Common use of Development and Regulatory Milestones Clause in Contracts

Development and Regulatory Milestones. In partial consideration of the rights granted by Xxxxxxx to Forest hereunder and subject to the terms and conditions set forth in this Agreement (including Section 6.3), Forest shall pay to Xxxxxxx the applicable milestone payment within [*] Business Days after the achievement of each of the following milestone events: Acceptance by the FDA of an NDA for a Licensed Product $[*] Approval of an NDA for a Licensed Product in the United States and Forest does not deliver a termination notice pursuant to Section 11.2.3 with respect to the United States or this Agreement in its entirety within 10 Business Days after receipt of such approval $[*] Receipt of all Milestone Regulatory Approvals for a Licensed Product in a Major European Market and Forest does not deliver a termination notice pursuant to Section 11.2.3 with respect to such Major European Market or this Agreement in its entirety within 10 Business Days after receipt of such Milestone Regulatory Approvals $[*] Receipt of all Milestone Regulatory Approvals for a Licensed Product in Japan and Forest does not deliver a termination notice pursuant to Section 11.2.3 with respect to Japan or this Agreement in its entirety prior to such Milestone Regulatory Approvals $[*] Approval of an NDA (or supplement thereto) for a Licensed Product in the United States for an Indication that (a) [*] and (b) [*], and [*] (the “New Indication Milestone”) $[*]; provided that [*] If the New Indication Milestone has not already been achieved, approval of an NDA (or supplement thereto) for a Licensed Product in the United States for [*] that [*] that is [*], and [*]. For clarity, [*]. $[*]

Development and Regulatory Milestones. In partial consideration of the rights granted by Xxxxxxx to Forest hereunder and subject Subject to the terms of this Section 5.3 (and conditions set forth in this Agreement (including subject further to Section 6.35.5), Forest shall pay to Xxxxxxx the applicable milestone payment Celgene will notify Prothena within [***] Business Days days following the first achievement by Celgene under this Agreement and after the achievement Effective Date of each of the following milestone events: Acceptance by the FDA of an NDA for a Licensed Product $[*] Approval of an NDA for a Licensed Product event described below in the United States and Forest does not deliver a termination notice pursuant to this Section 11.2.3 5.3 with respect to the United States first (and only the CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. first) Licensed Product to achieve such milestone event under this Agreement, and Celgene shall thereafter pay the applicable non-refundable, non-creditable amounts set forth below associated with the applicable milestone event in accordance with Section 5.3.2 (each, a “Regulatory Milestone Payment”): 1. Celgene (a) delivers written notice to Prothena at the Celgene Decision Date electing to further Develop any Licensed Product that is not an Enabled Antibody Product, or (b) at any time thereafter Initiates a Phase 2 Clinical Trial of a Licensed Product that is not an Enabled Antibody Product Fifty-Five Million Dollars ($55,000,000) N/A 2. Receipt under this Agreement in its entirety within 10 Business Days after receipt of such approval $[*] Receipt of all Milestone Regulatory Approvals for a Licensed Product for the first Select Indication in a Major European Market and Forest does not deliver a termination notice pursuant to Section 11.2.3 with respect to such Major European Market or this Agreement in its entirety within 10 Business Days after receipt of such Milestone Regulatory Approvals the U.S. issued by the FDA [***](the “First U.S. Approval Milestone”) [***] Dollars ($[***]) [***] Dollars ($[***]) 3. Receipt under this Agreement of all Milestone Regulatory Approvals for a Licensed Product for the first Select Indication in Japan and Forest does not deliver a termination notice pursuant to Section 11.2.3 with respect to Japan or this Agreement in its entirety prior to such Milestone Regulatory Approvals the EU issued by the EMA [***] [***] Dollars ($[***]) [***] Approval Dollars ($[***]) 4. Receipt under this Agreement of an NDA (or supplement thereto) all Regulatory Approvals for a Licensed Product for the first Select Indication in Japan issued by the United States for an Indication that MHLW [***] [***] Dollars (a$[***]) [***] and Dollars (b$[***]) CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], and [*] HAS BEEN OMITTED BECAUSE IT IS BOTH (the “New Indication Milestone”I) $[*]; provided that [*] If the New Indication Milestone has not already been achieved, approval NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. 5. Receipt under this Agreement of an NDA (or supplement thereto) all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the United States for U.S. issued by the FDA [***] that [***] Dollars ($[***]) [***] Dollars ($[***]) 6. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the EU issued by the EMA [***] [***] Dollars ($[***]) [***] Dollars ($[***]) 7. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in Japan issued by the MHLW [***] [***] Dollars ($[***]) [***] Dollars ($[***]) Subject to the remainder of this Section 5.3.1, each of the foregoing milestones in this Section 5.3.1 shall be payable a maximum of one (1) time as set forth in the foregoing chart regardless of the number of Licensed Products achieving the applicable milestone event (i.e., a maximum of seven (7) Regulatory Milestone Payments may be made pursuant to this Section 5.3.1), and no Regulatory Milestone Payment shall be due hereunder for subsequent or repeated achievement of such milestone event (whether by an Enabled Antibody Product or any other Licensed Product). For the avoidance of doubt, (a) the maximum amount payable by Celgene pursuant to this Section 5.3.1 is Two Hundred Forty-Two Million Five Hundred Thousand Dollars ($242,500,000) assuming that each of the milestone events in this Section 5.3.1 were achieved by a Licensed Product that is not an Enabled Antibody Product, (b) the maximum amount payable by Celgene pursuant to this Section 5.3.1 is One Hundred Twenty-Six Million Dollars ($126,000,000) assuming that each of the milestone events in this Section 5.3.1 were achieved by a Licensed Product that is an Enabled Antibody Product, and (c) in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product, (i) Celgene shall pay the applicable amount with respect to Enabled Antibody Product set forth above associated with the applicable milestone event in lieu of the amount with respect to Licensed Product other than Enabled Antibody Product set forth above, and (ii) subject to the immediate subsequent sentence of this Section 5.3.1, no Regulatory Milestone Payment shall be due hereunder for subsequent or repeated achievement of such milestone event (whether by an Enabled Antibody Product or any other Licensed Product). Notwithstanding the foregoing, in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product and such milestone is subsequently achieved for the first (and only the first) Licensed Product that is not an Enabled Antibody Product (“First Subsequent Regulatory Milestone”), then Celgene will notify Prothena within [***] days following such CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. first achievement and shall be obligated to pay Prothena an additional amount equal to the portion of the Regulatory Milestone Payment for such First Subsequent Regulatory Milestone in excess of the applicable Regulatory Milestone Payment for Enabled Antibody Product associated with such milestone event. By way of example, solely for illustrative purposes, if the First U.S. Approval Milestone is first achieved for an Enabled Antibody Product and subsequently achieved for a Licensed Product that is not an Enabled Antibody Product, then Celgene shall pay to Prothena [*]. For clarity, [*]. *] Dollars ($[***]) for such First Subsequent Regulatory Milestone.

Development and Regulatory Milestones. In partial consideration of the rights granted by Xxxxxxx to Forest hereunder and subject Subject to the terms and conditions herein (including this Section 13.7 (Development and Regulatory Milestones), Section 13.11 (Additional Payment Terms) and, in the event Nurix exercises a Profit-Share Option, Section 11.2.3 (Profit-Share Products) and Section 11.2.4 (Milestone Payments Related to the Profit-Share Triggering Events), as applicable), and on a Licensed Product-by-Licensed Product basis, Seagen shall pay the applicable amount set forth in the table below in this Section 13.7 (Development and Regulatory Milestones) associated with the corresponding milestone event set forth opposite such payment in the table below, in each case, once upon first achievement (including by any Affiliate of Seagen or any Sublicensee) of the applicable Development and Regulatory Milestone Event with respect to a Licensed Product (each event described in #1-#10 in the table below, a “Development and Regulatory Milestone Event,” and each respective payment, a “Development and Regulatory Milestone Payment”) under this Agreement for a Licensed Product: (including Section 6.3), Forest shall pay to Xxxxxxx the applicable milestone payment within 1) [*] Business Days [*] (2) [*] [*] (3) [*] [*] (4) [*] [*] (5) [*] [*] (6) [*] [*] (7) [*] [*] (8) [*] [*] (9) [*] [*] (10) [*] [*] 1.1.1 [*]. 