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`REDACTED - PUBLIC VERSION
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`Original filing date: May 9, 2024
`Redacted filing date: May 13, 2024
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`TABLE OF CONTENTS
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`I.
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`II.
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`Introduction. ............csscccsccscsessccssccesccrenccesscesscsesccesecesancesecessceesceseccsencessecssecssssenaneransescesasen 1
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`Legal Standard.............cccscccssrosccscccccscscsscseroresecccccconsscsorenenessccccscenesesesosenesscscccsesnesesesorenees 1
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`TID.=«—_—Argument 00...ccecscssscsssssccessscsscccsessccsessscsssssescncssnsncsessncssssesescncsessnesessncssecasescnesessncsensnsesens2
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`IV.
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`CONCLUSION ........cccccsescccvccccccscscsescconccovevecccscsescconsnccececenscsssonencscneneececsoconscosenenccecenensccsecsenccece6
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
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`Inre Avandia Mktg., Sales Pracs. & Prod. Liab. Litig.,
`924 F.3d 662 (3d Cir. 2019)... ee eececcsscesceseeeseeeseseseeceeeeeaecssesseeeecseeeseeeesaessaeaaeseaeseeeaseaes 1,2
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`Bank ofAm. Nat’l Tr. & Sav. Ass’n v. Hotel Rittenhouse Assocs.,
`800 F.2d 339 (3d Cir. 1986)... cee eecsecsseeseseseceseeecceeescecseeeaeeseceseeeseecessessaesseeeaeseaeeseenaseeeeeaes2
`
`In re Cendant Corp.,
`260 F.3d 183 (3d Cir. 2001)... eee cccccsesceseesseeeeseeseeecseessceseeeseesaeseeeaesseeeeeseeeeaeeeaeeeeeaessaeees 1
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`Guardant Health, Inc. v. Foundation Med., Inc.,
`C.A. No. 17-1616-LPS-CJB, D.I. 447 (D. Del. Jun. 16, 2020)... eee eeeeeseeeseeceeeeeeeeeeeaeeees 5
`
`Leucadia, Inc. v. Applied Extrusion Techs., Inc.,
`998 F.2d 157 (3d Cir. 1993)... eee esesecsseeseeseeesecesesesceeaeeeecenecseesaeeseecseeesesseeeaessaeaaeseaesseeeaseeneeaes 6
`
`Littlejohn v. Bic Corp.,
`851 F.2d 673 (3d Cir. 1988)... eee cecsscsseeeeeeseeesesesceccsceceaeeaeeesceseeeaceseseeeaeesaesaeseaesseeeaseaes 1,2
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`Miller v. Indiana Hosp.,
`16 F.3d 549 (3d Cir. 1994)... eee cecssceseeesceseseeesseseceseecseesseeseeeseeeaeeeesaessaeeaeeeaecseeeaeeneeeaeseaeees2
`
`Mosaid Techs. Inc. v. LSI Corp.,
`878 F. Supp. 2d 503 (D. Del. 2012)... eceeseesscesceeeecseeseeeseeeseeeaceeeessesaesseseaeseaeeaeeseseneeease2
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`Nitto Denko Corp. v. Hutchinson Tech. Inc.,
`C.A. No. 16-3595 (CCC/MF), 2017 WL 2782639 (D.N.J. Mar. 3, 2017) .......escesesceeeeeeeeeeeees 5
`
`Nixon v. Warner Commc’ns, Inc.,
`A435 U.S. 589 (1978)... ecceccssccscesecesecesceesceecceeessecseesseceeeseeeaseseeeseescessaseaessaeeaeeeaeeaeenseeaeeaessaeees 6
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`Pansy v. Borough ofStroudsburg,
`23 F.3d 772 (3d Cir. 1994)... eeeccsccsccesceesceseceseseseseecseeeseeeeeeeeeseeaeeeeeaessaeeaeeeeesaeeeaeeeeeeseees2,5
`
`il
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`L
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`INTRODUCTION
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`Pursuantto the Protective Order (D.I. 91) as modified by the Court’s November14, 2023
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`Order (D.I. 155), Defendants Moderna, Inc. and ModernaTX,Inc. (“Moderna”) respectfully
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`movethis Court to seal Moderna’s sensitive and confidential information and to grant leave to
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`file a partially redacted version of Plaintiffs’ Amended Complaint for Patent Infringement
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`(D.I. 301) (“Amended Complaint’). As explained in more detail below, the portions marked for
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`redaction contain Moderna’s sensitive and confidential
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`technical
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`information,
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`including
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`confidential trade secrets.
