IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
`BAUSCH HEALTH IRELAND LIMITED
`and SALIX PHARMACEUTICALS, INC.,
`
`Plaintiffs,
`
`v.
`
`Civil Action No. 1:22-cv-00020 (Kleeh)
`
`MYLAN LABORATORIES LTD.; AGILA
`SPECIALTIES INC.; MYLAN API US LLC;
`MYLAN INC.; VIATRIS INC.; and MYLAN
`PHARMACEUTICALS INC.,
`
`Defendants.
`
`DEFENDANT MYLAN PHARMACEUTICALS INC.’S FIRST SET OF
`REQUESTS FOR PRODUCTION TO PLAINTIFFS (Nos. 1-132)
`
`Pursuant to Rules 26 and 34 of the Federal Rules of Civil Procedure, Defendant Mylan
`
`Pharmaceuticals Inc. (“MPI” or “Defendant”) requests that Plaintiffs Bausch Health Ireland
`
`Limited (“Bausch”) and Salix Pharmaceuticals, Inc. (“Salix”) (collectively “Plaintiffs”) serve
`
`written responses to the following Requests and produce the requested documents and other items
`
`within thirty (30) days of service, at the offices of Wilson Sonsini Goodrich & Rosati, Professional
`
`Corporation, 900 South Capital of Texas Highway, Las Cimas IV, Fifth Floor, Austin, TX 78746,
`
`or at such other location and time as the parties may agree, and permit the inspection and copying
`
`of the following documents and other tangible items that are in Ravgen’s possession, custody, or
`
`control. These Requests are continuing in nature and require supplemental production in
`
`accordance with the Federal Rules of Civil Procedure.
`
`Bausch Health Ireland Exhibit 2005, Page 1 of 28
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`

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`DEFINITIONS
`
`1.
`
`“Plaintiffs” and “You” means individually and collectively, Bausch Health Ireland
`
`Limited and Salix Pharmaceuticals, Inc. its officers, directors, current and former employees,
`
`counsel, agents, consultants, representatives, and any other Persons acting on behalf of any of the
`
`foregoing, including affiliates, parents, divisions, joint ventures, licensees, franchisees, assignees,
`
`predecessors and successors in interest, and any other legal entities, whether foreign or domestic,
`
`that are owned or controlled by Bausch and/or Salix, any entity owned in whole or in part by,
`
`affiliated with, or controlled in whole or in part by Bausch and/or Salix, and entities acquired
`
`through merger or acquisition.
`
`2.
`
`“Defendant” means Mylan Pharmaceuticals Inc., and its officers, directors,
`
`employees, agents, attorneys, parents, subsidiaries, affiliated or predecessor corporations, and any
`
`other Person or entity acting on its behalf or subject to its control.
`
`3.
`
`“Synergy” means Synergy Pharmaceuticals Inc., and its officers, directors,
`
`employees, agents, attorneys, parents, subsidiaries, affiliated or predecessor corporations, and any
`
`other Person or entity acting on its behalf or subject to its control.
`
`4.
`
`“Callisto” means Callisto Pharmaceuticals Inc., and its officers, directors,
`
`employees, agents, attorneys, parents, subsidiaries, affiliated or predecessor corporations, and any
`
`other Person or entity acting on its behalf or subject to its control.
`
`5.
`
`“AmbioPharm” means AmbioPharm, Inc., and its officers, directors, employees,
`
`agents, attorneys, parents, subsidiaries, affiliated or predecessor corporations, and any other Person
`
`or entity acting on its behalf or subject to its control.
`
`
`
`2
`
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`6.
`
`The term “Patents-in-Suit” refers to: United States Patent Nos. 7,041,786 (“the ’786
`
`patent”), 9,610,321 (“the ’321 patent”), 9,616,097 (“the ’097 patent”), 9,919,024 (“the ’024
`
`patent”), 9,925,231 (“the ’231 patent”) and 10,011,637 (“the ’637 patent”).
