ECLI:NL:GHAMS:2025:1656

Uitspraak

AMSTERDAM COURT OF APPEAL

Netherlands Commercial Court of Appeal

Case numbers: 200.332.426 and 200.340.963

Judgment given on 24 June 2025

In the matter of

Claimant in appeal in 200.332.426

defendant in appeal and claimant in cross-appeal in 200.340.963

the private company with limited liability

PHARMACEUTICAL RESEARCH ASSOCIATES GROUP B.V.,

Groningen (the Netherlands),

represented by A. Attaïbi, lawyer,

Claimant in appeal, defendant in cross-appeal in 200.340.963

defendant in appeal in 200.332.426

the corporation incorporated under the laws of Canada

DIAMEDICA THERAPEUTICS INC.,

Minneapolis, Minnesota (United States of America),

represented by J.M. Boelens, lawyer.

The respective parties are referred to below as PRA and DiaMedica.

1.Summary

1.1.

This case concerns clinical research that PRA conducted in 2013 and 2014 for DiaMedica on the effects of a compound (DM-199) as possible treatment for type II diabetes. According to the draft report, the research did not show DM-199 to be effective for treatment of type II diabetes.

1.2.

DiaMedica refused to approve PRA’s draft report, claimed ownership of data that PRA allegedly withheld, and sued for damages. PRA filed a counterclaim, alleging DiaMedica is abusing the legal process.

1.3.

In appeal this Court finds that PRA did not withhold the data from DiaMedica that DiaMedica alleges to be entitled to, and finds PRA not liable for the alleged damages. PRA’s counterclaim is also largely denied, as it cannot be established that DiaMedica abused the legal process.

2.The procedure

2.1.

The NCC gave a first partial judgment on the merits on 21 April 2023 (the 2023 Judgment).^[1]That judgment mainly covers the ownership of digital data and documents, and PRA’s obligation to provide that digital data and those documents to DiaMedica. DiaMedica’s claims were partly awarded. PRA appealed the 2023 Judgment (case no. 200.332.426 in appeal).

2.2.

The NCC gave a second and final judgment on the merits on 7 February 2024 (the 2024 Judgment)^[2]concerning mainly the damages claimed by DiaMedica and the damages claimed by PRA in the counterclaim. NCC largely denied both the claim and the counterclaim. DiaMedica appealed that judgment (case no. 200.340.963 in appeal) and PRA filed a cross-appeal.

Case no. 200.332.426

2.3.

In addition to the file of first instance, the following documents were submitted to the Court:

PRA’s initiating document in appeal against the 2023 Judgment;
PRA’s statement of grounds of appeal, with exhibits;
DiaMedica’s statement of defence on appeal, with exhibits.

Case no. 200.340.963

2.4.

In addition to the file of first instance, the following documents were submitted to the Court:

DiaMedica’s initiating document in appeal against the 2024 Judgment;
PRA’s writ of summons for an earlier date of appearance in appeal;
DiaMedica’s statement of grounds of appeal, with exhibits;
PRA’s statement of defence on appeal including grounds for cross-appeal, with exhibits;
DiaMedica’s objection to PRA’s statement of defence and the decision by the Court on that objection;
DiaMedica’s statement of defence on cross-appeal.

In both cases

2.5.

The Court held a case management hearing in both appeals simultaneously on 24 June 2024. The court record of that hearing is part of the casefile in both cases.

2.6.

The Court held a hearing on the merits in both appeals simultaneously on 20 March 2025. The court record of that hearing and the exhibits mentioned therein are part of the casefile in both cases.

3.The facts

3.1.

DiaMedica is a biopharmaceutical company. It developed a compound called DM-199 with possible medical applications.

3.2.

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

3.3.

On 18 March 2013, PRA and DiaMedica entered into an agreement for clinical trials management services (the Agreement) pursuant to which PRA would manage the Clinical Trial of DM-199, 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 DM199 in Healthy Subjects and Patients with Type 2-Diabetes Mellitus.

3.4.

A preliminary final version of the clinical study protocol dated 15 March 2013 was attached to the Agreement. The final version (version 6.0) of the clinical study protocol (the Protocol) was agreed upon on 14 January 2014.

3.5.

The relevant provisions of the Agreement are:

“[…]

7.1

Inspection by Sponsor[DiaMedica, the Court]

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.

[…]

12.2

PRA's Agreement:

a. PRA will indemnify, defend and hold harmless Sponsor and its employees, officers, and directors against any and all losses, costs, expenses and damages, including but not limited to reasonable attorney's fees, based on a personal injury or other damages resulting from PRA' s negligence, recklessness, intentional misconduct, or material breach of this Agreement hereunder, except for any claim to the extent the claim arose as a result of Sponsor's negligence, recklessness, intentional misconduct or material breach of this Agreement.

[…]

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.[…]”

3.6.

