Bob Dormer Presenting at ACI Conference


November 13, 2007

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