`
`
`
` Erning Xia, Ph.D.
`
`
`
`
` 585-388-1519 (H)
` 585-489-2647 (C)
`
`
`93 Chippenham Dr
`
`
`
`Penfield, New York 14526
`
`EDUCATION
`Ph.D. in Pharmaceutics, University of Iowa
`M.S. in Biopharmaceuticals, China Pharmaceutical
`University
`B.S. in Pharmacy, Nanjing College of Pharmacy
`
`KEY MARKETED PRODUCTS
`
`
`
`Peroxi ClearTM
`
`2014
`
`
`2012
`
`
`Lotemax Gel (NDA)
`2010
`
`Biotrue™ (MPS)
`
`
`2010
`Soothe XH (Xtra Hydration™)
`
`2009
`Besivance® (NDA)
`
`
`
`2007
`Soothe PF
`
`
`
`
`2004
`ReNu MPS (MoistureLoc™)
`
`Brimonidine Tartrate (ANDA)
`2003
`
`Ciprofloxacin Eye Drop (ANDA)
`2001
`
`
`
`
`Collyrium Eye Wash
`
`1999
`
`
`Preservision Tablet
`
`
`1998
`
`ReNu MPS (MultiPlus™)
`
`1997
`
`
`
`
`
`PROFESSIONAL EXPERIENCE
`
`
`
`
`
`Fulcrum International Technologies, Inc., Sep. 2013 – Present, CTO
`
`
`
`• Technology Consulting
`
`
`• Developed water-soluble based nutritional product for eye fatigue (7-Hours™)
`• Disinfection technology development for medical devices
`• Contact lens related solution developments such as extraction, hydration, packaging, cleaning
`and comforting
`• Eye drop platforms for daily disposable contact lens
`• Zero uptake of preservative systems for contact lens applications
`• Eye cream/eye drop double action system for treating pulp eyes
`• Ophthalmic composition for eye whitening
`• Generic Ophthalmic Product developments
`• Periocular skin care compositions comprising gentle preservative
`• Developed healthy eye lash serum - Sedusoie™
`
`
`
` DISTINGUISHED
` RESEARCH FELLOW
`
` CHIEF TECHNOLOGY OFFICER
`
`
`
`
`Valeant Pharmaceuticals, Rochester, NY, 2009-Aug. 2013, Program Director/Research Fellow
`• Expert in ANDA/505B(2) with QbD Implementation
`• Business Development Committee
`• Led Vision Care ideation initiatives
`
`
`
`1
`
`APOTEX 1006, pg. 1
`
`

`

`• Developed an enhanced and stabilized Hydrogen Peroxide platform with a controlled
`neutralization profile (Peroxi ClearTM)
`• Developed Hyaluronan-based multi-purpose solution platform (Biotrue™)
`• B+L FDA Design Control Expert.
`• Strong interpersonal, negotiation, communication, and problem solving skills.
`• Experienced in working with cross-functional teams with demonstrated ability to mentor and
`develop the necessary leadership skills in the subordinates.
`• Proven ability to form credible relationships with clients, and internal peers and subordinates
`• Provides technical direction for the development, design, and products integration for customer
`engagement from definition phase through implementation.
`• Applies significant knowledge of industry trends and developments to improve service to our
`customers.
`• Makes sure that company marketing strategy matches capability of R & D.
`• Easily recognizes system deficiencies and implements effective solutions.
`• Developed an aseptic processing concept for biopolymer(s)
`
` + L, Rochester, NY. 2006-2008, Site Leader/Research Fellow
`Integrated Jinan (50 FTE’s China) R&D and RA into Bausch + Lomb Global R&D and
`•
`provided technical support and service in following areas – liquid formulation, Vitamin
`formulation, Q/Q matches, new preservative synthesis, global product registrations in China,
`global clinical trials etc)
`• Established a bilingual SOP system for quality risk management (in China facility)
`• Established the very first preservative efficacy testing facility (both USP and EP) in China
`• Established an capability of synthesizing drug related compounds for LE family of products
`• Established one of the best Vitamin testing facility in China
`• Developed and validated product specific analytical methods for each of B + L Preservision
`products with a precision less than 1.0%
`• Established state-of-the-art analytical testing facility and provided services for B & L Global
`R&D and marketed products in China
`
` + L, Rochester, NY. 2004-2005, Research Fellow
`• Managed GPS (Gentle preservative systems) initiatives in US R&D
`• Developed Alginate-based dry eye platform (Soothe™)
`• Led dry eye initiatives and dry eye portfolio management (both OTC and Rx)
`• Represent R&D at critical senior level meetings with corporate executives as well as external
`collaboration
`Identify lead formulation candidates and compound selection for clinical development via
`preformulation studies
`• Leader of Globe Supply Strategy Team (API’s and Chemicals)
`• Developed strategic business partners to discover new technologies related to product
`developments
`• Committee Member of Bausch + Lomb Technical Ladder Committee
`• Patent review committees for both pharmaceutical and vision care
`
`•
`
` B
`
` B
`
` B
`
` + L, Rochester, NY. 2001-2004, Sr. Principal Formulation Process Scientist
`• Managed and prepared Product Development Manuals and CMC sections for NDA and ANDA.
`
`
`
`2
`
`APOTEX 1006, pg. 2
`
`

