Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 1 of 23 PageID #: 12615
`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 1 of 23 PagelD #: 12615
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`EXHIBIT 9
`EXHIBIT 9
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 1 of 23 PagelD #: 12615
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`EXHIBIT 9
`EXHIBIT 9
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 2 of 23 PageID #: 12616
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`C. A. No. 22-252 (MSG)
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Plaintiffs,
`
`v.
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`MODERNA, INC. and MODERNATX, INC.,
`
`Defendants.
`_______________________________________
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`MODERNA, INC. and MODERNATX, INC.,
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`Counterclaim-Plaintiffs,
`
`v.
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`Counterclaim-Defendants.
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`PLAINTIFFS’ FIRST SET OF REQUESTS FOR PRODUCTION TO
`DEFENDANTS (NOS. 1–98)
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`Pursuant to Fed. R. Civ. P. 34, Plaintiffs Arbutus Biopharma Corporation (“Arbutus”) and
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`Genevant Sciences GmbH (“Genevant,” together “Plaintiffs”), direct the following requests for
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`production to Defendants Moderna, Inc. and ModernaTX Inc. (collectively, “Moderna” or
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`“Defendants”). Responses to these requests shall be served upon Plaintiffs’ undersigned counsel
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`within 30 days of service of these requests, or at such time and location as may be mutually
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`agreed upon by the parties. Copies shall be produced as they are kept in the ordinary course of
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`business, including their labeling as to the source of the documents. Pursuant to Fed. R. Civ. P.
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`1
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 3 of 23 PageID #: 12617
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`26(e), these requests are continuing and require supplemental answers.
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`DEFINITIONS
`
`1.
`
`The “Accused Product” shall be construed to include, but not be limited
`
`to, Moderna’s mRNA-1273 COVID-19 mRNA LNP vaccine product (“Moderna’s COVID-19
`
`vaccine”) or any supplemental or booster COVID-19 mRNA LNP vaccine product, including
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`the mRNA-1273.214 Omicron bivalent booster.
`
`2.
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`“And” and “or” shall be construed either disjunctively or conjunctively as
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`necessary to bring within the scope of these requests any information ordocuments that might be
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`deemed outside their scope.
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`3.
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`“Complaint” means the complaint filed by Plaintiffs in the United States
`
`District Court for the District of Delaware on February 28, 2022 as Civil Action No. 1:22-cv-
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`00252-MN.
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`4.
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`The term “communication” means any transmission of information from
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`one person to another, including, without limitation, by personal meeting, telephone, facsimile,
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`electronic transmission, including electronic mail, and teleconference.
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`5.
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`“Document” is used in its broadest sense, and includes any written,
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`printed, typed, recorded, electronic or graphic matter of every type, however and by whomever
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`prepared, produced, reproduced, disseminated or made, in any form, including but not limited to,
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`letters, calendars, correspondence, email, telegrams, memoranda, electronic files, spreadsheets,
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`databases, records, minutes, contracts, agreements, leases, communications, microfilm, bulletins,
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`circulars, pamphlets, studies, reports, notices, diaries, summaries, books, messages, instructions,
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`work assignments, notes, notebooks, drafts, data sheets, data compilations, worksheets, statistics,
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`speeches, tapes, tape recordings, magnetic, photographic, an any other writings or sound
`
`2
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 4 of 23 PageID #: 12618
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`recordings. “Document” includes any version, copy, or reproduction not identical to the original
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`or a produced copy.
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`6.
`
` “You,” “your,” and “Defendants” means, collectively and singly,
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`Moderna, Inc. and ModernaTX Inc., and their officers, directors, employees, agents,
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`consultants, any divisions, subsidiaries, affiliates, parent companies, any joint ventures to which
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`they may be a party, consultants, agents, and accountants, including any person who served in
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`such a capacity at any time.
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`7.
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`“Refer,” “refer to,” “relate,” or “relate to” shall mean any document or
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`electronically stored information that evidences, reflects, mentions, discusses, constitutes,
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`concerns, relates to (directly or indirectly), contradicts, or in any other way is factually or
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`logically connected to the matter discussed, or pertains to its subject matter.
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`8.
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`The use of the singular form of any word shall include the plural and vice
`
`versa.
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`9.
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`10.
`
`11.
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`The terms “all,” “each,” and “any” shall be construed as all and any.
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`The term “LNP” means “lipid nanoparticle.”
