Life Sciences, Pharma, Biotech
VISCHER’s life sciences group is the leading practice group of its kind in Switzerland. We represent over 60 private and public companies, from start-ups to listed companies. Our expertise spans the full range of disciplines including:
- transactions & financing
- partnering, licensing & commercialisation
- know-how & innovation management
- regulatory, administrative procedures & compliance
Why does VISCHER focus on Life Sciences?
We understand the industry. Understanding the client requires more than just analysing the legal issues. Clients in the life sciences field share a number of challenges not routinely encountered in other industries: long product development cycles, equity based financing, complex intellectual property issues, strategic alliances or partnering, and a fast changing regulatory environment. Our life sciences team has extensive experience and a solid understanding of the issues affecting the pharmaceutical, biotech, medical devices, food, near-food and related industries.
"An ounce of prevention is worth a pound of cure." We focus on creating a sound legal and regulatory foundation for your company. By working with you on a long term basis, we ensure that legal pitfalls are prevented and that evolving legal needs are identified and addressed in time. Understanding, counselling, implementing and reviewing – each step is designed to support you.
From start-up to maturity. Our specialised attorneys advise companies in all stages of development including start-ups, VC financed development stage companies, and publicly traded industry leaders. Knowing the demands of industry partners, the regulators and the capital markets is essential for putting projects and companies on the right track, from the very beginning.
Protect your key assets. Patents and know-how represent your key assets. Our focus is the protection of your intellectual property rights by securing inventors' rights; assisting in setting an information policy; and designing the relevant clauses in employment, consulting, supply, manufacturing, clinical trials, partnering and financing agreements.
Incentivise your team. Our tax team, using our corporate and labour expertise, has helped to find solutions to incentivise employees in many companies. We have drafted and implemented a large number of stock option and share plans, and advised on tax structuring and corresponding rulings with various cantonal tax authorities.
Contracts – Procedures – Litigation. Our services cover the concept, design, and preparation of sector-specific contracts for the development, manufacture, commercialisation and distribution of drugs and medical devices. We assist in administrative procedures before regulatory authorities or the admission board of the stock exchange. We represent your company in legal disputes and administrative inquiries.
We consider it vital to be involved in the lawmaking. We have been actively involved in the Swiss legislation process on the amendments of the Swiss Therapeutic Products Act (Heilmittelgesetz), the Swiss Transplantation Act (Transplantationsgesetz), the Swiss Act on Genetically Modified Organisms (Gentechnikgesetz), the Swiss Patent Act (Patentgesetz) and the draft of the new Tobacco Products Act (Tabakproduktegesetz).
VISCHER‘s life sciences group is the largest practice group of its kind in Switzerland.
Our life sciences group stays abreast of the latest developments and takes an active role in pursuing innovative solutions for our clients. We actively promote the development of sector specific know-how among our team of lawyers and cover all areas of business and administrative law.
We strive for solutions that support your business model in an optimal way while remaining flexible.
For complex or long term mandates, we establish a client team to ensure comprehensive legal services with a high level of expertise. This team organisation enables us to provide cost effective professional services and to maintain our focus on the client's specific needs.
VISCHER provides legal advice in Swiss law. Services in French and Chinese are provided by team members with those mother tongues. A strong network of correspondent law firms around the world enables us to handle cross border mandates swiftly and efficiently.
Our attorneys are also active in the academic field and lecture on the following topics: environmental law (University of Basel and University of St. Gallen), biotechnology law (University of St. Gallen), R&D Law (University of Applied Sciences in Winterthur) and food law (University of St. Gallen - Executive School of Management, Technology and Law).
Transactions & Financing
Growth Financing. We have advised companies and investor syndicates in over 60 financing rounds in the life sciences field with deal values from CHF 300'000 to CHF 145 million. We have drafted and negotiated a number of bridge loans from CHF 3 million to CHF 25 million for venture backed life sciences companies, many of them converted into equity.
