`Friday, May 3, 2024 10:01 AM
`Laura Fairneny; Hillier, Drew Alan
`QE - Samsung Bioepis; MYL_REG_IPR; 'Lora Green'; 'Franklin Chu';
`'rcerwinski@geminilaw.com'; 'azalcenstein@geminilaw.com';
`'bmorris@geminilaw.com'; Brausa, Adam R.; Durie, Daralyn J.; Davis, Kira A; Weires,
`Rebecca; Regeneron-MoFo-IPR; Wilk, Matthew M.; Cobb, Jeremy; Caine, David A.
`RE: IPR2023-00884: Additional Discovery
`
`[EXTERNAL EMAIL from nmclaughlin@rmmslegal.com]
`
`From:
`Sent:
`To:
`Cc:
`
`Subject:
`
`To
`help
`prot
`ect
`your
`priva
`cy,
`
`Counsel:
`
`Mylan and Biocon have no objection to the production of the requested materials set forth in Samsung’s April 16 email.
`
`Regards,
`Neil
`
`| P A R T N E R
`N E I L B . M C L A U G H L I N P H . D .
`N M C L A U G H L I N @ R M M S L E G A L . C O M
`D I R E C T | 3 1 2 . 2 2 2 . 7 2 4 1
`O F F I C E | 3 1 2 . 5 2 7 . 2 1 5 7
`
`S I X W E S T H U B B A R D S T R E E T | C H I C A G O I L 6 0 6 5 4
`W W W . R M M S L E G A L . C O M
`
`This email message and any attachments are being sent by Rakoczy Molino Mazzochi
`Siwik LLP, are confidential, and may be privileged. If you are not the intended recipient,
`please notify us immediately by replying to this message, and destroy all copies of this
`message and any attachments. Thank you.
`From: Neil B. McLaughlin
`Sent: Thursday, May 2, 2024 1:31 PM
`To: Laura Fairneny <laurafairneny@quinnemanuel.com>; Hillier, Drew Alan <DHillier@mofo.com>
`Cc: QE - Samsung Bioepis <qe-samsungbioepis@quinnemanuel.com>; MYL_REG_IPR <MYL_REG_IPR@rmmslegal.com>;
`'Lora Green' <lgreen@geminilaw.com>; 'Franklin Chu' <fchu@geminilaw.com>; 'rcerwinski@geminilaw.com'
`1
`
`Samsung Bioepis Exhibit 1069
`Page 1
`
`
`
`<rcerwinski@geminilaw.com>; 'azalcenstein@geminilaw.com' <azalcenstein@geminilaw.com>;
`'bmorris@geminilaw.com' <bmorris@geminilaw.com>; Brausa, Adam R. <ABrausa@mofo.com>; Durie, Daralyn J.
`<DDurie@mofo.com>; Davis, Kira A <KiraDavis@mofo.com>; Weires, Rebecca <RWeires@mofo.com>; Regeneron-
`MoFo-IPR <Regeneron-MoFo-IPR@mofo.com>; Wilk, Matthew M. <Matthew.Wilk@arnoldporter.com>; Cobb, Jeremy
`<Jeremy.Cobb@arnoldporter.com>; Caine, David A. <David.Caine@arnoldporter.com>
`Subject: RE: IPR2023-00884: Additional Discovery
`
`Counsel:
`
`Mylan is taking this request under advisement. Initially, based on the general descriptions provided, we do not believe
`that they contain any information designated confidential by Mylan. However, we have undertaken a review of those
`materials in order to confirm and will not be able to provide confirmation until that review is complete. Given the
`number of documents, and the length of many of the documents, we will need at least another day before we can
`provide that confirmation.
`
`Thank you for your patience.
`
`Regards,
`Neil
`
`| P A R T N E R
`N E I L B . M C L A U G H L I N P H . D .
`N M C L A U G H L I N @ R M M S L E G A L . C O M
`D I R E C T | 3 1 2 . 2 2 2 . 7 2 4 1
`O F F I C E | 3 1 2 . 5 2 7 . 2 1 5 7
`
`S I X W E S T H U B B A R D S T R E E T | C H I C A G O I L 6 0 6 5 4
`W W W . R M M S L E G A L . C O M
`
`This email message and any attachments are being sent by Rakoczy Molino Mazzochi
`Siwik LLP, are confidential, and may be privileged. If you are not the intended recipient,
`please notify us immediately by replying to this message, and destroy all copies of this
`message and any attachments. Thank you.