Appendix E to the Agreement is the payment schedule. The relevant provision of the payment schedule is:

“[…]

Payment conditions

[…]

upon Submission of the Final Report 10% 186,864.80[euro, the Court]”

3.7.

The relevant provisions of the Protocol are:

“[…]

3.5.4

Drug Concentration Measurement

The bioanalysis of DM-199 in plasma samples will be performed at Intertek (San Diego, CA, USA) using a validated enzyme-linked immunosorbent assay (ELISA) method. The bioanalytical methodology and procedures will be documented in a Bioanalytical Study Plan. The Bioanalytical Report will be included in the Clinical Study Report.

[…]

3.6.2.1 Pharmacokinetic Evaluation

PK evaluation will be done by Intertek. A PK report with PK results will be provided to PRA and this report will be added to the Clinical Study Report of this study.[…]”

3.8.

In April 2013, PRA started the DM-199 clinical trial. The clinical trial ended on 3 October 2014. The database containing the clinical trial data was locked on 22 October 2014 and the clinical trial data was unblinded on 23 October 2014.

3.9.

In November 2016, PRA shared the latest (5th) draft clinical study report of the DM-199 trial (the Draft Report) with DiaMedica. The main conclusion of the Draft Report was that DM-199 was safe, but not effective as a treatment for type 2 diabetes. Under the heading “
Vendor Information” the Draft Report mentions “
DiaMedica USA Inc. contracted Intertek (San Diego, CA, USA) for the analysis of DM-199 pharmacokinetics (PK) and anti-drug antibodies (ADA).”

To date DiaMedica has refused to approve the Draft Report.

3.10.

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 that is DiaMedica’s property under Article 9.0 of the Agreement, and to transfer that data to a custodian appointed by that court and to be held in judicial custody.

3.11

On 7 December 2022, the bailiff attached copies of the data referred to in the leave for 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. Subsequently, the bailiff surrendered these copies and the data carrier to the judicial custodian. DigiJuris, in its capacity as custodian, continues to hold the digital files and refuses to return them to PRA.

4. The claim, the counterclaim, the NCC’s decisions and the appeal and cross-appeal

First instance (the NCC)

4.1.

DiaMedica requested that the NCC:

a. order PRA to pay DiaMedica EUR 75,000,000.00 in damages, to be increased by applicable interest from the day of default until the day of payment in full;

b. declare that DiaMedica is the rightful owner of the Documents;

c. order PRA to allow and tolerate that DiaMedica exercises its rights as owner of the Documents and to cooperate with the surrender of the Documents by the judicial custodian of the Documents to DiaMedica, on pain of an immediately payable penalty of EUR 10,000.00 to be forfeited by PRA for each violation of this order to be increased with an immediately payable penalty of EUR 10,000.00 for each day such violation continues;

d. order PRA to pay the costs of these proceedings, including the costs of the attachments, to be increased by statutory interest. Diamedica defines “the Documents” as: Under the Agreement, PRA generated certain data at DiaMedica’s behest (the
"Documents").

4.2.

In the counterclaim PRA request that the NCC order DiaMedica to fulfill 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 by statutory interest

4.3.

The NCC in the 2023 Judgment defined
Documentsas
the Physical Documents and Digital Data to be surrendered by PRA pursuant to DiaMedica’s claimand
Physical Documentsas
: the physical documents to be surrendered by PRA pursuant to DiaMedica’s claim.

The NCC declared that DiaMedica is the rightful owner of the Physical Documents. The NCC ordered PRA to allow and tolerate that DiaMedica exercises its rights as owner of the Physical Documents and to cooperate with the surrender of the Physical Documents and the data carrier with the digital data by the judicial custodian to DiaMedica under several conditions. These conditions included that any digital data outside of the scope of DiaMedica’s property right, was to be returned to PRA and the General Data Protection Regulation (GDPR) was to be complied with. Lastly, the NCC ordered PRA to reimburse DiaMedica for the costs of the attachment, estimated at EUR 3,430.53.

4.4.

The 2023 Judgment was explicitly not declared enforceable notwithstanding any remedy. On 2 May 2023, the bailiff instructed by DiaMedica served the 2023 Judgment on PRA and ordered PRA to comply with the judgment.

4.5.

PRA subsequently amended its counterclaim and requested that the NCC also:

3) declare the execution of the 2023 Judgment by DiaMedica:

a. unlawful; and

b. null and void, or alternatively, to annul the execution of the 2023 Judgment;

4) declare that the execution of the 2023 Judgment by DiaMedica

constitutes a wrongful act towards PRA;

5) order DiaMedica to comply with the 2023 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) execution of the 2023 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) execution of the 2023 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 (5)a. and (5)b. above, subject to a penalty of EUR 50,000 (fifty thousand euros) for each day of noncompliance with this order;

6) 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 of EUR 100,000 (hundred thousand euros) for each breach of this prohibition;

7) declare the prohibition (6) to remain in effect until and unless a final
res judicatajudgment would be rendered on DiaMedica’s revindication.

4.6.

