 
relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan; and  
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of al l know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in Belgium.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".8 
 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly  related to, and not exclusively used in respect of, the 
manufacture, use and sale of eplerenone  in Belgium, Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of eplerenone  in 
Belgium.  
(4) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding eplerenone  in Belgium with contract manufacturer […] to the 
Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assign ment to the Purchaser  of the supply agreement it has in place concerning 
the Divestment Business, subject to the consent of the third party ([…]).  
                                                 
7  Mylan will include all cust omer lists and records since 2014 in the Divestment Business.  
8  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in fa vor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
21 
 (5) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Div estment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divest ment Business. In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(6) The Purchaser will be given an option (to be exercised  within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(7) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to eplerenone  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Belgium for 
eplerenone ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” na me, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;9 and  
(g) monies owed to the Parties by customers for the purchase of eplerenone , and 
monies owed by the Parties to suppliers for materials used in the production of 
eplerenon e. 
(8) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that  asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
 
 
 
PRODUCT : MYLAN 'S LATANOPROST  PRODUCTS  
Territory: Belgium  
(1) The Divestment Business consists of Mylan's rights, title and interests in latanoprost  in 
                                                 
9  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
22 
 Belgium (currently  marketed under the name Latanotears ) including the right to develop, 
manufacture and use latanoprost  with a view to its sale and marketing in any form in 
Belgium. Latanoprost is no longer under exclusivity and  is used to reduce inter ocular 
pressure in pa tients with various types of glaucoma and ocular hypertension .  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing latanoprost  in Belgium. It includes in particular:  
(a) the sale of exist ing latanoprost finished product inventory, sales and promotional 
material in Belgium to the extent available;  
(b) all latanoprost -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and con tact details, 
whilst only the information related to latanoprost in Belgium  specifically will be 
provided;10  
(c) the transfer of the marketing authorization for latanoprost in Belgium including all 
relevant dossiers, as well as the information contained in the  relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, reco rds and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in ; and  
(e) Full transfer of the national trademark related to latanopr ost in Belgium or, in case 
of a wider than national specific latanoprost trademark, an irrevocable, assignable, 
sub-licensable, perpetual and royalty free license to use the trademark for the 
Divestment Business.  
The items referred to under (a) - (e) are h ereinafter collectively referred to as " Assets 
of the Divestment Business ".11 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of latanoprost  in Belgium, Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and s ale of latanoprost  in 
Belgium.  
(4) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost  in Belgium with contract manufacturer […] to the 
Purchaser in accordance with applicable l aw. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the supply agreement it has in place concerning 
the Divestment Business, subject to the consent of the third party. I n the event that consent 
for the assignment can not be obtained, at the option of the Purchaser Mylan commits to offer 
a back -to-back arrangement for the supply of the product to the Purchaser for the duration of 
the relevant third party contract and, in any case, for no longer than three years.  
                                                 
10  Mylan will include all customer lists and r ecords since 2014 in the Divestment Business.  
11  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in favor of third par ties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
23 
 (5) Mylan w ill transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost  in Belgium  with licensor […] to the Purchaser in 
accordance with applicable law. Mylan commits to make its best efforts to facil itate the 
assignment to the Purchaser  of the license agreements it has in place concerning the 
Divestment Business, subject to the consent of the third party.  
(6) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfe r of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier o f the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(7) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(8) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to latanoprost  after Dives tment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Belgium for 
latanoprost ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;12 and  
(g) monies owed to the Parties by customers for the purchase of latanoprost , and 
monies owed by the Parties to suppliers for materials used in the producti on of 
latanoprost . 
(9) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestmen t Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
                                                 
12  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
24 
 PRODUCT : MYLAN 'S LATANOPROST /TIMOLOL  PRODUCTS  
Territory: Belgium  
(1) The Divestment Business consists of Mylan's rights, title and interests in latanoprost/t imolol  
in Belgium  (currently marketed under the name Timolatears ) including the right to develop, 
manufacture and use latanoprost/timolol  with a view to its sale and marketing in any form in 
Belgium . Latanoprost/timolol is no longer under exclusivity and  is used to reduce inter 
ocular pressure in patients with various types of glaucoma and ocular hypertension .  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  latanoprost/timolol  in Belgium . It includes in particular : 
(a) the sale of existing latanoprost/timolol finished product inventory, sales and 
promotional material in Belgium to the extent available;  
(b) all latanoprost/timolol -related contracts, commitments, and customer records, 
meaning  customer credit records, customer invoices, purchase orders and contact 
details, whilst only the information related to latanoprost/timolol  in Belgium 
specifically will be provided;13  
(c) the transfer of the marketing authorization for latanoprost/timolol in Belgium 
including all relevant dossiers, as well as the information contained in the relevant 
full registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in Belgium ; 
and 
(e) Full transfer of the national trademark related to latanoprost /timolol  in Belgium or, 
in case of a wider than national specific latanoprost /timolol  trademark, an 
irrevocable, assignable, sub -licensable, perpetual and royalt y free license to use the 
trademark for the Divestment Business.  
The items referred to under (a) - (e) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".14 
 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of latanoprost/timolol  in Belgium , Mylan shall have the right to 
retain the ownership of such asset and shall grant to th e Purchaser at no additional charge an 
exclusive and perpetual right to use such asset for the manufacture, use and sale of 
latanoprost/timolol  in Belgium . 
                                                 
13  Mylan will include all customer lists and records since 201 4 in the Divestment Business.  
14  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
25 
 (4) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost/timolol  in Belgium  with contract manufacturers […] to 
the Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the supply agreements it has i n place concerning 
the Divestment Business, subject to the consent of the third party.  In the event that consent 
for the assignment cannot be obtained, at the option of the Purchaser Mylan commits to offer 
a back -to-back arrangement for the supply of the p roduct to the Purchaser for the duration of 
the relevant third party contract and, in any case, for no longer than three years.  
(5) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latan oprost/timolol  in Belgium  with licensor […] to the Purchaser in 
accordance with applicable law. Mylan commits to make its best efforts to facilitate the 
assignment to the Purchaser  of the license and supply agreements it has in place concerning 
the Divestm ent Business, subject to the consent of the third party.  
(6) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost/timolol  in Belgium  with licensor […] to the Purchaser in 
accord ance with applicable law. Mylan commits to make its best efforts to facilitate the 
assignment to the Purchaser  of the supply agreements it has in place concerning the 
Divestment Business, subject to the consent of the third party.  
(7) Mylan commits to make it s best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the  costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestme nt 
Business to the Purchaser.  
(8) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maint ain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(9) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to latanoprost/timolol  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Belgium  for 
latanoprost/timolol ; 
(e) any other asset not part of the Divestment Business or whi ch is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;15 and  
                                                 
15  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
26 
 (g) monies owed to the Parties by customers for the purchase of latanoprost/timolol , 
and monies owed by the Parties to suppliers for materials used in the production of 
latanoprost/timolol . 
(10) 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) i n the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S PREGABALIN  PRODUCTS  
Territory: Belgium  
(1) The Divestment Business consists of Mylan's rights, title and interests in pregabalin  in 
Belgium  (currently marketed under the name Pregabalin Mylan ) including the right to 
develop, manufacture and use pregabalin  with a view to its sale and marketin g in any form 
in Belgium . Pregabalin is no longer under exclusivity and  is indicated  and primarily used  for 
peripheral and central neuropathic pain, but is also used as an ‘add -on' to existing treatment 
in patients who have partial seizures that cannot be controlled with their current treatment . 
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  pregabalin  in Belgium . It includes in particular : 
(a) the sale of existing pregabalin finished product inventory, sales and promotional 
material in Belgium to the extent available;  
(b) all pregabalin -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to pregabalin  in Belgium specifically will be 
provided;16  
(c) access to Mylan’s dossier for pregabalin in order for the Purchaser to obtain its 
own marketing authorization for pregabalin;17 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in Belgium.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".18 
 
                                                 
16  Mylan will include all customer lists and records since 2014 in the Divestm ent Business.  
17  Mylan’s marketing authorization for pregabalin was obtained via the centralized procedure and therefore 
cannot be transferred only as it relates to one country to the Purchaser (see explanation in the Form RM).  
18  For the avoidance of dou bt, the Divestment Business is transferred subject to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, market ing and sale . 
 
27 
 (3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of pregabalin  in Belgium , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclus ive 
and perpetual right to use such asset for the manufacture, use and sale of pregabalin  in 
Belgium . 
(4) Pending the Purchaser applying for its own marketing authorizations for the Divestment 
Business, Mylan will appoint the Purchaser as the exclusive distrib utor of the Divestment 
Business for a period of up to two years and will, during this period, support the Purchaser 
in applying for its own marketing authorizations. During this two -year period, Mylan shall 
enter into a transitory non -exclusive manufacturi ng and/or supply agreement relating to the 
existing forms of the product in  Belgium.  
(5) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product in 
Belgium for an additional year after the two -year period noted above (i.e., up to three years 
in total). Such transitory arrangement shall include appropriate provisions designed to ensure 
the continued supply by Mylan to the Purchaser. It shall not contain provisions requiring the 
delivery of minimum supply volumes or batches.  
(6) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding pregabalin in Belgium with […] for the packaging of the produ ct to 
the Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the agreement it has in place concerning the 
Divestment Business, subject to the consent of the third party . In the event that consent for 
the assignment cannot be obtained, at the option of the Purchaser Mylan commits to offer a 
back -to-back arrangement for the supply of the product to the Purchaser for the duration of 
the relevant third party contract and, in any c ase, for no longer than three years.  
(7) At the option of the Purchaser, Mylan commits to make its best efforts to cooperate with the 
Purchaser to effectuate the transfer of the Divestment Business and to undertake all 
regulatory changes that would be required  as a result of such transfer. Until transfer of the 
Divestment Business, Mylan will bear the costs for updates to maintain the current 
registration of the dossier of the Divestment Business.  In addition, Mylan will bear the 
dossier preparation and regulat ory filing costs for all the updates of the dossier triggered by 
the transfer of the Divestment Business to the Purchaser.  
(8) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, s ubject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(9) The Divestment Business shall not inc lude:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to pregabalin  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties for pregabalin ; 
 
28 
 (e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;19 and  
(g) monies owed to the Parties by customers for the purchase of pregabalin , and 
monies owed by the Parties to suppliers for materials used in the production of 
pregabalin . 
(10) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN'S VENLAFAXINE  PRODUCTS  
Territory: Belgium  
(1) The Divestment Business consists of Mylan's rights, title and interests in venlafaxine  in 
Belgium (currently marketed under the name Venlafaxine Mylan ) including the right to 
develop, manufacture and use venla faxine  with a view to its sale and marketing in any form 
in Belgium. Venlafaxine is no longer under exclusivity and  is used to treat depression and 
anxiety disorders . 
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  venlafaxine in Belgium . It includes in particular : 
(a) the sale of existing venlafaxine  finished product inventory, sales and promotional 
material in Belgium (to the extent available);  
(b) all venlafaxine -related contracts, commi tments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to venlafaxine  in Belgium specifically will be 
provided;20  
(c) the transfer of the marketing authorizatio ns for venlafaxine  in Belgium including 
all relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan; and  
(d) an irrevocable, assign able, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Di vestment Business with a view to its sale in Belgium ;  
                                                 
19  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
20  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
 
29 
 The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".21 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Sch edule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of venlafaxine  in Belgium, Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no a dditional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of venlafaxine  in 
Belgium.  
(4) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding venlafaxine  in Belgium with contract manufacturer […] to the 
Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the supply agreement it has in place concerning 
the Divestment Bus iness, subject to the consent of the third party.  In the event that consent 
for the assignment cannot be obtained, at the option of the Purchaser Mylan commits to offer 
a back -to-back arrangement for the supply of the product to the Purchaser for the durat ion of 
the relevant third party contract and, in any case, for no longer than three years.  
(5) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive packaging 
agreement relating to the existing forms of the product in Belgium for up  to three years, 
which period may be extended by one year, and an additional year thereafter, upon request 
by the Purchaser and subject to the approval of the Monitoring Trustee on the basis that such 
extension is necessary for the Purchaser to continue co mmercializing the Divestment 
Business.  Such transitory arrangement shall include appropriate provisions designed to 
ensure the continued supply by Mylan to the Purchaser. It shall not contain provisions 
requiring the delivery of minimum supply volumes or b atches.  
(6) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestme nt Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered  by the transfer of the Divestment 
Business to the Purchaser.  
(7) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(8) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research  and development, clinical data and studies or intellectual property 
relating to venlafaxine  after Divestment Closing ; 
                                                 
21  For the avoidance of doubt, the Divestme nt Business is transferred subject to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in favo ur of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
30 
 (d) all marketing authorizations currently held by the Parties outside of Belgium for 
venlafaxine ; 
(e) any other asset not part of the Divestment  Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;22 and  
(g) monies owed to the Parties by customers for the  purchase of venlafaxine , monies 
owed by the Parties to suppliers for materials used in the production of 
venlafaxine . 
(9) 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) in th e Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S DOXAZOSIN  PRODUCTS  
Territory: the Cz ech Republic  
(1) The Divestment Business consists of Mylan's rights, title and interests in doxazosin  in the 
Czech Republic  (currently marketed under the name Doxazosin Mylan ) including the right 
to develop, manufacture and use doxazosin  with a view to its sal e and marketing in any form 
in the Czech Republic . Doxazosin is no longer under exclusivity and  is used as an  anti-
hypertensive and  as a treatment for  benign prostatic hyperplasia (BPH ).  
(2) The Divestment Business includes the transfer of all assets predomin antly or exclusively 
used for the purposes of marketing  doxazosin in the Czech Republic . It includes in 
particular : 
(a) the sale of existing doxazosin finished product inventory, sales and promotional 
material in the Czech Republic  to the extent available;  
(b) all doxazosin -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to doxazosin  in the Czech Republic specifically 
will be provided;23  
(c) the transfer of the marketing authorization for doxazosin in the Czech Republic 
including all relevant dossiers, as well as the information contained in the relevant 
full registration dossier(s), relating to the current and/or pending marketing 
authoriza tions available to Mylan; and  
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are re lated to the development, 
                                                 
22  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
23  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
 