We have acted in a multitude of transactions involving life sciences companies, advising companies and investor syndicates, structuring deals and advising on the transfer of intellectual property rights.
Selected recent transactions include:
- We advised CRISPR Therapeutics AG in its Series B financing with total proceeds of nearly USD 140 million. CRISPR Therapeutics AG with corporate seat in Basel is a biopharmaceutical company focused on translating CRISPR-Cas9 gene-editing technology into trans-formative medicines.
- We advised ProteoMediX in its Series B Financing of CHF 3.2 million. ProteoMediX, in Schlieren, is a diagnostic company developing non-invasive diagnostic tests for the accurate detection, prognosis and therapy-selection of cancer.
- We advised investors in the CHF 20 million (USD 21 million) Series D financing of GenKyoTex, in Plan-les-Ouates, Geneva. GenKyoTex focuses on developing drugs that stop the production of damaging oxygen species in the body (NOX inhibitors). The financing was led by NeoMed Management, who along with co-leads VI Partners and BioMedInvest are new investors in the Company.
- We advised Inthera Bioscience, a Zurich based biopharmaceutical company focused on the development of first-in-class targeted small molecule therapies for solid tumours, in its EUR 3.4 million seed financing round.
- We advised LifeCare Partners (Switzerland) and LSP Life Sciences Partners (Netherlands) as lead investors in a CHF 15 million financing round of Kuros Biosurgery AG, a biotechnology company based in Zurich, developing novel biomaterials and bioactive-biomaterial combination products.
- We advised Memo Therapeutics, a Basel/Zurich based spin-off company from ETH Zurich, developing a disruptive platform technology for antibody discovery in its CHF 2.3 million seed financing round.
- We advised investors in the seed financing of Lunaphore Technologies SA, in Lausanne, with an innovative tissue diagnostics platform, primarily for analysis and classification of tumours.
- We advised BiognoSYS AG, a leading company acting in the field of next-generation proteomics, in a significant Series C funding from a corporate investment fund.
- We advised NOUSCOM AG, domiciled in Basel, in a EUR 12 million Series A financing co-led by LSP and Versant Ventures. NOUSCOM's technology focuses on viral vectors and oncolytic viruses, which infect and kill tumour cells and stimulate an immune response against cancer cells throughout the body.
- We advised ENDOSENSE, a pioneer and leader in force-sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, in an USD 40.3 million (CHF 37.4 million) Series C financing.
- We advised Advanced Osteotomy Tools – AOT AG, in Basel, in conducting a substantial Series C round, financing AOT's program for CE-certification of the CARLOTM-System (Cold Ablation Robot-guided Laser Osteotome).
- We advised AstraZeneca as investor in a USD 80 million financing round of ADC Therapeutics Sàrl, Epalinges: an oncology drug development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major solid and haematological cancers.
- We advised Anokion SA, in Lausanne, in its closing of a Series A financing round for CHF 33 million (USD 37.5 million). The spin-off from the École Polytechnique Fédérale de Lausanne (EPFL) has developed a technology for retraining white blood cells to induce therapeutic immune tolerance.
- We advised Anergis in Lausanne, a company discovering and developing proprietary allergy vaccines, in a financing round totalling CHF 8 million being co-led by Sunstone Capital, BioMedInvest and Renaissance PME/Vinci Capital.
- We advised Sonetik in a Series A2-financing by existing investors, BB Biotech Ventures, and a new investor joining the consortium, Aeris Capital.
- We advised anwerina AG, a life science company specialized in the development and marketing of innovative orthopaedic pharmaceutical and medical products, in the financing by RIEMSER Arzneimittel AG.
- We advised Pantec Biosolutions AG, in Liechtenstein, a company developing innovative technologies for transdermal drug delivery, in a CHF 20 million investment realised in two financing rounds.
