Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 1 of 13 PageID #: 20207
`
`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.
`MODERNA, INC. and MODERNATX, INC.,
`
`Counterclaim-Plaintiffs,
`
`v.
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Counterclaim-Defendants.
`
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`C.A. No. 22-252 (MSG)
`
`HIGHLY CONFIDENTIAL –
`OUTSIDE COUNSEL’S EYES ONLY
`
`LETTER TO THE HONORABLE MITCHELL S. GOLDBERG IN OPPOSITION
`TO PLAINTIFFS’ MOTION TO COMPEL RULE 30(b)(6) TESTIMONY
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`Travis J. Murray (#6882)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`tmurray@morrisnichols.com
`
`Attorneys for Defendants
`
`OF COUNSEL:
`
`Patricia A. Carson, Ph.D.
`Jeanna M. Wacker, P.C.
`Mark C. McLennan
`Caitlin Dean
`N. Kaye Horstman
`Shaoyao Yu
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4800
`
`Alina Afinogenova
`KIRKLAND & ELLIS LLP
`200 Clarendon Street
`Boston, MA 02116
`(617) 385-7500
`
`

`

`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 2 of 13 PageID #: 20208
`
`Yan-Xin Li
`KIRKLAND & ELLIS LLP
`555 California Street, 27th Floor
`San Francisco, CA 94104
`(415) 439-1400
`
`May 1, 2024
`
`2
`
`

`

`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 3 of 13 PageID #: 20209
`
`
`
`Dear Judge Goldberg:
`
`For weeks, the parties have negotiated the scope of testimony to be provided in response
`to their respective Rule 30(b)(6) notices. Moderna ultimately agreed to provide testimony in
`response to 72 of Plaintiffs’ 87 topics. Relevant to this motion, Moderna negotiated with Plaintiffs
`to reach a reasonable compromise on Plaintiffs’ Topic Nos. 32 and 50, which Moderna consistently
`objected to on the grounds of relevance and burden. Plaintiffs squarely rejected all compromise
`efforts and moved to compel testimony on these topics. D.I. 287. Moderna opposes Plaintiffs’
`motion to compel and respectfully requests the Court deny it.
`
`Topic No. 32
`
`Plaintiffs’ Topic No. 32 broadly seeks testimony on seven scientific articles—only one of
`which relates to Moderna’s COVID-19 vaccine, the Accused Product in this case. The remainder
`relate to unaccused pipeline products, including vaccines for Zika virus and various influenza
`viruses and therapies for oncology, inherited genetic disorders, hemophilia, and diabetes. See D.I.
`287, Exs. 3–8. Moderna objected to Topic No. 32 on the grounds of, inter alia, relevance and
`burden, and offered to prepare a witness to testify to the single article relating to the Accused
`Product. Plaintiffs rejected this compromise.
`
`Topic No. 32 is Plaintiffs’ latest effort to obtain expansive discovery into Moderna’s
`unaccused pipeline products under the spurious rationale that they are part of the same vaccine
`platform and thus relevant to copying and willfulness. See, e.g., D.I. 287 at 1. Plaintiffs raised
`almost the same argument when they moved to compel production of Moderna’s Investigational
`New Drug (IND) applications for unaccused pipeline products. D.I. 184 at 1–2. In ruling on
`Plaintiffs’ motion, the Court limited this discovery to the Chemistry, Manufacturing, and Controls
`sections of three INDs with similar molar ratios to the Accused Product. D.I. 229 at 2. Moderna
`has already agreed to prepare a witness on the selection of the lipid molar ratios used in the product
`candidates covered by those three INDs (Nos. 029026, 029493, and 029703) in response to Topic
`Nos. 29 and 30. Ex. 14. Plaintiffs should not be able to use a 30(b)(6) topic to sidestep the Court’s
`order limiting discovery on unaccused products.