The NCC in the 2024 Judgment ordered PRA to pay DiaMedica an additional amount of EUR 9,488.52 in attachment costs, denied DiaMedica’s remaining claims and awarded costs to PRA. Ruling on the amended counterclaim, the NCC declared the enforcement of the 2023 Judgment by DiaMedica invalid and ordered DiaMedica to:

a) return to the judicial custodian all original Physical Documents, as they were obtained by DiaMedica through the enforcement of the 2023 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 2023 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,

and prohibited 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, until a final judgment is rendered on DiaMedica’s revindication claim allowing DiaMedica to obtain and use the Physical Documents;

and awarded costs to PRA.

In appeal against the 2023 Judgment (case no.200.332.426) (NCCA)

4.7.

PRA requests that the Court annul the 2023 Judgment, dismiss DiaMedica’s claims and award costs to PRA.

In appeal against the 2024 Judgment (200.340.963) (NCCA)

4.8.

DiaMedica requests that the Court annul the 2024 Judgment and:

order PRA to pay damages as formulated in first instance, plus interest starting as of 21 October 2016;
order PRA to pay DiaMedica’s actual lawyer’s fees incurred to date in both instances, plus statutory interest;
order PRA to repay to DiaMedica all that has been paid by DiaMedica pursuant to the 2023 Judgment, plus statutory interest; and
award costs to DiaMedica.

In the cross-appeal (case no. 200.340.963) (NCCA)

4.9.

PRA requests in cross-appeal that the Court partially annul the 2024 Judgment and:

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;
order DiaMedica to pay the full costs of the proceedings in appeal and cross-appeal.

5.The considerations

The jurisdiction of the Court / applicable law

5.1.

Both parties agree that the Dutch courts, including the NCC and the NCCA, have jurisdiction to hear the claims of both parties. Based on Article 26 section 1 of Brussels I (recast)^[3]the Court is the competent court to hear these appeals.

5.2.

The Agreement includes a choice of law for the law of the state of New York. The Court will apply New York law when dealing with the claims that are based on the Agreement. In so far as PRA’s claims concern wrongful acts, the Court will apply Dutch law. This follows from Article 4 section 1 of the Rome II Regulation.^[4]

The 2023 Judgment

The appeal by PRA

5.3.

PRA filed 15 grounds for appeal, concerning the facts the NCC established (ground for appeal 1), the interpretation of the Agreement by the NCC (grounds for appeal 2, 3, 4 and 10), the legal reasoning of the NCC (grounds for appeal 5, 6, 7, 8 and 9) and the application of the GDPR (grounds for appeal 11, 12 and 13). Grounds for appeal 14 and 15 target the award of costs and the decision of the 2023 Judgment. In particular, PRA does not agree with the NCC’s judgment that DiaMedica is the rightful owner of the attached Physical Documents, and that PRA has to cooperate with the surrender of the Physical Documents, including the data carrier with digital data. PRA argues
inter aliathat DiaMedica does not specify which documents it purportedly owns. Rather, it simply states that it owns “everything” as is reflected in its definition of Documents. According to PRA, that points out that this definition covers both digital and physical documents, “everything” is an unworkable and overly broad qualification.

5.4.

The Court considers the definition of DiaMedica unhelpful and the definition of the NCC does not clarify sufficiently what is meant. In its written submissions DiaMedica described the data/Documents it wanted and claimed to be entitled to only in generic terms. During the hearing on the merits in appeal the Court asked DiaMedica to specify the data it wants to receive. DiaMedica stated that all the data it needs, wants to receive and claims to be entitled to are the pharmacokinetic data (PK data) in the PK report. It is common ground between the parties that the PK report (as mentioned in 3.6.2.1. of the Clinical Study Protocol, see paragraph 3.7 above) was not added as an attachment to the Draft Report. According to DiaMedica, if that data had been provided, DiaMedica would not have initiated the current legal proceedings. As explained to the Court, the PK data is blood values that indicate how the compound is absorbed and metabolized by the human body. According to DiaMedica, that data provides essential information, and from the Agreement it follows that PRA was obliged to provide that information. By refusing to deliver the PK data to DiaMedica, PRA is in material breach of its obligations under the Agreement, according to DiaMedica.

5.5.

The Court will limit the considerations in this appeal to the PK data, as DiaMedica has failed to specify to which other data, if any, its claim to receive “Documents” pertains. As DiaMedica was directly involved in the design of the clinical trial and the drafting of the Protocol it knew what kind of data the clinical trial was to generate. DiaMedica should therefore have been able to specify what other kinds of data, if any, – apart from the PK data – it allegedly is entitled to receive from PRA. The Court therefore does not accept DiaMedica’s argument that it is unable to further specify the data that it is seeking from PRA.

5.6.

