Acceptance of Modified eSAS 2 Development Program Clause Samples

Acceptance of Modified eSAS 2 Development Program. (a) Unless Chiron terminates the eSAS 2 Development Program under Section 8.3 below or elects to continue the eSAS 2 Development Program unaffected without such Material Modification under Section 3.3.2, the Parties shall promptly, but not later than thirty (30) days after preparation by Chiron of a modified eSAS 2 Development Program under Section 3.3.2 meet and consult with respect to the proposed modified eSAS 2 Development Program. Without limiting the other bases on which it shall be reasonable for Gen-Probe to withhold approval, it shall be reasonable for Gen-Probe to withhold approval of any Modification that could result in a material degradation in assay sensitivity or specificity, or that affects Gen-Probe’s effort or contribution of resources or the amount of costs for which Gen-Probe is entitled to be reimbursed by Chiron. Subject to the unconditional rights of Gen-Probe under Section 3.2.1(a) above to preclude Chiron from reimbursement for Material Modifications and to withhold participation in the regulatory approval process, it shall be unreasonable to withhold approval of any request for modification made (i) to reflect actual eSAS 2 Development Costs incurred (or not incurred) to the date of such proposed modification that (A) with respect to the eSAS 2 Instrument taken as a whole, when aggregated with all previously authorized modifications, falls within [***] percent ([***]%) of the original Budget approved and in effect as of the date this eSAS 2 Addendum was executed by the Parties, or (B) with respect to any discreet component, when aggregated with all previous authorized modifications for such component, falls within [***] percent ([***]%) of the original portion of the Budget for such component approved and in effect as of the date this eSAS 2 Addendum was executed by the Parties, or (ii) to reflect actual changes to the Timeline incurred to the date of such proposed modification which do not impact the Budget in excess of the foregoing thresholds. (b) Each Party shall, upon completion of the consultation and review under paragraph (a), deliver to the other Party either a written acceptance of the proposed modified eSAS 2 Development Program or a detailed written statement specifying the basis for rejection. The requesting party may, in response to a rejection, revise the proposed modified eSAS 2 Development Program to reflect the discussions of the Parties, and redeliver the revised proposed modified eSAS 2 Development Program for ...