`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 1 of 24 PagelD #: 14306
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`EXHIBIT I
`EXHIBIT I
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`
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 2 of 24 PageID #: 14307
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`
`Plaintiffs,
`
`
`
`v.
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`MODERNA, INC. and MODERNATX, INC.,
`
`
`Defendants.
`
`C.A. No. 22-252 (MSG)
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`)))))))))))
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`)))))))))))
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`MODERNA, INC. and MODERNATX, INC.,
`
`
`Counterclaim-Plaintiffs,
`
`v.
`
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`
`Counterclaim-Defendants.
`
`
`
`
`
`DEFENDANTS’ OBJECTIONS AND RESPONSES TO PLAINTIFFS’
`FIRST SET OF REQUESTS FOR PRODUCTION (NOS. 1–98)
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`Pursuant to Fed. R. Civ. P. 34, Defendants Moderna, Inc. and ModernaTX Inc.
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`(collectively, “Moderna” or “Defendants”) respond to Plaintiffs Arbutus Biopharma Corporation
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`(“Arbutus”) and Genevant Sciences GmbH’s (“Genevant,” and collectively, “Plaintiffs”) First Set
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`of Requests for Production (“Requests” and each individually, a “Request”).
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`GENERAL OBJECTIONS
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`The following general responses and objections apply to each individual response to
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`Plaintiffs’ Requests, as if fully set forth therein. The failure to repeat any of the following General
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`Objections in the specific responses below shall not be deemed a waiver of such objection or
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`limitation.
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`
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 3 of 24 PageID #: 14308
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`1.
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`For Requests for which Moderna indicates it will not produce any documents,
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`Moderna remains willing to meet and confer regarding the scope and relevance of the Request.
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`2.
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`Moderna objects to the Requests to the extent they purport to impose burdens and
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`duties that exceed the scope of reasonable and permissible discovery under the Federal Rules of
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`Civil Procedure, the Local Civil Rules of the United States District Court for the District of
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`Delaware (the “Local Rules”), or any other orders or pronouncements of the Court.
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`3.
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`Moderna objects to Plaintiffs’ definition of “You,” “Your,” and “Defendants” to
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`the extent the terms include entities that are third parties and/or that Moderna does not control.
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`Unless otherwise indicated, when the term “Moderna” and “Defendants” are used herein, they
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`refer only to Moderna, Inc. and ModernaTX Inc.
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`4.
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`Moderna objects to Plaintiffs’ definition of “Patents-in-Suit” as seeking
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`information that is not relevant to the claims or defenses of any party to this action and not
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`proportionate to the needs of the current case. Moderna’s use of the term “Patents-in-Suit” is
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`defined below.
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`5.
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`Moderna objects to the Requests to the extent they seek documents that are not in
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`Moderna’s possession, custody, or control, or to the extent the documents are publicly available.
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`6.
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`Moderna objects to the Requests to the extent they seek proprietary or confidential
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`business information, trade secrets, or other sensitive information. To the extent that the response
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`to any Request requires the disclosure of any non-privileged proprietary or confidential
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`information, trade secrets, or other sensitive information, Moderna will provide such information
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`subject to the orders entered in this case and any agreement between the parties.
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`7.
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`Moderna objects to the Requests to the extent they seek the production of
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`documents and things subject to confidentiality obligations owed to third parties (by agreement or
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`2
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 4 of 24 PageID #: 14309
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`by law) that prohibit or restrict their disclosure by Moderna. Moderna will not provide such
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`documents or things without either the consent of the relevant third party or an order compelling
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`the production thereof, and/or without providing the relevant third party an opportunity to object
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`to the production. Moderna may produce documents with redactions made or maintained at the
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`direction of U.S. for foreign government. Moderna has indicated below in response to Requests
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`where Moderna has agreed to produce documents that such documents may contain redactions.
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`However, Moderna’s investigation is ongoing and the nature and extent of redactions in response
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`to any of Plaintiffs’ Requests is at this time unknown.
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`8.
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`Moderna objects to the extent the Requests call for information that is subject to
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`federal, state, and foreign data protection laws, and the production of which would violate such
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`privacy laws, including but not limited to The Gramm-Leach-Bliley Act, 15 U.S.C. § 6801 et seq.