For the avoidance of doubt, the Court notes that the bailiff has attached 51 binders of hard copy documents (the Physical Documents). Although DiaMedica asked the NCC to declare that DiaMedica is the rightful owner of the Documents and to order PRA to allow and tolerate that DiaMedica exercises its rights as owner of the Documents and to cooperate with the surrender of the Documents by the judicial custodian of the Documents to DiaMedica, the Court understands the claims of DiaMedica in appeal as not extending to those Physical Documents, as DiaMedica does not claim that the PK data is part of those Physical Documents. Therefore no decision regarding those 51 binders is taken.

Interpretation of the Agreement

5.7.

The Court will now rule on the claim, as now properly understood, that PRA is to provide the PK report to DiaMedica and is liable for its failure to do so. DiaMedica bases its claims on the Agreement, so the Court will have to interpret that agreement.

5.8.

Applying New York law in this case means giving a plain meaning to the terms of the contract, because when “
parties set down their agreement in a clear, complete document, their writing should as a rule be enforced according to its terms.” (
W.W.W. Assocs. v.Giancontieri, 77 N.Y.2d 157 (1990)).

5.9.

Article 9 of the Agreement between DiaMedica and PRA defines “Data” as: “
All data[…]
generated by PRA in the course of conducting the Services”. PRA convincingly argues that the PK data is not data “
generated by” PRA, as the Protocol provides that Intertek was to do the PK evaluation. The Protocol also states that “[a]
PK report with PK results will be provided to PRA and this report will be added to the Clinical Study Report of this study.”While PRA was to provide the relevant blood samples to Intertek during the Study, Intertek was responsible for performing the pharmacokinetic analysis and drafting the PK report. Any data generated in the course of Intertek’s analysis, and indeed the PK Report Intertek was to provide to PRA, is data generated by Intertek, not by PRA. It follows that Article 9 of the Agreement provides no legal basis for DiaMedica’s legal claim against PRA concerning the missing PK data and PK report.

Conclusion

5.10.

The Court finds that it is not to be expected that the PK report will contain data generated by PRA. Therefore, it cannot be considered “Data” as defined by Article 9 of the Agreement. Consequently, DiaMedica cannot claim ownership of the PK data under this provision, nor can it claim any other legal right to this data in relation to PRA. DiaMedica’s claims concerning the data must therefore be denied. It follows that PRA is not liable for the costs of the prejudgment attachment on the Physical Documents (as tangible property). The NCC’s decision in the 2023 Judgment concerning these costs will therefore be annulled. For the decision on the costs of the prejudgment recovery attachment, see paragraph 5.25 below.

5.11.

In conclusion, the 2023 Judgment cannot be upheld. Therefore, there is no need to discuss other issues raised by PRA in its Statement of Grounds for Appeal, concerning
inter aliathe correct standard of causation required under New York law to find a breach of contract or award damages, the transfer of ownership of data or the impossibility of revindication of digital data under Dutch law. The considerations on the GDPR and the grounds of appeal against those considerations are also moot.

The 2024 Judgment

The appeal by DiaMedica

5.12.

DiaMedica filed five grounds of appeal, concerning the alleged breach of the Agreement by PRA (ground of appeal 1), the reasoning on damages (grounds of appeal 2 and 3) and the awarded costs (ground of appeal 4). Ground of appeal 5 targets the decision of the 2024 Judgment, denying DiaMedica’s claim for damages.

5.13.

The Court must consider whether or not PRA is in breach of the Agreement by (1) withholding data and/or (2) refusing DiaMedica access to the study site. Given the considerations in paragraphs 5.4 and 5.5 above, PRA’s alleged breach of withholding data is focussed on the PK data, as DiaMedica was unable to clarify what other data or documents, if any, it failed to receive. Only if PRA breached the Agreement, issues of causality, remedies, damages and costs become relevant. The Court notes there are no grounds of appeal against the rejection by the NCC of any other alleged ground for liability of PRA.

PRA did not withhold data

5.14.

The Court finds PRA did not breach the Agreement by not providing the PK report to DiaMedica as part of the Draft Report. This follows from the contractual framework, as will be explained below.

5.15.

According to the “Updated Master Planning” dated 2 October 2014, which PRA shared via email with DiaMedica, Intertek was to provide the PK report to PRA on 19 January 2015. PRA denies it ever received the PK report. Counsel for PRA mentioned in a letter, dated 16 February 2018, to DiaMedica: “
PRA also needs the bioanalytical reports from Intertek, San Diego, CA. To date PRA has not received these. We kindly request DiaMedica to provide these final reports promptly.” This correspondence was discussed during the hearing on the merits in this appeal. DiaMedica maintains that PRA is in breach of the Agreement by not providing the PK report to DiaMedica, as DiaMedica argues this is the responsibility of PRA as the contract research organisation.

5.16.

