Common use of Independent Performance of Additional Development Activities Clause in Contracts

Independent Performance of Additional Development Activities. (a) If the PSC fails to approve for inclusion in the Split Territory Global Development Plan an Additional Development Proposal proposed by a Party for a Secondary Indication Study(ies) for a Split Territory Licensed Product, such Proposing Party may, upon notice to the other Party (the “Non-Proposing Party”), conduct the proposed Secondary Indication Study(ies) at its own expense; provided, however, that if the Proposing Party receives written notice from the Non-Proposing Party [***]. (b) Notwithstanding anything in Section 6.2.7 (Right of Reference) to the contrary, if the PSC does not approve an Additional Development Proposal, unless and until the Non-Proposing Party delivers an Additional Development Opt-In Notice with respect to such Additional Development Activity, as described in Section 5.2.5.4 (Opt-In for Additional Development Activities), the Non-Proposing Party shall not have any rights under Section 6.2.7 (Right of Reference) with respect to any information or data generated from any Secondary Indication Study that was the subject of the unapproved Additional Development Proposal. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Independent Performance of Additional Development Activities. (ai) If the PSC JDC fails to approve for inclusion in the Split Territory Global RLP Development Plan an a Proposing Party’s Additional Development Proposal proposed by a Party for a Secondary Indication Supplemental Study(ies) for a Split Territory such Regional Licensed Product, such the Proposing Party may, upon notice to the other Party (the “Non-Proposing Party”), conduct the proposed Secondary Indication Supplemental Study(ies) at its own expense; provided, provided however, that if the Non-Proposing Party receives written notice from determines -50- reasonably and in good faith that the performance of such proposed Supplemental Study(ies) would pose safety concerns or other ethical concerns, then the Proposing Party will not undertake such Supplemental Study(ies) unless and until the Non-Proposing Party [***]determines that such Additional Development Activities should be permitted. (bii) Notwithstanding anything in Section 6.2.7 (Right of Reference) Sections 7.1.3 and 7.3 to the contrary, if the PSC JDC does not approve an Additional Development Proposal, unless and until the Non-Proposing Party delivers an Additional Development Opt-In Notice with respect to such Additional Development Activity, as described in Section 5.2.5.4 (Opt-In for Additional Development Activities5.1.2.4(d), the Non-Proposing Party shall will not have any rights under Section 6.2.7 (Right of Reference) 7.1.3 and 7.3, as applicable, with respect to any information or data generated from any Secondary Indication Supplemental Study that was the subject of the unapproved Additional Development Proposal. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “Proposal or from any future information or data generated from any future Clinical Studies with respect to the same Indication, other than (A) to use such information or data to determine whether to deliver an Additional Development Opt-In Notice in accordance with Section 5.1.2.4(d), (B) as permitted pursuant to the SDEA, (C) as required by Law and (D) [...***...]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.