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Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 1 of 16 PageID #:
`34995
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`_______________________________
`GENENTECH, INC. and CITY OF
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`HOPE,
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`Plaintiffs,
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`v.
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`AMGEN, INC.
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`Defendant.
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`_______________________________)
`GENENTECH, INC. and CITY OF
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`HOPE,
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`Plaintiffs,
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`AMGEN, INC.
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`Defendant.
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`_______________________________)
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`Civ. No. 17-1407- CFC, Consol.
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`Civ. No. 18-924-CFC
`
`REPORT AND RECOMMENDATION OF SPECIAL MASTER
`
`Rodney A. Smolla, Special Master
`
`District Court Judge Colm Connolly assigned these consolidated matters to
`
`the Special Master in a Memorandum Order entered on March 30, 2020. The District
`
`Court’s order broadly instructed the Special Master to determine whether the sealed
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 2 of 16 PageID #:
`34996
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`redacted filings of the parties comply with the legal principles that govern the sealing
`
`of documents filed in federal judicial proceedings as established by the Supreme
`
`Court of the United States, the United States Court of Appeals for the Third Circuit,
`
`and the Federal Rules of Civil Procedure.
`
`This Report and Recommendation: (1) describes the process through which
`
`the duties of the Special Master were completed; (2) briefly summarizes the
`
`applicable legal principles governing sealing; (3) recites the legal positions on the
`
`issues taken by the parties and explains the Special Master’s approval and
`
`endorsement of their positions; and (4) concludes with a recommended order
`
`detailing the mechanics of how the parties should comply with this Report and
`
`Recommendation, to ensure that all material that should be unsealed is unsealed, and
`
`all that should remain sealed remains sealed.1
`
`A separate Sealed Appendix is filed contemporaneously with this Report and
`
`Recommendation. That Sealed Appendix contains a document-by-document
`
`review, in which the nature of every retained sealing or partial redaction is described,
`
`and the legal basis justifying continued sealing or redaction is succinctly explained.
`
`
`
`
`
`
`1 The recitation of law in this Report and Recommendation has been kept short.
`The Court is well-familiar with the controlling principles. The parties, through the
`initial guidance provided by the Special Master, and as evidenced in their thorough
`subsequent briefing, are as well. There is no disagreement as to the guiding legal
`principles.
`
`
`
`2
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 3 of 16 PageID #:
`34997
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`I. The Process
`
`
`
`The Parties and the Special Master agreed on a process for streamlining the
`
`review ordered by Judge Connolly and mandated by Third Circuit precedent. It may
`
`well serve as a useful model for future similar undertakings. The Special Master
`
`issued an Interim Order providing legal guidance to the parties regarding the nature
`
`of material that should not be sealed, and the nature of material that could justifiably
`
`be sealed, and the nature of the factual showing required to justify sealing. The
`
`Parties then engaged in their own self-review of all previously sealed material,
`
`engaging in a self-critique in which material previously filed under seal was
`
`voluntarily designated for unsealing. As to filings that, in whole or in part, should
`
`in either Party’s view remain sealed, the Parties submitted to the Special Master the
`
`proffered legal and factual justifications. This process undoubtedly saved a great
`
`deal of time and expense. Even so, between them the Parties still submitted several
`
`hundred principal documents or attached exhibits for which continued sealing was
`
`urged, in whole or in part. As to those documents, the Special Master considered
`
`the Parties’ legal submissions and the Parties’ application of law to fact as to each
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`document. As required by Third Circuit precedent, each specific sealing and
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`redaction was reviewed by the Special Master.
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`
`
`
`
`
`
`3
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`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 4 of 16 PageID #:
`34998
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`II. The Applicable Legal Principles
`
`A. The Three Tiers of Review
`
`Three discrete bodies of
`
`law govern
`
`the principles pertaining
`
`to
`
`
`
`
`
`
`confidentiality, sealing, and redactions of documents in federal court litigation.
`
`They apply in ascending orders of scrutiny.
`
`First, there are principles governing the issuance of protective orders in federal
`
`litigation. These principles emanate from Rule 26(c) of the Federal Rules of Civil
`
`Procedure, and the attendant gloss courts have applied to the application of Rule
`
`26(c). See Pansy v. Borough of Stroudsburg, 23 F.3d 772, 783-92 (3d Cir. 1994).
