Case 1:18-cv-00924-CFC-SRF Document 477 Filed 01/13/20 Page 1 of 89 PageID #: 33718
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE
`
`Plaintiffs,
`
`C. A. No.: 17-1407-CFC-SRF
`(CONSOLIDATED)
`
`v.
`
`AMGEN INC.,
`
`___________________Defendant.
`GENENTECH, INC.,
`
`PUBLIC VERSION
`
`Plaintiff,
`
`C.A. No. 18-924-CFC-SRF
`
`v.
`
`AMGEN INC.,
`
`Defendant.
`
`OPENING LETTER TO THE HONORABLE
`SHERRY R. FALLON RESPONDING TO THE DECEMBER 30.2019 ORAL ORDER
`
`C.A. No. 17-1407-CFC-SRF:
`
`C.A. No. 18-924-CFC-SRF:
`
`YOUNG CONAWAY STARGATT &
`TAYLOR LLP
`Melanie K. Sharp (No. 2501)
`Janies L. Higgins (No. 5021)
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`(302)571-5034
`msharp@ycst.com
`jhiggins@ycst.com
`
`SMITH KATZENSTEIN & JENKINS, LLP
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`Jennifer M. Rutter (No. 6200)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skj law.com
`eormerod@skjlaw.com
`jrutter@skjlaw.com
`
`Attorneys for Defendant Amgen Inc.
`
`Attorneys for Defendant Amgen Inc.
`
`Dated January 13, 2020
`
`25859323.1
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`Case 1:18-cv-00924-CFC-SRF Document 477 Filed 01/13/20 Page 2 of 89 PageID #: 33719
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`Dear Magistrate Judge Fallon:
`
`I. Motion to Compel Unredacted Licenses to the Patents-in-Suit Under the
`Terms of the Stipulated Protective Orders. Having launched the accused products in July
`2019 and thus now being subject to Genentech claims for monetary damages, Amgen seeks an
`order compelling Genentech to produce unredacted versions of its settlement agreements and
`licenses to the patents-in-suit in accordance with the Stipulated Protective Orders in the above-
`captioned litigations. Not only do the licenses at issue (the “Licenses”) concern the patents-in-
`suit, but they are the only Avastin and Herceptin biosimilar product licenses in existence.
`Indeed, the Court already determined, consistent with controlling Federal Circuit precedent, that
`the Licenses are discoverable. Ex. 1, Oct. 16, 2019 Hr’g Tr. at 293:9-13, 17-21; see also
`ResQNet.com, Inc. v. Lansa, Inc., 594 F.3d 860, 872 (Fed. Cir. 2010) (in determining damages,
`“the most reliable license in this record” was a settlement agreement to the patent in suit).
`
`Despite this—and notwithstanding the changed posture of the case with regard to damages—
`Genentech and its third-party licensees Pfizer, Teva, Celltrion, and Mylan (the “Third Parties”)
`continue to block Amgen’s access. First, they insist on redacting terms critical to assessing the
`full consideration exchanged between the settling parties. Second, they have blocked Amgen
`“Designated Inside Counsel” under the Protective Orders from viewing key information in the
`agreements. The Court should reject these arbitrary restrictions, as discussed below.
`
`A.
`Background. In March 2019, Amgen first moved to compel the Licenses
`that existed as of that time (Avastin Case, D.I. 290). However, the Third Parties intervened to
`prevent their production, arguing unsuccessfully at a May 2019 hearing that the documents were
`irrelevant and too sensitive to produce. See, e.g., Ex. 2, May 16, 2019 Hr’g Tr. at 63:17-66:12.
`The Court then granted-in-part and denied-in-part Amgen’s motion but did so without prejudice,
`compelling Genentech to produce the Licenses under the terms of the existing Protective Orders,
`permitting redactions only to the dates on which the licensed party could launch its biosimilar,
`and terms unrelated to the “value placed upon any of the patents.” Avastin Case, D.I. 387. The
`Court indicated that these redactions were appropriate given the then-current posture of the case,
`as Amgen had not launched either product and Genentech had not yet moved for a preliminary
`injunction. Ex. 2, May 16, 2019 Hr’g Tr. at 48:1-9, 70:11-71:22. It was also unclear at the time
`the degree to which the Licensees’ launch dates would be relevant to any monetary damages
`analysis—Amgen did not yet know whether the “value placed upon ... the patents” in the
`licenses (Avastin Case, D.I. 387) was based on the launch dates.
