Sole Development. If either Sanofi or BMS wishes to pursue the development of any New Indication or Line Extension, such Party (the “Proposing Party”) shall propose such development to the other Party (the “Other Party”) in the context of the Development Committee. If the Other Party decides not to pursue such development, as evidenced by its negative vote in the Development Committee with respect to such development and irrespective of whether such Party has the Lead for the Product with respect to which such development is proposed, then the Development Committee shall submit such proposal to the License Steering Committee, which shall decide whether the Proposing Party may proceed alone with such development. If the License Steering Committee agrees to permit such sole development, the Proposing Party shall be entitled to undertake such development at its sole cost and expense.
Sole Development. Until the definitive supply agreement described in Section 8.3 has been executed by the Parties, Cephalon agrees to supply Sanofi-Synthelabo and Sanofi-Synthelabo agrees to purchase exclusively from Cephalon, Sanofi-Synthelabo's requirements of Cephalon Compounds and Development Compounds for any studies for which Sanofi-Synthelabo has undertaken Sole Development pursuant to Article 11. Cephalon may engage third party manufacturers to produce the Cephalon Compounds and Development Compound with the prior written consent of Sanofi-Synthelabo, which consent shall not be unreasonably withheld. Cephalon shall provide all clinical and pre-clinical supply At Cost. All such supplies shall be in dosage form and packaging as specified by Sanofi-Synthelabo.
Sole Development. If the Parties decide a Maritime Link Expansion is necessary and one Party decides not to invest in a Maritime Link Expansion, the other Party has the right to proceed to complete such a Maritime Link Expansion on its own.
Sole Development. If either Party presents a proposal to the JRC to include in the Discovery Program the development of an Immunoconjugate and it is not included in the Discovery Program pursuant to Section 2.11(a), then either Party may, at its option and at its sole expense, conduct such development outside the scope of the Discovery Program (the “Solely Developed Immunoconjugate”). The sole-developing Party shall propose to the JRC the Solely Developed Immunoconjugate for inclusion in the Discovery Program when the Solely Developed Immunoconjugate has completed IND Preparation (unless the naked Antibody directed against the same Target as the Solely Developed Immunoconjugate is an IFM), and shall do so by submitting to the JRC a copy of the IND filing following the IND filing date. The JRC shall decide whether or not to include the Solely Developed Immunoconjugate into the Discovery Program (outside of the customary Opt-In Rights exercise under Section 5.4 below) with the non-developing Party’s representatives on the JRC having the final decision making authority solely with respect to such decision and the following shall apply:
