throbber
Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 1 of 24 PageID #: 14306
`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 1 of 24 PagelD #: 14306
`
`EXHIBIT I
`EXHIBIT I
`
`

`

`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 2 of 24 PageID #: 14307
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`MODERNA, INC. and MODERNATX, INC.,
`
`
`Defendants.
`
`C.A. No. 22-252 (MSG)
`
`)))))))))))
`
`)))))))))))
`
`
`
`
`
`
`
`
`
`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)
`
`Pursuant to Fed. R. Civ. P. 34, Defendants Moderna, Inc. and ModernaTX Inc.
`
`(collectively, “Moderna” or “Defendants”) respond to Plaintiffs Arbutus Biopharma Corporation
`
`(“Arbutus”) and Genevant Sciences GmbH’s (“Genevant,” and collectively, “Plaintiffs”) First Set
`
`of Requests for Production (“Requests” and each individually, a “Request”).
`
`GENERAL OBJECTIONS
`
`The following general responses and objections apply to each individual response to
`
`Plaintiffs’ Requests, as if fully set forth therein. The failure to repeat any of the following General
`
`Objections in the specific responses below shall not be deemed a waiver of such objection or
`
`limitation.
`
`

`

`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 3 of 24 PageID #: 14308
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`1.
`
`For Requests for which Moderna indicates it will not produce any documents,
`
`Moderna remains willing to meet and confer regarding the scope and relevance of the Request.
`
`2.
`
`Moderna objects to the Requests to the extent they purport to impose burdens and
`
`duties that exceed the scope of reasonable and permissible discovery under the Federal Rules of
`
`Civil Procedure, the Local Civil Rules of the United States District Court for the District of
`
`Delaware (the “Local Rules”), or any other orders or pronouncements of the Court.
`
`3.
`
`Moderna objects to Plaintiffs’ definition of “You,” “Your,” and “Defendants” to
`
`the extent the terms include entities that are third parties and/or that Moderna does not control.
`
`Unless otherwise indicated, when the term “Moderna” and “Defendants” are used herein, they
`
`refer only to Moderna, Inc. and ModernaTX Inc.
`
`4.
`
`Moderna objects to Plaintiffs’ definition of “Patents-in-Suit” as seeking
`
`information that is not relevant to the claims or defenses of any party to this action and not
`
`proportionate to the needs of the current case. Moderna’s use of the term “Patents-in-Suit” is
`
`defined below.
`
`5.
`
`Moderna objects to the Requests to the extent they seek documents that are not in
`
`Moderna’s possession, custody, or control, or to the extent the documents are publicly available.
`
`6.
`
`Moderna objects to the Requests to the extent they seek proprietary or confidential
`
`business information, trade secrets, or other sensitive information. To the extent that the response
`
`to any Request requires the disclosure of any non-privileged proprietary or confidential
`
`information, trade secrets, or other sensitive information, Moderna will provide such information
`
`subject to the orders entered in this case and any agreement between the parties.
`
`7.
`
`Moderna objects to the Requests to the extent they seek the production of
`
`documents and things subject to confidentiality obligations owed to third parties (by agreement or
`
`2
`
`

`

`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
`
`documents or things without either the consent of the relevant third party or an order compelling
`
`the production thereof, and/or without providing the relevant third party an opportunity to object
`
`to the production. Moderna may produce documents with redactions made or maintained at the
`
`direction of U.S. for foreign government. Moderna has indicated below in response to Requests
`
`where Moderna has agreed to produce documents that such documents may contain redactions.
`
`However, Moderna’s investigation is ongoing and the nature and extent of redactions in response
`
`to any of Plaintiffs’ Requests is at this time unknown.
`
`8.
`
`Moderna objects to the extent the Requests call for information that is subject to
`
`federal, state, and foreign data protection laws, and the production of which would violate such
`
`privacy laws, including but not limited to The Gramm-Leach-Bliley Act, 15 U.S.C. § 6801 et seq.
`
`(financial information); The Health Insurance Portability and Accountability Act and the
`
`regulations thereunder, 45 C.F.R. Part 160 and Subparts A and E of Part 164 (medical information).
`
`Moderna will produce documents consistent with its obligations under these laws. With respect
`
`to all regulatory filings, Moderna will not produce documents from subsections which contain
`
`patient Personal Identifiable Information, including Module 5, as such documents are not relevant
`
`to the issues in dispute, and therefore not proportional to the needs of the case, in part due to the
`
`immense burden in redacting Personal Identifiable Information from such documents.
`
`9.
`
`Moderna objects to Plaintiffs’ Requests to the extent they seek information,
`
`documents, and/or things protected from disclosure by the attorney-client privilege, work product
`
`doctrine, common-interest privilege, and/or any other applicable privilege, immunity or protection,
`
`including in connection with the common-interest doctrine. Nothing contained in these responses
`
`should be considered a waiver of any attorney-client privilege, work-product protection, or any
`
`3
`
`