`
`Plaintiffs’ additional explanations of the purported relevance of Topic No. 32 are similarly
`unavailing. Although Plaintiffs assert that this topic is necessary to test Moderna’s “ability to
`formulate mRNA-LNPs using Plaintiffs’ technology” and “Moderna’s purported development of
`its own LNP technology,” D.I. 287 at 1, Moderna already agreed to provide a witness on
`development of its SM-102 LNP platform and the lipid molar ratios used in the Accused Product
`in response to Topic Nos. 23–28. Ex. 14. Plaintiffs have not explained what relevant information
`they hope to obtain that is not already covered by Topic Nos. 23–28 and the article identified in
`Topic No. 32, on which Moderna has agreed to provide a witness. Plaintiffs appear to suggest
`testimony on the remaining articles provides needed discovery into Moderna’s methods of
`manufacture. While any such testimony is of, at best, questionable relevance to the Asserted
`Claims—which claim compositions, not methods of manufacture—Moderna has agreed to prepare
`a witness on Moderna’s manufacturing methods in response to Topic Nos. 20–22. Ex. 14.
`
`In the face of these unconvincing assertions of relevance, Plaintiffs suggest that there
`would be minimal burden on Moderna to investigate, for each article, “(a) the lipid molar ratio
`
`
`
`

`

`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 4 of 13 PageID #: 20210
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`used and the reason it was selected, (b) the identity of the lipids used, (c) the manufacturing method
`used to prepare the LNPs, (d) the tolerability and immunogenicity of the mRNA-LNPs featured in
`the study, and (e) the role that each study played in contributing to Moderna’s development of its
`SM-102 LNP platform.” D.I. 287 at 1. But that is not the case. The articles identified by Plaintiffs
`in Topic No. 32 were published years ago—more than a decade ago in the case of one article and
`at least five years ago in the case of five other articles. It would be extremely difficult, if not
`impossible, for Moderna to investigate the data, formulations, manufacturing methods, and other
`material underlying the information reported in each article, and the articles otherwise speak for
`themselves.
`
`By way of example, the “proof of concept” article identified in Topic No. 32 was published
`in 2013, and the sole author, Antonin de Fougerolles, left Moderna that same year. The de
`Fougerolles article does not list LNP formulations, manufacturing methods used to prepare LNPs,
`and other categories of information identified by Plaintiffs in their motion as purportedly
`“minimally burdensome” for Moderna to investigate. The other six articles implicated by this topic
`are also missing this or similar information, and Moderna would need to locate and sift through
`years of information to prepare a witness on Plaintiffs’ proposed topic scope. Plaintiffs’ request
`that Moderna undertake burdensome investigations into unaccused products simply to provide
`testimony on Topic No. 32 is not proportional, particularly where Plaintiffs have failed to
`adequately articulate the relevance of the testimony sought. The parties are presently trying to
`schedule 25+ depositions in five weeks before fact discovery closes, and Moderna would be
`significantly prejudiced if it had to divert resources to conduct a burdensome and disproportionate
`investigation into various unaccused products.
`
`Topic No. 50
`
`Plaintiffs’ position as to Topic No. 50 is similarly meritless. As explained below, Moderna
`has agreed to prepare various witnesses on topics related to Moderna’s reliance on the § 1498
`defense based on the U.S. Government’s inclusion of the 52-227 clause in its C-0100 supply
`contract. D.I. 58. However, Plaintiffs insist on seeking a Moderna witness to testify to the
`Government’s decision—not Moderna’s—to affirm its authorization and consent for any patent
`liability by filing a Statement of Interest in this lawsuit in 2023 (D.I. 49). That is irrelevant to the
`§ 1498 inquiry.
`
`Moderna has already agreed to provide testimony on the only relevant aspect of Topic No.
`50: the -0100 and -0017 Contracts, including the negotiation relating to the inclusion of FAR
`Clause 52.227-1 and /or FAR Clause 52.227-1 Alt I and an overview of the goods and services
`Moderna provided under that contract.1 However, Plaintiffs have also raised baseless conspiracy
`theories that Moderna made a quid pro quo agreement with the Government by offering something
`in return for the Statement of Interest, such as discounted vaccines for the uninsured. See D.I. 59.