31 
 manufacture, use of the Divestment Business with a view to its sale in the Czech 
Republic.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".24 
(3) If and to the exten t that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of doxazosin  in the Czech Republic , Mylan shall have the right to 
retain the ownership of such asset and shall grant to the Purchaser at no additional charge an 
exclusive and perpetual right to use such asset for the manufacture, use and sale of 
doxazosin  in the Czech Republic . 
(4) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding doxazosin  in the Czech Republic with licensor and contract 
manufacturer  […] to the Purchaser in accordance with applicable law. Mylan commits to 
make its best efforts to facilitate  the assignment to the Purchaser  of the license and supply 
agreements it has in place concerning the Divestment Business, subject to the consent of the 
third party. I n the event that consent for the assignment cannot be obtained, at the option of 
the Purch aser Mylan commits to offer a back -to-back arrangement for the supply of the 
product to the Purchaser for the duration of the relevant third party contract and, in any case, 
for no longer than three years.  
(5) Mylan commits to make its best efforts to cooperat e with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to main tain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchas er. 
(6) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketa bility and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(7) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectua l property 
relating to doxazosin  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of the Czech 
Republic  for doxazosin ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
busines s of the Parties other than the Divestment Business;   
                                                 
24  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
32 
 (f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;25 and  
(g) monies owed to the Parties by customers for the purchase of doxazosin , and 
monies owed by the Par ties to suppliers for materials used in the production of 
doxazosin . 
(8) 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) in the Divestment Business and necessary for the 
contin ued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
*****  
PRODUCT : MYLAN 'S PREGABALIN  PRODUCTS  
Territory: Czech Republic  
(1) The Divestment Business consists of Mylan's rights, title and interests in pregabalin  in the 
Czech Republic  (currently marketed under the name Pregabalin Mylan ) including the right 
to develop, manufacture and use pregabalin  with a view to its sale and marketing in any 
form in the Czech Republic . Pregabalin is no longer under exclusivity and  is indicated and 
primarily used for peripheral and central neuropathic pain, but is also used as an ‘add -on' to 
existing treatment in patients who have partial seizures that cannot be controlled with their 
current  treatment . 
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  pregabalin in the Czech Republic . It includes in 
particular : 
(a) the sale of existing pregabalin finished product inventory,  sales and promotional 
material in the Czech Republic  to the extent available;  
(b) all pregabalin -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the inf ormation related to pregabalin  in the Czech Republic  specifically 
will be provided;26 
(c) access to Mylan’s dossier for pregabalin in order for the Purchaser to obtain its 
own marketing authorization for pregabalin;27 and 
(d) an irrevocable, assignable, sub -licensab le and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in the Czech 
Republic . 
                                                 
25  With the excep tion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
26  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
27  Mylan’s marketing authorization for pregabalin was obtained via the cen tralized procedure and therefore 
cannot be transferred only as it relates to one country to the Purchaser (see explanation in the Form RM).  
 
33 
 The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".28 
 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of pregabalin  in the Czech Republic , Mylan shall have the right to 
retain the ownership of such asset and shall grant to the Purchaser at n o additional charge an 
exclusive and perpetual right to use such asset for the manufacture, use and sale of 
pregabalin  in the Czech Republic . 
(4) Pending the Purchaser applying for its own marketing authorizations for the Divestment 
Business, Mylan will appoin t the Purchaser as the exclusive distributor of the Divestment 
Business for a period of up to two years and will, during this period, support the Purchaser 
in applying for its own marketing authorizations. During this two -year period, Mylan shall 
enter int o a transitory non -exclusive manufacturing and/or supply agreement relating to the 
existing  forms of the product in the Czech Republic . 
(5) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing  forms of the product in the 
Czech Republic  for an additional year after the two -year period noted above (i.e., up to three 
years in total) . This period may be further extended by one year, and an additional year 
thereafter, upon re quest by the Purchaser and subject to the approval of the Monitoring 
Trustee on the basis that such extension is necessary for the Purchaser to continue 
commercializing the Divestment Business . Such transitory arrangement shall include 
appropriate provisio ns designed to ensure the continued supply by Mylan to the Purchaser. It 
shall not contain provisions requiring the delivery of mi nimum supply volumes or batches . 
(6) Mylan will transfer all historical information (orders, price, etc.) concerning its relations hip, 
if applicable, regarding pregabalin in the Czech Republic  with […] for the packaging of the 
product to the Purchaser in accordance with applicable law. Mylan commits to make its best 
efforts to facilitate the assignment to the Purchaser  of the agreeme nt it has in place 
concerning the Divestment Business, subject to the consent of the third party . In the event 
that consent for the assignment cannot be obtained, at the option of the Purchaser Mylan 
commits to offer a back -to-back arrangement for the supp ly of the product to the Purchaser 
for the duration of the relevant third party contract and, in any case, for no longer than three 
years.  
(7) At the option of the Purchaser, Mylan commits to make its best efforts to cooperate with the 
Purchaser to effectuate the transfer of the Divestment Business and to undertake all 
regulatory changes that would be required as a result of such transfer. Until transfer of the 
Divestment Business, Mylan will bear the costs for updates to maintain the current 
registration of th e dos sier of the Divestment Business . 
(8) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
                                                 
28  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(includ ing any confidentiality obligations) or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
34 
 (9) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinic al data and studies or intellectual property 
relating to pregabalin  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties for pregabalin;  
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;29 and  
(g) monies owed to the Parties by customers for the purchase of pregabalin , and 
monies owed by t he Parties to suppliers for materials used in the production of 
pregabalin . 
(10) 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) in the Divestment Business and necessary for the  
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S ZIPRASIDONE  PRODUCTS  
Territory: the Czech Republic  
(1) The Divestment Business cons ists of Mylan's rights, title and interests in ziprasidone  in the 
Czech Republic  (currently marketed under the name Ziprasidone Mylan ) including the right 
to develop, manufacture and use ziprasidone  with a view to its sale and marketing in any 
form in the Czech Republic . Ziprasidone is no longer under exclusivity and  is used to treat 
schizophrenia and (paediatric) mania . 
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  ziprasidone in the Czech Republic . It includes in 
particular : 
(a) the sale of existing ziprasidone finished product inventory, sales and promotional 
material in the Czech Republic  to the extent available;  
(b) all ziprasidone -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to ziprasidone  in the Czech Republic  
specifically will be provided;30  
                                                 
29  With the except ion of the sale of inventory existing at Divestment Closi ng and sold to the Purchaser.   
30  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
 
35 
 (c) the transfer of the marketing authorization for ziprasidone in the Czech Republic 
including all relevant dossiers, as well as the information contained in the relevant 
full registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan; and  
(d) an irrevocable, assignable, su b-licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment  Business with a view to its sale in the Czech 
Republic.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".31 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this S chedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of ziprasidone  in the Czech Republic , Mylan shall have the right 
to retain the ownership of such asset and shall grant to the Purc haser at no additional charge 
an exclusive and perpetual right to use such asset for the manufacture, use and sale of 
ziprasidone  in the Czech Republic . 
(4) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product  in the 
Czech Republic  for up to three years, which period may be extended by one year, and an 
additional year thereafter, upon request by the Purchaser and subject to the approval of the 
Monito ring Trustee on the basis that such extension is necessary for the Purchaser to 
continue commercializing the Divestment Business.  Such transitory arrangement shall 
include appropriate provisions designed to ensure the continued supply by Mylan to the 
Purch aser. It shall not contain provisions requiring the delivery of minimum supply volumes 
or batches.  
(5) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding ziprasidone  in the Czech Republic  with […] for the packaging of the 
products to  the Purchaser in accordance with applicable law. Mylan commits to make its 
best efforts to facilitate the assignment to the Purchaser  of the packaging  agreement it has in 
place concerning the Divestment Busines s, subject to the consent of the respective parties.  In 
the event that consent for the assignment cannot be obtained, at the option of the Purchaser 
Mylan commits to offer a back -to-back arrangement for the supply of the product to the 
Purchaser for the du ration of the relevant third party contract and, in any case, for no longer 
than three years.  
(6) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory chang es that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business. In addition, Mylan will bear the dossie r preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
                                                 
31  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(including any confiden tiality obligations) or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
36 
 (7) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire  one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(8) The Divestme nt Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to ziprasidone  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of the Czech 
Republic  for ziprasidone ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress  or trade dress of any 
of its subsidiaries ;32 and  
(g) monies owed to the Parties by customers for the purchase of ziprasidone , and 
monies owed by the Parties to suppliers for materials used in the production of 
ziprasidone . 
(9) If there is any asset or personnel w hich is not covered by paragraph 2 of this Schedule but 
which is both used (exclusively or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substit ute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S ELETRIPTAN  PRODUCTS  
Territory: Denmark  
(1) The Divestment Business consists of Mylan's rights, title and interests in eletriptan  in 
Denmark  (currently marketed under the name Eletriptan Mylan ) including the right to 
develop, manufacture and use eletriptan  with a view to its sale and marketing in any form in 
Denmark . Eletriptan is no longer under exclusivity and  is used for the acute treatment of the 
headache phase of migraine attacks, with or with out aura.   
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  eletriptan in Denmark . It includes in particular : 
(a) the sale of existing eletriptan finished product inventory, sales and p romotional 
material in Denmark to the extent available;  
                                                 
32  With the except ion of the sale of inventory existing at Divestment Closing  and sold to t he Purchaser.   
 
37 
 (b) all eletriptan -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to eletriptan in Denmark  specifically will be 
provided;33  
(c) the transfer of the marketing authorization for eletriptan  in Denmark  including all 
relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the cu rrent and/or pending marketing 
authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in Denmark.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Bu siness ".34 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of eletriptan  in Denmark , Mylan shall hav e the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of eletriptan  in 
Denmark . 
(4) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existin g forms of the product in 
Denmark  for up to three years, which period may be extended by one year, and an additional 
year thereafter, upon request by t he Purchaser and subject to the approval of the Monitoring 
Trustee on the basis that such extension is necessary for the Purchaser to continue 
commercializing the Divestment Business.  Such transitory arrangement shall include 
appropriate provisions designe d to ensure the continued supply by Mylan to the Purchaser. It 
shall not contain provisions requiring the delivery of minimum supply volumes or batches.  
(5) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of th e Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(6) The Purchaser will be given an option (to be exer cised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Busines s to be supervised by the Monitoring Trustee.  
                                                 
33  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
34  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality obligati ons) or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
38 
 (7) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to eletriptan  after Divestment Cl osing ; 
(d) all marketing authorizations currently held by the Parties outside of Denmark  for 
eletriptan ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Myla n” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;35 and  
(g) monies owed to the Parties by customers for the purchase of eletriptan , and monies 
owed by the Parties to suppliers for materials used in the production of eletriptan . 
(8) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business,  that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S SILDENAFIL (PAH)  PRODUCTS  
Territory: Estonia  
(1) The Divestment Business consists of Mylan's rights, title and interests in sildenafil  in 
Estonia  (curr ently marketed under the name Mysildecard ) including the right to develop, 
manufacture and use sildenafil (PAH)  with a view to its sale and marketing in any form in 
Estonia, only for the pulmonary arterial hypertension ( PAH ) indication . Sildenafil (PAH) is  
no longer under exclusivity.  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  sildenafil (PAH) in Estonia . It includes in particular : 
(a) the sale of existing sildenafil (PAH)  finished  product inventory, sales and 
promotional material in Estonia to the extent available;  
(b) all sildenafil (PAH) -related contracts, commitments, and customer records, 
meaning customer credit records, customer invoices, purchase orders and contact 
details, whils t only the information related to sildenafil (PAH)  in Estonia 
specifically will be provided;36   
                                                 
35  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
36  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
 
39 
 (c) access to Mylan’s dossier for sildenafil (PAH) in order for the Purchaser to obtain 
its own marketing authorization for sildenafil (PAH);37 
(d) an irrevocable, assig nable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the D ivestment Business with a view to its sale in Estonia ; and  
(e) Full transfer of the national trademark related to sildenafil (PAH) in Estonia or, in 
case of a wider than national specific sildenafil (PAH)  trademark, an irrevocable, 
assignable, sub -licensable, perpetual and royalty free license to use the trademark 
for the Divestment Business.  
(f) The items referred to under (a) - (e) are hereinafter collectively referred to as " Assets of the 
Divestment Business ".38 
(3) If and to the extent that the know -how listed in pa ragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of sildenafil (PAH)  in Estonia , Mylan shall have the right to retain 
the ownership of such asset and s hall grant to the Purchaser at no additional charge an 
exclusive and perpetual right to use such asset for the manufacture, use and sale of sildenafil 
(PAH)  in Estonia . 
(4) Pending the Purchaser applying for its own marketing authorizations for the Divestment 
Business, Mylan will appoint the Purchaser as the exclusive distributor of the Divestment 
Business for a period of up to two years and will, during this period, support the Purchaser 
in applying for its own marketing authorizations. During this two -year pe riod, Mylan shall 
enter into a transitory non -exclusive manufacturing and/or supply agreement relating to the 
existing forms of the product in  Estonia.  
(5) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or s upply agreement relating to the existing forms of the product in  
Estonia  for an additional year after the two -year period noted above (i.e., up to three years in 
total). This period may be further extended by one year, and an additional year thereafter, 
upon request by the Purchaser and subject to the approval of the Monitoring Trustee on the 
basis that such extension is necessary for the Purchaser to continue commercializing the 
Divestment Business . Such transitory arrangement shall include appropriate pro visions 
designed to ensure the continued supply by Mylan to the Purchaser. It shall not contain 
provisions requiring the delivery of minimum supply volumes or batches.  
(6) Mylan will transfer all historical information (orders, price, etc.) concerning its rela tionship, 
if applicable, with the Estonian Sick Fund to  the Purchaser in accordance with applicable 
law. Mylan commits to make its best efforts to facilitate the assignment to the Purchaser  of 
the price  agreement it has in place concerning the Divestment B usiness, subject to the 
consent of the respective parties.  
(7) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
                                                 
