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Contract analysis / litigation-hold-memo.docx
litigation-hold-memo.docx
High · 1
Medium · 7
Standard · 1
I. PURPOSE AND LEGAL OBLIGATION
High
⚑ Penalty / liquidated damages
I. PURPOSE AND LEGAL OBLIGATION As you are aware, Calderwood & Harkness LLP has been retained by Genome Dx Therapeutics Inc. ("GenomeDx" or "GDT") to prosecute patent infringement claims against Helios Precision Diagnostics, Inc. ("Helios") based on Helios's commercialization of the ProstaSignal™ Genomic Classifier. The engagement letter between Calderwood & Harkness and GenomeDx was executed on March 12, 2025. We an
II. BACKGROUND OF THE LITIGATION
Medium
⚑ Assignment / subcontracting
II. BACKGROUND OF THE LITIGATION The following summary is provided to give GenomeDx employees who receive this hold notice sufficient context to identify and preserve relevant materials. This summary is necessarily abbreviated and should not be treated as a comprehensive statement of the legal theories or factual allegations that will be asserted in the litigation. A. The Patents-in-Suit GenomeDx is the owner by assi
III. SCOPE OF THE LITIGATION HOLD
Medium
⚑ Liability cap to check against exposure
III. SCOPE OF THE LITIGATION HOLD A. Effective Date This litigation hold is effective immediately as of March 14, 2025. It will remain in full force and effect until Calderwood & Harkness LLP provides written notice that the hold has been released. Under no circumstances should any individual at GenomeDx assume that the hold has been released absent express written confirmation from this firm. The pendency of the hol
IV. IDENTIFICATION OF KEY CUSTODIANS
IV. IDENTIFICATION OF KEY CUSTODIANS The following eleven (11) individuals have been identified as key custodians whose files, documents, and ESI must be preserved in their entirety. Each custodian must be individually notified of this litigation hold and must acknowledge receipt of the hold notice in writing, as described in Section VII below. The identification of key custodians is based on our current understandin
1. Dr. Rajan Mehta — Chief Technology Officer
1. Dr. Rajan Mehta — Chief Technology Officer Dr. Mehta is a named inventor on the '271, '893, and '647 Patents and has served as the technical lead for the development of the Decipher® genomic classifier. Dr. Mehta is likely to possess documents relating to the conception and reduction to practice of the inventions claimed in the patents-in-suit, gene selection methodologies, classifier design and architecture, vali
2. Dr. Kevin Ostrowski — Vice President, intellectual Property
2. Dr. Kevin Ostrowski — Vice President, intellectual Property Dr. Ostrowski is a named inventor on the '647 Patent and oversees GenomeDx's entire patent portfolio, which currently comprises 47 issued U.S. patents, 12 pending U.S. patent applications, and 19 international family members. Dr. Ostrowski possesses patent prosecution files, freedom-to-operate analyses, prior art search reports, patentability opinions, li
3. Dr. Miriam Langford — Chief Executive Officer
3. Dr. Miriam Langford — Chief Executive Officer Dr. Langford possesses strategic communications regarding GenomeDx's competitive positioning vis-à-vis Helios and other competitors in the genomic prostate cancer diagnostics market. Her files are expected to include board communications with Pinnacle Biosciences Capital, LP (GenomeDx's majority equity holder, holding approximately 62.4% of the outstanding equity), bus
4. Victoria Sung — General Counsel
4. Victoria Sung — General Counsel Ms. Sung possesses legal files pertaining to GenomeDx's intellectual property portfolio, licensing agreements (including the Veridian Molecular Labs license), IP enforcement correspondence, and regulatory filings. Her files may also include insurance communications with Greystone Specialty Insurance Co. relating to IP enforcement insurance coverage under policy number GSI-IP-2024-07
5. Thomas Brennan — Chief Financial Officer
5. Thomas Brennan — Chief Financial Officer Mr. Brennan possesses financial records that will be central to GenomeDx's damages case. These records include revenue data (GenomeDx's fiscal year 2024 revenue was approximately $387.6 million), per-test reimbursement records (average reimbursement of approximately $4,210 per test), market share analyses (reflecting an approximate decline from 74% market share prior to the
6. Dr. Carolyn Xu — Former Principal Scientist
6. Dr. Carolyn Xu — Former Principal Scientist Dr. Xu is a named inventor on the '271 and '893 Patents. She departed GenomeDx in 2023 and is currently employed at Cascadia Genomics, Inc. Although Dr. Xu is no longer a GenomeDx employee, GenomeDx must preserve all documents in its possession, custody, or control that originated from or were sent to Dr. Xu during her tenure at GenomeDx. This includes any files that rem
7. Dr. Priya Shah — Senior Scientist
7. Dr. Priya Shah — Senior Scientist Dr. Shah is a named inventor on the '647 Patent. She possesses research data, laboratory notebooks, and technical documents relating to the development of the combined biomarker-clinical variable model that is the subject of the '647 Patent's claims. Dr. Shah's files may also contain comparative analyses, internal presentations regarding the advantages of the combined model, and c
8. Dr. David Petrossian — Named Inventor
8. Dr. David Petrossian — Named Inventor Dr. Petrossian is a named inventor on the '271 Patent. His current employment status with GenomeDx is to be confirmed. Dr. Petrossian possesses historical research and development documents relating to the original multi-gene expression classifier methods that are the subject of the '271 Patent. If Dr. Petrossian is no longer employed by GenomeDx, the same preservation princip
