Development Events. In consideration for the rights granted to Provention under this Agreement, Provention shall make the following one-time, non-refundable, non-creditable (i.e., to any other obligation of Provention hereunder) Development Event Payments (each, a “Development Event Payment”) to MacroGenics, upon the first achievement by a member of the Provention Group of the corresponding event (each, a “Development Event”). Each Development Event Payment listed in the table below shall be payable only once upon the first achievement of the corresponding Development Event.
Development Events. In connection with the Discovery and Development of Licensed Products that are Covered by a Valid Claim of Licensed Patent Rights, or the Manufacture of which Licensed Products is Covered by a Valid Claim of a Licensed Patent Right, and directed against a given Target hereunder, Licensee shall pay, or cause to be paid, to Alnylam the following payments upon the achievement of the events set forth below: Development Event: (in [**]): Initiation of GLP Toxicology Studies $ [**] Initiation of the first Phase I Study $ [**] Initiation of the first Phase II Study $ [**] Initiation of the first Phase III Study for the first Indication $ [**] Initiation of first Phase III Study for a second Indication $ [**] First filing of an NDA in the U.S. for the first Indication $ [**] First filing of an NDA in the EU for the first Indication $ [**] First filing of an NDA in Japan for the first Indication $ [**] First filing of an NDA in the U.S. or EU for a second Indication $ [**] Regulatory Approval in the U.S. for the first Indication $ [**] Regulatory Approval in the EU for the first Indication $ [**] Regulatory Approval in Japan for the first Indication $ [**] Regulatory Approval in the U.S. or EU for a second Indication $ [**]
Development Events. All events that are considered to be for the purpose of cultivating, stewarding, and/or recognizing donors and prospective donors of LCCC shall be cleared through the Foundation to ensure coordination of fundraising activities. The Foundation is not responsible for directing or coordinating events for LCCC that are not for the purposes outlined in this section.
Development Events. Within thirty (30) days of the date of achievement of the applicable Development Event described below, Roche will pay to SGX the following non-refundable event payments on a Collaboration Product-by-Collaboration Product basis:
(a) Clinical Candidate Selection $[...***...]
(b) Initiation of Phase 1 $[...***...]
(c) Initiation of Phase 2 $[...***...] ***CONFIDENTIAL TREATMENT REQUESTED
(d) Initiation of Phase 3 $[...***...]
(e) Receipt of first Regulatory Approval $[...***...] Roche shall make each of such payments only once for the first occurrence of the requisite event for the Collaboration Product regardless of how many times the event may be subsequently achieved with the particular Collaboration Product. Roche shall make each of such payments for the first Collaboration Product to achieve the applicable event, provided that (i) if Roche ceases all development of a particular Collaboration Product after having made one or more payments with respect to such Collaboration Product under this Section 3.3 following accomplishment of any Development Event, there shall be no payment due upon the accomplishment of that same Development Event with respect to a subsequent Collaboration Product; and (ii) if Roche has received Regulatory Approval for a Collaboration Product and continues development of an additional Collaboration Product ("Subsequent Product"), payments will be due under this Section 3.3 for the achievement of Development Events by the Subsequent Product (including those Development Events which may have been achieved by the Subsequent Product prior to such receipt of Regulatory Approval).
Development Events. All events that are considered to be for the purpose of cultivating, stewarding, and/or recognizing donors and prospective donors shall be cleared through the Foundation to ensure coordination of fundraising activities. The Foundation is not responsible for directing or coordinating events for the Consortium Board that are not for the purposes outlined in this section.
Development Events. (a) For each Development Target, MAGENTA shall pay up to a total of [***] upon achievement of the following development events by a Product directed toward such Development Target (each, a “Development Milestone”): [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
(b) Within [***] of the achievement of a Development Milestone, MAGENTA shall notify HDPR of such achievement and pay to HDPR the amount associated with achievement of such Development Milestone.
(c) The Development Milestone payments in the table above shall be payable by MAGENTA to HDPR upon the first achievement of each such Development Milestone for the first Product directed toward a Development Target that achieves the Development Milestone, but not for any subsequent Products directed to the same Development Target that achieves the same Development Milestone. If development of a Product directed toward a Development Target is discontinued before such Product has achieved all of the foregoing Development Milestones, then Development Milestones achieved by any subsequent Product directed toward such Development Target shall be waived for any previously paid Development Milestones, but not for any previously unpaid Development Milestones.
