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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`APPLICATION NO.
`
`14/096,346
`
`ISSUE DATE
`
`09/22/2015
`
`PATENT NO.
`
`9138456
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`2832
`
`210
`
`7590
`
`09/02/2015
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`PO BOX 2000
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`The projected patent numberandissue date are specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustmentis 0 day(s). Any patent to issue from the above-identified application will include
`an indication of the adjustmenton the front page.
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`If a Continued Prosecution Application (CPA) wasfiled in the above-identified application, the filing date that
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`APPLICANT(s) (Please see PAIR WEBsite http://pair.uspto.gov for additional applicants):
`
`Cubist Pharmaceuticals, Inc., Lexington, MA;
`Sandra O'Connor, Hudson, NH;
`Sophie Sun, Lexington, MA;
`Gaauri Naik, Cambridge, MA;
`
`The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location
`for business investment, innovation, and commercialization of new technologies. The USA offers tremendous
`resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation
`worksto encourage andfacilitate business investment. To learn more about why the USA is the best country in
`the world to develop technology, manufacture products, and grow your business, visit SelectUSA. gov.
`
`IR103 (Rey. 10/09)
`
`AMNEAL EX.1002
`
`AMNEAL EX. 1002
`
`

`

`
`Receipt date: 01/06/2014
`Application Number
`14096346
`14096346 - GAU: 1676
`
`
`Filing Date
`2013-12-04
`INFORMATION DISCLOSURE
`First Named Inventor|Sandra O'Connor
`
`STATEMENT BY APPLICANT
`(Not for submission under 37 CFR 1.99)
`
`
`WO
`PA
`ire
`
`Art Unit
`
`Examiner Name
`
`| 465
`
`1676
`
`
`
`
`
`Li Komatsu
`
` Attorney Docket Number
`
`| 552815 (CPT-011USDV)
`
`
`Lhange(s) applied
`O'Connor etal.
`
`Oo documen 24 2012-10-25|CUBIST PHARMA20120270772
`MCEY
`"
`29/2015
`
`
`
`23
`
`20110207658
`
`
`
`20090197799
`
`20020111311
`
`20070116729
`
`25
`
`26
`
`2?
`
`2011-08-25
`
`Kelleher, ThomasJ.
`
`Keith et al.
`
`Govardhan etal.
`
`2009-08-01
`
`2002-08-01
`
`2007-05-01
`
`
`
`
`
`
`
`
`
`
`
`
`If you wish to add additional U.S. Published Application citation information please click the Add button. Add
`FOREIGN PATENT DOCUMENTS
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`Pages,Columns,Lines
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`ae
`.
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`.
`.
`
`
`Examiner] Cite|Foreign Document Publication - . where Relevant
`
`
`“ey
`.
`Applicant of cited
`
`
`Initial No|Number3 Date Passages cr Relevant
`
`Document
`.
`Figures Appear
`
`
`
`1
`
`2
`
`W02001/044274 A1
`
`WO2001/053330 A2
`
`
`
`4
`
`W0O2002/056829 A2
`
`2001-06-21
`
`CUBIST
`PHARMACEUTICALS,
`INC
`
`2001-07-26
`
`CUBIST
`PHARMACEUTICALS,
`INC
`
`2002-07-25
`
`CUBIST
`PHARMACEUTICALS,
`INC
`
`INTRABIOTICS
`3 2002-07-18|PHARMACEUTICALS,WO2002/055537 A1
`INC.
`
`
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/L.K//
`
`AMNEAL EX.1002
`
`AMNEAL EX. 1002
`
`