`From: Laura Fairneny <laurafairneny@quinnemanuel.com>
`Sent: Wednesday, May 1, 2024 8:15 PM
`To: Hillier, Drew Alan <DHillier@mofo.com>
`Cc: QE - Samsung Bioepis <qe-samsungbioepis@quinnemanuel.com>; MYL_REG_IPR <MYL_REG_IPR@rmmslegal.com>;
`'Lora Green' <lgreen@geminilaw.com>; 'Franklin Chu' <fchu@geminilaw.com>; 'rcerwinski@geminilaw.com'
`<rcerwinski@geminilaw.com>; 'azalcenstein@geminilaw.com' <azalcenstein@geminilaw.com>;
`'bmorris@geminilaw.com' <bmorris@geminilaw.com>; Brausa, Adam R. <ABrausa@mofo.com>; Durie, Daralyn J.
`<DDurie@mofo.com>; Davis, Kira A <KiraDavis@mofo.com>; Weires, Rebecca <RWeires@mofo.com>; Regeneron-
`MoFo-IPR <Regeneron-MoFo-IPR@mofo.com>; Wilk, Matthew M. <Matthew.Wilk@arnoldporter.com>; Cobb, Jeremy
`<Jeremy.Cobb@arnoldporter.com>; Caine, David A. <David.Caine@arnoldporter.com>
`Subject: RE: IPR2023-00884: Additional Discovery
`
`2
`
`Samsung Bioepis Exhibit 1069
`Page 2
`
`
`
`Mylan counsel,
`
`Per the below, Regeneron informed us on a meet and confer today that they will not produce any of the documents
`requested in my April 16 email below until Mylan confirms that there is no objection based on Mylan confidentiality
`issues. Although we do not understand how any of the requested information could possibly include Mylan confidential
`information, can you please confirm you have no objection?
`
`Regards,
`Laura
`
`From: Laura Fairneny <laurafairneny@quinnemanuel.com>
`Sent: Wednesday, May 1, 2024 9:13 PM
`To: Hillier, Drew Alan <DHillier@mofo.com>
`Cc: QE - Samsung Bioepis <qe-samsungbioepis@quinnemanuel.com>; 'MYL_REG_IPR@rmmslegal.com'
`<MYL_REG_IPR@rmmslegal.com>; 'Lora Green' <lgreen@geminilaw.com>; 'Franklin Chu' <fchu@geminilaw.com>;
`'rcerwinski@geminilaw.com' <rcerwinski@geminilaw.com>; 'azalcenstein@geminilaw.com'
`<azalcenstein@geminilaw.com>; 'bmorris@geminilaw.com' <bmorris@geminilaw.com>; Brausa, Adam R.
`<ABrausa@mofo.com>; Durie, Daralyn J. <DDurie@mofo.com>; Davis, Kira A <KiraDavis@mofo.com>; Weires, Rebecca
`<RWeires@mofo.com>; Regeneron-MoFo-IPR <Regeneron-MoFo-IPR@mofo.com>; Wilk, Matthew M.
`<Matthew.Wilk@arnoldporter.com>; Cobb, Jeremy <Jeremy.Cobb@arnoldporter.com>; Caine, David A.
`<David.Caine@arnoldporter.com>
`Subject: RE: IPR2023-00884: Additional Discovery
`
`Drew,
`
`I appreciate the meet and confer earlier today and write to respond to the requests you made during our discussion.
`
`First, we will confirm with Mylan that it does not object to the requested production. As explained on the call, we do
`not understand why this step is necessary given that the requested materials relate to Regeneron’s fact witnesses and
`documents, but we will nevertheless make this request of Mylan in the interest of reaching agreement on these issues.
`
`Second, SB agrees not to seek any additional deposition of Dr. Yancopoulos or Ms. Chu based on the production of the
`additional discovery assuming Regeneron does not submit any further declaration from these witnesses.
`
`Third, SB agrees that documents produced on an Outside Counsel’s Eyes Only basis in the Mylan Litigation can be
`designated as Outside Counsel Eye’s Only in this IPR.