`

`• Managed a development group in the areas of sterile products for eye care markets such as
`antibiotic, anti-inflammatory, Glaucoma, anti-allergy, artificial tears, ocular lubricants, AMD,
`contact lens solutions and other nutraceticals.
`• Managed to develop new controlled delivery systems (emulsions, nano-suspensions, In-situ gelling
`system, implants, tablets, capsules etc.).
`• Managed formulation transfer and established specifications based on the capability of the
`manufacturing process and the analytical methods.
`• Heavily involved in multi-functional trouble shooting and problem solving (product recalls,
`reformulation, de-formulation etc.).
`• Developing an opportunistic approach for new category of pharmaceutics and/or eye care products
`with increased patentabilities.
`• External technology evaluations
`
`
` B
`
` + L, Rochester, NY. 1999-2001, Principal Formulation Process Scientist
`• Actively involved in the formulation and development of new products (such as: sustained release
`solid/liquid dosage forms) for general eye care products and contact lens care products.
`• Engaged in the formulation and development of surgical products for general eye care.
`• Transferred technology (internationally and domestically).
`• Served as a technical liaison between formulation dept., process development dept., manufacturing
`facilities and QA dept.
`
` B
`
`•
`
` + L, Rochester, NY. 1995-1999, Sr. Formulation Process Scientist
`• Actively involved in the formulation and development of parenteral products for general eye care
`products and contact lens care products.
`• Actively involved in the formulation and development of solid and semi-solid form for general eye
`care products and contact lens care products.
`• Actively involved in the searching and research of new disinfectants for ophthalmic dosage forms.
`• Good hands-on experiences of developing sterile filtration and bulk sterilization processes for
`various parenteral products.
`Introduced hands-off cleaning and disinfecting concepts and developed No-rub cleaning and
`disinfecting solutions for lens care/general eye care products and product strategies.
`• Evaluated and developed laboratory/pilot process for scale up and transferred several products to
`the manufacturing facilities domestically and internationally.
`• Served as technical liaison between formulation dept., process development dept. and
`manufacturing facilities.
`• Lead pilot plant experiences and projects for constructing pilot and manufacturing facilities.
`Authorship of technical evaluation, safety issues, cost estimating and manufacturing procedures.
`• Good hands-on experience and knowledge in utilizing state-of-the-art technology and equipment in
`preformulation/formulation and process development.
`• Set up SOP systems for operation of R&D facilities under FDA and ISO-approval operations.
`
`College of Pharmacy, University of Iowa, Iowa City, Iowa, Jan. 1990- 1995, Research and
`Teaching Assistant
`• Worked on different biopharmaceutical projects sponsored by Alcon Laboratories, Inc. and
`Angelini Pharmaceuticals, Inc., Italy/U.S.A.
`• Actively involved ophthalmic preformulation/formulation developments of ocular drug delivery
`system.
`
`
`
`3
`
`APOTEX 1006, pg. 3
`
`

`

`• Developed and performed high throughput pharmacological screening for dry eye drugs using cell
`culture method (in-vitro) and pharmacokinetics (in-vivo) study in ocular drug delivery using a
`bioanalytical HPLC assay.
`• Successfully discovered a potential drug candidate for dry eye disease (FDA Clinical III).
`• Performed animal experiments including corneal and sclera dosing, eye tissue dissection, blood
`sample collection, corneal permeability determination, and intraocular pressure measurement etc.
`
`
`Illinois State University, Normal, Illinois, Jan. 1988-Dec. 1989, Research Associate
`• Actively involved in isolation, purification and quantification of RNA/DNA from different rat
`tissues with different diets and ages.
`• Five papers published from this study led scientists in this field to a better understand of the
`relationship between aging process and diet.
`
`
`College of Pharmacy, China Pharmaceutical University, Aug. 1985-Dec. 1987, Assistant
`Professor and Research Associate
`• Actively involved in teaching and research area related to the preformulation/formulation of solid
`dosage form of polysaccharide drugs from the traditional Chinese medicines.
`• Prepared batch records and performed contract manufacture of batches for evaluating of taste-
`masking, bioavailability, stability, toxicity, clinical performance.
`• Designed models for evaluating biological activities of polysaccharides.
`• Evaluated the potentials of using polysaccharides as controlled released materials for anticancer
`drugs.
`
`
`HONORS AND AWARDS:
`• Awarded as an honored Distinguished Research Fellow at Shandong Institute of Pharmaceutical
`Research, Jinan, China (2014)
`• Bausch & Lomb In Focus Recognition (2010)
`• Adjunct Professor of Shandong University, China (2008)
`• QiLu Friendship Award (Shandong Government, China, 2008)
`• Awarded as an honored Distinguished Research Fellow at Shandong Institute of Pharmaceutical
`Research, 2008 (Jinan, China)
`• Bausch + Lomb CSO Innovation Award, 2007 (Rochester, New York)
`• National AWARD-Science Spectrum Trailblazer (2005, Baltimore)
`• National EMERALD AWARD-Career Achievement in Industry (2004, Nashville, Tenn.)
`• Commitment Awards (2001, Bausch + Lomb)
`• President Awards (2001, Bausch + Lomb)
`• Focus of Excellence (1995, 96, 97, 98, 99, 00, 01, 02, 03, 04, 05, 06 and 07 Bausch + Lomb)
`• Member of the Delta Chapter of the Rho Chi Pharmacy Honor Society (1991)
`• Award for the outstanding graduate student thesis (1985)
`
`ORGANIZATIONS:
`• American Association of Pharmaceutical Scientists (AAPS)
`• The Association for Research in Vision and Ophthalmology (ARVO)
`• Sigma Xi Society (American Chemistry Association)
`• Parenteral Drug Association (PDA)
`• American Chemical Society (ACS)
`
`•
`
`
`
`4
`
`APOTEX 1006, pg. 4
`
`