37  Mylan’s marketing authorization for sildenafil (PAH) was obtained via the centralized procedure and 
therefore cannot be transferred only as it relates to one cou ntry to the Purchaser (see explanation in the 
Form RM).  
38  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
40 
 transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a resu lt of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing  costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(8) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(9) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to sildenafil (PAH)  after Divestment Closing ; 
(d) all marketing authorizations currently held by the P arties for sildenafil (PAH) ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;39 and  
(g) monie s owed to the Parties by customers for the purchase of sildenafil (PAH) , and 
monies owed by the Parties to suppliers for materials used in the production of 
sildenafil (PAH) . 
(10) If there is any asset or personnel which is not covered by paragraph 2 of this Sc hedule but 
which is both used (exclusively or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * *  * 
PRODUCT : MYLAN 'S ELETRIPTAN  PRODUCTS  
Territory: Finland  
(1) The Divestment Business consists of Mylan's rights, title and interests in eletriptan  in 
Finland  (currently marketed under the name Eletriptan Mylan ) including the right to 
develop, manufacture and  use eletriptan  with a view to its sale and marketing in any form in 
Finland . Eletriptan is no longer under exclusivity and  is used for the acute treatment of the 
headache phase of migraine attacks, with or without aura.  
(2) The Divestment Business includes th e transfer of all assets predominantly or exclusively 
                                                 
39  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
41 
 used for the purposes of marketing  eletriptan in Finland . It includes in particular : 
(a) the sale of existing eletriptan finished product inventory, sales and promotional 
material in Finland to the extent a vailable;  
(b) all eletriptan -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to eletriptan  in Finland specifically will be 
provid ed;40  
(c) the transfer of the marketing authorization for eletriptan  in Finland  including all 
relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in Finland.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".41 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of eletriptan  in Finland , Mylan shall have the right to retain the 
ownership of such as set and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of eletriptan  in 
Finland . 
(4) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existin g forms of the product in 
Finland  for up to three years, which period may be extended by one year, and an additional 
year thereafter, upon request by the Purchaser and subject to the approval of th e Monitoring 
Trustee on the basis that such extension is necessary for the Purchaser to continue 
commercializing the Divestment Business.  Such transitory arrangement shall include 
appropriate provisions designed to ensure the continued supply by Mylan to t he Purchaser. It 
shall not contain provisions requiring the delivery of minimum supply volumes or batches.  
(5) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all reg ulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will be ar the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(6) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
                                                 
40  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
41  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
42 
 who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(7) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to eletriptan  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Finland  for 
eletriptan ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress  or trade dress of any 
of its subsidiaries ;42 and  
(g) monies owed to the Parties by customers for the purchase of eletriptan , and monies 
owed by the Parties to suppliers for materials used in the production of eletriptan . 
(8) If there is any asset or personnel whi ch is not covered by paragraph 2 of this Schedule but 
which is both used (exclusively or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitut e will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S DOXAZOSIN  PRODUCTS  
Territory: France  
(1) The Divestment Business consists of Mylan's rights, title and interests in doxazosin  in 
France  (currently marketed under the name Doxazosin Mylan ) including  the right to 
develop, manufacture and use doxazosin  with a view to its sale and marketing in any form in 
France . Doxazosin is no longer under exclusivity and  is used as an  anti-hypertensive and  as 
a treatment for  benign prostatic hyperplasia (BPH ).  
(2) The D ivestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  doxazosin in France . It includes in particular : 
(a) the sale of existing doxazosin finished product inventory, sales and promotional 
material  in France to the extent available;  
(b) all doxazosin -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
                                                 
42  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
43 
 whilst only the information related to doxazosin in France specifically will be 
provided;43  
(c) the transfer of the marketing authorization for doxazosin in France including all 
relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending mark eting 
authorizations available to Mylan; and  
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights, data books, records and effective arrangements for the 
transfer of all know -how to the extent th at these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in France . 
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".44 
(3) If and to the ex tent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of doxazosin  in France , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of doxazosin  in 
France . 
(4) Mylan will transfer all historical information (orders, price, etc.)  concerning its relationship, 
if applicable, regarding doxazosin  in France with licensor and  contract manufacturer  […] to 
the Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the license and supply agreements it has in place 
concerning the Divestment Business, subject to the consent of the respective parties.  In the 
event that consent for the assignment cannot be obtained, at the option of the Purchaser 
Mylan commits to offe r a back -to-back arrangement for the supply of the product to the 
Purchaser for the duration of the relevant third party contract and, in any case, for no longer 
than three years.  
(5) Mylan commits to make its best efforts to cooperate with the Purchaser to ef fectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registrat ion of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(6) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness  of this Divestment Business to be supervised by the Monitoring Trustee.  
                                                 
43  Mylan will include all customer lists and records since 2014 in th e Divestment Business.  
44  For the avoidance of doubt, the Divestment Business is transferred subject  to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in favor of third parties, 
including those a s to development, manufacture, distribution, marketing and sale . 
 
44 
 (7) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to doxazosin  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of France  for 
doxazosin ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divest ment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;45 and 
(g) monies owed to the Parties by customers for the purchase of  doxazosin , and 
monies owed by the Parties to suppliers for materials used in the production of 
doxazosin . 
(8) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the  Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
*****  
PRODUCT : MYLAN 'S ELETRIPTAN  PRODUCTS  
Territory: France  
(1) The Divestment Business consists of Mylan's rights, title and interests in eletriptan  in France 
(currently marketed under the name Eletriptan Mylan ) including the right to develop, 
manufacture and use eletriptan  with a view to its sale and marketing in any form in France . 
Eletriptan is no longer under exclusivity and  is used for the acute treatme nt of the headache 
phase of migraine attacks, with or without aura.  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  eletriptan in France . It includes in particular : 
(a) the sale of exi sting eletriptan finished product inventory, sales and promotional 
material in France to the extent available;  
(b) all eletriptan -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and cont act details, 
whilst only the information related to eletriptan  in France specifically will be 
provided;46  
                                                 
45  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
46  Mylan will include all customer lists and records since 2014 in the Divestment Bus iness.  
 
45 
 (c) the transfer of the marketing authorization for eletriptan  in France  including all 
relevant dossiers, as well as the information contained in the rele vant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, record s and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in France.  
The items referred to under (a) - (d) are hereinafter coll ectively referred to as " Assets 
of the Divestment Business ".47 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, us e and sale of eletriptan  in France , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of eletriptan  in 
France . 
(4) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product  in 
France  for up to three years, which period may be extended by one year, and  an additional 
year thereafter, upon request by the Purchaser and subject to the approval of the Monitoring 
Trustee on the basis that such extension is necessary for the Purchaser to continue 
commercializing the Divestment Business.  Such transitory arrange ment shall include 
appropriate provisions designed to ensure the continued supply by Mylan to the Purchaser. It 
shall not contain provisions requiring the delivery of minimum supply volumes or batches.  
(5) Mylan commits to make its best efforts to cooperate wi th the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain  the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(6) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketabili ty and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(7) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual pr operty 
relating to eletriptan  after Divestment Closing ; 
                                                 
47  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in favor of third parties, 
including those as to development , manufacture, distribution, marketing and sale . 
 
46 
 (d) all marketing authorizations currently held by the Parties outside of France  for 
eletriptan ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parti es other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;48 and 
(g) monies owed to the Parties by customers for the purchase of  eletriptan , and monies 
owed by the Parties to supplie rs for materials used in the production of eletriptan . 
(8) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
*****  
PRODUCT : MYLAN 'S LATANOPROST /TIMOLOL  PRODUCTS  
Territory: France  
(1) The Divestment Business consists of Mylan's rights, title  and interests in latanoprost/timolol  
in France  (currently marketed under the name Latanoprost/timolol Mylan ) including the 
right to develop, manufacture and use latanoprost/timolol  with a view to its sale and 
marketing in any form in France . Latanoprost/t imolol is no longer under exclusivity and  is 
used to reduce inter ocular pressure in patients with various types of glaucoma and ocular 
hypertension .  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the pur poses of marketing  latanoprost/timolol in France . It includes in particular : 
(a) the sale of existing latanoprost/timolol finished product inventory, sales and 
promotional material in France to the extent available;  
(b) all latanoprost/timolol -related contracts, c ommitments, and customer records, 
meaning customer credit records, customer invoices, purchase orders and contact 
details, whilst only the information related to latanoprost/timolol  in France 
specifically will be provided;49  
(c) the transfer of the marketing a uthorization for latanoprost/timolol  in France  
including all relevant dossiers, as well as the information contained in the relevant 
full registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  and 
(d) an ir revocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufactu re, use of the Divestment Business with a view to its sale in France.  
                                                 
48  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
49  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
 
47 
 The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".50 
(3) If and to the extent that the know -how listed in paragraph 2(d) ab ove of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of latanoprost/timolol  in France , Mylan shall have the right to 
retain the ownership of such asset and shall grant to  the Purchaser at no additional charge an 
exclusive and perpetual right to use such asset for the manufacture, use and sale of 
latanoprost/timolol  in France . 
(4) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost/timolol  in France with c ontract manufacturer  […] to the 
Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the supply agreement it has in  place concerning 
the Divestment Business, subject to the consent of the respective parties.  In the event that 
consent for the assignment cannot be obtained, at the option of the Purchaser Mylan 
commits to offer a back -to-back arrangement for the supply of  the product to the Purchaser 
for the duration of the relevant third party contract and, in any case, for no longer than three 
years.  
(5) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding  latanoprost/timolol  in France  with licensor and supplier […] to the 
Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the license and supply agreement it has in place 
conce rning the Divestment Business, subject to the consent of the third party.  
(6) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and re gulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(7) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personn el, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(8) The Divestment Business shall no t include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to latanoprost/timolol  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outs ide of France  for 
latanoprost/timolol ; 
                                                 
50  For t he avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, d istribution, marketing and sale . 
 
48 
 (e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;51 and 
(g) monies owed to the Parties by customers for the purchase of  latanoprost/timolol , 
and monies owed by the Parties to suppliers for materials used in the production of 
latanoprost/timolol . 
(9) If there is any asset or personnel wh ich is not covered by paragraph 2 of this Schedule but 
which is both used (exclusively or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitu te will be offered to the Purchaser.  
*****  
PRODUCT : MYLAN 'S SILDENAFIL (PAH)  PRODUCTS  
Territory: France  
(1) The Divestment Business consists of Mylan's rights, title and interests in sildenafil  in France  
(currently marketed under the name Mysildecard ) includin g the right to develop, 
manufacture and use sildenafil (PAH)  with a view to its sale and marketing in any form in 
France, only for the pulmonary arterial hypertension ( PAH ) indication . Sildenafil (PAH) is 
no longer under exclusivity.  
(2) The Divestment Busines s includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  sildenafil (PAH) in France . It includes in particular : 
(a) the sale of existing sildenafil (PAH)  finished product inventory, sales and 
promotional material in  France to the extent available;  
(b) all sildenafil (PAH) -related contracts, commitments, and customer records, 
meaning customer credit records, customer invoices, purchase orders and contact 
details, whilst only the information related to sildenafil (PAH)  in France 
specifically will be provided;52  
(c) access to Mylan’s dossier for sildenafil (PAH) in order for the Purchaser to obtain 
its own marketing authorization for sildenafil (PAH)53 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all re levant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in France; and  
                                                 
51  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
52  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
53  Mylan’s marketing aut horization for sildenafil (PAH) was obtained via the centralized procedure and 
therefore cannot be transferred only as it relates to one country to the Purchaser (see explanation in the 
Form RM).  
 
49 
 (e) Full transfer of the national trademark related to sildenafil (PAH) in France  or, in 
case of a wider than national specific sildenafil (PAH) trademark, an irrevocable, 
assignable, sub -licensable, perpetual and royalty free license to use the trademark 
for the Divestment Business.  
The items referred to under (a) - (e) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".54 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or p redominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of sildenafil (PAH)  in France , Mylan shall have the right to retain 
the ownership of such asset and shall grant to the Purchaser at no additional charge an 
exclu sive and perpetual right to use such asset for the manufacture, use and sale of sildenafil 
(PAH)  in France . 
(4) Pending the Purchaser applying for its own marketing authorizations for the Divestment 
Business, Mylan will appoint the Purchaser as the exclusive distributor of the Divestment 
Business for a period of up to two years and will, during this period, support the Purchaser 
in applying for its own marketing authorizations. During this two -year period, Mylan shall 
enter into a transitory non -exclusive manuf acturing and/or supply agreement relating to the 
existing forms of the product in France . 
(5) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product in 
France  for an additional year after the two -year period noted above (i.e., up to three years in 
total) . This period may be further extended by one year, and an additional year thereafter, 
upon request by the Purchaser and subject to the approval of the Monitoring Trustee on the 
basis that such extension is necessary for the Purchaser to continue commercializing the 
Divestment Business . Such transitory arrangement shall include appropriate provisions 
designed to ensure the continued supply by Mylan to the  Purchaser. It shall not contain 
provisions requiring the delivery of minimum supply volumes or batches . 
(6) In relation to the existing tender contracts,  Mylan will transfer all historical information 
(orders; price; etc.) concerning its relationship with the  […] to which Mylan is selling its 
sildenafil (PAH) products through tenders.  Mylan commits to make its best efforts to 
support the Purchaser to obtain the […] consent for the transfer the tender contract s. 
(7) Mylan commits to continue its participation in te nders for the Divestment Business up until 
Divestment Closing . If Mylan were to win any tenders pertaining to sildenafil (PAH)  before 
Divestment Closing , Mylan commits to make its best efforts to facilitate the assignment of 
the relationship or the contrac t in line with the provisions contained in this Schedule 
concerning existing tender contracts.  
(8) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory chan ges that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossi er preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
                                                 
54  For the avoidance of doubt, the Divestment Business is tr ansferred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
50 
 (9) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hir e one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(10) The Divestm ent Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to sildenafil (PAH)  after Divestment Closing ; 
(d) all marketing authorizations currently held b y the Parties  for sildenafil (PAH) ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;55 and 
(g) monies owed to the Parties by customers for the purchase of  sildenafil (PAH) , and 
monies owed by the Parties to suppliers for materials used in the production of 
sildenafil (PAH) . 
(11) If there is any asset or personnel which is no t covered by paragraph 2 of this Schedule but 
which is both used (exclusively or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will b e offered to the Purchaser.  
*****  
PRODUCT : MYLAN 'S TADALAFIL (PAH)  PRODUCTS  
Territory: France  
(1) The Divestment Business consists of Mylan's rights, title and interests in tadalafil (PAH)  in 
France  (currently marketed under the name Talmanco ) including the ri ght to develop, 
manufacture and use tadalafil (PAH)  with a view to its sale and marketing in any form in 
France . Tadalafil (PAH) is no longer under exclusivity and  is used to treat pulmonary 
arterial hypertension ( PAH ).  
(2) The Divestment Business includes th e transfer of all assets predominantly or exclusively 
used for the purposes of marketing  tadalafil (PAH) in France . It includes in particular : 
(a) the sale of existing tadalafil (PAH)  finished product inventory, sales and 
promotional material in France to the extent available;  
(b) all tadalafil (PAH) -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
                                                 