- We advised Vivocell Biosolutions AG, in Zug, a company establishing a cord blood stem cell bank for autologous and allogene precaution, in a CHF 24 million investment realised in a series of financing rounds.
Project Financing. We help entrepreneurs in the early stages, even before they have established their business. We provide legal tools for project financing.
Spin-offs. We have assisted a big number of Spin-offs from the Eidgenössische Technische Hochschule (ETH), the École Polytechnique Fédérale de Lausanne (EPFL), the University of Zurich and the University of Basel and are familiar with the many challenges of such Spin-offs.
Building a Swiss presence. We have assisted a number of international Swiss players building up a Swiss presence including transfer of IP, operations, inter-company arrangements and solving the related tax challenges.
Tax Advice (including VAT). We assist companies in implementing optimal tax structures. For start-ups, we obtain formal tax relief and analyse their VAT needs. Our tax experts assist in all tax matters.
Corporate Governance. We design the optimal corporate governance structure tailored to the needs of your company. Our expertise with listed companies helps us design structures for smaller companies, which allow for future growth. For listed companies, we advise on disclosures and public reporting requirements. For management transactions, we advise on structure, timing and compliance with reporting requirements.
Capital Markets. (Initial public offering and secondary offering). We have introduced six major life sciences companies to the SIX Swiss Exchange or (with US counsel) to NASDAQ (market caps between CHF 320 and 1'500 million) and have assisted in the secondary offering (deal values between CHF 50 and 400 million). We are recognised as listing experts at the SIX Swiss Stock Exchange and thus can file the listing application on the company’s behalf.
Selected recent transactions include:
- We assisted CRISPR Therapeutics AG in all Swiss law matters for its initial public offering at NASDAQ raising USD 56 million. CRISPR Therapeutics AG with corporate seat in Basel is a biopharmaceutical company focused on translating CRISPR-Cas9 gene-editing technology into trans-formative medicines.
- We assisted AC Immune SA, in Lausanne, in all Swiss law matters for its initial public offering at NASDAQ raising USD 66 million. AC Immune is a clinical stage Swiss-based biopharmaceutical company focused on neurodegenerative diseases with four product candidates in clinical trials. VISCHER AG has been advising AC Immune since its inception in 2003 in all previous financing rounds A to E.
- We advised Kuros (SIX: KURN) in its reversed stock split at a ratio of 100:1. Kuros is a leading biosciences company focused in the field of tissue repair and regeneration.
- We advised Cytos Biotechnology Ltd. (SIX: CYTN) in a financing transaction that raised a total of CHF 24.3 million by selling 8.1 million shares at a price of CHF 3 per share.
Management Buy-Out. We have assisted in several management buy-outs, implementing the tax-driven structure on the buyer's side and the related finance documentation.
Mergers & Acquisitions. Our M&A team assists our clients in the preparation of M&A transactions. We assist buyers and sellers in due diligence, contract negotiation and closing; we also resolve IP, tax, regulatory, labour, environmental, real estate, and other ancillary issues.
Selected recent transactions include:
- We advised (Kuros Biosciences Ltd. (SIX:KURN) in its combination with Xpand Biotechnology B.V. Xpand's novel orthobiologic MagnetOs was approved for sale in the European Union in July 2016 and is under regulatory review in the US.
- We assisted Celgene (NASDAQ: CELG) in its acquisition of EngMab for USD 600 million. EngMab's focus is on T-cell bispecific antibodies (TCBs). TCBs bind simultaneously to a target on a tumour cell and to the T-cell receptor complex, resulting in the death of the malignant cell.
- We advised Cytos Biotechnology Ltd. (SIX: CYTN) in the combination with Kuros Biosurgery Holding AG, a leading biosciences company in the field of tissue repair and regeneration.
- We advised Mind-NRG, in Geneva, in the sale of Mind-NRG to Minerva Neurosciences. Mind-NRG's main asset is MIN-301, a compound in development for the treatment of patients suffering from Parkinson's disease.