The Agreement states under specifications of Activities:

“Item Responsible Company

[…]

Analysis of drug concentration Sponsor”

The Draft Report mentions “
DiaMedica USA Inc. contracted Intertek (San Diego, CA, USA) for the analysis of DM-199 pharmacokinetics (PK) and anti-drug antibodies (ADA).” DiaMedica does not argue that the Draft Report is incorrect in this respect. During the hearing on the merits, counsel for DiaMedica did not dispute that it contracted with Intertek directly. On the contrary, he conceded that there could very well be a direct contractual relationship between DiaMedica and Intertek. The Court therefore finds – as insufficiently contested – that DiaMedica contracted directly with Intertek.

5.17.

The Agreement provides in Article 2.4.a of the Agreement: “
In the event that Sponsor contracts directly with a subcontractor[…]
, PRA will not be responsible for the performance of the subcontractor, and Sponsor will[…]
be responsible for any delays or changes to the Project Schedule or Budget for Services that result from the performance of the subcontractor.” Thus, it follows from the Agreement that PRA is not responsible for the performance of subcontractors directly contracted by DiaMedica, such as Intertek. Based on the plain meaning of this provision, this includes the fact that Intertek apparently did not provide the PK report to PRA and/or DiaMedica. DiaMedica argues that PRA’s statement that it “
lawfully retained the Documents under the laws of the state of New York”, should be read as an admission that it withheld data that DiaMedica is entitled to. However, bearing in mind the definition of Documents that DiaMedica uses, the Court does not read PRA’s statement as an unconditional admission that PRA is (unlawfully) retaining the PK report, as PRA has also contended that it does not have the PK report in its possession. Therefore PRA is not in breach of the Agreement.

5.18.

DiaMedica is wrong to argue that the Court should accept a breach of the Agreement by PRA as
res judicatabased on the 2023 Judgment. The main thrust of the appeal of PRA against the 2023 Judgment is PRA’s contention that PRA was under no obligation to provide additional data to DiaMedica. PRA raised this point unequivocally in appeal, so the reasoning in the 2023 Judgment that PRA is in breach of the Agreement, because PRA did not provide all data to DiaMedica, is not
res judicatabetween PRA and DiaMedica.

5.19.

In conclusion, DiaMedica’s argument that PRA is in breach of the Agreement by withholding the PK data is not successful.

PRA did not refuse DiaMedica access to the study site

5.20.

In appeal, DiaMedica argues that if DiaMedica had been allowed access to the study site and underlying study records, blood tests could have been easily and quickly examined. Without the ability to audit the study results, DiaMedica was not able to determine whether procedural errors had occurred. DiaMedica has consistently maintained that it was denied access to the study site and that it was unable to determine whether the study was properly performed per the Agreement. DiaMedica contends that this constitutes a clear and material breach of the Agreement.

5.21.

PRA explicitly denies it refused DiaMedica access. For example, in its Statement of Defence on Damages Appeal, PRA notes it “
has always allowed DiaMedica access to the Study site and Source Documents, DiaMedica personnel and DiaMedica-appointed monitors visited the Study site dozens of times during the performance of the Study to perform ‘Source Data Verification’[…]
: to determine the Study was carried out in accordance with the Protocol, to audit records, and to ensure that the Source Data from Source Documents was entered into the eCRFs in Oracle Clinical accurately. PRA even explicitly offered DiaMedica another visit in the fall of 2017 for an audit (including the review of Source Documents); DiaMedica, in response, declined.”

5.22.

DiaMedica does not dispute that it had access to the site during the clinical trial, but notes no visits took place “
after the finale phase (part D) had been conducted”. DiaMedica further notes it declined to visit the site in 2017 as such visit would have been a waste of time, given the fact that PRA refused to provide additional information. The Court agrees that no relevant information would be gained from visiting the site of the clinical trial, years after the clinical trial had been conducted there. The Court finds no breach of the Agreement by PRA here. However, the Court understands that the real issue is that DiaMedica was not allowed sufficient access to the site during the clinical trial in order to examine the study data. Given that PRA disputes that it ever failed to allow access, the Court finds that DiaMedica has insufficiently substantiated when, specifically, PRA denied DiaMedica access to the study site and, in doing so, breached the Agreement.

PRA is not in breach of the Agreement

5.23.

DiaMedica fails to show that PRA is in breach of the Agreement. As DiaMedica does not develop or sufficiently support any factual assertions that would – if proven – lead to a different decision, the Court reaches this conclusion without the need for (further) evidence. DiaMedica’s offer to provide further evidence is therefore not relevant.

5.24.

Based on Article 12.2 of the Agreement, DiaMedica claims the attorney fees in full, both for the proceedings in first instance and in appeal of the 2024 Judgment. PRA disputes DiaMedica’s reading of the Agreement, and rightly so. Article 12.2. of the Agreement provides: “
PRA will indemnify, defend and hold harmless Sponsor[…]
against any and all losses, costs, expenses and damages, including but not limited to reasonable attorney's fees[…]
resulting from PRA's[…]
material breach of this Agreement hereunder”. As there is no material breach of the Agreement by PRA, PRA is not contractually liable for DiaMedica’s (reasonable) attorney’s fees.

5.25.

