Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 1 of 23 PageID #: 1404
`Case 1:15-cv—00697-RGA Document 99-3 Filed 08/14/17 Page 1 of 23 PageID #: 1404
`
`EXHIBITS H - M
`
`EXHIBITS H - M
` PUBLIC VERSION
`
`PUBLIC VERSION
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 2 of 23 PageID #: 1405
`
`
`EXHIBIT H
`
`Hospira’s Witness List
`
`Hospira intends to call the following witnesses to testify at trial. The “Will Call” list
`
`
`
`represents a good faith statement of those witnesses Hospira presently intends to call live. The
`
`“May Call” list represents a good faith statement of those witnesses that Hospira may call live or
`
`by deposition designation.
`
`Hospira reserves the right to call any additional witnesses necessitated by any of the
`
`Court’s pretrial or trial rulings. Hospira also reserves the right to call, either live or by
`
`deposition: (a) additional witnesses to provide foundational testimony should any party contest
`
`the authenticity or admissibility of any material proffered at trial; (b) substitute witnesses for any
`
`identified witness whose employment or other relationship with Hospira changes such that he or
`
`she is no longer able, available or willing to testify on Hospira’s behalf at trial; (c) any witnesses
`
`identified by Amneal; (d) any witnesses required to rebut Amneal’s case; or (e) additional
`
`witnesses to respond to issues raised after the submission of this list, such as the testimony of any
`
`witness who has not yet been deposed.
`
`I.
`
`Will Call – Witnesses Hospira Expects to Call Live at Trial
`
`Priyanka Roychowdhury (co-inventor of Patents-in-Suit who will
`regarding development of the claimed subject matter)
`
`David Engels (U.S. Sterile Injectables Portfolio Lead, Pfizer, Inc., who will testify
`regarding the commercial performance of Precedex Premix)
`
`testify
`
`Robert Linhardt (expert witness in the field of pharmaceutical formulation and
`development who will testify regarding infringement and validity).
`
`Michael Ramsay (expert witness in the field of sedation and anesthesiology who
`will testify regarding infringement and validity).
`
`Christopher Gerardi (expert witness in the field of economics who will testify
`regarding secondary considerations of non-obviousness).
`
`1.
`
`2.
`
`
`3.
`
`4.
`
`
`5.
`
`
`
`
`
`1
`
`
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 3 of 23 PageID #: 1406
`
`
`II. May Call – Witnesses Hospira May Call Live or by Deposition Designation
`
`Robert Cedergren
`
`Rao Tata-Venkata
`
`Narasimhan Mani
`
`Custodian(s) of Records
`
`6.
`
`7.
`
`8.
`
`9.
`
`
`
`
`
`
`2
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 4 of 23 PageID #: 1407
`
`
`EXHIBIT I
`
`Amneal’s Witness List
`
`Amneal intends to call the following witnesses to testify at trial. The “Will Call” list
`
`
`
`represents a good faith statement of those witnesses Amneal presently intends to call live. The
`
`“May Call” list represents a good faith statement of those witnesses that Amneal may call live or
`
`by deposition designation.
`
`Amneal reserves the right to call any additional witnesses necessitated by any of the
`
`Court’s pretrial or trial rulings. Amneal also reserves the right to call, either live or by
`
`deposition: (a) additional witnesses to provide foundational testimony should any party contest
`
`the authenticity or admissibility of any material proffered at trial; (b) substitute witnesses for any
`
`identified witness whose employment or other relationship with Amneal changes such that he or
`
`she is no longer able, available or willing to testify on Amneal’s behalf at trial; (c) any witnesses
`
`identified by Hospira; (d) any witnesses required to rebut Hospira’s case; or (e) additional
`
`witnesses to respond to issues raised after the submission of this list, such as the testimony of any
`
`witness who has not yet been deposed.
`
`III. Will Call – Witnesses Amneal Expects to Call Live at Trial
`
`Dr. Alpaslan Yaman (expert witness in the field of pharmaceutical formulation,
`packaging, manufacture, and development of parenteral drug products, who will
`testify regarding invalidity)
`
`Dr. James G. Cain (expert witness in the fields of clinical anesthesiology and
`sedation who will testify regarding invalidity)
`
`Dr. Daniel A. Bloch (expert witness in the field of biostatistics who will testify
`regarding non-infringement of the ’106 patent)
`
`Mr. Ivan T. Hofmann (expert witness in the field of economics who will testify
`regarding secondary considerations of non-obviousness)
`
`1.
`
`2.
`
`
`3.
`
`
`4.