55  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
51 
 whilst only the information related to tadalafil (PAH)  in France specifical ly will be 
provided;56  
(c) access t o Mylan’s dossier for tadalafil  (PAH) in order for the Purchaser to obtain 
its own marketing authorization  for tadalafil (PAH);57 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectua l property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in France; and  
(e) Full transfer of the national trademark related to tadalafil (PAH) in France  or, in 
case of a wider than national specific tadalafil (PAH) trademark, an irrevocable, 
assignable, sub -licensable, perpetual and royalty free license to use the trademark 
for the Divestment Busi ness.  
The items referred to under (a) - (e) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".58 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related  to, and not exclusively used in respect of, the 
manufacture, use and sale of tadalafil (PAH)  in France , Mylan shall have the right to retain 
the ownership of such asset and shall grant to the Purchaser at no additional charge an 
exclusive and perpetual ri ght to use such asset for the manufacture, use and sale of tadalafil 
(PAH)  in France . 
(4) Pending the Purchaser applying for its own marketing authorizations for the Divestment 
Business, Mylan will appoint the Purchaser as the exclusive distributor of the Dive stment 
Business for a period of up to two years and will, during this period, support the Purchaser 
in applying for its own marketing authorizations. During this two -year period, Mylan shall 
enter into a transitory non -exclusive manufacturing and/or supply  agreement relating to the 
existing forms of the product in France . 
(5) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product in 
France  for an addit ional year after the two -year period noted above (i.e., up to three years in 
total) . This period may be further extended by one year, and an additional year thereafter, 
upon request by the Purchaser and subject to the approval of the Monitoring Trustee on the 
basis that such extension is necessary for the Purchaser to continue commercializing the 
Divestment Business . Such transitory arrangement shall include appropriate provisions 
designed to ensure the continued supply by Mylan to the Purchaser. It shall n ot contain 
provisions requiring the delivery of minimum supply volumes or batches . 
(6) In relation to the existing tender contracts,  Mylan will transfer all historical information 
(orders; price; etc.) concerning its relationship with the […] to which Mylan is  selling its 
tadalafil (PAH) products through tenders.  Mylan commits to make its best efforts to support 
                                                 
56  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
57  Mylan’s marketing authorization for tadalafil (PAH) was obtained via the centralized procedure and 
therefore cannot be transferred only as it relates to one country to the Purchaser (see explanation in the 
Form RM).  
58  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
52 
 the Purchaser to obtain the […] consent for the transfer the tender contract s. 
(7) Mylan commits to continue its participation in tenders for the Divestmen t Business up until 
Divestment Closing . If Mylan were to win any tenders pertaining to tadalafil (PAH)  before 
Divestment Closing , Mylan commits to make its best efforts to facilitate the assignment of 
the relationship or the contract in line with the provi sions contained in this Schedule 
concerning existing tender contracts.  
(8) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
requir ed as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regul atory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(9) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel,  subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(10) The Divestment Business shall not i nclude:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to tadalafil (PAH)  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties for tadalaf il (PAH) ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;59 and 
(g) monies owed to the Parties by customers for the purchase of  tadalafil (PAH) , and 
monies owed by the Parties to suppliers for materials used in the production of 
tadalafil (PAH) . 
(11) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
*****  
                                                 
59  With the except ion of the sale of inventory existing at Divestment Cl osing  and sold to the Purchaser.   
 
53 
 PRODUCT : MYLAN 'S ALPRAZOLAM  PRODUCTS  
Territory: Greece  
(1) The Divestment Business consists of Mylan's rights, title and interests in alprazolam  in 
Greece  (currently marketed under the name Alprazolam Mylan ) including the right to 
develop, manufacture an d use alprazolam  with a view to its sale and marketing in any form 
in Greece . Alprazolam is no longer under exclusivity and  is used to treat anxiety or panic 
disorders . 
(2) The Divestment Business includes the transfer of all assets predominantly or exclusivel y 
used for the purposes of marketing  alprazolam in Greece . It includes in particular : 
(a) the sale of existing alprazolam finished product inventory, sales and promotional 
material in Greece to the extent available;  
(b) all alprazolam -related contracts, commitment s, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to alprazolam in Greece  specifically will be 
provided;60 
(c) the transfer of the marketing authorization for alprazolam  in Greece  including all 
relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Bu siness with a view to i ts sale in Greece.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".61 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of alprazolam  in Greece , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charg e an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of alprazolam  in 
Greece . 
(4) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing  forms of the product  in 
Greece  for up to three years, which period may be extended by one year, and an additional 
year thereafter, upon request by the Purchaser and subject to the approval of the Monitoring 
Trustee on the basis that such extension is nece ssary for the Purchaser to continue 
commercializing the Divestment Business.  Such transitory arrangement shall include 
appropriate provisions designed to ensure the continued supply by Mylan to the Purchaser. It 
shall not contain provisions requiring the d elivery of minimum supply volumes or batches.  
                                                 
60  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
61  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confi dentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
54 
 (5) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such tr ansfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for al l the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(6) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable lo cal employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(7) The Divestment Business shall not include:  
(a) any manufacturing  facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to alprazolam  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Greece  for 
alprazolam ; 
(e) any oth er asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;62 and  
(g) monies owed to the Parties by customers for the purchase of alprazolam , and 
monies owed by the Parties to suppliers for materials used in the production of 
alprazolam . 
(8) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
*****  
PRODUCT : MYLAN 'S EPL ERENONE  PRODUCTS  
Territory: Hungary  
(1) The Divestment Business consists of Mylan's rights, title and interests in eplerenone in 
Hungary  (currently marketed under the name Eplerenone Mylan ) including the right to 
develop, manufacture and use eplerenone  with a view to its sale and marketing in any form 
in Hungary . Eplerenone is no longer under exclusivity and  is used to treat hypertension and 
specific types of heart failure .  
                                                 
62  With the except ion of the sale of inventory existing at Divestment Closing  and sold t o the Purchaser.   
 
55 
 (2) The Divestment Business includes the transfer of all assets predominantly or exclusivel y 
used for the purposes of marketing  eplerenone in Hungary . It includes in particular : 
(a) the sale of existing eplerenone finished product inventory, sales and promotional 
material in Hungary  to the extent available;  
(b) all eplerenone -related contracts, commitme nts, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to eplerenone  in Hungary specifically will be 
provided; 63  
(c) the transfer of the marketing authorization f or eplerenone in Hungary including all 
relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan; and  
(d) an irrevocable, assignable,  sub-licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestm ent Business with a view to its sale in Hungary.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".64 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of eplerenone in Hungary , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no addition al charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of eplerenone in 
Hungary . 
(4) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding eplerenone i n Hungary  with contract manufacturer […] to the 
Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the supply agreement it has in place concerning 
the Divestment Business, su bject to the consent of the third party ([…]). I n the event that 
consent for the assignment cannot be obtained, at the option of the Purchaser Mylan 
commits to offer a back -to-back arrangement for the supply of the product to the Purchaser 
for the duration  of the relevant third party contract and, in any case, for no longer than three 
years.  
(5) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes tha t would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business. In addition, Mylan will bear the dossier prep aration and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
                                                 
63  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
64  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(including any confidentiality oblig ations) or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
56 
 (6) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one o r more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(7) The Divestment Bus iness shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to eplerenone  after Divestment Closing ; 
(d) all marketing authorizations currently held b y the Parties  outside of Hungary  for 
eplerenone ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;65 and  
(g) monies owed to the Parties by customers for the purchase of eplerenone , and 
monies owed by the Parties to suppliers for materials used in the production of 
eplerenone . 
(8) If there is any asset or personnel which is not covered b y paragraph 2 of this Schedule but 
which is both used (exclusively or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered t o the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S ALPRAZOLAM  PRODUCTS  
Territory: Iceland  
(1) The Divestment Business consists of Mylan's rights, title and interests in alprazolam  in 
Iceland  (currently marketed under the name Alprazolam Mylan ) including the right to 
develop, manufacture and use alprazolam  with a view to its sale and marketing in any form 
in Iceland . Alprazolam is no longer under exclusivity and  is used to treat anxiety or panic 
disorders .  
(2) The Divestment Business includes the transfer of all assets pr edominantly or exclusively 
used for the purposes of marketing  alprazolam in Iceland . It includes in particular : 
(a) the sale of existing alprazolam finished product inventory, sales and promotional 
material in Iceland to the extent available;  
(b) all alprazolam -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
                                                 
65  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
57 
 whilst only the information related to alprazolam in Iceland  specifically will be 
provided;66  
(c) the transfer of the m arketing authorization for alprazolam  in Iceland  including all 
relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufac ture, use of the Divestment Business with a view to its sale in Iceland.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".67 
(3) If and to the extent that the know -how listed in paragraph 2(d)  above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of alprazolam  in Iceland , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of alprazolam  in 
Iceland . 
(4) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply a greement relating to the existing forms of the product  in 
Iceland  for up to three years, which period may be extended by one year, and an additional 
year thereafter, upon request by the Purchaser and subject to the approval of the Monitoring 
Trustee on the  basis that such extension is necessary for the Purchaser to continue 
commercializing the Divestment Business.  Such transitory arrangement shall include 
appropriate provisions designed to ensure the continued supply by Mylan to the Purchaser. It 
shall not contain provisions requiring the delivery of minimum supply volumes or batches.  
(5) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(6) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more P ersonnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(7) The Divestment Business sh all not include:  
(a) any manufacturing facility;  
                                                 
66  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
67  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality obligations)  or restr ictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
58 
 (b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to alprazolam  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside  of Iceland  for 
alprazolam ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;68 and  
(g) monies owed to the Parties by customers for the purchase of alprazolam , and 
monies owed by the Parties to suppliers for materials used in the production of 
alprazolam . 
(8) If there is any asset or personnel which is not covered by paragr aph 2 of this Schedule but 
which is both used (exclusively or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Pu rchaser.  
*****  
PRODUCT : MYLAN 'S ALPRAZOLAM  PRODUCTS  
Territory: Ireland  
(1) The Divestment Business consists of Mylan's rights, title and interests in alprazolam  in 
Ireland  (currently marketed under the name Gerax69 Mylan ) including the right to develop, 
manufac ture and use alprazolam  with a view to its sale and marketing in any form in Ireland . 
Alprazolam is no longer under exclusivity and  is used to treat anxiety or panic disorders . 
(2) The Divestment Business includes the transfer of all assets predominantly or ex clusively 
used for the purposes of marketing  alprazolam in Ireland . It includes in particular : 
(a) the sale of existing alprazolam finished product inventory, sales and promotional 
material in Ireland to the extent available;  
(b) all alprazolam -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to alprazolam in Ireland  specifically will be 
provided;70 
(c) the transfer of the marketing authoriza tion for alprazolam  in Ireland  including all 
relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  and 
                                                 
68  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
69  Gerax is no t a registered trademark.  
70  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
 
59 
 (d) an irrevocable, assig nable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the D ivestment Business with a view to its sale in Ireland . 
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".71 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Sch edule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of alprazolam  in Ireland , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no ad ditional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of alprazolam  in 
Ireland . 
(4) Mylan commits n either  to register the Gerax  brand in Ireland  nor to oppose the future 
registration of the Gerax  brand name by the  Purchaser in Ireland . The Purchaser will ha ve 
the right to use the Gerax brand in Ireland . 
(5) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the produc t in 
Ireland  for up to three years, which period may be extended by one year, and an additional 
year thereafter, upon request by the Purchaser and subject to the approval of the Monitoring 
Trustee on the basis that such extension is necessary for the Purch aser to continue 
commercializing the Divestment Business.  Such transitory arrangement shall include 
appropriate provisions designed to ensure the continued supply by Mylan to the Purchaser. It 
shall not contain provisions requiring the delivery of minimum supply volumes or batches.  
(6) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until trans fer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of th e dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(7) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legi slation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(8) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw mate rials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to alprazolam  after Divestment Closing ; 
                                                 
71  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiali ty obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
60 
 (d) all marketing authorizations currently held by the Parties outside of Ireland  for 
alprazolam ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;72 and  
(g) monies owed to the Parties by customers for the purchase of alprazolam , and 
monies owed by the Parties to suppliers for materials used in the production of 
alprazolam . 
(9) If there is any asset or personnel which is not covered by paragraph 2 of this Schedule but 
which is both used (exclus ively or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
*****  
PRODUCT : MYLAN 'S GABAPENTIN  PRODUCTS  
Territory: Ireland  
(1) The Divestment Business consists of Mylan's rights, title and interests in gabapentin  in 
Ireland  (currently marketed under the name Gabapentin Ireland ) including the right to 
develop, manufacture and use gabapentin  with a view to its sale  and marketing in any form 
in Ireland . Gabapentin is no longer under exclusivity and  is used both as a monotherapy to 
prevent partial epileptic seizures (epileptic fits starting in one specific part of the brain) and 
also as an ‘add -on' to existing treatme nts in patients who have partial seizures .  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  gabapentin in Ireland . It includes in particular : 
(a) the sale of existing gabapentin finish ed product inventory, sales and promotional 
material in Ireland to the extent available;  
(b) all gabapentin -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst on ly the information related to gabapentin in Ireland  specifically will be 
provided;73  
(c) the transfer of the marketing authorization for gabapentin in Ireland including all 
relevant dossiers, as well as the information contained in the relevant full 
registrati on dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan; and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arra ngements for the 
                                                 
72  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Pu rchaser.   
73  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
 
