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| Introduction |
| Santaris Pharma a/s is a Danish company incorporated under and complying with the rules of the Danish Public Companies Act. The Company's operations are funded from equity financing contributed by its shareholders, which largely comprise life science venture investment groups based in Denmark and other European countries. The Company complies with all Danish corporate and statutory legislation to which it is subject, but also strives to match best practices in regard to Danish and international principles and standards of good corporate governance. |
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| Management |
| The Board retains overall responsibility for and control of the Company, including the implementation, monitoring and control of the Company's business activities. The day-to-day management - ensuring the right organization, allocation of resources, implementation of strategies and reporting to the Board of Directors - is the responsibility of the Management which is comprised by the Company's senior executives Søren Tulstrup (CEO & President), Dr. Henrik Ørum (CSO and VP Business Development), Henrik Stage (VP & CFO), Dr. Troels Koch (VP & CTO), Dr. Art Levin (VP, President US operations and CDO.), Bolette Wildt (VP HR & Legal Affairs) and Stu Mackey (VP and BDO). |
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| Board of Directors |
| The Company is governed by a Board of Directors, which has eight members. Four members represent some of the Company’s major shareholders (Søren Carlsen from Novo Ventures, Martien van Osch from Forbion Capital Partners, Holger Reithinger from Global Life Science Ventures and Edwin de Graaf from Gilde Healthcare Partners), three are independent members with senior management experience in the international pharmaceutical industry (Flemming Ørnskov, Walter Wenninger and Claus Bræstrup). In addition, two investor representatives (Claus Andersson from Sunstone Lifescience Ventures Fund and Hans Jørgen Madsen from LD Pensions) are entitled to attend meetings of the Board as Official Observers. The Board meetings take place at least six times a year. The Board actively contributes to developing the Company as a focused biopharmaceutical business and advises the Executive Management on its decisions and operations, including overall Company strategies, investment and growth plans, management appointments, R&D strategies and commercial priorities and objectives. |
The Board is chaired by Dr Flemming Ørnskov, who meets with the members of the Board in the absence of the Executive Management after each Board meeting. The Board's duties are defined in the Rules of Procedures for the Board of Directors. |
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| Board Committees |
| The Board also functions through two committees: the Audit Committee and the Remuneration and Appointments Committee. |
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| The Audit Committee |
| The Audit Committee is comprised of two Board elected members: Edwin de Graaf and Holger Reithinger. Henrik Stage, CFO, is Secretary to the Committee. The Committee is responsible for reviewing the Company's annual accounts prior to their submission for approval to the full Board. The Committee also monitors and approves the Company's accounting policies, and the effectiveness of the internal financial controls and financial reporting procedures. The Audit Committee provides a forum through which the Company's external auditor reports to the Board. The auditor attends its meetings and has the opportunity to meet privately with Committee members in the absence of Executive Management. In addition, the Audit Committee is responsible for recommending the appointment and removal of the auditors and determining the level of audit fees. The Committee also monitors the scope and results of the audit, the independence and objectivity of the auditing company and its performance. In order to safeguard auditor objectivity and independence, the Audit Committee discusses and approves any non-audit services to be performed by the auditor, including services relating to tax, share valuation, and any other accounting and auditing-related advice. |
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| The Remuneration and Appointments Committee |
| The Remuneration and Appointments Committee has three Board elected members: Martien van Osch who chairs the Committee, Flemming Ørnskov, and Walter Wenninger. Bolette Wildt, General Counsel, is Secretary to the Committee. |
The Committee determines the terms of service and remuneration of the CEO and other members of the Executive Management. It also determines the overall remuneration policy for all employees and recommends and presents proposals for the issuance of warrants from time to time to the Company's executives, key employees, consultants and/or directors for the Board of Directors approval. In addition, the Committee approves and advises the Board of Directors on the sale or purchase of equity securities by directors or employees of the Company. The Committee also sets targets for executive performance related bonus plans operated by the Company. |
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Human Resources |
| The Company strives to appoint talented employees with competencies, skills, knowledge and experience appropriate for the roles they undertake. The Company has a range of policies which are aimed at retaining and incentivizing key staff. Objectives are set for departments and employees that are derived from the Company's overall business objectives. |
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| Regulatory Compliance |
| Documented quality procedures are in place to ensure the maintenance of regulatory compliance. As a biopharmaceutical research and development company, Santaris Pharma pays particular attention to compliance with the requirements of the US Food & Drug Agency (FDA), the European Medicines Evaluation Agency (EMEA) and national medicines regulatory agencies in territories where the Company conducts research and development. Furthermore the Company strives to ensure that it and its external contractors comply with Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines. |
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| Health and Safety |
| The Company pays strict attention to the health and safety of its employees and complies with the recommendations of the Danish Working Environment Service. In addition, the Company has established pharmacovigilance and patient adverse event reporting procedures to monitor and guide immediate action in response to health issues encountered by patients undergoing clinical trials with the Company's experimental drugs. An independent external Data Monitoring Committee, comprised of recognized international clinical experts has also been established to monitor, review and advise the Company in respect of the safety of patients treated with the Company's potential new medicinal products. |
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| Auditors |
PricewaterhouseCoopers Statsautoriseret Revisionsaktieselskab Strandvejen 44 DK-2900 Hellerup |
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| Legal Advisors |
Advokatfirma Mazanti-Andersen, Korsø Jensen & Partnere St. Kongensgade 69 DK-1264 Copenhagen |
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| Bankers |
Danske Bank Nørre Voldgade 68, Boks 1193 DK- 1011 Copenhagen K |