`
`
`
`
`
`1
`
`
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 5 of 23 PageID #: 1408
`
`
`IV. May Call – Witnesses Amneal May Call Live or by Deposition Designation
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Robert Cedergren
`
`Priyanka Roychowdhury
`
`David Engels (by deposition designation)
`
`Rao Tata-Venkata (by deposition designation)
`
`Custodian(s) of Records
`
`2
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 6 of 23 PageID #: 1409
`
`
`EXHIBIT J
`
`Hospira’s Witness Designations
`
`Pursuant to Local Rule 16.3(c)(7), Hospira provides the following designations of
`
`
`
`deposition testimony. Hospira reserves the right to: (a) use at trial any of its deposition
`
`designations (including affirmative designations and counter designations) as affirmative
`
`designations or counter designations; (b) submit by paper, read, or show videotape of deposition
`
`excerpts; (c) use any deposition designations (including affirmative designations or counter
`
`designations) identified by Amneal; (d) supplement its deposition designation testimony
`
`(including affirmative designations and counter designations) with that of persons who are
`
`presently listed as trial witnesses by either party in the event that such witnesses are not called at
`
`trial; (e) designate additional portions of deposition transcripts for the purpose of authentication
`
`of documents, if required; (f) revise or supplement its designations in light of the Court’s rulings
`
`and in light of Amneal’s claims and defenses that remain to be tried; and (g) use any and all
`
`deposition testimony, whether or not designated, for cross-examination, impeachment, or rebuttal
`
`purposes.
`
`To the extent any portions of these designations include objections or colloquy of counsel
`
`to certain questions, Hospira reserves the right to remove those objections or colloquy before the
`
`deposition excerpts are played or read into evidence.
`
`Mani, Narasimhan (11/18/2016)
`
`
`Plaintiff’s Designations
`
`Line Start
`
`Line End
`
`Defendant’s
`Objections
`
`Defendant’s Counter-
`Designations
`
`Line Start
`
`Line End
`
`5:6
`6:19
`9:12
`
`
`
`5:12
`8:6
`10:4
`
`
`
`H, P, R
`
`
`
`
`
`1
`
`
`
`
`
`
`
`Plaintiff’s
`Objections to
`Defendant’s
`Counter-
`Designations
`
`
`
`
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 7 of 23 PageID #: 1410
`
`
`16:1
`
`19:15
`20:22
`24:7
`24:16
`25:3
`29:24
`32:6
`33:15
`
`33:20
`
`18:24
`
`20:8
`23:2
`24:9
`24:22
`29:11
`31:22
`32:16
`33:17
`
`34:8
`
`H, P, R
`
`H, P, R
`H, P, R
`H, P, R
`
`H, P, R
`AT, H, P, R
`
`SC, H, P, R,
`IO
`SC, H, P, R,
`IO
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`AT, H, P, R
`
`18:25
`19:7
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`38:13
`
`
`19:4
`19:13
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`39:14
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`R, H, IC
`
`
`35:16
`36:3
`37:10
`38:22
`43:19
`
`35:15
`35:18
`36:25
`37:16
`42:20
`
`
`Roychowdhury, Priyanka (11/30/2016)
`
`
`Plaintiff’s Designations
`
`Line Start
`
`Line End
`
`Defendant’s
`Objections
`
`Defendant’s Counter-
`Designations
`
`Line Start
`
`Line End
`
`6:12
`9:2
`13:10
`16:3
`17:9
`19:14
`22:21
`23:10
`25:15
`26:5
`28:10
`29:4
`30:6
`36:17
`38:14
`39:7
`41:18
`42:8
`
`6:16
`9:6
`14:5
`16:12
`18:14
`21:6
`23:7
`24:23
`25:23
`26:16
`28:23
`29:9
`32:8
`38:9
`39:2
`39:14
`41:23
`42:18
`
`
