ECLI:NL:RBAMS:2024:732

Uitspraak

judgment

AMSTERDAM DISTRICT COURT

Netherlands Commercial Court

NCC District Court

Case number: C/13/730389 (NCC 22/018)

Judgment

7 February 2024

Claimant, and defendant in the counterclaim:

DIAMEDICA THERAPEUTICS, INC,

Minneapolis, Minnesota (United States of America),

represented by B.F.H. Rumora-Scheltema, lawyer,

Defendant, and claimant in the counterclaim:

PHARMACEUTICAL RESEARCH ASSOCIATES GROUP B.V.,

Groningen (the Netherlands),

represented by A. Attaïbi, lawyer.

The parties are referred to as DiaMedica and PRA. They are jointly referred to as the ‘Parties’. The term ‘lawyer’ has the meaning as defined in Article 3.1.1 NCC Rules of Civil Procedure (NCCR).

1.Procedural history

1.1.

The proceedings to date are listed in the 21 April 2023 judgment (the ‘April Judgment’, publication number ECLI:NL:RBAMS:2023:2540). In the April Judgment, the Court ruled only on DiaMedica’s claim for revindication of documents and data.

1.2.

DiaMedica submitted a statement supplementing the grounds for its claim for damages on 26 July 2023.

1.3.

On 18 October 2023, PRA submitted its statement of defence against the claim for damages, including a statement of counterclaim. On 2 November 2023, PRA submitted a brief containing an increase of the counterclaim and additional exhibits.

1.4.

On 15 November 2023, DiaMedica submitted a motion for indemnity proceedings pursuant to Article 210 Dutch Code of Civil Procedure (DCCP). This motion was denied by the Court in its judgment dated 27 November 2023 (publication number ECLI:NL:RBAMS:2023:7593).

1.5.

On 4 December 2023, DiaMedica submitted its statement of defence against the counterclaim.

1.6.

The Parties submitted further exhibits.

1.7.

The Court held a hearing on 7 December 2023. Several persons representing the Parties attended the hearing in person or online (by videoconference). The lawyers of the Parties presented their cases, and submitted notes. The Court made a record (
proces-verbaal) of this hearing.

1.8.

The judgment date was set for today.

1.9.

Subsequently, as allowed by the Court, the Parties submitted exhibits on their costs leading up to and including the hearing on 7 December 2023, and briefs commenting on the additional exhibits.

2.Facts

2.1.

DiaMedica is a biopharmaceutical company. It developed a drug which was intended for the treatment of type 2 diabetes mellitus, called DM-199.

2.2.

PRA conducts clinical trials regarding the efficacy of newly developed pharmaceutical products. PRA is now a part of a larger international organisation after its merger into ICON plc in 2021.

2.3.

In March 2013, the Parties signed an Agreement for Clinical Trials Management Services (the ‘Agreement’). The relevant provisions of this Agreement are the following:

“(…)

Whereas PRA is engaged in the business of providing services related to the design, management and implementation of clinical development programs for the pharmaceutical, biotechnology and medical device industries; and

Whereas Sponsor [DiaMedica] desires to engage PRA to perform such services in connection with its pharmaceutical product known as DM-199 under development by or under control of Sponsor according to the Protocol titled,
“A Double-Blinded, Placebo-Controlled, Single-Dose and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof of Concept of DM-199 in Healthy Subjects and Patients with Type 2 Diabetes Mellitus”(the “Study”), which is attached hereto and incorporated herein by reference;

(…)

2.1

Components of this Agreement

(…)

c. Project Schedule.

i. The Project Schedule is attached hereto as Appendix C, which is incorporated herein by reference and includes major project milestones and deadlines for completion of each milestone. The Project Schedule identifies the Study Parts. PRA will not initiate each Study Part until it receives Sponsor’s prior written approval, which approval is in the sole discretion of Sponsor.

(…)

5.4

Representations and Warranties of PRA

(…)

b. PRA further represents and warrants that it will make available to Sponsor or to the responsible regulatory authority relevant records, programs, and data as may be reasonably requested by Sponsor for purposes related to filing and prosecution of Sponsor’s related new drug applications or other regulatory submissions.

(…)

Inspections

7.1

Inspection by Sponsor

During the term of this Agreement, PRA will permit representatives of Sponsor who are not competitors of PRA to examine, at a reasonable time during normal business hours and subject to at least ten (10) business days prior written notice to PRA: (i) the facilities where the Services are being conducted; (ii) related study documentation; and (iii) any other relevant information necessary for Sponsor to confirm that the Services are being conducted in conformance with applicable standard operating procedures, this Agreement and in compliance with applicable laws and regulations. PRA will provide copies of any materials reasonably requested by Sponsor during such inspection at no additional cost to Sponsor.

(…)

Ownership of data and intellectual property

All data (including without limitation, written, printed, graphic, video and audio material, and information contained in any computer database or computer readable form) generated by PRA in the course of conducting the Services (the “Data”) and related to the Services will be Sponsor’s property. Any copyrightable work created in connection with performance of the Services and contained in the Data will be considered work made for hire, whether published or unpublished, and all rights therein will be the property of Sponsor as employer, author and owner of copyright in such work.

PRA understands and agrees that the underlying rights to the intellectual property and materials that are the subject of this Agreement, including, without limitation, all intellectual property rights in Sponsor’s drug candidates or products and assays, are owned solely by Sponsor.

(…)

Notwithstanding the foregoing, Sponsor agrees that PRA possesses or may in the future possess analytical methods, computer technical expertise and software, which have been independently developed by PRA and which will remain the sole and exclusive property of PRA, except to the extent that improvements or modifications include, incorporate or are based upon Sponsor’s information. Improvements or enhancements made to PRA’s processes or methods which are independently developed incidental to the provision of Services hereunder will remain the sole property of PRA.

(…)

Governing Law

This Agreement will be governed in all respects by the laws of the State of New York, USA without regard to its conflict of laws principles of any jurisdiction.

(…)”

2.4.

The final version of the protocol referred to in the Agreement (the Protocol)^[1]reads - in so far as relevant to this case - as follows:

“(…)

3.7

Data Quality Assurance

(…)

Regulatory authorities, the IEC and/or the Sponsor may request access to all source documents, eCRFs, and other study documentation for on-site audit or inspection. Direct access to these documents must be guaranteed by the Investigator, who must provide support at all times for these activities.

