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 Licensed Product for the first (1st) Indication [**] [**] [**] [**] [**] (11) Regulatory Approval in Japan for Licensed Product for the first (1st) Indication [**] [**] [**] [**] [**] (12) Regulatory Approval in the U.S. for Licensed Product for a second (2nd) Indication [**] [**] [**] [**] [**] The event payments set forth in this Section 9.1(a) are payable once for each Licensed Product to achieve the applicable event. If, upon achievement of a particular event for a Licensed Product, any previous (i.e., higher in the above table) event payment has not been paid for such Licensed Product, then each event payment payable upon achievement of any such previous event shall become payable with the payment of the event payment for the subsequent event then achieved. For purposes of clarity, if a Party opts-out, in no event shall the Continuing Party be responsible for payment of any previous event payment that was payable, but not paid, by the Party opting-out.
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Sources: Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
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; andand [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
(B) [**] percent ([**]%) if opt-out occurs after First Phase II Completion.. Development Event Column A [**] Column B [**] Column C [**] Column D [**] Column E [**]
(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 Licensed Product for the first (1st) Indication [**] [**] [**] [**] [**]
(11) Regulatory Approval in Japan for Licensed Product for the first (1st) Indication [**] [**] [**] [**] [**]
(12) Regulatory Approval in the U.S. for Licensed Product for a second (2nd) Indication [**] [**] [**] [**] [**] Total Development Event Payments [**] [**] [**] [**] [**] The event payments set forth in this Section 9.1(a) are payable once for each Licensed Product to achieve the applicable event. If, upon achievement of a particular event for a Licensed Product, any previous (i.e., higher in the above table) event payment has not been paid for such Licensed Product, then each event payment payable upon achievement of any such previous event shall become payable with the payment of the event payment for the subsequent event then achieved. For purposes of clarity, if a Party opts-out, in no event shall the Continuing Party be responsible for payment of any previous event payment that was payable, but not paid, by the Party opting-out. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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