`
`Second, federal courts recognize a common-law right of access to judicial
`
`records. “The existence of a common law right of access to judicial proceedings and
`
`to inspect judicial records is beyond dispute.” Publicker Industries, Inc. v. Cohen,
`
`733 F.2d 1059, 1066 (3d Cir. 1984). There is a “presumption in favor of access to
`
`‘public records and documents, including judicial records and documents.’” Bank of
`
`America National Trust & Savings Association v. Hotel Rittenhouse Associates, 800
`
`F.2d at 343, quoting Nixon v. Warner Communications, Inc., 435 U.S. 589, 597
`
`(1978).
`
`Third, “the public and the press have a First Amendment right of access to
`
`civil trials.” In re Avandia Marketing Sales Practices & Product Liability Litigation,
`
`924 F.3d 662, 673 (3d Cir. 2019), citing Publicker, 733 F.2d at 1070. “[T]he First
`
`
`
`4
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 5 of 16 PageID #:
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`Amendment, independent of the common law, protects the public’s right of access
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`to the records of civil proceedings.” Republic of Philippines v. Westinghouse
`
`Electric Corporation, 949 F.2d 653, 659 (3d Cir. 1991), citing Publicker, 733 F.2d
`
`at 1070. “The First Amendment right of access requires a much higher showing than
`
`the common law right to access before a judicial proceeding can be sealed.” In re
`
`Cendant Corp., 260 F.3d 183, 198 n. 13 (3d Cir. 2001). Any restriction on the First
`
`Amendment right of public access is “‘evaluated under strict scrutiny.’” Avandia,
`
`924 F.3d at 673, quoting PG Publishing Company v. Aichele, 705 F.3d 91, 104 (3d
`
`Cir. 2013).
`
`Of these three, it is the middle tier, the common-law access right, that is
`
`principally in play in this Report and Recommendation.
`
`B.
`
`The Common-Law Right of Access
`
`
`
`1. The Avandia Guidance
`
`
`
`While not purporting to articulate exhaustively what substantive showings
`
`will justify sealing or redacting a judicial record and what showings will not, the
`
`Third Circuit’s landmark ruling in Avandia did provide substantial guidance.
`
`Avandia confirmed the long-standing truism that the presumption of public access is
`
`“‘not absolute.’” Avandia, 924 F.3d at 672, quoting Bank of America, 800 F.2d at
`
`344. The presumption of public access may be overcome.
`
`
`
`5
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 6 of 16 PageID #:
`35000
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`The critical divide is the distinction between material containing palpable
`
`trade secrets or proprietary business practices that will produce present commercial
`
`and competitive harm, on the one hand, and vague, conclusory assertions of
`
`commercial or competitive harm, or assertions that in fact appear grounded in
`
`reputational interests and embarrassment, on the other. A party’s “‘vague assertions
`
`that the transcript contains secretive business information, and that disclosure would
`
`render [it] at a tactical disadvantage’ [are] insufficient to overcome that strong
`
`presumption.” Avandia, 924 F.3d at 676, quoting LEAP Sys., Inc. v. MoneyTrax,
`
`Inc., 638 F.3d 216, 221-22 (3d Cir. 2011). The touchstone is the persuasive
`
`demonstration of specific, concrete, particularized of harm.
`
`2. The Publicker Categories
`
`The Third Circuit’s 1984 opinion in Publicker, decided some 25 years prior
`
`to Avandia, endures as one of the most important substantive guides to what material
`
`may justifiably remain sealed. In a paragraph describing situations in which sealing
`
`could be justified, the Third Circuit postulated three categories: one involving “the
`
`content of the information at issue,” a second “the relationship of the parties,” and
`
`the third “the nature of the controversy.” Publicker, at 733 F.2d at 1073.
`
`The Third Circuit then offered examples. For “the content of the
`
`information,” it used as an example “safeguarding a trade secret.” Id. For the
`
`“relationship of the parties,” it posited a suit by a client to prevent a lawyer from
`
`
`
`6
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 7 of 16 PageID #:
`35001
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`disclosing confidential information protected by the attorney-client privilege. Id.
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`The Third Circuit then gave as an example of “the nature of the controversy,” a
`
`passage which reads in its entirety: “A similar situation would be presented where
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`there is a binding contractual obligation not to disclose certain information which to
`
`the court seems innocuous but newsworthy; in that situation unbridled disclosure of
`
`the nature of the controversy would deprive the litigant of his right to enforce a legal
`
`obligation.” Id. at 1073-74.