`

`HOBBIES:
`Free Style Stir-Fry Cooking
`Travelling
`Basketball
`
`U.S. PATENTS (including patent publications and applications from US and European Patent offices)
`
`
`“Treatment of Contact Lenses with Aqueous Solution Comprising a Biquanide
`1.
`Disinfectant and A Complementary Phosphate-Borate Buffer”, Xia E., J. Roglskyl and L. Simpson
`(ReNu MPS).
`
`U.S. Patent
`World Patent
`European Patent
`
`6,143,244
`1999024541 A1
`1,049,763 B1
`
`
`
`“Compositions Comprising Polyquaterniums in Combination with Polymeric
`2.
`Biquanides for Disinfecting Contact Lenses”, Xia E. and D. Heiler (ReNu MPS).
`U.S. Patent
`
`6,153,568
`World Patent
`1999024543 A1
`European Patent
`1030903 A1
`
`
`
`“Treatment of Contact Lenses with Aqueous Solution Comprising Carbonate Salts for
` 3.
`Enhanced Cleaning”, Xia E., L. Simpson and J. Denick,
`U.S. Patent
`
`6,309,658 B1
`World Patent
`
`1999043363
`European Patent
`1,030,692 B1
`
`“Treatment of Contact Lenses with Aqueous Solution Comprising A Biguanide
`4.
`Disinfectant Stabilized by A Polomamine”, Xia E. and D. Heiler (ReNu MPS).
`
`U.S. Patent
`
`6,309,596 B1.
`
`“Treatment of Contact Lenses with Aqueous Solution Comprising Biguanide
`5.
`Disinfectant Stabilized by Tyloxapol”, Xia E.,
`U.S. Patent
`
`6,369,112 B1
`
`
`
`
`
`“Composition and Method for Inhibiting Uptake of Biguanide Disinfectants by
`6.
`Poly(Ethylene)”, Xia E., R. Smerbeck, J. Denick.,
`U.S. Patent
`
`6,514,528 B1
`World Patent
`2003011350 A2
`European Patent
`1414303 A2
`
`
`
`7. “Composition and Method for Inhibiting Uptake of Biguanide Antimicrobials by
` Hydrogels”, Xia E., R. Smerbeck,
`U.S. Patent
`
`6,528,464 B1
`World Patent
`2003015835 A1
`European Patent
`1416976 A1
`
`8. “Reversible Gelling System for Ocular Drug Delivery”, Xia E., R. Smerbeck,
`U.S. Patent
`
`6,703,039 B2
`World Patent
`2002045683 A2
`
`
`
`
`
`5
`
`APOTEX 1006, pg. 5
`
`

`

`European Patent
`
`1,339,386 B1
`
`
`
`9. “High Osmolyte Cleaning and Disinfection Method and Solution for Contact Lenses”,
`Xia E., L. Simpson, R. Christine,
`U.S. Patent
`
`6,790,816 B2
`World Patent
`2002064715 A2
`
`
`
`10. “Compositions with Enhanced Antimicrobial Efficacy against E. coli”, Xia E., J.
`Salamone, R. Borazjani, Z. Hu, et al (ReNu MoistureLoc™).
`U.S. Patent
`
`7,067,479
`World Patent
`2004030709 A1
`
`
`
`“Oligosaccharide-Containing Compositions and Uses Thereof”, Xia E.,
`11.
`U.S. Patent
`
`7,192,937 B2
`World Patent
`2006014194 A1
`
`“Antimicrobial Composition and Uses Thereof”, Xia E., A. Dobie, J. Denick
`12.
`U.S. Patent
`
`7,632,869 B2
`World Patent
`2005115485 A1
`European Patent
`1,748,798 B1
`
` “Lens Care Solutions Comprising Alkyldimonium Hydroxypropyl
`13.
`Alkylglucosides”, Xia E., Millard K.
`U.S. Patent
`
`7,632,794 B1
`European Patent
`2,348,850 B1
`Canadian Patent
`2735665 (1-22-2013)
`
`
`
`
`
`14. “Method of Treating Inflammation of the Eye”, Xia E. (Soothe® Dry Eye)
`U. S. Patent
`
`7,659,259 B2
`
`
` “Composition for Treating Dry Eye and Related Methods of Manufacture and
`15.
`
`Methods of Use”, Xia E., Salamone J., Liu M. (Soothe® Dry Eye)
`
`U.S. Patent
`
`8,114,420 B2
`
`16. “Ophthalmic Compositions with an Amphoteric Surfactant and Hyaluronic Acid”, Xia
`E., Burke S., Venkatesh S., Barniak V. (BiotrueTM)
`U.S. Patent
`
`8,119,112 B2
`World Patent
`2009097028A1
`European Patent
`2,240,150 B1
`Singapore Patent
`201004759-5
`Canadian Patent
`2713308
`
`
`
`17.
`Venkatesh S.
`
`U.S. Patent
`World Patent
`European Patent
`
`
` “Ophthalmic Compositions Containing Diglycine”, Burke, S., Xia E., Scheuer C., and
`
`8,138,156 B
`2008049042 A3
`2,081,549 A2
`
`
`
`6
`
`APOTEX 1006, pg. 6
`
`