`Although this theory is unfounded (as confirmed by two years of discovery), Moderna offered a
`witness to confirm that Moderna had not “asked for, or offered or gave anything in exchange for,
`the Government’s Statement of Interest” and “Moderna’s decision to provide free vaccines for the
`
`1 Moderna has also agreed to provide testimony on other aspects of the -0100 and -0017 Contracts
`in response to Topic Nos. 45–48. Ex. 14.
`
`
`
`2
`
`

`

`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 5 of 13 PageID #: 20211
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`
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`uninsured as part of its Commitment to Patient Access in the U.S.”2 Ex. 14. Plaintiffs were still
`unsatisfied and filed this motion to compel. The parties’ dispute boils down to whether it is relevant
`and proportional for Moderna to also provide a witness on Moderna’s knowledge of the
`“Government’s decision to assert that Section 1498 applied to the -0010 contract and to file a
`statement of interest.” D.I. 287, Ex. 10 at 4. It is not.
`
`Moderna’s knowledge of the Government’s decision to file a Statement of Interest has no
`bearing on any issue in dispute or the application of § 1498. Throughout the meet-and-confer
`process, Plaintiffs continually failed to explain the relevance of this information, and their vague
`assertions of relevance in this motion provide no further clarity. For example, Plaintiffs suggest
`they need testimony on this additional scope in order to probe the “evidentiary value” of the
`Government’s Statement of Interest. D.I. 287 at 2. But any concerns about “evidentiary value”
`should be resolved by Moderna’s agreement to provide a witness to testify to “whether Moderna
`asked for, or offered or gave anything in exchange for, the Government’s Statement of Interest.”
`Ex. 14 at Topic No. 50. And as Moderna told Plaintiffs when the parties were negotiating the scope
`of Topic No. 50, any information regarding why the U.S. Government filed its Statement of
`Interest should be sought from the U.S. Government, which is the best-placed entity to answer
`these questions. Asking Moderna to speculate on decisions made by another entity is not a proper
`subject for Rule 30(b)(6) testimony.
`
`Additionally, any suggestion by Plaintiffs that they need testimony on the full scope of
`Topic No. 50 to probe Moderna’s communications with the U.S. Government and “dispute”
`Moderna’s common interest privilege claims is unfounded. Moderna has produced thousands of
`communications with the U.S. Government in this case and withheld only five communications
`under the common interest privilege. By contrast, Plaintiffs have withheld over 6,000
`communications under the common interest privilege. That Plaintiffs identified “testing”
`Moderna’s privilege claims as a rationale supporting their motion to compel demonstrates that they
`are interested in seeking discovery on discovery rather than testimony on relevant issues.
`
`*
`*
`*
`For the foregoing reasons, Moderna respectfully requests the Court deny Plaintiffs’ motion
`to compel.
`
`Respectfully,
`
`/s/ Travis Murray
`
`Travis Murray (#6882)
`
`
`cc:
`
`All Counsel of Record (via CM/ECF and electronic mail)
`
`
`
`2 Plaintiffs assert in their motion that “Moderna has only agreed to offer testimony about
`negotiations concerning the referenced FAR provisions and ‘whether Moderna asked for, or
`offered or gave anything in exchange for the Government’s Statement of Interest.’” D.I. 287 at 2.
`That is incorrect, as Moderna also offered testimony on its decision to provide free vaccines for
`the uninsured. See Ex. 14 at Topic No. 50.
`
`3
`
`

`

`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 6 of 13 PageID #: 20212
`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 6 of 13 PagelD #: 20212
`
`EXHIBIT 14
`EXHIBIT 14
`
`

`

`#
`
`Plaintiffs' Original Topic Scope
`
`The process used to manufacture the Accused Product, including
`Moderna’s research and development of the process; any issues
`encountered in scaling-up the process; any comparisons between
`different manufacturing processes, including the process described in
`Lloyd B. Jeffs et al., A Scalable, Extrusion-Free Method for Efficient
`Liposomal Encapsulation of Plasmid DNA , Pharm. Res., vol. 22, no. 3, pp.