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`(financial information); The Health Insurance Portability and Accountability Act and the
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`regulations thereunder, 45 C.F.R. Part 160 and Subparts A and E of Part 164 (medical information).
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`Moderna will produce documents consistent with its obligations under these laws. With respect
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`to all regulatory filings, Moderna will not produce documents from subsections which contain
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`patient Personal Identifiable Information, including Module 5, as such documents are not relevant
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`to the issues in dispute, and therefore not proportional to the needs of the case, in part due to the
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`immense burden in redacting Personal Identifiable Information from such documents.
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`9.
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`Moderna objects to Plaintiffs’ Requests to the extent they seek information,
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`documents, and/or things protected from disclosure by the attorney-client privilege, work product
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`doctrine, common-interest privilege, and/or any other applicable privilege, immunity or protection,
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`including in connection with the common-interest doctrine. Nothing contained in these responses
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`should be considered a waiver of any attorney-client privilege, work-product protection, or any
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`3
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 5 of 24 PageID #: 14310
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`other applicable privilege or doctrine. Moderna does not intend to produce information or
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`documents that would divulge any privileged information. Any such disclosure is inadvertent and
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`shall not be deemed a waiver of any applicable privilege or immunity.
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`10. Moderna objects to the Requests as overly broad and unduly burdensome and
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`therefore not proportionate to the needs of the case, including to the extent they seek “all” or “any”
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`documents, things, and communications, without further limitations as to scope or time. Such
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`scope is overly broad and the production of “all” or “any” documents would be unduly
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`burdensome, and documents beyond those necessary and sufficient to describe such information
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`are neither relevant nor proportionate to the needs of the case. Moderna also objects to Requests
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`as overly broad and unduly burdensome and therefore not proportionate to the needs of the case,
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`including to the extent they seek communications to or from “Moderna” as a whole, which has
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`thousands of employees. Moderna will conduct a reasonable search from a proportionate number
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`of custodians, and produce relevant, non-cumulative documents sufficient to provide the
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`information requested.
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`11. Moderna objects to these Requests to the extent they seek documents or things that
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`are unreasonably duplicative or cumulative of other discovery requests, to the extent that discovery
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`can be obtained by less burdensome means, and to the extent the requested information is publicly
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`available, or in the possession of Plaintiffs. To the extent Moderna objects to any Request that is
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`duplicative or cumulative of another Request, in whole or in part, each and every objection to such
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`Request shall be deemed incorporated by reference in response to any other Request for which
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`there is overlap, whether or not such incorporation by reference is expressly stated.
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`4
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 6 of 24 PageID #: 14311
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`12. Moderna objects to the Requests to the extent they seek information that is not
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`relevant to the claims or defenses of any party to this action or are not proportionate to the needs
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`of the case.
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`13. Moderna objects to the Requests as overly broad and unduly burdensome and
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`therefore not proportionate to the needs of the case, including to the extent that they seek
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`information concerning products not accused of infringement and therefore not at issue in This
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`Action, including dozens of Moderna’s pipeline products (past or present) involving over a decade
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`of research and development efforts.
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`14.
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`By responding to Plaintiffs’ Requests, Moderna does not acknowledge or concede
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`the truth or accuracy of any characterization, allegation, or statement made in the Requests.
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`15.
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`By producing or agreeing to produce requested documents, Moderna does not
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`concede that any of the information sought or provided is relevant, material, or admissible or that
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`the search for or production of these documents was proportionate to the needs of the case.
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`Moderna reserves all objections or other questions as to the competency, relevance, materiality,
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`privilege, or admissibility as evidence, in any subsequent proceeding in or trial of this or any other
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`action for any purpose whatsoever, of any document or thing identified or provided in response to
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`these Requests. A partial response to any Request to which Moderna has objected, in whole or in
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`part, does not constitute a waiver of any objection.
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`16. Moderna objects to the Requests to the extent they encompass documents or things
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`for which the burden or expense of production outweighs the likely benefit in resolving the issues
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`in this litigation, including without limitation, documents in electronic form that are not reasonably
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`accessible or retrievable.
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`5
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 7 of 24 PageID #: 14312
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`17.
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`The failure of Moderna to make a specific objection to a particular Request is not,
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`and shall not be construed as, an admission that responsive information or documents exist.