- We advised the sellers of REDVAX GmbH, in Schlieren, in its sale to Pfizer. REDVAX is a spin-off from Redbiotec AG, a privately held Swiss biopharmaceutical company, based in Zurich-Schlieren. REDVAX develops a preclinical human cytomegalovirus (CMV) vaccine candidate, a herpes virus.
- We advised 4-Antibody AG, a biotechnology company developing novel immune system activating treatments for cancers and infectious diseases, in the sale of the company to Agenus Inc. (NASDAQ: AGEN) for an initial payment of USD 10 million in shares and contingent payments that may exceed USD 40 million. We have been advising 4-Antibody since its first financing round.
- We advised Okairos and selling shareholders (including BioMedInvest, LSP, Novartis Venture Fund) in the sale of Okairos AG, a Swiss developer of vaccine technologies, to GlaxoSmithKline Plc for EUR 250 million. We have been advising Okairos since its first financing round in various commercial and financing matters.
- We advised the sellers Matignon, BB Biotech and Signet in the sale of their stakes in Anteis SA, a Swiss based company that develops, manufactures and distributes injectable medical devices based on bio-polymer transformation.
- We advised AstraZeneca on the Swiss law aspects of its acquisition of Spirogen, a privately-held biotech company focused on antibody-drug conjugate technology for use in oncology, through its global biologics research and development arm MedImmune for an initial consideration of USD 200 million and up to USD 240 million milestone-based contingent payments.
- We represented the sellers of GlycoVaxyn AG (including Sofinnova Partners, Index Ventures and Edmond de Rothschild Investment Partners) in the sale of GlycoVaxyn AG to GlaxoSmithKline (GSK) for a consideration of USD 190 million, valuing this privately held Swiss vaccine company in Schlieren-Zurich at USD 212 million in total. GlycoVaxyn's innovative biological conjugation platform originates from ETH Zurich and enables the development of a new generation of conjugate vaccines against major bacterial infections. We have been advising GlycoVaxyn in several financing rounds (raising approximately CHF 50 million) as well as in its major collaborations with GSK and Janssen Pharmaceutica.
- We have been advising Covagen in its sale to an affiliate of Janssen Pharmaceutica which belongs to Johnson & Johnson. Covagen AG, located in Schlieren near Zurich, is a privately-held biopharmaceutical company specializing in the development of multispecific protein therapeutics through FynomAb® by fusing fully human Fynomer binding proteins to antibodies. VISCHER has been assisting Covagen in its inception, has been advising Covagen in all its financing rounds as well as in major collaborations and acted for Covagen in the Swiss law matters involved in its sale.
- We advised YFM Equity Partners’ portfolio company Fishawack in its acquisition of Swiss medical communication service provider Phocus Holding GmbH.
Restructuring and Demergers. We help companies benefit from the flexibility created by the Swiss Merger Law including spin-offs, split-offs, and divestitures. Our firm has published one of the leading commentaries on this law and has gained an excellent reputation in this field.
Fund Formation and Management. We assist in structuring, forming and administering funds established in Switzerland.
- We assisted Swiss BioMedPartners, one of the leading European healthcare venture capital firms, in the establishment and closing of BioMedInvest II L.P., its second healthcare venture capital fund, which raised CHF 106 million. BioMedInvest II L.P. is a healthcare-dedicated fund that invests in private early- to mid-stage companies in Germany, Switzerland and neighbouring European countries.
Swiss Venture Capital and Private Equity. We advise Switzerland based VCs and private equity companies on investments made both in and outside Switzerland and, if required, coordinate foreign counsel.
Non-Swiss Venture Capital and Private Equity. We advise VCs and private equity companies on Swiss portfolio investments, including requirements set by German tax legislation.