`
`3. The Carve-Out for Discovery Motions
`
`In Leucadia, Inc. v. Applied Extrusion Technologies, Inc., 998 F.2d 157 (3d
`
`Cir. 1993), the Third Circuit held that the common-law right of access did not attach
`
`to discovery motions. In excluding “discovery motions,” Leucadia relied heavily
`
`on the fundamental principle that underlying discovery material itself is not a judicial
`
`record. There is no common law right of access to “raw discovery.” Id. at 157. If
`
`in the course of discovery, disputes arise, parties may file “discovery motions”
`
`seeking the intervention of a court to resolve the disputes. Those motions may
`
`require attachment of “raw discovery” materials, such as excerpts from depositions
`
`or interrogatory answers. The core learning of Leucadia is that the common-law
`
`right of access does not attach to such motions, or their exhibits containing raw
`
`discovery, because this would have the effect of converting material that is normally
`
`not a “judicial record” into material that is. The key passage in Leucadia thus
`
`
`
`7
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 8 of 16 PageID #:
`35002
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`explained that “a holding that discovery motions and supporting materials are
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`subject to a presumptive right of access would make raw discovery, ordinarily
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`inaccessible to the public, accessible merely because it had to be included in motions
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`precipitated by inadequate discovery responses or overly aggressive discovery
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`demands.” Id. at 157.
`
`4. The Procedural Requirements
`
`Avandia contemplates a rigorous process of judicial review. The right of
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`access must not be demoted to “a mere formality.” Avandia, 924 F.3d at 676. To
`
`ensure that proper weight is given to “the public’s strong interest in the openness of
`
`judicial records,” a District Court must engage in “a document-by-document
`
`review.” Id. Casual, superficial review does not suffice. “Again, the strong
`
`presumption of openness inherent in the common law right of access ‘disallows the
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`routine and perfunctory closing of judicial records.’” Id., citing In re Cendant Corp.,
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`260 F.3d at 193-94.
`
`The substantive and procedural standards that must be met to overcome the
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`presumption of access are onerous by definition and design. The party seeking to
`
`seal judicial records must satisfy “a heavy burden.” Miller v. Indiana Hospital, 16
`
`F.3d 549, 551 (3d Cir. 1994). The party seeking to have a record sealed “must show
`
`that ‘the material is the kind of information that courts will protect and that
`
`disclosure will work a clearly defined and serious injury to the party seeking
`
`
`
`8
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 9 of 16 PageID #:
`35003
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`closure.’” Avandia, 924 F.3d at 677-78, quoting Miller, 16 F.3d at 55. In granting a
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`sealing order, a “District Court should articulate ‘the compelling[,] countervailing
`
`interests to be protected,” make “specific findings on the record concerning the
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`effects of disclosure, and provide[ ] an opportunity for interested third parties to be
`
`heard.’” Avandia, 924 F.3d at 677-78, quoting In re Cendant Corp., 260 F.3d at 194.
`
`“‘In delineating the injury to be prevented, specificity is essential.’” Id. Generalized
`
`incantations that secrecy is required to prevent competitive or commercial harm are
`
`not enough to carry the movant’s burden. “‘Broad allegations of harm, bereft of
`
`specific examples or articulated reasoning, are insufficient.’” Id.
`
`The factfinding required by district courts must be careful and meticulous in
`
`order to vindicate the rights of the public and the integrity of the judicial process
`
`itself, notwithstanding the private interests or preferences of the litigants, even when
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`they are in agreement. “‘[C]areful factfinding and balancing of competing interests
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`is required before the strong presumption of openness can be overcome by the
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`secrecy interests of private litigants.’” Avandia, 924 F.3d at 677-78, quoting
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`Leucadia, 998 F.2d at 167.
`
`
`
`The Third Circuit’s Avandia opinion mandates a “document-by-document”
`
`review of the claimed propriety of sealing. “[I]t must be clear from the record that
`
`the district court engaged in a particularized, deliberate assessment of the standard
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`as it applies to each disputed document.” Id.