`362–71 (Mar. 2005) (“Jeffs 2005”), and including but not limited to the
`process scale; the impact, if any, of process parameters, including the
`type of mixer(s) used, on the properties and/or characteristics of the
`Accused Product, including physical and chemical properties (including
`particle size and mRNA encapsulation), safety, efficacy, toxicity,
`immunogenicity, inflammatory response, potency, stability, storage, and
`manufacturability; and Moderna’s reasons for selecting the process
`and/or particular process conditions and/or parameters for the Accused
`Product.
`
`20
`
`21
`
`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 7 of 13 PageID #: 20213
`
`Notes to Plaintiffs Post M&C
`
`4/12: we asked Plaintiffs to identify which specific
`aspects of the method in Jeffs 2005 Plaintiffs
`claimed was relevant to the '651 patent (e.g.
`equipment, process parameters etc.). Plaintiffs did
`not identify those aspects, but Plaintiffs agreed that
`if one of Moderna's 30(b)(1) witnesses is able to
`answer questions about any testing Moderna has
`done comparing to Jeffs 2005, they would be
`satifisifed with Moderna's current response. We
`understand we're in agreement.
`
`Moderna 3/25/2024 Offered
`Scope
`
`An overview of the
`manufacturing process for the
`accused product, including
`the reasons for selecting that
`process.
`
`Revised Scope / Clarification - new scope
`(4/12) in red
`new scope 4/18 in blue
`Moderna maintains its relevance
`objection to the scope of this topic
`beyond the previously offered scope. On
`the meet-and-confer, Plaintiffs specifically
`inquired about comparisons to Jeffs et al.
`However, Plaintiffs have not asserted that
`the Accused Product is manufactured
`using any method disclosed in the '651
`patent. No method claims/patents are
`asserted. Reference to a publication, and
`not even an asserted claim, takes
`Plaintiffs' request even further afield from
`any claim or defense at issue in this
`litigation and, without tying the sought
`testimony to any element of the asserted
`claims, Plaintiffs have failed to establish
`how any such testimony could be relevant
`to copying. Plaintiffs are free to ask
`witnesses about their review of
`publications in the witnesses' 30(b)(1)
`capacity.
`
`
`
`
`;
`
`the impact, if any, of such incorporation on LNP characteristics and
`properties, including physical and chemical properties (including particle
`size and mRNA encapsulation), safety, efficacy, toxicity, immunogenicity,
`inflammatory response, potency, stability, storage, and
`manufacturability; and Moderna’s reasons for its manner of
`
`An overview of the
`manufacturing process for the
`accused product, including
`the
`
` and the reasons for
`selecting that process.
`
`The witness will be prepared to describe
`at a high-level the R&D that underlies the
`manufacturing process for the accused
`product.
`
`Moderna maintains that the R&D generally is too
`burdensome to prepare a witness on, and the
`witness will not be prepared to recall every study or
`aspect of development.
`
`4/12: The impact of Moderna's method of
`
`
`
`
`4/12 note: we understand the concept Plaintiffs are
`interested in is
`; Plaintiffs
`are able to ask the witness about the various terms
`they've included in the Topic.
`
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 8 of 13 PageID #: 20214
`
`22
`
`The use and/or incorporation of PEG into LNPs, including via
`
`
` tests, analyses, results, and discussions regarding the
`degree to which
`
`
`
`
`
`
`
`An overview of the
`manufacturing process for the
`accused product,
`
` and the
`reasons for selecting that
`process.
`
`
`
`The witness will be prepared to describe
`at a high-level the R&D that underlies the
`manufacturing process for the accused
`product,
`
`Moderna maintains that the R&D generally is too
`burdensome to prepare a witness on, and the
`witness will not be prepared to recall every study or
`aspect of development.