`
`Genentech thereafter produced highly-redacted versions of the Licenses that withheld
`nearly all terms relevant to valuation, in violation of the Court’s order. Avastin Case, D.I. 536,
`at 1-2. Subsequently, in July 2019, Amgen launched its Avastin and Herceptin biosimilars, and
`Genentech sought a preliminary injunction against Amgen in both actions and amended its
`complaint in the Herceptin Case to seek monetary damages. In September 2019, Genentech and
`Pfizer entered into a new settlement and license agreement to patents that Genentech asserts
`against Amgen in the Avastin Case, and Pfizer again sought to shield relevant terms from
`production. As a result of these developments, Amgen moved to compel properly-produced
`versions of the Licenses, and the Court on October 16, 2019 ordered Pfizer to produce its
`Avastin litigation license agreement to outside counsel, permitting redactions only to non-public
`25859323.1
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`Case 1:18-cv-00924-CFC-SRF Document 477 Filed 01/13/20 Page 3 of 89 PageID #: 33720
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`launch dates (Ex. 1, Oct. 16, 2019 Tr. at 293:4-13, 298:18-20), but reserving ruling on whether
`the document could be disclosed to in-house counsel or experts under the Protective Order (id. at
`293:9-13, 297:7-14). In permitting redactions to non-public launch dates, the Court understood
`(based in part on Pfizer’s suggestion) that the agreements would disclose the launch delay
`elsewhere in general terms (e.g., six months). Ex. 1, Oct. 16, 2019 Hr’g Tr. at 299:2-300:6. This
`suggestion, however, was incorrect, which Amgen only discovered after the redacted license was
`produced. The Court also reserved ruling on the production of unredacted agreements with the
`remaining third parties (Mylan, Celltrion, and Teva) to allow Amgen and the Third Parties
`additional time to meet and confer. Id. at 295:2-5. Despite conferring further, Mylan, Celltrion,
`and Teva still refuse to, at minimum, allow Genentech to produce their licenses consistent with
`the Court’s October 16 order regarding Pfizer’s license. The Third Parties have also insisted on
`restricting access to any future-produced versions of the Licenses (e.g., ones with fewer
`redactions) to outside counsel only and sought to impose other unwarranted conditions on the
`production, such as requiring Amgen to forgo - in a future litigation against Genentech that has
`not even been filed - seeking discovery of settlement agreements or licenses to the patents-in-
`suit between Genentech and the Third Parties.
`
`Argument. The Court Should Order that the Licenses be Produced
`B.
`Without Redactions. The Court in May 2019 ordered Genentech to produce the Licenses
`without redacting “terms of the licensing and/or settlement agreements that have any relevance
`to the value placed upon any of the patents implicated therein, including .. . any other
`consideration identified in the agreements.” D.I. 387, at 2 (emphasis added). But Genentech
`failed to comply, redacting nearly every consideration-related term. As Amgen only discovered
`after their production, the Licenses required ^
`
`but redacting
`Ex. 3, at GNEAVA-AMG-02901673-75 (identifying
`other terms, including staggered launch timing) (subsequently reproduced with fewer
`redactions); Ex. 4, at GNEAVA-AMG-02901738-41 (same); Ex. 5, at GNEAVA-AMG-
`02909310-12 (same). Accordingly, assessing the monetary value, if any, of licenses to the
`patents-in-suit, an inquiry that bears on the determination of patent damages under 35 U.S.C.
`§284, requires disclosure not only of the launch dates, but, critically, the consideration that
`Genentech provided these parties to induce them into their licenses - consideration that will
`likely demonstrate that the licensed patents had little to no relative value. See Ericsson, Inc. v.
`D-LinkSys., Inc., 773 F.3d 1201, 1227 (Fed. Cir. 2014) (“[Licenses may be presented to the jury
`to help the jury decide an appropriate royalty award.”) (citing Georgia-Pacific Corp. v. U.S.
`Plywood Corp., 318 F.Supp. 1116, 1120 (S.D.N.Y. 1970).