(…)

2.5.

In April 2013 PRA started the DM-199 clinical trial.

2.6.

The clinical trial ended on 3 October 2014. Subsequently, the database containing the clinical trial data was locked (on 22 October 2014) and the clinical trial data were unblinded (on 23 October 2014).

2.7.

In November 2016, PRA shared the latest draft clinical study report of the DM-199 trial (the Draft Report) with DiaMedica. The conclusion of the Draft Report was that DM-199 was safe, but, due to the positive results in the placebo group, not effective as a treatment for type 2 diabetes. To date DiaMedica has declined to approve the Draft Report because – in its view – PRA refused to provide all data necessary to assess the clinical trial.

2.8.

By judgment dated 28 November 2022, the Court in Summary Proceedings of the District Court of the Northern Netherlands granted leave for
inter aliaa prejudgment attachment on all data which are DiaMedica’s property under Article 9.0 of the Agreement, and to transfer these data to a depositary appointed by the Court and be held in judicial custody.

2.9.

On 7 December 2022, the bailiff attached copies of the data referred to in the attachment leave (the Attachment), by having 51 hardcopy folders scanned by the custodian and copying certain “digital files”, which were not specified by the bailiff in his official record, to a data carrier, and subsequently surrendered these copies and the data carrier to the judicial custodian.

2.10.

By judgment of 21 December 2022, the Court in Summary Proceedings of the District Court of Amsterdam denied an application to lift the Attachment because DiaMedica’s revindication claim was not shown on summary enquiry to be without merit, nor was the attachment and custody of the data detrimental to PRA.

2.11.

By judgment dated 21 April 2023 (the April Judgment), this Court ordered PRA to allow and tolerate that DiaMedica exercises its rights as owner of the physical documents related to the clinical trial (the Physical Documents) and to cooperate with the surrender of the Physical Documents, including the data carrier with digital data relating to the clinical trial (the Digital Data), by the judicial custodian to DiaMedica.

2.12.

On 2 May 2023, the bailiff instructed by DiaMedica served the April Judgment on PRA, and ordered PRA to comply with the judgment.

2.13.

On 15 June 2023, PRA lodged an appeal against the April Judgment.

3.DiaMedica’s claims for damages

3.1.

By the notification referred to under para. 1.4 of the April Judgment, DiaMedica amended its claim as initiated by writ of summons so that its remaining claims now read that the Court by judgment, enforceable notwithstanding appeal to the extent permitted by law:

order PRA to pay DiaMedica damages in the amount of USD 74,375,914 plus interest, or, alternatively (if the Court rejects DiaMedica’s claim for costs of a new study, see para. 3.3 below) USD 67,688,401 plus interest after 31 July 2023,

order PRA to pay the full costs of these proceedings, to be increased by statutory interest,

order PRA to pay the post-judgment costs (
nakosten), to be increased by statutory interest.

3.2.

The damages claim (claim 1) seeks damages allegedly caused by PRA as a result of breach of contract as well as non-contractual causes of action under New York law: breach of the implied covenant of good faith and fair dealing, fraudulent inducement and fraudulent or negligent representation.

3.3.

Claim 1 consists of the following components (including interest through 31 July 2023):

i) the costs of a new study USD 6,687,513
ii) a loss of income from a licence agreement in May 2014 USD 21,044,685
iii) a value decrease of DiaMedica's business USD 37,890,636
iv) the inability to raise funds through an offering of shares

in November 2014
USD 8,753,080

Total = USD 74,375,914

Under the alternative claim component (i) is replaced by a claim to return the amounts already paid to PRA under the Agreement (CAD 2,755,270.63).

If the Court is unable to assess the damage suffered by DiaMedica, DiaMedica requests the Court to refer the matter to quantification proceedings (
schadestaatprocedure) pursuant to Article 612 DCCP.

3.4.

Claim 2 includes the following elements:

additional attachment costs,
judgment enforcement costs,
attorney’s fees,
expert’s fees, and
legal costs awarded in these proceedings to date.

4.Discussion of DiaMedica’s claim for damages

Violation of Article 21 DCCP?

4.1.

PRA’s preliminary defence – which must be dealt with first – is that DiaMedica violated Article 21 DCCP by repeatedly presenting facts incorrectly and incompletely, taking false, misleading or inconsistent positions, providing no or insufficient substantiation and withholding information. PRA argues DiaMedica should therefore be declared inadmissible in its claims. Alternatively, in PRA’s view, the Court should take measures in the context of allocating the burden of proof, denying DiaMedica the right to make further written submissions or awarding costs in these proceedings.

4.2.

Under Article 21 DCCP the parties have an obligation to make a full and truthful presentation of the facts that are relevant to the decision in the matter. In the event of non-compliance, the court may draw such adverse inferences as it considers appropriate.

4.3.

The Court notes that many of the issues raised by PRA relate to an alleged lack of evidence of facts presented by DiaMedica. However, Article 21 DCCP only applies to questions of fact; it does not concern issues that pertain to the weighing of evidence – that is, issues as to whether a party has or has not proven its case. Only where a fact presented by one party is disputed by the counterparty, and the court believes it is relevant for the decision of the case, does the matter of evidence arise.
Whether or not a party can change its position during the proceedings is not regulated by Article 21 DCCP either, but by the principle of due process.

Furthermore, the parties are free to provide their own interpretation of the facts they presented. Insofar as the issues raised by PRA relate to interpretation, they cannot result in a violation of Article 21 DCCP.

Only where facts which are relevant to the decision are presented in an incorrect or misleading way, or omitted, does Article 21 come into play.

