New Lines of Therapy. Subject to Section 3.1(c)(i)(3) below, in the event that BMS/BMKK (as one party) or Merck/MJ (as the other party) (the “Interested Party”) wishes to initiate a Clinical Trial program, and thereafter seek Approval, for a new line of therapy within either a new, or an existing approved (for example, second line therapy once third line therapy has been approved), Indication for Final Product in Japan, and the other Party (BMS/BMKK or Merck/MJ) does not, subject to Section 3.1(c)(i)(3), wish to amend the Long-Term Development Plan to include the activities necessary to seek Approval in Japan for such new line of therapy in Japan (the “Non-Interested Party”), then the Interested Party shall have the right, but not the obligation, to conduct such Clinical Trial program and to perform all other Confidential Treatment has been requested by ImClone Systems Incorporated for portions of this document. necessary activities to seek and obtain Approval for such specific new line of therapy for Final Product in Japan, at the Interested Party’s sole cost and expense, provided that if the SCJ by majority vote reasonably determines that there are good grounds to believe that the proposed course of activities are reasonably likely to be significantly detrimental to the product profile or marketing of Final Product for any one or more Indications or lines of therapy that have been previously approved (or that have been previously filed and are awaiting regulatory approval) in Japan (by way of example, and without limitation, because the proposed protocol is poorly designed or is likely to yield poor results), or to materially adversely impact the Commercialization of Final Product in the EU or the U.S., or that the proposed course of activities presents a medical risk/benefit that is so unfavorable as to be incompatible with the welfare of patients, then the Interested Party shall not proceed. The Interested Party shall be entitled to cross-reference any data generated or controlled by a Non-Interested Party anywhere in the world in support of such new line of therapy for Development and registration of same in Japan.