`
`“Test” or “testing” shall be construed to include but not be limited to any
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`test, evaluation, comparison, analysis, study, experiment or trial for any purpose, including
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`clinical trials or results, including any submissions to any governmental, regulatory,
`
`contracting, or granting agency or entity, whether published or unpublished.
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`12.
`
`“Operation Warp Speed” shall refer to the public-private partnerships,
`
`individually and collectively, initiated by the U.S. government to facilitate and accelerate the
`
`development, manufacture, and distribution of COVID-19 vaccines, therapeutics, and
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`diagnostics.
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`3
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 5 of 23 PageID #: 12619
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`13.
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`“Patents-in-Suit” shall mean any patents presently or later asserted in this
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`litigation. Presently, this means U.S. Patent Nos. 8,058,069 (the “’069 patent”), 8,492,359 (the
`
`“’359 patent”), 8,822,668 (the “’668 patent”), 9,364,435 (the “’435 patent”), 9,504,651 (the
`
`“’651 patent”), and 11,141,378 (the “’378 patent”).
`
`14.
`
`“The Alnylam litigation” refers to Alnylam Pharmaceuticals, Inc. v.
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`Moderna, Inc., ModernaTX, Inc., and Moderna US, Inc., C.A. No. 22-cv-335-CFC (D. Del.).
`
`REQUESTS FOR PRODUCTION
`
`REQUEST FOR PRODUCTION NO. 1
`
`
`
`A copy of Biologics License Application 125752, including all correspondence,
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`amendments, and supplements relating thereto.
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`REQUEST FOR PRODUCTION NO. 2
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`
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`All documents related to the preparation of Biologics License Application 125752.
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`REQUEST FOR PRODUCTION NO. 3
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`
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`A copy of any other U.S. or foreign regulatory submission relating to approval or
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`emergency authorization of the Accused Product, including all correspondence, amendments, and
`
`supplements relating thereto.
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`REQUEST FOR PRODUCTION NO. 4
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`
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`All documents related to the research and development of the Accused Product.
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`REQUEST FOR PRODUCTION NO. 5
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`
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`All documents related to the manufacture of the Accused Product.
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`REQUEST FOR PRODUCTION NO. 6
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`
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`All documents related to Operation Warp Speed.
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`
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`4
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 6 of 23 PageID #: 12620
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`REQUEST FOR PRODUCTION NO. 7
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`
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`Documents sufficient to show the time it took to develop the Accused Product.
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`REQUEST FOR PRODUCTION NO. 8
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`All documents related to the decision to utilize LNPs in the Accused Product, including but
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`not limited to any document concerning the advantages of LNPs compared to other technologies;
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`the consideration of alternatives to LNPs for use in the Accused Product; and the testing or
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`development of any COVID-19 vaccine product without LNPs.
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`REQUEST FOR PRODUCTION NO. 9
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`
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`All documents related to any comparisons between LNPs including but not limited to
`
`comparisons of LNPs with different lipid compositions or different lipid molar ratios.
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`REQUEST FOR PRODUCTION NO. 10
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`All patents, publications, or other documents relied on or considered in the development
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`and selection of LNPs for the Accused Product.
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`REQUEST FOR PRODUCTION NO. 11
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`All documents related to any comparison between the Accused Product and any other
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`COVID-19 vaccine product, including but not limited to comparisons between potential vaccine
`
`products in connection with the research and development, preclinical testing, clinical testing, or
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`regulatory approval of the Accused Product.
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`REQUEST FOR PRODUCTION NO. 12
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`All documents related to the formulation of the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 13
`
`All documents related to the selection of the formulation of the Accused Product, including
`
`but not limited to documents related to the consideration, research and development, and/or testing
`
`5
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 7 of 23 PageID #: 12621
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`of that formulation or any alternative formulations.
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`REQUEST FOR PRODUCTION NO. 14
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`All documents related to the lipid composition or lipid molar ratio of the LNPs in the
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`Accused Product.
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`REQUEST FOR PRODUCTION NO. 15
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`All documents related to the selection of the lipid composition or lipid molar ratio of, or to
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`the determination of any variability of the lipid molar ratio in, the LNPs in the Accused Product,
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`including but not limited to documents related to the consideration, research and development,
`
`and/or testing of the lipid composition or lipid molar ratio of the LNPs in the Accused Product or
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`any alternative lipid compositions or lipid molar ratios.
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`REQUEST FOR PRODUCTION NO. 16
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`All documents related to the manufacturing process for the Accused Product, including but
`
`not limited to the manufacturing process for the LNPs in the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 17
`
`All documents related to the selection of the manufacturing process for the Accused
`
`Product, including but not limited to the manufacturing process for the LNPs in the Accused
`
`Product, and including but not limited to documents related to the consideration, research and
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`development, and/or testing of those manufacturing processes or any alternative manufacturing
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`processes.
`
`REQUEST FOR PRODUCTION NO. 18
`
`All documents related to the identity of each manufactured batch of the Accused Product,
`
`including but not limited to documents sufficient to show the identity of the manufacturer, the date
`
`and location the batch was manufactured, the size of the batch, the intended market for the batch,
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`6
`
`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 8 of 23 PageID #: 12622
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`the characteristics and testing of the batch, the specification for the batch, the lipid molar ratio of
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`the batch, and the status of the batch.
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`REQUEST FOR PRODUCTION NO. 19
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`All documents relating to the analytical procedures used to characterize the Accused
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`Product at any point during or after manufacturing.
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`REQUEST FOR PRODUCTION NO. 20
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`All documents related to the selection of the analytical procedures used to characterize the
`
`Accused Product at any point during or after manufacturing, including but not limited to documents
`
`related to the consideration, research and development, and/or testing of those procedures or any
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`alternative procedures.
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`REQUEST FOR PRODUCTION NO. 21
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`All documents related to any changes to the formulation, lipid composition, lipid molar
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`ratio, manufacturing process, product characteristics, or methods used to characterize the Accused
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`Product and any reasons for such changes.
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`REQUEST FOR PRODUCTION NO. 22
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`All documents related to any efforts by or on behalf of Defendants to avoid infringement of
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`or design around the Patents-in-Suit, including but not limited to any modifications considered or
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`made to the Accused Product to avoid infringement.
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`REQUEST FOR PRODUCTION NO. 23
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`All documents related to any regulatory or manufacturing specifications for the Accused
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`Product, including but not limited to the selection of such specifications.
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`REQUEST FOR PRODUCTION NO. 24
`
`All documents related to any batch of the Accused Product found to be out of specification.
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`7
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 9 of 23 PageID #: 12623
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`REQUEST FOR PRODUCTION NO. 25
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`All documents related to any testing conducted to characterize the Accused Product
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`including but not limited to any testing related to: the lipid composition of the LNPs, the lipid
`
`molar ratio of the LNPs; the mRNA content of the LNPs; the percentage encapsulation of mRNA
`
`in the LNPs; and the structural characteristics of the LNPs (including but not limited to diameter,
`
`polydispersity, and microstructure).
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`REQUEST FOR PRODUCTION NO. 26
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`All documents related to any testing conducted to characterize LNPs during development or
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`manufacturing of the Accused Product, including but not limited to testing of: the lipid composition
`
`of the LNPs; the lipid molar ratio of the LNPs; the mRNA content of the LNPs; the percentage
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`encapsulation of mRNA in the LNPs; and the structural characteristics of the LNPs (including but
`
`not limited to diameter, polydispersity, and microstructure).
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`REQUEST FOR PRODUCTION NO. 27
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`All documents related to the development of any analytical procedure for characterizing
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`LNPs during development or manufacturing of the Accused Product, including but not limited to
`
`the development of any analytical procedure for characterizing: the lipid composition of the LNPs;
`
`the lipid molar ratio of the LNPs; the mRNA content of the LNPs; the percentage encapsulation of
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`mRNA in the LNPs; and the structural characteristics of the LNPs (including but not limited to
`
`diameter, polydispersity, and microstructure), and any results from using such analytical procedure.
`
`REQUEST FOR PRODUCTION NO. 28
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`Any internal communications or communications with third parties, including but not
`
`limited to collaborators, contractors, or regulatory entities, regarding the development or selection
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`of any analytical procedure for characterizing LNPs, including but not limited to the lipid
`
`8
`
`
`
`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 10 of 23 PageID #: 12624
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`composition of the LNPs, including the lipid molar ratio; the mRNA content of the LNPs; the
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`percentage encapsulation of mRNA in the LNPs; and the structural characteristics of the LNPs,
`
`including diameter, polydispersity, and microstructure, and any results from such analytical
`
`procedures.