61 
 transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in Ireland ;  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".74 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of gaba pentin  in Ireland , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of gabapentin  in 
Ireland . 
(4) Myla n will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding gabapentin  in Ireland  with licensor […] to the Purchaser in 
accordance with applicable law. Mylan commits to make its best efforts to fac ilitate the 
assignment to the Purchaser  of the license agreement it has in place concerning the 
Divestment Business, subject to the consent of the third party.  
(5) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transf er of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(6) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment  Business to be supervised by the Monitoring Trustee.  
(7) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to gabapentin  after Dives tment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Ireland  for 
gabapentin ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
                                                 
74  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
62 
 (f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;75 and  
(g) monies owed to the Parties by customers for the purchase of gabapentin , and 
monies owed by the Parties to suppliers for materials used in the production  of 
gabapentin . 
(8) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment B usiness, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S ALPRAZOLAM  PRODUCTS  
Territory: Italy  
(1) The Divestment Business consists of Mylan's rights, title and interests in alprazolam  in Italy 
(curren tly marketed under the name s Frontal and Alprazolam Mylan ) including the right to 
develop, manufacture and use alprazolam  with a view to its sale and marketing in any form 
in Italy. Alprazolam is no longer under exclusivity and  is used to treat anxiety or panic 
disorders . 
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  alprazolam in Italy. It includes in particular : 
(a) the sale of existing alprazolam finished product inventory, sales a nd promotional 
material in Italy to the extent available;  
(b) all alprazolam -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to alprazolam in Italy  specifically will be 
provided;76 
(c) the transfer of the marketing authorization for alprazolam  in Italy including all 
relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the curre nt and/or pending marketing 
authorizations available to Mylan;  
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business wi th a view to its sale in Italy; and  
(e) if applicable, f ull transfer of the national trademark related to alprazolam in Italy  
or, in case of a wider than n ational specific alprazolam  trademark, an irrevocable, 
assignable, sub -licensable, perpetual and royalty free license to use the trademark 
for the Divestment Business . 
                                                 
75  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
76  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
 
63 
 The items referred to under (a) - (e) are hereinafter collectively referred to as " Asset s 
of the Divestment Business ".77 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of alprazolam  in Italy, Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of alprazolam  in Italy. 
(4) With respect to Alpr azolam Mylan oral drops, Mylan will transfer all historical information 
(orders, price, etc.) concerning its relationship, if applicable, regarding alprazolam  in Italy 
with contract manufacturer […] to the Purchaser in accordance with applicable law. Mylan  
commits to make its best efforts to facilitate the assignment to the Purchaser  of the supply  
agreement it has in place concerning the Divestment Business, subject to the consent of the 
third party.  In the event that consent for the assignment cannot be ob tained, at the option of 
the Purchaser Mylan commits to offer a back -to-back arrangement for the supply of the 
product to the Purchaser for the duration of the relevant third party contract and, in any case, 
for no longer than three years.  
(5) Mylan will also transfer all historical information (orders, price, etc.) concerning its 
relationship, if applicable, regarding Alprazolam Mylan oral drops  with […] for the supply 
of the product to the Purchaser in accordance with applicable law.   
(6) With respect to Frontal,  Mylan will transfer all historical information (orders, price, etc.) 
concerning its relationship, if applicable, regarding alprazolam  in Italy with licensor […] to 
the Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the license agreement it has in place concerning 
the Divestment Business, subject to the consent of the third party.  
(7) Also with respect to Frontal, in the (unlikely) event that the transfer to the Purchaser occu rs 
prior to the closing of the Transaction, Mylan will transfer all historical information (orders, 
price, etc.) concerning its relationship, if applicable, regarding the Frontal trademark license  
in Italy with licensor […] to the Purchaser in accordance w ith applicable law. Mylan 
commits to make its best efforts to facilitate the assignment to the Purchaser  of the license 
agreement it has in place concerning the Divestment Business, subject to the consent of the 
third party.  If the transfer to the Purchase r occurs following the closing of the Transaction, 
[…] 
(8) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of product in Italy for 
up to three years, which p eriod may be extended by one year, and an additional year 
thereafter, upon request by the Purchaser and subject to the approval of the Monitoring 
Trustee on the basis that such extension is necessary for the Purchaser to continue 
commercializing the Divest ment Business.  Such transitory arrangement shall include 
appropriate provisions designed to ensure the continued supply by Mylan to the Purchaser. It 
shall not contain provisions requiring the delivery of minimum supply volumes or batches.  
(9) Mylan commits to  make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
                                                 
77  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
64 
 bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(10) In relation to the existing tender contracts, Mylan commits to make its best efforts to suggest 
the Purchaser of the Divestment Business to the relevant tender authorities as the new 
supplier of the product for the rem ainder of the tender duration.  
(11) Mylan commits to continue its participation in tenders for the Divestment Business up until 
Divestiture Closing. If Mylan were to win any tenders pertaining to alprazolam  in Italy 
before Divestiture Closing, Mylan commits to make its best efforts to suggest the Purchaser 
of the Divestment Business to the relevant tender authorities as the new supplier of the 
product for the remainder of the tender duration.  
(12) At the option of the Purchaser, and in case any of the tender contract ing entities would 
decide not to accept the Purchaser as the new supplier with respect to the existing tender 
contract s, Mylan will enter into a transitional dual distributorship arrangement related to the 
Divestment Business lasting until the relevant mar keting authorization  is transferred to the 
name of the Purchaser on an at -cost basis which determination will be  overseen by the 
Monitoring Trustee. Mylan commits to make its best efforts to ensure that no supply 
disruption will occur or any other supply i ssue that might lead to the termination of the 
contract.  
(13) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(14) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to alprazolam  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Italy for 
alprazolam ; 
(e) any other asset not part of the Divestment Business  or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;78 and  
(g) monies owed to the Parties by customers for the purchase  of alprazolam , and 
monies owed by the Parties to suppliers for materials used in the production of 
alprazolam . 
                                                 
78  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
65 
 (15) 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) in the Dives tment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
*****  
PRODUCT : MYLAN 'S LATANOPROST /TIMOLOL PRODUCTS  
Territory: Italy  
(1) The Divestment Business consists of Mylan's rights, title and interests in latanoprost/timolol  
in Italy (currently marketed under the name Latanoprost/timolol Mylan ) including the right 
to develop, manufacture and use latanoprost/timolol  with a view to its sale and marketing in 
any form in Italy. Latanoprost/timolol is no longer under exclusivity and  is used to reduce 
inter ocular pressure in patients with various types of glaucoma and ocular hypertension . 
(2) The Divestment Business includes the transfer of all  assets predominantly or exclusively 
used for the purposes of marketing  latanoprost/timolol in Italy. It includes in particular : 
(a) the sale of existing latanoprost/timolol finished product inventory, sales and 
promotional material in Italy to the extent avai lable;  
(b) all latanoprost/timolol -related contracts, commitments, and customer records, 
meaning customer credit records, customer invoices, purchase orders and contact 
details, whilst only the information related to latanoprost/timolol  in Italy  
specifically w ill be provided;79 
(c) the transfer of the marketing authorization for latanoprost/timolol  in Italy including 
all relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending market ing 
authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that  these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in Italy.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".80 
(3) If and to the exten t that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of latanoprost/timolol  in Italy, Mylan shall have the right to retain 
the ownership of such asset and shall grant to the Purchaser at no additional charge an 
exclusive and perpetual right to use such asset for the manufacture, use and sale of 
latanoprost/timolol  in Italy. 
                                                 
79  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
80  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions applicable there to in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
66 
 (4) Mylan will transfer all historical information (order s, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost/timolol  in Italy with c ontract manufacturer  […] to the 
Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the  Purchaser  of the supply agreement it has in place concerning 
the Divestment Business, subject to the consent of the respective parties. I n the event that 
consent for the assignment cannot be obtained, at the option of the Purchaser Mylan 
commits to offer a back -to-back arrangement for the supply of the product to the Purchaser 
for the duration of the relevant third party contract and, in any case, for no longer than three 
years.  
(5) Mylan will transfer all historical information (orders, price, etc.) concernin g its relationship, 
if applicable, regarding latanoprost/timolol  in Italy with licensor and supplier […] to the 
Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the license  and supply agreement it has in place 
concerning the Divestment Business, subject to the consent of the third party.  
(6) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to underta ke all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Myl an will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(7) The Purchaser will be given an option (to be exercised within one year after the Dive stment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring  Trustee.  
(8) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to latanoprost/timolol  after Divestment Closing ; 
(d) all marketing author izations currently held by the Parties outside of Italy for 
latanoprost/timolol ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trade mark and Mylan trade dress or trade dress of any 
of its subsidiaries ;81 and  
(g) monies owed to the Parties by customers for the purchase of latanoprost/timolol , 
and monies owed by the Parties to suppliers for materials used in the production of 
latanoprost/tim olol. 
(9) If there is any asset or personnel which is not covered by paragraph 2 of this Schedule but 
                                                 
81  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
67 
 which is both used (exclusively or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, t hat asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S SILDENAFIL (PAH)  PRODUCTS  
Territory: Latvia  
(1) The Divestment Business consists of Mylan's rights, title and interests in sildenafil  in Latvia  
(currentl y marketed under the name Mysildecard ) including the right to develop, 
manufacture and use sildenafil (PAH)  with a view to its sale and marketing in any form in 
Latvia, only for the pulmonary arterial hypertension ( PAH ) indication . Sildenafil (PAH) is 
no longer under exclusivity.  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  sildenafil (PAH) in Latvia . It includes in particular : 
(a) the sale of existing sildenafil (PAH)  finished produ ct inventory, sales and 
promotional material in Latvia to the extent available;  
(b) all sildenafil (PAH) -related contracts, commitments, and customer records, 
meaning customer credit records, customer invoices, purchase orders and contact 
details, whilst only the information related to sildenafil (PAH)  in Latvia 
specifically will be provided;82  
(c) access to Mylan’s dossier for sildenafil (PAH) in order for the Purchaser to obtain 
its own marketing authorization  for sildenafil (PAH);83 
(d) an irrevocable, assignable, su b-licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment  Business with a view to its sale in Latvia; and 
(e) Full transfer of the national trademark related to sildenafil (PAH) in Latvia  or, in 
case of a wider than national specific sildenafil (PAH) trademark, an irrevocable, 
assignable, sub -licensable, perpetual a nd royalty free license to use the trademark 
for the Divestment Business.  
The items referred to under (a) - (e) are hereinafter collectively referred to as " Assets of the 
Divestment Business ".84 
(3) If and to the extent that the know -how listed in paragraph 2(d ) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of sildenafil (PAH)  in Latvia , Mylan shall have the right to retain 
                                                 
82  Mylan will include all customer lis ts and records since 2014 in the Divestment Business.  
83  Mylan’s marketing authorization for sildenafil (PAH) was obtained via the centralized procedure and 
therefore cannot be transferred only as it relates to one country to the Purchaser (see explanatio n in the 
Form RM).  
84  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
68 
 the ownership of such asset and shall grant t o the Purchaser at no additional charge an 
exclusive and perpetual right to use such asset for the manufacture, use and sale of sildenafil 
(PAH)  in Latvia . 
(4) Pending the Purchaser applying for its own marketing authorizations for the Divestment 
Business, Myl an will appoint the Purchaser as the exclusive distributor of the Divestment 
Business for a period of up to two years and will, during this period, support the Purchaser 
in applying for its own marketing authorizations. During this two -year period, Mylan s hall 
enter into a transitory non -exclusive manufacturing and/or supply agreement relating to the 
existing forms of the product in Latvia . 
(5) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreemen t relating to the existing forms of the product in 
Latvia  for an additional year after the two -year period noted above (i.e., up to three years in 
total) , which period may be extended by one year, and an additional year thereafter, upon 
request by the Purc haser and subject to the approval of the Monitoring Trustee on the basis 
that such extension is necessary for the Purchaser to continue commercializing the 
Divestment Business . Such transitory arrangement shall include appropriate provisions 
designed to en sure the continued supply by Mylan to the Purchaser. It shall not contain 
provisions requiring the delivery of minimum supply volumes or batches.  
(6) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Dives tment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestme nt Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(7) The Purchaser will be given an option (to be exercised w ithin one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be  supervised by the Monitoring Trustee.  
(8) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to sildenafil (PAH)  after Divestment Clo sing; 
(d) all marketing authorization s currently held by the Parties for sildenafil (PAH);  
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan  trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;85 and  
                                                 
85  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
69 
 (g) monies owed to the Parties by customers for the purchase of sildenafil (PAH) , and 
monies owed by the Parties to suppliers for materials used in the production of 
sildenafil ( PAH) . 
(9) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, t hat asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S SILDENAFIL (PAH)  PRODUCTS  
Territory: Lithuania  
(1) The Divestment Business consists of Mylan's rights, title and interests in sildenafil  in 
Lithuania  (currently marketed under the name Mysildecard ) including the right to develop, 
manufacture and use sildenafil (PAH)  with a view to its sale and marketing in any form in 
Lithuania, only for the pulmonary arterial hypertension ( PAH ) indication . Sildenafil (PAH ) 
is no longer under exclusivity.   
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  sildenafil (PAH) in Lithuania . It includes in particular : 
(a) the sale of existing sildenafil (PAH)  finished product inventory, sales and 
promotional material in Lithuania to the extent available;  
(b) all sildenafil (PAH) -related contracts, commitments, and customer records, 
meaning customer credit records, customer invoices, purchase orders and contact 
detai ls, whilst only the information related to sildenafil (PAH)  in Lithuania 
specifically will be provided;86 
(c) access to Mylan’s dossier for sildenafil (PAH) in order for the Purchaser to obtain 
its own marketing authorization for sildenafil (PAH) ;87 
(d) an irrevocab le, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use  of the Divestment Business with a view to its sale in Lithuania ; 
and 
(e) Full transfer of the national trademark related to sildenafil (PAH) in Lithuania  or, 
in case of a wider than national specific sildenafil (PAH) trademark, an 
irrevocable, assignable, sub -licensable, perpetual and royalty free license to use the 
trademark for the Divestment Business.  
The items referred to under (a) - (e) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".88 
                                                 
86  Mylan will include all customer lists and records since 2014 in the Divestment Business .  
87  Mylan’s marketing authorization for sildenafil (PAH) was obtained via the centralized procedure and 
therefore cannot be transferred only as it relates to one country to the Purchaser (see explanation in the 
Form RM).  
 
