Interlocutory Relief After Contractual Termination: Mandatory Effect, Country-by-Country Balance of Justice, and “Becomes Insolvent” in Pharma Licensing

Case: Piramal Critical Care B.V. v Brepco Biopharma Limited (Approved)
Citation: [2026] IEHC 467
Court: High Court of Ireland (Commercial)
Judge: Ms. Justice Eileen Roberts
Date: 14 July 2026

1. Introduction

This decision concerns an application for interlocutory injunctions to restrain a licensor-manufacturer (the defendant, an Irish pharmaceutical developer) from implementing two termination notices against its exclusive EU/UK/Norway commercialisation partner (the plaintiff, a Netherlands-incorporated pharmaceutical company). The product at the centre of the dispute is Neoatricon®, a paediatric dopamine hydrochloride formulation, protected by a time-limited EU regulatory exclusivity window following EMA authorisation (10 years from May 2024, with generic entry possible after May 2034).

The commercial arrangements comprised:

• a Licence Agreement (7 October 2022, as amended) granting exclusive commercialisation rights across 29 countries in the EU, the UK and Norway; and
• a Manufacture and Supply Agreement (24 July 2023) under which the defendant would exclusively supply product to the plaintiff.

Two separate terminations were challenged:

• March Notice (4 March 2026): termination on a country-by-country basis for 25 “Terminated Countries”, relying on the plaintiff’s failure to launch within clause 14.2 timelines (12 months for Germany/the Netherlands/Sweden; 18 months for others), subject to narrow exceptions.
• April Notice (7 April 2026): termination for all 29 countries on 30 days’ notice, relying on clause 14.7.2 (“becomes insolvent”).

The case raised (i) the proper approach to interlocutory relief where injunctions effectively compel continuation of complex contractual performance, (ii) whether “status quo” relief can be “mandatory in substance”, (iii) how the “balance of justice” should be assessed where a licensor’s exclusivity window is steadily eroded by delay, and (iv) the materiality threshold for non-disclosure at the ex parte stage.

2. Summary of the Judgment

On non-disclosure, the Court rejected the contention that the ex parte injunction should be discharged for material non-disclosure.

3. Analysis

3.1 Precedents Cited and Their Influence

• Merck Sharp & Dohme Corporation v. Clonmel Healthcare Limited [2020] IR 1, [2019] IESC 65
  The Court treated Merck as the governing authority emphasising flexibility and the overarching objective: to regulate the period to trial “in the most pragmatic and fair way possible” and with the “least risk of injustice”. Critically, the Court adopted Merck’s preference that adequacy of damages be assessed as part of the balance of convenience/justice, rather than as a rigid precondition.
• Maha Lingam v HSE [2005] IESC 89
  Cited for the higher threshold for mandatory injunctions—a “strong case, likely to succeed at trial”. The Court used it as the benchmark once it concluded that (for most countries) the relief was “mandatory in substance”.
• Ryanair v Skyscanner [2022] IECA 64
  The Court relied on this Court of Appeal authority for the principle that “mandatory” is identified by substance not phraseology, and for the rationale behind the higher threshold: mandatory relief is often more intrusive and harder to unwind.
• Ó Murchú trading as Talknology v. Eircell Limited [2001] IESC 15
  The plaintiff invoked Ó Murchú to argue that even if an injunction has mandatory aspects, it may still be aimed at preserving the status quo. The Court accepted the relevance but distinguished the present dispute in practical terms: here, the injunction would enable the plaintiff to attempt launches in countries where there was “no real history of performance to be preserved”.
• O'Leary v Volkswagen Group Ireland Limited [2013] IEHC 318
  Relied upon by the defendant to support the proposition that an injunction restraining a purported termination can be “mandatory” because it requires the defendant to observe a relationship it claims has lawfully ended. The Court treated the authority as part of the spectrum of approaches but ultimately decided on the facts that this case’s practical substance was indeed mandatory for the non-launched territories.
• Benson Fuels Limited v Flogas Ireland Limited [2023] IEHC 214 and Betty Martin Financial Services Limited v EBS DAC [2019] IECA 327
  These were used to contrast cases where a long-running and successfully operating relationship made “status quo” preservation more natural and supervision concerns less acute. Roberts J. distinguished them: the present relationship was fractured, performance was disputed, and the relief would compel complex collaboration to achieve future launches rather than preserve settled operations.
• Bambrick v Cobley [2006] 1 ILRM 81
  Applied to the duty of candour on ex parte applications, and the objective test of “materiality” (to be construed reasonably, not excessively), as well as the “penal” nature of the jurisdiction to set aside for non-disclosure.
• Nolan v Dildar [2020] IEHC 243
  Considered on the obligation to disclose material deterioration affecting an undertaking as to damages. Roberts J. used it to reject a broad proposition that any company reliant on parental support must, as a matter of course, exhibit full financials at the ex parte stage.