`
`4/12: The impact of Moderna's
`
`
`
`
`4/12 note: we understand the concept Plaintiffs are
`interested in is
`
`
`; the
`accuracy, precision of the instruments, methods, and/or tests used to
`measure any of the foregoing; and the impact, if any, of
` on LNP characteristics and
`properties, including physical and chemical properties (including lipid
`composition and lipid molar ratio), safety, efficacy, toxicity,
`immunogenicity, inflammatory response, potency, stability, storage, and
`manufacturability, including on particles at various stages of the
`formulation process. See, e.g., MRNA-GEN-00503784; MRNA-GEN-
`00527739; MRNA-GEN-00594220 at *594325.003; MRNA-GEN-
`0126805–06; MRNA-GEN-01263122.
`
`
`
`
`
`
`Plaintiffs are able to ask the witness about the
`various terms they've included in the Topic.
`
`23
`
`Moderna’s selection of LNPs as a delivery vehicle and/or platform for
`mRNA, including Moderna’s research and development of alternative
`delivery vehicles and/or platforms; Moderna’s comparisons of LNPs to
`alternative delivery vehicles and/or platforms; the data on which
`Moderna relied to select LNPs as a delivery vehicle and/or platform for
`mRNA; and the reasons why Moderna selected LNPs as a delivery vehicle
`and/or platform for mRNA.
`
`Moderna's SM-102 LNP
`platform that is used in the
`accused product, including
`the reasons Moderna selected
`that LNP platform for use in
`the accused product.
`
`4/17: Plaintiffs agreed that they will
`identify documents on which they seek
`testimony in response to this Topic for
`Moderna's consideration.
`
`As stated at the parties' meet-and-confer, Moderna
`is willing to consider preparing a witness on specific
`documents timely identified by Plaintiffs that
`Plaintiffs argue are relevant to this topic. However,
`Moderna maintains its objections that this topic as
`drafted and explained by Plaintiffs is unduly
`burdensome and not proportional. Plaintiffs have
`failed to explain the relevance of non-LNP delivery,
`nor have Plaintiffs asserted patents that cover
`"LNPs" generally.
`
`4/12 Note: Plaintiffs agreed to identify specific
`documents in response to this Topic for Moderna to
`consider preparing a witness on.
`
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 9 of 13 PageID #: 20215
`
`24
`
`25
`
`26
`
`Moderna’s efforts to develop LNPs for the delivery of mRNA, including
`the lipid compositions and lipid molar ratios tested; the properties and
`characteristics of the lipid compositions and lipid molar ratios tested,
`including with respect to their physical and chemical properties, safety,
`efficacy, toxicity, immunogenicity, inflammatory response, potency,
`stability, storage, and use in manufacturing; comparisons between
`different lipid compositions and/or different lipid molar ratios; and
`Moderna’s reasons for selecting particular lipid compositions or lipid
`molar ratios.
`
`The rationale for the lipid
`molar ratios used in the
`accused product.
`
`The rationale for the lipid molar ratios
`used in the accused product, including
`changes to the lipid molar ratio of the SM-
`102 LNP platform in earlier product(s).
`
`4/17: Moderna understands that the
`parties are in agreement with respect to
`this Topic.
`
`The research and development of the lipid compositions and lipid molar
`ratios used in the Accused Product, including Moderna’s research and
`development of the
`
`, see, e.g., Moderna’s Responses to Plaintiffs’ Interrogatory
`Nos. 1, 3, 7, and 9; the individuals involved in researching and
`;
`developing the
`the lipid compositions and lipid molar ratios used and/or tested during
`the research and development of the
`; the properties and characteristics of the
`compositions and ratios tested, including with respect to efficacy,
`particle size, mRNA encapsulation, heterogeneity, and stability.
`
`
`
`
`All differences between the
`, see Moderna’s Response to Plaintiffs’ Interrogatory No.
`13, and any other lipid molar ratio used with the Accused Product in
`2020 or after; Moderna’s reasons for selecting or modifying the
`
`, and any other formulation
`for use with respect to the Accused Product in 2020 or after; all
`documents or communication concerning any differences between such
`formulations; and all correspondence or representations made to
`regulatory agency regarding any differences.
