Common use of Additional Applications Clause in Contracts

Additional Applications. If the development and marketing of a given Licensed Product for a given Application other than (i) prostate cancer or (ii) endometriosis or uterine fibroids is proposed by PRAECIS to the Development Subcommittee (on the cost-sharing basis set forth in Section 4.5) but not approved, then PRAECIS may, but shall not be required to, carry out Development Phase activities with respect to such Licensed Product for such Application, at its own expense. If the Joint Steering Committee determines that Phase II or Phase III Clinical Trials funded by PRAECIS demonstrate safety and efficacy of such Licensed Product for such Application and that such Application is commercially viable, and Synthelabo determines that the commercialization of such Application should be pursued in the Territory, then Synthelabo shall promptly reimburse PRAECIS for *** (***%) of all Development Costs theretofore incurred by PRAECIS with respect to such Licensed Product for such Application and shall share on an equal basis all future Development Costs required for FDA Registration Approval of such 38 Licensed Product for such Application, Section 4.5 notwithstanding. Within sixty (60) days after such determination, the Development Subcommittee shall add the continued development and marketing of such Licensed Product for such Application to the Core Development Plan and/or the Supplemental Development Plan by amendment, which amendment shall be approved by the Joint Steering Committee within thirty (30) days thereafter; and Synthelabo and PRAECIS, as applicable, shall promptly and diligently pursue such continued development and marketing, in accordance with Article 4 and Article 5 hereof.

Additional Applications. If the development and marketing of a given Licensed Product for a given Application other than (i) prostate cancer or (ii) endometriosis or uterine fibroids is proposed by PRAECIS to the Development Subcommittee (on the cost-sharing basis set forth in Section 4.5) but not approved, then PRAECIS may, but shall not be required to, carry out Development Phase activities with respect to such Licensed Product for such Application, at its own expense. If the Joint Steering Committee determines that Phase II or Phase III Clinical Trials funded by PRAECIS demonstrate safety and efficacy of such Licensed Product for such Application and that such Application is commercially viable, and Synthelabo determines that the commercialization of such Application should be pursued in the Territory, then Synthelabo shall promptly reimburse PRAECIS for CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS (*) DENOTE SUCH OMISSIONS. *** (***%) of all Development Costs theretofore incurred by PRAECIS with respect to such Licensed Product for such Application and shall share on an equal basis all future Development Costs required for FDA Registration Approval of such 38 Licensed Product for such Application, Section 4.5 notwithstanding. Within sixty (60) days after such determination, the Development Subcommittee shall add the continued development and marketing of such Licensed Product for such Application to the Core Development Plan and/or the Supplemental Development Plan by amendment, which amendment shall be approved by the Joint Steering Committee within thirty (30) days thereafter; and Synthelabo and PRAECIS, as applicable, shall promptly and diligently pursue such continued development and marketing, in accordance with Article 4 and Article 5 hereof.