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`In support of this motion, Modernaattaches as Exhibit A the Declaration of Don Parsons,
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`Vice President of Delivery Science and Development at ModernaTX,
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`Inc., who is
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`knowledgeable about Moderna’s confidential information that Moderna seeks to seal and is
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`familiar with its sensitivity. The Amended Complaint contains Moderna’s highly confidential
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`information, and the Court should maintain that material underseal in order to prevent serious
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`and real harm to Moderna. Release of Moderna’s highly confidential information tothe public
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`and Moderna’s competitors would create a clearly defined and serious injury to Moderna, as
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`discussed in detail below.
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`Il.
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`LEGAL STANDARD
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`Third Circuit common law presumesa public right of access to judicial records; however
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`it also protects business and financial information when access would cause economic harm,
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`including competitive harm. In re Avandia Mktg., Sales Pracs. & Prod. Liab. Litig., 924 F.3d
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`662, 672 (3d Cir. 2019). “Although the commonlaw right to public access is a recognized and
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`venerated principle, courts have also recognized the accompanyingprinciple that the right is not
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`absolute.” In re Cendant Corp., 260 F.3d 183, 194 (3d Cir. 2001) (citations and quotations
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`omitted); see also Littlejohn v. Bic Corp., 851 F.2d 673, 678 (3d Cir. 1988) (“Despite the
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`presumption, courts may deny accessto judicial records, for example, where they are sources of
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`business information that might harmalitigant’s competitive standing.”’).
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`This presumption is overcome where a movant shows “that the interest in secrecy
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`outweighs the presumption.” In re Avandia Mktg., 924 F.3d at 672 (quoting Bank ofAm. Nat’l
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`Tr. & Sav. Ass’n v. Hotel Rittenhouse Assocs., 800 F.2d 339, 344 (3d Cir. 1986)). This showing
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`may be made by demonstrating that disclosure will work a clearly defined and serious injury to
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`the movant and that the material is the kind of information that courts will protect. See In re
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`Avandia Mktg., 924 F.3d at 672 (citing Miller v. Ind. Hosp., 16 F.3d 549, 551 (3d Cir. 1994)).
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`The Court will apply a “good cause” standard justifying sealing or redacting judicial records,
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`requiring a “balancing process, in which courts weigh the harm ofdisclosing information against
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`the importance of disclosure to the public.” Mosaid Techs. Inc. v. LSI Corp., 878 F. Supp. 2d
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`503, 507-08 (D. Del. 2012) (citing Pansy v. Borough ofStroudsburg, 23 F.3d 772, 787 (3d Cir.
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`1994)).
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`Il.
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`ARGUMENT
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`Good cause exists here to seal or partially seal paragraphs 56—58, 77-78, 98-99, 119-
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`120, 143-144, 169-170, and 190-191 of the Amended Complaint because these paragraphs
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`contain Moderna’s highly confidential technical and business information. Disclosure of such
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`information would cause real and serious competitive harm to Moderna and the information
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`doesnot needto be disclosed to the public to understandthefilingsat issue.
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`Although the public’s presumptive common law right of access to judicial records
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`attaches to materials filed in connection with a pretrial motion of a non-discovery nature, this
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`right is “not absolute” and may be overcome by a showing that the material sought to be sealed
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`“is the kind of information that courts will protect and will work a clearly defined and serious
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`injury to the party seeking closure.” In re Avandia Mktg., 924 F.3d 662, 673 (3d Cir. 2019)
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`(citation omitted). Here, the material Moderna seeksto redact from the Amended Complaint is
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`the type of limited information of the kind that courts in the Third Circuit have recognized as
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`protectable, namely highly sensitive and confidential
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`technical
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`information regarding
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`Moderna’s proprietary and trade secret manufacturing methods for its COVID-19 Vaccine,
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`including steps in the manufacturing process and parametersfor those steps.
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`The harms caused by revealing Moderna’s confidential information are discussed below,
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`and further in the attached declaration of Don Parsons (Exhibit A), Vice President of Delivery
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`Science and Development at ModernaTX, Inc., who is familiar with this information and its
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`sensitivity. As Dr. Parsons explains,
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`there is significant competition between established
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`vaccine suppliers, including suppliers with mRNA-based vaccines, like Moderna, and any
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`information about one of these competitors, even seemingly minor information, may prove
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`competitively advantageous. Ex. A, ¥ 7.
