COMMERCIAL LAW
our EXPERTISE:
ThE cornerstone
of your success
Deep and broad expertise in commercial law related to Canada’s Food & Drugs Act, Competition Act, and Patent Act positions the firm as a trusted partner in advancing clients' commercial success.
Advising on all aspects of commercial transactions, including negotiating and drafting complex agreements such as licensing, distribution, manufacturing, and supply contracts. Agreements tailored to meet each client’s business objectives while mitigating legal risks and ensuring compliance with Canadian legal and regulatory frameworks.
Strategic counsel on advertising & promotional material, in a variety of media, destined for healthcare professionals, patients, and the general public.
Advertising & Promotion
Advertising therapeutic products in Canada is highly regulated and extremely complex. Federal law, principally the Food and Drugs Act and the Competition Act apply, as well as Health Canada policies. Additionally, industry codes such as IMC Code, PAAB, and the ASC Code; all come into play. Furthermore, provincial regulation of healthcare professionals such as doctors and pharmacists also comes into play.
Clients rely on our deep and broad experience navigating this complex regulatory framework to ensure their messages to healthcare professionals, patients, and the general public get through in a compliant way.
Clinical Research
There is no more important forum for smooth legal review than in the arena of clinical research. Not only is the clock ticking on limited IP assets, but unmet medical need at the bedside needs to be addressed.
We provide efficient legal review of all Clinical Research-related agreements, including Clinical Study/Clinical Trial Agreements (CSA/CTS), Sponsored Research Agreements, Patient Brochures, Informed Consent Forms (ICF), Investigator Agreements, Contract Research Organization (CRO) Agreements.
Productive, established, working relationships with legal counterparts at sites and institutions expedites the legal review process.
Commercial Contracts
Our pragmatic in-house counsel approach ensures only important legal risks are addressed. We bring workable solutions to negotiation impasses, ensuring business keeps moving smoothly.
Experience includes drafting, negotiation and review of service agreements with service providers, including Healthcare Professionals (HCPs); Hospital & GPO RFP review, Wholesaler/Logistics Services Provider Agreements, and contracts with industry partners throughout the supply chain.
Patient Support Programs (PSPs)
Specialized legal counsel to manufacturers with Patient Support Programs (PSPs) in Canada. These programs operate within a complex regulatory framework that includes federal and provincial privacy laws, healthcare compliance standards, and industry-specific codes of conduct. The firm advises on structuring PSPs to ensure compliance with laws governing the collection and use of patient personal information and health data. From drafting robust agreements with service providers, to navigating data-sharing arrangements and regulatory audits, to ensuring compliance with drug advertising and pricing regulations.
Privacy Law
Comprehensive legal guidance to navigate the dual regulatory framework of federal and provincial privacy laws. At the federal level, the Personal Information Protection and Electronic Documents Act (PIPEDA) sets baseline standards for handling personal information. Provincially, laws such as Ontario’s Personal Health Information Protection Act (PHIPA) govern the collection, use, and disclosure of personal health information. The firm helps clients understand and comply with these overlapping regimes, ensuring data practices meet strict confidentiality standards. From privacy audits to breach response strategies, to serving as the company’s designated Privacy Officer in Canada, the firm helps protect sensitive information and maintain compliance.
Product Listing Agreements
Expert legal counsel on Product Listing Agreements (PLAs) for manufacturers navigating Canada’s complex reimbursement landscape, including negotiating Letters of Intent with the pan-Canadian Pharmaceutical Alliance (pCPA), drafting PLAs with federal and provincial public insurers, as well as private insurers. Advice on pricing, compliance, and implementation strategies to align with regulatory and contractual requirements, ensuring seamless market access and reimbursement for therapeutic products.