Additional Studies. If required or requested for the purpose of registering and/or commercializing the Product in any particular country in the Territory, Ipsen shall be authorized to conduct the required or requested pre-clinical, clinical or other studies, including Phase IV studies (collectively “Additional Studies”), relating to the Product, subject to prior written notification to Auxilium and subject to Sections 4.5.1 and 4.5.2 below. ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. 4.5.1. Ipsen shall provide Auxilium with the study plans and/or protocols relating to such Additional Studies before such Additional Studies are started and Auxilium shall have the right to review and comment on such study Plans and/or protocols.
Appears in 2 contracts
Sources: License and Distribution Agreement (Auxilium Pharmaceuticals Inc), License and Distribution Agreement (Auxilium Pharmaceuticals Inc)