1. SRC/CPPT/2013/Jan/Version12 Uniting the World of Pharmaceutical Research Part of US based Arnold A Semler Inc, in business since 1946 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company

2. SRC/CPPT/2013/Jan/Version12 2 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Company Overview  Established in 2006  Internally funded, with strong financials  Combined leadership experience of over 250 years in the pharmaceutical, biotechnology and device industries  A qualified team of over 186 members with extensive expertise in the development of both generic and patented products Los Angeles Bangalore Salem Europe Bangladesh Malaysia Locations in red denotes SRC offices and blue denotes partner offices South Africa South Korea China Japan Taiwan

3. SRC/CPPT/2013/Jan/Version12 3 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company To build long-term relationships with our customers, vendors, staff and investors through best-in-class business practices, R&D services and scientific innovation. To be one of the most trusted partners in pharmaceutical development to assist our clients in improving the quality of human life. To be committed to deliver the highest quality of services in meeting our customers’ requirements on time and every time. Sincerity Respect for people Commitment MissionVision Values Quality Policy Corporate Philosophy

4. SRC/CPPT/2013/Jan/Version12 4 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Quality Strategy & Deployment People Infrastructure Process & Systems Team of 186 members Talent sourced from various global Pharma & CRO’s Thought leaders Well defined 317 SOP’s and QM Regulatory compliant equipments Operational review mechanism Metric management & IQA Compliance to GCP, GLP, ISO standards & Part 11 requirements Deployment of SAP for effective & optimal utilization of resources State of the art facilities Regulatory accepted Hardware/ Software applications Technology networks across locations

5. SRC/CPPT/2013/Jan/Version12 5 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Clinical Development Feasibilities Consulting Study Execution Allied Services* Study types Clinical end point Patient PK Stem cells Devices Formulation Development Generics & NCEs Diverse dosage forms Analytical Development Assay & RS method development Stability studies Polymorphic form characterization Validation Method conversions Service Overview Pharmaceutical Development Clinical PK (compartmental & non - compartmental) Food effects & drug interactions Special population studies Bioanalytical Method development & validation Sample analysis Invitro binding BE studies Bioavailability & BioequivalenceClinical Development [Patient Studies] *Allied Services Medical and Scientific Writing Biometrics & Data Management Regulatory services (ANDA, NDA,DMF preparation and submission) MoreMore…MoreMore…

6. SRC/CPPT/2013/Jan/Version12 6 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Well-equipped pharmaceutical development laboratories Pharmaceutical Development More… 144-bed, well-equipped, GCP compliant facility Sample analysis capability: over 20,000/month WHO, FDA audited BABE facility Bioavailability & Bioequivalence (BABE) Over 200 methods available More… Enrolment as per protocol requirements Clinical Development More… Equipment and Facilities - Overview Dynamic & experienced clinical development team Qualified and experienced medical & scientific writers

7. SRC/CPPT/2013/Jan/Version12 7 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Regulatory & Quality Compliance TypeDescription Facility ApprovalDCGI approval for Salem & Bangalore clinical facility Pharmacy-State Drug Controller, approval for Facilities in Bangalore & Salem -Approval to store Schedule X drugs Pollution ControlKarnataka State Pollution Control Board approval for J.P. Nagar and Hebbal facilities in Bangalore Regulatory Inspection-Inspected by US FDA -Inspected by DCGI -Inspected by WHO with ‘Nil’ critical/major NC -Inspected by MoH Turkey -Expected Inspections: EU authority Quality compliance & Initiatives-ISO 9001 : 2008 for managerial requirements -ISO 27001 : 2005 for Information Security Management System

8. SRC/CPPT/2013/Jan/Version12 8 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Regulatory Competency RegulatorDetails (Approved & pending for approval)ServiceSponsor WHOApproved : 08 studiesBA/BEIndian generics USFDAApproved: 03 studiesBA/BEIndian generics USFDAPending for approval : 01 productPDUS generics USFDAPending for approval : 01 studyCDUS generics TurkeyFacility approval awaitedBA/BENA BrazilPending for submission: 02 productsPDUS generics SRC has adequate experience in various regulatory guidelines. Cumulative experience of over 500 regulatory submissions. Studies conducted at SRC’s facilities viz Salem and Bangalore (Clinical and Analytical) have been inspected by WHO & USFDA. Studies conducted for EU, MHRA and Canada regulatory is due for inspection Systems & procedures have found to be compliant for MoH (Turkey) submission. Inspection is completed and approval is awaited.

