IEHC 467 — IEHC 467 — High Court

THE HIGH COURT

COMMERCIAL

[2026] IEHC 467

2026 No. 1317 P

(2026 No. 26 COM)

BETWEEN

PIRAMAL CRITICAL CARE B.V.

PLAINTIFF

AND

BREPCO BIOPHARMA LIMITED

DEFENDANT

JUDGMENT of Ms. Justice Eileen Roberts delivered 14 July 2026

Introduction

1. This judgment relates to an application by the plaintiff (“Piramal”) for interlocutory

injunctive relief seeking to restrain the defendant (“Brepco”) from implementing or giving

effect to two separate termination notices served by Brepco. The termination notices

purported to terminate (with different effect) the commercial arrangements between the 2

parties for the commercialisation of the drug Neoatricon® (also described in this judgment

as the “Product”) in the EU, Norway and the United Kingdom. Piramal also seeks to

restrain Brepco from appointing any replacement commercialisation party pending the

determination of these proceedings.

2. The first termination notice in respect of which injunctive relief is sought is dated 4 March

2026 (the “March Notice”). It purported to terminate the commercial arrangements

between Piramal and Brepco, comprising the Licence Agreement dated 7 October 2022 (as

amended) (the “Licence Agreement”) and the Manufacture and Supply Agreement dated

24 July 2023 (the “Supply Agreement”) in respect of the 25 countries defined in the

March Notice as the "Terminated Countries"1 with effect from 13 March 2026. While the

March Notice was a single document, it terminated each licence for each country

individually.

3. The March Notice was served in reliance on clause 14.2 of the Licence Agreement which

will be considered in further detail in this judgment. In basic terms however clause 14.2

permits Brepco to terminate the commercial arrangements on a country-by-country basis in

the event that Piramal does not launch the Product in the applicable country or countries by

specified time periods which run from the date of the granting of the relevant Licensed

Territory Marketing Authorisation. There are limited exceptions to this termination

provision, as will be discussed.

4. On 12 March 2026, being the day before the expiry of the notice period specified in the

March Notice, Piramal issued these proceedings and applied for ex parte injunctive relief

which was granted by Cregan J. in the terms sought and on the basis of the usual

undertaking as to damages being furnished. From that time Brepco was unable to enforce

1 Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia and Spain. 3

the March Notice. However, the commercial relationship between the parties remained in

place for the UK, Germany and Italy where Piramal had launched the Product within the

relevant contracted time periods. Those 3 jurisdictions were not included in the Terminated

Countries specified in the March Notice.

5. On 7 April 2026 Brepco served the second termination notice (the “April Notice”),

without prejudice to the validity of the March Notice. The April Notice purported to

terminate the commercial relationship with effect from 27 May 2026 for all the 29

countries covered by the Licence Agreement. Accordingly, the April Notice applies not

only to the 25 Terminated Countries (and Sweden which had been terminated previously

but is not the subject of challenge in this injunction application)2 but also for Germany, the

UK and Italy. The stated basis of termination was different – being a termination under

clause 14.7.2 of the Licence Agreement permitting termination on 30 days’ notice by

either party if the other party “becomes insolvent”. This provision will also be considered

in some detail in this judgment.

6. On 28 April 2026 these proceedings were transferred to the Commercial List and Piramal

was permitted to amend its proceedings (and injunction application) to include the April

Notice. The interlocutory application was heard by this court over 2 days on 16 and 17

June 2026.

7. In addition to the usual arguments regarding the appropriateness of interlocutory relief,

there is an argument advanced by Brepco that the interim relief was obtained in

circumstances amounting to material non-disclosure and that the interlocutory relief should

also be refused on that basis alone.

2 On 18 June 2025, Brepco served a termination notice purporting to terminate Piramal’s rights in respect of Sweden with effect from 1 July 2025 (the "Swedish Termination Notice"). Piramal disputes the validity of the Swedish Termination Notice in these proceedings but it does not form part of the interlocutory relief sought in the present application. 4

The Parties and Key Background

8. Piramal is a limited company incorporated under the laws of the Netherlands. It carries on

business as a pharmaceutical enterprise engaged, among other things, in the

commercialisation, marketing, distribution and sale of pharmaceutical and healthcare

products. It is a subsidiary of Piramal Pharma Limited, a company which according to its

latest financial accounts has over 8,500 employees, a total income of approximately €850

million and a business which includes hundreds of newly launched pharmaceutical

products as well as established products. Piramal Pharma Limited is one part of the

Piramal Group, an Indian industrial conglomerate based in Mumbai with operations in

over 30 countries and a brand presence in more than 100 markets. I am advised that the

Piramal Group has a valuation of over US$10 billion.

9. Brepco is a small private limited company, incorporated in Ireland. It is engaged in the

development of pharmaceutical products but its business is focused on the production and

sale of a single product – Neoatricon®. Following a period of 15 years research and

clinical trials, Brepco developed Neoatricon® which is a pre-diluted and ready to use

paediatric formulation of Dopamine Hydrochloride used for the treatment of hypotension

in seriously ill neonates, infants and older children up to 18 years of age.

10. Brepco received EU marketing authorisation for the Product on 27 May 2024 – this is the

most relevant date for present purposes. A product licence for the UK was obtained in

February 2025 and for Norway in May 2025.

11. Under the EU marketing licence the European Medicines Agency (“EMA”) will not

accept any application for an identical product within 8 years from approval and will not

approve an identical product for at least two additional years. Therefore Brepco has a 10-

year exclusivity window within which to commercialise the Product in the EU. After May 5

2034 it will be possible for competitors to obtain a licence to sell a generic version of the

Product in the EU.3

12. Brepco did not itself have the ability to commercialise the Product it developed and

accordingly it contracted with Piramal as a suitable experienced entity to achieve

commercialisation across the EU within a short period of the Product being authorised.

The Licence Agreement

13. On 7 October 2022, (in advance of EMA approval), Piramal and Brepco entered into the

Licence Agreement which granted Piramal an exclusive, sub-licensable, royalty bearing

licence to the Brepco intellectual property rights, marketing authorisations and related

materials in respect of the Product. Piramal was granted exclusive rights in respect of the

commercialisation, marketing, storage, distribution and sale of the Product in the European

Union, Norway and the United Kingdom (the “Licensed Territory”), comprising a total

of 29 countries. The Licence Agreement also refers to Piramal’s rights in relation to the

Product in South Africa but such rights are different in a number of material respects and

are not encompassed in this application. Regardless of the outcome of this application, the

parties will continue to deal with each other in relation to the commercialisation of the

Product in South Africa.

14. Piramal is required by the Licence Agreement to make certain payments to Brepco

including various fixed payments linked to the achievement of certain milestones, profit

share payments on a country by country basis (on a sliding scale changing with time) and a

consulting fee. To date, €4.2 million has been paid by Piramal to Brepco. The profit share

payments start with 80% in favour of Piramal for the first 2 years following the First

Commercial Sale of the Product in each applicable country, reducing to 70% for the next 2

3 Because Norway is part of the European Economic Area (EEA), its pharmaceutical regulatory framework is harmonised with EU legislation 6

years and then 60% after 4 years. Piramal is also entitled to retain a Marketing Fee as

defined. The Licence Agreement therefore envisages that both parties will share in the

profits generated by the sale of the Product in each country – but Piramal retains the

greater level of profits on sales within each country, particularly in the early years.