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`AT, H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`AT, H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`
`8:23
`14:15
`25:11
`26:17
`27:15
`28:1
`28:24
`29:10
`33:19
`34:16
`36:2
`36:14
`38:10
`39:7
`42:25
`45:1
`48:2
`50:3
`
`2
`
`9:1
`14:17
`25:14
`27:14
`27:25
`28:9
`29:3
`30:1
`34:7
`34:19
`36:7
`36:16
`38:13
`40:20
`43:5
`45:21
`48:24
`50:23
`
`Plaintiff’s
`Objections to
`Defendant’s
`Counter-
`Designations
`
`
`
`
`R, S
`
`R, S
`V, S
`
`
`
`
`
`S
`
`
`S, H
`S
`
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 8 of 23 PageID #: 1411
`Case 1:15-cv—00697-RGA Document 99-3 Filed 08/14/17 Page 8 of 23 PageID #: 1411
`
`
`
`
`S, V
`S, V
`
`
`
`
`S, F
`S, F
`9
`S, F
`S F
`
`
`
`
`
`
`
`
`
`
`
`A, R (105:1-4)
`A,R(10521—4)
`
`S, F, K
`S, F, K
`
`
`R, LC
`R, LC
`R, LC
`R, LC
`R, LC
`R, LC
`R, S, F
`R, S, F
`S
`S
`
`I
`I, A (158)
`, A (158)
`
`
`R
`R
`
`
`
`
`
`
`
`
`
`
`
`
`I I
`
`51:5
`50:24
`H, P, R
`44:25
`44:19
`52:5
`51:24
`H, P, R
`47:11
`46:17
`53:15
`53:11
`H, P, R
`47:23
`47:14
`57:8
`57:2
`H, P, R
`50:23
`49:2
`58:8
`58:6
`H, P, R
`51:23
`51:16
`60:19
`60:9
`H, P, R
`53:10
`53:1
`61:7
`61:2
`H, P, R
`55:3
`53:18
`66:12
`66:10
`H, P, R
`57:1
`55:13
`68:10
`68:5
`H, P, R
`57:24
`57:10
`73:3
`72:18
`H, P, R
`59:2
`58:9
`74:14
`74:12
`H, P, R
`60:8
`60:5
`82:16
`81:12
`H, P, R
`61:23
`61:8
`83:11
`82:20
`H, P, R
`63:6
`62:18
`84:5
`84:2
`H, P, R
`64:4
`63:13
`85:25
`85:20
`H, P, R
`66:9
`65:4
`86:6
`86:4
`H, P, R
`67:2
`66:13
`90:10
`89:19
`H, P, R
`69:13
`68:15
`104:2
`103:23
`H, P, R
`70:17
`70:4
`105:4
`104:21
`H, P, R
`73:3
`72:18
`106:18
`105:21
`H, P, R
`73:14
`73:9
`107:5
`107:1
`H, P, R
`74:11
`73:20
`111:6
`110:23
`H, P, R
`74:23
`74:15
`111:13
`111:10
`H, P, R
`75:22
`75:17
`118:20
`118:13
`H, P, R
`79:19
`78:1
`122:15
`122:11
`H, P, R
`80:16
`79:23
`127:25
`127:22
`H, P, R
`82:16
`80:18
`139:24
`138:17
`H, P, R
`84:1
`83:12
`148:4
`147:13
`H, P, R
`84:10
`84:6
`148:12
`148:10
`H, P, R
`85:3
`84:17
`156:20
`155:3
`H, P, R
`89:18
`89:15
`158:1
`157:17
`H, P, R
`91:9
`91:5
`159:4
`158:15
`H, P, R
`91:20
`91:15
`160:23
`160:18
`H, P, R
`93:13
`93:4
`172:14
`171:14
`H, P, R
`94:21
`94:18
`174:23
`174:21
`H, P, R
`97:5
`96:11
`176:24
`176:21
`H, P, R
`99:14
`99:8
`177:25
`177:14
`H, P, R
`105:20
`105:5
`106:19
`106:22
`H, P, R
`
`
`——
`113:6
`113:14
`H, P, R
`
`
`——
`114:2
`114:10
`H, P, R
`
`
`——
`148:5
`148:9
`H, P, R
`
`
`——
`149:7
`149:19
`H, P, R
`
`
`——
`151:9
`152:25
`H, P, R
`
`
`——
`153:9
`154:23
`H, P, R
`
`
`——
`156:21
`156:24
`H, P, R
`
`
`——
`
`
`
`
`
`3
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 9 of 23 PageID #: 1412
`
`
`157:16
`158:14
`159:19
`160:2
`160:17
`161:6
`170:15
`174:20
`176:20
`
`
`
`
`
`
`
`157:6
`158:6
`159:16
`159:23
`160:9
`161:3
`169:23
`173:21
`175:7
`
`
`
`
`
`
`
`Cedergren, Robert (11/16/2016)
`
`
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`
`
`
`
`
`
`
`Plaintiff’s Designations
`
`Line Start
`
`Line End
`
`Defendant’s
`Objections
`
`5:6
`9:2
`15:23
`17:19
`20:4
`21:19
`
`24:17
`25:23
`28:20
`29:15
`30:11
`32:9
`33:19
`34:2
`39:6
`39:19
`40:17
`44:15
`46:10
`49:22
`50:16
`
`5:9
`9:3
`16:23
`18:4
`20:11
`22:4
`
`24:19
`25:25
`28:23
`29:23
`30:14
`32:20
`33:25
`34:3
`39:14
`40:3
`41:18
`44:24
`46:22
`50:3
`50:20
`
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`
`18:5
`25:19
`27:21
`29:3
`29:24
`32:5
`
`33:5
`36:24
`40:4
`46:23
`48:22
`49:16
`51:8
`52:10
`55:18
`56:17
`58:6
`59:10
`60:8
`63:3
`68:8
`
`4
