PrimaPharmaCommercialization Capabilities

Confidential & Proprietary

Confidential & Proprietary

PrimaPharma “Solution”uOur team of scientists, engineers and quality experts

work directly with the customer to identify necessarytechnical and regulatory tasks for a successfulclinical trial, FDA submission and commerciallaunch/distribution

uPrimaPharma has proven track record of successfulFDA approved drugs, devices and biologics for use incommercial and clinical applications

uWe maintain a team of outside contractors, includingsuppliers, testing laboratories and variousmanufacturing capabilities to provide additionalsupport if required

uPartnership opportunities

Confidential & Proprietary

Company HistoryuPrivately held CDMO since 1992 located in San

Diego, CaliforniauAseptic liquid filling, injectables, ophthalmic

and OTC’suNew management team organized in 2009uCurrently FDA Drug and Device registered facilityuCalifornia State Food Drug Branch Drug & DeviceuISO 13485: 2003 currently certified by BSI

(notified body)u34 full-time employees

Confidential & Proprietary

Management Teamu Mark Livingston, President & CEO (2009)

u Former Executive: Danco Laboratoriesu Co-Founder; predecessor entity, Sorrento Biochemical, Inc.u Former President/CEO Motels of America, Incu Former President Road Runner Sports, Incu Former CEO Price Quest, Inc

u Anthony Dziabo, V.P. Product Development, Regulatory Affairs & Qualityu Formerly V.P. R&D Allergan and Medtronicu 23 U.S. Patents

u Larry J. Braga, V.P. Operations (2009)u Formerly Genentech (currently Roche), Collagen Corporation

(currently Allergan), and Rhone Poulenc Rorer (currently Sanofi-Aventis)

u 3 U.S. Patents

Confidential & Proprietary

Management TeamuNayaz Ahmed PhD, RAC (US, EU), CQA, Director, QC –

Analytical Services & Product Development uFormer consultant at CargiluFormer Scientist at LKT LabsuFormer member, NIH/NCI Peer Review CommitteeuMember of SCI Advisory Board, Biopep Solutions, Inc.u4 US Patents

uArshad Chaudry, Director of QC, Microbiology & ValidationsuMember of PrimaPharma management team (20+

years)uOver 20 years experience microbiology and

pharmaceutical product developmentuMember of management team responsible for

obtaining approval of several drugs & medical devices

Management Team

u Sarah Dziabo, Associate Director Quality Assuranceu 15 years experience in cGMP operations including technical

writing, document control, GMP auditing, Quality Systems, ISO 13485, ISO the lab one, FDA inspections, Manufacturing support and project management.

u Former Medtronic Cardiopulmonaryu Former Alsuis medical deviceu Former Micro Quality Labs

uHampar Karageozian, Chairman of the Boardu Formerly Sr. Vice President of Research at Allerganu Founder of Four Pharmaceutical Companiesu Currently CEO of Allegro OphthalmicsuOver 30 worldwide patents

Confidential & Proprietary

Manufacturing ExpertiseuCommercial NDA, ANDA and PMA products

uLiquids, solids, vials, syringes, btc, & tubesuClinical manufacturing-small scale runsuClinical labeling & packaging (blinded,

randomized trials)uFormulation developmentuAnalytical testing development & validationuMicrobiological development & testing uRegulatory support for FDA application

submission-CMC packages

Confidential & Proprietary

Manufacturing CapabilitiesuManual aseptic filling for small lot sizes up to 5,000

units under ISO Class 5 conditions (process approved for commercial or clinical products)

uSemi-automated aseptic (RABS) nested tray filling, syringe or vial

uTerminal sterilization by steam, dry heat or irradiation

uSemi-automated non-sterile filling for larger batch sizes >10,000 units (Nasal Pump)

uFormulation expertise to support sterile emulsions, sterile powders (API’s), sterile lipids, sprays, gels, peptides, MAB’s and recombinant proteins

Confidential & Proprietary

Laboratory CapabilitiesuAnalytical Chemistry

uUPLCuGCuFTIRuUV VisuKFuViscometer

uMicrobiologyuSterility TestinguBioburden uEndotoxinuAseptic Process QualificationuMLTuFacility Environmental Monitoring

Confidential & Proprietary

Process DevelopmentuAseptic Manufacturing

uDrug ProductsuFormulation DevelopmentuBlow, Fill, SealuSyringe FillinguEmulsionsuSuspensionuGelsuSpraysuUnique Container/Closure SystemsuScale Up & Build OUT (GMP Compliance)uNetwork of Approved Contractors (Gamma, E-Beam,

Analytical Chemistry, CRO’s, Regulatory. Etc.)