`
`Sent:
`Recipient:
`
`Lehr Mary </O=CAR1ER-
`W ALLACE/OU=CRANMAJL/CN=RECIPIENTS/CN=EXCHANGE/CN=MLEHR>
`Tuesday, November 11, 2003 2:56:40 PM
`Balwani Gul <GBalwani@medpointepharma.com>;Cupo Frank
`<FCupo@medpointepharma. com>;Dang Grace <gdang@medpointeinc. com> ;He
`Weixuan <WHe@medpointepharma.com>;Mortko Henry
`<HMortko@medpointepharma.com>; Yayac Cindy <CYayac@medpointepharma.com>
`Cc:
`D'Addio Alex <ADAddio@medpointepharma.com>
`Subject:
`Wednesday Cough/Cold Meeting
`Attachments: Projects2.xls
`
`In place ofthe Wednesday Cough/Cold meeting this week, we will meet to discuss ongoing and proposed projects,
`resources, and timing in preparation for the FY 2005 budget. Please review the attached Jist of projects and come to the
`meeting prepared to identify specific activities performed by you and your reports to support and/or execute each project.
`At this initial meeting we will focus on providing task details and timing required to complete projects that require 2 or
`more FTEs and identifying individuals needed for each task. Note that the MX projects are included in the list to serve as
`"markers" until substitute products are identified.
`
`PLAINTIFFS'
`TRIAL EXHIBIT
`PTX0255
`
`~
`
`EXHIBIT
`
`i D' 1'1-ddlb-IJ
`I o tv r ~.,~~
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03470939
`
`PTX0255-00001
`
`1
`
`CIP2122
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`
`Product and Process Development Projects
`
`Priority
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`2
`2
`2
`2
`2
`2
`2
`2
`2
`2
`2
`2
`
`Project
`Astelin - Quality 0-B 5502BN Bottle Resin
`Astelin - Feasibility Study - V Bottom/Pump Placer
`Astelin - Evaluate NC08 Pump Actuator
`Astelin - Nasal Spray Reformulation
`Qualify Alternate Astelin NS Manufacturing and Testing Site
`Tussi-12D Suspension- Commitments to Compliance
`Update Tannate Drug Substance Assay- JFC Methods
`Preformulation Evaluation of Tannate Actives
`Sina-12X- Monltor Stability Programs
`Ryna-12X- Monitor Stability Programs
`Tussi-12X Suspension - Develop Formulation & Methods
`Tussi-12X Tablets- Develop Formulation & Methods
`Packaging Evaluation forT an nate Products
`Doral Tablets- Dissolution Profile Testing and Evaluation
`Depen - Qualify Manufacturing Site
`Optivar- Manufacturing Process Transfer Support
`Depen/Soma - Degradation Evaluation
`Astelin - Maintain Commercial Supply
`EZ Chrome Computer Validation (21 CFR 11)
`Cranbury GMP Compliant Operational Procedures (SOPs)
`Cranbury GMP Compliant Set-Up lQ/OQ/PQ Lab Equipment
`Cranbury GMP Compliant Training
`Astelin - Sample Package Fill Optimization
`Astelin - Qualify_ Calmar-Albert Pump
`Astelin - Transfer E:xtractables Method to Valois
`Quality - Support Site Audits
`Intellectual Property/Due Diligence/Tech Evai/Licensing
`Reference Standards Program
`Soma Sustained Release - Develop Formulation
`Modernize Decatur Analytical Methods
`Drug Substance Optimization
`Analytical Site Change Submission for Transferred Products
`Astelin- Full Pump Release Testing at Valois
`Astelin- Full Pump Release Testing at Calmar
`Decrease Phenylephrine Tannate Overage
`Anti-oxidant for Cough/Cold Products
`Optivar - Smaller Sample Size
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA APTX03470940
`
`PTX0255-00002
`
`2
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`
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`2
`2
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`3
`4
`4
`4
`4
`4
`4
`4
`4
`5
`5
`5
`5
`
`Astelin -Justify Removal of Nitrosamine Specification for Pump
`Soma 350 - Qualify Alternate Manufacturing Site
`Sina-12 MX Suspension - Feasibility Evaluation
`Sina-12 MX Tablets- Feasibility Evaluation
`Sina-12 MX Suspension - Develop Formulation and Methods
`Sina-12 MX Tablets- Develop Formulation and Methods
`Sina-12 MX Tablets- Transfer Process and Methods
`Sina-12 MX Suspension - Transfer Process and Method
`Ryna-12 MX Suspension - Feasibility Evaluation
`Ryna-1 2 MX Tablets- Feasibility Evaluation
`Ryna-12 MX Tablets- Transfer Process and Methods
`Ryna-12 MX Suspension- Transfer Process and Method
`Ryna-12 MX Suspension - Develop Formulation & Methods FY05
`Ryna-12 MX Tablets- Develop Formulation & Methods FY05
`Fluorofelbamate- Develop for IND
`Fluorofelbamate - Preformulation Evaluation
`Fluorofelbamate- IND and Scale-Up Support
`Dora! Tablets - Qualify New Drug Substance Supplier
`Fluorofelbamate - Develop And Evaluate Clinical Capsule Stability
`Tussi-12X Backup Suspension - Develop Formulation & Methods
`Tussi-12X Backup Tablets- Develop Formulation & Methods
`Astelin-D (Decongestant) - Feasibility Evaluation
`Soma - Lower Dose
`Astelin - Qualify 0-B Equistar Bottle Resin
`Facility/Lab/Office Management
`Dora! Tablets- Intermediate Dose
`Fluorofelbamate- Develop Tablet formulation
`Fluorofelbamate - Develop Pediatric Formulation
`Felbamate - Qualify Recrystallization (Orgamol)
`Soma 350 - DevelopNalidate New Deg Products Method
`Astelin - Investigate Elimination of BAC Adjustment Step
`Butisol - Validate Residual Acetone/ETAC Test Method
`Astelin NS/Steroid Combo - Feasibility of Dual Chamber
`Soma CC - Revise Current Dissolution Method
`Soma CC- DevelopNalidate New Deg Products Method
`Support Marketing (e.g., color change)
`Astelin - Develop Pediatric Product
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA APTX03470940
`
`PTX0255-00003
`
`3
`
`