`
`
`
`9
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 10 of 16 PageID
`#: 35004
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`III. The Submissions of the Parties
`
`A. Genentech’s Legal Arguments
`
`
`
`Genentech grounds its claims for continued sealing or redaction of certain
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`designated materials on its need to retain the confidentiality of proprietary trade
`
`secrets or other competitively sensitive information. Such material is at the core of
`
`that type of material that is routinely treated as overcoming the common-law
`
`presumption of access. The revelation of trade secrets, or of other competitively
`
`sensitive information that may not meet the formal definition of “trade secret,” but
`
`nonetheless is shown to be of the nature that would work palpable competitive harm
`
`on a party, is precisely the type of material most likely to successfully rebut the
`
`presumption favoring access. As the Supreme Court observed in Nixon v. Warner
`
`Communications, “courts have refused to permit their files to serve as … sources of
`
`business information that might harm a litigant’s competitive standing.” Nixon, 435
`
`U.S. at 598. So too, the Third Circuit has recognized that “[d]ocuments containing
`
`trade secrets or other confidential business information may be protected from
`
`disclosure.” Leucadia, 998 F.2d at 166. Thus “[d]espite the presumption, courts may
`
`deny access to judicial records, for example, where they are sources of business
`
`information that might harm a litigants competitive standing.” Littlejohn v. Bic
`
`Corp., 851 F.2d 673, 678 (3d Cir. 1988), citing Nixon, 435 U.S. at 598.
`
`
`
`
`
`10
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 11 of 16 PageID
`#: 35005
`
`B. Amgen’s Legal Arguments
`
`
`
`Amgen groups its proffered retained sealings and redactions into four
`
`categories:
`
`(1)
`
`Sensitive and proprietary manufacturing and trade secret information;
`
`(2)
`
`Sensitive and confidential material reflecting commercial and regulatory
`
`intelligence, planning and/or strategy;
`
`(3)
`
`Sensitive and proprietary legal information, including privileged material
`
`produced in response to the Court’s waiver orders; and
`
`(4)
`
`Sensitive and confidential pre-litigation material reflecting the parties’
`
`substantive exchanges during the non-public pretrial exchanges under the Biologics
`
`Price Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262.
`
`
`
`Sealing of material is legally justified under all four of these categories.
`
`The first two categories identified by Amgen are essentially alternative
`
`phrasings to the same principles relied upon by Genentech. They fall well within
`
`the confines of the types of material that the Third Circuit has identified as
`
`appropriate for sealing under the standards of Publicker, Avandia, and related cases.
`
`As to the third category, confidential legal information is the sort of
`
`relationship-based exception to the common-law access rule specifically described
`
`in Publicker.
`
`And the final category, confidential exchanges arising from the BPCIA
`
`
`
`11
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 12 of 16 PageID
`#: 35006
`
`process, is an extraneously imposed confidentiality obligation—imposed by
`
`Congress, after all—carrying even greater weight than Publicker’s recognition that
`
`contractual obligations may justify sealing or redaction. The BPCIA is a process
`
`prescribed by Congress to streamline biosimilar product litigation through
`
`negotiations directed at identifying patents to litigate or license. The Act by its terms
`
`treats these exchanges as confidential. 42 U.S.C. § 262(l)(1)(C) (“No person that
`
`receives confidential information . . . shall disclose any confidential information to
`
`any other person or entity, including the reference product sponsor, without the prior
`
`written consent of the [biosimilar] applicant.”).
`
`On top of these four substantive justifications, much of the material
`
`designated for continued sealing or redaction by both parties falls squarely within
`
`the carve-out for discovery motions and accompanying attachments recognized in
`
`Leucadia.
`
`C. Factual Documentation
`
`
`
`Both Genentech and Amgen provided comprehensive and persuasive factual
`
`explanation and documentation as to why the material each identified as appropriate
`
`for sealing does in fact meet the criteria summarized above. Both parties submitted
`
`numerous, lengthy, and detailed factual declarations by highly placed and expert
`
`employees within their respective companies. Those substantial declarations
`
`explained generally, and with reference to specific documents in the record, the
`
`
`
`12
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 13 of 16 PageID
`#: 35007
`
`factual predicate for continued sealing. The positions and qualifications of those
`
`declarants, as well as the substance of their presentations, are discussed as germane
`
`in the Sealed Appendix.
`
`
`
`In generic terms, without broaching reference to specific redacted or sealed
`
`material, the submissions of the parties were in alignment in describing the intensely
`
`competitive scientific and business arena in which they compete. Both have
`
`persuasively established the justification for sealing various docket entries and
`
`accompanying exhibits. The proffered justifications include, among others, trade
`
`secrets, proprietary scientific research, highly sensitive manufacturing information,
`
`the confidential terms of settlement and license agreements, business intelligence,
`
`regulatory strategies, and confidential legal information.