`

`
`
`Application Number
`14096346
`14096346 - GAU: 1676
`
`
`Filing Date
`2013-12-04
`INFORMATION DISCLOSURE
`
`First Named Inventor|Sandra O'Connor
`STATEMENT BY APPLICANT
`(Not for submission under 37 CFR 1.99)
`
`
`
`Receipt date: 01/06/2014
`
`
`
`
`
`
`Art Unit
`
`| 1654s
`
`1676
`
`Examiner Name
`
`Li Komatsu
`
`Attorney Docket Number
`
`| 552815 (CPT-011USDV}
`
`
`
`
`
`
`
`
`
`
`
`12 2006-01-26_|Vaya, Navin20060018934
`
`
`
`
`
`
`
`13 2006-02-02_|Vaya, Navin20060024365
`
`
`
`20060264513
`
`2006-11-23
`
`Leone-Bay etal.
`Lemiepirere-Fechnotogies—ine—
`
`
`
`14
`Change (s) applied
`toLde men
`
`/NCEY
`5/29/2015) 18 2006-11-30|Friedman, Doron20060269485
`
`
`16
`
`20070116729
`
`2007-05-24
`
`Palepu, Nageswara R.
`
`
`
`
`
`17 2007-08-16_|Kelleher, Thomas20070191280
`
`
`
`
`
`
`
`18 2008-09-11_|Birnbaum, Eva R.20080220441
`
`
`
`19 2009-08-06_|Keith, Dennis20090197799
`
`
`
`
`
`
`
`
`
`20 2010-02-18_|Keith, Dennis20100041589
`
`Palepu et al.
`21 2011-05-26|EAGLE Pr90110124551
`
`
`
`
`
`Palepu et al.
`22 2011-07-14—|EAGLE PHARMA20110172167
`
`
`
`
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/L.K//
`
`AMNEAL EX.1002
`
`AMNEAL EX. 1002
`
`

`

`
`
`
`
`
`
`
`
`
`Receipt date: 01/06/2014
`Application Number
`14096346
`14096346 - GAU: 1676
`
`
`Filing Date
`2013-12-04
`
`INFORMATION DISCLOSURE First Named Inventor|Sandra O'Connor
`
`STATEMENT BY APPLICANT (,
`seer
`sie
`
`
`
`(Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`thestochsecoleoaren mem tetlc Li Komatsu
`
`Attorney Docket Number
`
`| 552815 (CPT-011USDV)}
`
`
`
`Govardhan, et al.
`C ANESNS/ AFIPliCe
`2002-08-15
`20020111311
`fe document
`GubichRhennasedisale-ires
`-08-
`.
`/MCEY
`,
`
`BALI/2O15
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`20020132762
`
`20030045484
`
`20030045678
`
`20040067878
`
`20040077601
`
`20040242467
`
`20050009747
`
`20050196418
`
`20060014674
`
`2002-09-19
`
`Borders, Donald B.
`
`2003-03-06
`
`Keith, Dennis
`
`2003-03-06
`
`Keith, Dennis
`
`2007-04-08
`
`Hill, Jason
`
`2004-04-22
`
`Adams, Sharlene
`
`2004-12-02
`
`Borders, Donald B.
`
`2005-01-13
`
`Kelleher, Thomas
`
`2005-09-08
`
`Yu, Ruey J.
`
`2006-01-19
`
`Keith, Dennis
`
`
`
`
`
`11
`
`20060018933
`
`2006-01-26
`
`Vaya, Navin
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/L.K//
`
`AMNEAL EX.1002
`
`AMNEAL EX. 1002
`
`