`

`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
`
`documents that would divulge any privileged information. Any such disclosure is inadvertent and
`
`shall not be deemed a waiver of any applicable privilege or immunity.
`
`10. Moderna objects to the Requests as overly broad and unduly burdensome and
`
`therefore not proportionate to the needs of the case, including to the extent they seek “all” or “any”
`
`documents, things, and communications, without further limitations as to scope or time. Such
`
`scope is overly broad and the production of “all” or “any” documents would be unduly
`
`burdensome, and documents beyond those necessary and sufficient to describe such information
`
`are neither relevant nor proportionate to the needs of the case. Moderna also objects to Requests
`
`as overly broad and unduly burdensome and therefore not proportionate to the needs of the case,
`
`including to the extent they seek communications to or from “Moderna” as a whole, which has
`
`thousands of employees. Moderna will conduct a reasonable search from a proportionate number
`
`of custodians, and produce relevant, non-cumulative documents sufficient to provide the
`
`information requested.
`
`11. Moderna objects to these Requests to the extent they seek documents or things that
`
`are unreasonably duplicative or cumulative of other discovery requests, to the extent that discovery
`
`can be obtained by less burdensome means, and to the extent the requested information is publicly
`
`available, or in the possession of Plaintiffs. To the extent Moderna objects to any Request that is
`
`duplicative or cumulative of another Request, in whole or in part, each and every objection to such
`
`Request shall be deemed incorporated by reference in response to any other Request for which
`
`there is overlap, whether or not such incorporation by reference is expressly stated.
`
`4
`
`

`

`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
`
`relevant to the claims or defenses of any party to this action or are not proportionate to the needs
`
`of the case.
`
`13. Moderna objects to the Requests as overly broad and unduly burdensome and
`
`therefore not proportionate to the needs of the case, including to the extent that they seek
`
`information concerning products not accused of infringement and therefore not at issue in This
`
`Action, including dozens of Moderna’s pipeline products (past or present) involving over a decade
`
`of research and development efforts.
`
`14.
`
`By responding to Plaintiffs’ Requests, Moderna does not acknowledge or concede
`
`the truth or accuracy of any characterization, allegation, or statement made in the Requests.
`
`15.
`
`By producing or agreeing to produce requested documents, Moderna does not
`
`concede that any of the information sought or provided is relevant, material, or admissible or that
`
`the search for or production of these documents was proportionate to the needs of the case.
`
`Moderna reserves all objections or other questions as to the competency, relevance, materiality,
`
`privilege, or admissibility as evidence, in any subsequent proceeding in or trial of this or any other
`
`action for any purpose whatsoever, of any document or thing identified or provided in response to
`
`these Requests. A partial response to any Request to which Moderna has objected, in whole or in
`
`part, does not constitute a waiver of any objection.
`
`16. Moderna objects to the Requests to the extent they encompass documents or things
`
`for which the burden or expense of production outweighs the likely benefit in resolving the issues
`
`in this litigation, including without limitation, documents in electronic form that are not reasonably
`
`accessible or retrievable.
`
`5
`
`