3.2 Legal Reasoning

(A) Contractual structure: two different terminations, two different injunction analyses

The Court treated the application as effectively two distinct injunction requests because: (i) the March Notice was a clause 14.2 launch-timeline termination applying to specific countries, while (ii) the April Notice was a clause 14.7.2 insolvency termination purportedly applying to all countries. Roberts J. emphasised that termination occurred on a country-by-country basis and therefore the balance of convenience could differ by territory.

(B) Prohibitory vs mandatory: “status quo” is not decisive if performance is prospective

Although framed as restraining enforcement of termination notices (prohibitory language), the Court found that for the 25 Terminated Countries the injunction’s practical substance was to compel ongoing exclusive collaboration to enable future launches—where there was limited evidence of actual launch preparation, no purchase orders in most territories, and an alleged strategy that could delay non-EU5 launches indefinitely.

This “prospective performance” element—rather than preservation of an established operating pattern—tipped the classification towards mandatory in substance (especially for non-launched territories), engaging the higher threshold (strong case likely to succeed). The Court left open that the lower threshold might apply to Germany/UK/Italy where the product had already been launched and the relationship was continuing in a more conventional “status quo” sense.

(C) March Notice: clause 14.2 and the limits of “phased launch” and estoppel arguments

Clause 14.2 granted the defendant a negotiated termination right if the product was not launched by fixed deadlines, with only two carve-outs:

• failure “solely due” to the defendant’s failure to supply under the Supply Agreement; or
• failure “as a result of Force Majeure” (with procedural notice expectations).

The plaintiff accepted it missed the contractual launch deadlines in 26 of 29 territories, and sought to justify this largely by an alleged phased EU launch strategy prioritising the “EU5” markets and by asserting an estoppel by convention (the defendant allegedly accepted that approach and could not rely on strict timelines).

Roberts J. was not satisfied that the alleged representation/understanding was identified “with precision” or that it clearly entailed agreement to launch beyond the clause 14.2 deadlines. The “solely due to failure to supply” exception was treated as a high bar, and the Court noted the absence of orders in most countries (making “failure to supply” difficult to establish as the sole cause). Force majeure was pleaded but not substantiated by particulars or notice.

While the judge did not finally determine the merits (as factual disputes were not resolvable on affidavit), she regarded the plaintiff’s prospects on the March Notice as materially weaker than on the April Notice, a conclusion that later influenced the balance of justice.

(D) April Notice: “becomes insolvent” and the evidential significance of going-concern support

The April Notice relied on clause 14.7.2. The defendant argued it was sufficient to show any of the disjunctive insolvency-related events and, in particular, that the plaintiff had “become insolvent”.

The Court identified that the meaning of “insolvent” was disputed and would be a trial issue, but found that on the interlocutory evidence the defendant had not established insolvency as a matter of fact. Key points were:

• a balance-sheet deficit is not determinative where liabilities are long-term intercompany loans not falling due until 2030 and renewable;
• audited accounts and directors’ statements supported a going-concern basis, with parent support expressly recorded;
• non-payment of disputed sums does not, without more, establish insolvency;
• the clause’s forward-looking language (“becomes insolvent”) sat uneasily with the fact that a balance-sheet deficit existed when the licence was executed and no concerns had been raised then.

On that basis, the plaintiff was found to meet even the higher mandatory-injunction threshold in relation to the April Notice (at least for the launched territories), because the insolvency justification appeared weak on the evidence available.

(E) Balance of justice: exclusivity windows, “time running”, and differential territorial outcomes

The Court’s balance-of-justice assessment was shaped by the product’s regulatory exclusivity window and the realistic time to trial (estimated 12–15 months, potentially longer with discovery and appeals). Roberts J. recognised that maintaining the status quo could consume a large fraction of the commercialisation window, to the licensor’s detriment—particularly where the licensee had not launched in most territories and offered limited clarity as to when it would.

The Court therefore split the outcome:

• Germany/UK/Italy (launched territories): the balance favoured preserving the existing operating position and restraining the April Notice. The plaintiff had met launch deadlines there and the insolvency ground was doubtful.
• 25 Terminated Countries (non-launched territories under March Notice): the balance favoured allowing the licensor to pursue alternative commercialisation arrangements given (i) missed deadlines, (ii) weak linkage to the narrow clause 14.2 exceptions, and (iii) the plaintiff’s EU5 sequencing case potentially postponing other launches for an extended period—placing the licensor’s exclusivity window at risk.