`
`7.
`
`The terms “Related Patent Families” and “Related Patents” refer to the Patents-in-
`
`Suit and all underlying patents and patent applications, including published and unpublished
`
`applications, abandoned applications and patents, parents, continuations, continuations-in-part,
`
`divisionals, reissues, foreign counterparts, and any other patents or patent applications claiming
`
`priority or reciting a relation to the Patents-in-Suit, claiming priority to any application to which
`
`one or more of the Patents-in-Suit claims priority, or to which the Patents-in-Suit claim priority,
`
`whether directly or indirectly, or recite a relation.
`
`8.
`
`The term “MSN Litigation” refers to the matter, Bausch Health Ireland Limited
`
`and Salix Pharmaceuticals, Inc. v. MSN Private Ltd. and MSN Pharmaceuticals Inc., Case No.
`
`21-10057 (D. NJ) filed on April 22, 2021.
`
`9.
`
`The term “Shailubhai” means Kumwar Shailubhai, a named inventor of the
`
`’786,’097, ’024, ’231, and ’637 patents, as well as any of his employees, affiliates, attorneys, or
`
`agents.
`
`10.
`
`The term “Nikiforovich” means Gregory Nikiforovich, a named inventor of the
`
`’786 patent, as well as any of his employees, affiliates, attorneys, or agents.
`
`11.
`
`The term “Jacob” means Gary S. Jacob, a named inventor of the ’786 patent, as
`
`well as any of his employees, affiliates, attorneys, or agents.
`
`12.
`
`The term “Comiskey” means Stephen Comiskey, a named inventor of the ’321,
`
`’097, ’024, ’231, and ’637 patents, as well as any of his employees, affiliates, attorneys, or agents.
`
`
`
`3
`
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`13.
`
`The term “Feng” means Ron Feng, a named inventor of the ’321, ’097, ’024, ’231,
`
`and ’637 patents, as well as any of his employees, affiliates, attorneys, or agents.
`
`14.
`
`The term “Foss” means John Foss, a named inventor of the ’321, ’097, ’024, and
`
`’231 patents, as well as any of his employees, affiliates, attorneys, or agents.
`
`15.
`
`The term “Bai” means Juncai Bai, a named inventor of the ’637 patent, as well as
`
`any of his employees, affiliates, attorneys, or agents.
`
`16.
`
`The term “R. Zhang” means Ruoping Zhang, a named inventor of the ’637 patent,
`
`as well as any of his employees, affiliates, attorneys, or agents.
`
`17.
`
`The term “Jia” means Jun Jia, a named inventor of the ’637 patent, as well as any
`
`of his employees, affiliates, attorneys, or agents.
`
`18.
`
`The term “Zhou” means Junfeng Zhou, a named inventor of the ’637 patent, as well
`
`as any of his employees, affiliates, attorneys, or agents.
`
`19.
`
`The term “Zhao” means Qiao Zhao, a named inventor of the ’637 patent, as well as
`
`any of his employees, affiliates, attorneys, or agents.
`
`20.
`
`The term “G. Zhang” means Guoqing Zhang, a named inventor of the ’637 patent,
`
`as well as any of his employees, affiliates, attorneys, or agents.
`
`21.
`
`22.
`
`23.
`
`24.
`
`“FDA” means the United States Food & Drug Administration.
`
`“NDA” means New Drug Application.
`
`“IND Application” means Investigational New Drug Application.
`
`“Communication” means any transmission of information between two or more
`
`persons, including information transmitted by way of telephone conversations, letters, faxes,
`
`email, computer links, written memorandums or other documents, bulletin board posting, and face-
`
`to-face conversations.
`
`
`
`4
`
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`25.
`
`26.
`
`The term “USPTO” means the United States Patent and Trademark Office.
