“Activities to be performed by or on behalf of a Party or its Affiliates as a condition or in connection with receipt of Regulatory Approval of a Licensed Product in the Territory, including any Phase 4 Clinical Trials or other post-marketing commitments as mandated or agreed to be conducted with a Regulatory Authority for such Licensed Product.

In addition, FDA provides the following definitions:

  • Postmarketing requirements (PMRs) include studies and clinical trials that sponsors are required to conduct under one or more statutes or regulations (see Background).
  • Postmarketing commitments (PMCs) are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statute or regulation”

Source: Law Insider


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