`
`Finally, we do not agree to allow Regeneron to redact the requested materials for relevance before production. As
`explained on the call, it’s not clear how Regeneron would be able to determine what is relevant versus what is not, and
`performing the redactions only requires more burden and delay in producing the materials.
`
`As discussed on the call, we need to resolve whether the parties can reach an agreement or are at an impasse by
`tomorrow. Please let me know your availability to meet and confer between 11:00 am to 5:00 pm ET.
`
`Regards,
`Laura
`
`From: Hillier, Drew Alan <DHillier@mofo.com>
`Sent: Tuesday, April 30, 2024 11:12 AM
`To: Laura Fairneny <laurafairneny@quinnemanuel.com>
`Cc: QE - Samsung Bioepis <qe-samsungbioepis@quinnemanuel.com>; 'MYL_REG_IPR@rmmslegal.com'
`3
`
`Samsung Bioepis Exhibit 1069
`Page 3
`
`
`
`<MYL_REG_IPR@rmmslegal.com>; 'Lora Green' <lgreen@geminilaw.com>; 'Franklin Chu' <fchu@geminilaw.com>;
`'rcerwinski@geminilaw.com' <rcerwinski@geminilaw.com>; 'azalcenstein@geminilaw.com'
`<azalcenstein@geminilaw.com>; 'bmorris@geminilaw.com' <bmorris@geminilaw.com>; Brausa, Adam R.
`<ABrausa@mofo.com>; Durie, Daralyn J. <DDurie@mofo.com>; Davis, Kira A <KiraDavis@mofo.com>; Weires, Rebecca
`<RWeires@mofo.com>; Regeneron-MoFo-IPR <Regeneron-MoFo-IPR@mofo.com>; Wilk, Matthew M.
`<Matthew.Wilk@arnoldporter.com>; Cobb, Jeremy <Jeremy.Cobb@arnoldporter.com>; Caine, David A.
`<David.Caine@arnoldporter.com>
`Subject: RE: IPR2023-00884: Additional Discovery
`
`[EXTERNAL EMAIL from dhillier@mofo.com]
`
`Laura,
`
`Thank you for the email. Before we have a call, as previously requested, please identify the specific transcript testimony
`that Samsung believes justifies this discovery request and explain the alleged relevance of the exhibits. We need this
`information so that we have a meaningful call. We are available May 1 or May 2 at 2:00 p.m. PT.
`
`Samsung was undoubtedly aware of the requested documents before the depositions in this proceeding of Dr.
`Yancopoulos and Ms. Chu. The subject of Dr. Yancopoulos’s and Ms. Chu’s testimony was also apparent in their
`declarations which were filed some time ago. If Samsung wanted to examine whether past statements were consistent,
`Samsung should have asked the witnesses about those statements at their depositions. Therefore, it is not clear to us
`why Samsung waited until after the depositions to request these materials.
`
`We will serve a higher-resolution printout of the PowerPoint presentation previously filed as Ex. 2007and a version of Ex.
`2011 without a trial exhibit stamp that had obscured some text on the cover page.
`
`Best,
`
`Drew
`
`Drew Alan Hillier
`Associate
`DHillier@mofo.com
`T +1 (858) 314-7711
`M +1 (858) 252-5131
`
`From: Laura Fairneny <laurafairneny@quinnemanuel.com>
`Sent: Friday, April 26, 2024 2:02 PM
`To: Hillier, Drew Alan <DHillier@mofo.com>
`Cc: QE - Samsung Bioepis <qe-samsungbioepis@quinnemanuel.com>; 'MYL_REG_IPR@rmmslegal.com'
`<MYL_REG_IPR@rmmslegal.com>; 'Lora Green' <lgreen@geminilaw.com>; 'Franklin Chu' <fchu@geminilaw.com>;
`'rcerwinski@geminilaw.com' <rcerwinski@geminilaw.com>; 'azalcenstein@geminilaw.com'
`<azalcenstein@geminilaw.com>; 'bmorris@geminilaw.com' <bmorris@geminilaw.com>; Brausa, Adam R.