`
`The parties have documented how the information contained in their proposed
`
`sealings and redactions, if disclosed, would visit upon them present commercial and
`
`competitive harm. In revealing sensitive and confidential business information to
`
`their competitors, they would be supplying those competitors with information
`
`regarding their knowledge, operations, capabilities, and strategies.
`
`In some instances, the prospect of harm is linear and direct. Competitors in
`
`the highly-competitive biologics marketplace could use Amgen’s or Genentech’s
`
`own research to the competitors’ competitive advantage to more effectively develop
`
`and manufacture products.
`
`
`
`13
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 14 of 16 PageID
`#: 35008
`
`In other instances, the harm is less linear and direct, but still entirely real.
`
`Both parties, as many in the industry, are constantly involved in litigation.
`
`Revelation of the terms of settlement agreements, which are among the documents
`
`for which continued sealing is often sought, could place the parties at a demonstrable
`
`disadvantage in navigating and negotiating other litigation contests with competitors
`
`in the same pharmaceutical space.
`
`
`
`The parties have established that in the highly competitive pharmaceutical
`
`industry environment, even seemingly minor pieces of information about a
`
`pharmaceutical company can be valuable to its competitors. So too, both parties have
`
`demonstrated that they go to extraordinary lengths to safeguard the integrity of their
`
`confidential information, both through the firewalls they impose to protect the
`
`information from outsiders, and the closely guarded “need to know” protocols they
`
`impose internally on their own employees.
`
`
`
`One size does not fit all in describing the specific nature of the proposed
`
`redactions. In some instances the material reflects commercial intelligence—
`
`research and strategic analysis of factors such as anticipated market share and
`
`penetration, sales volume, or pricing and discount strategy. These competitive
`
`assessments include inward-facing judgments on the parties’ own capacities as well
`
`as outward-facing judgments on the capacities of others. The proffered redactions
`
`also include information on the approaches of the parties to interfacing with
`
`
`
`14
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 15 of 16 PageID
`#: 35009
`
`government regulators in their highly regulated industry. The parties each expend
`
`substantial resources in conceptualizing how best to secure regulatory approval of
`
`their products. Public revelation of those strategies could undercut the effectiveness
`
`of those efforts, or provide competitors with value information they could exploit to
`
`their own advantage.
`
`In sum, the parties have engaged in appropriate self-restraint and self-scrutiny
`
`in placing into the public domain much of the material previously filed under seal.
`
`Having carefully scrutinized the sealings and redactions they seek to maintain, the
`
`Special Master approves and recommends continued sealing and redaction, as
`
`detailed more specifically in the accompanying Sealed Appendix.
`
`IV. Recommended Order
`
`
`
`This litigation has been expansive, and the mechanics of executing the
`
`operational directives of this Report and Recommendation are fraught with the
`
`potential for inadvertent error. The guiding principles are simple enough:
`
`(1) Any document previously sealed that is now to be unsealed in its entirety
`
`should be unsealed.
`
`(2) Any document previously sealed in its entirety that is now to continue to
`
`be sealed in its entirety should remain sealed.
`
`(3) Any document previously sealed in its entirety, or redacted in part, which
`
`is now to retain some justifiable redactions, but narrowed from the prior entire
`
`
`
`15
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 558 Filed 09/02/20 Page 16 of 16 PageID
`#: 35010
`
`sealing or redacted sealing, should be re-filed in its new form, with only the approved
`
`narrowed redactions continued.
`
`
`
`To implement these principles, the Parties have already conferred with the
`
`Clerk of the Court. As a result of that consultation, this Report and Recommendation
`
`recommends to the Court that the Parties be ordered to meet and confer and file a
`
`joint submission to the Clerk of Court, in the form of an Appendix (as opposed to
`
`document-by-document re-filings), with a courtesy copy to the Special Master, that
`
`will: (1) identify those filings that were previously sealed in whole or in part that
`
`should now be entirely unsealed; (2) identify those documents previously sealed that
`
`are now to be continued to be sealed in their entirety; and (3) compile in the one
`
`Appendix filing new versions of all documents previously filed entirely under seal
`
`or with redactions, in their new form, with the redactions narrowed as approved by
`
`the Special Master as listed in the Sealed Appendix, with the appropriate previously
`
`sealed or redacted material now public, and the continued and approved material
`
`redacted.
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`
`
`
`
`16
`
`

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