`
`18:8
`25:22
`28:8
`29:6
`29:25
`32:8
`
`33:7
`37:3
`40:14
`46:25
`49:2
`49:21
`51:17
`52:16
`56:8
`56:21
`58:16
`59:25
`62:22
`63:15
`68:23
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Defendant’s Counter-
`Designations
`
`Line Start
`
`Line End
`
`Plaintiff’s
`Objections to
`Defendant’s
`Counter-
`Designations
`Add 18:9-13
`
`
`
`
`Add 31:19-
`32:4
`S
`
`
`
`
`
`
`
`R, B
`I, B
`I, B
`S, F
`S
`S
`S
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 10 of 23 PageID #: 1413
`
`
`74:7
`77:16
`80:20
`83:12
`86:16
`87:8
`88:15
`92:3
`95:24
`106:24
`108:18
`114:12
`123:6
`133:7
`135:20
`144:25
`145:9
`152:3
`155:4
`155:16
`158:22
`160:5
`166:23
`167:24
`180:19
`
`185:20
`191:5
`191:17
`192:19
`194:6
`194:18
`196:20
`207:10
`207:19
`224:4
`
`S
`
`
`
`
`
`
`S
`S, M
`S, B
`
`
`M, MD, S
`
`
`Add 142:2-23
`Add 145:2-4
`S
`S, MD, M
`S
`
`
`
`
`S, F, MD, K,
`R
`
`S
`
`F, LC
`
`F, LC
`F, LC
`LC
`LC
`
`
`52:9
`79:25
`83:8
`114:24
`129:21
`137:15
`138:18
`158:14
`159:21
`166:23
`215:22
`226:19
`227:5
`227:12
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`H, P, R
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`51:8
`79:3
`80:21
`114:13
`128:4
`130:6
`138:12
`157:24
`159:13
`166:8
`215:16
`226:15
`227:4
`227:10
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`73:15
`77:10
`80:2
`83:3
`86:14
`87:2
`88:7
`91:23
`94:15
`105:16
`108:16
`114:10
`121:2
`130:6
`134:3
`142:24
`145:5
`151:23
`154:13
`155:12
`158:15
`159:22
`166:11
`167:21
`169:18
`
`185:8
`190:4
`191:6
`191:18
`193:17
`194:7
`195:5
`206:8
`207:11
`223:17
`
`5
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 11 of 23 PageID #: 1414
`
`
`EXHIBIT K
`
`Amneal’s Witness Designations
`
`Pursuant to Local Rule 16.3(c)(7), Amneal provides the following designations of
`
`
`
`deposition testimony. Amneal reserves the right to: (a) use at trial any of its deposition
`
`designations (including affirmative designations and counter designations) as affirmative
`
`designations or counter designations; (b) submit by paper, read, or show videotape of deposition
`
`excerpts; (c) use any deposition designations (including affirmative designations or counter
`
`designations) identified by Hospira; (d) supplement its deposition designation testimony
`
`(including affirmative designations and counter designations) with that of persons who are
`
`presently listed as trial witnesses by either party in the event that such witnesses are not called at
`
`trial; (e) designate additional portions of deposition transcripts for the purpose of authentication
`
`of documents, if required; (f) revise or supplement its designations in light of the Court’s rulings
`
`and in light of Hospira’s claims and defenses that remain to be tried; and (g) use any and all
`
`deposition testimony, whether or not designated, for cross-examination, impeachment, or rebuttal
`
`purposes.
`
`To the extent any portions of these designations include objections or colloquy of counsel
`
`to certain questions, Amneal reserves the right to remove those objections or colloquy before the
`
`deposition excerpts are played or read into evidence.
`
`Engels, David (11/11/2016)
`
`
`Defendant’s Designations
`
`Line Start
`
`Line End
`
`Plaintiff’s
`Objections1
`
`Plaintiff’s Counter-
`Designations
`Line Start
`Line End
`
`Defendant’s
`Objections to
`Plaintiff’s
`Counter-
`
`
`1 Hospira objects to playing designated deposition testimony for a witness who is called live at
`trial.