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`REQUEST FOR PRODUCTION NO. 29
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`All documents relating to the selection of regulatory acceptance criteria for the Accused
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`Product and justifications therefore, including but not limited to criteria for: pH, impurities, LNP
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`size and polydispersity, mRNA content, mRNA encapsulation, identity of lipid components and
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`lipid molar ratio.
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`REQUEST FOR PRODUCTION NO. 30
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`All documents relating to the characterization of LNPs before and after storage or transport
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`under different conditions, including protocols for and results of any stability studies.
`
`REQUEST FOR PRODUCTION NO. 31
`
`All documents related to any testing conducted during the manufacture of any batch of the
`
`Accused Product.
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`REQUEST FOR PRODUCTION NO. 32
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`All documents, including but not limited to testing protocols, regarding variation in lipid
`
`ratios, including molar ratios, within each batch and between batches of the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 33
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`All documents, including but not limited to testing protocols, regarding the variation in lipid
`
`ratios, including molar ratios, in each batch of the Accused Product before and after manufacture.
`
`REQUEST FOR PRODUCTION NO. 34
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`All documents related to any testing conducted on the materials used to manufacture the
`
`9
`
`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 11 of 23 PageID #: 12625
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`Accused Product, including but not limited to any testing on any of the lipids used to manufacture
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`the LNPs in the Accused Product.
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`REQUEST FOR PRODUCTION NO. 35
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`All documents related to, or constituting, communications with the FDA concerning the
`
`Accused Product.
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`REQUEST FOR PRODUCTION NO. 36
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`All documents related to, or constituting, communications with any U.S. government
`
`agency concerning the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 37
`
`All documents related to the FDA emergency authorization and/or approval process for the
`
`Accused Product.
`
`REQUEST FOR PRODUCTION NO. 38
`
`All documents related to any preclinical or clinical testing conducted in connection with the
`
`authorization or approval process for the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 39
`
`All documents relating to the preclinical study of Moderna’s COVID-19 vaccine authored
`
`by Corbett et al. and published on the website of The New England Journal of Medicine on July 28,
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`2020.1
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`REQUEST FOR PRODUCTION NO. 40
`
`All documents related to any proposed, contemplated, or actual package insert or labeling,
`
`
`1 See Corbett et al., “Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates,” NEJM
`383;16:1544-1555, 1546 (2020) (citing Hassett et al., “Optimization of Lipid Nanoparticles for Intramuscular
`Administration of mRNA Vaccines,” Mol. Ther. Nucl. Acids 15:1-11, 8 (2019)), available at
`https://www.nejm.org/doi/full/10.1056/nejmoa2024671#.
`
`10
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 12 of 23 PageID #: 12626
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`including revisions thereto, concerning the Accused Product.
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`REQUEST FOR PRODUCTION NO. 41
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`All documents related to or generated in connection with any research collaborations,
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`research partnerships, or funding arrangements between Defendants and any other entities or
`
`individuals in connection with the research and development of the Accused Product.
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`REQUEST FOR PRODUCTION NO. 42
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`All documents that constitute, or refer or relate to, documents or publications that
`
`Defendants assert (i) constitute prior art to the Patents-in-Suit, or (ii) render the Patents-in-Suit
`
`invalid.
`
`REQUEST FOR PRODUCTION NO. 43
`
`All documents related to the Patents-in-Suit, or any related patents or patent applications.
`
`REQUEST FOR PRODUCTION NO. 44
`
`All documents that Defendants may rely on to assert the invalidity, unenforceability, or
`
`non-infringement of any claim of the Patents-in-Suit or which otherwise refer or relate to any
`
`defense asserted by Defendants.
`
`REQUEST FOR PRODUCTION NO. 45
`
`All documents that constitute, or refer or relate to, any opinions regarding the Patents-in-
`
`Suit, including but not limited to (a) opinions relating to the validity, enforceability, or
`
`infringement of the Patents-in-Suit, or (b) freedom-to-operate opinions, as well as drafts of said
`
`opinions, and any documents considered, reviewed, used, or relied on in formulating and/or
`
`rendering said opinions.
`
`REQUEST FOR PRODUCTION NO. 46
`
`All documents related to, or reflecting, Defendants’ knowledge or awareness of the Patents-
`
`11
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 13 of 23 PageID #: 12627
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`in-Suit, or any related patents or patent applications.