Employee Participation (Option Plans, Share Plans). Our tax team, using our corporate and labour expertise, has helped find solutions for option and share plans which are a key tool to incentivise employees in many companies. We have drafted and implemented a large number of stock option and share plans, and advised on the drawing up of tax structures and obtaining any necessary rulings from the various cantonal tax authorities.
Partnering, Licensing and Commercialisation
Excellent ideas in the life sciences sector are created by innovative minds in both academic and industrial environments all around the world. Identifying and evaluating opportunities for developing and marketing new products through strategic alliances or licensing is an integral part of the Life Sciences business. Our attorneys assist clients in all aspects relating to licensing including how to resolve intellectual property risks such as availability, exclusivity, enforceability and unwanted obligations. We advise across a full range of issues that affect the process of contract formation including due diligence, IP, tax and accounting matters. We act for a wide range of life sciences companies in the negotiation and settlement of patent and know-how licences, confidentiality, subcontracting, agency, joint venture and R&D agreements, as well as other types of commercial agreements. Our services include:
Partner Evaluation. We assist in structuring an evaluation process, due diligence and drafting the appropriate legal documents to effectively protect your company’s interests from the very beginning of a potential corporate relationship.
Joint ventures and co-operations. Due to the particularities of the Swiss statutory law, joint venture arrangements and business co-operations need to be carefully considered and executed. VISCHER's experts understand that arrangements need to be tailor-made in order to protect your company's interest while avoiding legal pitfalls.
Recent examples of VISCHER's expertise include where:
- We represented a pharmaceutical company in the field of various therapeutical applications for steroids, to implement a worldwide licensing and IP strategy (deal volume over CHF 300 million).
- We advised The International Institute for the Safety of Medicines Ltd (ii4sm) on the provision of pharmacovigilance expert consulting and quality assurance services in a collaboration with Tata Consultancy Services and a collaboration with Kinapse providing services to the European Medicines Agency (EMA).
- We represent a number of venture financed Swiss start-up companies including AC Immune, 4-Antibody, Glycovaxyn, Pantec Biosolutions, Molecular Partners, Lumavita and Okairos in their numerous collaborations with industry (in particular licensing, clinical trials and manufacturing) and academia.
- We have been advising a listed Swiss company in its clinical trial agreements ranging from early phase I to phase III trials.
- We have been advising a biopharmaceutical company in its clinical trial agreements for several drug candidates including securing support from listed pharma companies, CROs, central labs, and external scientific advisors.
- We advised a major international pharma company in setting up its phase III clinical trial for a vaccine candidate with Swiss investigators.
- We advised an international CRO in establishing co-marketing agreements with major pharmaceutical companies.
- We advised a specialist cell media manufacturer in drafting and negotiating a distribution agreement for research reagents.
- We advised a specialty pharmaceutical company in modifying and terminating supply and distribution agreements following dissatisfying results of clinical studies.
- We advised a US life sciences technology company in setting up its product distribution and services agreements for Europe.
Securing Long-Term Interests. We support your company in establishing state-of-the-art contractual frameworks that reflect not only your company's temporary interests but also take account of long-term interests and unforeseen changes.
License and Know-How Transfer Agreements. We draft and negotiate licence and know-how transfer agreements. Our attorneys are familiar with the peculiarities of tech transfer units and research institutions (IP ownership and approvals).
Clinical Trial Agreements. We advise companies in compliance issues regarding clinical trials and other research projects involving humans and draft clinical trial agreements.
Manufacturing Agreements. We draft and negotiate manufacturing agreements, taking into account the special allocation of responsibilities and IP matters.
We draft and negotiate a wide array of commercial agreements that are specific to the industry, taking into account the particularities of the life sciences sector as well as IP, tax and accounting issues. Examples include contract research, contract manufacturing, clinical trial, supply, logistics, or distribution agreements.
Selected recent transactions include:
- We advised ABBA Therapeutics AG, a Swiss biotechnology company developing innovative immuno-oncology therapies under its licence from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND). Under the licence, ABBA Therapeutics AG will be able to use the OmniRat, OmniMouse and OmniFlic platforms to generate fully human mono- and bispecific antibodies.