70 
  
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of sildenafil (PAH)  in Lithuania , Mylan shall have the right to 
retain the ownership of such asset and shall grant to the Purchaser at no additional charge an 
exclusive and perpetual right to use such asset for the manufacture, use and sale of sildenafil 
(PAH)  in Lithuania . 
(4) Pending the Purchaser applying for its own marketing authorizations f or the Divestment 
Business, Mylan will appoint the Purchaser as the exclusive distributor of the Divestment 
Business for a period of up to two years and will, during this period, support the Purchaser 
in applying for its own marketing authorizations. Durin g this two -year period, Mylan shall 
enter into a transitory non -exclusive manufacturing and/or supply agreement relating to the 
existing forms of the product in Lithuania . 
(5) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product in  
Lithuania  for an additional year after the two -year period noted above (i .e., up to three years 
in total). This period may be extended by one year, and an additional year thereafter, upon 
request by the Purchaser and subject to the approval of the Monitoring Trustee on the basis 
that such extension is necessary for the Purchaser to continue commercializing the 
Divestment Business.  Such transitory arrangement shall include a ppropriate provisions 
designed to ensure the continued supply by Mylan to the Purchaser. It shall not contain 
provisions requiring the delivery of minimum supply volumes or batches.  
(6) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registr ation of the dossier of the 
Divestment Business. In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(7) The Purchaser will b e given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitivene ss of this Divestment Business to be supervised by the Monitoring Trustee.  
(8) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to sildenafil (PAH)  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties  for sildenafil (PAH) ; 
                                                                                                                                                      
88  For the avoidance of doubt, th e Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing an d sale . 
 
71 
 (e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestme nt Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;89 and  
(g) monies owed to the Parties by customers for the purchase of sildenafil (PAH) , and 
monies owed by the Parties to suppliers for materials us ed in the production of 
sildenafil (PAH) . 
(9) 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) in the Divestment Business and necessary for the 
continued viability and competiti veness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S LATANOPROST  PRODUCTS  
Territory: Luxembourg  
(1) The Divestment Business consists of Mylan's rights, title and interest s in latanoprost  in 
Luxembourg  (currently marketed under the name Latanotears ) including the right to 
develop, manufacture and use latanoprost  with a view to its sale and marketing in any form 
in Luxembourg . Latanoprost is no longer under exclusivity and  is used to reduce inter ocular 
pressure in patients with various types of glaucoma and ocular hypertension . 
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  latanoprost in Luxembourg . It includes in particular : 
(a) the sale of existing latanoprost finished product inventory, sales and promotional 
material in Luxembourg to the extent available;  
(b) all latanoprost -related contracts, commitments, and customer records, meaning 
customer credit re cords, customer invoices, purchase orders and contact details, 
whilst only the information related to latanoprost  in Luxembourg specifically will 
be provided;90  
(c) the transfer of the marketing authorization for latanoprost in Luxembourg 
including all relevan t dossiers, as well as the information contained in the relevant 
full registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in 
Luxembour g; and  
                                                 
89  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
90  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
 
72 
 (e) Full transfer of the national trademark related to latanoprost in Luxembourg  or, in 
case of a wider than national specific latanoprost trademark, an irrevocable, 
assignable, sub -licensable, perpetual and royalty free license to use the trademark 
for the Divestment Business.  
The items referred to under (a) - (e) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".91 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or p redominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of latanoprost  in Luxembourg , Mylan shall have the right to retain 
the ownership of such asset and shall grant to the Purchaser at no additional charge an 
exclus ive and perpetual right to use such asset for the manufacture, use and sale of 
latanoprost  in Luxembourg . 
(4) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost  in Luxembourg  with contract manufacturer […] to the 
Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the supply agreement it has in place concerning 
the Divestment Business, subject to th e consent of the third party.  In the event that consent 
for the assignment cannot be obtained, at the option of the Purchaser Mylan commits to offer 
a back -to-back arrangement for the supply of the product to the Purchaser for the duration of 
the relevant third party contract and, in any case, for no longer than three years.  
(5) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost  in Luxembourg  with licensor […] to the Purchaser i n 
accordance with applicable law. Mylan commits to make its best efforts to facilitate the 
assignment to the Purchaser  of the license agreements it has in place concerning the 
Divestment Business, subject to the consent of the third party.  
(6) Mylan commits to  make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(7) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(8) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
                                                 
91  For the avoidance of doubt, the Divestment Bus iness is transferred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
73 
 (c) any research and development, clinic al data and studies or intellectual property 
relating to latanoprost  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Luxembourg  
for latanoprost ; 
(e) any other asset not part of the Divestment Business or which is  used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;92 and  
(g) monies owed to the Parties by customers for the purchase of latanopr ost, and 
monies owed by the Parties to suppliers for materials used in the production of 
latanoprost . 
(9) 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) in the Divestment Busi ness and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S LATANOPROST /TIMOLOL  PRODUCTS  
Territory: Luxembourg  
(1) The Divestment Business consists of Mylan's rights, title and interests in latanoprost/timolol  
in Luxembourg  (currently marketed under the name Timolatears ) including the right to 
develop, manufacture and use latanoprost/timolol  with a view to its sale and m arketing in 
any form in Luxembourg . Latanoprost/timolol is no longer under exclusivity and  is used to 
reduce inter ocular pressure in patients with various types of glaucoma and ocular 
hypertension .  
(2) The Divestment Business includes the transfer of all ass ets predominantly or exclusively 
used for the purposes of marketing  latanoprost/timolol in Luxembourg . It includes in 
particular : 
(a) the sale of existing latanoprost/timolol finished product inventory, sales and 
promotional material in Luxembourg to the exten t available;  
(b) all latanoprost/timolol -related contracts, commitments, and customer records, 
meaning customer credit records, customer invoices, purchase orders and contact 
details, whilst only the information related to latanoprost/timolol  in Luxembourg 
specifically will be provided;93  
(c) the transfer of the marketing authorization for latanoprost/timolol in Luxembourg 
including all relevant dossiers, as well as the information contained in the relevant 
full registration dossier(s), relating to the current and/ or pending marketing 
authorizations available to Mylan;  
                                                 
92  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
93  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
 
74 
 (d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to t he extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in 
Luxembourg ; and  
(e) Full transfer of the national trademark related to latanoprost/timolol in 
Luxembourg or, in case of a wider than nat ional specific latanoprost/timolol 
trademark, an irrevocable, assignable, sub -licensable, perpetual and royalty free 
license to use the trademark for the Divestment Business.  
The items referred to under (a) - (e) are hereinafter collectively referred to as  "Assets 
of the Divestment Business ".94 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of latanopro st/timolol  in Luxembourg , Mylan shall have the right 
to retain the ownership of such asset and shall grant to the Purchaser at no additional charge 
an exclusive and perpetual right to use such asset for the manufacture, use and sale of 
latanoprost/timolol  in Luxembourg . 
(4) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost/timolol  in Luxembourg with contract manufacturer  […] 
to the Purchaser in accordance with applicable law. Mylan commits to make its best efforts 
to facilitate the assignment to the Purchaser  of the supply agreement it has in place 
concerning the Divestment Business, subject to the consent of the third party.  In the event 
that consent for the assignment cannot b e obtained, at the option of the Purchaser Mylan 
commits to offer a back -to-back arrangement for the supply of the product to the Purchaser 
for the duration of the relevant third party contract and, in any case, for no longer than three 
years.  
(5) Mylan will t ransfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost/timolol  in Luxembourg  with licensor […] to the 
Purchaser in accordance with applicable law. Mylan commits to make its best efforts to  
facilitate the assignment to the Purchaser  of the license and supply agreement it has in place 
concerning the Divestment Business, subject to the consent of the third party.  
(6) Mylan commits to make its best efforts to cooperate with the Purchaser to effectu ate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration o f the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(7) The Purchaser will be given  an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of t his Divestment Business to be supervised by the Monitoring Trustee.  
                                                 
94  For the avoidance of doubt, the Divestment Business is transfe rred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
75 
 (8) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to latanopr ost/timolol  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Luxembourg  
for latanoprost/timolol ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties ot her than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;95 and  
(g) monies owed to the Parties by customers for the purchase of latanoprost/timolol , 
and monies owed by the Parties to su ppliers for materials used in the production of 
latanoprost/timolol . 
(9) 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) in the Divestment Business and necessary for the 
contin ued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S PREGABALIN  PRODUCTS  
Territory: Luxembourg  
(1) The Divestment Business consists of Mylan's rights, title and interests in pregabalin  in 
Luxembourg  (currently marketed under the name Pregabalin Mylan ) including the right to 
develop, manufacture and use pregabalin  with a view to its sale and marketing in any form 
in Luxembourg . Pregabalin is no lo nger under exclusivity and  is indicated  and primarily 
used for peripheral and central neuropathic pain, but is also used as an ‘add -on' to existing 
treatment in patients who have partial seizures that cannot be controlled with their current 
treatment .  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  pregabalin in Luxembourg . It includes in particular : 
(a) the sale of existing pregabalin finished product inventory, sales and promotional 
material in Luxembourg to the extent available;  
(b) all pregabalin -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
                                                 
95  With the except ion of  the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
76 
 whilst only the information related to pregabalin  in Luxembourg specifically will 
be provided;96  
(c) access to Mylan’s dossier for pregabalin in order for the Purchaser to obtain its 
own marketing authorization for pregabalin;97 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all releva nt 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in 
Luxembourg ; and  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".98 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of pregabalin  in Luxembourg , Mylan shall have the right to retain 
the ownership of such asset and shall grant to the Purchaser at no additional charge an 
exclusive and perpetual right to  use such asset for the manufacture, use and sale of 
pregabalin  in Luxembourg . 
(4) Pending the Purchaser applying for its own marketing authorizations for the Divestment 
Business, Mylan will appoint the Purchaser as the exclusive distributor of the Divestment 
Business for a period of up to two years and will, during this period, support the Purchaser 
in applying for its own marketing authorizations. During this two -year period, Mylan shall 
enter into a transitory non -exclusive manufacturing and/or supply agreem ent relating to the 
existing forms of the product in  Luxembourg.  
(5) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product in  
Luxembourg  for an addi tional year after the two -year period noted above (i. e., up to three 
years in total) . This period may be extended by one year, and an additional year thereafter, 
upon request by the Purchaser and subject to the approval of the Monitoring Trustee on the 
basis that such extension is necessary for the Purchaser to continue commercializing the 
Divestment Business.  Such transitory arrangement shall include appropriate provisions 
designed to ensure the continued supply by Mylan to the Purchaser. It shall not cont ain 
provisions requiring the delivery of minimum supply volumes or batches.  
(6) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding pregabalin in Luxembourg with  […] for the packaging of th e 
product to the Purchaser in accordance with applicable law. Mylan commits to make its best 
efforts to facilitate the assignment to the Purchaser  of the agreement it has in place 
concerning the Divestment Business, subject to the consent of the third part y. In the event 
that consent for the assignment cannot be obtained, at the option of the Purchaser Mylan 
commits to offer a back -to-back arrangement for the supply of the product to the Purchaser 
                                                 
96  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
97  Mylan’s marketing authorization for pregabalin was obtained via the centralize d procedure and therefore 
cannot be transferred only as it relates to one country to the Purchaser (see explanation in the Form RM).  
98  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any  confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
77 
 for the duration of the relevant third party contract and, i n any case, for no longer than three 
years.  
(7) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such tran sfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(8) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable loca l employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(9) The Divestment Business shall not include:  
(a) any manufacturing f acility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to pregabalin  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties for pregabalin ; 
(e) any other asset not part of  the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;99 and  
(g) monies owed to the Parties by cu stomers for the purchase of pregabalin , and 
monies owed by the Parties to suppliers for materials used in the production of 
pregabalin . 
(10) If there is any asset or personnel which is not covered by paragraph 2 of this Schedule but 
which is both used (exclusiv ely or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S LATANOPROST /TIMOLOL  PRODUCTS  
Territory: the Netherlands  
(1) The Divestment Business consists of Mylan's rights, title and interests in latanoprost/timolol  
in the Netherlands  (currently marketed under the name Latanoprost/timolol Mylan ) 
including the right to develop, manufacture  and use latanoprost/timolol  with a view to its 
                                                 
99  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
78 
 sale and marketing in any form in the Netherlands . Latanoprost/timolol is no longer under 
exclusivity and  is used to reduce inter ocular pressure in patients with various types of 
glaucoma and ocular hyperten sion.  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  latanoprost/timolol in the Netherlands . It includes in 
particular : 
(a) the sale of existing latanoprost/timolol finished product inventory, sales and 
promotional material in the Netherlands to the extent available;  
(b) all latanoprost/timolol -related contracts, commitments, and customer records, 
meaning customer credit records, customer invoices, purchase orders and contact 
details, whi lst only the information related to latanoprost/timolol  in the 
Netherlands specifically will be provided;100 
(c) the transfer of the marketing authorization for latanoprost/timolol  in the 
Netherlands  including all relevant dossiers, as well as the information co ntained in 
the relevant full registration dossier(s), relating to the current and/or pending 
marketing authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in the 
Netherlands.  
The items referred to under (a ) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".101 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in res pect of, the 
manufacture, use and sale of latanoprost/timolol  in the Netherlands , Mylan shall have the 
right to retain the ownership of such asset and shall grant to the Purchaser at no additional 
charge an exclusive and perpetual right to use such asset f or the manufacture, use and sale of 
latanoprost/timolol  in the Netherlands . 
(4) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost/timolol  in the Netherlands  with c ontract manu facturer  
[…] to the Purchaser in accordance with applicable law. Mylan commits to make its best 
efforts to facilitate the assignment to the Purchaser  of the supply agreement it has in place 
concerning the Divestment Business, subject to the consent of the respective parties. I n the 
event that consent for the assignment cannot be obtained, at the option of the Purchaser 
Mylan commits to offer a back -to-back arrangement for the supply of the product to the 
Purchaser for the duration of the relevant third part y contract and, in any case, for no longer 
than three years.  
(5) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost/timolol  in the Netherlands  with licensor […] to the 
                                                 
100  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
101  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality  obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
79 
 Purchase r in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the license agreement it has in place concerning 
the Divestment Business, subject to the consent of the third party.  
(6) In relation to  the existing tender contracts,  Mylan will transfer all historical information 
(orders; price; etc.) concerning its relationship with […]. Mylan commits to make its best 
efforts to support the Purchaser to obtain the […] consent  for the transfer the tender  
contract s. 
(7) Mylan commits to continue its participation in tenders for the Divestment Business up until 
Divestment Closing . If Mylan were to win any tenders pertaining to latanoprost/timolol  
before Divestment Closing , Mylan commits to make its best efforts  to facilitate the 
assignment of the relationship or the contract in line with the provisions contained in this 
Schedule concerning existing tender contracts.  
(8) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer  of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of  the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(9) The Purchaser will be given an option (to b e exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment B usiness to be supervised by the Monitoring Trustee.  
(10) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to latanoprost/timolol  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of the 
Netherlands  for latanoprost/timolol ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than th e Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;102 and  
(g) monies owed to the Parties by customers for the purchase of latanoprost/timolol , 
and monies owed by the Parties to suppliers for  materials used in the production of 
latanoprost/timolol . 
(11) 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) in the Divestment Business and necessary for the 
                                                 
102  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purc haser.   
 