`
`
`
`1
`
`
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 12 of 23 PageID #: 1415
`
`
`7:8
`10:18
`17:20
`20:15
`22:11
`22:25
`27:3
`
`37:19
`41:7
`47:12
`50:15
`51:17
`53:14
`53:21
`
`76:17
`78:12
`84:4
`84:16
`86:11
`
`90:3
`92:7
`92:19
`96:20
`121:7
`125:7
`128:19
`133:13
`136:5
`
`
`
`7:14
`11:1
`18:6
`22:2
`22:20
`23:8
`27:9
`
`38:23
`41:25
`49:13
`51:4
`53:6
`53:19
`54:11
`
`77:2
`78:23
`84:10
`85:11
`87:8
`
`91:10
`92:11
`92:22
`98:8
`122:23
`125:15
`129:13
`133:20
`136:18
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`F, K
`
`
`
`
`I
`V
`
`
`
`
`
`
`
`
`18:7
`
`
`
`27:10
`27:15
`28:3
`28:12
`
`
`
`
`
`
`54:14
`56:7
`56:14
`58:11
`
`
`
`
`85:12
`39:15
`
`
`96:15
`
`122:24
`
`129:14
`
`136:19
`
`
`
`19:5
`
`
`
`27:12
`28:1
`28:9
`31:11
`
`
`
`
`
`
`55:5
`56:11
`58:8
`59:1
`
`
`
`
`86:10
`41:6
`
`
`97:8
`
`123:3
`
`130:4
`
`137:15
`
`Designations
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`H
`
`
`
`
`
`R, P
`
`
`
`
`
`
`
`
`
`
`
`Tata-Venkata, Rao (11/9/2016)
`
`
`Defendant’s Designations
`
`Line Start
`
`Line End
`
`Plaintiff’s
`Objections
`
`Plaintiff’s Counter-
`Designations
`
`Line Start
`
`Line End
`
`Defendant’s
`Objections to
`Plaintiff’s
`Counter-
`Designations
`
`2
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 13 of 23 PageID #: 1416
`Case 1:15-cv—00697-RGA Document 99-3 Filed 08/14/17 Page 13 of 23 PageID #: 1416
`
`
`7:6
`
`7:6 —
`10:9
`
`10:9 —
`10:20
`
`10:20 —
`16:19
`SC, P, R, IO,
`16:19
`SC, P, R, 10,
`F
`F
`
`18:24
`19:5
`——
`19:9
`19:14
`
`——
`20:7
`20:22
`
`——
`23:9
`23:12
`
`——
`23:22
`24:2
`
`——
`25:24
`28:16
`
`——
`40:5
`40:22
`SC, P, R, IO,
`F
`SC, P, R, IO,
`F
`SC, P, R, IO,
`F
`SC, P, R, IO,
`F
`F
`B, I, P, R
`B, I, P, R
`B, I, P, R
`B, I, P, R
`
`7:3
`7:3
`10:5
`10:5
`10:11
`10:11
`16:12
`16:12
`
`41:2
`
`41:6
`
`41:17
`
`75:14
`75:14
`75:21
`75:21
`
`41:5
`
`41:15
`
`41:17
`
`75:15
`75:15
`76:7
`76:7
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`42:7
`
`
`79:15
`79:15
`80:14
`80:14
`
`
`
`
`
`
`
`157:23
`162:19
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`41:19
`
`
`79:3
`79:3
`79:17
`79:17
`
`
`
`
`
`
`
`157:20
`162:9
`
`3
`
`
`
`B, I, P, R
`7C1
`B, I, P, R
`WW
`B, I, P, R
`B, I, P, R
`7C1
`C
`C
`I
`I
`B, P, R, MD,
`SC, IO
`SC, 10
`B, P, R, MD,
`163:3
`163:5
`SC, IO
`163:8
`163:11
`SC, 10
`163:8
`163:11
`B, P, R, MD,
`
`
`163:12
`164:8
`—-—SC, 10
`SC, IO
`B, P, R, MD,
`164:10
`164:10
`
`
`—-—SC, 10
`SC, IO
`B, P, R, MD,
`164:12
`164:14
`164:15
`165:21
`SC, IO
`SC, 10
`SC
`170:24
`
`
`17024 ——
`172:21
`C, V, P, R, B,
`
`
`172:21
`C, V, P, R, B,
`SC
`SC
`174:8
`
`173:22
`173:23
`174:8
`173:22 — 173:23
`174:16
`
`
`
`174216 ——
`
`80:23
`81:14
`82:3
`83:4
`111:6
`111:9
`154:20
`155:12
`162:8
`
`163:2
`
`80:15
`81:2
`81:18
`82:8
`111:3
`111:9
`154:11
`155:4
`162:6
`
`162:20
`
`170:20
`170220
`171:20
`171:20
`
`173:10
`173:10
`174:12
`174:12
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 14 of 23 PageID #: 1417
`Case 1:15-cv—00697-RGA Document 99-3 Filed 08/14/17 Page 14 of 23 PageID #: 1417
`
`
`175:10
`
`175:21
`
`P, R, V
`
`242:5
`242:5
`
`242:3
`242:3
`
`242:12
`24212
`250:12
`
`X
`X
`
`—_R, 1, SC
`
`184:17
`185:24
`186:6
`186:16
`192:3
`192:3
`198:24
`198:24
`243:20
`242:24
`
`24224 — 243:20
`250:24
`B
`250:25
`252:21
`252:21
`
`
`
`
`
`254:9
`
`255:16
`
`254:16
`
`256:3
`
`IO, MD, P,
`R, I, SC
`IO, MD, P,
`R, I
`
`273:18
`
`284:9
`
`B, P, R
`
`185:21
`186:4
`186:14
`186:18
`193:3
`193:3
`199:7
`199:7
`244:2
`244:2
`251:25
`254:8
`254:8
`
`
`258:20
`261:3
`263:6
`265:18
`
`
`
`
`R
`
`H, P, R
`
`
`
`
`H, P, R
`
`
`
`
`
`256:14
`258:24
`262:8
`263:15
`
`
`4
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 15 of 23 PageID #: 1418
`
`
`EXHIBIT L
`
`Hospira’s Statement of Intended Proofs
`
`Hospira hereby submits its statement of intended proofs. The following paragraphs are
`
`
`
`not exhaustive, and Hospira reserves the right to prove any matters identified in its pleadings,
`
`interrogatory responses, or expert reports. Hospira also intends to offer evidence as to the issues
`
`of fact and issues of law identified in this Pretrial Order. Furthermore, Hospira intends to offer
`
`evidence to rebut evidence that Amneal offers. Hospira reserves the right to amend and
`
`supplement these statements in response to Amneal’s pretrial activities, any subsequently
`
`produced discovery, or any pretrial ruling or decision of the Court. Hospira incorporates by
`
`reference its expert reports in support of any proof to be presented by expert testimony.