V. CATEGORIES OF DOCUMENTS AND ESI TO BE PRESERVED
Medium
⚑ Liability cap to check against exposure
V. CATEGORIES OF DOCUMENTS AND ESI TO BE PRESERVED The following categories describe, in greater detail, the types of documents and ESI that must be preserved under this litigation hold. These categories are intended to be illustrative, not exhaustive. If any GenomeDx employee possesses or is aware of documents that are potentially relevant to this litigation but that do not fall squarely within one of the categories
VI. IT SYSTEMS AND DATA SOURCES TO BE PRESERVED
Medium
⚑ Liability cap to check against exposure
VI. IT SYSTEMS AND DATA SOURCES TO BE PRESERVED In addition to the general preservation obligations described above, GenomeDx's Information Technology department is specifically directed to take the following steps immediately to ensure the preservation of all relevant documents and ESI. Victoria Sung is requested to coordinate with GenomeDx's Chief Information Officer (or equivalent) to ensure that these measures ar
VII. CUSTODIAN ACKNOWLEDGMENT PROCEDURE
VII. CUSTODIAN ACKNOWLEDGMENT PROCEDURE Proper implementation of this litigation hold requires that each identified custodian receive individual notice and confirm in writing that he or she understands the preservation obligations. The following procedures must be followed:
1. Distribution of Hold Notice. Victoria Sung is requested to distribute a copy of this me
1. Distribution of Hold Notice. Victoria Sung is requested to distribute a copy of this memorandum — or, if preferred, an adapted internal version of this memorandum prepared in coordination with and approved by Calderwood & Harkness — to each of the 11 identified custodians within three (3) business days of the date of this memorandum (i.e., by March 19, 2025). The notice should be delivered by email with a read rec
2. Written Acknowledgment. Each custodian must sign and return a written acknowledgment fo
2. Written Acknowledgment. Each custodian must sign and return a written acknowledgment form (a template of which is enclosed as Attachment A) confirming: (a) Receipt of the litigation hold notice; (b) Understanding of the obligation to preserve all documents and ESI that may be relevant to the litigation, including the obligation to suspend any routine destruction or deletion practices; (c) Identification of all loc
3. Return of Acknowledgments. Signed acknowledgment forms should be returned to Victoria S
3. Return of Acknowledgments. Signed acknowledgment forms should be returned to Victoria Sung. Copies of all signed acknowledgment forms must be transmitted to Peter Vassiliev at Calderwood & Harkness LLP for our records. We request that all acknowledgments be collected and transmitted within ten (10) business days of the date of this memorandum (i.e., by March 28, 2025).
4. Special Procedures for Dr. Carolyn Xu. Because Dr. Xu is a former employee now employed
Medium
⚑ Liability cap to check against exposure
4. Special Procedures for Dr. Carolyn Xu. Because Dr. Xu is a former employee now employed at Cascadia Genomics, Inc., GenomeDx's obligations with respect to Dr. Xu's data are limited to preserving all materials in GenomeDx's possession, custody, or control. GenomeDx should not independently contact Dr. Xu regarding any GenomeDx materials she may have retained after her departure. Any such communications should be co
5. Non-Responsive Custodians. If any custodian fails to return a signed acknowledgment for
5. Non-Responsive Custodians. If any custodian fails to return a signed acknowledgment form within the specified timeframe, Victoria Sung should follow up directly with the custodian and, if necessary, escalate the matter to the custodian's supervisor. Any persistent non-compliance should be reported to Calderwood & Harkness immediately.
VIII. ONGOING OBLIGATIONS AND PERIODIC REMINDERS
Medium
⚑ Liability cap to check against exposure
VIII. ONGOING OBLIGATIONS AND PERIODIC REMINDERS The litigation hold is not a one-time event. It imposes an ongoing, affirmative obligation on GenomeDx and each identified custodian to preserve relevant materials for the duration of the hold. The following ongoing obligations must be observed: Periodic Reminders. GenomeDx must issue periodic reminders to all custodians — at minimum, on a quarterly basis — reaffirming
IX. E-DISCOVERY COORDINATION
IX. E-DISCOVERY COORDINATION Calderwood & Harkness has engaged Canfield Document Solutions LLC as the e-discovery vendor for this matter. Canfield will provide data collection, processing, hosting, and review support throughout the course of the litigation. The project manager assigned to this engagement is Sandra Neville, who will serve as the primary point of contact for coordination with GenomeDx's IT department a
X. CONSEQUENCES OF NON-COMPLIANCE
Standard
⚑ Commercial term
X. CONSEQUENCES OF NON-COMPLIANCE We wish to underscore the gravity of the preservation obligations described in this memorandum. Failure to comply with the litigation hold may have severe consequences for GenomeDx and for individual employees. Sanctions Under Federal Rule of Civil Procedure 37(e). As discussed in Section I, Rule 37(e) authorizes courts to impose a range of sanctions for the loss of ESI that should h
XI. CONTACT INFORMATION
Medium
⚑ Confidentiality undertaking
XI. CONTACT INFORMATION All questions regarding the scope of this litigation hold, the categories of documents and ESI to be preserved, or the procedures for compliance should be directed to the following individuals: At Calderwood & Harkness LLP: Catherine Bloom, Responsible Partner Telephone: (415) 738-6244 Email: cbloom@calderwoodharkness.com Peter Vassiliev, Lead Associate Telephone: (415) 738-6318 Email: pvassil