Azierta

PRODUCTS SCOPE

TECHNICAL DUE DILIGENCE: LIFE SCIENCE MERGER AND ACQUISITIONS

Medicinal Products

Reduce the risk performing a Technical Due Diligence in your transaction with Azierta: Critical and weak points of the product, consequences, risks and recommendations will be presented. The due diligence can be completed with an Action Plan including investments and timing to solve the identified gaps as well as a Strategic Plan to maximize the product value on the market.

Medical Devices

Cosmetics

Biocides

Food Supplements

Technical Due Diligences

METHODOLOGY

KICK-OFF MEETING

» Establishment of the Project Strategy depending on the time available for the evaluation (Data Room with a limited timing or not).

» Both products and manufacturers information is compiled.

» A Guide Document with the critical parameters of the projects will be issued following this meeting and the team involved depending on the scope.

Azierta

DATA ROOM OR EVALUATION PHASE

» Whether it takes place in a Data Room or not, all the evaluations previously agreed will be performed during this phase.

» If possible, it is interesting to include interviews with the appointed Responsibles of the seller to ask those relevant questions compiled during the evaluation.

Regulatory Assessment » Registration dossier analyses versus current applicable European legislation (CMC, Pre-clinical and Clinical).

» Manufacturing process / Analytical Methods / Stability Data evaluation and their compliance with both the registration dossier and applicable European legislation.

» Deep Quality System Audit of the manufacturers (corresponding legislation depending on the product, GMP/GDP audits in Medicinal Products, ISO 13485, ISO 9001 or QSR for medical device companies.

Regulatory Compliance

Quality System Evaluation

IN CASE A PRODUCTION TRANSFER IS ESTIMATED

Cost Analyses » Manufacturing cost evaluation of the current manufacturer.

» Necessary regulatory steps: requirements, activities and timing.

» Technological impact: feasibility and investment needed. » Transfer cost.

Transfer Technology Evaluation

Technical Due Diligences

REPORTS

» Evaluation Report: Azierta will perform a Report with the following index: ¬ Introduction. ¬ Executive Summary with conclusions and Action Plan recommended. ¬ Technical Evaluation (per product)

˚ Critical Points: . Description. . Consequences and Risks. . Recommendation.

˚ Weak Points: . Description. . Consequences and Risks. . Recommendation.

PRESENTATION

Our team will present the Report to the company in a face to face.

ACTION PLAN

Azierta could support later on in the different activities defined in the Action Plan.

Proposal for Action Plan: including investment and timing considertations.

- Action Plan: including corrective actions.

- Strategic Plan Proposal for Market Access: taking into acount stakeholders and competitors

Azierta

Ana ÁlvarezProject Manager and Regulatory Affairs Expert

Ana is a key figure in the development of Azierta as partner and Regulatory Affairs Director. She has over 20 years of experience in Regulatory Affairs providing outstanding results in regulatory approvals, product development and regulatory compliance. She has a wide experience on switches from Rx to Non Rx drugs in the EU regulatory framework. Throughout her professional career

Ana has always worked directly and closely with manufacturing plants, thus achieving a great learning and experience in product development and CMC.

Ana is an active member of several committees related with OTC products since 2001 (i.e. OTC drugs, Medical Devices and Food Supplements) and also member of AEFI since 1997.

Mª Ángeles MuñozProject Leader

María Ángeles is a senior expert in Life Sciences with more tan 20 years of experience in pharmaceutical companies and Consultancy Sector, always related to Regulatory Compliance environment. María Ángeles is a senior leader who combines her comprehensive regulatory knowledge with strategic and business expertise. She has been Project Leader in more than 15 Due Diligences coordinating the technical evaluation, both industrial and regulatory.

Currently, she is responsible to develop, lead and manage all commercial activities of the consultancy business, implementing a commercial strategy oriented toward new product areas and emerging markets. María Ángeles is member of AEFI (Spanish Association of Pharmacists of the Industry).

TEAMAzierta has a multidisciplinary team of professionals with extensive experience in the pharmaceutical and medical device industries and advanced degrees in a wide variety of scientific fields offering different experts depending on the products and scope of Due Diligence, but the team will be formed by a Project Leader, Area Experts and Consultants if necessary. Project Leader and Area Experts CV’s are included as follows:

Jesús PardoMedical Devices Expert

Jesús is a senior expert in medical devices with more than 20 years of experience in medical devices consulting and regulatory affairs.

The services that Jesús provides are developing and implementing Quality Management Systems (QMS), CE certification for medical devices and medical

devices for IVD, QMS audits, quality and regulatory training courses.

He has collaborated in projects related with sterile active and non-active implants, electromedical devices, software as medical device and IVD products.

Technical Due Diligences

Alberto CarazoGMP and Industrial Expert

Alberto is a senior industry consultant specializing in pharmaceutical consulting. He has more than 25 years of experience in national and international pharmaceutical companies in managing areas as CEO, Operations, QP, R+D, Quality or Pharmaceutical bussiness development areas.

The services that Alberto provides include audits and manufacturing sites certification, quality systems support and global supply chain verification.

Alberto is a active member of AEFI, ISPE (International Society of Pharmacoepidemiology) and PDA.

Miguel AlcántaraAudits Expert (GMP/GDP)

Miguel is a senior quality assurance and audits expert. During 25 years, he collaborated with pharmaceutical companies as Technical Director, Audits Responsible and Quality Assurance Manger.

Miguel has a comprehensive compliance and quality systems knowledge in order to ensure his clients a complete global supply chain and quality support.

Miguel belongs to AEFI and Madrid Pharmacists Association.

Luis RosadoHealth Expert

Luis is a senior health expert with 30 years of experience in private and public sectors. The expertise that Luis provides include optimization of market access support, clinical management solutions, Healthcare centers management consultancy and advisory services to health authorities. Luis held management and public positions as Hospital Manager and Minister of Health (Valencia government).

He is also professor in several masters and universities. Luis is member of SEDISA (Spanish Society of Healthcare Managers) since 2005.

Ignacio AristeguiMedical Doctor

Ignacio Arístegui is a Medical Doctor who has over 20 years of experience in Medical Affairs and Clinical Research Departments of multinational Pharma and Biotech companies, holding several management responsiblities.

In his current position, as Medical Affairs Director in Azierta, he is responsible for providing Project and Team Management support for Medical Affairs,

Biomedical Research, & Compliance, for Human and Vet Health Industry, Health Care Providers, and the Academia fields.