`

`14096346 - GAlbnd76
`Bacsipigate: 01/06/2014
`Approved for use through 07/31/2012. OMB 0651-0031
`:
`eye
`.
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`Doc description: Information Disclosure Statement(IDS) Filed
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`
`Application Number
`14096346
`
`
`
`
`
`
`
`
`Filing Date
`2013-12-04
`INFORMATION DISCLOSURE First Named Inventor|Sandra O'Connor
`
`
`STATEMENT BY APPLICANT
`Art Unit
`| 54.1676
`
`Examiner Name
`obNeihesigned
`Li Komatsu
`Attorney Docket Number
`| 552815 (CPT-011USDV}
`
`( Not for submission under 37 CFR 1.99)
`
`
`
`U.S.PATENTS
`Remove
`
`
`Nameof Patentee or Applicant Pages,Columns,Lines where
`Kind
`Examiner) Cite
`.
`Relevant Passages or Relevant
`ae
`iy
`Initial
`No
`Code1
`of cited Document
`.
`Figures Appear
`
`
`Patent Number
`
`Issue Date
`
`1
`
`6696412
`
`2004-02-24
`
`Thomas J. Kelleher
`
`
`
`C ange(s) apbhed
`
`6716962
`
`13
`
`7138487
`
`
`to document,
`/MCE/
`B/RI/LOIS
`
`Borders > ot al.
`
`2004-04-06
`
`b-Mierelegvedieteghelags:
`
`2006-11-21
`
`Borders » ct al.
`“"itigeri-ine
`
`
`
`4
`
`7279597
`
`2007-10-09
`
`{eone-Bay » et al,
`pemispirerePechroogresiit
`
`
`
`Kelleher, etal.
`3 P@ubistPrarnaceudigalelin8058238 2011-11-15
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`6
`
`8003673
`
`2011-08-23
`
`Alderet al.
`
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`ae
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`.
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`Initial
`Number
`Cede] Date
`of cited Document
`.
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`
`
`
`
`
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`
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`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/L.K//
`
`AMNEAL EX.1002
`
`AMNEAL EX. 1002
`
`

`

`
`
`Receipt date: 01/06/2014
`
`
`Application Number
`14096346
`14096346 - GAU: 1676
`
`Filing Date
`2013-12-04
`INFORMATION DISCLOSURE
`First Named Inventor|Sandra O'CONNOR
`
`STATEMENT BY APPLICANT
`(Not for submission under 37 CFR 1.99)
`
`[1964
`Art Unit 1676
`
`Examiner Name
`
`Taiit Komatsu Attorney Docket Number
`
`
`| 592815 (CPT-011USDV)
`
`U.S.PATENT APPLICATION PUBLICATIONS
`
`
`Examiner] Kind|Publication.. Publication Nameof Patentee or Applicant Pages,Columns,Lines where
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`ve
`ty
`Cite No
`Relevant Passages or Relevant
`of cited Document
`Initial
`Number
`Code) Date
`.
`
`Figures Appear
`
`Remove
`
`2012-02-16
`
`Kelleheretal.
`
`2010-02-18
`
`Keith et al.
`
`2012-07-10
`
`
`
`
`
`20120149062
`
`20100041589
`
`20120270772
`
`20050027113
`
`20070128694
`
`
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`2005-02-03
`
`Vivian Pak Woon Miaoetal.
`
`2007-06-07
`
`Baltz et al.
`
`
`
`
`
`Add
`
`
`BAZISLONVS
`
`
`
`
`
`
`
`Clhangets}
`apptted
`seer
`Kelleher et al.
`to document
`
`MCE 6 SSubistPHharnacertigalediicen.20130280760 Al 2013-10-24
`
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`Initial*
`
`
`
`Cite
`No
`
`1
`
`Foreign Document
`Number3
`
`WO 00018418
`
`2
`
`WO 99027957
`
`
`
`
`
`Country
`Code? j
`
`Kind
`Code4
`
`Publication
`Date
`
`Name of Patentee or
`Applicant of cited
`Document
`
`Pages,Columns,Lines
`where Relevant
`Passages or Relevant
`Figures Appear
`
`Ts
`
`2000-04-06
`
`Cubist Pharmaceuticals
`
`1999-06-10
`
`Co.
`
` The Immune Response
`
`
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/L.K//
`
`AMNEAL EX.1002
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`AMNEAL EX. 1002
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`