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`REQUEST FOR PRODUCTION NO. 47
`
`All documents reflecting or related to communications by or on behalf of Defendants
`
`referring to Plaintiffs or any related companies (e.g., Tekmira Pharmaceuticals or Protiva
`
`Biotherapeutics), including but not limited to any communications related to Plaintiffs’ work on
`
`LNP technology.
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`REQUEST FOR PRODUCTION NO. 48
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`All documents related to any testing of the lipid formulations or LNP manufacturing
`
`methods described or claimed in the Patents-in-Suit, including but not limited to any testing by
`
`Defendants to reproduce any of the experiments in the Patents-in-Suit.
`
`REQUEST FOR PRODUCTION NO. 49
`
`All documents related to communications by or on behalf of Defendants to financial or
`
`securities analysts regarding the Patents-in-Suit, or any related patents or patent applications, or
`
`this lawsuit.
`
`REQUEST FOR PRODUCTION NO. 50
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`All documents related to press releases or communications by or on behalf of Defendants to
`
`reporters regarding the Patents-in-Suit, or any related patents or patent applications, or this lawsuit.
`
`
`
`REQUEST FOR PRODUCTION NO. 51
`
`All documents related to communications between Defendants and any purchaser of the
`
`Accused Product regarding the Patents-in-Suit, or any related patents or patent applications, or this
`
`lawsuit.
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`
`
`12
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 14 of 23 PageID #: 12628
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`REQUEST FOR PRODUCTION NO. 52
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`Any presentations regarding LNP technology or the Accused Product given by Defendants
`
`to FDA or any other regulatory body or any purchaser.
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`REQUEST FOR PRODUCTION NO. 53
`
`All documents related to any indemnification agreement or warranty between Defendants
`
`and any purchaser of the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 54
`
`All documents related to Defendants’ knowledge of any USPTO proceedings or any foreign
`
`patent office proceedings that concern the Patents-in-Suit, or any related patents or patent
`
`applications.
`
`REQUEST FOR PRODUCTION NO. 55
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`All documents related to Defendants’ involvement in any USPTO proceedings or any
`
`foreign patent office proceedings related to the Patents-in-Suit, or any related patents or patent
`
`applications.
`
`REQUEST FOR PRODUCTION NO. 56
`
`All documents related to any consideration given by Defendants to seeking a license under
`
`the Patents-in-Suit, or any related patents or patent applications, including but not limited to all
`
`communications related to a potential license.
`
`REQUEST FOR PRODUCTION NO. 57
`
`A copy of any patent license agreement relating to the Accused Product, including any
`
`agreement relating to the manufacture, use, or sale of the Accused Product, as well as documents
`
`sufficient to show any royalty payments Defendants made or received pursuant to those license
`
`agreements.
`
`13
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 15 of 23 PageID #: 12629
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`REQUEST FOR PRODUCTION NO. 58
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`A copy of any patent license agreement between Defendants and any entity relating to
`
`COVID-19 vaccines, as well as documents sufficient to show any royalty payments Defendants
`
`made or received pursuant to those license agreements.
`
`REQUEST FOR PRODUCTION NO. 59
`
`A copy of any patent license agreement between Defendants and any entity relating to LNP
`
`technology, as well as documents sufficient to show any royalty payments Defendants made or
`
`received pursuant to those license agreements.
`
`REQUEST FOR PRODUCTION NO. 60
`
`A copy of any written agreement, contract, or license concerning the development,
`
`manufacture, sale, or distribution of the Accused Product, including any exhibits or annexes to such
`
`written agreement, contract, or license.
`
`REQUEST FOR PRODUCTION NO. 61
`
`A copy of any written agreement, contract, grant, or license between Defendants and the
`
`U.S. Government concerning the development, manufacture, sale, or distribution of the Accused
`
`Product, including any exhibits or annexes to such written agreement, contract, or license.
`
`REQUEST FOR PRODUCTION NO. 62
`
`All documents related to any written agreement, contract, grant, or license between
`
`Defendants and the U.S. Government concerning the development, manufacture, sale, or
`
`distribution of the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 63
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`A copy of any written agreement, contract, grant, or license concerning funding from the
`
`U.S. Government relating to LNP therapeutics.