`

`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 7 of 24 PageID #: 14312
`
`17.
`
`The failure of Moderna to make a specific objection to a particular Request is not,
`
`and shall not be construed as, an admission that responsive information or documents exist.
`
`Likewise, any statement herein that Moderna will provide information or produce documents in
`
`response to an individual Request does not mean that Moderna, in fact, has any such information
`
`or documents, or that any such information or documents exist. Rather, any such statement reflects
`
`the intention of Moderna, subject to its objections, to conduct a reasonable search for responsive
`
`documents and information.
`
`18. Moderna objects to the Requests to the extent they are premature in light of the
`
`dates agreed to by the parties or set forth in the Court’s Scheduling Order, and amendments to the
`
`Court’s Scheduling Order (collectively, the “Scheduling Order”). Any documents or things that
`
`Moderna may provide in response are without prejudice to this objection.
`
`19. Moderna objects to the Requests to the extent they improperly seek premature
`
`expert discovery, or information that will be disclosed during the expert discovery phase of this
`
`litigation as set forth under the Local Rules, the Federal Rules of Civil Procedure, and the
`
`Scheduling Order.
`
`20. Moderna objects to the Requests to the extent that they relate to sales to the U.S.
`
`Government. Moderna will not provide discovery relating to those sales if Plaintiffs’ claims based
`
`on those sales are dismissed from the case pursuant to 28 U.S.C. § 1498.
`
`21. Moderna objects to Plaintiffs’ requests to the extent they seek information,
`
`documents, and/or things relating to batches and doses of the Accused Products not accused of
`
`infringement, including batches of doses of the Accused Products not made, used, offered for sale,
`
`or sold within the United States or imported into the United States, which are not accused of
`
`6
`
`

`

`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
`
`concerning such batches and doses.
`
`22. Moderna objects to Plaintiffs’ requests to the extent they seek information,
`
`documents, and/or things relating solely to batches and doses of the Accused Products subject to
`
`safe harbor under 35 U.S.C. § 271(e)(1), which are not relevant or proportional to the needs of the
`
`case. Moderna will not produce irrelevant information, documents, and/or things concerning such
`
`batches and doses.
`
`23. Moderna has not yet served its preliminary invalidity contentions and reserves the
`
`right to contend that terms of the Asserted Claims are invalid under § 112 as indefinite. Moderna’s
`
`use of any terms of the asserted claims in its responses is not an admission that such terms are
`
`definite.
`
`24. Moderna’s responses are based on Moderna’s current knowledge, understanding
`
`and belief and the information and documents available to it. Moderna has not yet received
`
`Plaintiffs’ infringement contentions or identification of Asserted Claims. Moderna reserves the
`
`right to, at any time, revise, correct, supplement, amend, or clarify any response or objection as
`
`this matter continues, whether as a result of subsequent investigation, later acquired information
`
`or otherwise.
`
`25. Moderna objects to the Requests as overly broad and unduly burdensome to the
`
`extent that they do not specify a time frame and are thus unlimited as to time. Moderna will not
`
`collect, review, produce or log documents dated after February 28, 2022. Further, absent a showing
`
`of good cause, Moderna will only collect, review, produce, and/or log documents from up to 6
`
`years before the filing of the complaint, with the exception of discovery related to asserted prior
`
`art, as required by Paragraph 4(e) of the D. Del. Default ESI Standard.
`
`7
`
`

`

`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 9 of 24 PageID #: 14314
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`26.
`
`By producing documents in response to the Requests, Moderna does not waive,
`
`intends to preserve, and is preserving all of its rights to assert that any and all such documents are
`
`confidential and proprietary. Documents produced by Moderna shall only be used in connection
`
`with this litigation in accordance with the orders entered in this litigation.
`
`27. Moderna incorporates by reference in each of its specific responses and objections
`
`below, as if set forth therein, each and every one of its general objections.
`
`1.
`
`“Plaintiffs” shall mean Arbutus Biopharma Corporation and Genevant Sciences
`
`DEFINITIONS
`
`GmbH, collectively.
`
`2.
`
`“This Case” or “this Action” refers to the above-captioned action, Arbutus
`
`Biopharma Corp., et al v. Moderna, Inc. et al, No. 1:22-cv-00252 (D. Del.).
`
`3.
`
`“Complaint” refers to the Complaint filed in This Action at D.I. 1, on February 28,
`
`2022, and any amendments thereto.
`
`4.
`
`“Patents-in-Suit” means U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668,
`
`9,364,435, 9,504,651, and 11,141,378.
`
`5.
`
`“Moderna’s COVID-19 Vaccine” shall mean Moderna’s mRNA-1273 COVID-19
`
`vaccine, including COVID-19 vaccine boosters (monovalent and bivalent).
`
`6.
`
`“Accused Products” shall mean Moderna’s COVID-19 Vaccine and any other
`
`Moderna product that Plaintiffs allege infringes the Patents-in-Suit.
`
`7.
`
`“Asserted Claim” shall mean each claim of the Patents-in-Suit that Plaintiffs allege,
`
`in the Complaint or in subsequent pleadings or disclosures, is infringed by one or more of the
`
`Accused Products, either directly or indirectly.
`
`8.
`
`“LNP” shall mean lipid nanoparticle.
`
`8
`
`