80 
 continued viabili ty and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S ATORVASTATIN  PRODUCTS  
Territory: Norway  
(1) The Divestment Business consists of Mylan's rights, title  and interests in atorvastatin  in 
Norway  (currently marketed under the name atorvastatin Mylan ) including the right to 
develop, manufacture and use atorvastatin  with a view to its sale and marketing in any form 
in Norway . Atorvastatin is no longer under ex clusivity and  is used to prevent cardiovascular 
disease in adults and to treat hyperlipidemia.103 
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  atorvastatin in Norway . It includes in particular : 
(a) the sale of existing atorvastatin finished product inventory, sales and promotional 
material in Norway to the extent available;  
(b) all atorvastatin -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to atorvastatin  in Norway specifically will be 
provided;104  
(c) the transfer of the marketing authorization for atorvastatin  in Norway  including all 
relevant dossiers, as well as  the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectu al property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in Norway.  
The items referred t o under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".105 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively u sed in respect of, the 
manufacture, use and sale of atorvastatin  in Norway , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the  manufacture, use and sale of atorvastatin  in 
Norway . 
                                                 
103  Abnormally elevated levels of lipids or lipoproteins in the blood.  
104  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
105  For the avoidance of doubt, the Divestment Business is transferred subject to any  contractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
81 
 (4) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product  in 
Norway  for up to three years, which period may be extended by one year, and an additional 
year thereafter, upon request by the Purchaser and subject to the approval of the Monitoring 
Trustee on the basis that such extension is necessary for the Purchaser to continue 
commercializing the Di vestment Business.  Such transitory arrangement shall include 
appropriate provisions designed to ensure the continued supply by Mylan to the Purchaser. It 
shall not contain provisions requiring the delivery of minimum supply volumes or batches.  
(5) Mylan commit s to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan w ill 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(6) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necess ary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(7) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, cl inical data and studies or intellectual property 
relating to atorvastatin  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Norway  for 
atorvastatin ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;106 and  
(g) monies owed to the Parties by customers for the purchase of atorva statin , and 
monies owed by the Parties to suppliers for materials used in the production of 
atorvastatin . 
(8) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
*****  
                                                 
106  With the except ion of the sale of invent ory existing at Divestment Closing  and sold to the Purchaser.   
 
82 
 PRODUCT : MYLAN 'S ELETRIPTAN  PRODUCTS  
Territory: Norway  
(1) The Divestment Business consists of Mylan's rights, title and interests in eletriptan  in 
Norway  (currently marketed under the name Eletriptan Mylan ) including the right to 
develop, manufacture and use eletriptan  with a view to its sale and marketing in any form in 
Norway . Eletriptan is no longer under exclusivity and  is used for the acute treatment of the 
headache phase of migraine attacks, with or without aura.  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  eletriptan in Norway . It includes in particular : 
(a) the sale of existing eletriptan finished product inventory, sales and promotional 
material in Norway to the extent available;  
(b) all eletriptan -related contracts, commitments, and customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to eletriptan  in Norway specifically will be 
provided;107  
(c) the transfer of the marketing authorization for eletriptan  in Norway  including all 
relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to i ts sale in Norway.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".108 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predomin antly related to , and not exclusively used in respect of, the 
manufacture, use and sale of eletriptan  in Norway , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perp etual right to use such asset for the manufacture, use and sale of eletriptan  in 
Norway . 
(4) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product i n 
Norway  for up to three years, which period may be extended by one year, and an additional 
year thereafter, upon request by the Purchaser and subject to the approval of the Monitoring 
Trustee on the basis that such extension is necessary for the Purchaser  to continue 
commercializing the Divestment Business.  Such transitory arrangement shall include 
appropriate provisions designed to ensure the continued supply by Mylan to the Purchaser. It 
shall not contain provisions requiring the delivery of minimum supp ly volumes or batches.  
                                                 
107  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
108  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obl igations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
83 
 (5) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the do ssier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(6) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislat ion, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(7) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw material s; 
(c) any research and development, clinical data and studies or intellectual property 
relating to eletriptan  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Norway  for 
eletriptan ; 
(e) any other asset not part of th e Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;109 and  
(g) monies owed to the Parties by custo mers for the purchase of eletriptan , and monies 
owed by the Parties to suppliers for materials used in the production of eletriptan . 
(8) 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) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S PREGABALIN  PRODUCTS  
Territory: Norway  
(1) The Divestment Business consists of Mylan's right, title and interest in pregabalin in Norway 
including the right to develop, manufacture and use  pregabalin to sell in any form. 
Pregabalin is no longer under exclusivity and  is indicated and  primarily used for peripheral 
and central neuropathic pain, but is also used as an ‘add -on' to existing treatment in patients 
who have partial seizures that cannot be controlled with their current treatment .  
                                                 
109  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
84 
 (2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  pregabalin in Norway . It includes in particular : 
(a) access to Mylan’s dossier for pregabalin in order for the Purchaser to obtain its 
own marketing authorization for pregabalin;110 and 
(b) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in Norway, 
including in particular the information in the registration dossier.  
(3) The items referred to under (a) - (b) are hereinafter jointly referred to as " Assets of the 
Divestment Busines s".111 
(4) If and to the extent that the know -how listed in paragraph 2( e) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of pregabalin  in Norway , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of pregabalin  in 
Norway . 
(5) Pending the Purchaser applying for its own ma rketing authorizations for the Divestment 
Business, Mylan will appoint the Purchaser as the exclusive distributor of the Divestment 
Business for a period of up to two years and will, during this period, support the Purchaser 
in applying for its own marketi ng authorizations. During this two -year period, Mylan shall 
enter into a transitory non -exclusive manufacturing and/or supply agreement relating to the 
existing forms of the product in  Norway.  
(6) At the option of the Purchaser, Mylan shall enter into a transi tory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product in  
Norway  for an additional year after the two -year period noted above (i. e., up to three years 
in total) . This period may be extended by one year, and a n additional year thereafter, upon 
request by the Purchaser and subject to the approval of the Monitoring Trustee on the basis 
that such extension is necessary for the Purchaser to continue commercializing the 
Divestment Business.  Such transitory arrangeme nt shall include appropriate provisions 
designed to ensure the continued supply by Mylan to the Purchaser. It shall not contain 
provisions requiring the delivery of minimum supply volumes or batches.  
(7) Mylan commits to make its best efforts to cooperate with  the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain t he current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
                                                 
110  Mylan’s marketing authorization for pregabalin was obtained via the centralized procedure and therefore 
cannot be transferred only as it relates to one country to the Purchaser (see explanation in Form RM).  
111  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in favour of third parties,  
including those relating to the develop ment , manufacture, distribution, marketing and sale  of pregabalin in 
Norway . 
 
85 
 (8) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability  and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(9) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual prop erty 
relating to pregabalin after the sale of the Divestment Product to the Purchaser;  
(d) all marketing authorizations relating to pregabalin held by the Parties outside of 
Norway;  
(e) any other asset not part of the Divestment Business or which is used in relati on to a 
business of the Parties other than the Divestment Business; and  
(f) the "Mylan" name, Mylan trademark and Mylan trade dress or trade dress of any of 
its subsidiaries.  
(10) If there is any asset or personnel which is not covered by paragraph 2 of this Schedu le but 
which is both used (exclusively or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
PRODUCT : MYLAN'S ALPRAZOLAM  PRODUCTS  
Territory: Portugal  
(1) The Divestment Business consists of Mylan's rights, title and interests in alprazolam  in 
Portugal  (currently marketed under the name Alprazolam Mylan ) including the right to 
develop, manufacture and use alprazo lam with a view to its sale and marketing in any form 
in Portugal . Alprazolam is no longer under exclusivity and  is used to treat anxiety or panic 
disorders .  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for  the purposes of marketing  alprazolam in Portugal . It includes in particular : 
(a) the sale of existing alprazolam  finished product inventory, sales and promotional 
material in Portugal to the extent available;  
(b) all alprazolam -related contracts, commitments, and  customer records, meaning 
customer credit records, customer invoices, purchase orders and contact details, 
whilst only the information related to alprazolam in Portugal  specifically will be 
provided;112 
                                                 
112  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
 
86 
 (c) the transfer of the marketing authorization for alpraz olam  in Portugal  including all 
relevant dossiers, as well as the information contained in the relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Busi ness with a view to its sale in Portugal.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".113 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of alprazolam  in Portugal , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional cha rge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of alprazolam  in 
Portugal . 
(4) Mylan will transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding alprazolam modifi ed release tablets  in Portugal  with licensor and 
contract manufacturer […]  to the Purchaser in accordance with applicable law. Mylan 
commits to make its best efforts to facilitate the assignment to the Purchaser  of the license 
agreement it has in place con cerning the Divestment Business, subject to the consent of the 
third party. I n the event that consent for the assignment cannot be obtained, at the option of 
the Purchaser Mylan commits to offer a back -to-back arrangement for the supply of the 
product to t he Purchaser for the duration of the relevant third party contract and, in any case, 
for no longer than three years.  
(5) At the option of the Purchaser, and to the extent national legislation allows for it, Mylan will 
license the name “Alprazolam Mylan” to the  Purchaser for a period of two years (or more, 
should the Purchaser express an interest to that effect) . To the extent that this is not allowed 
by national legislation and at the option of the Purchaser, Mylan will appoint the Purchaser 
as the exclusive distributor of the Divestment Business for a period of up to two years (or 
more, should the Purchaser express an interest to that effect) . 
(6) Mylan commits to make its best efforts to support the Purchaser in communicating the 
upcoming name change to physicians  and pharmacists. Mylan will also support the 
Purchaser’s representations vis -a-vis physicians and pharmacies that the Purchaser’s product 
is identical to the product carrying the Mylan name  for a period of up to 2 years (or more, 
should the Purchaser expr ess an interest to that effect) .  
(7) In relation to the existing tender contracts,  Mylan will transfer all historical information 
(orders; price; etc.) concerning its relationship with the different […] Mylan has tender 
agreements in Portugal for alprazolam. Mylan commits to make its best efforts to support 
the Purchaser to obtain the […] consent  for the transfer the tender contract s. 
(8) Mylan commits to continue its participation in tenders for the Divestment Business up until 
Divestment Closing . If Mylan were t o win any tenders pertaining to alprazolam  before 
                                                 
113  For the avoidance of doubt, the Divestment Business is transferred subject to any c ontractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
87 
 Divestment Closing , Mylan commits to make its best efforts to facilitate the assignment of 
the relationship or the contract in line with the provisions contained in this Schedule 
concerning existing tender contracts.  
(9) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Dives tment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier trigge red by the transfer of the Divestment 
Business to the Purchaser.  
(10) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who wou ld be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(11) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any resea rch and development, clinical data and studies or intellectual property 
relating to alprazolam  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Portugal  for 
alprazolam ; 
(e) any other asset not part of the Divestme nt Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;114 and  
(g) monies owed to the Parties by customers for t he purchase of alprazolam , and 
monies owed by the Parties to suppliers for materials used in the production of 
alprazolam . 
(12) 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) i n the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S LATANOPROST /TIMOLOL  PRODUCTS  
Territory: Portugal  
(1) The Divestment Business consists of Mylan's rights, title and interests in latanoprost/timolol  
                                                 
114  With the except ion of the sale of inventor y existing at Divestment Closing  and sold to the Purchaser.   
 
88 
 in Portugal  (currently marketed under the name Latanoprost/timolol Mylan ) including the 
right to develop, manufacture and use latanoprost/timolo l with a view to its sale and 
marketing in any form in Portugal . Latanoprost/timolol is no longer under exclusivity and  is 
used to reduce inter ocular pressure in patients with various types of glaucoma and ocular 
hypertension . 
(2) The Divestment Business incl udes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  latanoprost/timolol in Portugal . It includes in particular : 
(a) the sale of existing latanoprost/timolol finished product inventory, sales and 
promotional material in Portugal to the extent available;  
(b) all latanoprost/timolol -related contracts, commitments, and customer records, 
meaning customer credit records, customer invoices, purchase orders and contact 
details, whilst only the information related to latanoprost/t imolol  in Portugal 
specifically will be provided;115 
(c) the transfer of the marketing authorization for latanoprost/timolol  in Portugal  
including all relevant dossiers, as well as the information contained in the relevant 
full registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfe r of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in Portugal.  
The items referred to under (a) - (d) are hereinafter collectively referred to as " Assets 
of the Div estment Business ".116 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of latanoprost/timolol  in Portu gal, Mylan shall have the right to 
retain the ownership of such asset and shall grant to the Purchaser at no additional charge an 
exclusive and perpetual right to use such asset for the manufacture, use and sale of 
latanoprost/timolol  in Portugal . 
(4) Mylan wi ll transfer all historical information (orders, price, etc.) concerning its relationship, 
if applicable, regarding latanoprost/timolol  in Portugal  with licensor and supplier […] to the 
Purchaser in accordance with applicable law. Mylan commits to make its best efforts to 
facilitate the assignment to the Purchaser  of the license and supply agreement it has in place 
concerning the Divestment Business, subject to the consent of the third party. I n the event 
that consent for the assignment cannot be obtained, a t the option of the Purchaser Mylan 
commits to offer a back -to-back arrangement for the supply of the product to the Purchaser 
for the duration of the relevant third party contract and, in any case, for no longer than three 
years..  
(5) In relation to the exist ing tender contracts,  Mylan will transfer all historical information 
(orders; price; etc.) concerning its relationship with the […]. Mylan commits to make its best 
                                                 