`

`18. “Composition and Method for Treating, Reducing, Ameliorating, Or Preventing
`Infections”, Tyle P., Xia E., Wang H., Norton S., Gupta P., and Ward K. (Besivance®)
`U.S. Patent
`
`8,173,640 B1
`World Patent
`2008144347 A8
`
` 19.
`Venkatesh S.
`U.S. Patent
`
` “Composition And Methods for Treating, Reducing, Ameliorating, or Preventing
`20.
`Infections”, Tyle, P., Xia E., Wang H., Norton S.,etc. (Besivance®)
`U.S. Patent
`
`8,334,283 B2
`
`21.
`Venkatesh S.
`U.S. Patent
`
` “Ophthalmic Compositions Containing Diglycine”, Burke, S., Xia E., Scheuer C., and
`
`
`
`8,324,171 B1
`
`
`
` “Ophthalmic Compositions Containing Diglycine”, Burke, S., Xia E., Scheuer C., and
`
`
`
`
`
`8,664,180 B1
`
` “Nonionic Surfactant Containing Compositions for Cleaning Contact Lenses”, Xia E.,
`22.
`A. Dobie, J. Salamone, Z. Hu et al.
`Published U.S. Patent 2005118132/ P03294
`European Patent
`1,706,473 B1
`Canadian Patent
`2547641 (9-21-2010)
`
` “Gentle and Enhanced Preservative Systems”, Xia E., Hu Z.
`23.
`Published U.S. Patent 2005118129/ P03366
`World Patent
`2005053758 A1
`European Patent
`1,687,037 B1
`
`24. “Stability Enhancement of Solutions Containing Antimicrobial Agents”,
`Quenville, I., Xia E., Maier S., Lever W., Dobie A., and Heiler D.
`Published U.S. Patent 2005119141/ P03346
`World Patent
`2005053757 A8
`European Patent
`1,687,036 B8
`
` “Improving Disinfection Efficacy of Lens Care Regimen for Rigid Gas Permeable
`25.
`Contact Lenses”, Xia E., Salamone J.C.
`Published U.S. Patent 20070196329A1/ P03536
`World Patent
`2007084975
`European Patent
`1,976,571 B1
`
` “New Viscoelastic Composition, Method of Use and Packaging Device with Anti-
`26.
`Oxidant”, Xia E., Green G.
`Published U.S. Patent 20060073184/ P03227
`World Patent
`2006039458 A2
`European Patent
`1,796,628 B1
`
`
` “Ophthalmic Compositions with an Amphoteric Surfactant and an Anionic
`27.
`
`Biopolymer”, Xia E., Burke S.,
`Published U.S. Patent 20090196845 A1
`
`
`
`7
`
`APOTEX 1006, pg. 7
`
`

