Common use of The Projects Clause in Contracts

The Projects. AM shall be responsible for the conduct of, and shall bear all out-of-pocket expenses in connection with, the AM Projects. AM shall consult with the Combidex Project Team and the Code 7228 Project Team in developing plans for clinical trials. Cytogen shall be responsible for the conduct of, and shall bear all out-of-pocket expenses in connection with, the Cytogen Project. AM may conduct Phase III(b) Studies or Phase IV Studies at its own expense, and Cytogen shall have no rights to the benefits thereof. AM will be responsible for all fees paid for FDA approval, including fees paid to the FDA in connection with Combidex, prior to the Combidex Approval Letter Date. AM will be responsible for all fees for FDA approval, including fees payable to the FDA in connection with Code 7228 on filing of the Code 7228 NDA and up to the Code 7228 Approval Letter Date. AM will be responsible for all fees payable to the FDA in connection with the certification of its facilities for commercial production of Agent. Cytogen will be responsible for any other fees payable to the FDA in connection with (i) Code 7228 (in the Field of Use) and Combidex as such Agents incur FDA charges after their respective Approval Letter Dates and (ii) Feridex I.V. if a license is granted under Section 4.2 hereof. Cytogen shall reimburse AM for the Annual Product Registration Fee payable with respect to any NDA for an Agent while Cytogen has exclusive rights under this Agreement to such Agent. AM shall be responsible for the annual Establishment Registration Fee. If Cytogen desires to conduct any clinical study solely to enhance the marketing of any Agent and such study necessitates no material labeling change, then Cytogen shall be responsible for conducting any such study and shall be responsible for all costs incurred in connection therewith. AM and Cytogen shall agree to a protocol for such study, PROVIDED, HOWEVER, that Cytogen shall have final approval of any such protocol. If AM or Cytogen desires to conduct any clinical study to enhance the marketing of any Agent, which study supports any material changes to the labeling of such Agent, Cytogen and AM shall be responsible for sixty percent (60%) and forty percent (40%), respectively, of the costs incurred in connection therewith. AM and Cytogen shall agree to a protocol for such study, PROVIDED, HOWEVER, that Cytogen shall have final approval of any such protocol.