15. The Licence Agreement is subject to Irish law and jurisdiction and contains an entire

agreement clause. Clause 17.10 provides that: “No variation or amendment of this

Agreement will be effective unless it is made in writing and signed by each Party’s

authorised representative”. No such amendment was ever prepared.

16. The Licence Agreement remains in effect on a country-by-country basis from 7 October

2022 until the tenth anniversary date of the First Commercial Sale4 of the Product in each

country of the Licensed Territory (clause 14.1). Thereafter the Licence Agreement shall be

renewed automatically on a country-by-country basis for 5 years unless notice is given by

either party not less than two years in advance of the expiry of the applicable five year

period. It is worth noting that the Term of the Licence Agreement is therefore longer than

the exclusivity period available to Brepco on foot of the EMA authorisation.

17. Clause 6.1 of the Licence Agreement provides that each party shall perform their

respective obligations in a commercially reasonable, diligent, timely and collaborative

manner and in compliance with all Applicable Laws.

18. Clause 9.3 required Piramal to use “Commercially Reasonable Efforts” to launch the

Product in the Licensed Territories within a commercially reasonable time after the

relevant market authorisation had been granted and, in any event, “not later than” 12

months following the granting of the Licensed Territory Marketing Authorisation in

Germany, the Netherlands and Sweden, and 18 months following the granting of the

4 Defined to mean “the first sale of the Product following the granting of a Licensed Territory Marketing Authorisation in a country or countries of the Licensed Territory by [Piramal], its Affiliates or Distributors to a Third Party...” and excludes unsolicited requests under named patient programmes under clause 6.2. 7

Licensed Territory Marketing Authorisation in each other country of the Licensed

Territory.

19. Various termination provisions (some available to both parties) are included in the Licence

Agreement including a right to terminate for an uncured material breach, for failure to

make certain payments or on the grounds of insolvency. A specific right of termination of

particular relevance to the March Notice is the right of Brepco to terminate under clause

14.2 where the Product is not launched in a particular country within the launch period

specified.

20. Clause 14.2 of the Licence Agreement provides in material part as follows:

“Brepco shall have the right to terminate this Agreement on notice in writing to [Piramal]

on a country-by-country basis with respect to the applicable country or countries of the

Licensed Territory in the event that [Piramal] does not launch the Product within (i)

twelve (12) months following the granting of the Licensed Territory Marketing

Authorisation in Germany, the Netherlands and Sweden, and (ii) eighteen (18) months

following the granting of the Licensed Territory Marketing Authorisation in each other

country of the Licensed Territory, provided that the termination rights as set out under

above (sic) shall not apply if the cause of [Piramal’s] failure to comply with the foregoing

provisions is solely due to a failure by Brepco to supply Product pursuant to the provisions

of the Supply Agreement or as a result of Force Majeure.”

21. Clause 14.2 makes no mention of “Commercially Reasonable Efforts”.

22. The Licensed Territory Marketing Authorisation for the EU countries issued on 27 May

2024. Accordingly, the relevant 12 month period (for Germany, the Netherlands and

Sweden) expired on 27 May 2025 and the 18 month period (for all other countries in the

Licensed Territory) expired on 27 November 2025. 8

23. Unsurprisingly, the Licence Agreement contains many provisions regarding how the

parties will engage on matters such as pharmacovigilance, medical affairs, safety and

recalls. The Licence Agreement also provides for the establishment of a joint steering

committee to deal with development, manufacturing and regulatory concerns as well as

sales, marketing and distribution issues.

The Supply Agreement

24. The Licence Agreement contemplated (at clause 8) that Brepco would be responsible for

the manufacture and exclusive supply of the Product to Piramal and that Piramal would

exclusively purchase its requirements of the Product from Brepco.

25. On 24 July 2023, the parties entered into the Supply Agreement under which (at clause

3.1) Brepco agreed to supply the Product to Piramal on an exclusive basis for the Licensed

Territory and South Africa and Piramal agreed to take supplies of the Product on an

exclusive basis, subject to the terms of the Supply Agreement.

26. Under the Supply Agreement, Piramal is required to provide Brepco with a forecast of its

anticipated orders of the Product and to provide purchase orders at least three months

before the delivery date. Brepco is obliged to make the Product available by specified

delivery dates (clause 3.11), to provide certificates of analysis confirming compliance with

product specifications (clause 4.7), and to ensure that product batches have sufficient

remaining shelf life when delivered (clause 4.8).

27. The Supply Agreement also expressly records that the Product is supplied to Brepco by

Maiva Pharma Pvt Limited (“Maiva”), a company incorporated in India, pursuant to a

separate agreement between Brepco and Maiva dated 20 September 2019.

Arguments in relation to the March Notice 9

28. It is common case that Piramal did not launch, (and indeed has not to date launched), the

Product in the Licensed Territories within the relevant time periods specified, save for

Germany, the UK and Italy. In simple terms relevant to this application, Piramal did not

meet the contractually agreed timescales as it failed to launch the Product by 27 May 2025

in the Netherlands, and failed to launch the Product by 27 November 2025 in the other 24

Terminated Countries.

29. Brepco says that Piramal’s performance has been disastrous. Rather than launching in 29

countries within 18 months of authorisation, they say that Piramal has launched in only 3

countries and in most countries (at least 23 out of 29), Piramal has taken either no steps, or

minimal steps, to prepare for launch and has provided no sales forecasts nor placed any

orders for the Product. Save in relation to Spain and the Netherlands, Piramal does not say

when, if ever, it intends to launch in any of the other Terminated Countries. Even where

the Product has been launched (Germany, the UK and Italy), Piramal’s sales have, Brepco

says, been dismal.

30. This fact, Brepco argues, clearly entitled it to serve the March Notice in circumstances

where the cause of such a failure was not related at all, let alone “solely” due, to a failure

by Brepco to supply the Product to Piramal. Brepco says the termination language is

unambiguous – and was so negotiated for very good reason mindful of the limited period

available to it to assert exclusivity over the Product. It is not sufficient under clause 14.2

that Brepco’s failure to supply the Product has been one of several causes of the failure to

launch in time; it must be the “sole” cause. The second exception to an entitlement to

terminate under clause 14.2 is where the failure to launch is “as a result of Force

Majeure”.5 Brepco says that Piramal does not, in affidavits or submissions, rely on Force

5 Force Majeure is defined in relatively broad terms in clause 16 of the Licence Agreement by reference to circumstances beyond the reasonable control of a party for any reason, including specified circumstances set out.. 10

Majeure, although it is pleaded in bald terms. No particulars of Force Majeure have been

outlined and no Force Majeure notice was ever served as is envisaged by the terms of

clause 16 of the Licence Agreement.

31. Piramal argues that the failure to supply Product pursuant to the provisions of the Supply

Agreement must mean not just “supply” simpliciter but rather the failure to supply product

that meets the quality and other standards specified in the Supply Agreement. The court

agrees that that appears to be a reasonable interpretation, but it does not avail Piramal

where there has in fact been no orders placed for any Product.

32. While admitting that the time periods in the Licence Agreement have not been met for 26

of the 29 Licensed Territories, Piramal argues that they agreed a different

commercialisation strategy with Brepco which Brepco is now estopped from denying. That

strategy, they say, was a phased EU launch strategy under which the largest markets,

namely Germany, the UK, Italy, Spain and France (the "EU5"), were prioritised before

expansion into smaller markets. Piramal says this strategy was both commercially rational

and consistent with standard industry practice. It allowed Piramal to focus its resources

initially on the largest and most established pharmaceutical markets, where the potential

for uptake and return was greatest. It also avoided any possible adverse impact of a

premature launch in a smaller jurisdiction at a low or non-reimbursed price which would

have adverse consequences for pricing across Europe or a launch which might result in the

Product being inappropriately benchmarked against generic dopamine.