`
`However, the Third Parties still refuse to produce unredacted versions of the Licenses
`that lay bare the full extent of the consideration exchanged between the parties, claiming that the
`information (including ex-U.S. terms and launch dates) is not relevant to the damages inquiry
`and is too confidential. These arguments should be rejected. First, concerning ex-U.S. terms,
`the Court has already considered and rejected those arguments. At the October 16, 2019 hearing,
`the Court ordered Genentech and Pfizer to produce such ex-U.S. terms, having already decided
`that they are discoverable. Ex. 1, Oct. 16, 2019 Tr. at 293:14-21, 295:2-5. Second, although the
`Court previously allowed Pfizer to redact “the launch date only” from its license, this ruling was
`based on incomplete information in part due to Pfizer’s suggestion that other information in the
`agreements would reveal the launch delay in general terms (e.g., six months). Id. at 298:18-
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`Case 1:18-cv-00924-CFC-SRF Document 477 Filed 01/13/20 Page 4 of 89 PageID #: 33721
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`300:7. As Amgen only learned once Pfizer’s agreement was produced, this suggestion was
`inaccurate—without the launch dates themselves, Amgen cannot discern the agreed-upon launch
`delay. Third, the purported concern about the sensitivity of the Third Parties’ launch dates is a
`red herring. Amgen has already launched its Avastin and Herceptin biosimilars in the U.S. and
`in numerous countries abroad (and of course cannot and would not use any confidential
`information produced during discovery for competitive business decision-making elsewhere).
`And, since the October hearing, the Third Parties have been launching their biosimilar products
`in succession.1 Genentech, which bears the burden of proof on damages (and the Third Parties)
`should not be permitted to shield this relevant information from discovery, particularly because
`the Third Parties are rapidly making this information public themselves and a protective order
`exists to safeguard confidentiality in the interim. Alternatively, if Genentech continues to
`withhold the information, it should be precluded from arguing that the
`launch dates
`confer any value to the patents-in-suit, and from contesting Amgen’s contention that Genentech
`is willing to license the patents-in-suit to a competitor
`
`C.
`The Court Should Order that the Licenses be Produced Under the Existing
`Protective Orders. The Stipulated Protective Orders in these actions, which were the subject of
`extensive negotiation between the parties, sufficiently safeguard the confidentiality of the
`Licenses. The Protective Orders require that all persons bound to them, including outside
`counsel and “Designated Inside Counsel” (defined as in-house counsel “who, because of their
`duties and responsibilities, require access to CONFIDENTIAL Discovery Material. . .”) use
`confidential discovery “only for purposes of this Litigation ....” Avastin Case, D.I. 206, at
`TfTf28, 33(b), Herceptin Case, D.I. 47, at f^28(b), 31. The Protective Orders have additional
`requirements for “Designated Inside Counsel.” Before “Designated Inside Counsel” can obtain
`access to confidential material, they must execute an acknowledgement “to use
`CONFIDENTIAL Discovery Material solely for the purposes delineated within the Protective
`Order.” Avastin Case, D.I. 206 at j[37 and Exhibit B; Herceptin Case, D.I. 47 at ^31 and Exhibit
`B. Moreover, the identity of each “Designated Inside Counsel” must first be disclosed to the
`opposing party, which can then object to his or her receipt of confidential discovery material. Id.
`
`Importantly, in other litigations with Amgen—including cases in which the parties were
`direct competitors—the Third Parties (with the exception of Celltrion, who has not been a party
`to a suit with Amgen) stipulated to protective orders substantively similar to those here and
`permitted their confidential documents to be shared with designated Amgen in-house counsel.2
`
`1 See, e.g., https://generics.pharmaintelligence.informa.com/GB149492/Pfizer-Launches-US-
`Bevacizumab-At-A-23-Discount (Pfizer biosimilar Avastin U.S. launch);
`https://pharmaphorum.com/news/mvlan-and-biocon-launch-herceptin-biosimilar-in-us/ (Mylan
`biosimilar Herceptin U.S. launch).
`
`2 See Pfizer Inc. v. Amgen Fremont Inc. and Amgen Inc., No. 10667-VCP, Dkt. No. 155, at 1f6(B)
`(“Highly Confidential Discovery Material may be disclosed ... to ... (B) Up to five in-house
`counsel from each side . . .”) (Ex. 6); Amgen Inc. et al. v. Mylan Inc. et al., No. 17-cv-1235, Dkt.
`69, at |7 (W.D. Pa. Feb. 7, 2018) (“Confidential Attorney Eyes only Information may be
`disclosed . . . only to the following individuals ... (a) three (3) in-house counsel. ..”) (Ex. 7);
`Brigham and Women’s Hospital Inc. and Amgen Inc. et al. v. Teva Pharms. USA Inc. et al., No.