9. SRC/CPPT/2013/Jan/Version12 9 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company PeriodRegStudiesMan-daysInspector / Auditor AreaResult July 2010WHO0210 (2 inspectors) -Dr. A.J. Van Zyl -Ms. S. Croft BA/BECompleted without critical/major findings July 2011WHO0110 (2 inspectors) -Mrs. Iveta Streipa -Mr. Ignacio Moreno Fernandez BA/BECompleted without critical/major findings Dec 2011MoHNA08 (4 auditors) -Dr. Hilal Ilbars -Dr. Hanefi Ozbek -Yuk. Kimyager Ulku Terzi -Mine Kiraz BA/BE facility, Bangalore Inspection completed successfully & Certificate awaited May 2012USFDA0205 (01 inspector) -John A. IwenBA/BEInspection completed successfully Sept 2012USFDA0110 (2 inspectors) -Dr Arindam Dasgupta - Dr Daniel Aisen BA/BEInspection completed successfully Regulatory Inspection -Experience

10. SRC/CPPT/2013/Jan/Version12 10 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Activity milestone with key achievements 2007 Opening of Formulation & Analytical lab Initiation of commercial activities Acquired Salem clinical facility 2010 Opening of new clinical lab at Bangalore First WHO inspection Conduct of First USFDA study Awarded First International study 2006 Year of incorporation 2009 Change in business strategy and initiation of new services 2011 Bio Excellence award by Govt of Karnataka “No 1 Company” in LS category by growth DSIR accreditation by DST, Govt of India ISO 9001 & 27001 certification First patent application WHO inspection MoH Turkey inspection Geographical expansion (Asia CRO & Logic trials) 2012 2 USFDA inspections Udyog Rattan Excellence Award

11. SRC/CPPT/2013/Jan/Version12 11 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Alliance Management Name / Alliance Type of Alliance*CD*PD*BA/BE Logic TrialsStrategic alliance to manage South Africa specific studies / projects.  Asia CRO Alliance Strategic alliance to manage South East Asia sponsor requirements.  USA & EuropeService alliance with reputed CROs in US and EU to manage global clinical studies.  ICDDRAlliance to cater Bangladesh sponsor requirements.  View Business Development Team Profile * CD – Clinical Development, PD – Pharmaceutical Development, BA/BE – Bioavailability & Bioequivalence

12. SRC/CPPT/2013/Jan/Version12 12 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Awards and Recognitions Bio – Excellence Award 2012DSIR Recognition by DBT ISO 27001 : 2005 ISO 9001 : 2008 Udyog Ratan Excellence Award

13. SRC/CPPT/2013/Jan/Version12 13 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Solid OralsIR, MR Tablets/Capsules Liquid oralsSolutions, Suspensions, Dry Syrups TopicalsOintments/Creams/Gels OphthalmicsSuspension/ Ointments / Solutions ParenteralsLiquid Injections – Vials, Ampoules, PFS, Lyophilized injections Generic drug development (US, EU, Lat-AM and others) Fixed dose combination immediate release tablets/capsules Fixed dose combination extended release capsules Innovative Generics [e.g. 505 (B) (2)] Innovative Drug Delivery Technologies Effervescent Formulation (Lubrication optimizations studies) Tablet in Tablet Formulation (Compression coating) Novel drug delivery systems including Liposomes … Patent filed for Bioenhanced Formulations The invention relates to a pharmaceutical composition comprising a poorly water soluble active ingredient, at least one solubilizer and at least one pharmaceutically acceptable excipient, and a process for manufacturing the same Dedicated Oncology / High Potency Products Area with Isolators Process Development Laboratories Process Scale Up Facilities Analytical Testing Laboratories Pharmaceutical Development Track Record

14. SRC/CPPT/2013/Jan/Version12 14 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Bioavailability & Bioequivalence Total number of studies297 Volunteers dosed14,742 Samples analyzed2,93,548 Track Record