`
`The term “The Comiskey Declaration” refers to the declaration of Stephen
`
`Comiskey signed on February 18, 2015 and filed with the United States Patent Office under 37
`
`C.F.R. § 1.132 during the prosecution of United States Patent Application No. 13/421,769, which
`
`issued as U.S. Patent No. 9,616,097.
`
`27.
`
`The term "The Second Comiskey Declaration" refers to the declaration of Stephen
`
`Comiskey signed on September 06, 2016 and filed with the United States Patent Office under 37
`
`C.F.R. § 1.132 during the prosecution of United States Patent Application No. 14/845,644, which
`
`issued as U.S. Patent No. 9,610,321.
`
`28.
`
`The term “Avicel PH112” refers to a proprietary microcrystalline cellulose
`
`manufactured by Dupont and is an ingredient used in the studies that are the subject of both
`
`Comiskey Declarations identified as “a low-moisture carrier.”
`
`29.
`
`The term “Avicel PH102” refers to a proprietary microcrystalline cellulose
`
`manufactured by Dupont and is an ingredient used in the studies that are the subject of both
`
`Comiskey Declarations identified as “a regular grade carrier.”
`
`30.
`
`The term “Bai reference” refers to the International Application Published under
`
`the Patent Cooperation Treaty as WO 2012/118973 A2 on September 7, 2012, and any applications
`
`claiming priority to US Provisional Application No. 61/447,891.
`
`31.
`
`The term “Secondary Considerations” or “Objective Indicia” refers to secondary
`
`considerations of nonobviousness as the term is used in Graham v. John Deere Co., 338 U.S. 1,
`
`18 (1966), and subsequently developed cases.
`
`32.
`
`The terms “License” and “Licensee,” as used herein, shall include the meaning of
`
`sublicense and sublicensee, and any further subordinations thereto.
`
`
`
`5
`
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`33.
`
`“Document” shall include, without limitation, all written, graphic or otherwise
`
`recorded material, including without limitation, electronically stored information regardless of the
`
`form of storage medium, microfilms or other film records or impressions, tape recordings or
`
`computer cards, floppy disks or printouts, any and all papers, photographs, films, recordings,
`
`memoranda, books, records, accounts, Communications, letters, telegrams, correspondence, notes
`
`of meetings, notes of conversations, notes of telephone calls, inter-office memoranda or written
`
`Communications of any nature, recordings of conversations either in writings or upon any
`
`mechanical or electrical recording devices, notes, papers, reports, analyses, invoices, canceled
`
`checks or check stubs, receipts, minutes of meetings, time sheets, diaries, desk calendars, ledgers,
`
`schedules, Licenses, financial statements, telephone bills, and any differing versions of any of the
`
`foregoing, whether so denominated, formal, informal or otherwise, as well as copies of the
`
`foregoing which differ in any way, including by the addition of handwritten notations or other
`
`written or printed matter of any nature, from the original. The foregoing specifically includes
`
`information stored in a computer database and capable of being generated in documentary form.
`
`34.
`
`“Communication” means, without limitation, any transmission, conveyance or
`
`exchange of a word, statement, fact, thing, idea, Document, instruction, information, demand or
`
`question by any medium, whether by written, oral or other means.
`
`35.
`
`The term “Person” shall refer to any individual, corporation, proprietorship,
`
`association, joint venture, company, partnership or other business or legal entity, including
`
`governmental bodies and agencies.
`
`36.
`
`“Prior Art” means all things, patents, publications, disclosures, sales, or other acts
`
`or occurrences included within the broadest meaning of 35 U.S.C. § 102 (or any subpart thereof)
`
`and 35 U.S.C. § 103, and all things, patents, publications, disclosures, sales, or other acts or
`
`
`
`6
`
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`occurrences that any Person or entity has identified as “prior art” or relevant to the invalidity of
`
`the patent(s) identified in the relevant request.
`
`37.
