Contract analysis

I. PURPOSE AND BACKGROUND The purpose of this memorandum is to document in detail the agreed technology-assisted review ("TAR") protocol and workflow between Calderwood & Harkness LLP and DataVault Litigation Solutions, LLC ("DataVault") for the processing, reviewing, and producing of electronically stored information ("ESI") collected from Solstice Biomedical Devices Ltd. ("Solstice" or "SBD") and its wholly owned U

II. SCOPE OF ESI COLLECTION A. Data Sources and Custodians ESI has been collected from the following key custodians at Solstice Biomedical Devices Ltd. and Solstice Biomedical, Inc., as identified in the Litigation Hold Notice issued on May 11, 2024 (three days after service of the Complaint). The custodian list was developed in consultation with Solstice's General Counsel, Eamon Rourke, and was subsequently validate

1. Niamh Cassidy, Vice President, Regulatory & intellectual Property — Ms. Cassidy serves as the primary custodian for patent-related and product development communications. Her files are expected to contain the most significant volume of documents relating to the design and development of the PrecisionEdge™ product lines, including communications with outside patent counsel, internal IP strategy documents, and corre

2. Dr. Fiona Tierney, Chief Executive Officer — A limited collection has been made of Dr. Tierney's high-level strategic communications, including board presentations, executive committee meeting materials, and communications with senior leadership regarding the PrecisionEdge™ product lines. The scope of collection from Dr. Tierney's custodial sources was narrowed by agreement with the client to focus on communicatio

3. Eamon Rourke, General Counsel — Mr. Rourke's legal department communications are a significant source of potentially privileged materials. His custodial files include communications with outside counsel (including Calderwood & Harkness LLP and prior counsel), internal legal opinions, litigation hold documentation, and contract files related to licensing discussions. Documents from Mr. Rourke's files will be subjec

4. Brendan Molloy, Chief Financial Officer — Mr. Molloy's files include financial records related to the accused products, including sales data, margin analysis, revenue projections, cost-of-goods-sold calculations, and pricing information. These documents are relevant to Apex's damages claims and to Solstice's potential defenses regarding the measure of damages.

5. Engineering and Product Development Team Leads for the PrecisionEdge™ Product Lines (PE-5000, PE-12000, and PE-15000 Series) — This group includes Dr. Patrick Hennessy (Lead Design Engineer, PE-5000 Series), Aoife Brennan (Lead Design Engineer, PE-12000 Series), and Tomás Flynn (Lead Design Engineer, PE-15000 Series). Their custodial files include CAD drawings, design specifications, engineering change orders, tes

6. Regulatory Affairs Personnel Involved in FDA Clearance of Accused Products — This group includes Siobhán Doyle (Director of Regulatory Affairs) and Conor McHugh (Senior Regulatory Specialist). Their files include 510(k) submissions, FDA correspondence, clinical evaluation reports, biocompatibility testing data, and other regulatory submissions related to the PrecisionEdge™ product lines. Data Sources. ESI has been

III. TAR PLATFORM AND METHODOLOGY SELECTION A. Platform. DataVault will use its proprietary continuous active learning platform, DataVault Insight™ version 4.2, as the primary technology platform for all TAR-related processing and review activities. DataVault Insight™ is a cloud-hosted, browser-based platform with integrated document review, coding, analytics, and production capabilities. The platform has been valida

IV. SEED SET SELECTION AND INITIAL TRAINING A. Seed Set Composition The quality and representativeness of the initial seed set is foundational to the effectiveness of the CAL workflow. Accordingly, the seed set has been designed to capture the full diversity of document types, subject matters, and responsiveness characteristics present in the 312,000-document universe. The initial seed set will comprise approximately

1. Stratified random sample: 2,500 documents selected through a stratified random sample from the full 312,000-document universe. The stratification ensures proportional representation across custodians, date ranges, file types, and data sources. DataVault will execute the stratified random sampling using its platform's statistical sampling module, with stratification layers defined as follows: (a) custodian; (b) dat

2. Judgmental sample: Approximately 500 documents identified through targeted keyword searches, as described in Section IV.B below. The judgmental sample is intended to supplement the random sample by ensuring that documents containing key technical terminology — which may be underrepresented in a purely random sample due to the relatively low richness of highly technical documents in the overall population — are inc

1. Each document in the 3,000-document seed set will be reviewed by at least one senior attorney — either Christy Bauer or Peter Vassiliev. The seed set will be divided into approximately equal batches, with each attorney responsible for reviewing approximately 1,500 documents.

2. Documents presenting ambiguous or borderline responsiveness determinations, or documents raising novel privilege issues, will be flagged for dual review. Both Christy Bauer and Peter Vassiliev will independently review such flagged documents and confer to reach a consensus coding decision.

3. Where the two senior attorneys are unable to reach consensus on a coding determination, the matter will be escalated to Marcus Delgado (Responsible Partner) for final resolution. Mr. Delgado's coding decision will be treated as dispositive for purposes of the seed set.

4. Seed set coding is targeted for completion within five (5) business days of ingestion, with a target completion date of August 19, 2024.

5. Upon completion of seed set coding, the coded seed set will be uploaded to DataVault Insight™ to initialize the CAL classifier. DataVault will confirm successful ingestion of the seed set coding data and will generate an initial classifier performance baseline report.

V. TRAINING ROUNDS AND ITERATIVE LEARNING A. Training Round Structure Following initialization of the CAL classifier with the coded seed set, DataVault Insight™ will begin prioritizing documents for attorney review based on classifier uncertainty. Specifically, the platform will present for review those documents whose relevance scores fall closest to the classification boundary (i.e., documents for which the classif

1. Recall exceeds 85% on a statistically valid random sample drawn from the document population, with a confidence level of 95% and a margin of error of ±3%.