Based on the above analysis, the Court rules that the issues raised by PRA in this context are insufficient to amount to a violation of Article 21 warranting the imposition of measures by the Court. The Court’s decision is based on three particular points:

First, while it is true that DiaMedica’s submissions in the proceedings did not refer to every email where it expressed its cautious response, such a reference was in the Court’s view not necessary, because DiaMedica acknowledged (in its statement supplementing grounds for its damages claim) that it was cautious about giving too much weight to statements given by André [X] (PRA’s Vice President Medical Affairs and Early Development Services at the time, ‘[X]’) and referred to its email dated 25 February 2014 (see para. 37 of the statement).
Second, there is no violation of Article 21 DCCP where DiaMedica fails to disclose information it is unaware of. On the basis of DiaMedica’s statements and PRA’s rebuttal, it is not clear to the Court which documents and data were available to DiaMedica in 2014 and the years after, nor is it clear which visits DiaMedica made or wished to make to PRA’s study site. The Court did not rule on this issue in the April Judgment.

 Third, DiaMedica could and should have mentioned a successful public offering of shares in May 2014, given its statement that the November 2014 public offering was cancelled because of
inter aliaa statement made by [X] in February 2014. However, this is not relevant for purposes of the Court’s analysis and decisions.

Applicable law

4.4.

As this is an international matter, the Court must first assess, on its own initiative, which law is applicable to the various underlying issues.

4.5.

The main allegations relied on by DiaMedica to support its claims are as follows:

PRA (represented by [X]) made false statements regarding the design of the clinical study prior to entering into the Agreement,

[X] reported positive interim test results which after unblinding proved unfounded,

PRA refused to provide DiaMedica access to the study data and study site.

4.6.

The interpretation of the Agreement and the consequences of an (alleged) breach of contractual obligations are governed by New York law, pursuant to the choice of law clause in the Agreement which fulfils the requirements of Article 3 of the Rome I Regulation^[3](see para 4.5 of the April Judgment). This also applies to the issue as to whether PRA refused to provide DiaMedica access to the study data and study site, because PRA’s obligation to give DiaMedica access to the study data and study site is explicitly provided for in the Agreement (Articles 5.4(b), 7.1 and 9.0 of the Agreement and Article 3.7 of the Protocol which was incorporated by reference into the Agreement).

4.7.

The same applies to the obligations allegedly breached by PRA insofar as these obligations are not covered by specific provisions of the Agreement, such as the issue as to whether PRA is liable for reporting positive interim test results which after unblinding proved unfounded. These obligations are not ‘non-contractual obligations’ under Article 1 of the Rome II Regulation.^[4]The parties were unanimous, taking the view that the obligations were non-contractual in nature, but the Court notes the EU Court of Justice case law to the effect that the deciding factor in determining whether an action relates to a contract or not is whether “the interpretation of the contract between the defendant and the applicant appears indispensable to establish the lawful or, on the contrary, unlawful nature of the conduct complained of against the former by the latter”.^[5]This case law was generated in the context of jurisdiction issues under the Brussels regime.^[6]However, as the Court of Justice ruled in the
Amazoncase,^[7]the concepts of ‘contractual obligation’ and ‘non-contractual obligation’ in the Rome I and Rome II Regulations are to be interpreted “taking into account the aim that those regulations should be applied consistently with each other and with the Brussels regime”, more specifically when it relates to the “distinction (…) between matters relating to contract and matters relating to tort, delict and quasi-delict.”

4.8.

The Court cannot see how the lawful or unlawful nature of reporting any allegedly unfounded interim test results can be determined without:

interpreting the contract with respect to the existence of a contractual obligation to report interim test results,
determining the status of interim test results,
determining the stage of the clinical study where these results were given, and
determining the contents of the unblinded data generated under the Agreement.

Therefore, the Court’s conclusion is that the interpretation of the Agreement is indispensable. This means, under the ECJ standard, that New York law is also applicable to DiaMedica’s statements regarding the alleged reporting of interim test results.

4.9.

The Court reaches the same conclusion when it comes to DiaMedica’s argument that [X], acting on behalf of PRA, made false statements regarding the design of the clinical study prior to entering into the Agreement. In addition, in the Court’s opinion, even if the interpretation of the Agreement were not to be deemed indispensable under the ECJ standard, New York law would be applicable, since under Article 12(1) of the Rome II Regulation a non-contractual obligation arising out of dealings prior to the conclusion of a contract would be governed by the law that applies to the contract.

Study design

4.10.

DiaMedica’s reasoning emphasises the following points:

In late 2011, PRA solicited DiaMedica with a proposal to conduct a clinical study to determine the safety and efficacy of DM-199 as a treatment for type 2 diabetes.
During subsequent discussions [X] spoke about the consistency and reliability of PRA's previous clinical studies in type 2 diabetes. According to DiaMedica, [X] in these discussions repeatedly stated that PRA's study design "worked like clockwork", meaning that every time it had been conducted, the study design – involving sequestration of patients – had never resulted in any positive responses in subjects receiving placebo treatment (the control group). As such, a positive response could only occur as the result of an active drug.
The knowledge, experience and global reach PRA presented induced DiaMedica to engage in further discussions and finally to enter into the Agreement with PRA.

4.11.

It is helpful to recite the key points of New York law here. To state a claim for fraudulent inducement under New York law, a plaintiff must establish that: (1) the defendant made a representation; (2) regarding a material existing fact; (3) which was false; (4) known by the defendant to be false; (5) the representation was made for the purpose of inducing plaintiff to rely upon it; and (6) that plaintiff reasonably did so rely; (7) in ignorance of its falsity; and (8) suffered damages or injury as a result.

Plaintiff may not rely on defendants' purported misrepresentations of future intent to perform; plaintiff must identify misrepresentations of presently existing facts made to induce plaintiff to enter the (..) Agreement.^[8]

4.12.

Even if the Court were to assume for purposes of argument that [X] on behalf of PRA praised PRA’s study design as “working like clockwork”, the context shows that this statement by [X] was not intended as a guarantee against positive results in trial participants who are not administered DiaMedica’s drug. A reasonable person of the same kind as the parties would not have understood the statement that way in the same circumstances.

4.13.

Moreover, DiaMedica did not argue that this alleged statement by [X] was a false statement regarding the history of PRA’s study design. DiaMedica did not allege that PRA’s study design prior to it being applied to DiaMedica’s drug had ever generated any positive responses in subjects receiving placebo treatment, nor that PRA in its study for DiaMedica failed to sequester the patients participating in the trial. When conducting the study for DiaMedica, [X] assumed that any positive responses could be nothing else but evidence of efficacy of the compound (see the emails under para. 4.15 below).

