Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com

2. We are all in the business of improving the quality of human lives. Each of us, whether client or service provider, are joined in the commitment to reach critical milestones faster, deliver clinical materials on time, control costs, and above all to ensure quality. At Xcelience, we call this Molecular Responsibility™, the commitment to hold ourselves to ever-increasing high standards of quality, service performance, and drug development expertise that in turn enable our clients to overcome drug development challenges and improve chances for compound success. Partnering with a specialist like Xcelience for early phase development can significantly reduce product risk and accelerate drug development timelines. We are early drug development made easy – at last.

3. Core Competencies API Characterization Polymorph Screening, Salt Screening, Drug Product Characterization Analytical Services Method Development and Validation, Waters and Agilent Instrumentation Dosage Form Development and Manufacturing Solids, Semi-solids, Liquids Manufacturing, Packaging and Labeling Direct Fill API into Capsules Matching placebo formulation Creation and qualification of blinded reference product Process qualification Technology transfer Process optimization Blister Packaging Stability Program Management Broad variety of temperature and humidity conditions

5. We have more experience than any other provider

6. > 100 APIs, >130 batches

7. Defined programs deliver proven results.

8. API into capsule projects are on average completed 45% faster than traditional formulation development efforts, and in some cases have enabled our clients to shave from 13 to as much as 17 weeks from total development time.

9. We have greater capacity than any other service provider.

10. Three dedicated Xcelodose® systems; two in the GMP area, and the third in the experimental area.

12. Service Overview

13. Preformulation Services Solid Characterization Drug Substance Characterization Thermal information X-ray Powder Diffraction Particle size Moisture Content Morphology Salt Selection screening Polymorph screening Purity determinations Solid-state stability Photostability Intrinsic Dissolution Reference Standard Qualifications Solution Characterization Drug substance evaluation pKa determination Partition and distribution coefficient pH Solubility profile Other Services Excipient compatibility Accelerated stability (ICH conditions) Chiral Stability

14. Analytical Services Method Development, Qualification, and Validation Raw Material Testing (Selected) Stability Sample Analysis Dissolution Testing Residual Solvent Analysis Chiral Determination Cleaning Evaluations Technical Packages for Drug Substances

15. Formulation Development Solids Tablets, capsules, sustained release, coatings Semi-Solids Ointments, creams, gel Dispersed Systems Emulsions, suspensions Liquids Orals, ophthalmic, parenterals

16. Formulation Development for Poorly Soluble Compounds Conventional Formulations/Processes Use water soluble excipients Micronize the API pH modifiers citric acid, succinic acid etc Solubilizing/wetting agents sodium laurel sulfate, Tween 80 Alternate Processing Add drug to aqueous granulating solution containing wetting/solubilizing agent Dissolve API in hydroalcoholic/ alcoholic granulating solution May alter API characteristics Form Solid dispersion/solution in hot melt process using CFS1200™ Complexing agents (Cyclodextrins) Liquid fill hard gelatin capsule

17. Manufacturing Manufacturing Tablets and capsules API in a capsule Liquids in a capsule Suspensions Emulsions Semi-solids Non-sterile liquid Reference Product Blinding Packaging and Labeling Expertise Creation of matching placebo formulation Creation and qualification of blinded reference product Process qualification Technology transfer Process definition optimization

19. Tooling, card/wallet (CR) and patient kits

20. Global procurement of comparator medications

21. Supported with product pedigree documents

22. Primary packaging

23. Filling of API into bottles (AIB)

24. Filling of API into capsules (AIC)

25. Powder filling into sachet/pouch

26. Blister packaging including cold form aluminum blisters

27. Card/wallet sealing

28. Bottle packaging

29. Labeling and assembly services

30. Multi-language booklet labeling

31. Open label / double blind labeling, disclosure envelopes

32. Randomization services

33. Patient kit assembly

34. Warehousing and distribution

35. cGMP warehousing of clinical supplies

36. Storage and handling of schedule II-V products

38. Convenient Location Tampa, Florida Location Laurel Facility (24,000 ft2) cGMP Compliant FDA Inspected 2008, December (PAI) 2006, June (General Systems) 2003, August (General Systems) DEA Schedule License 2007, October II to V Manufacturing I to V Analytical

39. Why Xcelience? Quality-First Focus Three FDA audits (2008, 2006, 2003) with the last being a PAI Numerous client audits/year reinforce compliance with latest regulations Low staff turnover Speed Accelerated drug development programs to meet critical milestones Strong on-time project completion record Agility Cross-training program for pharmaceutical development staff Flexible manufacturing model, dedicated equipment Technology Market leadership for Powder-in-Capsule programs with Xcelodose® precision powder micro-dosing systems Expanded process technology capabilities designed to deliver improved manufacturing outcomes in a manner consistent with QbD Cutting edge preformulation technology including the XRD for polymorph screens, salt screens, and crystallinity determination Blister packaging with tooling design for a wide variety of dosage forms Expertise Ability to attract top talent with successful drug development track records More Xcelodose™ experience than any other CRO, >100 APIs, >130 batches Partnership Unique project team structure feel likes an extension of client facility Leveraging size to our advantage to provide personal attention

40. Choose Xcelience Quality-First Focus. Expertise. Flexibility. Partnership