`
`I.
`
`INFRINGEMENT
`
`1.
`
`Hospira expects to prove by a preponderance of the evidence that Amneal
`
`infringed Claims 1-4 of the ‘158 patent; Claims 1-7 of the ‘470 patent; Claims 1 and 5 13 of the
`
`‘527 patent; and Claims 1-9 of the ‘106 patent by filing ANDA No. 207551 for the Amneal
`
`ANDA Products with a paragraph IV certification as to the Patents-in-Suit.
`
`2.
`
`Hospira expects to prove by a preponderance of the evidence that the
`
`manufacture, use, offer for sale, sale, and/or importation of the Amneal ANDA Products will
`
`infringe Claims 1-4 of the ‘158 patent; Claims 1-7 of the ‘470 patent; Claims 1 and 5 of the ‘527
`
`patent; and Claims 1-9 of the ‘106 patent.
`
`3.
`
`To prove infringement of the Patents-in-Suit, Hospira expects to present, among
`
`other things, portions of ANDA No. 207551, admissions by Amneal, and expert testimony.
`
`II.
`
`VALIDITY
`
`Amneal bears the burden of proof with respect to alleged invalidity. To the extent that
`
`Amneal is able to establish a prima facie case of invalidity, Hospira intends to present evidence
`
`
`
`1
`
`
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 16 of 23 PageID #: 1419
`
`
`in rebuttal. Hospira reserves the right to present appropriate rebuttal evidence in response to the
`
`invalidity arguments that Amneal presents at trial.
`
`Based on the intended proofs that Amneal has disclosed to date—and assuming Amneal
`
`is able to establish a prima facie case of invalidity on any of the following bases—Hospira
`
`intends to present evidence as set forth below.
`
`A.
`
`4.
`
`Anticipation
`
`Hospira expects to show that Amneal has failed to satisfy its burden of proving by
`
`clear and convincing evidence that the Trissel reference satisfies every element of any asserted
`
`claim because the reference does not disclose at least (1) a ready-to-use dexmedetomidine
`
`formulation, (2) a composition for parenteral administration to a patient; (3) a composition
`
`disposed within a sealed glass container; or (4) a composition that exhibits no more than about
`
`2% decrease in the concentration of dexmedetomidine when stored in a sealed glass container for
`
`five months.
`
`5.
`
`Hospira expects to show that Amneal has failed to satisfy its burden of proving by
`
`clear and convincing evidence that the subject matter of any asserted claim was in public use
`
`before the invention. The asserted public use of Precedex Concentrate does not involve a ready-
`
`to-use formulation containing 4 µg/mL dexmedetomidine.
`
`6.
`
`Hospira expects to establish this lack of anticipation by introducing, for example,
`
`admissions by Amneal, the Trissel reference, the Precedex Concentrate label, stability
`
`information regarding dexmedetomidine, and expert testimony.
`
`B.
`
`7.
`
`Non-Obviousness
`
`Hospira expects to show that Amneal has failed to prove by clear and convincing
`
`evidence that the claimed subject matter of any asserted claim would have been obvious to a
`
`POSA in view of the Precedex Concentrate label in combination with various other prior art
`
`2
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 17 of 23 PageID #: 1420
`
`
`references at least because the references would not have taught a POSA to develop a ready-to-
`
`use dexmedetomidine formulation with a reasonable expectation of success, did not teach the use
`
`of a sealed glass container for the formulation, and did not teach a formulation having no more
`
`than about 2% decrease in the concentration of dexmedetomidine after five months of storage.
`
`8.
`
`Hospira expects to present, among other things, literature references regarding
`
`pharmaceutical development, stability information regarding dexmedetomidine, and fact-witness
`
`and expert testimony.
`
`9.