`<ABrausa@mofo.com>; Durie, Daralyn J. <DDurie@mofo.com>; Davis, Kira A <KiraDavis@mofo.com>; Weires, Rebecca
`<RWeires@mofo.com>; Regeneron-MoFo-IPR <Regeneron-MoFo-IPR@mofo.com>; Wilk, Matthew M.
`<Matthew.Wilk@arnoldporter.com>; Cobb, Jeremy <Jeremy.Cobb@arnoldporter.com>; Caine, David A.
`<David.Caine@arnoldporter.com>
`Subject: RE: IPR2023-00884: Additional Discovery
`
`4
`
`Samsung Bioepis Exhibit 1069
`Page 4
`
`
`
`External Email
`
`Drew,
`
`Upon review of the trial transcript in the Mylan Litigation and the available deposition designations at that same trial
`from Ms. Chu, it appears that Dr. Yancopoulos and Ms. Chu provided testimony in the Mylan Litigation on subject matter
`that is substantially similar to their depositions in this IPR. SB should be allowed to examine Dr. Yancopoulos’s and Ms.
`Chu’s prior testimony in the Mylan Litigation for consistency with their IPR declarations and testimony. The exhibits
`cited in that prior testimony are necessary for us to fully evaluate and effectively use any statements therein.
`
`As to Exhibits 2007 and 2011, at his deposition, Dr. Yancopoulos testified that there appeared to be information missing
`or obscured in both exhibits. See Yancopoulos Dep. Tr. at 16:13-17:3, 227:23-228:10.
`
`We are available to meet and confer on Monday from 2-5pm ET or on Tuesday from 10am-2pm ET.
`
`Regards,
`Laura
`
`From: Hillier, Drew Alan <DHillier@mofo.com>
`Sent: Thursday, April 25, 2024 5:01 PM
`To: Laura Fairneny <laurafairneny@quinnemanuel.com>
`Cc: QE - Samsung Bioepis <qe-samsungbioepis@quinnemanuel.com>; 'MYL_REG_IPR@rmmslegal.com'
`<MYL_REG_IPR@rmmslegal.com>; 'Lora Green' <lgreen@geminilaw.com>; 'Franklin Chu' <fchu@geminilaw.com>;
`'rcerwinski@geminilaw.com' <rcerwinski@geminilaw.com>; 'azalcenstein@geminilaw.com'
`<azalcenstein@geminilaw.com>; 'bmorris@geminilaw.com' <bmorris@geminilaw.com>; Brausa, Adam R.
`<ABrausa@mofo.com>; Durie, Daralyn J. <DDurie@mofo.com>; Davis, Kira A <KiraDavis@mofo.com>; Weires, Rebecca
`<RWeires@mofo.com>; Regeneron-MoFo-IPR <Regeneron-MoFo-IPR@mofo.com>; Wilk, Matthew M.
`<Matthew.Wilk@arnoldporter.com>; Cobb, Jeremy <Jeremy.Cobb@arnoldporter.com>; Caine, David A.
`<David.Caine@arnoldporter.com>
`Subject: RE: IPR2023-00884: Additional Discovery
`
`[EXTERNAL EMAIL from dhillier@mofo.com]
`
`Laura,
`
`We are looking into providing higher-resolution copies of Exhibits 2007 and 2011, although we are not aware of any
`“missing” information.
`
`Regarding “the collaboration agreement between Bayer and Regeneron,” we believe copies are equally available to
`Samsung at SEC.gov.
`
`Regeneron would like to meet and confer to understand the remainder of Samsung’s request. Before we schedule a
`call, please identify the specific testimony in the depositions of Karen Chu and George Yancopoulos on which Samsung is
`relying to attempt to justify the additional discovery. For each requested exhibit, please explain the alleged relevance so
`that we can have a meaningful meet and confer.