4.14.

Therefore, the Court’s conclusion is that the requirements of New York law are not met. DiaMedica cannot rely on fraudulent inducement to support its claims.

Interim test results

4.15.

DiaMedica argues that starting in February 2014, [X] informed DiaMedica of positive interim test results consisting of substantial weight loss and glucose level decreases in several persons participating in the clinical trial:

 in his email of 25 February 2014 4:27 AM^[9](Exhibit 15 DiaMedica), [X] reported to [Y]:^[10]“
Regarding the main study, I start to see convincing signs of efficacy in certain patients, which to my experience is hopeful because it occurred already < 14 days. The latest results of this morning are added here for your information, the divergence between the last 2 subjects, of which one is clearly consistent with placebo treatment and the other (407) showing normalizing of fasting glucoses, is striking. If I see these results, I am very curious to know what a dose of 15 mcg/kg will do. Of course we need patience here, but I feel quite some enthousiasm currently.”

 the same day (at 7:00:31 AM CST)^[11][X] wrote to [Y]: "
I have studied approximately 40 compounds over 20 years for safety, tolerability and efficacy, some variation in the way placebo treated patients behave was indeed present, but never to the extent as manifested by subject 407. The latter cannot be else than efficacy based on an active compound."

 in his email of 12 March 2014^[12][X] wrote to [Y] and [Z]:^[13]

“Also I followed the results of subject 407 with great astonishment in the last 14 days. The drop in fasting glc in subject 407 over time was impressive compared to for example subject 405 where fasting glc steadily rose as under placebo (or inefficacious compound). My gut feeling is that subject 407 has received the 15 mcg/kg dose and I was eagerly waiting for the results of the C-peptide levels on day 28, however, the fasting c-peptide does not show any difference from baseline level, but we may be too early to see it.”

Unblinding of the study data (in October 2014) and the subsequent provision of the Draft Report showed results that deviated significantly from the positive interim results that [X] had communicated to DiaMedica, some of which appeared to have been observed in placebo participants. According to DiaMedica, it was persuaded by [X]'s firmness, close involvement, knowledge and experience, as well as PRA's professionalism, and relied on [X]'s statements on the positive interim test results and considered them in taking critical business decisions, such as the cancellation of licensing negotiations with MedImmune in May 2014 and the cancellation of a public offering of shares in November 2014.

4.16.

The Court notes that DiaMedica did not point to any provision in the contract (the Agreement and related documents) containing an obligation for PRA to report interim test results to DiaMedica. This means that the statements made by [X] mentioned in para. 4.15 were not made pursuant to any obligation under the Agreement. This suggests [X]’s communications were more informal and off-the-record, such that there was little reason for them to induce any reliance at all.

4.17.

In any event, New York law
inter aliarequires the statements to be fraudulent or negligent representations, and furthermore that the plaintiff must have reasonably relied on the misrepresentations.^[14]The Court finds that DiaMedica cannot have (reasonably) relied on the statements made by [X] in the emails mentioned in para. 4.15. All statements were made in the stage of the clinical trial where all data were double-blinded, which means that DiaMedica did not know, nor did [X] or anyone else at PRA know, which participants received the drug and which participants a placebo. This shows that [X] made the statements without full knowledge of the facts needed to suggest efficacy of DiaMedica’s drug, as DiaMedica well knew. His statements were focussed on only a couple of participants, and therefore cannot be characterised as interim results, but are to be considered off-the-cuff observations in ongoing discussions between professionals during the trial. This is also evident from the language used by [X]:
“hopeful”, “we need patience here“, “gut feeling”and
“we may be too early to see”.

4.18.

As a professional biopharmaceutical company DiaMedica knew or should have known the limited significance of these observations. The emails exchanged in the time period [X]’s statements were made show that it did know [
emphasis added by the Court]:

 “ “
We appreciate yourobservationson our study. We are currently studying placebo, 3 and 15 mcg/kg dm199 doses randomized in blocks of 6 so we will see the dose responsewhen the study is unblinded.It looksfrom the first 7 subjects so far we are seeing an effect butwith the blind we are hesitant to draw any real conclusions.”;^[15]this email precedes the second 25 February 2014 email relied on by DiaMedica, but is nevertheless relevant in order to see how [X]’s initial observations in the first email - dated 25 February 2014 4:27 AM - were perceived by DiaMedica;

 “ “
While the study is blindeditlooks likeSubjects 401, 403 and 407 are responding in the MTT and possibly HbA1c.Hate to go too far with blinded databut looks promisingat this early stage.”;^[16]

 “
“Subject 407had the largest % reduction in their glucose AUC in the MTT on Day 28. It was down close to 35% from the baseline MTT on Day -1. Thanks for your comments. As you can tell we arecautiously excitedby the data we've seen to date, althoughwell aware that it is blindedandsometimes surprising things are noted in studies.”;^[17]

 “ “
Patient 407 had a remarkable drop in FBG levels.Hopefullywe'll continue seeing this type of response andwhen we unblind the studywe arenot surprised.”^[18]

 “ “
Thanks [X] foryour thoughts. Fascinating. We do not appear to be a secretogogue like a GLPI analog.If we are correctit is having an insulin sensitization effect. There is literature suggesting that ACEi and ARBs also act as insulin sensitiziers. Tissue kallikrein should counterbalance the RAS somewhat so that may be part of its MoA. Anyway itdoes lookquite different in man than in ZDF rats.More data to come.”^[19]

4.19.

The conclusion of the Court’s analysis is that, in light of the contents of these emails, DiaMedica cannot have reasonably relied on the statements made by [X] as comprehensive test results. Insofar as DiaMedica relied on phone calls allegedly made by [X] on the same test results, it failed to state the contents of such phone calls. Therefore, the Court cannot reach a different conclusion regarding the phone calls than it did regarding the emails. Any claims based on fraudulent or negligent misrepresentation under New York law are therefore denied.

Access to study data and study site

4.20.

