Bob Dormer Presenting at ACI Conference

ACI: Structuring, Negotiating and Managing Win-Win Pharma and Biotech Collaborative Agreements conference.

The Westin New York at Times Square

New York, NY

Bob Dormer presenting: Making an Early Assessment of the Impact of Generics and Regulatory Matters on the Collaboration

• Protecting against authorized generics earlier in the agreement
• Anticipating what is on the horizon for biogenerics
• status of legislation
• Increasing sensitivity in Washington regarding FDA safety and efficacy issues
• emphasis on post-marketing safety
• increased scrutiny of direct-to-consumer advertising and other marketing materials
• Understanding the current FDA rules and framework
• confidential data issues
• reps and warranties
• exclusivities
• Hatch-Waxman on patent term extension
• Drafting an agreement that complies with current regulatory standards
• pre-approval and post approval
• manufacturing
• labeling and promotion issues
• Getting specific clarity in the agreement regarding who has regulatory responsibility
• reporting and recordkeeping requirements
• who is going to hold and control the regulatory asset?
• responding to the agency
• reporting adverse events
• in a co-promote – who will deal with misbranding allegations?
• determining who will deal with recalls
• Ensuring review of the development and regulatory history of the product prior to entering into the deal