Uitspraak
AMSTERDAM COURT OF APPEAL
1.Summary
2.The procedure
- 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.
- 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.
3.The facts
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.
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).”
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.
"Documents").
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.
res judicatajudgment would be rendered on DiaMedica’s revindication.
- 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.
- 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
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.
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)).
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.
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.
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.
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.
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.
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.
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.”
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 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.
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.”
res judicatabetween the parties.
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.
fulfil its obligations under the Agreement”, must be denied. PRA has failed to show DiaMedica is in breach of the Agreement.
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.
6.The decision
- 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;
- 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.
- 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;
- 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;
- 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;