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`Likewise, any statement herein that Moderna will provide information or produce documents in
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`response to an individual Request does not mean that Moderna, in fact, has any such information
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`or documents, or that any such information or documents exist. Rather, any such statement reflects
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`the intention of Moderna, subject to its objections, to conduct a reasonable search for responsive
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`documents and information.
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`18. Moderna objects to the Requests to the extent they are premature in light of the
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`dates agreed to by the parties or set forth in the Court’s Scheduling Order, and amendments to the
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`Court’s Scheduling Order (collectively, the “Scheduling Order”). Any documents or things that
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`Moderna may provide in response are without prejudice to this objection.
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`19. Moderna objects to the Requests to the extent they improperly seek premature
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`expert discovery, or information that will be disclosed during the expert discovery phase of this
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`litigation as set forth under the Local Rules, the Federal Rules of Civil Procedure, and the
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`Scheduling Order.
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`20. Moderna objects to the Requests to the extent that they relate to sales to the U.S.
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`Government. Moderna will not provide discovery relating to those sales if Plaintiffs’ claims based
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`on those sales are dismissed from the case pursuant to 28 U.S.C. § 1498.
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`21. Moderna objects to Plaintiffs’ requests to the extent they seek information,
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`documents, and/or things relating to batches and doses of the Accused Products not accused of
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`infringement, including batches of doses of the Accused Products not made, used, offered for sale,
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`or sold within the United States or imported into the United States, which are not accused of
`
`6
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 8 of 24 PageID #: 14313
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`infringement. Moderna will not produce irrelevant information, documents, and/or things
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`concerning such batches and doses.
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`22. Moderna objects to Plaintiffs’ requests to the extent they seek information,
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`documents, and/or things relating solely to batches and doses of the Accused Products subject to
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`safe harbor under 35 U.S.C. § 271(e)(1), which are not relevant or proportional to the needs of the
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`case. Moderna will not produce irrelevant information, documents, and/or things concerning such
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`batches and doses.
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`23. Moderna has not yet served its preliminary invalidity contentions and reserves the
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`right to contend that terms of the Asserted Claims are invalid under § 112 as indefinite. Moderna’s
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`use of any terms of the asserted claims in its responses is not an admission that such terms are
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`definite.
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`24. Moderna’s responses are based on Moderna’s current knowledge, understanding
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`and belief and the information and documents available to it. Moderna has not yet received
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`Plaintiffs’ infringement contentions or identification of Asserted Claims. Moderna reserves the
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`right to, at any time, revise, correct, supplement, amend, or clarify any response or objection as
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`this matter continues, whether as a result of subsequent investigation, later acquired information
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`or otherwise.
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`25. Moderna objects to the Requests as overly broad and unduly burdensome to the
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`extent that they do not specify a time frame and are thus unlimited as to time. Moderna will not
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`collect, review, produce or log documents dated after February 28, 2022. Further, absent a showing
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`of good cause, Moderna will only collect, review, produce, and/or log documents from up to 6
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`years before the filing of the complaint, with the exception of discovery related to asserted prior
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`art, as required by Paragraph 4(e) of the D. Del. Default ESI Standard.
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`7
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 9 of 24 PageID #: 14314
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`26.
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`By producing documents in response to the Requests, Moderna does not waive,
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`intends to preserve, and is preserving all of its rights to assert that any and all such documents are
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`confidential and proprietary. Documents produced by Moderna shall only be used in connection
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`with this litigation in accordance with the orders entered in this litigation.
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`27. Moderna incorporates by reference in each of its specific responses and objections
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`below, as if set forth therein, each and every one of its general objections.
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`1.
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`“Plaintiffs” shall mean Arbutus Biopharma Corporation and Genevant Sciences
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`DEFINITIONS
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`GmbH, collectively.
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`2.
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`“This Case” or “this Action” refers to the above-captioned action, Arbutus
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`Biopharma Corp., et al v. Moderna, Inc. et al, No. 1:22-cv-00252 (D. Del.).
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`3.
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`“Complaint” refers to the Complaint filed in This Action at D.I. 1, on February 28,
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`2022, and any amendments thereto.
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`4.
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`“Patents-in-Suit” means U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668,
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`9,364,435, 9,504,651, and 11,141,378.
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`5.
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`“Moderna’s COVID-19 Vaccine” shall mean Moderna’s mRNA-1273 COVID-19
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`vaccine, including COVID-19 vaccine boosters (monovalent and bivalent).