33. The phased approach was also, Piramal says, necessitated by product availability

constraints. Sven Toms in his affidavit sworn 24 April 2026 (at para. 15 ) avers that “… as

a matter of practical reality, the Plaintiff simply did not have stable, saleable supply

sufficient to support concurrent launches across multiple jurisdictions. In those

circumstances, prioritising Germany, Italy and the UK – where regulatory and pricing 11

work was furthest advanced and where supply would have the greatest impact – was

operationally unavoidable and commercially rational.”

34. Whatever may have been the rationale, it is clear from the affidavit of Sven Toms sworn

24 April 2026 (at para. 19) that Piramal “… intentionally sequenced execution until EU5

pricing was stabilised, supply was reliable, and reference-pricing risk had been

mitigated.”

35. Piramal argue that a necessary consequence of the phased strategy was a knock-on effect

on the timing of launch and commercialisation in later sequenced markets. That may be

correct but the real question at issue is whether the phased strategy of itself made it clear or

inevitable that the later sequenced countries would be launched not only after the EU5 but

also outside the contractually agreed timescales.

36. Piramal say that delays within Brepco’s sphere of responsibility affecting supply, release,

documentation, shelf life or product availability in the earlier-priority markets were liable

to have downstream effects on the timing of launch and commercialisation of later-priority

markets. This is however a very generalised statement and does not sit easily with the

express wording of clause 14.2 which limits the exceptions to Brepco’s right to terminate

for late launch to the two specific scenarios previously outlined.

37. In response, Brepco admits that Piramal communicated an intention to launch in “phases”.

Paul Breen says at para. 16 of his second affidavit sworn 11 May 2026 that “any phased or

sequenced approach to launch was unobjectionable in principle, but only provided that

[Piramal] complied with the timeframes set out in relation to all territories.”

38. Paul Breen avers at paras. 17 and 19 of that affidavit that: “It is not the case, however, that

[Piramal] ever communicated – still less that [Brepco] agreed – that a launch in the five

largest territories would be a pre-condition to a launch in every other territory, or that for

so long as [Piramal] had failed to launch in one of the EU5 territories, [Piramal] would 12

be entitled to choose to delay launch in the 23 other territories for years beyond the

contractually agreed timeframes…. That is something [Brepco] would never have

countenanced. It would have been completely inconsistent with the Licence Agreement”,

and at para. 19 that: “It would have been a completely different thing for [Piramal] to have

told [Brepco] that 'our plan is to launch most quickly in Germany, the UK, France, Italy

and Spain – but if we are delayed in any of those 5 countries, that will delay the launch in

the other 24 countries beyond the contractually agreed timeframes'. That was never said

and it would never have been agreed.”

39. Brepco’s position therefore is that it was not made aware of any plan to defer the launch in

24 countries until the Product was established in the EU5 countries, and beyond the

timeframes expressly set out in the Licence Agreement. Brepco denies that it ever agreed

to or acquiesced in any delays in launching beyond the contractual timeframes. Brepco has

exhibited documentary evidence showing that since March 2025 Brepco repeatedly

expressed serious concern in writing about prospective and actual delays in launching

across the EU within the agreed timeframes. Brepco reiterated its right to terminate if

launch dates were not met, and it actually exercised its clause 14.2 rights for Sweden in

June 2025. I am not satisfied on the basis of the affidavit evidence that Piramal has in fact

yet identified with precision the representation they allege Brepco accepted which,

according to Piramal, has the effect of amending the terms of the Licence Agreement and

the Supply Agreement insofar as launch time limits are concerned.

Arguments in relation to the April Notice

40. The April Notice was served pursuant to clause 14.7.2 of the Licence Agreement which

provides as follows:

“Either Party may terminate this Agreement by giving at least thirty (30) Business Days'

prior written notice to the other Party if: […] 13

a Party becomes insolvent, or if an interim order is applied for or made, or a voluntary

arrangement approved, or a voluntary arrangement is proposed or approved or an

administration order is made, or a receiver or administrative receiver is appointed of any

of a Party's assets or undertaking or a winding-up resolution or petition is passed or

presented (otherwise than for the purposes of reconstruction or amalgamation), or if any

circumstances arise which entitle the court or a creditor to appoint a receiver,

administrative receiver or administrator or to present a winding-up petition or make a

winding-up order, or other similar or equivalent action is taken against or by a Party by

reason of its insolvency or in consequence of debt, or if a Party makes any arrangement

with its creditors.”

41. Relying on the disjunctive nature of the various circumstances prescribed by this clause,

Brepco says, and I agree, that it is sufficient if any one of the envisaged circumstances is

found to arise. There are no “formal” insolvency petitions or applications in place against

Piramal and therefore the particular circumstance relied on by Brepco to ground the April

Notice is the first one, namely that Piramal has “become insolvent”.

42. Piramal strongly denies that it is insolvent and says it was and remains solvent. It argues

that the April Notice is nothing more than a contrived attempt to bolster Brepco’s position

in these proceedings and to find a way to terminate Piramal’s rights in those 3 jurisdictions

where it launched the Product within the contemplated contracted period. Piramal note that

the April Notice was not foreshadowed by any correspondence expressing concern about

Piramal’s solvency.

43. Furthermore Piramal says that the wording of this provision “becomes insolvent” is

self-evidently future-facing or future-looking and it envisages a situation where, following

the entry into the agreement, one party becomes insolvent. Breco accepts the clause is 14

forward looking but disagrees that the state of insolvency must arise between the date of

the execution of the contract and the date on which the insolvency was raised.

44. Brepco says that Piramal has a €24 million balance sheet deficit; massive ongoing losses

(€6 million in 2025); and €13 million in liabilities falling due this year with no apparent

resources to repay them. Brepco argues that Piramal has provided no evidence of any legal

right to continued financial support from group entities and that Piramal’s insolvency is

evidenced by its failure or delay in paying Brepco what it is owed.

45. There is a dispute as to whether certain milestone payments have become payable and of

course that dispute cannot be resolved in this interlocutory application. I would not

however treat a party as necessarily insolvent simply because it delayed or failed to make

certain disputed payments.

46. It is accepted that Piramal has a balance sheet deficit. However, as confirmed by Mr

Toms, Piramal’s liabilities are long-term intercompany loans which do not fall due for

repayment until 2030 and are renewable. The Piramal audited and filed financial

statements for the year ending 31 December 2024 note that the parent company, Piramal

Pharma, will continue to make available such funds as Piramal requires to continue on a

going-concern basis. The auditors have audited Piramal on a going-concern basis and

thereby made an independent assessment that Piramal has sufficient funds to meet its

liabilities as they fall due.6 Furthermore there is nothing to suggest that Piramal has

“become” insolvent since it executed the Licence Agreement (noting the wording in clause

14.7.2). On the contrary, the financial statements show that Piramal had a balance sheet

6 This is so for the 2024 audited accounts. Furthermore the Piramal Annual Report 2025 referring to the financial statements as at 31 December 2025 note that: “The directors have made an assessment and confirm that the Company will have sufficient funds, either through its operations, financing facilities available to it or funding from its ultimate parent company, Piramal Pharma Limited, to meet its liabilities as they fall due for that period…. Piramal Pharma Limited has confirmed to continue to make available such funds to meet its liabilities as they fall due for the period of at least 12 months from the approval of the financial statements. Therefore, the management has prepared the financial statements on a going concern basis.” 15

deficit when the Licence Agreement was executed and it appears no issue was ever raised

by Brepco until it served the April Notice.