`25859323.1
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`Case 1:18-cv-00924-CFC-SRF Document 477 Filed 01/13/20 Page 5 of 89 PageID #: 33722
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`Here, however, they refuse, suggesting that the information would provide Amgen’s in-house
`counsel an unfair advantage in settlement negotiations. Their position assumes, without any
`support, that Amgen’s “Designated Inside Counsel” will flout the Protective Order. That is
`baseless. Amgen has strictly complied with the applicable Protective Orders throughout these
`litigations. In any event, the Licenses would provide no settlement negotiation advantage to
`Amgen. Because Amgen launched its biosimilars nearly six months ago, there is no risk that
`Amgen will inappropriately use information in the Licenses to negotiate settlement agreements
`that leapfrog the Third Parties. Indeed, Mylan and Pfizer recently launched their own Herceptin
`and Avastin biosimilars.
`
`Restricting access to outside counsel would impede Amgen’s ability to develop its
`damages defenses and expert reports. Amgen’s “Designated Inside Counsel” actively participate
`in this litigation, working hand-in-hand with outside counsel on every aspect of the case,
`including to direct important strategy decisions, and are admitted pro hac vice and subject to this
`Court’s jurisdiction. They are experienced litigators who understand their ethical obligations and
`are not involved in competitive business decision-making activities at Amgen. An outside
`counsel only restriction would effectively shut Amgen’s in-house litigators out from developing
`Amgen’s damages case (which we expect the Licenses to pervade) and prevent Amgen from
`having meaningful involvement in the preparation of expert reports. This Court has routinely
`permitted in-house counsel access to confidential documents under these circumstances3, and it
`should do so here.
`
`08-cv-464, Dkt. No. 52, at f (D. Del. Feb. 27, 2009) (providing access to “Confidential”
`discovery material to “up to four designated in-house attorneys ...”) (Ex. 8).
`
`3 See R.R. Donnelley & Sons Co. v. Quark, Inc., 2007 WL 61885, at *l-*2 (D. Del. Jan. 4, 2007)
`(allowing chief patent counsel access to “Attorneys’ Eyes Only” material as he “declared the role
`... is strictly to ‘supervise the legal decision-making related to ... intellectual property portfolio
`and its enforcement”); Avery Dennison Corp. v. Minnesota Mining & Mfg. Co., 2001 WL
`1339402, at *2 (D. Del. Oct. 26, 2001) (rejecting a “top” confidentiality protective order tier that
`would exclude in-house counsel, noting that “in-house counsel should not be denied access to
`confidential information produced under the terms of an appropriate protective order”);
`Boehringer Ingelheim Pharm., Inc. v. Hereon Labs. Corp., 1990 WL 160666, at *2 (D. Del. Oct.
`12, 1990) (allowing in-house counsel access to confidential discovery material where individuals
`were “responsible for any major decisions concerning this lawsuit”).
`
`25859323.1
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`Case 1:18-cv-00924-CFC-SRF Document 477 Filed 01/13/20 Page 6 of 89 PageID #: 33723
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`YOUNG CONAWAY STARGATT &
`TAYLOR, LLP
`
`SMITH, KATZENSTEIN & JENKINS LLP
`
`/s/ Melanie K. Sharp
`
`/s/ Neal C. Belgam
`
`Melanie K. Sharp (No. 2501)
`James L. Higgins (No. 5021)
`1000 North King Street
`Wilmington, DE 19801
`(302)571-6600
`msharp@ycst.com
`ihiggins@ycst.com
`
`Attorneys for Amgen Inc.
`
`Dated: January 13, 2020
`
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`Jennifer M. Rutter (No. 6200)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skj law.com
`eormerod@skj law.com
`irutter@skjlaw.com
`
`Attorneys for Amgen Inc.
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`25859323.1
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`5
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`Case 1:18-cv-00924-CFC-SRF Document 477 Filed 01/13/20 Page 7 of 89 PageID #: 33724
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
` C. A. No.: 17-1407-CFC-SRF
` (CONSOLIDATED)
`
`
`
`
`
`
`C.A. No.: 18-924-CFC-SRF
`
`
` )
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`GENENTECH, INC. and CITY OF 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.,
`
` Plaintiffs,
`
`v.
`
`AMGEN INC.,
`
` Defendant.