`
`14
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 16 of 23 PageID #: 12630
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`REQUEST FOR PRODUCTION NO. 64
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`All documents related to any negotiations between Defendants and any third party,
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`including but not limited to the U.S. Government, related to any written agreement, contract, or
`
`grant, concerning the development, manufacture, sale, or distribution of the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 65
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`All documents related to the nature and extent of the U.S. government’s involvement, if
`
`any, in the development, manufacture, sale, or distribution of the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 66
`
`All documents related to how doses of the Accused Product were distributed and to whom
`
`(including but not limited to customers of drug stores, grocery stores, private medical practices, or
`
`on military bases).
`
`REQUEST FOR PRODUCTION NO. 67
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`All documents related to Defendants’ understanding of who was the true beneficiary of any
`
`contract with the U.S. Government concerning the development, manufacture, sale, or distribution
`
`of the Accused Product.
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`REQUEST FOR PRODUCTION NO. 68
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`All correspondence between Defendants and the U.S. Government relating to who was the
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`true beneficiary of any contract with the U.S. Government concerning the development,
`
`manufacture, sale, or distribution of the Accused Product.
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`REQUEST FOR PRODUCTION NO. 69
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`All documents related to any negotiations or communications between Defendants and third
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`parties, including but not limited to the U.S. Government, about the price of the Accused Product.
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`
`
`15
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`
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 17 of 23 PageID #: 12631
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`REQUEST FOR PRODUCTION NO. 70
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`All regulatory submissions regarding the Accused Product submitted to U.S. or foreign
`
`regulatory bodies.
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`REQUEST FOR PRODUCTION NO. 71
`
`All communications and documents concerning communications with any regulatory
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`agency regarding the Accused Product, including but not limited to communications with the FDA,
`
`European Medicines Agency/European Medicines Evaluation Agency, or any other U.S. or foreign
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`regulatory body.
`
`REQUEST FOR PRODUCTION NO. 72
`
`Any Investigational New Drug (“IND”) applications involving the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 73
`
`Organization charts and/or employee directories sufficient to identify any officers, directors
`
`or employees of Defendants involved in any stage of the conceptualization, design, research,
`
`development, testing, commercialization, marketing, manufacturing, or regulatory authorization or
`
`approval process for the Accused Product.
`
`REQUEST FOR PRODUCTION NO. 74
`
`All documents related to any brand plans, long range plans, competitive analyses, market
`
`surveys, sales projections, and contracting strategies for the Accused Product.
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`REQUEST FOR PRODUCTION NO. 75
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`All documents related to Defendants’ efforts to market, promote, or publicize the Accused
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`Product, including but not limited to documents describing any advantages related to the LNP
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`technology of the Accused Product.
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`
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`16
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 18 of 23 PageID #: 12632
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`REQUEST FOR PRODUCTION NO. 76
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`All documents related to any forecasting or other model used by Defendants to develop
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`their market and/or sales projections for the Accused Product.
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`REQUEST FOR PRODUCTION NO. 77
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`All documents related to any forecasts or budgets relating to the Accused Product,
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`including historical forecasts or budgets and current forecasts and budgets.
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`REQUEST FOR PRODUCTION NO. 78
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`A copy of all profit-and-loss statements, whether historical, current, or projected, for the
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`Accused Product.
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`REQUEST FOR PRODUCTION NO. 79
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`All documents related to the projected sales of the Accused Product, including projected
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`profits.
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`REQUEST FOR PRODUCTION NO. 80
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`Documents sufficient to show, on a monthly basis, the following information for the
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`Accused Product:
`
`(a) Units made in the United States;
`
`(b) Units sold in the United States to the United States Government;
`
`(c) Units sold in the United States to entities other than the United States Government;
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`(d) Units made in the United States and sold outside the United States;
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`(e) Revenue from those sales;
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`(f) Costs attributable to those sales;
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`(g) Profits from those sales.
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`17
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 19 of 23 PageID #: 12633
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`REQUEST FOR PRODUCTION NO. 81
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`A copy of any commercial agreement Defendants have made with any third party relating
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`to the Accused Product, including but not limited to any document relating to a payment or
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`financial commitment made by Defendants to develop and/or market the Accused Product.
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`REQUEST FOR PRODUCTION NO. 82
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`Documents sufficient to show the first commercial offer for sale of the Accused Product,
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`including when the first commercial offer for sale occurred.