`
`To the extent that Amneal is able to establish a prima facie case of obviousness,
`
`Hospira expects to demonstrate that objective indicia of non-obviousness rebut that showing.
`
`The embodiment of the Patents-in-Suit, Precedex Premix, is a commercial success that met a
`
`long-felt but unmet need for a safer, more convenient, and more stable dexmedetomidine
`
`formulation. The value of Precedex Premix has been recognized in the industry, with current
`
`manufacturers of generic dexmedetomidine concentrate products now seeking approval to
`
`market generic versions of Precedex Premix.
`
`10.
`
`Hospira expects to present, among other things, commercial information
`
`regarding Precedex Premix and competing products, evidence regarding the benefits of the
`
`Precedex Premix formulation and the desire for such a product among medical professionals,
`
`along with fact-witness and expert testimony.
`
`C. Written Description
`
`11.
`
`Hospira expects to show that Amneal has failed to prove by clear and convincing
`
`evidence that the inventors lacked possession of the claimed invention with respect to the free-
`
`base form (in addition to the pharmaceutically acceptable salt form). Hospira expects to
`
`introduce, among other things, the specification of the Patents-in-Suit as well as fact-witness and
`
`expert testimony.
`
`3
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 18 of 23 PageID #: 1421
`
`
`12.
`
`Hospira expects to show that Amneal has failed to prove by clear and convincing
`
`evidence that the inventors lacked possession of the claimed invention with respect to the 0.005-
`
`50 µg/mL dexmedetomidine concentration range recited in certain asserted claims. Hospira
`
`expects to introduce, among other things, the Patents-in-Suit as well as fact-witness and expert
`
`testimony.
`
`D.
`
`13.
`
`Definiteness
`
`Hospira expects to show that Amneal cannot meet its burden of proving by clear
`
`and convincing evidence that a POSA would not understand with reasonable certainty the scope
`
`of the ‘106 patent claim term “about 2% decrease in the concentration of dexmedetomidine” in
`
`light of the patent specification. Hospira expects to present the specification of the Patents-in-
`
`Suit and expert testimony.
`
`III. RELIEF
`
`14.
`
`Hospira expects to prove that it is entitled to an order, under 35 U.S.C. §
`
`271(e)(2)(A), that Amneal’s submission to the FDA of its ANDA with a paragraph IV
`
`certification as to the Patents-in-Suit was an act of infringement of at least one Asserted Claim.
`
`15.
`
`Hospira expects to prove that it is entitled to a declaration, under 35 U.S.C. §
`
`271(a), (b), and/or (c), that Amneal would infringe at least one asserted claim by the
`
`manufacture, use, offer for sale, sale, and/or importation of the Amneal ANDA Products before
`
`the expiration of the Patents-in-Suit (including added periods of exclusivity).
`
`16.
`
`Hospira expects to prove that it is entitled to injunctive relief, under 35 U.S.C. §
`
`271(e)(4)(B) and/or 35 U.S.C. § 283, enjoining Amneal and all officers, agents, servants,
`
`employees, privies, and others acting for, on behalf of, or in concert with them, from infringing
`
`any asserted claim before the expiration of the Patents-in-Suit (including added periods of
`
`exclusivity).
`
`4
`
`

`

`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 19 of 23 PageID #: 1422
`
`
`17.
`
`Hospira expects to prove that it is entitled to an order, under 35 U.S.C. §
`
`271(e)(4)(A), that the effective date of any FDA approval of Amneal’s ANDA will not be earlier
`
`than
`
`the expiration of
`
`the Patents-in-Suit (including added periods of exclusivity).
`
`5
`
`

`

`
`
`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 20 of 23 PageID #: 1423
`
`EXHIBIT M
`
`Amneal’s Statement of Intended Proofs
`
`Pursuant to Local Rule 16.3(c)(8), Amneal submits the following brief statement of the
`
`
`
`primary matters Amneal intends to prove at trial. This statement is not exhaustive, and Amneal
`
`reserves the right to prove any matter identified in its pleadings, discovery responses, expert
`
`reports, and the accompanying statements of issues of facts and issues of law that remain to be
`
`litigated at trial. Amneal also intends to offer evidence as to the issues of fact and issues of law
`
`identified in this Pretrial Order. Amneal may also provide additional proof to rebut any proof
`
`offered by Hospira before and during trial, in response to rulings by the Court, or for other good
`
`cause. Amneal reserves the right to modify or amend this Statement to the extent necessary in
`
`response to Hospira’s pretrial activities, any subsequently produced discovery, or any pretrial
`
`ruling or decision of the Court. Amneal incorporates by reference its expert reports in support of
`
`any proof to be presented by expert testimony.
`
`I.
`
`NON-INFRINGEMENT
`
`1.
