EXCiPACT TM EXCiPACT TM International Pharmaceutical Excipients Certification Minimize risks – maximize benefits

Why EXCiPACT TM ? Risks in the pharmaceutical supply chain are not just API related, excipients may be impacted Risks in the pharmaceutical supply chain are not just API related, excipients may be impacted Regulators Regulators expect Market Authorization Holders to secure their supply chain The appropriate way to achieve this is by a substantial increase of periodical, physical audits The economical burden associated to these requirements are impacting both manufacturers and users  Excipact Certification scheme is the industry response to help mitigate the risks and address the auditing challenge EXCiPACT TM - Minimise the Risks, Maximise the Benefits

3 A voluntary self regulated initiative of the global pharmaceutical excipient manufacturing, distributing and processing industry supported by excipient users EXCiPACTTM ensures current GMP and GDP requirements are applied to pharmaceutical excipients through a recognized auditing and certification process thereby increasing safety and reliability as well as transparency of the pharmaceutical supply chain  EXCiPACT TM is accepted from all major stakeholders including relevant authorities globally  As an independent organization EXCiPACT TM will be able to objectively set cGMP and cGDP standards today and in the future  EXCiPACT TM certification provides a cost efficient method of ensuring cGMP and cGDP are applied throughout the pharmaceutical supply chain by reducing the audit burden What is EXCiPACT TM ?Vision EXCiPACT TM - Minimise the Risks, Maximise the Benefits

4  Ease of Access: Certification from many 3 rd party audit organizations  Evolutionary: builds on existing ISO 9001 certification and uses well known IPEC-PQG GMP guides  Simple: easy to understand and apply for all stakeholders  Inclusive: applicable to all pharmaceutical excipients manufacturers and distributors  Permits the supplier to proactively demonstrate commitment to cGMP and cGDP in the manufacture and supply of their pharmaceutical excipient EXCiPACT TM Certification Benefits EXCiPACT TM - Minimise the Risks, Maximise the Benefits

5 Development of concept / business plan by EXCiPACT TM GSC April 2011 Cross referenced acceptance of Rx360 and EXiPACT TM by 3.Q Trademark protection by 2Q Acceptance and acknowledgement by IPEC, CEFIC...by 3Q Base funding completed by 90% by 4Q Hiring of staff, establishement of the advisory board by 1.Q 2012 Start of operations by 1Q EXCiPACT TM Certification Key Milestones for Implementation EXCiPACT TM - Minimise the Risks, Maximise the Benefits

Products Approval/Qualification of 3rd party audit companies issuing the Excipact certificate Excipient GMP Annex to ISO 9001 and/or ANSI standard Excipients GDP Annex to ISO 9001 and/ or ANSI standard Requirements for auditor competency and 3rd party audit organisations providing certification Services Oversight of pharmaceutical excipient manufacturer and distributor certification Auditor competency development and qualification Website with certification status, including statistical data on compliance EXCiPACT TM Certification Products and Services Managed by Excipact, a not for Profit organisation EXCiPACT TM - Minimise the Risks, Maximise the Benefits

EXCiPACT TM EXCiPACT TM International Pharmaceutical Excipients Certification Backups Minimize risks – maximize benefits

8 EXCiPACT TM Certification Cost savings for stakeholders Cost for EXCiPACT TM Audit EXCiPACT TM Supplier Pharmaceutical Company Audit fee~ 15’000€ Certificate fee~ 5’000€ Internal cost~ ’000€ Total cashout~ ’000€ Total cost in 3 years 30’000€ Audit reduction of 25 to 50% at 12 audits p.y. assumed 20’000€ to 50’000€ savings per year Audit reduction 25% to 50% 50’000€ to 100’000€ per Year Total Savings in 3 years 60’000€ to 150’000€ Total Savings in 3 years 150’000€ to 300’000€ Benefit 30’000 – 120’000€150’000 – 300’000€ EXCiPACT TM - Minimise the Risks, Maximise the Benefits

Supplier passes on audit report User can verify audit report and certificate with EXCiPACT TM Agreement with supplier Provides audit report and Certificate Legal Agreement with 3 rd party audit Organisations Publish list and list of Certificates / validity on website 9 EXCiPACT TM Certification The process and relationship EXCiPACT TM 3rd Party Audit Organisation Excipient user Excipient Supplier Excipient user EXCiPACT TM - Minimise the Risks, Maximise the Benefits

1.Supplier selects approved 3 rd party audit company 2.EXCiPACT TM issues registration no to 3 rd party audit company 3.Audit will be performed and certificate issued 4.Supplier pays audit fee (including certification fee) to 3 rd party certification body 5.3 rd party audit company pays certification fee to EXCiPACT TM and informs about audit result 6.Supplier provides audit results to excipient user and upon request audit documentation 7.Excipient user can verify the audit with EXCiPACT TM 8.EXCiPACT M reserves rights to attend audit or to analyse audit report in order to warrant standards 10 EXCiPACT TM Certification Certification Process Flow EXCiPACT TM 3 RD Party Audit Organisation Excipient user Excipient Supplier Excipient user EXCiPACT TM - Minimise the Risks, Maximise the Benefits

EXCiPACT TM Certification EXCiPACT TM Certification Quality Assurance of Certification Certificate on file and accessible on the web site Audit of third party certification body for Excipact standard compliance Access to third party auditing process for Quality assurance purpose Periodic review and renewal of 3rd party authorisation to certify against Excipact standards EXCiPACT TM - Minimise the Risks, Maximise the Benefits