Development and Regulatory Milestones. Subject to the terms of this Section 5.3 (and subject further to Section 5.5), Celgene will notify Prothena within [***] days following the first achievement by Celgene under this Agreement and after the Effective Date of each milestone event described below in this Section 5.3 with respect to the 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 ($55,000,000) N/A 2. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the U.S. issued by the FDA [***](the “First U.S. Approval Milestone”) [***] Dollars ($[***]) [***] Dollars ($[***]) 3. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the EU issued by the EMA [***] [***] Dollars ($[***]) [***] Dollars ($[***]) 4. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in Japan issued by the MHLW [***] [***] Dollars ($[***]) [***] Dollars ($[***]) CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. 5. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the U.S. issued by the FDA [***] [***] Dollars ($[***]) [***] 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 ($126,000,000) assuming that each of the milestone events in this Section 5.3.1 were achieved by a Licensed Product that is an Enabled Antibody Product, and (c) in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product, (i) Celgene shall pay the applicable amount with respect to Enabled Antibody Product set forth above associated with the applicable milestone event in lieu of the amount with respect to Licensed Product other than Enabled Antibody Product set forth above, and (ii) subject to the immediate subsequent sentence of this Section 5.3.1, no Regulatory Milestone Payment shall be due hereunder for subsequent or repeated achievement of such milestone event (whether by an Enabled Antibody Product or any other Licensed Product). Notwithstanding the foregoing, in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product and such milestone is subsequently achieved for the first (and only the first) Licensed Product that is not an Enabled Antibody Product (“First Subsequent Regulatory Milestone”), then Celgene will notify Prothena within [***] days following such CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. first achievement and shall be obligated to pay Prothena an additional amount equal to the portion of the Regulatory Milestone Payment for such First Subsequent Regulatory Milestone in excess of the applicable Regulatory Milestone Payment for Enabled Antibody Product associated with such milestone event. By way of example, solely for illustrative purposes, if the First U.S. Approval Milestone is first achieved for an Enabled Antibody Product and subsequently achieved for a Licensed Product that is not an Enabled Antibody Product, then Celgene shall pay to Prothena [***] Dollars ($[***]) for such First Subsequent Regulatory Milestone.
Appears in 1 contract
Sources: Global License Agreement (Prothena Corp Public LTD Co)
Development and Regulatory Milestones. Subject to the terms of and conditions herein (including this Section 5.3 13.7 (Development and subject further to Section 5.5Regulatory Milestones), Celgene will notify Prothena within [***] days following Section 13.11 (Additional Payment Terms) and, in the first achievement by Celgene under this Agreement event Nurix exercises a Profit-Share Option, Section 11.2.3 (Profit-Share Products) and after Section 11.2.4 (Milestone Payments Related to the Effective Date of each milestone event described 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 5.3 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 the 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) a Licensed Product to achieve such milestone (each event under this Agreement, and Celgene shall thereafter pay described in #1-#10 in the applicable non-refundable, non-creditable amounts set forth below associated with the applicable milestone event in accordance with Section 5.3.2 (eachtable below, a “Development and Regulatory Milestone Event,” and each respective payment, a “Development and 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 ($55,000,000) N/A
2. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the U.S. issued by the FDA [***]Product:
(the “First U.S. Approval Milestone”1) [***] Dollars ($[***]) [***] Dollars ($[***])
3. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the EU issued by the EMA [***] [***] Dollars ]
($[***]2) [***] Dollars ($[***])
4. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in Japan issued by the MHLW [***] [***] Dollars ]
($[***]3) [***] Dollars ($[***]) CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
5. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the U.S. issued by the FDA [***] [***] Dollars ]
($[***]4) [***] Dollars ($[***])
6. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the EU issued by the EMA [***] [***] Dollars ]
($[***]5) [***] Dollars ($[***])
7. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in Japan issued by the MHLW [***] [***] Dollars ]
($[***]6) [*] [*]
(7) [*] Dollars ($[*]
(8) [*] [*]
(9) Subject [*] [*]
(10) [*] [*]
13.7.1 [*].
13.7.2 Each Development and Regulatory Milestone Payment is payable up 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 per Licensed Product as set forth in the foregoing chart 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 achieving or Licensed Degraders for Milestones, Royalties, and Option-Triggering Events)) that contains the applicable milestone event same Licensed Degrader(s) (i.e.as determined in accordance with Section 13.11.1 (Determining Same vs Distinct Licensed Products or Licensed Degraders for Milestones, a maximum of seven (7) Regulatory Milestone Payments may be made pursuant to this Section 5.3.1Royalties, and Option-Triggering Events)), then the corresponding Development and no Regulatory Milestone Payment shall be due hereunder payable at an amount that is [*] of the amount listed above for subsequent or repeated 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 such milestone event Development and Regulatory Milestone Event by a First Licensed Product that is a Profit-Share Product at the time of such achievement, the Milestone Payment for the achievement of such Development and Regulatory Milestone Event by the Second Licensed Product shall [*]);
(whether by an Enabled Antibody Product or any other Licensed Product). For the avoidance of doubtc) if, (a) the maximum amount payable by Celgene pursuant to this Section 5.3.1 after a Development and Regulatory Milestone Event 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 contains one (1) or more specific Licensed Degrader(s), such Development and Regulatory Milestone Event 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 subsequently achieved by a another distinct Licensed Product that is an Enabled Antibody Productcontains any distinct Licensed Degrader(s), then the corresponding Development and (c) in the event that any Regulatory Milestone Payment shall be payable at [*] of the foregoing milestones in this Section 5.3.1 is first achieved amount listed above for an Enabled Antibody Productsuch Development and Regulatory Milestone Payment;
(d) with respect to Development and Regulatory Milestone Events [*], the achievement of [*] shall be deemed to include [*]; and
(e) (i) Celgene shall pay the applicable amount upon achievement of any of Development and Regulatory Milestone Events [*] above with respect to Enabled Antibody Product set forth above associated with a Licensed Product, if the applicable milestone event in lieu first achievement of the amount any of Development and Regulatory Milestone Events [*] with respect to such Licensed Product other than Enabled Antibody Product set forth abovehas not occurred, such unachieved milestone shall simultaneously be deemed achieved and payable, and (ii) subject to the immediate subsequent sentence upon achievement of this Section 5.3.1, no any of Development and Regulatory Milestone Payment shall be due hereunder for subsequent or repeated Events [*] above with respect to a Licensed Product, if the first achievement of Development and Regulatory Milestone Event [*] with respect to such Licensed Product has not occurred, such unachieved milestone event (whether by an Enabled Antibody Product or any other Licensed Product). shall simultaneously be deemed achieved and payable.