`

` “Compositions with Enhanced Antimicrobial Efficacy against Acanthamebae”, Xia
`29.
`E., R. Borazjani, J. Salamone, D. Ammon, Z. Hu, A. Dobie
`Published U.S. Patent 20080031846A1/ P03097
`World Patent
`2004030710 A1
`European Patent
`1,545,635 B1
`
` “Compositions for Reducing, Ameliorating, Treating, or Preventing Condition of Dry
`30.
`Eye and Methods of Making and Using Same”, Xia E., Dobie A.
`Published U.S. Patent 20080275000 A1/ P04445
`W.O. Patent
`
`2008137496 A1
`European Patent
`2,155,162 B1
`Canadian Patent
`2685230 (10-16-2012)
`
`31. “Pharmaceutical Formulations Comprising Polyanionic Materials And Zinc Based
`Preservatives”, Xia E., Lavoie P., Dobie A., Kleiber T.
`Published U.S. Patent 20070212420A1/ P03942
`World Patent
`2007106723 A2
`European Patent
`1,993,619 B1
`
` “Packaging Solution”, Hook D., Xia E., Salamone J.
`32.
`Filed U.S. Patent
`U.S. Serial No.11/613,356/ P03837
`World Patent
`2008079522 A1
`European Patent
`EP 2094321 B1
`
`European Patent
`
`28.
`
`2,130,527 B1 (Biotrue™)
`
` “Zinc Preservative Composition and Method of Use”, Xia E., Salamone J., Borazjani
`
`Published U.S. Patent 20050214382/ P03459
`World Patent
`2005097067 A1
`European Patent
`1,734,923 B1
`
` “Peroxide Contact Lens Care Solution”, Millard K., Xia E. et al
`33.
`Published U.S. Patent 20110311646 A1/ P05194 (Peroxi ClearTM )
`World Patent
`2011159364 A1
`European Patent
`2,397,538 A1
`
` “Method for Manufacturing Contact Lenses”, Xia E., Rastogi S., et al.
`34.
`Published U.S. Patent 20040119176/ P03126
`World Patent
`2004058489 A1
`European Patent
`1,575,762 A1
`
`R.
`
`
`
`
`
`
`
`
`
`
`
` “Absorption and Controlled Release of Polyethers from Hydrogel Biomaterials”, Jani
`35.
`D., Salamone J., Hu Z., Xia E.
`Published U.S. Patent 20040115270 A1/ P03106
`World Patent
`WO 2004055148 A1
`European Patent
`1,570,038 A1
`
`36. “Use of a Cationic Polysaccharide to Enhance Biocidal Efficacies against
`
`
`
`8
`
`APOTEX 1006, pg. 8
`
`

`

`Microrganisms”, Xia E., Dobie A., Salamone J., Hu Z., Borazjani, R., Quenville I.
`Published U.S. Patent 2005119221/ P03295
`World Patent
`2005053760 A1
`European Patent
`EP 1694369 A1
`
`
`
`
`
`37. “Gentle Preservative Composition for Self-Preserving Solutions”, Xia E., Salamone J.
`Published U.S. Patent 2005118058
`World Patent
`2005053759 A1
`European Patent
`EP 1696970 A1
`
`
`
` “Gentle Preservative Composition”, Xia E., Salamone J.
`38.
`Published U.S. Patent 20050266095/ P03365
`World Patent
`2006007219 A1
`European Patent
`EP 1755688 A1
`
`
`39. “Prevention of Loss of Tight Junction Using Carbohydrates”, Xia E., Salamone J., and
`
`McCanna D.
`Published U.S. Patent 2005020983/ P03328
`World Patent
`2005089772 A2
`
`
`
`40. “Compositions Comprising A Dissociated Glucocorticoid Receptor Agonist (SEGRA)
`and An Immunosuppressive Agent for Treating Dry Eye”, Xia E., Hu Z.
`Published U.S. Patent 20080009437/ P04142
`World Patent
`2008005686 A8
`European Patent
`EP 2051736 A2
`Canadian Patent
`2650478 (8-13-2013)
`Singapore Patent
`200807851-1
`
`
`
`
`
` “Pharmaceutical Formulations Comprising Polyanionic Materials and Source of
`41.
`Hydrogen Peroxide”, Xia E., Allen M (Soothe)
`Published U.S. Patent 20090220618 A1/ P04664 (Soothe™)
`
`42. “Polysaccharide and Polyol Composition for Treating Dry Eye and Related Method of
`Manufacture and Methods of Use (Part II)”, Salamone J. C., Xia E., Liu M.X.
`Published U.S. Patent 20060222623/ P03767
`World Patent
`2006127121 A2
`
`43. “Ophthalmic Composition Comprising Aloe Vera”, Xia Erning
`Published U.S. Patent 20060134060/ P03656
`World Patent
`2006068899 A3
`
`
`
`
` “Ophthalmic Composition Comprising Both Loteprednol Etabonate And
`44.
`Cyclosporine for Dry Eye Therapy”, Xia Erning, Z. Hu and Tyle P.
`Published U.S. Patent 20060148686/ P03706
`World Patent
`2006073786 A3
`
`
`45. “Radiation-Absorbing Materials, Ophthalmic Solutions Containing Same, And
`Method of Treating Ophthalmic Devices”, Xia E., Lai Yu-Chin
`Published U.S. Patent 20060197067/ P03426
`
`
`
`9
`
`APOTEX 1006, pg. 9
`
`

