Initial Development Plan. The initial Development Plan for the Product shall be prepared by the Parties following the Parties’ consultation with the applicable Regulatory Authorities in the EU pursuant to Section 5.2.1(b). To the extent that future “national meetings” with the Regulatory Authorities in a specific country or territory within the Territory provide guidance with respect to the risk management plan or Development Activities in such country or territory, the Parties shall consider such guidance in updating and amending the Development Plan pursuant to Section 4.3.3.
Appears in 2 contracts
Samples: Development and License Agreement (Auxilium Pharmaceuticals Inc), Development and License Agreement (Auxilium Pharmaceuticals Inc)
Initial Development Plan. The initial Development Plan for the Bulk Product shall be prepared by the Parties following the Parties’ taking into consideration any consultation with the or guidance from any applicable Regulatory Authorities in the EU pursuant to Section 5.2.1(b)Authorities. To the extent that future “national meetings” with the Regulatory Authorities in a specific country or territory within the Territory provide guidance with respect to the risk management plan or Development Activities in such country or territory, the Parties shall consider such guidance in updating and amending the Development Plan pursuant to Section 4.3.3.
Appears in 2 contracts
Samples: Collaboration Agreement (Auxilium Pharmaceuticals Inc), Collaboration Agreement (Auxilium Pharmaceuticals Inc)