It follows that DiaMedica’s claims for damages must be denied in full. The other issues raised by DiaMedica in appeal therefore lack relevance. As these claims for damages are denied, the prejudgment recovery attachment DiaMedica levied against PRA is unfounded. PRA is therefore not liable for the costs of that attachment.

The cross-appeal by PRA

5.26.

PRA filed six grounds for appeal, concerning the rejection of PRA’s arguments based on Article 21 Dutch Code of Civil Procedure (DCCP) (ground 1), the alleged breach of the Agreement by DiaMedica (ground 2), the alleged misuse of procedural law by DiaMedica (ground 3), the facts the NCC established (ground 4), the application of New York law to DiaMedica’s non-contractual claims (conditional ground 5). Ground 6 targets the decision of the 2024 Judgment.

The conditional ground for appeal

5.27.

The Court did not reassess DiaMedica claims based on fraudulent inducement and negligent misrepresentation (see paragraph 5.12 above). This means the condition under which PRA appeals against the findings on the law applicable to these claims is not met. The Court therefore will not discuss the arguments PRA advances in its conditional ground for cross-appeal 5.

DiaMedica is not in breach of the Agreement

5.28.

PRA requested that the Court 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 in refusing to approve the Draft Report.

5.29.

DiaMedica’s defence in appeal rests on the assertion that the NCC already ruled that DiaMedica is not in breach of the Agreement in the 2023 Judgment. According to DiaMedica, this has become
res judicatabetween the parties as this point was not raised in the appeal against the 2023 Judgment. DiaMedica also raises the point that the final payment only becomes due “
upon PRA providing the final report to DiaMedica.”

5.30.

In the 2023 Judgment the NCC ruled on the alternative defence of PRA that it had a common law or statutory right to suspend its cooperation to provide any additional data to DiaMedica. The NCC held:

“B) May PRA retain the Physical Documents or suspend its obligation to surrender these documents?

[…]

4.49.

Equally, PRA does not have a right to suspend its obligation to surrender the Physical Documents to DiaMedica. DiaMedica is not in breach of any obligation under the Agreement, nor is there any 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.”

5.31.

As PRA relied on a breach of the Agreement by DiaMedica both as the basis for its alternative defence and as the basis for part of its counterclaim, it should have anticipated the NCC would rule on this point in the 2023 Judgment, as it did. The reasoning by the NCC is not limited to the counterclaim but rejects unconditionally PRA’s argument that DiaMedica was in breach of the Agreement. As PRA did not raise this issue in the appeal against the 2023 Judgment, this means this reasoning has become
res judicatabetween the parties.

5.32.

However, even in the alternative, PRA’s claim fails. The payment schedule (appendix E to the Agreement) states the (last) 10% is due “
upon Submission of the Final Report”. While PRA states that DiaMedica’s approval of the Draft Report is “
not strictly mandated by the Agreement”, it also claims DiaMedica is in breach of the Agreement by not approving the Draft Report. The Court finds this reasoning contradictory and therefore insufficient to support a claim for payment before the final report is submitted. The Court notes PRA does not rely on a potential future failure to pay the final invoice by DiaMedica after receiving the final report. Thus, only after submitting the final report could the last 10% (an amount of EUR 186,864.80) become due.

5.33.

PRA does not identify any other obligation that DiaMedica failed to perform. Therefore, the counterclaim to order DiaMedica to “
fulfil its obligations under the Agreement”, must be denied. PRA has failed to show DiaMedica is in breach of the Agreement.

5.34.

As PRA does not develop nor sufficiently support any factual assertions that would – if proven – lead to a different decision, the Court reaches this conclusion without the need for (further) evidence. PRA’s offer to provide evidence is therefore not relevant.

Abuse of process: these proceedings

5.35.

Under Dutch law, abuse of process exists when a party pursues a legal claim, although it was wrong to do so, considering the blatant absence of any legal or factual basis for that claim and considering the interests of the opposing party.^[5]The mere fact that DiaMedica does not prevail in these proceedings, is insufficient. PRA has to show that DiaMedica availed itself of arguments it knew in advance (or should have known in advance) to be false. This high bar is not met in these proceedings because there was a reasonable argument to be made that PRA might have been withholding at least some relevant information. Indeed, DiaMedica prevailed on this point before the NCC.

Abuse of process: US proceedings

5.36.

According to PRA, DiaMedica has brought claims against PRA in New York, Delaware, Minnesota and North Carolina, about the same subject matter. These US courts did not rule on a compensation of legal costs in those proceedings, in part because DiaMedica withdrew its actions before a ruling could be given.

5.37.

PRA claims DiaMedica’s proceedings in the United States relied on the same frivolous grounds as DiaMedica’s claims in these proceedings. Had DiaMedica not withdrawn its cases in the United States proceedings, PRA might have requested a compensation for legal costs. PRA therefore claims damages.

5.38.