DiaMedica’s reasoning is as follows:

With the receipt of the Draft Report in November 2016, DiaMedica had not yet obtained all the information to which it was entitled under the Agreement.
PRA refused to provide DiaMedica with the full (underlying) study data set and denied DiaMedica access to its facility to perform an on-site audit unless and until DiaMedica agreed to finalise the draft clinical study report and make the last payment due.
Because of PRA's refusal DiaMedica was unable to assess the accuracy of the conduct of the study and the reported results, fulfil its obligations as a study sponsor and approve the Draft Report.
The lack of an accurate final study report also prevented DiaMedica from moving forward with the development of DM-199 as a treatment for type 2 diabetes.

4.21.

It is helpful to recite the key points of New York law here. In order to prove a breach of contract cause of action under New York law, the claimant must prove that a defendant's breach was the proximate cause of its damages. The damages which a party may recover for a breach of contract include damages which ordinarily and naturally ensue from the non-performance. In the law of contracts, as in torts, causation in fact is established if the defendant's breach of duty was a substantial factor in producing the damage. This test is satisfied if the defendant's actions would be thought of by people generally as having operated to an important extent in producing the harmful result. It is not necessary that the breaches be the exclusive cause or the sole cause of the damages. Damages must nevertheless be reasonably certain and directly traceable to the breach, not remote or the result of other intervening causes. To break the legal chain, the intervening act must have been of such an extraordinary nature or so attenuated from the defendant’s conduct that responsibility for the injury should not reasonably be attributed to it.^[20]

4.22.

Turning to the case at hand, this means that DiaMedica must show that not having access to the study data and study site was the direct and proximate cause of the cancellation of the negotiations with MedImmune to license DM-199 in May 2014 and the cancellation of the public offering and drop in equity in November 2014. In the Court’s opinion, DiaMedica failed to do so.

4.23.

DiaMedica argues that it was forced to discontinue the licensing and the

public offering of shares “
because of the litigation risks associated with not factoring in the positive results[reported by [X]; see para. 4.15; comment added by the Court]
into economic terms of the licensing agreement and the market value of its shares.^[21]However, it did not explain how the alleged lack of access to the study data and the study site played a role in these decisions.

4.24.

When it comes to the public offering of shares, the 2 December 2014 email^[22]shows that it is much more likely that the cancellation of the public offering and drop in equity were caused by the results of the clinical trial showing no efficacy of DiaMedica’s drug:
“DiaMedica has tried over the Summer and early Fall unsuccessfully to raise additional capital. We announced a financing in late October, but had to withdraw that financing in light of upcoming clinical trial results and lack of interest from investors prior to the data. We did receive the TFL from PRA in mid-November. The trial did not meet any of the secondary efficacy endpoints. We announced the trial results on November 17th and our stock has dropped from about $0.40 to $0.05 since we announced the results.”

4.25.

Insofar as DiaMedica argues that these events result from not being able to present a coherent explanation for the disappointing study results, the Court notes that:

 DiaMedica does not dispute it had remote access to the study data in 2014;^[23]the access is also evidenced by the emails quoted in para. 4.18 of this judgment, and

 it took DiaMedica almost three years after the remote access to the data had ended and the data were unblinded (in October 2014) to raise a dispute under the Agreement. If the lack of underlying documents was in fact the cause of DiaMedica’s damages, it could and would have raised the dispute much earlier.

4.26.

The alleged lack of access to the study data and study site does not warrant conducting (parts of) the study all over again, by a different CRO, as DiaMedica claims, or in the alternative, returning the money paid for the services provided by PRA.

First, the primary focus since 2015 has been on the development of DM-199 for the treatment of acute ischemic stroke (AIS) and cardio-renal disease (CRD).^[24]Under these circumstances it does not make sense to redo the clinical trial in an effort to develop a drug for type 2 diabetes.

Second, DiaMedica did not argue that PRA made substantial errors when conducting the study or that the outcome was incorrect, but only that it was unable to determine whether the study was properly performed.^[25]Under the April Judgment DiaMedica has been granted access to the underlying documents and data. Through the enforcement of the April Judgment DiaMedica obtained the Physical Documents relating to the study. PRA did not challenge the enforcement prior to DiaMedica submitting its statement supplementing the grounds for its claim for damages.^[26]While drafting the statement supplementing its grounds, DiaMedica therefore had access to the Physical Documents. The access to the Physical Documents did not prompt DiaMedica to rely on any of these documents to substantiate any major shortcomings in the way the clinical trial was conducted. If there were any substantial errors evidenced by these documents, DiaMedica would certainly have submitted these errors to the Court. Moreover, it could have asked for a stay of the proceedings until the decision was given on PRA’s appeal in order for it to obtain the remainder of the data (if allowed by the NCC Court of Appeal), but it decided not to do so.

Conclusions as to DiaMedica’s damages claims

4.27.

The above leads to the conclusion that DiaMedica’s claims for damages are denied.

Costs of the proceedings

4.28.

DiaMedica is unsuccessful with its damages claim, but its revindication claims were awarded (see the April Judgment). On balance, however, the Court finds that DiaMedica is to be considered the unsuccessful party because the revindication claims also served to substantiate the damages claims and these claims are dismissed in today’s judgment.

4.29.

In the counterclaim PRA seeks full compensation of its costs of these and other proceedings. Therefore, the Court will deal with that claim first before deciding on the amount of the costs that DiaMedica will have to pay to PRA in the original action.

5.PRA’s counterclaims

5.1.

In its brief dated 2 November 2023, PRA increased its counterclaim initiated in its statement of counterclaim, so that its claims now read that the Court by judgment, enforceable notwithstanding appeal to the extent permitted by law:

order DiaMedica to fulfil its obligations under the Agreement and/or to pay PRA any amounts due under the Agreement and/or the full damages it has suffered as a result of DiaMedica’s breach of the Agreement and/or abuse of rights and/or acting in tort towards PRA and/or any other ground in refusing to approve the Draft Report and subsequently suing PRA for a frivolous claim, to be increased with statutory interest;

declare the enforcement of the April Judgment by DiaMedica:

a. unlawful, and

b. null and void,

c. or alternatively, to annul the enforcement of the April Judgment;

3. declare the enforcement of the April Judgment by DiaMedica constitutes a wrongful act (
onrechtmatige daad) towards PRA;