(F) Adequacy of damages and undertakings: parent-company fortification matters

Consistent with Merck, damages adequacy was treated within the overall balance. The Court engaged with:

• the licensor’s claim that delay damages were substantial and difficult to quantify (including market opportunity loss within a finite exclusivity period);
• the licensor’s concern as to recoverability under the plaintiff’s undertaking as to damages, given financial statements showing dependence on group support;
• the plaintiff’s argument that the licensor had limited resources to meet a substantial damages award if the plaintiff ultimately succeeded.

A key practical point was the “fortification” of the undertaking: the plaintiff produced a parent-company undertaking, reducing (though not eliminating) recoverability concerns. The Court also noted cross-cutting commercial realities: ongoing commercialisation in the three large territories and separate continuing dealings in South Africa would create some revenue streams.

(G) Non-disclosure: materiality, proportionality, and financial disclosure at ex parte stage

The Court rejected the allegation that the ex parte injunction had been obtained by material non-disclosure. Applying Bambrick v Cobley [2006] 1 ILRM 81, Roberts J. treated materiality as objective and cautioned against an excessive approach.

The Court considered three alleged omissions:

• No orders in most territories: the ex parte affidavit referred to Spain and the Netherlands; the Court considered it would have been clear that other orders were not being relied upon.
• The EU5 sequencing strategy: the Court did not treat its absence as culpable; if anything, it might have been supportive of the plaintiff’s case, but the Court noted it was not articulated at that stage.
• Financial position/undertaking adequacy: the Court rejected the proposition that reliance on parent support automatically requires disclosure of detailed financial statements at the ex parte stage; concerns can be addressed later by challenge or fortification. The “insolvency” premise was not established on the evidence.

3.3 Impact

• Territory-sensitive interlocutory outcomes: the judgment is a clear example of the High Court tailoring interlocutory relief to the practical realities of performance and market position on a country-by-country basis, even within a single integrated licence/supply relationship.
• Mandatory-by-effect in complex commercialisation contracts: the decision reinforces that where an injunction would, in practical terms, enable a claimant to begin or complete substantial performance not previously achieved (e.g., launching in multiple countries), the court may characterise it as mandatory notwithstanding prohibitory wording—raising the threshold.
• Regulatory exclusivity as a balance-of-justice factor: “time running” in an exclusivity window can weigh heavily against maintaining a non-performing exclusive licence pending trial, because the lost opportunity cannot be fully restored by a later merits judgment.
• “Becomes insolvent” clauses and going-concern evidence: while the meaning of “insolvent” was left to trial, the court’s approach indicates that audited going-concern treatment and documented parent support can be significant in resisting interlocutory termination grounded on insolvency assertions.
• Non-disclosure discipline without over-penalisation: the court signalled restraint in deploying the penal jurisdiction to discharge ex parte relief, especially where alleged omissions are debatable, not clearly material, or later addressed through fortification of undertakings.

4. Complex Concepts Simplified

• Interlocutory injunction: a temporary order preserving (or adjusting) the parties’ position until trial, aimed at minimising the risk of injustice.
• Prohibitory vs mandatory injunction: a prohibitory injunction restrains action; a mandatory injunction compels action. Courts look at substance, not drafting. If the effect is to force ongoing performance of a disputed relationship, it may be treated as mandatory.
• Balance of convenience / balance of justice: the court weighs which course (grant/refuse) carries the lower risk of injustice, factoring in damages, practicality, time to trial, and the parties’ real-world positions.
• Undertaking as to damages: the applicant’s promise to compensate the respondent if it later turns out the injunction should not have been granted. Courts may require “fortification” (e.g., a parent guarantee) if recoverability is uncertain.
• Estoppel by convention: a party may be prevented from insisting on strict contractual rights if both sides proceeded on a shared assumption/understanding and it would be unjust to depart from it. The court here emphasised the need to identify the alleged representation/assumption precisely, especially against an “entire agreement” clause and strict negotiated timelines.
• Regulatory exclusivity window: a period after authorisation during which competitors cannot obtain approval for identical/generic products. Delay within this window can permanently reduce a product’s commercial potential.

5. Conclusion

Roberts J.’s decision in Piramal Critical Care B.V. v Brepco Biopharma Limited [2026] IEHC 467 illustrates a distinctly pragmatic, risk-focused application of interlocutory injunction principles in a highly regulated, time-sensitive pharmaceutical licensing context. The Court:

• treated the relief as potentially mandatory in substance where it would enable significant future performance (new launches) rather than preserve settled operations;
• applied a country-by-country balance of justice, granting protection only for territories where launch had occurred and the insolvency termination appeared weak;
• refused to restrain the clause 14.2 termination for non-launched countries, giving significant weight to negotiated launch deadlines and the licensor’s diminishing exclusivity window; and
• rejected alleged material non-disclosure, emphasising objective materiality and proportionality, and noting that undertaking concerns can be addressed through fortification.