`

`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 10 of 24 PageID #: 14315
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`9.
`
`“Operation Warp Speed” shall refer to the public-private partnership by the U.S.
`
`Government as it relates to facilitating the development of Moderna’s COVID-19 Vaccine.
`
`10.
`
`11.
`
`12.
`
`“EUA” shall mean Emergency Use Authorization.
`
`“BLA” shall mean Biologics License Application.
`
`“IND” shall mean Investigational New Drug.
`
`SPECIFIC RESPONSES AND OBJECTIONS
`
`REQUEST FOR PRODUCTION NO. 1:
`
`A copy of Biologics License Application 125752, including all correspondence,
`amendments, and supplements relating thereto.
`
`RESPONSE TO REQUEST FOR PRODUCTION NO. 1:
`
`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 “all correspondence, amendments, and
`
`supplements relating” to BLA No. 125752, which presumes that all such submissions,
`
`correspondence, amendments, and supplements are relevant. Moderna will not search for or
`
`produce irrelevant documents, including documents relating to aspects of the Accused Products
`
`that are not relevant to the Asserted Claims. Moderna objects to this Request to the extent it seeks
`
`proprietary, confidential, or trade secret information of Moderna or of others to whom Moderna is
`
`under an obligation of confidentiality (by agreement or by law).
`
`Subject to and without waiving any of its general or specific objections, Moderna will
`
`produce BLA No. 125752, excluding subsections containing patient Personal Identifiable
`
`Information.
`
`REQUEST FOR PRODUCTION NO. 2:
`
`All documents related to the preparation of Biologics License Application 125752.
`
`9
`
`

`

`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 11 of 24 PageID #: 14316
`
`RESPONSE TO REQUEST FOR PRODUCTION NO. 59:
`
`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] copy of any patent license agreement
`
`between Defendants and any entity relating to LNP technology,” which presumes that all such
`
`agreements 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 restrictions. Moderna objects to this
`
`Request to the extent it seeks documents that are protected by confidentiality obligations to third
`
`parties that prohibit or restrict their disclosure by Moderna and will not produce such documents.
`
`Moderna 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 documents responsive to this Request as it relates to U.S. patent license
`
`agreements pertaining to the LNPs in Moderna’s COVID-19 vaccine identified after a reasonable
`
`and proportionate search.
`
`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.
`
`67
`
`

`

`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 12 of 24 PageID #: 14317
`
`RESPONSE TO REQUEST FOR PRODUCTION NO. 60:
`
`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 documents concerning the “development,
`
`manufacture, sale, or distribution” of the Accused Product, which is of enormous scope and which
`
`presumes all such agreements are relevant. Moderna will not produce irrelevant and/or non-
`
`responsive documents, including those relating to the manufacture and distribution of the Accused
`
`Product. Moderna will not search for documents relating to the sale of doses of the Accused
`
`Product that were not made, used, offered for sale, or sold within the United States or imported
`
`into the United States, which are not accused of infringement. 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 restrictions. Moderna objects to this Request to the extent it seeks
`
`documents that are protected by confidentiality obligations to third parties that prohibit or restrict
`
`their disclosure by Moderna (by agreement or by law) and will not produce such documents.
`
`Moderna 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 is willing
`
`to meet and confer regarding the scope of this Request.
`
`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.
`
`68
`
`

`

`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
`
`prohibit or restrict their disclosure by Moderna (by agreement or by law) and will not produce such
`
`documents.
`
`Subject to and without waiving any of its general or specific objections, Moderna will
`
`produce an executed copy of Contract No. W911QY20C0100 between Moderna and the United
`
`States Government and any amendments thereto, which may include redactions made at the
`
`Government’s direction. Moderna is willing to meet and confer regarding any additional scope.
`
`REQUEST FOR PRODUCTION NO. 64:
`
`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.
`
`RESPONSE TO REQUEST FOR PRODUCTION NO. 64:
`
`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 negotiations
`
`between Defendants and any third party . . . related to any written agreement, contract, or grant,
`
`concerning the development, manufacture, sale, or distribution of the Accused Product,” which
`
`presumes that all such documents are relevant. Moderna will not produce irrelevant and/or non-
`
`responsive documents. Moderna will not search for documents relating to doses that were not
`
`made, used, offered for sale, or sold within the United States or imported into the United States,
`
`which are not accused of infringement. 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 restrictions. Moderna objects to this Request as seeking the production of documents
`
`72
`
`