- We advised AC Immune SA in a worldwide exclusive license agreement and research collaboration with Janssen Pharmaceuticas (Johnson & Johnsen (NYSE: JNJ)) to develop and commercialise therapeutic anti-Tau vaccines for the treatment of Alzheimer's disease and potentially other tauopathies, including the lead therapeutic vaccine for an upfront payment and milestone payments potentially totalling up to USD 509 million.
- We advised GlycoVaxyn AG, a leader in the development of innovative vaccines, entering into research and development collaboration and license agreement with Janssen Pharmaceuticas (JPJ) and with GlaxoSmithKline Biologicals (GSK), to develop a multivalent bacterial vaccine on the basis of its unique, proprietary in vivo glycosylation platform.
- Following the acquisition of GlycoVaxyn by GSK, GSK commissioned the management team to create a new company, LimmaTech Biologics AG, in Schlieren near Zurich, which acquired GlycoVaxyn's operational research business. LimmaTech Biologics is not a GSK owned company. GSK and LimmaTech Biologics have signed a research agreement with a minimum term of five years to allow LimmaTech Biologics to develop novel bioconjugate antigen-based vaccines exclusively for GSK. VISCHER assisted LimmaTech Biologics starting at foundation and then in the collaboration agreement with GSK.
- VISCHER assists CRISPR Therapeutics in all Swiss law matters regarding a joint venture to discover, develop and commercialize new breakthrough therapeutics to cure blood disorders, blindness and congenital heart disease. Bayer will provide a minimum of USD 300 million in R&D investments to the JV over the next five years. In addition, Bayer will acquire a minority stake in CRISPR Therapeutics for USD 35 million in cash.
- We advised CRISPR Therapeutics in all Swiss law matters of the strategic research collaboration concluded with Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) focused on the use of CRISPR's gene editing technology, known as CRISPR-Cas9, to discover and develop potential new treatments aimed at the underlying genetic causes of human disease, to be used in the field of cystic fibrosis and sickle cell disease. As part of the collaboration, Vertex made an up-front commitment of USD 105 million to CRISPR, including USD 75 million in cash and a USD 30 million equity investment in addition to downstream profit sharing and royalty payments.
Innovation and Know-How Management
The proper protection of inventions and innovative concepts generated by companies in the life sciences sector is of utmost importance for their sustained success. Our attorneys offer their legal expertise not only on the available options to protect your company's innovations by contractual arrangements but also on strategies and procedures to comprehensively protect your innovations by registered intellectual property rights. Our specialized lawyers keep a close eye on the legislation and case law regarding life sciences-related intellectual property, including the ongoing amendment concerning biotech inventions in the Swiss patent act.
Protection of Research Results. Our attorneys understand that patents are an important business tool and form part of an overall business strategy. We work with patent lawyers specialised in various technical areas to ensure optimum patent coverage and defence that are tailored to the specific needs of our clients. We develop international protection strategies for patents, trademarks and domain names.
Leading Edge Technologies. We are familiar with transactions involving checkpoint inhibitors, vaccines, gene editing, small molecules, diagnostics, antibodies, genomics, proteomics, RNAi, drug delivery technologies, immunohematology, and other platform technologies.
Transfer of Intellectual Property. We structure, negotiate and draft transfer and development agreements for Life Sciences companies.
Intellectual Property Due Diligence. VISCHER's experts conduct due diligence reviews of intellectual property rights typically in the framework of mergers or acquisitions. We analyse the legal status of these rights and identify the legal issues which your company will presumably wish to deal with when determining the conditions of the envisaged transaction.