`
`The terms “relate to,” “refer to,” “relating to,” and “referring to” mean relating to
`
`referring to, concerning, mentioning, reflecting, pertaining to, evidencing, involving, describing,
`
`discussing, commenting on, embodying, responding to, supporting, contradicting, or constituting
`
`(in whole or in part), as the context makes appropriate.
`
`38.
`
`The terms “include” and “including” mean include without limitation and including
`
`without limitation, respectively.
`
`39.
`
`40.
`
`Use of the singular also includes the plural and vice-versa.
`
`The words “or” and “and” shall be read in the conjunctive and in the disjunctive
`
`wherever they appear, and neither of these words shall be interpreted to limit the scope of these
`
`Interrogatories.
`
`41.
`
`The use of a verb in any tense shall be construed as the use of the verb in all other
`
`tenses.
`
`42.
`
`The term “identify” in relation to a Person means to state his or her full name and:
`
`(a) present business address(es), position and business affiliation, and business telephone number;
`
`or, if current information is not known, (b) the last known business and home addresses, position
`
`and business affiliation, and business telephone numbers. Once any Person has been identified
`
`properly, it shall be sufficient thereafter when identifying that same Person to state the name only.
`
`43.
`
`The term “identify” in relation to an entity means to state the entity’s: (a) full name;
`
`(b) state of incorporation or formation; (c) current or last known business address; and (d) current
`
`or last known telephone number. Once an entity has been identified properly, it shall be sufficient
`
`thereafter when identifying that same entity to state the name only.
`
`
`
`7
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`44.
`
`The term “identify” in relation to a Document means to state: (a) the date the
`
`Document was created; (b) the author of the Document; (c) the recipient of the Document; (d) any
`
`Person or entity receiving a copy of the Document by “cc,” “bcc,” or otherwise; (e) a basic
`
`description of the nature of the Document, including, if applicable; (f) the title of the Document;
`
`and (g) whether the Document has been or is being produced in this litigation, the dates or identifier
`
`number affixed to the Document. Documents to be “identified” include Documents in Plaintiffs’
`
`possession, custody, or control, Documents known by Plaintiffs to have existed but no longer exist,
`
`and other Documents of which Plaintiffs has knowledge or information.
`
`45.
`
`The term “identify” in relation to a Communication means: (a) to state the date of
`
`the Communication; (b) to identify all Documents relating to such Communications; (c) to describe
`
`the content and substance of the Communication; (d) to identify the Persons who received or were
`
`involved in the Communication; and (e) to identify the Person or Persons most knowledgeable
`
`about the Communication.
`
`INSTRUCTIONS
`
`The following instructions shall apply to each of the Document Requests herein:
`
`1.
`
`In answering the following Document Requests, furnish all available information,
`
`including information in the possession, custody, or control of any of Plaintiffs’ attorneys,
`
`directors, officers, agents, employees, representatives, associates, investigators, affiliates, owners,
`
`partnerships, parents or subsidiaries, and Persons under Plaintiffs’ control, who have the best
`
`knowledge, not merely information known to Plaintiffs based on Plaintiffs’ personal knowledge.
`
`If you cannot fully respond to the following Document Requests after exercising due diligence to
`
`secure the information requested thereby, so state, and specify the portion of each Document
`
`Requests that cannot be responded to fully and completely. In the latter event, state what efforts
`
`
`
`8
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`were made to obtain the requested information and the facts relied upon that support the contention
`
`that the Document Requests cannot be answered fully and completely; and state what knowledge,
`
`information or belief Plaintiffs has concerning the unanswered portion of any such Document
`
`Requests.
`
`2.
`
`Electronic records and computerized information must be produced in accordance
`
`with the formats governing the exchange of electronically stored information typically agreed to
`
`in ANDA litigation, otherwise agreed upon by the parties or ordered by the Court.
`
`3.