1.1.2 Each Development and Regulatory Milestone Payment is payable up to a maximum of one (1) time per Licensed Product as set forth in the table above, upon first achievement of the applicable Development and Regulatory Milestone Event for such Licensed Product, regardless of the number of times the applicable Development and Regulatory Milestone Event is achieved with respect to such Licensed Product; provided, that: (a) the maximum aggregate amount payable by Seagen to Nurix with respect to all Development and Regulatory Milestone Events shall be [*]; (b) if, after a Development and Regulatory Milestone Event is achieved by a Licensed Product (including a Licensed Degrader-Antibody Conjugate) that contains one (1) or more specific Licensed Degrader(s), such Development and Regulatory Milestone Event is subsequently achieved by another distinct Licensed Product (as determined in accordance with Section 13.11.1 (Determining Same vs Distinct Licensed Products or Licensed Degraders for Milestones, Royalties, and Option-Triggering Events)) that contains the same Licensed Degrader(s) (as determined in accordance with Section 13.11.1 (Determining Same vs Distinct Licensed Products or Licensed Degraders for Milestones, Royalties, and Option-Triggering Events)), then the corresponding Development and Regulatory Milestone Payment shall be payable at an amount that is [*] of the amount listed above for such Development and Regulatory Milestone Payment. By way of example and not limitation, if a Licensed Product (“First Licensed Product”) contains the same Licensed Degrader that is contained in another Licensed Product (“Second Licensed Product”), and the Second Licensed Product achieves a Development and Regulatory Milestone Event that had previously been achieved by such First Licensed Product, then the applicable Development and Regulatory Milestone Payment for such achievement by the Second Licensed Product shall be [*] described in this Section 13.7.2(b). For clarity, (x) [*] shall apply to any Second Licensed Product that (i) was a Profit-Share Product prior to the Nurix Opt-Out Date for such Second Licensed Product, and (ii) achieves a Development and Regulatory Milestone Event after the applicable Nurix Opt-Out Date, regardless of when the First Licensed Product achieved the relevant Development and Regulatory Milestone Event (including if such achievement occurred while the Second Licensed Product was a Profit-Share Product), and (y) any Development and Regulatory Milestone Event achieved by a Profit-Share Product prior to the Nurix Opt-Out Date for such Profit-Share Product shall [*] for purposes of this Section 13.7.2(b) (i.e., if a Second Licensed Product achieves a Development and Regulatory Milestone Event after the achievement of each such Development and Regulatory Milestone Event by a First Licensed Product that is a Profit-Share Product at the time of such achievement, the following milestone events: Acceptance Milestone Payment for the achievement of such Development and Regulatory Milestone Event by the FDA of an NDA for Second Licensed Product shall [*]); (c) if, after a Development and Regulatory Milestone Event is achieved by a Licensed Product $that contains one (1) or more specific Licensed Degrader(s), such Development and Regulatory Milestone Event is subsequently achieved by another distinct Licensed Product that contains any distinct Licensed Degrader(s), then the corresponding Development and Regulatory Milestone Payment shall be payable at [*] Approval of an NDA the amount listed above for a Licensed Product in the United States such Development and Forest does not deliver a termination notice pursuant to Section 11.2.3 Regulatory Milestone Payment; (d) with respect to Development and Regulatory Milestone Events [*], the United States or this Agreement in its entirety within 10 Business Days after receipt achievement of such approval $[*] Receipt shall be deemed to include [*]; and (e) (i) upon achievement of all any of Development and Regulatory Milestone Regulatory Approvals for Events [*] above with respect to a Licensed Product in a Major European Market Product, if the first achievement of any of Development and Forest does not deliver a termination notice pursuant to Section 11.2.3 Regulatory Milestone Events [*] with respect to such Major European Market or this Agreement in its entirety within 10 Business Days after receipt Licensed Product has not occurred, such unachieved milestone shall simultaneously be deemed achieved and payable, and (ii) upon achievement of such any of Development and Regulatory Milestone Regulatory Approvals $Events [*] Receipt of all Milestone Regulatory Approvals for a Licensed Product in Japan and Forest does not deliver a termination notice pursuant to Section 11.2.3 above with respect to Japan or this Agreement in its entirety prior to such a Licensed Product, if the first achievement of Development and Regulatory Milestone Regulatory Approvals $Event [*] Approval of an NDA (or supplement thereto) for a with respect to such Licensed Product in the United States for an Indication that (a) [*] and (b) [*], and [*] (the “New Indication Milestone”) $[*]; provided that [*] If the New Indication Milestone has not already been achievedoccurred, approval of an NDA (or supplement thereto) for a such unachieved milestone shall simultaneously be deemed achieved and payable. 1.1.3 Notwithstanding the foregoing, no Development and Regulatory Milestone Payments shall be due with respect to any Unprotected Licensed Product in the United States for [*] that [*] that is [*]Product, and [*]. For clarity, [*]. $[*].