`

`47. “Ophthalmic Solution with a Flavoring Agent as a Dosing Indicator and Method for
`Indicating Dosage of an Ophthalmic Solution”, Xia E., Salamone J. C.
`Published U.S. Patent 20060292189/ P03535
`World Patent
`2006132868 A1
`
`2006096422
`
`World Patent
`
`46. “Ophthalmic Compositions for Dry Eye Therapy”, Xia E., Denick J., Rich Smerbeck
`(Lotemax Gel™)
`Published U.S. Patent 20070110812/ P03310
`
`48. “Ophthalmic Solution with A Flavoring Agent”, Xia E., Salamone J. C.
`Published U.S. Patent 20060292188/ P03538
`World Patent
`2006132870 A1
`
`49. “Topical Preservative Compositions”, Xia E., Lever W.
`Published U.S. Patent 20060292105/ P03416
`World Patent
`2007002780 A3
`
` “Long Lasting Alginate Dry Eye, Related Methods of Manufacture and Method of
`50.
`Use”, Xia E., Dharmendra J. (Soothe™)
`Published U.S. Patent 20070004672/ P03537/P03585
`World Patent
`2008137826 A3
`
`
`
`
`
`
`
`
`
`
`
` “Method for Improving Water Solubility of Chitosan”, Hu Zhenze and E. Xia
`51.
`Published U.S. Patent 2006028728/ P03239
`World Patent
`2007002345 A3
`
` “Enhanced Disinfecting Composition for Medical Device Treatments”, Xia E.,
`
`
`
`52.
`Salamone J.
`Published U.S. Patent 20050261148/ P03413
`World Patent
`2005115487 A1
`
`
`
`
` “Contact Lens with Improved Biocidal Activity and Related Methods and Materials”,
`
`53.
`Xia E.
`Published U.S. Patent 20060067981/ P03409
`World Patent
`2006039460 A2
`
`
`54. “Polysaccharide and Polyol Composition for Treating Dry Eye and Related Method of
`Manufacture and Methods of Use (Part I)”, Salamone J. C., Xia E., Liu M.X (Soothe™).
`Published U.S. Patent 20060223727/ P03508
`World Patent
`2006127121 A3
`
`55. “Lens Care Solutions for Use with Contact Lenses or Contact Lens Cases That Contain
`Silver”, Sharma Ravi, Xia E.
`Published U.S. Patent 20080218686 A1/ P04181
`World Patent
`2008109598 A3
`
`
`
`
`10
`
`APOTEX 1006, pg. 10
`
`

`

` “Composition and Method for Cleaning and Treating Surgical Devices”, Xia E., Huang
`56.
`H., Lever W., Yan Wenyan.
`Published U.S. Patent 20050277562/ P03408
`
`
`“Use of Aroma Compounds as Defoaming Agents for Ophthalmic Solutions with High
`57.
`
`Concentration of Surfactants”, Burke S., Ammon D., Xia E.
`
`Published U.S. Patent 20070148099 A1
`
`“Compositions for Reducing, Ameliorating, Treating, or Preventing Condition of Dry
`58.
`
`eye And Methods of Making and Using Same”, Xia E., Jani, D.
`
`Published U.S. Patent 20080280853 A1
`
`59. “Biguanide Ointment and Method of Treatment and Prevention of Infection”, Xia E.,
`Wang H., and Tyle P.
`Published U.S. Patent 20080161405 A1/ P03976
`
`
`
`60. “Compositions Comprising Alkyldimonium Hydroxypropyl Alkylglucosides”, Xia E.,
`Millard K.
`Published U.S. Patent 20100075919 A1/ P04721
`
`
`
`61. “Combination Antiviral Composition & Method of Use”, Xia E., Wang H., Venkatesh
`S., Gupta P.
`Published U.S. Patent 20070142478 A1/ P04024
`
`62. “Composition Comprising Quinolone And Methods For Treating or Controlling
`Infections”, Venkatesh S., Wang H., Xia E., Jonasse M.
`Published U.S. Patent 20090082337 A1/ P03891
`World Patent
`2009042395 A1
`European Patent
`EP 2205246 A1
`Canadian Patent
`2698221 (12-11-2012)
`Singapore Patent
`201001527-9
`
`
`
`63. “Method and Composition for Contact Lenses”, Xia E., Hu Z., Jani D., Ammon D.,
`Salamone J.
`Published U.S. Patent 20060073185 A1/ P03930
`
`
`
`64. “Composition Comprising Antihistamines or Mast Cell Stabilizers, and Methods of
`Making And Using Same”, Xia E., Vo T.
`Published U.S. Patent 20090005362 A1/ P04469
`
`
`
` “Ophthalmic Composition Comprising Diglycine as A Tear Protein Stabilizer”,
`65.
`Burke S., Xia E., Kwok K., Davio S.
`Published U.S. Patent 20080095754 A1/ P04100
`World Patent
`2008049043 A2
`
` “Ophthalmic Pharmaceutical Compositions and Uses Thereof”, Xia E.
`66.
`Published U.S. Patent 20080057022 A1/ P04254 (Soothe™)
`European Patent
`EP 2068821 A2
`
`
`
`
`11
`
`APOTEX 1006, pg. 11
`
`