`
`If Plaintiffs’ response to a particular Document Request is a statement that Plaintiffs
`
`lacks the ability to comply fully and completely with that Document Request, Plaintiffs must
`
`answer each such Document Request to the fullest extent Plaintiffs deems possible; specify the
`
`portion of each Document Request that Plaintiffs claims to be unable to answer fully and
`
`completely; state the facts upon which Plaintiffs rely to support its contention that it is unable to
`
`answer the Document Request fully and completely; and state what knowledge, information, or
`
`belief Plaintiffs’ have concerning the unanswered portion of each such Document Request.
`
`4.
`
`Plaintiffs’ obligation to respond to these Document Requests is continuing and its
`
`responses are to be supplemented to include subsequently acquired information in accordance with
`
`the requirements of Rule 26(e) of the Federal Rules of Civil Procedure. If Plaintiffs subsequently
`
`obtain information that renders its answers to these Document Requests incomplete or inaccurate,
`
`Plaintiffs must amend its answers to make them complete and accurate.
`
`REQUESTS FOR PRODUCTION
`
`REQUEST NO. 1: A complete, unredacted copy of NDA 208745, including any
`
`supplements and correspondence with the FDA related to that application.
`
`
`
`9
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`REQUEST NO. 2:
`
` A complete, unredacted copy of any IND Applications in your
`
`possession that refer in any way to plecanatide.
`
`REQUEST NO. 3: A complete, unredacted copy of all non-privileged documents that
`
`are in Your possession or control that refer to, summarize, document, or include any
`
`communications between You and the FDA concerning NDA 208745, as well as any amendments
`
`or supplements to said NDA.
`
`REQUEST NO. 4: All non-privileged documents that relate to the Patents-in-Suit or
`
`Related Applications, including but not limited to, foreign search reports and testimony in
`
`litigations, disputes, oppositions, and related proceedings throughout the world involving
`
`plecanatide.
`
`REQUEST NO. 5: All agreements and draft agreements that relate to the manufacture,
`
`sale, marketing, or distribution in any way of any dosage form containing plecanatide, including
`
`all agreements and draft agreements between any entity (including but not limited to both corporate
`
`entities named as Plaintiffs in this case) concerning any product approved under NDA 208745.
`
`REQUEST NO. 6: All documents, including laboratory notebooks and all available
`
`experimental data, pertaining to the experiments described in The Comiskey Declaration,
`
`including any and all experimental results not summarized or included in said declaration.
`
`REQUEST NO. 7: All documents, including laboratory notebooks and all available
`
`experimental data, pertaining to the experiments described in The Second Comiskey Declaration,
`
`including any and all experimental results not summarized or included in said declaration.
`
`REQUEST NO. 8: A complete and accurate printed copy of the complete document
`
`identified in footnote 1 to The Comiskey Declaration and The Second Comiskey Declaration.
`
`
`
`10
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`REQUEST NO. 9: All non-privileged documents that relate to, refer to, or consist of
`
`the “References Cited” section of the Patents-in-Suit or Related Applications, including but not
`
`limited to all U.S. Patent Documents, Foreign Patent Documents, and Other Publications listed
`
`therein.
`
`REQUEST NO. 10: All product specification sheets, or any non-privileged document in
`
`Your possession or control that refers in any way to the content, characteristics, ingredients, or
`
`function in a pharmaceutical formulation of any material sold under the Avicel® trade name,
`
`including but not limited to any document identifying Avicel PH 102, 112, or 200 as reflected in
`
`U.S. Patent No. 9,610,321, Column 5, lines 25-30.
`
`REQUEST NO. 11: All product specification sheets, or any non-privileged document in
`
`Your possession or control that is not privileged that refers in any way to the content,
`
`characteristics, ingredients or function in a pharmaceutical formulation of any material sold under
`
`the Celphere® trade name, including but not limited to any document identifying Celphere SCP-
`
`100 as reflected in U.S. Patent No. 9,610,321, Column 5, line 27.