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`REQUEST FOR PRODUCTION NO. 83
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`All documents related to the offer for sale of the Accused Product, including without
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`limitation documents identifying Defendants’ role in those activities and all efforts by Defendants
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`or any third party working with Defendants or on Defendants’ behalf to design, develop, make,
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`and/or market the Accused Product.
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`REQUEST FOR PRODUCTION NO. 84
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`All documents related to any studies, preprints, or other publications relating to the
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`development or testing of the Accused Product, including but not limited to all manuscripts of the
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`same, reviews of same, and correspondence relating to same.
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`REQUEST FOR PRODUCTION NO. 85
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`A copy of each U.S. or foreign patent or patent application owned by, assigned to, or
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`licensed to Defendants that describes, claims, or otherwise relates to the Accused Product.
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`REQUEST FOR PRODUCTION NO. 86
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`A copy of each U.S. or foreign patent or patent application owned by, assigned to, or
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`licensed to Defendants that relates to COVID-19 or LNPs.
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`
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`18
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 20 of 23 PageID #: 12634
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`REQUEST FOR PRODUCTION NO. 87
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`All communications with any third party, including any U.S. government agency, referring
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`or relating to any patent or patent application owned by, assigned to, or licensed to Defendants that
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`describes, claims, or otherwise relates to the Accused Product or relates to COVID-19 or LNPs.
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`REQUEST FOR PRODUCTION NO. 88
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`All documents relating to Defendants’ seeking indemnification from the U.S. Government
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`for infringing the Patents-in Suit.
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`REQUEST FOR PRODUCTION NO. 89
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`All documents related to any work performed by third parties related to the Accused
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`Product, including but not limited to any development, testing, or manufacturing work performed
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`by third parties related to the Accused Product.
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`REQUEST FOR PRODUCTION NO. 90
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`Curricula vitae or resumes for each witness listed in Defendants’ initial disclosures.
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`REQUEST FOR PRODUCTION NO. 91
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`A copy of any document referred to in any of Defendants’ responses to interrogatories
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`served on Defendants in this case, or the identification of which is sought by any such
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`interrogatories.
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`REQUEST FOR PRODUCTION NO. 92
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`A copy of any document reviewed, considered, or relied upon when answering any
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`interrogatories served on Defendants in this case.
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`REQUEST FOR PRODUCTION NO. 93
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`A copy of any document reviewed, considered, or relied upon by Defendants in preparation
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`of their invalidity contentions.
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`19
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 21 of 23 PageID #: 12635
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`REQUEST FOR PRODUCTION NO. 94
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`A copy of any document that Defendants intend to introduce at trial, or introduce with
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`respect to any motion, opposition, or hearing in this action.
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`REQUEST FOR PRODUCTION NO. 95
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`All documents produced in the Alnylam litigation, Alnylam Pharmaceuticals, Inc. v.
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`Moderna, Inc., ModernaTX, Inc., and Moderna US, Inc., C.A. No. 22-cv-335-CFC (D. Del.).
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`REQUEST FOR PRODUCTION NO. 96
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`All pleadings, correspondence, transcripts, discovery requests, discovery responses, or other
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`documents associated with the Alnylam litigation, Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.,
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`ModernaTX, Inc., and Moderna US, Inc., C.A. No. 22-cv-335-CFC (D. Del.), including but not
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`limited to requests for production, responses to requests for production, interrogatories,
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`interrogatory responses, discovery correspondence, briefs, deposition transcripts, and hearing
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`transcripts.
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`REQUEST FOR PRODUCTION NO. 97
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`50 vials of the Accused Product from each lot referenced in Biologics License Application
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`125752 or that has otherwise been manufactured by or on behalf of Moderna, and the material
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`safety data sheet and any handling and storage instructions and histories for each sample.
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`REQUEST FOR PRODUCTION NO. 98
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`A 10 g sample (divided into five 2 g aliquots) of each ingredient in the Accused Product,
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`and the material safety data sheet and any handling and storage instructions and histories for each
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`sample.
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`20
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`Case 1:22-cv-00252-MSG Document 193-9 Filed 01/16/24 Page 22 of 23 PageID #: 12636
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`/s/ Nathan R. Hoeschen
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Nathan R. Hoeschen (No. 6232)
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`nhoeschen@shawkeller.com
`Attorneys for Plaintiffs
`
`OF COUNSEL:
`David I. Berl
`Adam D. Harber
`Thom
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