NON-JOINT DEVELOPMENT Clause Samples

NON-JOINT DEVELOPMENT. In the event that (a) the Joint Development Team does not reach agreement to approve a proposed Additional Development Program, or (b) the Joint Steering Committee does not approve a proposed Additional Development Program, or (c) the Parties are otherwise unable to reach agreement to commence an Additional Development Program proposed by either Party, then either Party shall have the right to conduct such Additional Development Program, and shall provide written notice of its intent to commence such Additional Development Program to the Joint Steering Committee. The Party or Parties commencing such Additional Development Program pursuant to this Section 4.3.2 is/are referred to as the "Developing Party." The Developing Party shall, except as provided below, pay ************************* of the Development Expenses incurred in connection with the Additional Development Program and all regulatory activities in connection therewith. If the Developing Party files an NDA in the United States or a Major Market Country of the E.U. and receives regulatory approval for the use of Procysteine I.V. in the treatment or prevention of the Other Indication specified for the Additional Development Program, the other Party shall reimburse the Developing Party for ****************** of the Development Expenses incurred by the Developing Party pursuant to this Section 4.3.2. In addition, if the Developing Party is Transcend and (i) BI wishes to retain commercialization rights to Procysteine I.V. for the treatment or prevention of the Other Indication specified for the Additional Development Program, BI shall, within thirty (30) days after receipt of regulatory approval in the United States, or a Major Market Country of the E.U., pay to Transcend any agreed-upon milestone payments set forth in the Other Indication Program Plan; or (ii) if BI does not wish to retain commercialization rights to Procysteine I.V. for the treatment or prevention of the Other Indication specified for the Additional Development Program, all rights relating to Procysteine I.V. for the -20- 28 treatment or prevention of the Other Indication specified for the Additional Development Program in the Territory shall revert to Transcend, and the licenses granted under Section 3.1 shall terminate with respect to Procysteine I.V. for the treatment or prevention of such Other Indication specified for the Additional Development Program. BI shall indicate to Transcend in writing within thirty (30) days after re...