`
`REQUEST NO. 12: All product specification sheets, or any non-privileged document in
`
`Your possession or control that is not privileged that refers in any way to the content,
`
`characteristics, ingredients or function in a pharmaceutical formulation of any material sold under
`
`the Advantose® trade name, including but not limited to any document identifying ADVANTOSE
`
`100, as reflected in U.S. Patent No. 9,610,321, Column 9, lines 33-36.
`
`REQUEST NO. 13: All product specification sheets, or any non-privileged document in
`
`Your possession or control that is not privileged that refers in any way to the content,
`
`characteristics, ingredients or function in a pharmaceutical formulation of any material sold under
`
`the Prosolv® trade name, including but not limited to any document identifying Prosolv SMCC 90
`
`
`
`11
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`LM, as reflected in U.S. Patent No. 9,610,321, Column 16, 27-28, and lines 53-54; or PROSOLV
`
`LM90 as identified in Col. 88, line 57 of the same patent.
`
`REQUEST NO. 14: All non-privileged documents that relate to, refer to, or consist of
`
`any foreign search reports and testimony in litigations, disputes, oppositions, and related
`
`proceedings throughout the world involving plecanatide.
`
`REQUEST NO. 15: All non-privileged documents in your possession or control that
`
`relate to, refer to, or consist of any reference to the naturally occurring peptides uroguanylin and
`
`guanylin, including but not limited to human uroguanylin, rat uroguanylin and opossum
`
`uroguanylin, and human guanylin, rat guanylin and opossum guanylin, and the use of said
`
`compounds (alone or in combination) as guanylate cyclase receptor agonists, for the regulation of
`
`fluid and electrolyte transport in the huma GI tract by, e.g., serving as paracrine regulators of CFTR
`
`activity, and/or for the treatment of constipation.
`
`REQUEST NO. 16: All non-privileged documents in your possession or control that
`
`relate to, refer to, or consist of any reference to human uroguanylin, and its use for controlling
`
`intestinal absorption and regulating intestinal fluid and electrolyte transport.
`
`REQUEST NO. 17: All non-privileged documents and communications referring to, or
`
`relating to U.S. Patent No. 5,140,102.
`
`REQUEST NO. 18: All non-privileged documents and communications referring to or
`
`relating to Forte et al., New Physiol. Sci, 1996, 11, 17-24.
`
`REQUEST NO. 19: All non-privileged documents and communications referring to or
`
`relating to Li et al., Regulatory Peptides, 1997, 68, 45-56.
`
`REQUEST NO. 20: All non-privileged documents and communications referring to or
`
`relating to Joo et al., Physiology, 1999, G633-G644.
`
`
`
`12
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`REQUEST NO. 21: All non-privileged documents and communications referring to or
`
`relating to Hamra et al., Endocrinology, 1996, 137(1).
`
`REQUEST NO. 22: All non-privileged documents and communications referring to or
`
`relating to Nakazato, J. Gastroenterol, 2001, 36, 219-225.
`
`REQUEST NO. 23: All non-privileged documents and communications referring to and
`
`relating to WO 01/25266.
`
`REQUEST NO. 24: All documents pertaining to your investigation, due diligence, and
`
`eventual acquisition of assets of Synergy in a bankruptcy court supervised auction and sale,
`
`through which the worldwide rights to the TRULANCE® product were acquired by You.
`
`REQUEST NO. 25: All documents relating to Your stalking horse bid in connection with
`
`the Synergy bankruptcy, including but not limited to the preparation of the stalking horse bid and
`
`any evaluation by You of the commercial value of TRULANCE®.
`
`REQUEST NO. 26: All documents in your possession or control that refer to, relate to,
`
`or include any documents associated with the bankruptcy court supervised auction and sale,
`
`through which the worldwide rights to the TRULANCE® product were acquired by You.
`
`REQUEST NO. 27: All documents acquired by You in connection with the Your
`
`acquisition of TRULANCE®.