2. Precision exceeds 80% on a statistically valid random sample drawn from the documents classified as responsive.

3. Marginal gain in recall from an additional training round is less than 1.0 percentage point, as demonstrated by the elbow curve analysis.

4. Two consecutive training rounds show less than 2% change in overall classifier scores (precision, recall, and F1), indicating that the classifier's performance has converged and is no longer materially changing with additional training data. Upon confirmation that stabilization criteria have been met, DataVault will apply the final classifier to the entire remaining unreviewed population. All documents receiving a

VI. VALIDATION METHODOLOGY A. Statistical Validation of Recall Upon completion of the TAR process — including application of the stabilized classifier to the full document population — DataVault will conduct a rigorous statistical validation of recall to confirm that the classifier has achieved the required performance threshold. DataVault will draw a statistically random validation sample from the documents classifi

1. The responsive documents identified in the validation sample will be added to the training set and the classifier will be retrained.

2. Additional targeted keyword searches will be run to identify potential pockets of responsive documents that the classifier may have missed.

3. A second validation sample will be drawn and reviewed following retraining.

4. This iterative process will continue until the 85% recall threshold is achieved on a validation sample. B. Precision Validation In addition to recall validation, a separate validation of precision will be conducted. DataVault will draw a random sample from the documents classified as responsive by the CAL classifier. The sample size for precision validation will be approximately 1,500 documents, calculated to achi

VII. QUALITY CONTROL METRICS AND REPORTING A. Ongoing QC During Review DataVault will implement the following quality control ("QC") measures throughout the active review period to ensure the accuracy and consistency of attorney coding decisions: • Random QC sampling: Ten percent (10%) of each reviewer's coded documents will be selected at random and re-reviewed by a senior attorney (Christy Bauer or Peter Vassiliev)

VIII. PRODUCTION FORMAT AND SPECIFICATIONS A. Production Format All documents will be produced in accordance with the ESI protocol agreed by the parties in the Joint discovery Plan filed on July 15, 2024. The production format specifications are as follows: • Native format production: Spreadsheets (.xlsx) and databases will be produced in native format, preserving formulas, pivot tables, and embedded data. Native fil

IX. COST ESTIMATE AND BUDGET MANAGEMENT DataVault's total estimated charges for the engagement are $141,200. This estimate was provided by DataVault in its Statement of Work dated August 2, 2024, and is based on the estimated data volume (1.2 TB raw / 900 GB processed), the estimated document count (312,000 documents), and the anticipated scope of processing, hosting, and production activities. The $141,200 estimate

X. TIMELINE AND KEY MILESTONES The following table sets forth the key milestones and target dates for the TAR workflow. All dates are subject to adjustment based on the pace of the review, the number of training rounds required to achieve classifier stabilization, and any unforeseen circumstances. Any material changes to the timeline will be communicated promptly to Marcus Delgado and Christy Bauer. The timeline has

XI. DEFENSIBILITY CONSIDERATIONS The TAR protocol described in this memorandum has been designed to withstand judicial scrutiny under the standards articulated in Rio Tinto PLC v. Vale S.A., 306 F.R.D. 125 (S.D.N.Y. 2015) (Peck, M.J.), and its progeny. In Rio Tinto, the court held that the use of TAR for document review is an acceptable practice, provided that the methodology is reasonable, transparent, and subject t

1. Transparent methodology: The TAR methodology, including the selection of CAL over TAR 1.0, the composition of the seed set, the training round structure, and the stabilization criteria, is fully documented in this memorandum. This documentation can be disclosed to the Court and, if appropriate, to opposing counsel in the event of a challenge to the sufficiency of Solstice's production.

2. Senior attorney involvement: The seed set and initial training rounds are reviewed exclusively by senior attorneys (Christy Bauer and Peter Vassiliev) with substantive knowledge of the case. Coding decisions are not delegated entirely to contract reviewers, which reduces the risk of coding errors and strengthens the defensibility of the training data.

3. Statistical validation: Recall and precision are validated through statistically rigorous sampling procedures, with confidence levels and margins of error that meet or exceed industry standards. The validated recall target of 85% is well above the thresholds that courts have accepted as reasonable.

4. Ongoing quality control: The QC measures described in Section VII — including 10% random sampling, inter-reviewer agreement rate tracking, and weekly reporting — exceed industry benchmarks and provide a continuous record of review quality.

5. Disclosure to opposing counsel: Consistent with the Joint discovery Plan's ESI protocol provisions, Calderwood & Harkness is prepared to disclose the general TAR methodology to opposing counsel at Hargrove, Tate & Bennington LLP if challenged. This willingness to disclose is itself a factor that courts have considered favorable to the producing party in TAR-related disputes. In the event that Apex challenges the s

XII. DATAVAULT POINTS OF CONTACT AND COMMUNICATION PROTOCOL DataVault Project Manager. DataVault's designated project manager for this engagement is to be confirmed by DataVault upon formal execution of the engagement letter. The project manager will serve as the primary day-to-day point of contact for Peter Vassiliev on all matters relating to data processing, platform configuration, classifier performance, and prod

XIII. APPROVALS This memorandum and the TAR protocol described herein are submitted for approval. Upon approval, this memorandum will serve as the governing document for all TAR-related activities in connection with the defense of Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA (D. Del.). This protocol is approved by: CALDERWOOD & HARKNESS LLP By: ________ Name: Marcus Delgado