47. In fact, the allegation of insolvency on the part of Piramal is relied on by Brepco as the

foundation for four different arguments it advances. It is the basis for the April Notice. It is

used to suggest that damages would be an inadequate remedy for Brepco if the injunctions

were granted and Brepco prevails at trial. It is relied on to support the proposition that the

undertaking as to damages given by Mr Agrawal on behalf of Piramal is insufficient or of no

value. And it is used to support the allegation of material non-disclosure at the ex parte

stage.

48. There is a dispute as to the contractual meaning of “insolvent” and that will have to be

resolved at trial. There is no evidence before the court however that Piramal is unable to pay

its debts as they fall due. The court has evidence of the continuing parent support by Piramal

Group as noted by the independent auditors and the fact that the balance sheet issues are

explained by inter-company debts which do not yet fall due for payment. While there are

certainly some legitimate concerns raised about the financial health of Piramal, I am not

persuaded that they would necessarily meet the status of “insolvency” as envisaged in

clause 14.7.2 – although that will of course be a matter for the trial judge.

The Law

49. As this is an application for interlocutory injunctions heard on affidavit the court cannot

determine any factual disputes at this stage. There have been very many judgments

delivered in cases where interlocutory relief has been sought. Parties, as in this case, often

refer to various judgments in support of their position that relief should be granted or

refused. Of course there are general principles which the court should apply in every case.

It is important to observe however that each case will turn on its own particular facts and 16

this is an area of the law where decisions in one case cannot easily be applied in all

respects to another case.

50. It is worth noting in this case that there are in fact two injunctions sought. Both arise

between the same parties and seek to prevent termination of the same commercial

relationship. However, there are two separate termination notices which cover different

countries and which have been issued on an entirely different basis from each other.

Termination takes place on a country-by-country basis and is challengeable on a

country-by-country basis. It will be necessary to consider the March Notice and the April

Notice separately in determining the balance of convenience, including the adequacy of

damages, in each case.

51. The leading Supreme court authority of Merck Sharp & Dohme Corporation v. Clonmel

Healthcare Limited [2020] IR 1, [2019] IESC 65, emphasises the essential flexibility of

injunctive relief. The essential role of the court is to endeavour to regulate the period

between the commencement of the proceedings and the trial of the action in the most

pragmatic and fair way possible which causes the least risk of injustice to the respective

parties.

52. In its detailed assessment of the correct approach to applications for injunctive relief the

Supreme Court in Merck noted that the preferable approach is to consider the adequacy of

damages as part of the balance of convenience, or the balance of justice. O’Donnell J. (as

he then was) stated at para. 48 that: “An injunction should not be granted merely because

an applicant can tick the relevant boxes of arguable case, inadequacy of damages, and

ability to provide an undertaking as to damages, and by the same token should not be

refused merely because damages may be awarded at trial.”

53. There is a considerable dispute in the present case as to whether the injunctions sought are

prohibitory or mandatory in nature. The relevance of the latter distinction is, of course, the 17

standard of the threshold test to be applied in determining whether the plaintiff meets the

criteria to obtain the requested injunctive relief .

The standard to be applied

54. Piramal says the injunctions sought are prohibitory injunctions seeking to restrain Brepco

from giving effect to the March Notice and the April Notice. Piramal argues that what the

injunctions seek to do pending the trial of the action is to maintain the status quo that

subsisted at the date the proceedings were issued. That status quo has subsisted for the past

three-and-a-half years whereby the parties were contractually bound under the Licence

Agreement and the Supply Agreement.

55. That being so, Piramal says the injunctive relief it seeks attracts the lower standard of a fair

or serious issue to be tried and they say that they have raised such an issue in respect of both

the March Notice and the April Notice.

56. Brepco disagrees. It says that the injunctions are mandatory in effect – compelling Brepco to

continue to deal on an exclusive basis with Piramal pending the outcome of these

proceedings. Brepco asserts that the standard to be applied in this application is therefore the

higher standard of a “strong case, likely to succeed at trial” (see Maha Lingam v HSE [2005]

IESC 89) rather than the lower “fair or serious issue to be tried”. It is accepted by all parties

that the “serious issue to be tried” test is a low threshold for a plaintiff to meet.7

57. In support of its argument Brepco says that the effect of the injunctions is not passive, but

active – requiring the performance of positive obligations under the Licence Agreement and

the Supply Agreement including that the parties actively engage on product forecasting,

pharmacovigilance, product recalls, and ongoing participation in the Joint Steering

7 Described by Collins J. in Betty Martin (para. 42): “It may be useful to regard this threshold as akin to the threshold that applies where a party seeks to dismiss a claim against it pursuant to the inherent jurisdiction….” 18

Committee meetings and governance as well as cooperation in relation to the prosecution of

any infringement actions concerning Brepco’s intellectual property.

58. When analysing whether an interlocutory injunction is truly prohibitory or mandatory, a

court does not simply look at the words used in the notice of motion. Rather the court

looks at the substance of what the injunctive orders seek to do. As Murray J. noted in

Ryanair v Skyscanner [2022] IECA 64 (at para. 33 (ii)):

“In determining whether an order is ‘mandatory’ for this purpose, the court is concerned

to identify the substance of the relief sought, the matter therefore not being judged on the

basis of the phraseology of the order. Any positive assertion can be expressed as a

negative. The converse is also true….”

59. Murray J. continues at para. 36 of his judgment to note that: “The reason the cases usually

impose a higher standard on a person seeking relief that is properly described as

mandatory is that the relief is, for that reason, generally more intrusive, usually imposes a

greater burden on the party made subject to it and because it will often be more difficult to

undo the consequences of a mandatory order than a prohibitory order, should the

defendant prevail at trial.”

60. Piramal says that if the orders they seek are granted this would prohibit Brepco from

terminating the Licence Agreement or the Supply Agreement and also prohibit them from

entering into new third party agreements. Piramal says that the orders would not bind the

parties together or compel them to act in some forced liaison beyond the terms upon which

they have already agreed under the Licence Agreement and the Supply Agreement.

Piramal points out that in Ryanair the injunction sought would have required Skyscanner

to undertake obligations they actually had no obligation to undertake before the injunction

was sought, and that this is not analogous to the present situation. 19

61. In support of its argument on this point Piramal relies on the Supreme Court decision in Ó

Murchú trading as Talknology v. Eircell Limited [2001] IESC 15. In that case the High

Court had refused an injunction the effect of which would have been to compel Eircell to

continue supplying “ready to go” mobile phones to Mr Ó Murchú and to treat him as an

authorised agent for that purpose. Mr Justice Geoghegan upheld the decision of the High

Court. He stated at p. 5 that: “Although the injunctions sought in this case may arguably be

classified as “mandatory” they are not of that type. They are directed simply towards

retaining the status quo pending the outcome of the action, which is the normal purpose of

a prohibitive injunction.”