Development and Regulatory Milestones. In partial consideration of Astellas shall pay to Aquinox the rights granted by Xxxxxxx to Forest hereunder and subject to the terms and conditions one-time, non-refundable, non-creditable payments set forth in this Agreement (including Section 6.3), Forest shall pay to Xxxxxxx the table below within [***] days of the first achievement by a Product of the applicable milestone payment within [*] Business Days after event (whether by Astellas or its Affiliate or Sublicensee). For the achievement avoidance of doubt, each of the following milestone events: Acceptance payments shall be payable only once regardless of the number of times achieved by the FDA of an NDA for a Licensed Product $one or more Products. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. EXECUTION VERSION CONFIDENTIAL [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] If at the time of the achievement of a milestone for the Primary Indication (including if the first Regulatory Approval in Japan is for the Primary Indication), Astellas has not made payment for one or more prior milestones for the Primary Indication, Astellas shall make the payment for such prior milestone(s) together with the payment for the achieved milestone, irrespective of an NDA for a Licensed Product in the United States and Forest does not deliver a termination notice pursuant to Section 11.2.3 with whether such prior milestone had actually been achieved. With respect to the United States or this Agreement in its entirety within 10 Business Days after receipt of such approval $milestones [***] Receipt of all Milestone Regulatory Approvals for a Licensed Product in a Major European Market and Forest does not deliver a termination notice pursuant to Section 11.2.3 with respect to such Major European Market or this Agreement in its entirety within 10 Business Days after receipt of such Milestone Regulatory Approvals $[*] Receipt of all Milestone Regulatory Approvals for a Licensed Product in Japan and Forest does not deliver a termination notice pursuant to Section 11.2.3 with respect to Japan or this Agreement in its entirety prior to such Milestone Regulatory Approvals $[*] Approval of an NDA (or supplement thereto) for a Licensed Product in the United States for an Indication that *], (a) if at the time of the achievement of milestone [***], Astellas has not made payment for milestone [***], Astellas shall make the payment for milestone [***] together with the payment for milestone [***], and (b) if at the time of the first [***], Astellas has not made payment for either or both of milestones [***] and [***], Astellas shall make the payment for such prior milestone(s), in each case, irrespective of whether such prior milestone(s) had actually been achieved. With respect to milestones [***] and [***], (i) if at the time of the achievement of milestone [***], Astellas has not made payment for milestone [***], Astellas shall make the payment for milestone [***] together with the payment for milestone [***], and (ii) if at the time of the first [***] (excluding the “New Indication Milestone”) $[***]; provided that ), Astellas has not made payment for either or both of milestones [***] If the New Indication Milestone has not already been achieved, approval of an NDA (or supplement thereto) for a Licensed Product in the United States for and [*] that [*] that is [*], and Astellas shall make the payment for such prior milestone(s), in each case, irrespective of whether such prior milestone(s) had actually been achieved. [*]**] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. For clarity, [*]. $[*]EXECUTION VERSION

Development and Regulatory Milestones. In partial consideration of the rights granted by Xxxxxxx to Forest hereunder and subject Subject to the terms and conditions herein (including this Section 13.7 (Development and Regulatory Milestones), Section 13.11 (Additional Payment Terms) and, in the event Nurix exercises a Profit-Share Option, Section 11.2.3 (Profit-Share Products) and Section 11.2.4 (Milestone Payments Related to the Profit-Share Triggering Events), as applicable), and on a Licensed Product-by-Licensed Product basis, Seagen shall pay the applicable amount set forth in the table below in this Section 13.7 (Development and Regulatory Milestones) associated with the corresponding milestone event set forth opposite such payment in the table below, in each case, once upon first achievement (including by any Affiliate of Seagen or any Sublicensee) of the applicable Development and Regulatory Milestone Event with respect to a Licensed Product (each event described in #1-#10 in the table below, a “Development and Regulatory Milestone Event,” and each respective payment, a “Development and Regulatory Milestone Payment”) under this Agreement for a Licensed Product: (including Section 6.3), Forest shall pay to Xxxxxxx the applicable milestone payment within 1) [*] Business Days [*] (2) [*] [*] (3) [*] [*] (4) [*] [*] (5) [*] [*] (6) [*] [*] (7) [*] [*] (8) [*] [*] (9) [*] [*] (10) [*] [*] 13.7.1 [*]. 