BIOTECH & LIFE SCIENCES
FAL Lawyers have been an important advisor to biotechnology and medical devices companies for nearly 20 years, as well as funded research bodies, CRCs, Universities and government bodies involved in research in the life science sector. We’ve helped them raise funds and capital, conduct clinical trials and commercialise their IP while also assisting them with their unique corporate, commercial and “business-as-usual” legal requirements, taking into account applicable regulatory frameworks and taxation considerations that apply to their business.
The means by which biotech and medical technology companies transact with their customers, such as hospitals, can be extremely complex. We have the experience to ensure that this happens quickly, effectively and ethically, having acted for government, hospitals, healthcare providers and technology companies.
Our services in the Life Sciences sector:
- Contracts & Agreements
- Corporate Structuring / Transition
- Corporate Governance
- Grants / Capital Fund Raising
- Mediation and Dispute Resolution
- Intellectual Property
- Information Technology
- Patent & Technology Commercialisation
- Trade Marks & Brand Strategy
- IP Litigation & Dispute Resolution
- Taxation Exemptions
- Customs & International Trade
FAL advised a major Medical research institution on participation in a state-funded research centre, including negotiations with the Department of Health over the millions of dollars in funding, philanthropic monies, rights as Committee of Management and establishment of various therapeutic centres.
Benitec Biopharma (ASX:BLT): Benitec is a leading ASX-listed gene silencing company developing novel treatments for chronic and life threatening conditions. FAL advised Benitec on a successful $8 million raising.
Benitec Biopharma: FAL advised on the successful acquisition in 2012 of U.S.-based Tacere Therapeutics, a ddRNAi company.
On behalf of a listed biotechnology company, FAL conducted an intensive 2 year negotiation (including mediation) with a key Commonwealth Research Agency regarding commercial, licensed technology field and patent management rights. Through our careful conduct of this negotiation, our client’s desired outcome was achieved and the framework was laid for the re-building of a mutually beneficial relationship with the Commonwealth Research Agency.
Benitec Biopharma: Collaboration with the Centre for Biomedicine & Genetics at the City of Hope in LA, USA, for the co-development and clinical trials of Benitec’s RNA-based HIV therapeutic, including advice in relation to the Office of the Gene Technology Regulator; the Special Access Scheme under sections 18 and 19 of the Therapeutic Goods Act 1989 (Cth); USA FDA requirements, GMP and GLP.
Victorian Cytology Service, Inc. (VCS), National HPV Vaccination Program Register: The VCS is a government-funded pathology laboratory which was selected by the Commonwealth Department of Health and Ageing (DOHA) to establish a National Register to support the human papilloma virus (HPV) vaccination program. FAL was engaged as sole legal advisers to negotiate numerous agreements including the head contract with the DOHA and the supporting software contract between VCS and the sub-contractor for the development of the IT system to run the Register.
FAL Lawyers advised on the collaboration with Centre for Biomedicine & Genetics at the City of Hope in LA, USA (a leading research and treatment centre for cancer, diabetes and other life-threatening diseases), for the co-development and clinical trial in humans of Benitec’s RNA-based HIV therapeutic.
FAL assisted a CRC spinoff company developing polymers for use as corrective ocular implants regarding compliance with the US Food & Drug Authority (FDA) and CE regulations, leading to accreditation of the facility.
Nurse-on-Call is a State-wide telephone health assistance service funded by DHS and provided by a private operator. FAL was appointed by the Victorian Department of Human Services (DHS) to advise on the legal aspects of setting up the service, which has now been running successfully for 4 years.
Vision CRC: FAL acted for Vision CRC on its establishment and on matters such as intellectual property, commercialisation, patent & technology licensing corporate governance, structuring issues, clinical trials and ethics committees.