The NCC ruled that PRA did not furnish any information regarding the grounds provided by DiaMedica to litigate before these US courts or whether these courts gave a decision on PRA’s costs in these proceedings. In appeal, PRA still provides very little information on the content of the claims DiaMedica pursued in the US proceedings. Nor did PRA elaborate on any decisions on the costs by those US courts, although it seems likely that – to a certain extent – these exist, even considering the fact some cases were withdrawn. Therefore, PRA’s counterclaim is denied insofar as PRA bases those claims on the abuse of proceedings in various US states due to lack of sufficiently supported factual assertions.

Violation of 21 DCCP

5.39.

In addition to and in support of the claims based on abuse of process in these proceedings, PRA claims DiaMedica violated Article 21 DCCP. PRA points to several assertions or omissions by DiaMedica that, according to PRA, violate Article 21 DCCP. PRA argues that 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.

5.40.

Article 21 DCCP requires the parties to make a full and truthful presentation of the facts that are relevant to the decision in the matter. A violation of Article 21 DCCP would be grounds for adverse inferences, including discretionary sanctions.

5.41.

PRA claims that DiaMedica should have disclosed it never relied on statements made by [X], that it approached PRA for clinical study services first, that at the time DiaMedica’s representatives were “more than satisfied” with PRA and that there had been a successful public offering in May 2014. (See paragraphs 4.15 to 4.19 of the 2024 Judgment for the relevant background, that is otherwise outside the scope of this appeal). These matters were relevant for the damages DiaMedica claimed in the proceedings before the NCC.

5.42.

It is true that DiaMedica attached great importance to the statements of [X] in the first instance. That in itself does not imply that DiaMedica did not provide a truthful representation to the NCC. Contemporary praise for the clinical trial is not a fact to be disclosed as it is of limited legal relevance. In these proceedings it has not been established that DiaMedica relied on statements made by [X]. In that context PRA insufficiently supports that it suffered any (procedural) harm.

5.43.

As the NCC did, the Court finds that 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. Here the Court finds that DiaMedica did violate Article 21 DCCP, as the question of causation very much was in contention between the parties and Article 21 DCCP requires the parties to fully present the relevant facts, not just the facts it relies on. However, the Court sees insufficient grounds for any discretionary sanction beyond the acknowledgment that here Article 21 DCCP was violated.

5.44.

As the claims of DiaMedica are denied in full, the only possible sanctions that are still relevant, beyond the acknowledgement that DiaMedica did violate Article 21 DCCP, would lie in the realm of costs, and indeed the remedy that PRA seeks is the award of full legal costs. However, the alleged violations of Article 21 DCCP are in and of themselves not sufficient legal ground to award full legal costs: the legal standard to award full legal costs is substantially stricter and requires a finding of abuse of process.

Abuse of process: liability arising from the bailiff’s action

5.45.

The NCC found that the bailiff failed to observe the two-day period of Article 439 DCCP. Therefore, the enforcement of the 2023 Judgment was declared invalid. DiaMedica was ordered to return the Physical Documents and to destroy any digital data that it obtained through the enforcement of the judgment. However, the NCC denied PRA’s claim for a declaration that the enforcement of the judgment constituted a wrongful act. Part of ground of appeal in cross-appeal 3 is directed against that decision.

5.46.

PRA is right in stating that the enforcement of the 2023 Judgment is a wrongful act for which DiaMedica can be held responsible and strict liability applies. The case law quoted by the NCC is not applicable, because the facts in this case are different. As all of DiaMedica’s claims will be rejected and the 2023 Judgment will be annulled, DiaMedica is strictly liable for any damages caused by its prejudgment attachments and any enforcement of the 2023 Judgment. DiaMedica’s actions in levying the prejudgment attachment and enforcing the 2023 Judgment are – retroactively – wrongful acts. As a consequence, the declaratory relief PRA seeks will be awarded. However, the wrongful actions of the bailiff do not have any bearing on the proceedings at hand. They do not merit PRA’s claim for full and actual legal costs.

5.47.

The Court notes that DiaMedica did not formulate any grounds of appeal against the reasoning of the NCC in paragraphs 6.17 to 6.24 of the 2024 Judgment, ruling the enforcement of the 2023 Judgment invalid. Therefore, paragraphs 8.4. to 8.7. in the decision of the 2024 Judgment will be confirmed. This means Diamedica is not allowed to obtain and use the attached documents. The prohibition stays in force.

In both cases

No further taking of evidence

5.48.

The Court reaches its conclusions without the need for further evidence, as neither party has developed or sufficiently supported factual assertions that would – if proven – result in a different decision in these proceedings.

Costs (case no. 200.332.426)

5.49.

In case no. 200.332.426 DiaMedica is the unsuccessful party in appeal. The 2023 Judgment will be annulled in full. The Court will award costs in appeal on the basis of the ordinary rates applicable in NCCA cases.

5.50.