`
`Hospira bears the burden of proof on infringement of the patents-in-suit. Amneal
`
`will, to the extent necessary, introduce evidence to rebut Hospira’s contentions that Amneal
`
`infringed Claims 1-9 of the ‘106 patent by filing ANDA No. 207551 for the Amneal ANDA
`
`Products with a paragraph IV certification as to the patents-in-suit.
`
`2.
`
`Amneal will also introduce evidence to rebut Hospira’s contentions that the
`
`manufacture, use, offer for sale, sale, and/or importation of the Amneal ANDA Products will
`
`infringe Claims 1-9 of the ’106 patent.
`
`3.
`
`To rebut Hopira’s contentions on infringement of the patents-in-suit, Amneal
`
`expects to present, among other things, portions of ANDA No. 207551 and expert testimony.
`
`
`
`1
`
`

`

`
`
`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 21 of 23 PageID #: 1424
`
`II.
`
`INVALIDITY
`
`A.
`
`4.
`
`Obviousness
`
`Amneal intends to prove at trial that Claims 1-4 of the ’158 patent; Claims 1-7 of
`
`the ’470 patent; Claims 1 and 5 of the ’527 patent; and Claims 1-9 of the ’106 patent would have
`
`been obvious under 35 U.S.C. § 103(a) based on the Precedex Premix product and label, either
`
`alone, or in combination with various other prior art references and/or the knowledge of those of
`
`skill in the art.
`
`5.
`
`Amneal also intends to prove that Claims 1-4 of the ’158 patent; Claims 1-7 of the
`
`’470 patent; Claims 1 and 5 of the ’527 patent; and Claims 1-9 of the ’106 patent would have been
`
`obvious under 35 U.S.C. § 103(a) by prior public use of medical personnel in accordance with the
`
`2010 Precedex Label, as evidenced by at least the Cain Reference, either alone or in combination
`
`with other prior art.
`
`6.
`
`To prove obviousness, Amneal expects to present, among other things, expert
`
`testimony, fact witness testimony, prior art references, other references reflecting the state of the
`
`art as of the priority date of the asserted patents, the differences, if any between the asserted
`
`claims and what is disclosed in the prior art, the motivation to pursue the claimed inventions, the
`
`reasonable expectation of success a POSA would have had in doing so, and the lack of secondary
`
`considerations of non-obviousness.
`
`B.
`
`7.
`
`Anticipation
`
`Amneal intends to prove at trial that Claims 1-3 of the ’158 patent; Claims 1-6 of
`
`the ’470 patent; Claims 1 and 5 of the ’527 patent; and Claims 1-8 of the ’106 patent are
`
`anticipated under 35 U.S.C. § 102(b) by Trissel.
`
`8.
`
`To prove anticipation, Amneal expects to present, among other things, expert
`
`testimony and Trissel.
`
`
`
`2
`
`

`

`
`
`Case 1:15-cv-00697-RGA Document 99-3 Filed 08/14/17 Page 22 of 23 PageID #: 1425
`
`C.
`
`9.
`
`Indefiniteness
`
`Amneal intends to prove that, to the extent the claim element “for at least five
`
`months exhibits no more than about 2% decrease in the concentration of dexmedetomidine” is not
`
`merely an inherent result, Claims 1-9 of the ’106 patent are invalid under 35 U.S.C. § 112 for
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`indefiniteness. Amneals intends to show that the claim term in light of the patent specification
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`does not inform those skilled in the art about the scope of the invention with reasonable certainty.
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`10.
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`To prove indefiniteness, Amneal expects to introduce, among other things, the
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`specification of the patents-in-suit, fact witness and expert testimony, and references showing the
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`knowledge of those of skill in the art.
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`D.
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`11.
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`Lack of Adequate Written Description
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`Amneal intends to prove that Claims 1-4 of the ’158 patent; Claims 1-7 of the ’470
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`patent; Claims 1 and 5 of the ’527; and Claims 1-9 of the ’106 patent are invalid under 35 U.S.C.
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`§ 112 for insufficient written description support for dexmedetomidine free base composition.
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`Amneal intends to show that the listed inventors lacked possession of the free base composition
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`(and pharmaceutically acceptable salt forms) of dexmedetomidine.
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`12.
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`Amneal also intends to prove that Claims 1-7 of the ’470 patent; and Claims 1-5
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`and 7-9 of the ’106 patent are invalid under 35 U.S.C. § 112 for insufficient written description
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`support for the claimed ranges of 0.005 to 50 µg/mL dexmedetomidine concentrations. Amneal
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`expects to introduce, among other things, the specification of the patents-in-suit, in addition to fact
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`witness and expert testimony.
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`III. RELIEF
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`13.
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`A judgment declaring that Amneal has not and does not infringe, directly,
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`indirectly, literally or under the doctrine of equivalents, any valid and enforceable asserted claim
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`of the ’158 patent, the ’470 patent, the ’527 patent, and the ’106 patent; that Amneal has a la