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`Moderna seeks only to partially seal the Amended Complaint. As described briefly
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`below, and further explained in the Declaration of Don Parsons, the portions Moderna seeksto
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`redact contain Moderna’s confidential information, including highly confidential and sensitive
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`information regarding Moderna’s proprietary technologyrelating to its manufacturing methods
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`for its COVID-19 Vaccine, known as mRNA-1273 or “SpikeVax.” Ex. A, {{ 6-9. SpikeVax is
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`comprised of messenger RNA (mRNA)whichis delivered using lipid nanoparticles (LNPs). /d.,
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`§| 3. Moderna’s proprietary LNP is comprised of four lipid components including SM-102,
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`cholesterol, phospholipid, and a polyethylene glycol (PEG) lipid conjugate. Jd. With respect to
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`Moderna’s formulation, Moderna considers its precise formulation,
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`including the specific
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`quantities of ingredients, a trade secret, which is not public knowledge. Jd., §] 8. With respect to
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`Moderna’s manufacturing process for SpikeVax, Modernaconsiders its process-as-a-whole a
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`trade secret, including the steps in the process, the records of each step, the parameters or
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`specification for each step (such as timing, sequence, amount and kind of raw materials,
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`temperatures, measurements, equipmentusedetc.). /d., | 9. Moderna hasnot publicly disclosed
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`its proprietary manufacturing process.Id.
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`Specifically, Moderna has not publicly disclosed information within the Amended
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`Complaint. Paragraphs 56-58, 77—78, 98-99, 119-120, 143-144, 169-170, and 190-191 disclose
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`specific information concerning the composition of Moderna’s COVID-19 Vaccine and
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`Moderna’s proprietary and trade secret manufacturing methods for its COVID-19 Vaccine
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`including steps in the manufacturing process and parametersfor those steps.
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`Because of the highly competitive nature of the vaccine supplier market, Moderna has
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`spent significant effort and resources to develop these manufacturing methods and formulations
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`and the release of such information to the public, including Moderna’s competitors, would harm
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`Moderna. Ex. A, § 7. Because there are so few competitors in the vaccine supplier market, the
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`market is highly competitive, and any information about one of the competitors, even seemingly
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`minor information, may prove competitively advantageous.
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`Jd. Additionally,
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`there are
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`companies considering entering the vaccine market and companies developing mRNA-based
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`vaccines and therapeutics for other diseases or developing lipid nanoparticles for mRNA-based
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`products. Id.
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`If the confidential information were made public, Moderna’s competitors would be able
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`to potentially replicate Moderna’s products, features within Moderna’s products, and methods
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`of making mRNA-LNPproducts, or make decisions about where, when, and how to offer
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`directly competitive goods with full knowledge of Moderna’s technology. Ex. A, J 10.
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`Moderna’s competitors would gain a significant advantage in creating their own business
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`strategies, which would put Modernaat a significant competitive disadvantage, causing it real
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`and serious harm. Jd. Moderna’s competitors may also seek patent claims to cover Moderna’s
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`technology. Id.
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`Moderna has always taken extensive measures to maintain the confidentiality of its
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`technical information. Ex. A, § 5. Moderna has been extremely concerned about the protection
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`of its confidential information during this litigation and has been very careful to always protect
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`this information. Jd. Moderna has invested significant resources to develop this information as
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`well, id., § 7, and this informationis of the type that courts have recognizedasprotectable. See,
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`e.g., Nitto Denko Corp. v. Hutchinson Tech. Inc., No. CV 16-3595 (CCC/MF), 2017 WL
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`2782639, at *2 (D.N.J. Mar. 3, 2017)
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`(granting motion to seal “confidential
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`technical
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`information” where such information “wasnot intended to be seen by competitors .
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`.
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`. for review
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`and potential use against the parties” and parties were in “highly competitive [] industry”);
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`Guardant Health, Inc. v. Foundation Med., Inc., C.A. Nos. 17-1616-LPS-CJB, D.I. 447 (D. Del.
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`Jun. 16, 2020) (granting motion to redact confidential information concerning defendant’s
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`confidential technical information).
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`Disclosure of Moderna’s confidential information regarding either the technical details
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`of Moderna’s precise formulation and the proprietary manufacturing process for SpikeVax
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`would “work a clearly defined and serious injury” to Moderna,as such disclosure would provide
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`Moderna’s competitors, customers, and potential
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`licensors or
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`licensees with otherwise
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`confidential information regarding Moderna’s products andstrategies, as well as a competitive
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`advantage in both the vaccine supplier market and in negotiations with Moderna. See Pansy, 23
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`F.3d at 786. Moreover, because this “case involves private litigants” and their confidential
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`information, there is “little legitimate public interest” in the proposed redactions. Jd. at 788.