`
`REQUEST NO. 28: The December 12, 2018 agreement to acquire certain assets of
`
`Synergy Pharmaceuticals, Inc., including all non-privileged documents preceding that agreement
`
`in which the assets that were the subject of the transaction were valued.
`
`REQUEST NO. 29: All documents in your possession or control that pre-date the
`
`December 12, 2018 agreement to acquire certain assets of Synergy Pharmaceuticals, Inc. and
`
`reference, in any way, any anticipated, expected, or possible generic competition for
`
`
`
`13
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`TRULANCE®, and/or the impact of such competition on the value of the worldwide rights to the
`
`TRULANCE® product.
`
`REQUEST NO. 30: All documents in your possession, custody or control relating in
`
`anyway to any due diligence in connection with the acquisition of assets by you from Synergy,
`
`whether or not that due diligence led to an acquisition of assets.
`
`REQUEST NO. 31: All documents relating in any way to Your efforts to continue
`
`leveraging the comprehensive irritable bowel syndrome (IBS) portfolio held by Bausch, with
`
`TRULANCE® being a natural complement to XIFAXAN® (rifaximin) product, as stated by
`
`Joseph C. Papa in the letter to shareholders in the 2019 Bausch Health Annual Report.
`
`REQUEST NO. 32: All documents that describe, document, or relate in any way to the
`
`scale, depth and strength of Bausch’s sales footprint in gastroenterology and primary care,
`
`including but not limited to the “Salix team” which was said to “be able to offer physicians and
`
`patients multiple treatment options that span the types of IBS,” as stated by Joseph C. Papa in the
`
`letter to shareholders in the 2019 Bausch Health Annual Report.
`
`REQUEST NO. 33: A copy of each and every agreement that You have, or have
`
`negotiated, with any entity that involves the manufacture, use, sale, or contemplated sale of a
`
`generic version of TRULANCE® in the United States at any time.
`
`REQUEST NO. 34: All documents concerning the experimental and factual support for
`
`all portions of the Patents-in-Suit and statements made to the USPTO in the prosecution of the
`
`Patents-in-Suit, including in the prosecution of any application in the claimed priority applications
`
`of the Patents-in-Suit.
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`
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`14
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`Bausch Health Ireland Exhibit 2005, Page 14 of 28
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`REQUEST NO. 35: All agreements held between You and or your counsel concerning
`
`any consulting services provided to you regarding plecanatide by any named inventor of any patent
`
`in suit.
`
`REQUEST NO. 36: All documents concerning or related to the earliest priority date that
`
`You assert for each claim of the Patents-in-Suit.
`
`REQUEST NO. 37: Documents sufficient to identify the individuals who allegedly
`
`conceived of, and/or reduced to practice or assisted in the reduction to practice of, the alleged
`
`invention(s) or subject matter claimed in the Patents-in-Suit.
`
`REQUEST NO. 38: All documents written or reviewed by the inventors of the Patents-
`
`in-Suit pertaining to the subject matter of the Patents-in-Suit, including applications in the priority
`
`claim of the Patents-in- Suit.
`
`REQUEST NO. 39: All documents concerning Defendants’ alleged infringement of any
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`claim of the Patents-in-Suit.
`
`REQUEST NO. 40: All documents relating to agreements with any company or
`
`companies for the development, sale, marketing, or promotion of plecanatide, or a pharmaceutical
`
`composition thereof, including, but not limited to, any agreements and drafts thereof.
`
`REQUEST NO. 41: All documents prepared for and/or shared in any due diligence
`
`concerning any agreement, license, or negotiation related to plecanatide, or a pharmaceutical
`
`composition thereof, the Patents-in-Suit, the applications that issued as the Patents-in-Suit, and the
`
`applications in the claimed priority chain of the Patents-in-Suit.