`

` “Ophthalmic Composition with HA”, Xia E., Burke S., Venkatesh S., Barniak V.
`67.
`Published U.S. Patent 20100286010/P04667
`
` “Compositions Comprising Polymers Having Amino Sugar Units and Methods of
`68.
`making and Using Same”, Xia E., Burke S., Cody C.
`Published U.S. Patent 20110195927 A1/ P04803
`World Patent
`WO 2010030725 A1
`Canadian Patent
`2736380 (5-28-2013)
`
` “Pharmaceutical Formulations Comprising Stabilized Polysaccharides and Source of
`69.
`Hydrogen Peroxide”, Xia E., Allen M. (Soothe)
`Published U.S. Patent 20090304811A1/ P04764
`World Patent
`2009152028 A3
`European Patent
`EP 2346513 A1
`Canadian Patent
`2714395 (4-16-2013)
`
`70. “Ophthalmic Composition”, Xia E., Denick J., Smerbeck R.
`Published U.S. Patent 20100234336 A1/ P03310C1 (Loteprednol Etabonate Gel)
`
`
`
`
`
`71. “Lens Care Solutions with Functionalized Alkydimonium Hydroypropyl
`Alkylglucosides”, Millard K., Xia E.,
`Published U.S. Patent 20110142786 A1/ P04788 CIP
`World Patent
`WO 2010033526 A3
`
`
`
` “Composition Comprising Quinolone And Methods For Treating or Controlling
`72.
`Infections”, Venkatesh S., Wang H., Xia E., Jonasse M.
`Published U.S. Patent 20110251147 A1
`
`
`
` “Composition for Treating Dry Eye and Related Methods of Manufacture and
`73.
`methods of Use”, Xia E., Salamone J., Liu M.
`Published U.S. Patent 20110301250 A1.
`
`
`
`
`
` “Improving Disinfection Efficacy of Lens Care Regimen for RGP Contact Lenses”,
`74.
`Borazjani, R., Smerbeck R., Ammon D., Salamone J., Xia E.
`Filed U.S. Patent
`U.S. Serial No. 10/724,797/ P03250
`World Patent
`2007084975 A1
`Europen Patent
`EP 1976571 A1
`
` “Use of A Diglycine/Borate Buffer Combination to Enhance the Antimicrobial
`75.
`
`Efficacy of An Ophthalmic Composition”, Burke S., Xia E., Venkatesh S.
`Filed U.S. Patent
`U.S. Serial No. 60/852,539/ P04162
`
`
`
`76. “Ophthalmic Composition”, Xia E., Denick J., Smerbeck R.
`Published U.S. Patent 20120028947 A1/ P03310C (Loteprednol Etabonate Gel)
`
`77. “Lens Care Solutions for Silicon Hydrogel Contact Lenses”, Xia E., Salamone J.
`Filed U.S. Patent
`U.S. Series No. 10/462,165/ P03284
`
`
`
`
`12
`
`APOTEX 1006, pg. 12
`
`

`

`E.
`
`78.
`
` “Ophthalmic Compositions with Alkoxylated Natural Waxes”, Fridman, Krista; Xia,
`
`Filed U.S. Patent
`World Patent
`
`U.S. Serial No. 61/602764/ P05081
`2013126155 A1
`
` “Artificial Tear Solution Containing Poly(ethylene glycol) PEG-Lipids for Dry Eye
`79.
`Treatment’, Hu Z., Xia E., Salamone J.
`Filed U.S. Patent
`U.S. Serial No. 60/753,210/ P01651
`World Patent
`2007076274 A2
`
`
`
`
`
`80. “Salt Free Hyaluronate Ophthalmic Solution”, Venkatesh S., Xia E.
`Filed U.S. Patent
`U.S. Serial No. 60/946,801/ P03962
`World Patent
`2009006130 A3
`
`81. “Stable Biquanide Composition and Method of Treatment and Prevention of
`Infection”, Levy B., J.C. Salamone, R. Borazjani, E. Xia
`Filed U.S. Patent
`U.S. Serial No. 60/752,413/ P03590
`
`
`
`
`
` “Stabilization of Pharmaceutical Compositions Comprising Alexidine by
`83.
`Optimization of pH”, Wang H., Xia E., and Venkatesh S.
`Filed U.S. Patent
`U.S. Serial No.11/614,504/ P04015
`
`82. “Dry Eye Composition Comprising Liposaccharide(s)”, Xia E.
`Filed U.S. Patent
`U.S. Serial No. 60/752,967/ P03742
`
`84. “Preservative Free Composition for Treating Dry Eye”, Xia E.
`Filed U.S. Patent
`U.S. Series number 60/916,326/ P04498
`World Patent
`20080280853 A1
`
`
`
`
`
`
`
`
`85. “Topical Pharmaceutical Composition Comprising Alexidine for Herpes Simplex
`Infection”, Xia E., Tyle P., Wang H., Bruner L.
`Filed U.S. Patent
`U.S. Series number 60/830,326/ P04088
`
` “Ophthalmic Composition Comprising Odorants for Lens Care Products”, Salamone
`86.
`J.C., E. Xia, R. Borazjani, D. Ammon
`Filed U.S. Patent
`U.S. Serial No. 60/754,059/ P03591/3705
`
`
`
`
`
`87. “Pharmaceutical Composition Comprising Alexidine and/or Anti-fungi Drug”, Xia E.,
`Wang H., Venkatesh S., Gupta P.
`Filed U.S. Patent
`U.S. Serial No. 60/760,880/ P03939
`
`88. “Pharmaceutical Composition Comprising Alexidine and Other Anti-bacterial Drugs”,
`Xia E., Wang H., Venkatesh S., Gupta P.
`Filed U.S. Patent
`U.S. Serial No. 60/830,319/ P04053
`
`
`
` “Method of Preserving Ophthalmic Solution”, Xia E., Salamone J. C.
`89.
`Filed U.S. Patent
`U.S. Serial No. 10/858,116/ P03365
`
`90.
`
` “Peroxide Contact Lens Care Solution with Amino Buffers”, Millard K., Xia E.
`
`
`
`13
`
`APOTEX 1006, pg. 13
`
`

