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`Helsinn Healthcare Exhibit 2053
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
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`Page 1 of 2
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`Both drug substance and drug product manufacturing establishments are ready for pre-7
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`approval inspection at this time as described in the establishment inforrnation attached to
`the Form FDA 356h.
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`Consistent with discussion at the pre—NDA meeting, 18-month drug product stability data
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`from the RP Scherer West, lnc., dba SP Pharmaceuticals manufacturing site is planned
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`for submission during review in the March 2003 tirnefrarne.
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`A letter appointing Dr. Craig Lehmann, August Consulting, as Authorized Representative
`for this NDA is attached to this cover letter. Dr. Lehrnann is also cited on the Form FDA
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`356h in this capacity. Please Contact him at 512-34-7—l’755, fax 512-347-9375, regarding
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`all matters pertaining to this NDA.
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`Patent information is also attached in this letter.
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`Please contact me at our corporate headquarters in Lugano, Switzerland, if I can be of
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`assistance. My phone number is 011-41-91-985-2121.
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`Sincerely,
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`HELSENN HEALTHCARE SA
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`Dario Ceriani, M. Chem. Pharm.
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`Senior Manager Regulatory Affairs
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`Dr. Craig Lehrnann Authorized Representative for the NDA (August Consulting)
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`Mr. Franco DeVecchi Sr., Authorized US Corporate Representative (VPCI Inc.)
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`: Letter appointing Dr. Lehmann as Authorized Representative for the NDA
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`Electronic files on CD with inventory (Archival. copy only)
`Patent Information
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`1 HNAL NDACOVerl_etter 2056:1102
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`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
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`HELSN0003537
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`PTX-321.0010
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`Page 2 of 2
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