Patent & Trademark Litigation. Working with patent attorneys locally and overseas, we represent clients in patent litigation. We prosecute and defend patent infringement actions and related claims for revocation in the Swiss courts and in multi-national patent disputes. We also assist in mediation proceedings. We further advise clients on trade mark matters and have considerable experience advising clients on filings and related opposition and revocation actions. We evaluate and help resolve technology ownership disputes.
Recent cases include:
- We advised a Swiss biopharmaceutical company in establishing a collaboration with a German university regarding the development and pre-clinical evaluation of human therapeutic antibodies.
- We advised a Swiss biopharmaceutical company in acquiring and sublicensing rights to proprietary mouse models for development of therapeutics for central nervous systems diseases.
- We advised a Swiss company in establishing and implementing a worldwide strategy for the distribution and marketing of its innovative blood sugar meter.
- We represent a number of firms as legal counsel or act as arbitrator in various disputes concerning the licensing and co-development of pharmaceuticals.
- We advised a manufacturer of a proprietary cell culture growth medium in negotiating a supply agreement with a global specialty pharmaceutical company.
- We advised an international medical device company in negotiating a supply agreement for infusion sets.
- We advised a medical device company in entering into a supply agreement regarding neuroprosthetic modules.
- We advised a Swiss biopharmaceutical company in establishing contractual relationships with CMOs for the development and manufacture of several drug candidates in the field of central nervous systems diseases.
- We advised a company developing orphan drugs in setting up a development and manufacturing agreement with an international CMO specializing in biopharmaceuticals.
- We advised a major Medtech company on the termination of its manufacturing agreement with a Polish manufacturer and in negotiating a new manufacturing agreement with a manufacturer in Central Europe.
Regulatory, Administrative Procedures and Compliance
The regulatory framework governing the life sciences sectors is complex and constantly evolving. Our specialised lawyers closely monitor the continuing regulatory developments and case law in this area.
Research. Research is a core issue in the life sciences sector. Our lawyers have extensive expertise in advising our clients in matters relating to their research projects. Swiss regulatory law is constantly changing. Our lawyers keep you up to date.
Approvals. Our regulatory experts are familiar with the modalities of the different types of approvals relevant in the life sciences sector and the particularities of the corresponding procedures. We assist our clients in the evaluation of the appropriate regulatory strategy and in the approval proceedings before the competent authorities (e.g. Swissmedic, Federal Office for Health, cantonal laboratories). We also represent our clients in procedures before the federal and cantonal administrative courts.
Clinical Trials. The regulation of clinical trials in Switzerland is somewhat different compared to that of the European Union. We have extensive experience in all legal issues pertaining to the conduct of clinical trials in Switzerland.
Quality Agreements. We support clients in ensuring that quality or technical agreements and the related responsibility matrix are aligned both with regulatory requirements and with existing manufacturing, supply or similar agreements; thus providing a reliable tool for quality assurance personnel.
Pricing, Reimbursement and Marketing. We protect our clients' interests in administrative proceedings in pricing, re-imbursement and marketing matters before the Swiss regulatory authorities and represent our clients in court.
Drug Advertising. We are familiar with the restrictions applicable to drug advertising in Switzerland and assist companies in complying with the respective rules and represent companies in respective investigations by the regulator.
Transborder Trade. Transborder trade of pharmaceuticals into Switzerland is not only an issue under Swiss patent law but also under Swiss regulatory law. Transborder trade of food and near-food products into Switzerland is highly regulated and involves detailed knowledge of relevant law and practice. We are familiar with the legal modalities and closely observe the political and administrative developments in this field.
Compliance. Compliance is a challenge in the fast changing regulatory environment of the life sciences sector. We can help companies to produce and implement policies and processes to ensure that they follow the numerous laws, rules and regulations (e.g., food law, gentech-regulation, data protection, and environmental law).
Investigations. Our attorneys specializing in public law assist in regulatory proceedings. An important focus here is administrative procedures relating to the marketing of health care and food products. Our attorneys also assist in criminal proceedings against companies and individuals.