`

`Filed U.S. Patent
`
`U.S. Series 61/356,122/ P05258
`
`91. “Ophthalmic Composition Comprising Diglycine”, Xia E., Kwok K., Burke S., et al.
`Filed U.S. Patent
`U.S. Serial No. 60/852,487/ P04153
`World Patent
`2008049043
`European Patent
`EP 2073800A2
`
`
`
`
`
`92. “Ophthalmic Compositions with an Amphoteric Surfactant and an Anionic
`
`Biopolymer”, 具有兩性表面活性劑及透明質酸的眼用組合物, Xia E., Burke S.,
`
`EP 2425864 A1 (Biotrue™)
`1147208
`
`European Patent
`Hong Kong Patent
`
`
`93. “Ophthalmic Composition Comprising Lyophilized Alexidine and Diluent in A
`Combo Device”, Xia E., Wang H., and Tyle P.
`Filed U.S. Patent
`U.S. Serial No.60/882,620/ P03977
`
` “Ophthalmic Composition Stabilized by EDTA”, Xia E., Allen M.
`94.
`Filed U.S. Patent
`U.S. Series number 12/023,509/ P04766
`
`
` “A Packaging Solution for Hilafilcon A and B That Improves On-Eye End of Day
`95.
`
`Comfort”, Xia E., Millard K., Jasek A., patent application, 2009 (P05114).
`
`96. “Gentle Preservative System Comprising Amine Oxide Compounds”, Millard K.,
`
`Wang H., Xia E., Patent application, 2009 (P05140).
`
`
`97. “Gentle Preservative System Comprising A Branched Trialkylamine Oxide in
`Combination With An Aliphatic Tertiary Amine Oxide”, Millard K., Xia E., Wang H., Marlowe Z.,
`patent application, 2009 (P05174).
`
`
` “Ophthalmic Compositions with an Amphoteric Surfactant, Hyaluronic Acid, and
`98.
`Polyquaternium-1”, Xia E., Burke S., Venkatesh S., Barniak V.
`Published U.S. Patent 20120283333 A1 (P04667C3, Biotrue™)
`
` “Composition for Treating Dry Eye and Related Methods of Manufacture and methods
`99.
`of Use”, Xia E., Salamone J., Liu M.
`Published U.S. Patent 20120122815 A1
`
`
`
` “A Packaging Solution for Hilafilcon A and B Lenses That Improves “On-Eye” End
`100.
`of Day Comfort”, Xia E. Hook Dan.
`U.S. Patent
`
`P05383
`
` “Poly(Nitrogen/Amine) Derivatives of A Natural Wax and Ophthalmic
`101.
`Compositions”, Xia E., etc (P05407)
`Filed U.S. patent
`U.S. Application No. 61/756,206
`
` “Peroxide Contact Lens Care Solution”, Millard K., Xia E., Groemminger S., Kilbury
`102.
`J., (P05194 C1)
`Filed U.S. patent
`
`U.S. Application No. 13/835,237
`
`
`
`14
`
`APOTEX 1006, pg. 14
`
`

`

`
` “Method of Reducing the Binding of Preservatives by Lipidure”, Xia E.,
`103.
`Giallombardo A., Li Y., Maziarz P., Liu M.,
`U.S. Patent
`
`P05672
`
` “Ophthalmic Composition Comprising Epsilon Polylysine”, Xia E., Barniak V., et al
`104.
`U.S. Patent
`
`P05684
`
` “Improved Biocidal Solution Comprising Surfactants with Lower HLB’s” Xia E., A.
`105.
`Giallombardo, K. Fridman.
`U.S. Patent
`
`
` “Packaging Solution”, Xia E., Hook D., etc
`106.
`European Patent
`EP 2409717A2
`Published U.S. Patent 2013/0202,547
`
`
`
`P05683
`
`
`PUBLICATIONS:
`
`Millard K., Xia E. et al, Characteristization of the Interaction betweenPeroxide Neutralizing
`1.
`Disks and a Platinum Modulating Compound rto Determine Mechanism of Act, AAO 2013.
`
`Kilbury J., Xia E. Millard K et al, Comparison of Biocidal Efficacy of Hydrogen Peroxide
`2.
`Disinfecting Systems and Total Peroxide Exposurer, ARVO 2012.
`
`Kilbury J., Xia E. Millard K et al, Comparison of Total Peroxide Exposure Values and Biocidal
`3.
`Efficacy of Hydrogen Peroxide Disinfecti