15. SRC/CPPT/2013/Jan/Version12 15 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Clinical Development Niche Expertise Special population studies in: Renal & hepatic impaired patients Obese subjects Healthy premenopausal women Postmenopausal women Patient PK studies in: Oncology Ophthalmology Nephrology Stem cell studies in: Gastroenterology Dermatology Device studies in: Neurology Nephrology Track Record Studies Initiated [2010-12] Completed Recruitment [2011-12] Scheduled Recruitment [2012-13] 19 [Global – 9 & Local - 9] 1100 patients2600 patients

16. SRC/CPPT/2013/Jan/Version12 16 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Integrated Services India’s first, independent organization to fully integrate drug development, clinical development and manufacturing services Scientific Expertise Combined leadership experience of over 250 years in the pharmaceutical industry; a qualified team of over 186 members with extensive expertise in the development & manufacturing of both generic and patented products Global Regulatory Experience Several decades of exposure to various regulatory bodies across the globe for both generic and patented products Adequate Resources State-of-the-art equipment and infrastructure across locations (over 60,000sft.) to facilitate smooth and quality services Value Proposition Capital Solutions Innovative capital solutions to emerging pharma, biotech and virtual companies.

17. SRC/CPPT/2013/Jan/Version12 17 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Value Proposition (cont.) SRC ServicesPartner Services Formulation Development Plant Setup API Characterization Preformulation Prototypes Stability Studies (short & long term) Facilitation of manufacturing licenses Scale up and Tech Transfer Commercial Manufacturing Pre Clinical Studies Phase IPhase IIPhase III (BA/BE) Analytical Development Pilot & Pivotal Batch Manufacturing Integrated Services

18. SRC/CPPT/2013/Jan/Version12 18 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company A Case Study in Integrated Services Pharmaceutical Development Team Formulation development Analytical method development & validation Tech transfer Clinical Development Team Protocol development Site selection Project management Monitoring Stat & PK support Reports Bioanalytical Team Method development (aqueous humor matrix) Method validation Sample analysis Client A US based pharmaceutical company Products Ophthalmology suspensions Ophthalmology ointments Regulatory Authority US FDA [505 (b) (2)] Knowledge Transfer

19. SRC/CPPT/2013/Jan/Version12 19 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Testimonials “We first contacted Semler Research to conduct some analytical method development work for an ANDA product. We were so impressed with the quality, timelines and dedication to the project, we have created a long- standing partnership with Semler Research in our drug development process which now also includes bio/clinical studies. For us, it has become a turnkey operation because Semler Research Services provides high quality integrated scientific solutions with a complete innovative approach to project management which exceeds the expectations of our drug development partners.” Chairman (US Pharma) “We have successfully worked with Semler Research Center (SRC) for bioavailability and bioequivalence studies. SRC’s in–depth understanding of clinical R&D and their sharp analytical approach clearly differentiates them. The SRC team is always focused on our specific requirements while providing a perspective of a large pharmaceutical corporation. Our association has been efficient, valuable and constructive.” Vice President (Indian Pharma) “We are very pleased to have built a professional relationship with Semler Research Center (SRC). They offer an in– depth understanding of pharmacology, study designs and analytical processes. They ensure thorough strategic planning for study execution and generate well articulated study reports. They are honest, diligent and forward thinking while retaining high quality. Their flexibility and responsiveness is remarkable. We look forward to continuing and growing our successful association with SRC.” Principal Scientist (Indian Pharma)

20. SRC/CPPT/2013/Jan/Version12 20 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company HEADQUARTERS Semler Research Center 11347 Vanowen Street North Hollywood CA 91605, USA T: +1-818-760-1000 F: +1-818-760-2142 REGISTERED OFFICE Semler Research Center #75A, 15 th Cross, 1 st Phase, J.P.Nagar, Bangalore 560078, India T: +91-80-4262-7200 F: +91-80-2664-0683 Website: www.semlerresearch.comE mail: info@semlerresearch.com Contact Information CLINICAL FACILITIES PA Arcade, # 21, 22, 23 Kodigehalli Main Road, Sahakarnagar Bangalore – 560092, India Sharon Hospital Campus, 18, Tanmag Road, Vinayagampatti, Salem 636006, India