4. order DiaMedica to comply with the April Judgment and to end and undo the current unlawful situation and wrongful act by ordering DiaMedica to:

a. return to the Judicial Custodian all original Physical Documents, as they were obtained by DiaMedica through the (unlawful) enforcement of the April Judgment via the bailiff,

b. destroy, delete and remove definitely from any (digital) data system, in the broadest sense, all digital or non-digital copies of the Physical Documents obtained by DiaMedica through the (unlawful) enforcement of the April Judgment, and

c. procure and confirm that DiaMedica itself, its attorneys, the bailiff and any other persons who obtained (copies of) the Physical Documents, have complied with these orders, subject to a penalty,

5. prohibit DiaMedica from using in any way possible the Physical Documents, any copies thereof and any information included therein, in the broadest sense, in the current and any other proceedings, subject to a penalty,

6. declare this prohibition will remain in effect unless and until a final (
res judicata) judgment is issued on DiaMedica’s revindication claim allowing DiaMedica to obtain and use the Physical Documents,

7. order DiaMedica to pay the costs of the proceedings, to be increased with statutory interest,

8. order DiaMedica to pay the post-judgment costs (
nakosten), to be increased with statutory interest.

5.2.

Under counterclaim 1 PRA is seeking:

i) compensation for damages due to a breach of the Agreement, in the amount of the last payment due under the Agreement of € 189,961.00, and
ii) payment of PRA's full costs of the proceedings (pre-proceedings and proceedings) in this

and all previous proceedings against DiaMedica, including:

 attorney's fees,

 legal costs awarded and judgment enforcement costs, and

 expert's fees.

In the alternative, in PRA’s view, the Court should award a (much) higher amount than the usual cost award based on the court-approved scale of costs (paras. 484, 492 and 493 of PRA’s statement of counterclaim).

6.Discussion of PRA’s counterclaims

Applicable law

6.1.

The Court first must determine the law applicable to the counterclaim, focusing on four key points.

6.2.

First, insofar as the counterclaims are based on breach of the Agreement, the same law applies as to the original claim (see para. 4.6): New York law.

6.3.

Second, in respect of the counterclaim for legal costs, there is no doubt that the costs of judicial proceedings and how these costs are distributed over the Parties at the end of the proceedings is a procedural matter which is excluded from the scope of the Rome I and Rome II Regulations (see Article 1(3) of both Regulations). Therefore, it is governed by the
lex fori(Article 10:3 Dutch Civil Code (DCC)), which is Dutch law. In the Court’s opinion this includes the question whether the way in which the proceedings before the Dutch courts were conducted amounts to abuse of (procedural) rights or wrongful act. Such a qualification is so intertwined with the applicable rules of procedure that it cannot be considered a separate issue to be decided by the
lex causae.

6.4.

Third, in respect of the counterclaim for costs of proceedings in other jurisdictions, the same applies to the question whether the way proceedings before foreign courts were conducted amounts to abuse of (procedural) law or a wrongful act. This question needs to be decided by the
lex foriof the court dealing with the proceedings. This finding is supported by the legislative history to Article 10:3 DCC, which states that where in proceedings before a Dutch court the question arises which procedural law is applicable in proceedings before a foreign court, the court may assume that the foreign court will also apply its domestic procedural law.^[27]

6.5.

Fourth, in respect of the counterclaim for damages relating to enforcement, the same applies to the validity of the enforcement in the Netherlands of this Court’s April Judgment (counterclaims 2 to 6). This is a domestic procedural matter, which is governed by Dutch procedural law.

Compensation for damages due to a breach of the Agreement (counterclaim 1(i))

6.6.

PRA alleges that DiaMedica by not approving the Draft Report breached Article 2.1(c) of the Agreement, and that this entitles PRA under New York law to immediately claim damages for a total breach and to be relieved of any obligation to tender or prove the ability to render future performance.

6.7.

In the April Judgment, the Court ruled that DiaMedica is not in breach of any obligation under the Agreement (see para. 4.49 of that judgment). Pursuant to Article 2.1(c)(i) of the Agreement the approval of the Draft Report is in the sole discretion of Sponsor, which is DiaMedica (see para. 4.48 of the April Judgment). The Court further ruled that there was no basis to permit a suspension by PRA now in anticipation of a potential future failure to pay the final invoice after receiving the Documents and approving the Draft Report (para. 4.49 of the April Judgment).

6.8.

This decision is a ‘binding final decision’ (
bindende eindbeslissing) under Dutch procedural law, which means that a court can only revisit such a decision where it is shown that the decision was based on an incorrect legal or factual basis.^[28]The arguments raised by PRA do not qualify as such. Counterclaim 1(i) will therefore be denied.

6.9.

The Court also denies PRA’s claim for the final payment for services rendered, because the agreed milestone that triggers that payment has not occurred. That milestone is the approval of the Draft Report in DiaMedica’s sole discretion. The Court notes that after DiaMedica has an opportunity to review documents provided by PRA (if allowed by the NCC Court of Appeal), there may come a day on which DiaMedica may no longer be allowed to withhold its approval: the discretion granted to DiaMedica by the agreement is not a licence to postpone payment indefinitely for no good reason.

Payment of full costs of legal proceedings (counterclaim 1(ii))

6.10.

PRA argues that DiaMedica recklessly pursued its frivolous claims against PRA in legal proceedings in courts outside and inside the Netherlands, and that this constitutes an abuse of (procedural) law and/or tort throughout all proceedings. On this basis PRA seeks compensation for the full costs of proceedings, incurred both in the Netherlands and abroad.

6.11.

As to the proceedings conducted between the Parties before foreign courts, the Court notes that PRA did not provide any details on these proceedings. It merely stated that:

DiaMedica withdrew the action initiated before the Southern District Court of New York in 2017 in the face of PRA's challenge to that court's jurisdiction,
PRA successfully challenged the personal jurisdiction of the United States District Court for the District of Delaware in 2018, and resisted DiaMedica's related motion seeking to transfer the matter to a third US jurisdiction,
the discovery proceedings before the Eastern District Court of North Carolina were no longer pursued by DiaMedica as a result of the April Judgment.

6.12.

In order to assess whether initiating these proceedings can be considered an abuse of procedural rights or a wrongful act, as PRA contends, the Court needs information regarding:

the grounds provided by DiaMedica to litigate before these courts, and whether it was reasonable for DiaMedica to rely on these grounds at the time,
whether the foreign courts gave a decision on PRA’s costs in these proceedings, or, if not, whether it was possible for PRA to request a decision on this point under applicable procedural law.