13.7.2 Each Development and Regulatory Milestone Payment is payable up to a maximum of one (1) time per Licensed Product as set forth in the table above, upon first achievement of the applicable Development and Regulatory Milestone Event for such Licensed Product, regardless of the number of times the applicable Development and Regulatory Milestone Event is achieved with respect to such Licensed Product; provided, that: (a) the maximum aggregate amount payable by Seagen to Nurix with respect to all Development and Regulatory Milestone Events shall be [*]; (b) if, after a Development and Regulatory Milestone Event is achieved by a Licensed Product (including a Licensed Degrader-Antibody Conjugate) that contains one (1) or more specific Licensed Degrader(s), such Development and Regulatory Milestone Event is subsequently achieved by another distinct Licensed Product (as determined in accordance with Section 13.11.1 (Determining Same vs Distinct Licensed Products or Licensed Degraders for Milestones, Royalties, and Option-Triggering Events)) that contains the same Licensed Degrader(s) (as determined in accordance with Section 13.11.1 (Determining Same vs Distinct Licensed Products or Licensed Degraders for Milestones, Royalties, and Option-Triggering Events)), then the corresponding Development and Regulatory Milestone Payment shall be payable at an amount that is [*] of the amount listed above for such Development and Regulatory Milestone Payment. By way of example and not limitation, if a Licensed Product (“First Licensed Product”) contains the same Licensed Degrader that is contained in another Licensed Product (“Second Licensed Product”), and the Second Licensed Product achieves a Development and Regulatory Milestone Event that had previously been achieved by such First Licensed Product, then the applicable Development and Regulatory Milestone Payment for such achievement by the Second Licensed Product shall be [*] described in this Section 13.7.2(b). For clarity, (x) [*] shall apply to any Second Licensed Product that (i) was a Profit-Share Product prior to the Nurix Opt-Out Date for such Second Licensed Product, and (ii) achieves a Development and Regulatory Milestone Event after the applicable Nurix Opt-Out Date, regardless of when the First Licensed Product achieved the relevant Development and Regulatory Milestone Event (including if such achievement occurred while the Second Licensed Product was a Profit-Share Product), and (y) any Development and Regulatory Milestone Event achieved by a Profit-Share Product prior to the Nurix Opt-Out Date for such Profit-Share Product shall [*] for purposes of this Section 13.7.2(b) (i.e., if a Second Licensed Product achieves a Development and Regulatory Milestone Event after the achievement of each such Development and Regulatory Milestone Event by a First Licensed Product that is a Profit-Share Product at the time of such achievement, the following milestone events: Acceptance Milestone Payment for the achievement of such Development and Regulatory Milestone Event by the FDA of an NDA for Second Licensed Product shall [*]); (c) if, after a Development and Regulatory Milestone Event is achieved by a Licensed Product $that contains one (1) or more specific Licensed Degrader(s), such Development and Regulatory Milestone Event is subsequently achieved by another distinct Licensed Product that contains any distinct Licensed Degrader(s), then the corresponding Development and Regulatory Milestone Payment shall be payable at [*] Approval of an NDA the amount listed above for a Licensed Product in the United States such Development and Forest does not deliver a termination notice pursuant to Section 11.2.3 Regulatory Milestone Payment; (d) with respect to Development and Regulatory Milestone Events [*], the United States or this Agreement in its entirety within 10 Business Days after receipt achievement of such approval $[*] Receipt shall be deemed to include [*]; and (e) (i) upon achievement of all any of Development and Regulatory Milestone Regulatory Approvals for Events [*] above with respect to a Licensed Product in a Major European Market Product, if the first achievement of any of Development and Forest does not deliver a termination notice pursuant to Section 11.2.3 Regulatory Milestone Events [*] with respect to such Major European Market or this Agreement in its entirety within 10 Business Days after receipt Licensed Product has not occurred, such unachieved milestone shall simultaneously be deemed achieved and payable, and (ii) upon achievement of such any of Development and Regulatory Milestone Regulatory Approvals $Events [*] Receipt of all Milestone Regulatory Approvals for a Licensed Product in Japan and Forest does not deliver a termination notice pursuant to Section 11.2.3 above with respect to Japan or this Agreement in its entirety prior to such a Licensed Product, if the first achievement of Development and Regulatory Milestone Regulatory Approvals $Event [*] Approval of an NDA (or supplement thereto) for a with respect to such Licensed Product in the United States for an Indication that (a) [*] and (b) [*], and [*] (the “New Indication Milestone”) $[*]; provided that [*] If the New Indication Milestone has not already been achievedoccurred, approval of an NDA (or supplement thereto) for a such unachieved milestone shall simultaneously be deemed achieved and payable. 13.7.3 Notwithstanding the foregoing, no Development and Regulatory Milestone Payments shall be due with respect to any Unprotected Licensed Product in the United States for [*] that [*] that is [*]Product, and [*]. For clarity, [*]. $[*].