(d) With respect to Development Milestones that may be triggered by a Product upon achievement of such Development Milestones by such Product in a second Indication, the payment of the Development Milestone for the first Indication shall always precede payment for the second Indication. By way of example, [***].
Development Events. (i) Until such time as either Party exercises its Opt-Out Right, Roche shall pay Alnylam [**] percent ([**]%) of the payments set forth in Column A below upon achievement of the corresponding event set forth below by or on behalf of Roche or any of its Related Parties.
(ii) If Alnylam unilaterally exercises its Opt-Out Right, Roche shall pay Alnylam an amount equal to [**] percent ([**]%) of the amount set forth in Column B, Column C, Column D or Column E in the chart below (as applicable) corresponding to the Opt-Out Point at which Alnylam exercised its Opt-Out Right, upon achievement of the corresponding event set forth below by or on behalf of Roche or any of its Related Parties from and after the effective date of Alnylam’s exercise of such Opt-Out Right.
(iii) If Roche unilaterally exercises its Opt-Out Right, Alnylam shall pay Roche the following percentages of the amount set forth in Column B, Column C, Column D or Column E in the chart below (as applicable) corresponding to the Opt-Out Point at which Roche exercised its Opt-Out Right, upon achievement of the corresponding event set forth below by or on behalf of Alnylam or any of its Related Parties from and after the effective date of Roche’s exercise of such Opt-Out Right:
(A) [**] percent ([**]%) if opt-out occurs at or before First Phase II Completion; and
(B) [**] percent ([**]%) if opt-out occurs after First Phase II Completion.
(1) Initiation of the first Phase I Study for Licensed Product [**] [**] [**] [**] [**]
(2) Initiation of the first Phase II Study for Licensed Product [**] [**] [**] [**] [**]
(3) Initiation of the first Phase III Study for Licensed Product for the first (1st) Indication [**] [**] [**] [**] [**]
(4) Initiation of the first Phase III Study for Licensed Product for a second (2nd) Indication [**] [**] [**] [**] [**]
(5) First filing of an NDA in the United States for Licensed Product for the first (1st) Indication [**] [**] [**] [**] [**]
(6) First filing of an NDA in the EU or with the EMEA for Licensed Product for the first (1st) Indication [**] [**] [**] [**] [**]
(7) First filing of an NDA in Japan for Licensed Product for the first (1st) Indication [**] [**] [**] [**] [**]
(8) First filing of an NDA in the United States for Licensed Product for a second (2nd) Indication [**] [**] [**] [**] [**]
(9) Regulatory Approval in the U.S. for Licensed Product for the first (1st) Indication [**] [**] [**] [**] [**]
(10) Regulatory Approval in the EU or from the EMEA for Lice...
Development Events. For the purposes of this Agreement, the rate of [*] as determined by step 3 [*] will be used for certain development payments and project decisions.
Development Events. In consideration for the rights granted to Provention under this Agreement, Provention shall make the following one-time, non-refundable, non-creditable (i.e., to any other obligation of Provention hereunder) Development Event Payments (each, a “Development Event Payment”) to MacroGenics, upon the first achievement by a member of the Provention Group of the corresponding event (each, a “Development Event”). Each Development Event Payment listed in the table below shall be payable only once upon the first achievement of the corresponding Development Event. Development Event Payment Development Event For 1st Indication For 2nd Indication [****] [****]United States dollars ($[****]) [****] [****] [****] United States dollars ($[****]) [****] United States dollars ($[****]) [****] [****] United States dollars ($[****]) [****] United States dollars ($[****]) [****] [****] United States dollars ($[****]) [****] United States dollars ($[****]) If for any reason the Phase III Study Development Event for any Indication does not occur prior to the occurrence of any BLA Approval Development Event for such Indication, then the Phase III Study Development Event shall be deemed to occur concurrently with the occurrence of the first BLA Approval Development Event.
Development Events. All events that are considered to be for the purpose of cultivating, stewarding, and/or recognizing donors and prospective donors of the University shall be cleared through the Foundation to ensure coordination of fundraising activities.