`
`The research and
`development of lipid molar
`ratios used in the Accused
`Product.
`
`The research and development of lipid
`molar ratios used in the Accused Product,
`including changes to the lipid molar ratio
`of the SM-102 LNP platform in earlier
`product(s).
`
`The research and
`development of lipid molar
`ratios used in the Accused
`Product.
`
`the rationale underlying the two changes
`to the lipid molar ratios in the formulation
`of the Accused Product
`
`During the meet-and-confer, Plaintiffs expressed a
`concern about the relevant timeframe that would
`be encompassed by the scope offered by Moderna
`for topic 23. To the extent Plaintiffs are concerned
`about whether any platform development prior to
`the decision to move forward with SM-102 would
`be covered, Moderna confirms that the scope
`offered for topic 23 would include such information
`if it was relied up on the SM-102 LNP platform.
`Moderna offers this only if Plaintiffs likewise
`provide a witness on Plaintiffs' rationale for
`selection the 50 mol% and 2 mol% cut-offs as
`requested in Moderna's Topic 9.
`
`Plaintiffs did not raise any disputes with this Topic.
`
`Moderna confirms that it will provide a witness on
`the rationale underlying the two changes to the
`lipid molar ratios in the formulation of the Accused
`Product, provided Plaintiffs will provide a witness
`on the rationale underlying Plaintiffs' reformulation
`efforts that led to the purported inventions of the
`Molar Ratio Patents, as requested in Moderna's
`Topic 8, and the rationale for selecting the ratio in
`Moderna Topic 11.
`
`4/12 Note: Plaintiffs confirmed no issues with
`respect to this Topic.
`
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 10 of 13 PageID #: 20216
`
`27
`
`28
`
`29
`
`The “SM-102 platform formulation,” see, e.g., Moderna’s Responses to
`Plaintiffs’ Interrogatory Nos. 7 and 9, including Moderna’s research and
`development of the SM-102 platform formulation; the individuals
`involved in researching and developing the SM-102 platform
`formulation; the lipid compositions and lipid molar ratios used and/or
`tested during the research and development of the SM-102 platform
`formulation; the properties and characteristics of the compositions and
`ratios tested, including with respect to efficacy, particle size, mRNA
`encapsulation, heterogeneity, and stability; and the reasons Moderna
`selected the SM-102 platform formulation for use with respect to the
`Accused Product.
`
`Moderna’s lipid compositions using a target lipid molar ratio of
`50:38.5:10:1.5, 48.5:38.9:11.1:1.5, or 48.0:38.5:11.0:2.5 (cationic
`lipid:cholesterol:phospholipid:conjugated lipid), including Moderna’s
`research and development into compositions using said lipid molar
`ratios; the individuals involved in researching and developing such
`compositions; testing of compositions using said lipid molar ratios; and
`any purported beneficial properties or results of said molar ratios
`compared to other ratios, including Moderna’s reasons for selecting
`them for its
`
`
`
`. See, e.g., Moderna’s Response to Plaintiffs’
`Interrogatory No 7
`The lipid compositions and lipid molar ratios used in Moderna’s
`Investigational New Drug Applications (“INDs”), including IND No. 17725
`(“mRNA-1647, CMV”), IND No. 17741 (“mRNA-1253, hMPV/PIV3”), and
`IND No. 19088 (“mRNA-1893, Zika”), any beneficial properties or results
`of those molar ratios compared to other ratios, and Moderna’s reasons
`for selecting those compositions and ratios. See, e.g., MRNA-GEN-
`00138763 at *138767.
`
`Moderna's SM-102 LNP
`platform used in the accused
`product, including the reasons
`Moderna selected that LNP
`platform for use in the
`accused product.
`
`To extent of any of the properties listed in
`plaintiffs' topic were part of the reasons
`why Moderna selected that LNP platform
`for use in the accused product, the
`witness could speak to them at a high-
`level.