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`6.
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`“Accused Products” shall mean Moderna’s COVID-19 Vaccine and any other
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`Moderna product that Plaintiffs allege infringes the Patents-in-Suit.
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`7.
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`“Asserted Claim” shall mean each claim of the Patents-in-Suit that Plaintiffs allege,
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`in the Complaint or in subsequent pleadings or disclosures, is infringed by one or more of the
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`Accused Products, either directly or indirectly.
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`8.
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`“LNP” shall mean lipid nanoparticle.
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`8
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 10 of 24 PageID #: 14315
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`9.
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`“Operation Warp Speed” shall refer to the public-private partnership by the U.S.
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`Government as it relates to facilitating the development of Moderna’s COVID-19 Vaccine.
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`10.
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`11.
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`12.
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`“EUA” shall mean Emergency Use Authorization.
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`“BLA” shall mean Biologics License Application.
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`“IND” shall mean Investigational New Drug.
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`SPECIFIC RESPONSES AND OBJECTIONS
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`REQUEST FOR PRODUCTION NO. 1:
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`A copy of Biologics License Application 125752, including all correspondence,
`amendments, and supplements relating thereto.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 1:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
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`information not relevant to any of the claims or defenses in this litigation and/or not proportional
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`to the needs of this case, including because it seeks “all correspondence, amendments, and
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`supplements relating” to BLA No. 125752, which presumes that all such submissions,
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`correspondence, amendments, and supplements are relevant. Moderna will not search for or
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`produce irrelevant documents, including documents relating to aspects of the Accused Products
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`that are not relevant to the Asserted Claims. Moderna objects to this Request to the extent it seeks
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`proprietary, confidential, or trade secret information of Moderna or of others to whom Moderna is
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`under an obligation of confidentiality (by agreement or by law).
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`Subject to and without waiving any of its general or specific objections, Moderna will
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`produce BLA No. 125752, excluding subsections containing patient Personal Identifiable
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`Information.
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`REQUEST FOR PRODUCTION NO. 2:
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`All documents related to the preparation of Biologics License Application 125752.
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`9
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 11 of 24 PageID #: 14316
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 59:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
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`information not relevant to any of the claims or defenses in this litigation and/or not proportional
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`to the needs of this case, including because it seeks “[a] copy of any patent license agreement
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`between Defendants and any entity relating to LNP technology,” which presumes that all such
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`agreements are relevant. Moderna will not produce irrelevant and/or non-responsive documents.
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for information not
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`relevant to any of the claims or defenses in this litigation and/or not proportional to the needs of
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`this case, specifically because it lacks reasonable temporal restrictions. Moderna objects to this
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`Request to the extent it seeks documents that are protected by confidentiality obligations to third
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`parties that prohibit or restrict their disclosure by Moderna and will not produce such documents.
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`Moderna objects to this Request as seeking the production of documents protected from discovery
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`by the attorney-client privilege, the work-product doctrine, or any other applicable privilege or
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`immunity. Moderna will not produce such documents.
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`Subject to and without waiving any of its general or specific objections, Moderna will
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`produce non-privileged documents responsive to this Request as it relates to U.S. patent license
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`agreements pertaining to the LNPs in Moderna’s COVID-19 vaccine identified after a reasonable
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`and proportionate search.
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`REQUEST FOR PRODUCTION NO. 60:
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`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.
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`67
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 12 of 24 PageID #: 14317
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 60:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
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`information not relevant to any of the claims or defenses in this litigation and/or not proportional
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`to the needs of this case, including because it seeks documents concerning the “development,
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`manufacture, sale, or distribution” of the Accused Product, which is of enormous scope and which
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`presumes all such agreements are relevant. Moderna will not produce irrelevant and/or non-
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`responsive documents, including those relating to the manufacture and distribution of the Accused
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`Product. Moderna will not search for documents relating to the sale of doses of the Accused
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`Product that were not made, used, offered for sale, or sold within the United States or imported
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`into the United States, which are not accused of infringement. Moderna objects to this Request as
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`overbroad, unduly burdensome, and calling for information not relevant to any of the claims or
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`defenses in this litigation and/or not proportional to the needs of this case, specifically because it
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`lacks reasonable temporal restrictions. Moderna objects to this Request to the extent it seeks
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`documents that are protected by confidentiality obligations to third parties that prohibit or restrict
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`their disclosure by Moderna (by agreement or by law) and will not produce such documents.