`
`REQUEST NO. 42: All documents concerning
`
`the marketing or promotional
`
`expenditures for TRULANCE®, including the costs of the sales force, detailing, product sampling,
`
`and all other promotional costs associated with TRULANCE®.
`
`
`
`15
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`Bausch Health Ireland Exhibit 2005, Page 15 of 28
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`REQUEST NO. 43: Documents sufficient to show the marketing, advertising, or
`
`promotion for TRULANCE® including, without limitation, any press releases and publications,
`
`any marketing plans, advertising plans, promotional programs, or strategies.
`
`REQUEST NO. 44: All documents relating to any market analysis by or on behalf of
`
`You concerning TRULANCE® or any pharmaceutical composition thereof.
`
`REQUEST NO. 45: Documents sufficient to show the sales, revenue, and/or profits for
`
`TRULANCE® since its first sale to the present.
`
`REQUEST NO. 46: Documents sufficient to show cost data (including unit costs), sales
`
`data, profit data, and market share data, including rebate, chargeback, and adjustment data, given
`
`on a monthly basis for TRULANCE® since its first sale to the present.
`
`REQUEST NO. 47: All documents relating to the forecast or projection for sales,
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`revenue, and profit for TRULANCE®.
`
`REQUEST NO. 48: All documents concerning or referring to products that compete for
`
`sales or market share with TRULANCE® (either in Plaintiff’s estimation, or that of third parties
`
`such as IMS, IQVIA, and/or Wolters Kluwer).
`
`REQUEST NO. 49: All documents, including laboratory notebooks and all available
`
`experimental data, pertaining to the molecular modeling experiments and the Examples described
`
`in U.S. Patent No. 7,041,186 at cols. 7:22 to 13:15, and 15:25 to 17:5.
`
`REQUEST NO. 50: All documents, including laboratory notebooks and all available
`
`experimental data, pertaining to the experiments described in Examples 1 through 100 as identified
`
`in U.S. Patent No. 9,610,321 Cols. 85-100.
`
`REQUEST NO. 51: All non-privileged documents that relate to U.S. Patent Appl. No.
`
`17/397,796, filed on August 09, 2021 or Related Applications, including but not limited to, all
`
`
`
`16
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`Bausch Health Ireland Exhibit 2005, Page 16 of 28
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`communications with the United States Patent and Trademark Office, all communications with
`
`foreign patent offices, including but not limited to foreign search reports, involving U.S. Patent
`
`Appln. No. 17/397,796, filed on August 09, 2021.
`
`REQUEST NO. 52: All non-privileged documents that relate to U.S. Patent Appl. No.
`
`17/478,027, filed on August 17, 2021 or Related Applications, including but not limited to, all
`
`communications with the United States Patent and Trademark Office, all communications with
`
`foreign patent offices, including but not limited to foreign search reports, involving U.S. Patent
`
`Appln. No. 17/478,027, filed on August 17, 2021.
`
`REQUEST NO. 53: All non-privileged documents that relate to U.S. Patent Appl. No.
`
`16/870,942, filed on May 9, 2020 or Related Applications, including but not limited to, all
`
`communications with the United States Patent and Trademark Office, all communications with
`
`foreign patent offices, including but not limited to foreign search reports, and related proceedings
`
`throughout the world involving U.S. Patent Appl. No. 16/870,942, filed on May 9, 2020.
`
`REQUEST NO. 54: All non-privileged documents that relate to PCT/US2014/041143
`
`with a Section 371(c)(1)/(2) date of December 4, 2015 or Related Applications, including but not
`
`limited to, all communications with the United States Patent and Trademark Office, all
`
`communications with foreign patent offices, including but not limited to foreign search reports,
`
`and related proceedings throughout the world involving PCT/US2014/041143.
`
`REQUEST NO. 55: All documents, including laboratory notebooks and all available
`
`experimental data, pertaining to the experiments and the Examples described in U.S. Patent No.
`
`10,011,637 at cols. 87:28 to