21. SRC/CPPT/2013/Jan/Version12 21 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Additional Information

22. SRC/CPPT/2013/Jan/Version12 22 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Equipment and Facilities Back to Equipment and Facilities Overview Pharmaceutical Development Granulators (High Shear, Fluidbed) Vial and Ampoule filling machines Multi-purpose equipment - Planetary Mixer, Granulator, Blender and other attachments Diffusion Blenders – V, Octagonal, Double Cone types Roller compactor Comminution Mill Fluid Bed Processor (top spray, bottom spray, tangential Instrumented Multi Station Tablet Press (D, B & BB Tooling) Bilayer Tablet press (D, B, BB tooling) Tablet Coating – solid pan of various sizes Blister (PVC-Alu and Alu-Alu) and Bottle packaging Homogenizer Dermatologicals processing pilot plant Stability Chambers (set to ICH Guidelines) HPLC (Waters, Agilent) with PDA, RI, fluorescence detectors and autosamplers UPLC with PDA detector Autotitrator with Karl-Fischer attachment FTIR and UV-Vis Spectrophotometer Brookefield Viscometer Osmometer Franz Diffusion Cell Apparatus Differential Scanning Calorimeter (Shimadzu) Thermo Gravimetric Analyzer (TGA) (Shimadzu) Moisture Analyzer USP dissolution Apparatus with auto sampler Tablet: USP Hardness Tester, USP Disintegration Tester & USP Friability Tester

23. SRC/CPPT/2013/Jan/Version12 23 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Pharmacology Units LOCATION 1 Dedicated facility located within Sharon Cancer Hospital campus in Salem, Tamil Nadu AREA: 15,000 sq. ft. with state-of-the-art technology for conducting BA/ BE studies including wireless monitoring system, pharmacy controlled by secured access FACILITY: 72 bed facility with a separate screening area, ambulatory sample collection, sample processing area and check-in areas LOCATION 2 In the heart of new Bangalore (less than a 15 minute drive from the international airport), Karnataka AREA: 20,000 sq. ft. equipped to conduct first-in-man, bioavailability and bioequivalence studies FACILITY: 72 bed independent facility with multiple housing units, screening area, pharmacy and a food court Bioanalytical Facility Sciex and Micromass instruments MDS Sciex LCMS/MS (API 3200 and API-4000) Waters quattro micro with HPLC as front end Water purification system Millipore RiOs 16 and Milli-Q Deep freezer with temperature control with GSM alarm system HPLC (Waters, Alliance 2695) UPLC (Waters) Refrigerated centrifuge (Hettich) ULTF (-80 0 C and -20 0 C)(Dairei) Fully secured facilities monitored with access controls and cameras Uninterrupted power supply-protected laboratory instrumentation Ocea Soft wireless monitoring system - environmental and instrument monitoring with alarm and mobile alarm system Full backup - daily, weekly, monthly and offsite Tandem Labs with highly efficient, streamlined and GLP- compliant SOPs Bioavailability & Bioequivalence Equipment and Facilities Back to Equipment and Facilities Overview

24. SRC/CPPT/2013/Jan/Version12 24 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Team Profile Resource RoleExperience (Yrs) Project managers Overall project delivery (timeline & quality) 6-8 Clinical team leaders Oversight to trial monitors Planning & coordination of site management activities 4-6 Medical writers Protocol development Development of ICD, IB, Diaries 3-5 Regulatory experts Development of regulatory dossier5-6 Medical monitors Safety issues oversight Medical query management 5-6 Biostatisticians Study design CRF design Generation of reports 2-4 Clinical research associates In-house & field-based monitoring1-3 Pharmacists Management of IMP supplies & inventory 4-6 Clinical trial assistants TMF & trial logistics management0-2 Back to Equipment and Facilities Overview Clinical Development