`

`
`Receipt date: 01/06/2014
`
`
`Application Number 14096346 - GAU: 1676 14096346
`
`Filing Date
`2013-12-04
`
`INFORMATION DISCLOSURE First Named Inventor|Sandra O'CONNOR
`
`STATEMENT BY APPLICANT
`
`
`An Unit 676 |
`
`
`
`
`Examiner Name
`
` :
`:
`ae
`Attorney Docket Number
`| 552815 (CPT-011USDV)
`
`Li Komatsu
`
`(Not for submission under 37 CFR 1.99)
`
`
`
`
`
`
`
`
`Palepu etal.
`
`9
`
`4482487
`
`1984-11-13
`
`Abbott et al,
`
`
`
`10
`
`4331594
`
`1982-05-25
`
`Hamill etal.
`
`11
`
`4439425
`
`1984-03-27
`
`Tarcsay etal.
`
`12
`
`5336756
`
`1994-08-09
`
`Schwartz etal.
`
`13
`
`8431539
`
`2013-04-30
`
`14
`
`6696412
`
`2004-02-24
`
`Kelleheretal.
`
`15
`
`8309061
`
`2012-11-13
`
`
`
`
`Changk(s) applied
`to doc iment,
`
`K-KG
`
`6/10/2015
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`og
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`wey
`Relevant Passages or Relevant
`Cite No
`.
`Number
`Code’! Date
`Initial
`of cited Document
`Figures Appear
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`

`14096346 - GAlbnd76
`Bacsipigate: 01/06/2014
`Approved for use through 07/31/2012. OMB 0651-0031
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`eye
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`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`
`Application Number
`14096346
`
`Filing Date
`2013-12-04
`INFORMATION DISCLOSURE First Named Inventor|Sandra O'CONNOR
`
`
`STATEMENT BY APPLICANT
`
` Art Unit | +664 1676
`
`( Not for submission under 37 CFR 1.99)
` eeigned
`Attorney Docket Number
`| 552815 (CPT-011USDV}
`
`Examiner Name
`
`=fi Komatsu
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`U.S.PATENTS Remove
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`Pages,Columns,Lines where
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`Kind
`Patent Number
`Examiner Cite
`Name of Patenteeor Applicant Relevant Passages or Relevant
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`No
`Code1
`of cited Document
`.
`Figures Appear
`
`
`1
`
`6194383
`
`2001-02-27
`
`Hammann etal.
`
`
`
`2
`
`5955509
`
`1999-09-21
`
`Webberet al.
`
`
`
`3
`
`5629288
`
`1997-05-13
`
`Lattrell et al.
`
`
`
`
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`
`4
`
`5387670
`
`1995-02-07
`
`Royet al.
`
`
`
`5
`5271935
`1993-12-21
`Francoet al.
`hange{s) applied
`
`tq docu mene,
`SRK
`
`6
`
`4887164
`
`1989-11-21
`
`Ferro
`
`6410/2015
`
`
`
`4331594
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`1982-05-25
`
`Hamill et al.
`~~idermetal,
`
`8604164
`
`2013-12-10
`
`Kelleheret al.
`
`7
`
`8
`
`AMNEAL EX. 1002
`
`