62. Brepco sought to distinguish that case on its facts arguing that it concerned the continued

supply of phones in a comparatively simple trading relationship. In the present case they

argue that the reliefs sought will compel Brepco to remain in a much more burdensome,

exclusive collaboration involving manufacture obligations, exclusive supply obligations,

regulatory cooperation and day-to-day coordination.

63. Brepco relies on the High Court decision in O’Leary v Volkswagen Group Ireland Limited

[2013] IEHC 318 and the comments of Moriarty J. who said at para. 14: “While it is

submitted for the Plaintiff that the substantive relief sought is actually prohibitory rather

than mandatory, what is sought is in essence a mandatory order, requiring the Defendant

to hold to and observe a relationship it contends has lawfully ended.” In distinguishing Ó

Murchú, Moriarty J. said “… the ratio of [Geoghegan J.’s] decision, upholding the High

Court refusal of interlocutory relief, was based on his agreement with the High Court that

damages were a sufficient remedy. Accordingly, it may reasonably be said that the initial

remarks were primarily obiter, but in any event, it seems to me in the present instance that

what the Plaintiff seeks by way of principal relief cannot be viewed as other than

mandatory.” 20

64. Counsel for Piramal urged the court not to be persuaded by that authority noting that it is a

High Court rather than a Supreme Court authority; that it arose against the backdrop of an

entitlement to terminate dealership contracts pursuant to a European regulation and that

there was significant delay on the part of the plaintiff in that case in challenging the

termination notice. He also urged the court to distinguish the line of authority dealing with

“keep open” provisions in trading leases arguing that the essential point in those cases was

that the courts would not require a defendant/tenant to continue to trade at a loss. In this

case, by contrast, Piramal says that the injunctions sought would not compel Brepco to

trade at a loss or to undertake any commercial activity which they do not otherwise intend

to undertake. I note however that Brepco say that they are losing money in having to

continue to deal exclusively with Piramal, particularly in those countries where no launch

activity has taken place at all. There were various minutes opened to the court where, for

example, comments were made such as “Brepco expressed concern that current dynamics

could “put them out of business” and that they are “not feeling supported”.

65. A recent case in which the threshold issue arose for consideration was the decision of

Mulcahy J. in Benson Fuels Limited v Flogas Ireland Limited [2023] IEHC 214. In that

case an injunction was sought restraining the defendant from terminating its exclusive

distribution agreement with the plaintiff. Mulcahy J. concluded that the applicable

threshold in that case was the lower one of a serious issue to be tried – noting that the

Court of Appeal had proceeded on this basis (without it appears any legal argument on the

point) in Betty Martin Financial Services Limited v EBS DAC [2019] IECA 327.

66. Central to that decision of Mulchay J. however was his finding on the facts that: “Set

against the background of a 40-year relationship pursuant to which the Plaintiff has

distributed the Defendant’s products without any difficulty arising, as is apparent even

from the Defendant’s letter purporting to terminate the relationship, it seems to me that the 21

injunction sought here is an injunction directed towards maintaining the status quo and is

not one which should be assessed against the higher threshold of a strong case likely to

succeed.” Neither the longevity of dealing or the quality of relationship are mirrored in the

present case.

67. Brepco seeks to distinguish Betty Martin pointing out that, unlike Piramal, that case

involved a sole family business that was found likely to be put out of business if the

injunction was granted. Furthermore there was no complaint about the agent’s competence

or performance. In contrast in the present case there are serious complaints about

performance and no allegation that Piramal would be put out of business by the grant of an

injunction given that Piramal commercialises hundreds of various products throughout the

world.

68. In this particular case there are arguments either way on the relevant threshold to be

applied and that question is, in my view, a very finely balanced one. It is true that the

substance of the injunction from a legal perspective is to maintain the status quo and keep

the parties bound to the agreements they were bound to before seeking the injunction. The

substance of the injunction sought from a practical perspective however, unlike in both

Benson and Betty Martin, appears in this case to arguably go beyond seeking merely to

keep the status quo in place. In this case Piramal has not already launched the Product in

the Terminated Countries. Rather it wishes, through the injunctive relief sought, to be

given the opportunity to launch the Product in countries it has not yet done so. There is no

real history of performance to be preserved, at least where the Product has not actually

been launched. Here there is a fractured relationship asserted and a pre-existing

documented performance dispute. The injunctions sought will tie the parties together

exclusively to commercialise a complex, technical and highly regulated Product. It is not

simply that Brepco will have to continue to supply the Product to Piramal as before (save 22

perhaps in the UK, Germany and Italy where it is launched). Rather, Brepco will have to

carry out actions it has not to date been required to carry out to cooperate with Piramal on

every aspect of the commercialisation in order to get the Product launched in the

Terminated Countries under the March Notice (although I accept that legally these are not

new obligations). It is not simply that Brepco will have to allow Piramal to continue to

carry on its business in the same compliant way it has done for years – there is an

allegation here of effectively no performance at all in multiple countries. For those reasons

I believe, on balance, that in practical terms, the essential substance of the injunctive relief

sought for most countries is mandatory in nature attracting the requirement for Piramal as

the party seeking same to satisfy the threshold of a strong case likely to succeed at trial.

Arguably however the lower threshold applies to those 3 countries where the product has

been launched and the parties are merely continuing to deal with each other as before.

69. In my view, and for the reasons already set out, Piramal would meet the higher threshold

in respect of the April Notice regarding the arguments it raises on insolvency. I am not

convinced however that Piramal would meet that threshold for the March Notice –

particularly for those countries covered by the March Notice where no evidence at all was

proffered of any orders being placed for the Product before the expiry of the contractually

agreed launch time limits. The primary argument raised by Piramal in that regard is

estoppel by convention which requires not just proof of the implementation of a phased

approach prioritising the EU5 (which is accepted) but also that the inevitable and agreed

consequence of this was to defer launch in all other countries (without apparently any new

time limit being agreed) until all the EU5 launches were completed. The latter point is

strongly denied by Brepco. The terms of the Licence Agreement were specifically

negotiated to require that any delay be “solely caused” by the failure of Brepco to supply

the Product. That is a high bar to meet. Those negotiated terms were never expressly 23

amended. I am doubtful that Piramal has a strong chance of succeeding in its argument

that their failure to launch the Product in the Terminated Countries was solely due to a

failure on the part of Brepco to supply the Product or that Brepco should now be estopped

from relying on the express terms of the Licence Agreement.

70. However I recognise that Piramal have some arguments to make in respect of the March

Notice and it could not be said at this point that their arguments have no prospect of

success. If the lower threshold applies I am satisfied that Piramal would meet that

threshold. In case I am incorrect in my view of the relevant threshold in this case I do not

propose to decide the matter on the basis of a failure to meet the higher threshold on the

March Notice. Rather I will now consider (in respect of both the March Notice and the

April Notice), the balance of convenience including the adequacy of damages, referencing

each Notice individually.

The balance of convenience

71. The court has to consider in this case whether the least risk of injustice lies in granting the

injunctions sought, which would have the effect of continuing the contractual relationship

pending a trial, or refusing the injunctions sought. All of this arises in the context of the

highly competitive global pharmaceutical market and an ever decreasing time period of

exclusivity within which Brepco can commercialise the Product.

72. I have to consider in that regard for how long any injunction might be required to remain

in place. The pleadings are at a stage where there is a defence and counterclaim delivered

and the parties are back before the Commercial Court on 20 July for further directions. At

that stage directions will be made for the exchange of letters seeking voluntary discovery.