25. SRC/CPPT/2013/Jan/Version12 25 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Services Back to Service Overview Pharmaceutical Development Generics and NCEs: Pre-formulation Proof of Concept Phase Appropriate CT Formulations Process development studies Scale-up and Technology transfer Commercial process / Formula development CACO-2 Cell permeability studies (out-sourced) Life cycle management Differentiated generics, 505 (b) (2) Dosage Forms: Tablets/Capsules – IR, MR Oral liquids / suspensions Injectables and Ophthalmics – liquids / lyophilized powders / suspensions Topicals – ointments / creams / gels NDDS - liposomes/ transdermals/ Liquid filled hard gelatin capsules Physico chemical evaluation Solubility studies (pH dependent aqueous solubility, solubility in co-solvents surfactant assisted solubility, equilibrium solubility) Intrinsic dissolution study in various pH conditions Salt design/screening and selection Dissociation constant redetermination Partition coefficient and log P determination Key Pre-clinical Services: Proof-of-concept & prototype formulations Bio-analytical support Screening through CACO-2 cell/animal models Animal Models: Rat, mouse, rabbit, guinea pig & dog Phase I: Small scale formulation for FIH / PoC study Tentative specifications for API Manufacturing of feasibility batches CTM manufacturing and packing as per GMP with strategic partners Early phase stability studies in HDPE bottles and various blister packs Phase II & III: Formulation dvpt. finalizing the trade dress of the formulation Complete analytical validation as per ICH guidelines Dvpt. of discriminating dissolution media Scale-up, process optimization & validation & manufacture of exhibit batches Final product specification for QC CMC support Polymorphism studies Particle size, surface area, bulk/ tapped density determination Particle size distribution Bulk/tapped density determination Binding constant determination Drug- excipient compatibility studies Containers and Closure studies Pre-Formulation Services:

26. SRC/CPPT/2013/Jan/Version12 26 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Key Bioanalytical Services: Method development Method validation Method transfer Analysis of in vitro ADME and in vivo PK/ADME samples by HPLC and LC- MS/MS Analysis of drug and metabolites in different biological fluids by HPLC and LC- MS/MS Analysis of toxico-kinetic study samples by HPLC and LC-MS/MS Back to Service Overview Formulations: Oral – tablets capsules disintegrating tablets suspensions Sub lingual Intramuscular Intravenous Routes of administration: Routine systemic Dermal/topical Ocular Infusion Intra-arterial Intra-nasal Intra-thecal Intra-tracheal Intra-intestinal Intra-rectal Intra-vaginal Intra-vesicular Bioavailability & Bioequivalence PK studies in patients: Oncology Ophthalmology Dermatology Psychiatric Renal Services

27. SRC/CPPT/2013/Jan/Version12 27 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Phase I,II, III Patient PK Studies Devices & Diagnostics PMS/NIS Project feasibilities Pre-study documentation & planning Regulatory Project & site management Monitoring Biostatistics & data management Post study documentation Back to Service Overview Clinical Development PMS: Post Marketing Studies NIS: Non-Interventional Studies Services Therapy Area Expertise Infectious diseases Neuro Psychiatry Oncology Gastroenterology Ear, Nose and Throat Ophthalmology Endocrinology Cardiovascular Auto immune & Rheumatology Dental Orthopedics Nutritional and metabolic disorders Respiratory/ Pulmonology Dermatology Urinary & Nephrology Gynecology

28. SRC/CPPT/2013/Jan/Version12 28 An ISO 9001 : 2008 & ISO 27001 : 2005 Certified Company Business Development Team Full NameTitleLocationQualificationExperience Joby GeorgeAssociate Director - BDIndiaBachelor’s in Pharmacy & Master’s in Business Administration (International Business) 15 yrs Ram PrasannaAssociate Director - BD USAMaster’s in Business Administration (Marketing) 09 yrs Subbaiah MDAssociate Director - BDIndiaBachelor’s in Science and Master’s in Human Resource 6.5 yrs Navdeep SharmaManager - BDIndiaMMS in Marketing & Mater’s in Business Administration 07 yrs Chris AcharManager -BDUSAMaster’s in Business Administration05 yrs Ashik DechammaExecutive – BD & Client Relations IndiaMaster’s in Science3.5 yrs Akshatha NExecutive – BDIndiaMaster’s in Science3.5 yrs Track Record SRC also works with several independent consultants in the industry across the globe Back to Partnership & Alliances