115  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
116  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual oblig ations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
89 
 efforts to support the Purchaser to obtain the […] consent  for the transfer the tender 
contr acts. 
(6) Mylan commits to continue its participation in tenders for the Divestment Business up until 
Divestment Closing . If Mylan were to win any tenders pertaining to latanoprost/timolol  
before Divestment Closing , Mylan commits to make its best efforts to fa cilitate the 
assignment of the relationship or the contract in line with the provisions contained in this 
Schedule concerning existing tender contracts.  
(7) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of th e Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(8) The Purchaser will be given an option (to be exer cised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Busines s to be supervised by the Monitoring Trustee.  
(9) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to latanoprost/timolol  after Dive stment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Portugal  for 
latanoprost/timolol ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;117 and  
(g) monies owed to the Parties by customers for the purchase of latanoprost/timolol , 
and monies owed by the Parties to suppliers for materials us ed in the production of 
latanoprost/timolol . 
(10) 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) in the Divestment Business and necessary for the 
continued viability and compet itiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
                                                 
117  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
90 
 PRODUCT : MYLAN 'S SILDENAFIL (PAH)  PRODUCTS  
Territory: Romania  
(1) The Divestment Business consists of Mylan's rights, title and int erests in sildenafil  in 
Romania  (currently marketed under the name Mysildecard ) including the right to develop, 
manufacture and use sildenafil (PAH)  with a view to its sale and marketing in any form in 
Romania, only for the pulmonary arterial hypertension (PAH ) indication . Sildenafil (PAH) 
is no longer under exclusivity.  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  sildenafil (PAH) in Romania . It includes in particular : 
(a) the sale of existing sildenafil (PAH)  finished product inventory, sales and 
promotional material in Romania to the extent available;  
(b) all sildenafil (PAH) -related contracts, commitments, and customer records, 
meaning customer credit records, customer invoices, purch ase orders and contact 
details, whilst only the information related to sildenafil (PAH) in Romania  
specifically will be provided;118 
(c) access to Mylan’s dossier for sildenafil (PAH) in order for the Purchaser to obtain 
its own marketing authorization for silde nafil (PAH);119 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the dev elopment, 
manufacture, use of the Divestment Business with a view to its sale in Romania ; 
and 
(e) Full transfer of the national trademark related to sildenafil (PAH) in Romania  or, 
in case of a wider than national specific sildenafil (PAH) trademark, an 
irrevo cable, assignable, sub -licensable, perpetual and royalty free license to use the 
trademark for the Divestment Business.  
(f) The items referred to under (a) - (e) are hereinafter collectively referred to as " Assets of the 
Divestment Business ".120 
(3) If and to the ex tent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of sildenafil (PAH)  in Romania , Mylan shall have the right to 
retain the ownership of such asset and shall grant to the Purchaser at no additional charge an 
exclusive and perpetual right to use such asset for the manufacture, use and sale of sildenafil 
(PAH)  in Romania . 
                                                 
118  Mylan will include all customer lists and records since 2014 in the Divestment Business.  
119  Mylan’s marketing authorization for sildenafil (PAH) was obtained via the centralized procedure and 
therefore canno t be transferred only as it relates to one country to the Purchaser (see explanation in the 
Form RM).  
120  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations 
(including any confidentiality obligations) or restrictions applicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
91 
 (4) Pending the Purchaser applying for its own marketing  authorizations for the Divestment 
Business, Mylan will appoint the Purchaser as the exclusive distributor of the Divestment 
Business for a period of up to two years and will, during this period, support the Purchaser 
in applying for its own marketing auth orizations. During this two -year period, Mylan shall 
enter into a transitory non -exclusive manufacturing and/or supply agreement relating to the 
existing forms of the product in Romania . 
(5) At the option of the Purchaser, Mylan shall enter into a transitory n on-exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product in 
Romania  for an additional year after the two -year period noted above (i.e., up to three years 
in total) . This period may be extended by one year, and an add itional year thereafter, upon 
request by the Purchaser and subject to the approval of the Monitoring Trustee on the basis 
that such extension is necessary for the Purchaser to continue commercializing the 
Divestment Business . Such transitory arrangement sh all include appropriate provisions 
designed to ensure the continued supply by Mylan to the Purchaser. It shall not contain 
provisions requiring the delivery of minimum supply volumes or batches.  
(6) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the cu rrent registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(7) The Pur chaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(8) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual property 
relating to sildenafil (PAH)  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties  for sildenafil (PAH) ; 
(e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than  the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;121 and  
(g) monies owed to the Parties by customers for the purchase of sildenafil (PAH) , and 
monies owed by the Parties to suppliers for  materials used in the production of 
sildenafil (PAH) . 
(9) If there is any asset or personnel which is not covered by paragraph 2 of this Schedule but 
                                                 
121  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
92 
 which is both used (exclusively or not) in the Divestment Business and necessary for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
PRODUCT : MYLAN 'S ELETRIPTAN  PRODUCTS  
Territory: Sweden  
(1) The Divestment Business consists of Mylan's rights, title and interests in eletriptan  in 
Sweden  (currently marketed under the name Eletriptan Mylan ) including the right to 
develop, manufacture and use eletriptan  with a view to its sale and marketing in any form in 
Sweden . Eletriptan is no longer under exclusivity and  is used for the acute treatment of the 
headache phase of migraine attacks, with or without aura.  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  eletriptan in Sweden . It includes in particular : 
(a) the sale of existing eletriptan finished product inventory, sales and promotional 
material in Sweden to the extent available;  
(b) all eletriptan -related contracts, commitments, and customer records, meaning 
customer credit records, customer invo ices, purchase orders and contact details, 
whilst only the information related to eletriptan  in Sweden specifically will be 
provided;122 
(c) the transfer of the marketing authorization for eletriptan  in Sweden  including all 
relevant dossiers, as well as the info rmation contained in the relevant full 
registration dossier(s), relating to the current and/or pending marketing 
authorizations available to Mylan;  and 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual proper ty rights , data books, records and effective arrangements for the 
transfer of all know -how to the extent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in Sweden.  
The items referred to under ( a) - (d) are hereinafter collectively referred to as " Assets 
of the Divestment Business ".123 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in re spect of, the 
manufacture, use and sale of eletriptan  in Sweden , Mylan shall have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufactur e, use and sale of eletriptan  in 
Sweden . 
                                                 
122  Myla n will include all customer lists and records since 2014 in the Divestment Business.  
123  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions a pplicable thereto in favor of third parties, 
including those as to development, manufacture, distribution, marketing and sale . 
 
93 
 (4) At the option of the Purchaser, Mylan shall enter into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product in  
Sweden  for up to three years, which period may  be extended by one year, and an additional 
year thereafter, upon request by the Purchaser and subject to the approval of the Monitoring 
Trustee on the basis that such extension is necessary for the Purchaser to continue 
commercializing the Divestment Busi ness. Such transitory arrangement shall include 
appropriate provisions designed to ensure the continued supply by Mylan to the Purchaser. It 
shall not contain provisions requiring the delivery of minimum supply volumes or batches.  
(5) Mylan commits to make its  best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain the current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestmen t 
Business to the Purchaser.  
(6) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to mainta in the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(7) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data a nd studies or intellectual property 
relating to eletriptan  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties outside of Sweden  for 
eletriptan ; 
(e) any other asset not part of the Divestment Business or which is used in relati on to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;124 and  
(g) monies owed to the Parties by customers for the purchase of eletriptan , and monies 
owed by the Parties to suppliers for materials used in the production of eletriptan . 
(8) 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) in the Divestment Business and necessar y for the 
continued viability and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
                                                 
124  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.   
 
94 
 PRODUCT : MYLAN 'S SILDENAFIL (PAH)  PRODUCTS  
Territory: United Kingdom  
(1) The Divestment Bus iness consists of Mylan's rights, title and interests in sildenafil  in the UK  
(currently marketed under the name Mysildecard ) including the right to develop, 
manufacture and use sildenafil (PAH)  with a view to its sale and marketing in any form in 
the UK, only for the pulmonary arterial hypertension ( PAH ) indication . Sildenafil (PAH) is 
no longer under exclusivity.  
(2) The Divestment Business includes the transfer of all assets predominantly or exclusively 
used for the purposes of marketing  sildenafil (PAH) in the UK . It includes in particular : 
(a) the sale of existing sildenafil (PAH)  finished product inventory, sales and 
promotional material in UK to the extent available;  
(b) all sildenafil (PAH) -related contracts, commitments, and customer records, 
meaning customer c redit records, customer invoices, purchase orders and contact 
details, whilst only the information related to sildenafil (PAH) in the UK  
specifically will be provided;125 
(c) access to Mylan’s dossier for sildenafil (PAH) in order for the Purchaser to obtain 
its own marketing authorization for sildenafil (PAH);126 
(d) an irrevocable, assignable, sub -licensable and royalty -free license for all relevant 
intellectual property rights , data books, records and effective arrangements for the 
transfer of all know -how to the ex tent that these are related to the development, 
manufacture, use of the Divestment Business with a view to its sale in UK; and  
(e) Full transfer of the national trademark related to sildenafil (PAH) in the UK  or, in 
case of a wider than national specific silde nafil (PAH) trademark, an irrevocable, 
assignable, sub -licensable, perpetual and royalty free license to use the trademark 
for the Divestment Business.  
(f) The items referred to under (a) - (e) are hereinafter collectively referred to as " Assets of the 
Divestm ent Business ".127 
(3) If and to the extent that the know -how listed in paragraph 2(d) above of this Schedule is not 
exclusively or predominantly related to , and not exclusively used in respect of, the 
manufacture, use and sale of sildenafil (PAH)  in UK, Mylan sh all have the right to retain the 
ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive 
and perpetual right to use such asset for the manufacture, use and sale of sildenafil (PAH)  in 
UK. 
(4) Pending the Purchaser applying  for its own marketing authorizations for the Divestment 
Business, Mylan will appoint the Purchaser as the exclusive distributor of the Divestment 
                                                 
125  Mylan will include a ll customer lists and records since 2014 in the Divestment Business.  
126  Mylan’s marketing authorization for sildenafil (PAH) was obtained via the centralized procedure and 
therefore cannot be transferred only as it relates to one country to the Purchaser (see explanation in the 
Form RM).  
127  For the avoidance of doubt, the Divestment Business is transferred subject to any contractual obligations  
(including any confidentiality obligations)  or restrictions applicable thereto in favor of third parties, 
includi ng those as to development, manufacture, distribution, marketing and sale . 
 
95 
 Business for a period of up to two years and will, during this period, support the Purchaser 
in applying for its own marketing authorizations. During this two -year period, Mylan shall 
enter into a transitory non -exclusive manufacturing and/or supply agreement relating to the 
existing forms of the product in the UK . 
(5) At the option of the Purchaser, Mylan shall ente r into a transitory non -exclusive 
manufacturing and/or supply agreement relating to the existing forms of the product in the 
UK for an additional year after the two -year period noted above (i.e., up to three years in 
total) . This period may be extended by one year, and an additional year thereafter, upon 
request by the Purchaser and subject to the approval of the Monitoring Trustee on the basis 
that such extension is necessary for the Purchaser to continue commercializing the 
Divestment Business . Such trans itory arrangement shall include appropriate provisions 
designed to ensure the continued supply by Mylan to the Purchaser. It shall not contain 
provisions requiring the delivery of mi nimum supply volumes or batches .  
(6) The Parties  also undertake to ensure tha t the applicable supply conditions described in the 
preceding two paragraphs will enable the Divestment Business to remain competitive 
irrespective of any adverse conditions resulting from the consequences of the exit of the 
United Kingdom from the Europea n Union.  
(7) Mylan will transfer all historical information (orders; price; etc.) conc erning its relationship 
with […] regarding the  regional  tender contract s for sildenafil (PAH)  in the UK . Mylan 
commits to make its best efforts to sup port the Purchaser to ob tain […] consent for the 
transfer the tender contract.  
(8) Mylan commits to continue its participation in tenders for the Divestment Business up until 
Divestment Closing . If Mylan were to win any tenders pertaining to sildenafil (PAH)  before 
Divestment Closing , Mylan commits to make its best efforts to facilitate the assignment of 
the relationship or the contract in line with the provisions contained in this Schedule 
concerning existing tender contracts.  
(9) Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the 
transfer of the Divestment Business and to undertake all regulatory changes that would be 
required as a result of such transfer. Until transfer of the Divestment Business, Mylan will 
bear the costs for updates to maintain th e current registration of the dossier of the 
Divestment Business.  In addition, Mylan will bear the dossier preparation and regulatory 
filing costs for all the updates of the dossier triggered by the transfer of the Divestment 
Business to the Purchaser.  
(10) The Purchaser will be given an option (to be exercised within one year after the Divestment 
Closing)  to hire one or more Personnel, subject to applicable local employment legislation, 
who would be  considered necessary to maintain the viability, marketability and 
competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.  
(11) The Divestment Business shall not include:  
(a) any manufacturing facility;  
(b) raw materials;  
(c) any research and development, clinical data and studies or intellectual prope rty 
relating to sildenafil (PAH)  after Divestment Closing ; 
(d) all marketing authorizations currently held by the Parties  for sildenafil (PAH) ; 
 
96 
 (e) any other asset not part of the Divestment Business or which is used in relation to a 
business of the Parties other than the Divestment Business;  
(f) the “Mylan” name, Mylan trademark and Mylan trade dress or trade dress of any 
of its subsidiaries ;128 and  
(g) monies owed to the Parties by customers for the purchase of sildenafil (PAH) , and 
monies owed by the Parties to suppliers  for materials used in the production of 
sildenafil (PAH) . 
(12) 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) in the Divestment Business and necessary for the 
continued viabil ity and competitiveness of the Divestment Business, that asset or personnel 
or adequate substitute will be offered to the Purchaser.  
* * * * *  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
128  With the except ion of the sale of inventory existing at Divestment Closing  and sold to the Purchaser.