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`
`
`APPLICATION NUMBER
`
`FILING OR 371(C) DATE
`
`14/096,346
`
`12/04/2013
`
`113613
`Lathrop & Gage
`
`28 State Street
`Boston, MA 02109-1775
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`TNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and‘Trademark Office
`Address: COMMTSSIONER, FOR PATENTS
`P.C.B
`Alexandria, \Ving-nia 22313-1450
`ATTY. DOCKET NO./TITLE
`
`FIRST NAMED APPLICANT
`
`Sandra O'Connor
`
`23961-US-DIV
`CONFIRMATION NO. 2832
`POWER OF ATTORNEYNOTICE
`
`MATAAAAA
`0000768592
`Date Mailed: 08/14/2015
`
`NOTICE REGARDING CHANGE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 08/10/2015.
`
`«The Power of Attorney to youin this application has been revoked by the assignee whohasintervened as
`provided by 37 CFR 3.71. Future correspondencewill be mailed to the new addressof record(37 CFR 1.33).
`Questions about the contents of this notice and the
`requirements it sets forth should be directed to the Office
`of Data Management, Application Assistance Unit, at
`(571) 272-4000 or (571) 272-4200 or 1-888-786-0101.
`
`/Uhill/
`
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`
`page 1 of 1
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`AMNEAL EX.1002
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`AMNEAL EX. 1002
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`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`TNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and‘Trademark Office
`Address: COMMTSSIONER, FOR PATENTS
`PC. Bo:
`Alexandria, Virznia 22313-1450
`www.uspto.gov
`
`FIRST NAMED APPLICANT
`ATTY. DOCKET NO./TITLE
`APPLICATION NUMBER
`FILING OR 371(C) DATE
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`14/096,346
`12/04/2013
`Sandra O'Connor
`CONFIRMATION NO. 2832
`POA ACCEPTANCE LETTER
`
`210
`MERCK
`
`P 0 BOX2000
`RAHWAY, NJ 07065-0907
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`AMTOAR
`000000076859248
`Date Mailed: 08/14/2015
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`NOTICE OF ACCEPTANCE OF POWER OF ATTORNEY
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`This is in response to the Power of Attorney filed 08/10/2015.
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`The Power of Attorneyin this application is accepted. Correspondencein this application will be mailed to the
`above addressas provided by 37 CFR 1.33.
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`Questions about the contents of this notice and the
`requirements it sets forth should be directed to the Office
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`/Thill/
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`AMNEAL EX.1002
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`AMNEAL EX. 1002
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`PARTB - EEE(S) TRANSMITTAL
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`Complete and send this form, together with applicablefeeis), to: Mail Mail Step ISSUE PRE.
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`AMNEAL EX.1002
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`Electronic Patent Application Fee Transmittal
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`Filing Date:
`
`04-Dec-2013
`
`Title of Invention:
`
`LIPOPEPTIDE COMPOSITIONS AND RELATED METHODS
`
`Sandra O'Connor
`First Named Inventor/Applicant Name:
`
`Filer:
`Dianne Pecoraro/Pia Paras-Sanjurjo
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`Utility Appl Issue Fee
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`AMNEAL EX.1002
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`Electronic Acknowledgement Receipt
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`23188623
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`Title of Invention:
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`LIPOPEPTIDE COMPOSITIONS AND RELATED METHODS
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`First Named Inventor/Applicant Name:
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`Sandra O'Connor
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`113613
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`Filing Date:
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`04-DEC-2013
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`Charge any Additional Fees required under 37 C.F.R. Section 1.20 (Post Issuance fees)
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`23961-Execlfee-12Aug2015.pdf do3ab8bde54e026d9096545 /aY390eb//3)
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`PTO/ALA/EG (07-12)
`Approved for use through 17/80/2074. OME 66510035
`US. Patent and Trademark Office; US DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond tc a collection of information untess it displays a valid OMB contro! number.
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`F thereby revoke all previous powers of attorney given in the application identified in the attached staternent
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`thereby appoint:
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`0021 0
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`Registration
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`As atiorney(s) ar ageni{s) to represent the undersigned before the United States Patent and Trademark Office (USPTO) in connection with
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` POWER OF ATTORNEY TO PROSECUTE APPLICATIONS BEFORE THE USPTO
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`nennnencfeneneeene= collectionofinformarttic!
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`Individual Name
`
`Address
`
`City
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`Country
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`Telephone
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`Assignee Name and Address: Cubist Pharmaceuticals LLC
`2000 Galloping Hill Road
`Kenilworth, New Jersey 07033
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`A copy of this form, together with a statement under 37 CFR 3.72(c} (Form PTO/AIA/96 or equivalent) is required to be
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`Signature
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`/Laura M. Ginkel, Reg. No. 51,737/
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`Date August 10, 2015
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`ee
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`AMNEAL EX.1002
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`Privacy Act Statement
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`The Privacy Act of 1974 (P.L, 93-378) requires that you be given certain information in connection with your
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`AMNEAL EX.1002
`
`AMNEAL EX. 1002
`
`

