Piramal Critical Care B.V. v Brepco Biopharma Ltd (Approved)

Factual and Procedural Background

This judgment concerns an interlocutory application by the Plaintiff for injunctive relief to restrain the Defendant from implementing two termination notices (the "March Notice" dated 4 March 2026 and the "April Notice" dated 7 April 2026) purporting to terminate country-by-country commercial arrangements under a Licence Agreement (7 October 2022) and a Supply Agreement (24 July 2023) for the commercialisation of a pharmaceutical product (the "Product") across a multi-country licensed territory. The March Notice purportedly terminated the Plaintiff's rights in a set of 25 "Terminated Countries" with effect from 13 March 2026, relying on a specific launch-failure clause in the Licence Agreement. The April Notice purported to terminate rights for all 29 licensed countries (including three jurisdictions where the Plaintiff had launched the Product) effective 27 May 2026, relying on an insolvency clause in the Licence Agreement.

On 12 March 2026 the Plaintiff obtained ex parte interim injunctive relief from Judge Cregan preventing enforcement of the March Notice. Proceedings were later transferred to the Commercial List, the Plaintiff amended to seek relief in respect of the April Notice, and the interlocutory application was heard on 16–17 June 2026. Judgment was delivered by Judge Roberts on 14 July 2026.

Legal Issues Presented

1. Whether interlocutory injunctive relief should be granted to restrain the Defendant from implementing or giving effect to the March Notice (termination for failure to launch within contractual time limits) in respect of the Terminated Countries.
2. Whether interlocutory injunctive relief should be granted to restrain the Defendant from implementing or giving effect to the April Notice (termination for insolvency) in respect of all licensed countries, and in particular the three jurisdictions where the Product had been launched.
3. Whether the injunctions sought are prohibitory or mandatory in substance and, relatedly, which legal threshold applies (the lower "serious or fair issue to be tried" threshold or the higher "strong case, likely to succeed" threshold).
4. Whether the ex parte interim relief obtained by the Plaintiff should be set aside for material non-disclosure.

Arguments of the Parties

Plaintiff's Arguments

• The Plaintiff sought to preserve the status quo and continue exclusive commercialisation pending trial; the injunctions are therefore prohibitory and attract the lower threshold of a serious issue to be tried.
• The Plaintiff relied on a phased-launch commercial strategy prioritising the largest markets (the "EU5") which it says justified later launches in other countries; it argued estoppel and that delays flowed from supply-related issues within the Defendant's responsibility in some jurisdictions.
• The Plaintiff denied insolvency and pointed to audited accounts, continuing parent-company support and an undertaking as to damages (later fortified by a parent company undertaking) to rebut concerns about recovery of damages.
• The Plaintiff disputed that material non-disclosure occurred at the ex parte stage and said the facts omitted were not culpably material to the discretion exercised then.

Defendant's Arguments

• The Defendant said the March Notice was valid under clause 14.2 because the Plaintiff failed to launch the Product within contractually agreed timeframes in the vast majority of licensed countries and the Licence Agreement limits exceptions to two narrow categories (solely due to Defendant supply failure or force majeure).
• The Defendant argued the April Notice was valid under clause 14.7.2 because the Plaintiff had "become insolvent" and that insolvency also undermined the adequacy of the Plaintiff's undertaking as to damages.
• The Defendant contended the injunctive relief sought was mandatory in substance (requiring continued exclusive collaboration and active cooperation) and should be tested by the higher threshold of a strong case likely to succeed.
• The Defendant also alleged material non-disclosure at the ex parte stage (notably that the Plaintiff had not placed launch orders in most countries; that a phased-launch strategy was not disclosed; and that the Plaintiff’s financial position was not fully disclosed).

Table of Precedents Cited

Court's Reasoning and Analysis

The court undertook the following analysis:

• The substance of the injunctions was examined to determine whether they were prohibitory (maintaining status quo) or mandatory (requiring positive continued cooperation). The court concluded the relief was mandatory in practical effect for most of the Terminated Countries (where no launch had occurred) and attracted the higher "strong case" threshold, while for the three jurisdictions where the Product had been launched the lower threshold arguably applied.
• On the March Notice (termination for failure to launch under clause 14.2), the court found that the Licence Agreement expressly permitted country-by-country termination where the Plaintiff failed to launch within specified timeframes, subject only to narrow exceptions (failure solely due to Defendant supply or force majeure). The Plaintiff's estoppel-by-convention/phased-launch argument was not shown to have the precision or agreed consequence required to displace the clear contractual wording. Many jurisdictions evidenced no purchase orders and the Plaintiff had not demonstrated that Defendant supply alone caused the failures. On balance the court doubted the Plaintiff had a strong chance of success for most countries under the higher threshold.
• On the April Notice (termination under clause 14.7.2 for insolvency), the court treated the insolvency allegation carefully. The Plaintiff's audited accounts, parent-company support and a parent company undertaking regarding damages weighed against a finding that the Plaintiff had "become insolvent" for clause 14.7.2 purposes at interlocutory stage. The court accepted that the Plaintiff met the higher threshold on the insolvency point in respect of the three launched jurisdictions.
• In balancing convenience and adequacy of damages, the court considered the limited exclusivity window for the Product, the loss of opportunity and irreversibility if third-party arrangements proceeded, the Defendant's interest in commercialising within the remaining exclusivity period, and the risk of claimant insolvency. The court concluded the balance of justice favoured granting an injunction in respect of the April Notice limited to the three jurisdictions where the Product had been launched, but refused injunctions in respect of the March Notice for the remaining Terminated Countries.
• On the allegation of material non-disclosure at the ex parte stage, the court applied the Bambrick v Cobley test and Nolan v Dildar guidance on undertakings. The court found no culpable material non-disclosure that would alone require setting aside the ex parte relief: the omissions were not of the degree of materiality or deliberate concealment necessary to void the interim order.

Holding and Implications

Holding:

• The court REFUSED injunctive relief in relation to the March Notice and discharged the interim relief previously in place in respect of that Notice (the Defendant is entitled to proceed with termination under the March Notice for the Terminated Countries).
• The court GRANTED injunctive relief in relation to the April Notice but only insofar as it purports to terminate the Plaintiff's rights in the three jurisdictions where the Product has been launched (identified in the judgment as Country A, Country B and Country C). The Defendant is restrained from implementing or giving effect to the April Notice in respect of those three jurisdictions pending trial.

Implications:

• Practically, the Plaintiff may continue exclusive commercialisation of the Product in the three launched jurisdictions for the duration of the interlocutory relief; the Defendant may proceed to make its own arrangements (including contracting third parties) in respect of the Terminated Countries following discharge of the interim relief related to the March Notice.
• No conclusion on the ultimate contractual entitlements was reached; the trial will determine the substantive issues (including the precise contractual meaning of "insolvent" and causation for launch failures).
• The court's provisional view was that no order on costs be made, but parties were allowed to make submissions on costs. Directions for trial preparation were to be fixed at the next commercial list hearing.