6.13.

PRA furnished no facts on these issues. Therefore, the Court is unable to make this assessment. PRA’s claim will therefore be denied in respect of the costs of the foreign legal proceedings.

6.14.

The only question remaining is therefore whether the way DiaMedica conducted the proceedings before the Dutch courts amounts to an abuse of procedural rights or a wrongful act.

6.15.

According to the Dutch Supreme Court’s case law, abuse of procedural law only exists if the claim should not have been brought, in view of its manifest lack of merit, in connection with the interests of the other party involved. This can only be the case if the claimant bases its claim on facts and circumstances which it knew or should have known to be incorrect or on statements of which it should have understood in advance that they had no chance of success. When assessing alleged abuse of procedural law or wrongful acts by initiating proceedings, restraint is appropriate, in view of the right to access to justice that is also guaranteed by Article 6 of the European Convention on Human Rights.^[29]

6.16.

In its April Judgment this Court granted most of DiaMedica’s revindication claims. This clearly shows that these claims were not manifestly without merit, and that the attachment of the revindicated documents and data was not unnecessary. The fact that DiaMedica added this claim only after the referral of the case to this Court is irrelevant. A party is allowed, under the conditions provided by Dutch procedural law, to amend its claims. In this judgment the Court denies DiaMedica’s claims for damages, but that does not mean it did not have an arguable case from the outset. As the Court’s discussion of DiaMedica’s claims for damages show, there was a case to be made for fraudulent inducement and misrepresentation under New York law. This means that the high threshold for abuse of procedural law is not met. Counterclaim 1(ii) is therefore denied.

Enforcement of the April Judgment (counterclaims 2 to 6)

6.17.

PRA argues that the enforcement by DiaMedica of this Court’s April Judgment was unlawful and null and void, as the bailiff failed to observe the statutory requirement of an 8-day (or at least a 2-day) prior notice before initiating the enforcement, and DiaMedica’s counsel failed to inform PRA’s counsel of the imminent enforcement.^[30]By doing so, in PRA’s view, it violated Articles 432, 491 and 439 DCCP and also committed a tort pursuant to Articles 6:162 and 6:172 DCC.

6.18.

The bailiff served the April Judgment on PRA on 2 May 2023, and ordered PRA to comply with the court order to allow and tolerate that DiaMedica exercises its right as owner of the Physical Documents and to cooperate with the surrender of the relevant documents as provided for in para. 5.2 of the April Judgment. DiaMedica alleges that on the same day, but after this order to PRA, the bailiff collected copies of the Physical Documents from the judicial custodian. The enforcement was also initiated regarding the order to cooperate with the surrender of the Digital Data, but DiaMedica ceased the required process of specification and selection on learning of the appeal proceedings initated by PRA. DiaMedica alleges that the bailiff handed over the Physical Documents to DiaMedica’s representative on 5 May 2023, which is after the 2-day period of Article 439 expired. According to DiaMedica, the 8-day period referred to by PRA (pursuant to Article 432 DCCP) was not applicable, as the custodian cannot be considered a ‘third party’ under that Article.

6.19.

The Court recites the relevant procedural law here. Under Article 430(3) DCCP a judgment may only be enforced after service on the party against whom the enforcement is sought. Where the judgment relates to the surrender of movables, the bailiff serving the judgment must also order the judgment-debtor to comply with the judgment within 2 days. The bailiff must not take further enforcement action until after expiration of the 2-day period (Article 491(1) in connection with Article 439(1) DCCP). Where enforcement is sought against a third party, an 8-day period must have lapsed after the judgment was served on the unsuccesful party (Article 432 DCCP) before the enforcement can be pursued.

6.20.

In this case the Court need not take a decision on whether the judicial custodian is a ‘third party’ under Article 432 DCCP. Even if the judicial custodian is not such a third party, the way in which the enforcement was carried out, in the Court’s view, violated Article 491(1) in connection with Article 439 DCCP:

The writ by which the April judgment was served on PRA did not contain any time period within which PRA was obligated to comply with the Court order to tolerate and cooperate with the surrender of the documents and data. The writ only contained such a notice period for the second part of the April Judgment (the cost award).
The bailiff instructed by DiaMedica to enforce the April Judgment did not observe the expiration of the 2-day period before taking possession of the Physical Documents. He did so the same day the writ was served on PRA. Pursuant to Article 491(2) a bailiff’s taking possession of the movables constitutes an act of enforcement. Although the bailiff handed over the Physical Documents to DiaMedica only 2 days later, the enforcement started when the bailiff took possession and this was too soon.

6.21.

The consequence of such irregularities (i.e. not observing the two day period of Article 439 DCCP) is that the subsequent enforcement was invalid (Article 65 DCCP).^[31]However, the enforcement is only to be declared invalid to the extent that it is likely that the addresssee of the writ and the subsequent enforcement is unreasonably prejudiced by the defect (Article 66(1) DCCP). As noted above, the writ served on PRA did not contain any time period within which PRA was obligated to comply with the Court order to cooperate with the surrender of the documents and data, whereas the writ did contain such a time period for the the cost award. It seems likely that PRA was under the impression that DiaMedica was not in a hurry to enforce this Court order, and therefore would wait to see whether or not PRA appealed the April Judgment. This likelihood is corroborated by the notion that DiaMedica’s lawyer would have to notify PRA’s
counselof any enforcement measure under Article 6.2 of the Code of Conduct of the Dutch Bar Association. DiaMedica’s lawyer in fact did not notify PRA’s lawyer of the initiation of the enforcement of the April Judgment. Instead, DiaMedica’s lawyer communicated to PRA’s lawyer that if she did not receive any confirmation from PRA by 5 May 2023 that PRA did not intend to appeal, she would advise her client (DiaMedica) to request an extension from the Court to submit its statement supplementing grounds for the damages claim.^[32]By doing so, PRA was induced to think it had ample time to appeal. If PRA had known at the time the April Judgment was served that the bailiff would take possession of the Physical Documents the same day the judgment was served, it is more than likely that PRA would have immediately initiated appeal proceedings in order to prevent DiaMedica from having access to the contents of the documents. But in fact, PRA did not know until DiaMedica submitted its statement supplementing grounds for its claim for damages, stating (in para. 59) that it “recently gained access to the Physical Documents”.^[33]The fact that PRA was not aware earlier is not surprising since the enforcement took place outside PRA’s ambit and without PRA’s knowledge: the Physical Documents were in the custody of the judicial custodian, the custodian transferred them to the bailiff, and the bailiff transferred them to DiaMedica. This was done without PRA’s knowledge and without it receiving any prior notification from DiaMedica’s lawyer.