`
`[PROPOSED] ORDER
`
`AND NOW, this ______ day of ___________, 2020, having considered Amgen’s
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`Motion to Compel filed on January 13, 2020 (“Motion”), along with any responses thereto and
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`any oral argument thereon;
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`IT IS HEREBY ORDERED that Amgen’s Motion is GRANTED. Within seven days
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`from the date of this Order, Genentech shall produce unredacted copies of its settlement
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`agreements and/or licenses to the patents-in-suit entered into with third parties Pfizer, Inc.,
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`Mylan Pharmaceuticals Inc., Teva Pharmaceutical Industries Ltd., and/or Celltrion, Inc. in
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`accordance with the Stipulated Protective Orders in the above-captioned litigations.
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`25859369.1
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`United States Magistrate Judge
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`Case 1:18-cv-00924-CFC-SRF Document 477 Filed 01/13/20 Page 8 of 89 PageID #: 33725
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`Exhibits 1 – 5
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`Redacted in their Entirety
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`Case 1:18—cv-00924-CFC-SRF Document 477 Filed 01/13/20 Page 9 of 89 PageID #: 33726
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`EXHIBIT 6
`EXHIBIT 6
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`Case 1:18-cv-00924-CFC-SRF Document 477 Filed 01/13/20 Page 10 of 89 PageID #: 33727
`EFiled: Jun 19 2015 04:46PM EDT
`GRANTED
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`Transaction ID 57434936
`Case No. 10667-VCL
`IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE
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`PFIZER INC.,
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`C.A. No. 10667-VCP
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`AMGEN FREMONT INC. (f/k/a Abgenix, Inc.)
`and AMGEN INC.,
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`
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`v.
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`Plaintiff,
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`Defendants.
`
`
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`[PROPOSED] ORDER GOVERNING THE
`PRODUCTION AND EXCHANGE OF CONFIDENTIAL
`AND HIGHLY CONFIDENTIAL INFORMATION
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`WHEREAS, the parties to the above-captioned action (the “Litigation”) are
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`engaged in discovery proceedings, which include, among other things, taking
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`depositions and producing documents; and
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`WHEREAS, those discovery proceedings will necessarily involve the
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`production of certain information that the parties to the Litigation (the “Parties,”
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`each a “Party”) believe to be confidential and sensitive commercial, financial, or
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`business information;
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`This Order Governing the Production and Exchange of Confidential and
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`Highly Confidential Information (the “Confidentiality Order”) will govern the
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`handling of documents, deposition testimony, deposition exhibits, deposition
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`transcripts, written discovery requests, interrogatory responses, responses to
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`requests to admit, and responses to requests for documents, and any other
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`{A&B-00343659}
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`information or material produced, given or exchanged, including any information
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`contained therein or derived therefrom (“Discovery Material”) by or among any
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`Party or non-Party providing Discovery Material (each a “Producing Party”) in this
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`Litigation.
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`1.
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`Any Producing Party may designate any Discovery Material as
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`“Confidential” under the terms of this Confidentiality Order if such party
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`reasonably believes in good faith that such Discovery Material contains non-
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`public, confidential, proprietary, or commercially sensitive information that
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`requires the protections provided in this Confidentiality Order (“Confidential
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`Discovery Material”). Any Producing Party may designate any Discovery Material
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`as “Highly Confidential” under the terms of this Confidentiality Order if such party
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`reasonably believes in good faith that disclosure of the Discovery Material other
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`than as permitted pursuant to Paragraph 6 of this Confidentiality Order is
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`substantially likely to cause injury to the Producing Party (“Highly Confidential
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`Discovery Material”).
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`2.
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`The designation of Discovery Material as Confidential Discovery
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`Material or Highly Confidential Discovery Material shall be made in the following
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`manner:
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`A.
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`In the case of documents or other materials (apart from
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`depositions or other pre-trial testimony): (i) by affixing the legend “Confidential”
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`or “Highly Confidential” to each page containing any Confidential Discovery
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`Material or Highly Confidential Discovery Material; or (ii) in the case of
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`electronically stored information produced in native format, by including
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`“Confidential” or “Highly Confidential” in the file or directory name, or by
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`affixing the legend “Confidential” or “Highly Confidential” to the media
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`containing the Discovery Material (e.g., CD-ROM, floppy disk, DVD).
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`B.