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`Moderna objects to this Request as seeking the production of documents protected from discovery
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`by the attorney-client privilege, the work-product doctrine, or any other applicable privilege or
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`immunity. Moderna will not produce such documents.
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`Subject to and without waiving any of its general or specific objections, Moderna is willing
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`to meet and confer regarding the scope of this Request.
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`REQUEST FOR PRODUCTION NO. 61:
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`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.
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`68
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 13 of 24 PageID #: 14318
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`extent it seeks documents that are protected by confidentiality obligations to third parties that
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`prohibit or restrict their disclosure by Moderna (by agreement or by law) and will not produce such
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`documents.
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`Subject to and without waiving any of its general or specific objections, Moderna will
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`produce an executed copy of Contract No. W911QY20C0100 between Moderna and the United
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`States Government and any amendments thereto, which may include redactions made at the
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`Government’s direction. Moderna is willing to meet and confer regarding any additional scope.
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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,
`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.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 64:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
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`information not relevant to any of the claims or defenses in this litigation and/or not proportional
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`to the needs of this case, including because it seeks “[a]ll documents related to any negotiations
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`between Defendants and any third party . . . related to any written agreement, contract, or grant,
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`concerning the development, manufacture, sale, or distribution of the Accused Product,” which
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`presumes that all such documents are relevant. Moderna will not produce irrelevant and/or non-
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`responsive documents. Moderna will not search for documents relating to doses that were not
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`made, used, offered for sale, or sold within the United States or imported into the United States,
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`which are not accused of infringement. Moderna objects to this Request as overbroad, unduly
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`burdensome, and calling for information not relevant to any of the claims or defenses in this
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`litigation and/or not proportional to the needs of this case, specifically because it lacks reasonable
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`temporal restrictions. Moderna objects to this Request as seeking the production of documents
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`72
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 14 of 24 PageID #: 14319
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`protected from discovery by the attorney-client privilege, the work-product doctrine, the common-
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`interest privilege, or any other applicable privilege or immunity. Moderna will not produce such
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`documents. Moderna objects to this Request to the extent it seeks documents that are protected by
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`confidentiality obligations to third parties that prohibit or restrict their disclosure by Moderna (by
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`agreement or by law) and will not produce such documents.
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`Subject to and without waiving any of its general or specific objections, Moderna will
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`produce responsive non-privileged communications between Moderna and the U.S. Government
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`relating to any final executed written agreement between Moderna and the U.S. Government
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`concerning Moderna’s COVID-19 Vaccine (which may include redactions at the Government’s
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`direction) identified after a reasonable and proportionate search.
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`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.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 65:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
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`information not relevant to any of the claims or defenses in this litigation and/or not proportional
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`to the needs of this case, including because it seeks “[a]ll documents related to the nature and
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`extent of the U.S. government’s involvement, if any, in the development, manufacture, sale, or
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`distribution of the Accused Product,” which presumes that all such documents are relevant.
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`Moderna will not produce irrelevant and/or non-responsive documents. Moderna objects to this
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`Request as overbroad, unduly burdensome, and calling for information not relevant to any of the
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`claims or defenses in this litigation and/or not proportional to the needs of this case, specifically
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`because it lacks reasonable temporal restrictions. Moderna objects to this Request as seeking the
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`production of documents protected from discovery by the attorney-client privilege, the work-
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`73
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 15 of 24 PageID #: 14320
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`calling for information not relevant to any of the claims or defenses in this litigation and/or not
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`proportional to the needs of this case, specifically because it lacks reasonable temporal restrictions.
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`Moderna objects to this Request as vague and ambiguous, at least with respect to the phrase “true
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`beneficiary,” which is not defined. Moderna objects to this Request as seeking the production of
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`documents protected from discovery by the attorney-client privilege, the work-product doctrine,
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`or any other applicable privilege or immunity. Moderna will not produce such documents.
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`Moderna objects to this Request to the extent it seeks a legal conclusion and/or expert discovery.
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`Moderna objects to this Request as duplicative of at least RFP Nos. 61 and 67. Moderna objects to
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`this Request to the extent it seeks documents that are protected by confidentiality obligations to
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`third parties that prohibit or restrict their disclosure by Moderna (by agreement or by law) and will
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`not produce such documents.