6.22.

Therefore, the Court rules that PRA was unreasonably prejudiced by the defect in the writ and the untimely enforcement of the April Judgment.

6.23.

This defect cannot be remedied by serving a corrective writ (Article 66(2) DCCP).This means that the writ is to be declared invalid, and therefore also any enforcement actions taken on the basis of this writ are invalid.

6.24.

The conclusion of the above is that counterclaims 2, 4, 5 and 6 will be awarded as reflected in the decisions below. The Court will not impose a penalty on DiaMedica for any non-compliance with counterclaims 5 and 6, as claimed by PRA. The Court expects that these orders will be complied with at this stage, given the fact that two independent parties, the bailiff and the judicial custodian, will be involved in the enforcement. If not, the Court (or the Court in Summary Proceedings) can order any appropriate relief that might be required at a later stage as needed. It will not do so now, as this may give rise to enforcement issues.

6.25.

The Court will deny counterclaim 3, which seeks a declaration by this Court that the enforcement of the April Judgment by DiaMedica also constitutes a wrongful act (
onrechtmatige daad) towards PRA. According to Supreme Court case law, the strict liability of the party instructing the bailiff to make an attachment does not extend to errors made by the bailiff in making the attachment.^[34]The Court holds that the same applies to errors made by the bailiff in the enforcement of a judgment. This means that the enforcement does not constitute a tort attributable to DiaMedica and that DiaMedica is not liable for any damages resulting from the bailiff’s error, including the enforcement costs paid by PRA. However, the absence of liability for damages does not affect the decision above to the effect that the enforcement is invalid, nor DiaMedica’s duty to undo the invalid enforcement measures, as set out above.

7.Costs of the proceedings

In the original action

7.1.

As the Court ruled in para. 4.28, DiaMedica is the predominantly unsuccessful party in the original action. Since PRA’s claims for compensation of its full costs or application of a higher rate for its lawyer’s fees are denied, the Court will estimate PRA’s costs on the basis of the ordinary rates applicable in NCC cases. Also, PRA’s claim for payment of its post-judgment costs (
nakosten) will be allowed.

7.2.

The Court will, however, award DiaMedica additional costs incurred for making the Attachment, which is € 9,488.52 in costs for the judicial custodian (DigiJuris B.V.^[35]). The Courts agrees that this is an oversight which needs to be rectified. In para. 4.61 of the April Judgment the Court awarded all attachment costs related to the claim for revindication of documents. In the April Judgment the Court ruled on PRA’s argument that the attachment costs were unnecessary, and there are no grounds to revisit this decision. Therefore, the Court will award a further amount of € 9,488.52 in attachment costs.

In the counterclaim

7.3.

A preponderance of PRA’s counterclaims will be awarded. Therefore, DiaMedica is the unsuccessful party and will be ordered to pay PRA’s costs incurred in the counterclaim proceedings. Also, PRA’s claim for payment of its post-judgment costs will be allowed.

8.Decisions

THE COURT:

In the original action

8.1.

orders PRA to pay to DiaMedica an additional amount of € 9,488.52 in attachment costs,

8.2.

denies DiaMedica’s remaining claims,

8.3.

orders DiaMedica to pay to PRA the costs of the proceedings, quantified up to this judgment at EUR 43,856.00 (EUR 28,000.00 in lawyer’s fees and EUR 15,856.00 in court fees), with the provision that if these costs are not paid within fourteen (14) days after the date of this judgment, statutory interest as referred to in Article 6:119 DCC will be due from the fifteenth (15th) day after the date of the judgment to the date of payment,

In the counterclaim

8.4.

declares the enforcement of the April Judgment by DiaMedica invalid,

8.5.

orders DiaMedica to:

a) return to the judicial custodian all original Physical Documents, as they were obtained by DiaMedica through the enforcement of the April Judgment,

b) destroy, delete and remove definitively from any (digital) data system, in the broadest sense, all digital or non-digital copies of the Physical Documents obtained by DiaMedica through the enforcement of the April Judgment, and

c) procure and confirm that DiaMedica itself, its attorneys, the bailiff, and any other persons who obtained (copies of) the Physical Documents have complied with these orders,

8.6.

prohibits DiaMedica from using the Physical Documents, any copies thereof and any information included therein, in the broadest sense, in the current and any other proceedings,

8.7.

declares that the prohibition is to remain in effect unless and until a final (
res judicata) judgment is rendered on DiaMedica’s revindication claim allowing DiaMedica to obtain and use the Physical Documents,

8.8.

orders DiaMedica to pay to PRA the costs of the proceedings, quantified up to this judgment at EUR 8,000.00 in lawyer’s fees, with the provision that if these costs are not paid within fourteen (14) days after the date of this judgment, statutory interest as referred to in Article 6:119 DCC will be due from the fifteenth (15th) day after the date of the judgment to the date of payment,

8.9.

denies all other counterclaims,

In the original claim and the counterclaim

8.10.

orders DiaMedica to pay the post-judgment costs (
nakosten) in the original claim and in the counterclaim for a combined amount of EUR 271 without service, plus EUR 90 with service, with the provision that if these costs are not paid within fourteen (14) days after the service of this judgment, statutory interest pursuant to Article 6:119 DCC will be due over the costs with effect from the fifteenth (15th) day after service of the judgment,

8.11.

declares that paragraphs 8.1, 8.3 and 8.5 through 8.10 of this judgment are enforceable notwithstanding appeal.

Done by C.W.D. Bom, L.S. Frakes and A.C. Bordes, Judges, assisted by W.A. Visser, Clerk of the court.

Issued in public on 7 February 2024.

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