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`Under such circumstances, Moderna’s interest in maintaining the confidentiality ofthe proposed
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`redacted information outweighs any countervailing public interest. See id. (“[I]f a case involves
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`private litigants, and concerns mattersoflittle legitimate public interest, that should be a factor
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`weighing in favor of granting or maintaining an order of confidentiality.”); Leucadia, Inc. v.
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`Applied Extrusion Tech., Inc., 998 F.2d 157, 166 (3d Cir. 1993) (“Documents containing trade
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`secrets or other confidential business information may be protected from disclosure” and
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`explaining that the court has “framed the inquiry as whether the need for secrecy outweighs the
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`presumption of access that normally attaches to such documents”); Nixon v. Warner Commc’ns,
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`Inc., 435 U.S. 589, 598 (1978) (“[C]ourts have refused to permittheir files to serve as ... sources
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`of business information that might harmalitigant’s competitive standing.”).
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`Asexplained above, paragraphs 56-58, 77—78, 98-99, 119-120, 143-144, 169-170, and
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`190-191 of the Amended Complaint contain technical details regarding Moderna’s proprietary
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`LNP formulation in SpikeVax and the related proprietary manufacturing process. Moderna’s
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`proposedredactions to the Amended Complaint redact the specific confidential material at issue,
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`leaving the remainder unredacted. These proposed redactions are narrow suchthat the public’s
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`ability to understand the Amended Complaintis not impaired any less than necessary to prevent
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`the release ofModerna’s mostsensitive technical information to its competitors, preventing clear
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`competitive harm. Moderna’s proposed redactions are narrow in scope and refer only to
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`Moderna’s confidential, sensitive technical or business information to prevent the serious harm
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`to Moderna which would be causedbyits public release as outlined in Dr. Parsons’s Declaration.
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`IV.
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`CONCLUSION
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`For the foregoing reasons, Moderna respectfully requests the Court grant Moderna’s
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`Motion to Seal with respect to Moderna’s highly confidential information.
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`Morris, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/Travis J. Murray
`
`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
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`Attorneys for Defendants
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`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 ClarendonStreet
`Boston, MA 02116
`(617) 385-7500
`
`Yan-Xin Li
`KIRKLAND & ELLIS LLP
`555 California Street
`San Francisco, CA 94104
`(415) 439-1400
`
`May9, 2024
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`
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`CERTIFICATE OF SERVICE
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`I hereby certify that on May 9, 2024, I caused the foregoing to be electronically filed with
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`the Clerk of the Court using CM/ECF, whichwill send notification of such filing to all registered
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`participants.
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`I further certify that I caused copies of the foregoing document to be served on May9,
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`2024, upon the following in the mannerindicated:
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`John W. Shaw, Esquire
`Karen E.Keller, Esquire
`Nathan R. Hoeschen, Esquire
`Emily S. DiBenedetto, Esquire
`SHAW KELLER LLP
`I.M.Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`Attorneysfor Plaintiffs Arbutus Biopharma
`Corporation and Genevant Sciences GmbH
`
`Daralyn J. Durie, Esquire
`Adam R.Brausa, Esquire
`Eric C. Wiener, Esquire
`Annie A. Lee, Esquire
`Shaelyn K. Dawson, Esquire
`MORRISON & FOERSTER LLP
`425 MarketStreet
`San Francisco, CA 94105-2482
`Attorneysfor PlaintiffArbutus Biopharma
`Corporation
`
`Kira A. Davis, Esquire
`MorRISON & FOERSTER LLP
`707 Wilshire Boulevard
`Los Angeles, CA 90017-3543
`Attorneysfor PlaintiffArbutus Biopharma
`Corporation
`
`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`
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`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
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`David N. Tan, Esquire
`MorRISON & FOERSTER LLP
`2100 L Street, NW, Suite 900
`Washington, DC 20037
`Attorneysfor PlaintiffArbutus Biopharma
`Corporation
`
`David I. Berl, Esquire
`Adam D. Harber, Esquire
`ThomasS. Fletcher, Esquire
`Jessica Palmer Ryen, Esquire
`Shaun P. Mahaffy, Esquire
`Anthony H. Sheh, Esquire
`Philip N. Haunschild, Esquire
`Falicia Elenberg, Esquire
`Jihad J. Komis, Esquire
`Matthew W. Lachman, Esquire
`WILLIAMS & CONNOLLY LLP
`680 Maine AvenueS.W.
`Washington, DC 20024
`Attorneysfor PlaintiffGenevant Sciences GmbH
`
`/s/ Travis J. Murray
`
`Travis J. Murray (#6882)
`
`