Post-Marketing Studies means marketing studies, epidemiological studies, modeling and pharmacoeconomic studies, investigator sponsored clinical trials and post-marketing surveillance studies of a Collaboration Product, other than Phase IV Clinical Trials, that are not intended for use as a basis for obtaining Regulatory Approval (e.g., for a further indication, label expansion or otherwise) with respect to such Collaboration Product.
The term "Cost of Post-Marketing Studies" shall mean the fully allocated cost of any clinical study undertaken with regard to a Licensed Product following approval in any Major Market Country.
Except as required by applicable Law, each Party agrees that it shall not publish or present the results of Development work or Post-Marketing Studies in the Shared Territory that are directed to any Collaboration Compound or Collaboration Product in the Field, including pre-clinical studies or clinical trials carried out as part of the Development Plan under this Agreement, without the prior approval of the applicable Committee, as set forth in Section 2.2.1(p).
The Development Plan shall also include the Joint Post-Marketing Studies (and budgets covering such studies).
BioMarin will be responsible for conducting the Joint Post-Marketing Studies listed in Schedule 3.5 and, unless otherwise agreed in a Study Plan, BioMarin will be responsible for conducting any other Joint Post-Marketing Studies.
Catalyst shall have sole responsibility for Commercializing all Licensed Products in the Territory, as provided in this Article 6, and Catalyst shall bear all of the costs and expenses, except Joint Post-Marketing Studies costs and expenses, incurred in connection with all such Commercialization activities.