`

`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-
`
`interest privilege, or any other applicable privilege or immunity. Moderna will not produce such
`
`documents. Moderna objects to this Request to the extent it seeks documents that are protected by
`
`confidentiality obligations to third parties that prohibit or restrict their disclosure by Moderna (by
`
`agreement or by law) and will not produce such documents.
`
`Subject to and without waiving any of its general or specific objections, Moderna will
`
`produce responsive non-privileged communications between Moderna and the U.S. Government
`
`relating to any final executed written agreement between Moderna and the U.S. Government
`
`concerning Moderna’s COVID-19 Vaccine (which may include redactions at the Government’s
`
`direction) identified after a reasonable and proportionate search.
`
`REQUEST FOR PRODUCTION NO. 65:
`
`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.
`
`RESPONSE TO REQUEST FOR PRODUCTION NO. 65:
`
`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 the nature and
`
`extent of the U.S. government’s involvement, if any, in the development, manufacture, sale, or
`
`distribution of 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 restrictions. Moderna objects to this Request as seeking the
`
`production of documents protected from discovery by the attorney-client privilege, the work-
`
`73
`
`

`

`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
`
`proportional to the needs of this case, specifically because it lacks reasonable temporal restrictions.
`
`Moderna objects to this Request as vague and ambiguous, at least with respect to the phrase “true
`
`beneficiary,” which is not defined. Moderna 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.
`
`Moderna objects to this Request to the extent it seeks a legal conclusion and/or expert discovery.
`
`Moderna objects to this Request as duplicative of at least RFP Nos. 61 and 67. Moderna objects to
`
`this Request to the extent it seeks documents that are protected by confidentiality obligations to
`
`third parties that prohibit or restrict their disclosure by Moderna (by agreement or by law) and will
`
`not produce such documents.
`
`Subject to and without waiving any of its general or specific objections, Moderna is willing
`
`to meet and confer regarding the scope of this Request.
`
`REQUEST FOR PRODUCTION NO. 69:
`
`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.
`
`RESPONSE TO REQUEST FOR PRODUCTION NO. 69:
`
`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 negotiations or
`
`communications between Defendants and third parties . . . about the price of 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,
`
`77
`
`

`

`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 16 of 24 PageID #: 14321
`
`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
`
`restrictions. Moderna objects to this Request as seeking the production of documents protected
`
`from discovery by the attorney-client privilege, the work-product doctrine, the common-interest
`
`privilege, or any other applicable privilege or immunity. Moderna will not produce such
`
`documents. Moderna objects to this Request as duplicative of at least RFP No. 61. Moderna objects
`
`to this Request to the extent it seeks documents that are protected by confidentiality obligations to
`
`third parties that prohibit or restrict their disclosure by Moderna (by agreement or by law) and will
`
`not produce such documents.
`
`Subject to and without waiving any of its general or specific objections, Moderna will
`
`produce non-privileged communications between Moderna and the U.S. Government relating to
`
`any executed written agreement between Moderna and the U.S. Government that reflects the price
`
`of Moderna’s COVID-19 Vaccine (which may include redactions at the Government’s direction)
`
`identified after a reasonable and proportionate search.
`
`REQUEST FOR PRODUCTION NO. 70:
`
`All regulatory submissions regarding the Accused Product submitted to U.S. or foreign
`regulatory bodies.
`
`RESPONSE TO REQUEST FOR PRODUCTION NO. 70:
`
`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
`
`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
`
`78
`
`

`

`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 17 of 24 PageID #: 14322
`
`relevant aspects of research and development of the LNPs in Moderna’s COVID-19 Vaccine that
`
`are identified after a reasonable and proportionate search.
`
`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.
`
`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
`
`States or imported into the United States, which are not accused of infringement. Moderna objects
`
`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
`
`83
`
`

`

`Case 1:22-cv-00252-MSG Document 210-9 Filed 02/02/24 Page 18 of 24 PageID #: 14323
`
`sales projections concerning accused sales of Moderna’s COVID-19 Vaccine identified after a
`
`reasonable and proportionate search.
`
`REQUEST FOR PRODUCTION NO. 75:
`
`All documents related to Defendants’ efforts to market, promote, or publicize the Accused
`Product, including but not limited to documents

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