It is not clear how long the discovery process will take or what further applications might

be brought in the context of trial preparation. While early hearing dates are available, if

discovery is delayed or protracted (a process unfortunately all too familiar), that will delay 24

matters overall. In the absence of significant delays in trial preparation, it is fair to assume

that the matter might be ready for trial in perhaps mid 2027 after which the parties would

await a judgment on the termination issue. An estimate of a further 12-15 months from

now before matters are finalised in the Commercial Court therefore appears a reasonable

assumption, although I appreciate that the period to completion could extend to 24 months

if matters are delayed by various discovery or other procedural challenges between now

and trial. Of course there may be further delays with appeals.

73. I also need to consider the respective positions of the parties. Piramal is an established

pharmaceutical business with global connections in the pharmaceutical industry. They have

already expended time, effort and money (estimated at €4.2m licence payments and €1m

marketing activity) in launching the Product and have in fact launched it in 3 countries.

74. Paul Breen and Seamus O’Loan were the two people behind Brepco who, since 2008, have

funded the research personally, worked without salary for many years and who eventually

achieved the EMA authorisation and other authorisations for the Product. They obviously

have an interest in recovering their investment and making a return in the limited time

period available to them to do so on an exclusive basis. They have averred to having an

emotional connection to the Product that goes beyond a purely commercial return.

75. Under the Licence Agreement and the Supply Agreement Brepco is entirely dependent on

Piramal to commercialise the Product in multiple jurisdictions. Piramal committed to

country-by-country timelines for launch. Piramal is depending on Brepco to supply the

Product to it. The parties, each with the benefit of legal advice, agreed strict timelines and

conditions for the exclusive commercialisation of the Product.

76. There is no evidence before the court in respect of 23 countries that Brepco failed to meet

any order for the Product as no orders were in fact placed. No specifics have been provided

of any Force Majeure matters potentially relevant. 25

77. In relation to France (one of the EU5), although preparatory work was done for a launch,

it also appears no orders were placed for the Product and that Piramal took the decision not

to launch there as do so “... would materially undermine or destroy the value of the

Product” (para. 72 of Mr Toms’ affidavit). Mr Toms avers at paragraphs 69 and 70 of his

affidavit that:

“69. In substance, therefore, the French route then available would have required launch

at a price point far below the premium pricing contemplated for the Product and, in the

Plaintiff's view, would have been commercially destructive.

70. The Plaintiff did not reach that view lightly.”

78. It is suggested by Mr Toms that safety data was requested from Brepco (but not supplied)

to enable a review to be undertaken on whether a better outcome could be obtained on

therapeutic value assessment and pricing in France. This, he says, shows that the delay in

launching in France cannot properly be laid at Piramal’s door. Brepco’s Mr Breen denies

this – he says safety data was provided in March 2023 and that all of it is publicly

available. He says that Piramal has failed to obtain pricing approval in France, failed to

provide any sales forecasts or failed to order any Product.

79. Mr Breen believes there are other roadblocks to launch in France and he avers that “any

suggestion that [Piramal’s] failure to launch in France was solely caused by [Brepco’s]

failure to supply the product, or by any other failures by [Brepco], is completely untrue

and unsupported by any evidence” (see paras. 87-90 Paul Breen affidavit sworn 27 March

2026). While I accept that there is a conflict of evidence in relation to who is responsible

for the delayed launch in France – and I cannot resolve that dispute in this application – I

do not believe that Piramal has clearly linked this dispute to any failure by Brepco to

supply the Product. Furthermore, the logical conclusion of Piramal’s position is that it has

no obligation at all to launch in any smaller country until launch has completed in the EU5. 26

In those circumstances the lack of clarity on the timing of any launch date in France has a

very significant impact on Brepco’s ability to commercialise the Product in the Terminated

Countries.

80. That leaves Spain and the Netherlands in respect of which some evidence was provided by

Piramal concerning the launch delays. In both countries some steps were taken towards

launch and Product was ordered but there was not (and still is not) any launch of the

Product there. There is disputed evidence of a supply issue in Spain, and in particular

whether a purchase order that had been placed by Piramal had or had not been cancelled

by it. In relation to the Netherlands there is disputed evidence regarding the placing of

some Product on hold by Piramal. These are not issues the court can determine in this

application. The estoppel argument however means there is, according to Piramal, no

obligation to yet launch in the Netherlands (which is not one of the EU5). There is no

outstanding order placed for Spain, regardless of who may have cancelled the first one.

81. If the injunctions are granted then legally the status quo will continue. That is generally a

persuasive reason to grant an injunction – however the court needs to consider what this

would mean in practice for the parties in this case.

The status quo

82. Leaving the status quo in place would mean that commercialisation activity would

continue by Piramal in Germany, Italy and the UK and they would be entitled to

exclusively commercialise the Product in the other 25 Terminated Countries. There is no

clarity on what activity would actually be likely to occur in those 25 countries or the

timing of that (including in France, being one of the EU5), although there appears to have

been some preliminary work towards a launch of the Product in both the Netherlands and

in Spain. Brepco would be unable to advance its commercialisation ambitions with a third

party in any of those 25 countries notwithstanding that the 10 year widow for exclusive 27

commercialisation is running all the time against Brepco. This situation arises against the

reality that there is no dispute that the agreed contractual timing for launch has not been

met for any of those 25 countries and in the teeth of a very specific negotiated clause each

party agreed with the benefit of legal advice that termination in those circumstances would

be permitted save where the “cause of [Piramal’s] failure to comply … is solely due to a

failure by Brepco to supply Product pursuant to the provisions of the Supply Agreement or

as a result of Force Majeure” (emphasis added).

83. Piramal argues that it is clear from Mr Breen’s affidavit that, if Brepco is free to do so, it

intends to proceed immediately to enter into new agreements with new service providers

(Eversana and Sciensus). That will, I accept, alter the status quo, compared with the

position that would exist if the Licence Agreement and the Supply Agreement were to

remain in place. This is a significant factor in my overall assessment of the balance of

justice. In reality if the existing interim injunction is discharged, or a further injunction is

refused on foot of the April Notice, that will immediately lead to a significant change in

the status quo which is likely to survive after the trial of the action whatever is the result –

leaving Piramal at best to a remedy in damages rather than a right to commercialise the

Product in line with the Licence Agreement and the Supply Agreement. That shift in the

status quo is particularly significant bearing in mind the time, money and effort expended

by Piramal to date in launching the Product.

84. On the other hand, the status quo leaves Brepco tied to a party who has engaged in no

commercialisation activity in many countries at a point when over 2 years of the 10 year

window has already passed and where the conclusion of this matter could be up to another

2 years away. That is almost half the available commercialisation window. If Brepco

cannot commercialise the Product in various countries within the 10 years available to it

then it is also unlikely to be able to meet the competition of generic brands at the end of 28

that period – so its losses may continue. If the injunctions are refused then Brepco would

be free to contract with third parties in relation to the 25 Terminated Countries (for the

March Notice) or for those countries as well as Italy, Germany and the UK (for the April

Notice).

Other arguments

85. Piramal says that if the injunctions are granted then Brepco will continue to receive the

monies that it is due under the Licence Agreement pending trial, because the Licence

Agreement will continue to subsist. Therefore Brepco will continue to get its 20% of profit

from the net sales of Product, and it will get its milestone payment if the requirements for

the milestone payment under clause 10.1.5 are triggered. That however is relatively cold

comfort to Brepco who complain that there are no sales at all in most jurisdictions, and no

sign of future sales there on which any profits might be generated for them.