`
`5
`
`Samsung Bioepis Exhibit 1069
`Page 5
`
`
`
`Sincerely,
`
`Drew
`
`Drew Alan Hillier
`Associate
`DHillier@mofo.com
`T +1 (858) 314-7711
`M +1 (858) 252-5131
`
`From: Laura Fairneny <laurafairneny@quinnemanuel.com>
`Sent: Tuesday, April 16, 2024 1:41 PM
`To: Brausa, Adam R. <ABrausa@mofo.com>; Durie, Daralyn J. <DDurie@mofo.com>; Davis, Kira A
`<KiraDavis@mofo.com>; Weires, Rebecca <RWeires@mofo.com>; Regeneron-MoFo-IPR <Regeneron-MoFo-
`IPR@mofo.com>; Wilk, Matthew M. <Matthew.Wilk@arnoldporter.com>; Cobb, Jeremy
`<Jeremy.Cobb@arnoldporter.com>; Caine, David A. <David.Caine@arnoldporter.com>
`Cc: QE - Samsung Bioepis <qe-samsungbioepis@quinnemanuel.com>; 'MYL_REG_IPR@rmmslegal.com'
`<MYL_REG_IPR@rmmslegal.com>; 'Lora Green' <lgreen@geminilaw.com>; 'Franklin Chu' <fchu@geminilaw.com>;
`'rcerwinski@geminilaw.com' <rcerwinski@geminilaw.com>; 'azalcenstein@geminilaw.com'
`<azalcenstein@geminilaw.com>; 'bmorris@geminilaw.com' <bmorris@geminilaw.com>
`Subject: IPR2023-00884: Additional Discovery
`
`External Email
`
`Counsel,
`
`Based on the recent depositions of Karen Chu and George Yancopoulos in this proceeding, Petitioner requests
`the following limited additional discovery pursuant to 37 C.F.R. § 42.51(b)(2):
`
`1. The deposition transcript of Karen Chu from Regeneron Pharmaceuticals, Inc. v. Mylan
`Pharmaceuticals, Inc., Case No. 22-cv-61-TSK (N.D.W. Va.) (“Mylan Litigation”) and all exhibits
`thereto;
`2. The deposition transcript of George Yancopoulos from the Mylan Litigation and all exhibits thereto;
`3. The trial exhibits from the Mylan Litigation cited in the trial testimony of Karen Chu and/or George
`Yancopoulos, including: PTX 0001, PTX 0003, PTX 0080, PTX 0188, PTX 0304, PTX 0311, PTX
`0491, PTX 0686, PTX 0932, PTX 1028C, PTX 1170, PTX 3131, PTX 3133, PTX 3150, PTX 3151,
`PTX 3167, PTX 3168, PTX 3187, PTX 3188, PTX 3216, PTX 3332, PTX 3333, PDX 1-1, PDX 1-2,
`PDX 3.001, PDX 3.002, PDX 3.004, PDX 3-0311-B, PDX 932-C, DTX 0019, DTX 0212, DTX 0216,
`DTX 0227, DTX 0228, DTX 0902, DTX 0913, DTX 0915, DTX 0916, DTX 2053, DTX 2053A, DTX
`2730, DTX 2745, DTX 3196, DTX 4070, DTX 4957, DTX 5073, DTX 5082, DTX 5385, DTX 7001,
`DTX 7212, DTX 7272, DTX 8127, DTX 8180, DTX 8190, DTX 9002, DTX 9003, DTX 9005, DTX
`9006;
`
`6
`
`Samsung Bioepis Exhibit 1069
`Page 6
`
`
`
`4. The following trial exhibits from the Mylan Litigation cited in the Court’s Memorandum Opinion and
`Order Following Bench Trial (ECF No. 692 in the Mylan Litigation): DTX 0213, DTX 0220, DTX
`0222, DTX 0226, DTX 0229, DTX 0230, DTX 0232, DTX 0234;
`5. The collaboration agreement between Bayer and Regeneron, and any amendments thereto; and
`6. Corrected copies of Exs. 2007 and 2011 that includes missing text and figures (see, e.g., Ex. 2007 at pp.
`39, 48 and Ex. 2011 at p. 1).
`
`Please let us know if Patent Owner agrees to make this limited production of requested documents.
`
`Regards,
`
`Laura Fairneny
`Partner
`quinn emanuel urquhart & sullivan, llp
`
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`212.849.7333 Direct
`212.849.7000 Main Office Number
`212.849.7100 FAX
`laurafairneny@quinnemanuel.com
`www.quinnemanuel.com
`
`NOTICE: The information contained in this e-mail message is intended only for the personal and confidential use of the recipient(s) named above. This message
`may be an attorney-client communication and/or work product and as such is privileged and confidential. If the reader of this message is not the intended
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`7
`
`Samsung Bioepis Exhibit 1069
`Page 7
`
`