Case 1:22-cv-00252-MSG Document 195-28 Filed 01/16/24 Page 1 of 8 PageID #: 13679
`Case 1:22-cv-00252-MSG Document 195-28 Filed 01/16/24 Page 1 of 8 PagelD #: 13679
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`EXHIBIT 21
`EXHIBIT 21
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`Case 1:22-cv-00252-MSG Document 195-28 Filed 01/16/24 Page 2 of 8 PageID #: 13680
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 22-252-MSG
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`HIGHLY CONFIDENTIAL –
`OUTSIDE COUNSEL’S EYES ONLY
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`Plaintiffs,
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`v.
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`MODERNA, INC. and MODERNATX, INC.,
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`Defendants.
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`MODERNA, INC. and MODERNATX, INC.,
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`Counterclaim-Plaintiffs,
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`v.
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`Counterclaim-Defendants.
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`DECLARATION OF ALLISON P. GRISWOLD IN SUPPORT OF MODERNA’S
`OPPOSITION TO PLAINTIFFS’ MOTION TO COMPEL
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`Case 1:22-cv-00252-MSG Document 195-28 Filed 01/16/24 Page 3 of 8 PageID #: 13681
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`I, Allison P. Griswold, hereby declare as follows:
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`1.
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`I am the Senior Manager, Quality Strategic Operations at ModernaTX, Inc.
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`(“Moderna”). In this role, I am familiar with Moderna’s Quality Control (“QC”) procedures,
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`including Moderna’s compliance with Current Good Manufacturing Practice (“CGMP”)
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`standards, FDA criteria and regulations which apply to drugs like Moderna’s COVID-19 Vaccine
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`“SpikeVax.” I have personal knowledge of the facts stated in this declaration or have become
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`aware of such facts through my role at Moderna. If called upon to testify, I could and would
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`competently testify thereto.
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`2.
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`I write this declaration in support of Moderna’s opposition to Plaintiffs’ Motion to
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`Compel production of samples from every drug product batch manufactured of SpikeVax.
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`3.
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`I understand this case relates to Moderna’s COVID-19 Vaccine, known as mRNA-
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`1273 or “SpikeVax.” SpikeVax is comprised of messenger RNA (mRNA) which is encased in
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`lipid nanoparticles (LNPs).
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`A.
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`SpikeVax is a Regulated Drug Product that is Approved by the FDA
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`Case 1:22-cv-00252-MSG Document 195-28 Filed 01/16/24 Page 4 of 8 PageID #: 13682
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`4.
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`SpikeVax is an FDA-approved drug product, which was initially authorized
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`pursuant to Emergency Use Authorization No. 27073, and later pursuant to Biologics License
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`Application No. 125752. During the FDA approval process, Moderna submits specifications for
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`the drug product and certain of its components, which provide limits for various physical and
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`chemical characteristics. Moderna’s specifications for its
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` mRNA-LNP, and drug
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`product include lipid content specifications. Each time a batch of
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` and drug product
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`is manufactured, Moderna tests a sample to ensure that the batch complies with the specification,
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`including lipid content. A Certificate of Analysis or “COA” is produced each time those tests are
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`carried out, which reports the results of each test to confirm whether it complies with the
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`specification. COAs are also included in Moderna’s submissions to the FDA.
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`5.
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`Because SpikeVax is an FDA-approved drug product, it is subject to regulations.
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`Inventory of batches and samples of drug product and its components is carefully controlled and
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`documented.
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`B.
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`6.
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`Request for Samples of Drug Product
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`I have been asked to describe the steps that would need to be taken to be able to
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`produce samples from each batch manufactured of SpikeVax.
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`7.
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`Retained samples of these batches may be held at Moderna’s Norwood location or
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`at third-party manufacturer sites across the United States.
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`8.
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`I have been part of a cross-functional team that has been working to prepare
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`samples from approximately 400 batches that were manufactured by third-party Catalent to
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`produce to Plaintiffs’ external laboratory. The majority of the samples have now arrived at
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`Moderna’s facilities, but were previously stored at Catalent’s facility in Indiana. The samples had
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`to be driven for over 12 hours under strict cold storage conditions to allow Moderna’s team to
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`prepare the samples for production.