86. Brepco says the court should not grant injunctions where compliance with those obligations

may require the supervision of a court – as they say would be necessary here. It is true that a

court should be slow to grant injunctions in either service contracts or trading contracts

because of the difficulty of assessing whether such injunctions are being obeyed on an

ongoing basis.

87. In Benson the evidence was that the commercial relationship between the parties had

operated successfully for over 40 years and indeed had continued to operate after expiry of

a 2018 agreement. Mulcahy J. found in the circumstances that there was little evidence that

ongoing supervision would be required by the court if the relationship was to continue

pending trial. Similarly in Betty Martin the court noted at para. 100 that “… the Agent is

an entity whose competence, diligence and/or integrity has never been impugned by the

EBS. There is no reason to believe that the three branches will not continue to operate

successfully pending trial in the event that the injunctions remain in place”. 29

88. This factual situation is not on all fours with the present case. However, the reality is that

whatever happens to this application the parties will continue to deal with each other in

relation to South Africa (where Piramal has an irrevocable licence) and will not continue

to deal with each other in Sweden where Brepco will commercialise the Product with a

third party (as Piramal’s entitlements have been terminated and are not challenged by way

of injunction). Counsel for Brepco argues that the consequences of having to continue to

deal with Piramal pursuant to a court injunction are however different. Brepco in that

scenario faces the prospect not just of being in breach of contract for failure to supply but

rather in breach of a court order that requires Brepco to supply Piramal with Product – thus

exposing Brepco to a contempt application.

89. Overall, I am not persuaded that the parties will be unable to continue to deal effectively

with each other if that is a consequence of this court’s order. While the agreements are

highly technical, the parties are sophisticated and well advised. I believe the concerns

regarding a requirement for the court to have to supervise the ongoing relationship are

perhaps overstated and that consideration does not appear to me to materially impact the

other components of the balance of justice.

Adequacy of damages

90. Of course in this case damages will be claimed by the successful party if it is ultimately

established that they were incorrectly injuncted. Insofar as arguments were made by the

parties as to the inadequacy of damages, the following summarises their respective

positions.

91. Brepco says that damages cannot compensate them adequately if the injunctions are granted.

First, they allege that they have an emotional connection to the Product, as its developer Mr

Breen avers at para. 186 of his first affidavit sworn 27 March 2026: “... for myself and the

Defendant's other employees, this business is about more than just money. While of course 30

we want the business to succeed and to make a financial return, we also have a huge

emotional investment in the drug that we have worked hard to create over more than a

decade and a half. We want to see Neoatricon® widely adopted because we firmly believe

that it has the potential to save the lives of seriously ill babies and children… we have made

a huge personal and financial investment in building this business up. We take enormous

pride in what we have achieved and we do not wish to see it destroyed by an injunction,

even if we would be left with a very large damages claim against the Plaintiff.”

92. Having said that, Mr Breen avers at para. 180 of his first affidavit that Brepco “… estimates

that the financial damage caused by any injunction would be very substantial, potentially in

the region of €19 million for each year of delay.”

93. Second, Mr Breen avers in his second affidavit that Brepco “has no source of revenue save

for sales of Neoatricon and payments under the Licence Agreement”. He says at para. 151

that if the current situation remains in place “… there is a very real risk that the Defendant

will be unable to continue to cover its costs and would become cash flow insolvent.”

94. Third, Brepco points to what it says are the precarious financial circumstances of Piramal if

it were ordered to pay damages to Brepco, as well as the real difficulty in calculating those

damages, particularly if no launch activity at all occurs in certain countries and poor

commercialisation occurs elsewhere. Brepco thus disputes the reality of it recovering

damages from Piramal if Brepco is left to recover damages rather than commercialise the

Product itself.

95. If Brepco were ultimately entitled to an award of damages having been wrongly restrained

by injunction from terminating the agreements, Brepco would be entitled to call on

Piramal’s undertaking as to damages which has been given to the court. It is well

established that the court can refuse to grant an interlocutory injunction, in the exercise of

its overall discretion, if it is not satisfied that the party giving the undertaking as to 31

damages will be in a position to honour it. The party who seeks to challenge the adequacy

of the undertaking as to damages bears the onus of demonstrating the inadequacy of the

undertaking when viewed against the losses they contend will be suffered.

96. Undoubtedly Piramal’s accounts display a difficult balance sheet position showing that

Piramal’s assets exceed its liabilities and that it is dependent on parent support to continue

as a going concern. I have to take into account however the parent commitment of funding

support noted in the financial accounts, the parent confirmation that inter-company loans

will not be called in as well as the recent provision to the court of an undertaking as to

damages directly from the parent company Piramal Pharma Limited. This parent company

is based in India and that fact alone would complicate enforcement should that prove

necessary – but this is not of itself a reason to discount an undertaking offered by a very

substantial global company.

97. Piramal says the loss that Brepco asserts it will suffer between now and any trial is highly

speculative. The recovery of any loss is predicated on Brepco being able to launch the

Product in other territories more successfully than Piramal could do if the existing

agreements continue.

98. That is undoubtedly so but Brepco wish to have the option to change arrangements to

commercialise the Product in countries where Piramal has failed to launch. Paul Breen avers

at paragraph 143 of his first affidavit that Brepco's “… urgent objective is to progress the

commercialisation of Neoatricon in the Terminated Countries as quickly as possible. There

is a finite 10-year period during which [Brepco] has the exclusive right to sell Neoatricon.

[Piramal] has already wasted almost two years by doing virtually nothing in the Terminated

Countries. Every single month is extremely valuable from [Brepco’s] perspective."

99. Piramal says this averment does not sit easily with the fact that there is little or no evidence

before the court of Brepco having taken any steps, urgent or otherwise, to progress the 32

commercialisation of Neoatricon in Sweden. Piramal argues that the same reality would

arise if Brepco was to now seek to progress the commercialisation of Neoatricon in other

countries.

100. Brepco has determined, rightly or wrongly, that its own plans would achieve a better

outcome for the commercialisation of the Product than Piramal will achieve if they remain

performing as they have done to date. If Brepco is wrong on that and Piramal are wrongly

injuncted then Brepco will most certainly face a damages claim.

101. On the other side of the argument, Piramal argues that if it is relegated to its remedy in

damages there is no reality to it ever recovering damages from Brepco, whose last

financial accounts show that it had cash reserves of just over one million euro. Piramal

says that the measure of expected damages would be many multiples of this if they

succeed. The counterargument is of course that Brepco would be expected to improve its

cash position if it was in fact able to commercialise the Product.

Conclusion on the Injunctive Relief

102. In summary therefore, if the injunctions are granted;

The agreements remain in place and Brepco must continue to use Piramal for all countries

until trial. Time is ticking away – most prejudicially against Brepco. There is no clarity on

when commercialisation will take place. In fact the EU5 argument appears to indefinitely

postpone launching in other countries. If Brepco win at trial they would be entitled to

damages from Piramal. While they have raised concerns about recovery, it is likely they

would recover on foot of the parent guarantee. However damages alone might not

compensate for the emotional aspect of the development of their only product.

Furthermore Brepco may not financially withstand a further period of no 33

commercialisation in the Terminated Countries. If Brepco can itself launch it may suffer

no loss.