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`In the case of depositions or other pre-trial testimony: (i) by a
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`statement on the record, by counsel, at the time of such disclosure or before the
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`conclusion of the deposition or testimony; or (ii) by written notice, sent to all
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`Parties within 10 business days of the deposition or other pre-trial testimony;
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`provided that only those portions of the transcript designated as Confidential
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`Discovery Material or Highly Confidential Discovery Material shall be deemed
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`Confidential Discovery Material or Highly Confidential Discovery Material. The
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`Parties may modify this procedure for any particular deposition or other pre-trial
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`testimony, through agreement on the record at such deposition or testimony,
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`without further order of the Court.
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`C.
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`Information revealed by inspection of things and premises
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`under Court of Chancery Rule 34 shall be treated as though it were designated
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`Highly Confidential provided that, prior to or at any time up to 30 days after the
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`inspection, the Party permitting inspection specifically identifies in writing which
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`3
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`of the Discovery Material that will be or that was disclosed by the inspection is to
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`be designated as Confidential or Highly Confidential. There will be no waiver of
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`confidentiality, or any privilege or immunity, by the inspection of Discovery
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`Material before it is copied and marked pursuant to this Confidentiality Order.
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`Inspection of Discovery Material by any Party shall be conducted by persons
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`eligible under Paragraph 6.
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`D.
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`In the case of any other Discovery Material, by written notice
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`that the Discovery Material constitutes Confidential Discovery Material or Highly
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`Confidential Discovery Material.
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`3.
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`The Parties agree that in order to produce and review Discovery
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`Material as quickly and efficiently as possible in light of the expedited schedule for
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`completion of document production, fact discovery, and expert discovery, the
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`Parties will always initially designate Discovery Material produced to another
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`Party as Highly Confidential.
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`A.
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`If a Receiving Party, after reviewing Discovery Material
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`produced by a Producing Party, believes in good faith that certain documents or
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`categories of documents initially designated as Highly Confidential should be
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`designated as Confidential or should have no confidentiality designation at all (the
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`“Re-Designation”), the Parties shall meet and confer to discuss the requested Re-
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`Designation.
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`B.
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`If the Parties agree upon a confidentiality Re-Designation, the
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`Producing Party shall confirm in writing the documents subject to such Re-
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`Designation and whether going forward such documents shall be treated as
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`Confidential or as lacking any confidentiality designation at all.
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`C.
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`In the event the Parties are unable to resolve any dispute
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`regarding a requested Re-Designation of Discovery Material, any request for
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`judicial intervention shall be governed by Paragraph 15.
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`4.
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`Inadvertent failure to designate Discovery Material as Confidential
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`Discovery Material or Highly Confidential Discovery Material shall not constitute
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`a waiver of such claim and may be corrected. A Producing Party may designate as
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`Confidential or Highly Confidential any Discovery Material that has already been
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`produced, including Discovery Material that the Producing Party inadvertently
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`failed to designate as Confidential or Highly Confidential, (i) by notifying in
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`writing the Party to whom the production has been made that the Discovery
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`Material constitutes Confidential Discovery Material or Highly Confidential
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`Discovery Material, or (ii) in a manner consistent with Paragraph 2. Upon
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`receiving such supplemental notice, the Parties shall thereafter mark and treat the
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`Discovery Material so designated as Confidential Discovery Material or Highly
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`Confidential Discovery Material, and such Discovery Material shall be fully
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`subject to this Confidentiality Order from the date of such supplemental notice
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`5
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`forward. The Party receiving such notice shall make a reasonable, good-faith
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`effort to ensure that any analyses, memoranda, notes, or other such materials
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`generated based upon such newly designated information are immediately treated
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`as containing Confidential Discovery Material or Highly Confidential Discovery
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`Material. In addition, upon receiving such supplemental written notice, any
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`receiving Party that disclosed the Discovery Material prior to its designation as
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`“Confidential” or “Highly Confidential” shall exercise its best efforts (i) to ensure
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`the return or destruction of such Discovery Material, (ii) to ensure that any
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`documents or other materials derived from such Discovery Material are treated as
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`if the Discovery Material had been designated as “Confidential” or “Highly
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`Confidential” when originally produced, (iii) to ensure that such Discovery
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`Material is not further disclosed except in accordance with the terms of this
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`Confidentiality Order, and (iv) to ensure that any such Discovery Material, and any
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`information derived therefrom, is used solely for the purposes described in
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`Paragraph 8 of this Confidentiality Order.
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`5.