`

`MERCK & CO., INC.
`
`CERTIFICATION
`
`|, Katie E. Fedosz, Senior Assistant Secretary of Merck & Co., Inc. (the
`
`“Company”), a corporation duly organized and existing underthe laws of the State of
`
`New Jersey, United States of America, do herebycertify that the attached, presently in
`
`full force and effect, is a true and correct copy of General Corporate Resolution #5,
`
`Patent Matters, as amended and readopted the Board of Directors of said Companyat
`
`a meeting thereof duly called and held on July 22, 2015, at which a quorum of Directors
`
`was present.
`
`IN WITNESS WHEREOF, | have hereunto subscribed my signature and
`
`affixed the seal of the Companythis 22" day of July, 2015.
`
`Senior Assistant Secretajy——
`
`(SEAL)
`
`United States of America)
`State of New Jersey
`County of Hunterdon
`
`)
`
`)Ss
`
`Subscribed and sworn to before me onthis 22"¢ day of July, 2015.
`
`id. Wan / MPabdyr,
`
`Notary Public
`
`SANDRA MARIE MCFADDEN
`NOTARY PUBLIC, STATE OF NEW JERSEY
`My COMMISSION EXPIRES JANUARY 18, 2020
`
`AMNEAL EX.1002
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`AMNEAL EX. 1002
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`

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`Page 1 of 1
`Amended 7/22/15
`
`General Corporate Resolution #5
`
`PATENT MATTERS
`
`RESOLVED, that any of the following:
`
`Kenneth C., Frazier - Chairman, President and Chief Executive Officer
`Michael J. Holston — Executive Vice President and General Counsel
`William Krovatin -- Senior Vice President and Assistant General Counsel
`Mark R. Daniel — Associate Vice President and Group Managing Counsel
`Gerard M. Devlin, Jr. - Managing Counsel, IP Litigation
`Catherine D. Fitch - Managing Counsel, Patents
`Laura M. Ginkel - Managing Counsel, Patents
`Sheldon O. Heber ~ Senior Counsel, Patents
`J.J.L. Mestrom — Managing Counsel, IP Animal Health
`Mary J. Morry — Senior Counsel, IP Litigation
`immac Thampoe — Managing Counsel, Biologics
`John C. Todaro ~- Managing Counsel, Patents
`Anna L. Cocuzzo — Assistant Managing Counsel, Biologics
`Gloria Fuentes — Assistant Managing Counsel, Biologics
`James Horgan — Assistant Managing Counsel, European Patents
`Cynthia A. Francisco — Director, Asset Management
`
`are authorized to execute and to revoke on behalf of Merck & Co., Inc. andits affiliates
`(including subsidiaries) the following documents relating to patent matters:
`
`Powers of attorney as fully in law as may be necessary and properin connection with
`the acquisition, registration, maintenance and enforcementof patents and applications
`for patents, including powersof attorneyrelating to the prosecution or defense of patent
`rights before courts of law or other governmentaltribunals, agencies or departments;
`affidavits and declarations; and any other documents which are necessary and proper
`for the acquisition, registration, maintenance, litigation and protection of patents.
`
`
`
`AMNEAL EX.1002
`
`AMNEAL EX. 1002
`
`

`

`PTO/AIA/S6 (08-12)
`Approved for use through 01/31/2013. OMB 0651-0031
`U.S. Patent and Trademark Office:'U.S, DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of1995. no persons arerequired to respond to a collection of information unlessit displays a valid OMB control number.
`
`STATEMENT UNDER 37 CER 3.73(c)
`Applicant/Patent Owner: Cubist Pharmaceuticals LLC
`
`Application No./Patent No.: 14/096 ,346
`Filed/Issue Date: 12/04/2013
`
`Titleq. LIPOPEPTIDE COMPOSITIONS AND RELATED METHODS
`
`Cubist Pharmaceuticals