103. If the injunctions are not granted:

Brepco is free to move ahead with third parties. Piramal loses the opportunity to

commercialise and is consigned to a remedy in damages if they win. The injunction has

likely permanently altered the outcome. The court needs to consider the strength of the

Piramal case to help evaluate the risk on this outcome. Piramal’s interest in the Product is a

financial one and it is one of many products it commercialises worldwide. Piramal could

only realistically recover damages if Brepco made money commercialising the Product,

but there is also an ongoing income stream involving Piramal regarding the Product in

South Africa.

104. Given the relative strength of the insolvency argument by Piramal and the fact that they

met the launch dates in Germany, the UK and Italy, in my view the balance of justice

favours granting the injunction sought in respect of the April Notice insofar as those

countries are concerned.

105. Different considerations arise however in relation to the March Notice. Not only is the

strength of challenge to the termination less strong in my view but there is little indication

from Piramal as to when commercialisation will happen in the remaining countries in

which launch has not taken place. Indeed it appears from the EU5 argument that Piramal

does not see itself as having any obligation to commercialise in any other country until the

Product is first launched in all the EU5 countries. The situation, in particular in relation to

France (in respect of which no orders have been placed for Product) indicates that this

alone could cause a lengthy delay in launching in other countries. From a financial

perspective Brepco may not be able to withstand the consequences of such a further delay.

Brepco’s interest in launching the Product throughout the Licensed Territories goes 34

beyond a purely financial interest. In circumstances where the window of opportunity is

closing for Brepco and given that their agreement specifically negotiated an exit for them

if launch dates were not met save in limited circumstances, the balance of justice appears

to favour permitting Brepco to now make its own arrangements to launch in those

countries. Of course Brepco may be unsuccessful or only moderately successful in doing

so – but that will be a matter for Brepco. If Piramal ultimately wins and Brepco faces a

potential claim for damages there are some concerns regarding Brepco’s ability to pay

such damages. However Brepco will earn money if the Product is commercialised and

there will of course be ongoing commercialisation (involving Piramal) in 3 of the larger

jurisdictions as well as in South Africa. This will create an income stream and should

result in an ability to recover damages if ultimately Piramal is injuncted but is successful at

trial. I therefore refuse to grant the injunction sought in respect of the March Notice.

Non-disclosure

106. Finally I will deal with the separate issue of material non-disclosure to the court at ex parte

stage alleged by Brepco.

107. One such matter which it is alleged ought to have been disclosed was that Piramal had not

placed any orders for the Product in the majority of the Licensed Territories. Another

matter that was not disclosed (but is now apparent from filed affidavits in the interlocutory

hearing) is that Piramal itself made a strategic decision to defer launch in multiple

countries. The final alleged non-disclosure was that Piramal could not pay on foot of the

undertaking it gave to the court. Brepco lay the blame for this alleged “material non-

disclosure” not with the lawyers but with Piramal itself.

108. Of course any party seeking ex parte relief owes the court a duty of candour and utmost

good faith. Full and fair disclosure is necessary. A court can set aside an order made ex 35

parte where that order was obtained on foot of an affidavit that is misleading, even if not

intentionally so, on the basis that the facts that ought to have been disclosed were material

to the exercise of the court’s discretion. The test of materiality is an objective one with

materiality to be construed in a reasonable and not excessive manner (see Bambrick v

Cobley [2006] 1 ILRM 81). The jurisdiction to set aside orders for material non-disclosure

is penal in nature and the courts should have regard to the proportionality between the

punishment and the offence. Even where material non-disclosure is found, the court has a

discretion to refuse relief or to set aside relief already granted but is not necessarily obliged

to do so. Much will depend on the particular circumstances including the materiality of the

facts not disclosed and whether there is any evidence of a deliberate attempt to mislead.

109. Piramal, through Mr Agrawal’s affidavit at para. 22, advised the court at ex parte stage that

Piramal “placed orders with [Brepco] for Product in relation to the Spanish and

Netherlands markets, with the intention that the Product would be launched in these

markets in April/May 2026. However, [Brepco] has refused to supply the Product and has

unilaterally cancelled the purchase orders placed in relation to Spain and the

Netherlands”. While Piramal did not disclose that no orders were placed for other

countries it would I believe have been clear to the court that as only 2 countries were

identified, there were no orders placed for the other countries in the Licensed Territories.

110. It appears from a review of the affidavit at ex parte stage that Piramal did not refer at all to

the EU5 strategy, that is now advanced as its main challenge to the March Notice. Instead

Piramal relied on a general claim (at para. 56) that Brepco could not rely upon contractual

launch timelines as a basis for termination in circumstances where delays arose from

matters within Brepco’s sphere of responsibility in the supply chain or where Brepco’s

own conduct materially hindered Piramal’s ability to perform its obligations. I do not

believe the failure to disclose the EU5 strategy amounts to culpable material non- 36

disclosure by Piramal. Indeed it would potentially have been more favourable to Piramal to

disclose this argument. The court is however entitled to take note that this now central

plank of Piramal’s case was not articulated at ex parte stage.

111. On the undertaking point, in Nolan v Dildar [2020] IEHC 243 Barniville J. (as he then

was) noted at para. 239 that “... a party giving an undertaking as to damages has an

obligation to draw to the attention of the court any material change for the worse in its

financial position”.

112. Mr Breen says at para. 100 of his second affidavit that the failure on the part of Piramal to

put evidence before the Court at the ex parte stage of its financial position constitutes “a

very clear and very serious breach of the plaintiff's disclosure obligations [which] is, in

and of itself, sufficient to warrant the discharge of the injunctions.”

113. This averment is predicated on the proposition that Piramal is insolvent, which I do not

believe is established on the available evidence. Secondly it is predicated on what I believe

is an incorrect proposition that every subsidiary company which depends on parental

support must in every case in which it is seeking ex parte relief disclose its financial

statements and details of its financial position to the court. A party is entitled to later

challenge the adequacy of any undertaking as to damages given by a plaintiff or to look for

an undertaking to be fortified bearing in mind the likely level of damages it might be

required to cover. Indeed that happened in the present case where financial statements

were later exhibited and a parent company guarantee was offered to the court to fortify the

previous Piramal undertaking.

114. I do not consider in this case that there was any material non-disclosure or attempt to

conceal information or to mislead the court at the ex parte stage, such as would, of itself,

require the interim injunction to be set aside for that reason alone. 37

Orders to be made

115. For the reasons outlined, I refuse injunctive relief in relation to the March Notice and

discharge the interim relief in place.

116. For the reasons outlined, I grant injunctive relief in relation to the April Notice, in respect

of Germany, the UK and Italy, and confirm that Brepco should be restrained, whether by

itself, its servants or agents from implementing or giving effect to the April Notice in

respect of those countries. In practical terms this will allow Piramal to continue to

exclusively commercialise the Product in those 3 jurisdictions in which it has already been

launched. The March Notice terminates Piramal’s exclusivity for the Terminated

Countries.

117. In relation to legal costs, my provisional view is that no order should be made. Each party

was both successful and unsuccessful in the totality of the applications overall. I will

however permit the parties to make submissions to me in the event that they wish to

advocate for a different order on costs.

118. I note that the parties are due to appear before this court for further directions on 20 July

2026 and they will have an opportunity at that stage to advise of any further matters which

arise from this judgment. The court will expect the parties to co-operate to bring on the

trial expeditiously in light of the injunctive relief in place and I will fix directions with that

objective in mind on 20 July.