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`Confidential Discovery Material may be disclosed, summarized,
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`described, characterized, or otherwise communicated or made available in whole
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`or in part only to the following persons for use in accordance with this
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`Confidentiality Order:
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`6
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`A.
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`The Parties and the directors, officers, employees, partners, and
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`management personnel and/or advisors of the Parties, or any subsidiary or affiliate
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`thereof, who are assisting with or making decisions concerning the Litigation, to
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`the extent deemed reasonably necessary by counsel of record for the purpose of
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`assisting in the prosecution or defense of the Litigation;
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`B.
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`Counsel who represent Parties in this Litigation (including in-
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`house counsel), and the partners, associates, paralegals, secretaries, clerical, regular
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`and temporary employees, and service vendors of such counsel (including outside
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`copying and litigation support services) who are assisting with the Litigation;
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`C.
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`Subject to Paragraph 7(B), experts, consultants, analysts,
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`scientific advisors, and patent agents assisting counsel for the Parties, including, as
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`needed, any additional individuals requested to assist them in such work;
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`D.
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`Subject to Paragraphs 7(C), 7(D), and 9, witnesses or
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`deponents, and their counsel, only to the extent necessary to conduct or prepare for
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`depositions or testimony in this Litigation;
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`E. Any person
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`indicated on
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`the face of a document or
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`accompanying covering letter, email, or other communication to be the author,
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`addressee, or an actual or intended recipient of the document, or, in the case of
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`meeting minutes and presentations, an attendee of the meeting;
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`7
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`F.
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`The Court, persons employed by the Court, interpreters, and
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`court reporters transcribing any hearing, trial, or deposition in this Litigation or any
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`appeal therefrom; and
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`G. Any other person only upon (i) order of the Court entered upon
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`notice to the Parties, or (ii) written stipulation of, or statement on the record by, the
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`Producing Party who provided the Discovery Material being disclosed, provided
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`that such person signs an undertaking in the form attached as Exhibit A hereto.
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`6.
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`Highly Confidential Discovery Material may be disclosed,
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`summarized, described, characterized, or otherwise communicated or made
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`available in whole or in part only to the following persons for use in accordance
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`with this Confidentiality Order:
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`A. Outside Counsel who represent Parties in this Litigation, and
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`the partners, associates, paralegals, secretaries, clerical, regular and temporary
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`employees, and service vendors of such Outside Counsel (including outside
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`copying and litigation support services – whether or not engaged directly by such
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`Outside Counsel) who are assisting with the Litigation, provided such Outside
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`Counsel have no current responsibilities relating to the Prosecution of any patent
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`application claiming priority to U.S. provisional patent application serial number
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`60/259,927 (the “’927 Provisional Application”);
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`8
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`B. Up to five in-house counsel from each side (“Designated In-
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`house Counsel”), and up to four additional in-house legal support personnel,
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`(“Designated In-house Support Staff”), who because of their duties and
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`responsibilities, require access to Highly Confidential Discovery Material;
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`(i) Designated In-house Counsel and Designated In-house
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`Support Staff may not include any individual who has, or will have during the
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`duration of this Litigation, the following responsibilities: (a) drafting claims
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`(including amending claims) in the Prosecution of any patent application claiming
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`priority to the ’927 Provisional Application and/or utility patent application serial
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`number 10/038,591 (the “’591 Application”), as well as any other application
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`representing the sequences disclosed in the ’927 Provisional Application and/or the
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`’591 Application as corresponding to antibody “6.1.1,” including applications
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`directed to formulation, use, or manufacturing; (b) the preparation of regulatory
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`submissions to the Food & Drug Administration (“FDA”) or participation in FDA
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`regulatory proceedings, if those submissions represent the sequences disclosed in
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`the ’927 Provisional Application and/or the ’591 Application as corresponding to
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`antibody “6.1.1”; and/or (c) any marketing, financial, or other business competitive
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`decision-making (not including decision-making as an attorney in the litigation) for
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`released products or potential future products that represent the sequences
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`9
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`disclosed in the ’927 Provisional Application and/or the ’591 Application as
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`corresponding to antibody “6.1.1.”
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`(ii) During the pendency of this Litigation, a Party that seeks
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`to designate a Designated Inside Counsel or Designated In-house Support Staff or
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`to designate a replacement Designated Inside Counsel or Designated In-house
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`Support Staff with a new designee, must first obtain an undertaking in the form
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`attac