`
`4/12 Note: Plaintiffs confirmed no issues with
`respect to this Topic.
`
`Moderna’s SM-102 LNP
`platform used in the Accused
`Product, including the reasons
`Moderna selected that LNP
`platform for use in the
`Accused Product
`
`Moderna expects that its revised scope for Topic 29
`will resolve this Topic.
`
`4/12 Note: Plaintiffs confirmed no issues with
`respect to this Topic after Moderna clarified that
`the revised scope for Topic 26 should cover this
`Topic.
`
`Willing to meet and confer
`
`The selection of the lipid molar ratios used
`in the product candidates covered by IND
`Nos. 029026, 029493, and 029703.
`
`Moderna is willing to provide the noted scope,
`which corresponds to the three INDs, the CMC
`sections of which Moderna has produced in
`accordance with the Court's order.
`
`4/17: Plaintiffs agreed with the existing
`scope.
`
`4/12 Note: Moderna will not put up a witness on
`Plaintiffs' additional scope because the Court
`already ruled on the scope of discovery on
`unrelated product INDs, which Moderna produced.
`Moderna's offered a witness on those INDs. We
`note that Moderna has separately agreed to
`additional scope for Topic 24/25 concerning the
`molar ratio development for the accused product
`that also includes earlier development of the SM-
`102 LNP platform ratio. This is sufficient and
`proportional, and Plaintiffs are free to ask
`Moderna's witnesses if the additional INDs are
`considered part of the same platform.
`
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 11 of 13 PageID #: 20217
`
`Willing to meet and confer
`
`The selection of the lipid molar ratios used
`in the product candidates covered by IND
`Nos. 029026, 029493, and 029703.
`
`Moderna is willing to provide the noted scope,
`which corresponds to the three INDs, the CMC
`sections of which Moderna has produced in
`accordance with the Court's order.
`
`statements concerning lipid
`molar ratios of the accused
`product in the Moderna/NIH
`Preprint article.
`
`4/17: Moderna understands that the
`parties are in agreement with respect to
`this Topic.
`
`4/12 Note: Plaintiffs did not raise this during the
`2nd meet-and-confer.
`
`We understand Plaintiffs are going to propose
`narrowing of this Topic to less than the current 7
`articles, which we explained would require
`independent investigations. Plaintiffs also agreed to
`identify specifics parts of the articles, as we
`explained that the articles have many authors who
`contributed various aspects which would be
`impossible to prepare on.
`
`4/12 Note: We note that Moderna has separately
`agreed to additional scope for Topic 24/25
`concerning the molar ratio development for the
`accused product that also includes earlier
`development of the SM-102 LNP platform ratio.
`This is sufficient and proportional, and Plaintiffs are
`free to ask Moderna's witnesses if the products
`described in these articles are considered part of
`the same SM-102 LNP platform.
`
`30
`
`32
`
`Investigational New Drug Applications submitted by Moderna to the U.S.
`Food & Drug Administration having drug product specifications for lipid
`compositions and/or lipid molar ratios falling within or overlapping (1)
`50 mol % to 65 mol % cationic lipid, (2) 3 mol % to 15 mol % of
`phospholipid, (3) 30 mol % to 40 mol % cholesterol or derivative thereof,
`and (4) 0.5 mol % to 2 mol % PEG-lipid or conjugated lipid that inhibits
`aggregation of particles and Moderna’s reasons for selecting those lipid
`compositions and lipid molar ratios.