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`Subject to and without waiving any of its general or specific objections, Moderna is willing
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`to meet and confer regarding the scope of this Request.
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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 parties, including but not limited to the U.S. Government, about the price of the Accused
`Product.
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`RESPONSE TO REQUEST FOR PRODUCTION NO. 69:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
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`information not relevant to any of the claims or defenses in this litigation and/or not proportional
`
`to the needs of this case, including because it seeks “[a]ll documents related to any negotiations or
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`communications between Defendants and third parties . . . about the price of the Accused Product,”
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`which presumes that all such documents are relevant. Moderna will not produce irrelevant and/or
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`non-responsive documents. Moderna objects to this Request as overbroad, unduly burdensome,
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`and calling for information not relevant to any of the claims or defenses in this litigation and/or
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`not proportional to the needs of this case, specifically because it lacks reasonable temporal
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`restrictions. Moderna objects to this Request as seeking the production of documents protected
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`from discovery by the attorney-client privilege, the work-product doctrine, the common-interest
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`privilege, or any other applicable privilege or immunity. Moderna will not produce such
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`documents. Moderna objects to this Request as duplicative of at least RFP No. 61. Moderna objects
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`to this Request to the extent it seeks documents that are protected by confidentiality obligations to
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`third parties that prohibit or restrict their disclosure by Moderna (by agreement or by law) and will
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`not produce such documents.
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`Subject to and without waiving any of its general or specific objections, Moderna will
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`produce non-privileged communications between Moderna and the U.S. Government relating to
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`any executed written agreement between Moderna and the U.S. Government that reflects the price
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`of Moderna’s COVID-19 Vaccine (which may include redactions at the Government’s direction)
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`identified after a reasonable and proportionate search.
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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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`RESPONSE TO REQUEST FOR PRODUCTION NO. 70:
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`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
`
`information not relevant to any of the claims or defenses in this litigation and/or not proportional
`
`to the needs of this case, including because it seeks “[a]ll regulatory submissions regarding the
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`Accused Product submitted to U.S. or foreign regulatory bodies,” which presumes that all such
`
`documents are relevant. Moderna will not produce irrelevant and/or non-responsive documents,
`
`including documents relating to aspects of the Accused Products that are not relevant to the
`
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`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 17 of 24 PageID #: 14322
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`relevant aspects of research and development of the LNPs in Moderna’s COVID-19 Vaccine that
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`are identified after a reasonable and proportionate search.
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`REQUEST FOR PRODUCTION NO. 74:
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`All documents related to any brand plans, long range plans, competitive analyses, market
`surveys, sales projections, and contracting strategies for the Accused Product.
`
`RESPONSE TO REQUEST FOR PRODUCTION NO. 74:
`
`Moderna objects to this Request as overbroad, unduly burdensome, and calling for
`
`information not relevant to any of the claims or defenses in this litigation and/or not proportional
`
`to the needs of this case, including because it seeks “[a]ll documents related to any brand plans,
`
`long range plans, competitive analyses, market surveys, sales projections, and contracting
`
`strategies for the Accused Product,” which presumes that all such documents are relevant.
`
`Moderna will not produce irrelevant and/or non-responsive documents. Moderna objects to this
`
`Request as overbroad, unduly burdensome, and calling for information not relevant to any of the
`
`claims or defenses in this litigation and/or not proportional to the needs of this case, specifically
`
`because it lacks reasonable temporal and geographic restrictions. Moderna will not search for
`
`documents relating to doses that were not made, used, offered for sale, or sold within the United
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`States or imported into the United States, which are not accused of infringement. Moderna objects
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`to this Request as vague and ambiguous, at least with respect to the phrases “long range plans”
`
`and “contracting strategies,” which are not defined. Moderna also objects to this Request as
`
`seeking the production of documents protected from discovery by the attorney-client privilege, the
`
`work-product doctrine, or any other applicable privilege or immunity. Moderna will not produce
`
`such documents.
`
`Subject to and without waiving any of its general or specific objections, Moderna will
`
`produce non-privileged brand plans, competitive analyses, market analysis, and forward-looking
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`sales projections concerning accused sales of Moderna’s COVID-19 Vaccine identified after a
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`reasonable and proportionate search.
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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
`Product, including but not limited to documents