The Court sets these costs at:

cost of service

EUR

106.73

court fee

EUR

21,141.00

lawyer’s fees

EUR

20,400.00

(3 × EUR 6,800.00)

total

EUR

41,647.73

Costs (case no. 200.340.963)

5.51.

In case no. 200.340.963 DiaMedica is the unsuccessful party in appeal. PRA is the (predominantly) unsuccessful party in cross-appeal, as PRA’s claims for damages are denied. The Court will award costs in appeal on the basis of the ordinary rates applicable in NCCA cases, halved for the cross-appeal.

5.52.

The Court sets these costs in the appeal at:

court fee

EUR

24,382.00

lawyer’s fees

EUR

20,400.00

(3 × EUR 6,800.00)

total

EUR

44,782.00

5.53.

The Court sets these costs in the cross-appeal at:

lawyer’s fees

EUR

10,200.00

(3 × EUR 6,800.00 × 0.5)

Costs (NCC proceedings)

5.54.

DiaMedica is the unsuccessful party in the original action. This means the award of costs in the original action in the 2024 Judgment will be confirmed. PRA is the unsuccessful party in the counterclaim, as PRA’s counterclaim was only successful in regard to the claim concerning the enforcement of the 2023 judgment and PRA’s claims for damages were rejected. In the counterclaim, the Court will therefore award costs to DiaMedica. The Court sets these costs in the counterclaim at:

lawyer’s fees

EUR

8,000.00

5.55.

Statutory interest and post-judgment costs will be awarded. The decisions will be enforceable notwithstanding any remedy.

6.The decision

In case no. 200.332.426

The Court:

6.1.

annuls the judgment given by the NCC on 21 April 2023 (case no. NCC 22/018 (C/13/730389));

6.2.

denies DiaMedica’s claims;

6.3.

orders DiaMedica to pay PRA’s costs of these proceedings, set at:

EUR 41,647.73 in appeal;
the costs following judgment of EUR 178.00;
if the orders are not complied with within 14 days after this judgment and this judgment is served: plus EUR 92.00 for costs following judgment and the costs of the writ of service;
to be increased by statutory interest pursuant to Article 6:119 DCC, if the order has not been paid within 14 days after this judgment or after the post-judgment costs have become due, until payment is made in full;

6.4.

declares this judgment enforceable notwithstanding any remedy;

In case no. 200.340.963

The Court:

6.5.

annuls the judgment given by the NCC on 7 February 2024 insofar as:

PRA was ordered to pay attachment costs (8.1 in that judgment);
DiaMedica was ordered to pay the costs of the proceedings in the counterclaim (8.8 in that judgment);
PRA’s claim for declaratory relief concerning the enforcement of the 2023 Judgment was denied.

and:

6.6.

denies DiaMedica’s claims concerning the attachment costs;

6.7.

declares that the enforcement by DiaMedica of the judgment given by the NCC on 21 April 2023 constitutes a wrongful act towards PRA;

6.8.

orders PRA to pay the costs of these proceedings in first instance in the counterclaim set at:

EUR 8,000.00 in the counterclaim;
to be increased by statutory interest pursuant to Article 6:119 DCC, if the costs order has not been paid within 14 days after this judgment, until payment is made in full;

6.9.

confirms all other decisions in the judgment given by the NCC on 7 February 2024 (case no. NCC 22/018 (C/13/730389);

6.10.

orders DiaMedica to pay the costs of these proceedings in appeal, set at:

EUR 44,782.00 in appeal;
the costs following judgment of EUR 178.00;
if the orders are not complied with within 14 days after this judgment and this judgment is served: plus EUR 92.00 for costs following judgment and the costs of the writ of service;
to be increased by statutory interest pursuant to Article 6:119 DCC, if the costs order has not been paid within 14 days after this judgment or after the post-judgment costs have become due, until payment is made in full;

6.11.

orders PRA to pay the costs of these proceedings in cross-appeal, set at:

EUR 10,200.00 in cross-appeal;
to be increased by statutory interest pursuant to Article 6:119 DCC, if the costs order has not been paid within 14 days after this judgment, until payment is made in full;

6.12.

declares this judgment enforceable notwithstanding any remedy;

6.13.

denies all other claims.

Done by P.F.G.T. Hofmeijer-Rutten, C.A. Joustra and P.B. Hugenholtz, court of appeal judges, assisted by E.J. van Veelen, clerk of the court.

Issued in public on 24 June 2025.

APPROVED FOR DISTRIBUTION IN eNCC

SIGNATURE PAGE 1 OF 2

P.F.G.T. Hofmeijer-Rutten (PRESIDING JUDGE)

SIGNATURE PAGE 2 OF 2

(CLERK OF THE COURT)

ECLI:NL:GHAMS:2025:1656

Arrest in hoger beroep over de verplichting tot verstrekking van onderzoeksdata door een contractonderzoekorganisatie

Uitspraak

AMSTERDAM COURT OF APPEAL

1.Summary

2.The procedure

3.The facts

5.The considerations

6.The decision

Voetnoten