`
`The experiments, methods, and results used, referenced, and/or
`reported in:
`a. the “proof of concept studies” referenced in Antonin de Fougerolles,
`Messenger RNA as a Novel Therapeutic Approach, Molecular Therapy ,
`vol. 21, supp. 1, S178 (May 2013), https://doi.org/10.1016/S1525-
`0016(16)34798-0 (“de Fougerolles 2013”);
`b. Justin M. Richner et al., Modified mRNA Vaccines Protect against Zika
`Virus Infection , Cell, vol. 168, pp. 1114–25 (Mar. 9, 2017) (“Richner
`2017”);
`c. Kapil Bahl et al., Preclinical and Clinical Demonstration of
`Immunogenicity by mRNA Vaccines against H10N8 and H7N9 Influenza
`Viruses , Molecular Therapy, vol. 25, no. 6, pp. 1316–27 (June 2017)
`(“Bahl 2017”);
`d. Staci Sabnis et al., A Novel Amino Lipid Series for mRNA Delivery:
`Improved Endosomal Escape and Sustained Pharmacology and Safety in
`Non-human Primates , Molecular Therapy, vol. 26, no. 6, pp. 1509–19
`(June 2018) (“Sabnis 2018”);
`e. Kimberly J. Hassett et al., Optimization of Lipid Nanoparticles for
`Intramuscular Administration of mRNA Vaccines , Molecular Therapy:
`Nucleic Acids, vol. 15, pp. 1–10 (Apr. 2019) (“Hassett 2019”);
`f. Robert A. Feldman et al., mRNA vaccines against H10N8 and H7N9
`influenza viruses of pandemic potential are immunogenic and well
`tolerated in healthy adults in phase 1 randomized clinical trials, Vaccine ,
`vol. 37, pp. 3326–34 (2019) (“Feldman 2019”); and
`g. Kizzmekia S. Corbett et al., SARS-CoV-2 mRNA Vaccine Development
`Enabled by Prototype Pathogen Preparedness , bioRxiv (June 11, 2020),
`https://doi.org/ 10.1101/2020.06.11.145920 (“the Moderna/NIH
`Preprint”),
`including the lipid compositions and lipid molar ratios used in de
`Fougerolles 2013, Richner 2017, Bahl 2017, Sabnis 2018, Hassett 2019,
`Feldman 2019, and the Moderna/NIH Preprint; and Moderna’s reasons
`for selecting those compositions and ratios.
`
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 325-10 Filed 05/20/24 Page 12 of 13 PageID #: 20218
`
`45
`
`All agreements between Moderna and the U.S. Government considered
`and/or entered into related to Operation Warp Speed or otherwise
`pertaining to the development and/or fulfillment or supply of a COVID-
`19 vaccine (including the -0100 Contract and -0017 Contract) and any
`negotiation, meeting, and communication from or to Moderna,
`including negotiations or communications about research and
`development funding, pricing, distribution, or timing.
`
`the -0100 Contract, including
`the negotiation relating to the
`inclusion of FAR Clause
`52.227-1 and/or FAR Clause
`52.227-1 Alt I and an overview
`of the goods and services
`Moderna provided under that
`contract
`
`46
`
`Documents submitted to the U.S. Government pursuant to the Contract
`Data Requirement List for Contract No. W911QY-20-C-0100 and
`Contract No. W58P05-22-C-0017.
`
`Willing to meet and confer
`
`high-level overview of the funding
`received by Moderna under the -0100
`Contract.
`
`4/18: Moderna also agrees to prepare a
`witness to testify to high level information
`regarding considerations of distribution
`and timing of supply of the vaccine in
`connection with the negotiation of the -
`0100 Contract
`4/17: Moderna agrees to prepare a
`witness to testify to high level information
`regarding the documents submitted
`pursuant to sections 4.9 and 4.10.
`
`47
`
`48
`
`Funding or support Moderna received from any U.S. Government entity
`related to the research and development, approval, manufacturing,
`distribution, fulfilment, supply, or sale of the Accused Product.
`
`Willing to meet and confer
`
`Moderna’s knowledge of and communications regarding the price the
`U.S. Government was willing to pay for the Accused product and money
`that the U.S. Government was willing to spend to obtain the Accused
`Product; Moderna’s negotiation with the U.S. Government on the price
`of the Accused Product and negotiations over additional money
`provided to Moderna from the U.S. Government.
`
`price of the Accused Product
`that the U.S. Government
`paid to Moderna under the -
`0100 Contract and the -0017
`Contract
`
`Moderna's witness(es) will be pr