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`Case 1:22-cv-00252-MSG Document 195-28 Filed 01/16/24 Page 5 of 8 PageID #: 13683
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`9.
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`The team that has been working for weeks to prepare these samples is comprised
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`of at least 15 individuals from various departments, including Quality Control, Quality Assurance,
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`Supply Chain, Compliance, and Regulatory. I expect that an additional 8 individuals will be
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`involved in inventorying the samples, packing the samples for shipment, and documenting their
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`removal from sample retention and processing for shipment.
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`10.
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`Every process carried out in relation to an approved drug product like SpikeVax
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`requires an approved written Standard Operating Procedure or “SOP.” Collection and production
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`of samples for litigation, including by removing regulatory retained samples, is not a standard
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`process that we carry out at Moderna, and as such there is no approved SOP. SpikeVax is
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`Moderna’s first commercial product and prior to this request, the company has not had to produce
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`samples for patent infringement litigation.
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`11.
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`To remove a sample that was reserved for regulatory retain for litigation purposes,
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`the removal must be documented through a change control process, which describes the deviation
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`from normal processes. The change control must be assessed and approved by other stakeholders,
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`including individuals from various departments including Quality Assurance (either internal
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`Quality Assurance, or External Quality Assurance where a contract manufacturing organization is
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`involved), Quality Control, Regulatory, Supply Chain, and Compliance. The change control
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`documentation records the deviation, who evaluated and approved the deviation, and describes the
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`oversight that was involved and what process was followed. The process to be followed is
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`described in a protocol, which for this sample collection must include details on how employees
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`will be trained to follow the protocol, where the samples are being transported to, how they are
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`maintained at required temperatures, and how the temperatures will be monitored.
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`Case 1:22-cv-00252-MSG Document 195-28 Filed 01/16/24 Page 6 of 8 PageID #: 13684
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`12.
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`Once an approved protocol is in place, the samples must be inventoried, which is a
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`process where individuals will physically verify the lot numbers of the samples, vial quantities
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`received for each lot and verify that the drug product containers are not damaged. For the drug
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`product, this includes inspecting the samples as they are kept in the freezer at
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`Occupational Health and Safety procedures require extensive personal protective equipment to be
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`worn, that two individuals enter the freezer together, and limit the time spent inside the freezer to
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`15 minutes at a time, and for no more than 60 minutes per shift. To inventory the samples from
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`approximately 400 Catalent lots, I estimate it would take 8-12 hours for three personnel working
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`together, which would have to be conducted over several days due to the restrictions on the amount
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`of time that can be spent in a
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` freezer.
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`13.
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`Once inventoried, the samples must be packed to be shipped at the required cold
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`condition. Again, this requires two people at a minimum going into the freezer and maintaining
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`temperature conditions for the samples. This is a time-consuming exercise as the samples need to
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`be physically packed and the container needs to be pre-conditioned to ensure it can maintain
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`required temperatures during shipment, which, depending on the vendor and container size and
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`availability, requires 1-3 days notice. To prepare to ship the samples from approximately 400
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`Catalent lots, I estimate it would take another 8-12 hours for three personnel working together.
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`14.
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`Each of the individuals involved in this exercise is performing these duties on top
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`of their regular roles and responsibilities at Moderna.
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`15.
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`Further, to the extent any samples that are less than one year past expiry (and are
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`therefore still subject to the regulations that require them to be retained) need to be pulled, each
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`individual sample would require a completed retain authorization before it could be pulled from
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`the storage. This would apply to any product type (e.g.
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`, DP, etc). Each authorization
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`Case 1:22-cv-00252-MSG Document 195-28 Filed 01/16/24 Page 7 of 8 PageID #: 13685
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`would need to be individually approved by a QC Director and QA Director. Given the sample-by-
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`sample requirement, this would become extremely burdensome if Moderna were required to
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`produce large numbers of samples that are not yet one year past expiry.
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`Request for Samples of
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`C.
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`18.
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`5
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`Case 1:22-cv-00252-MSG Document 195-28 Filed 01/16/24 Page 8 of 8 PageID #: 13686
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`I declare under penalty of perjury under the laws of the United States of America that the
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`foregoing is true and correct to the best of my knowledge.
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`Executed on this January 4, 2024
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`Respectfully submitted,
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`__ _________________
`Allison Griswold
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