Regulatory Due Diligence. For mergers and acquisitions involving regulatory matters in the Life Sciences sector, we conduct due diligence reviews. We analyse all regulatory aspects of the target company relevant to the envisaged transaction.
Material Benefits in the Drug Market. We are familiar with the rules and regulator's practice regarding the restrictions applicable to promises and acceptance of material benefits. We advise companies in respective compliance issues and support and represent them in investigations by the regulator.
Recent matters include where:
- We assisted Biogen (NASDAQ: BIIB) in the land purchase required for the one billion franc investment for a new biological manufacturing facility in Luterbach (Canton of Solothurn) expected to create 400 jobs.
- We advised a major international pharma company on setting up its phase III clinical trial for a vaccine candidate with Swiss investigators, and on regulatory matters in order to set up an international research project.
- We acted on behalf of a Swiss pharmaceutical company in administrative proceedings and in the subsequent court appeal concerning the listing of a medicinal product on the list of pharmaceutical specialties.
- We advised a major medical devices organisation in restructuring its business unit as a consequence of new regulatory laws.
- We reviewed a foreign energy drink on its compatibility with Swiss regulation laws and advised the manufacturer on regulatory issues regarding the import of the product into Switzerland.
- We advised a leading research company and analysed regulatory risks linked to extraction of bone cells from donors.
- We advise a major supermarket chain in implementing a new law in order to be able to sell low risk pharmaceuticals.
- We advise a major supermarket chain on regulatory issues regarding parallel imports of food and near-food products.
- We repeatedly provide advice regarding the labelling and advertising of food products with pharmaceutical-like ingredients.
- We act on behalf of individuals from a pharmaceutical company in administrative criminal and criminal proceedings.
- We have conducted an internal investigation concerning compliance issues for a major biotech company relating to a phase IV study.
- We represented the University of Zurich and the Swiss Federal Institute for Technology Zurich in their administrative proceedings and litigation concerning field trials with genetically modified wheat.
- We represented a leading European chain of institutes for assisted reproductive technology in implementing a new business case in the field of long-term storage of women’s egg cells for fertility precaution.
- We advised a major Swiss pharmaceutical company on regulatory matters in order to set up an international research project.
- We advised an international clinical services provider on securing compliance with Swiss laws when offering the services of study nurses to sponsoring pharmaceutical companies.
- We provide permanent advice to a major biotech company on its marketing practices and the marketing practices of its competitors.
- We provide advice to pharmacies relating to the permits for distributing traditional Chinese medicine products.
Our clients in the life sciences sector regularly require advice across a full range of issues affecting their business, including the following fields:
Litigation and Arbitration. We represent parties in litigation or arbitration and advise on opportunities to resolve disputes prior to or during proceedings. Dispute resolution is a core competence of VISCHER. With a team of 14 practitioners who primarily focus on litigation and arbitration, we have one of the largest litigation departments in Switzerland.
Employment Contracts and Litigation. Our dedicated employment law team has vast experience relating to employment contracts, consulting agreements, employment manuals and employment litigation before specialised employment courts.
Tax and VAT. VISCHER’s tax team is one of the largest tax teams in a commercial full service firm in Switzerland. Our main field of tax practice is corporate taxation and long-term assistance to corporations, i.e., setting up and maintaining tax structures within groups, both national and international. We set up principal structures, as well as domiciliary companies, for companies selling life sciences products outside Switzerland. We also negotiate tax holidays for start-ups. Our clients can expect competent, tailor-made solutions, encompassing both the underlying civil law structures and the resulting tax law issues.
Insolvency Law. We advise and represent both creditors and debtors in complex financial restructurings and advise directors and management about liability risks in insolvency situations.
Competition Law. We advise on diverse competition matters, including Swiss Competition Commission inquiries, compliance and merger investigations.
Unsolicited Takeovers. We advise on anti-takeover planning, execution, defence, director indemnification, and severance.
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