13.7.3 Notwithstanding the foregoing, in the event that no Development and Regulatory Milestone Payments shall be due with respect to any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product Unprotected Licensed 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 [***] Dollars ($[***]) for such First Subsequent Regulatory Milestone.
Appears in 1 contract
Sources: Collaboration and License Agreement (Nurix Therapeutics, Inc.)
Development and Regulatory Milestones. Subject In partial consideration of the rights granted by AstraZeneca to Licensee hereunder, Licensee shall pay to AstraZeneca the terms of this Section 5.3 (and subject further to Section 5.5), Celgene will notify Prothena following one-time payments within [***] days following the first achievement by Celgene under this Agreement and after the Effective Date achievement of each of the following milestone event described below in this Section 5.3 with respect to events, which shall be nonrefundable, non-creditable and fully earned upon the first achievement of the applicable milestone event: [***]
(and only the i) [***]
(ii) [***]
(iii) [***] [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
(iv) [***], HAS BEEN OMITTED BECAUSE IT IS BOTH
(Iv) 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 ($55,000,000) N/A
2. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the U.S. issued by the FDA [***]
(the “First U.S. Approval Milestone”vi) [***] Dollars ]
($[***]vii) [***] Dollars ($[***])
3. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the EU issued by the EMA [***] [***] Dollars ]
($viii) [***]
(ix) [***]
(x) [***]
(xi) [***]
(xii) [***]
(xiii) [***]
(xiv) [***] Dollars ($[***])
4. Receipt under If, at any time, the achievement of a milestone described in this Agreement Section 4.2.1 has occurred with respect to which a payment is due hereunder and any of all Regulatory Approvals for a Licensed Product the preceding milestones in this Section 4.2.1 have not been due or been paid, then each such skipped milestone payment shall become due and payable concurrently with the milestone payment for the first Select Indication in Japan issued by milestone, with respect to which payment is due. For clarity, each milestone payment is payable only once; no milestone payment shall be payable for subsequent or repeated achievements of such milestone event with one or more of the MHLW same or different Licensed Products. [***] [***] Dollars ($[***]) [***] Dollars ($[***]) = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***]BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL FILED WITH THE SECURITIES AND (II) IS EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE TYPE THAT THE REGISTRANT TREATS SECURITIES ACT OF 1933, AS PRIVATE OR CONFIDENTIALAMENDED.
5. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the U.S. issued by the FDA [***] [***] Dollars ($[***]) [***] 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 ($126,000,000) assuming that each of the milestone events in this Section 5.3.1 were achieved by a Licensed Product that is an Enabled Antibody Product, and (c) in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product, (i) Celgene shall pay the applicable amount with respect to Enabled Antibody Product set forth above associated with the applicable milestone event in lieu of the amount with respect to Licensed Product other than Enabled Antibody Product set forth above, and (ii) subject to the immediate subsequent sentence of this Section 5.3.1, no Regulatory Milestone Payment shall be due hereunder for subsequent or repeated achievement of such milestone event (whether by an Enabled Antibody Product or any other Licensed Product). Notwithstanding the foregoing, in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product and such milestone is subsequently achieved for the first (and only the first) Licensed Product that is not an Enabled Antibody Product (“First Subsequent Regulatory Milestone”), then Celgene will notify Prothena within [***] days following such CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. first achievement and shall be obligated to pay Prothena an additional amount equal to the portion of the Regulatory Milestone Payment for such First Subsequent Regulatory Milestone in excess of the applicable Regulatory Milestone Payment for Enabled Antibody Product associated with such milestone event. By way of example, solely for illustrative purposes, if the First U.S. Approval Milestone is first achieved for an Enabled Antibody Product and subsequently achieved for a Licensed Product that is not an Enabled Antibody Product, then Celgene shall pay to Prothena [***] Dollars ($[***]) for such First Subsequent Regulatory Milestone.
Appears in 1 contract
Development and Regulatory Milestones. Subject In partial consideration of the rights granted by AstraZeneca to Licensee hereunder, Licensee shall pay to AstraZeneca the terms of this Section 5.3 (and subject further to Section 5.5), Celgene will notify Prothena following one-time payments within [***] days following the first achievement by Celgene under this Agreement and after the Effective Date achievement of each of the following milestone event described below in this Section 5.3 with respect to events, which shall be nonrefundable, non-creditable and fully earned upon the first achievement of the applicable milestone event: [***]
(and only the i) [***]
(ii) [***]
(iii) [***] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIALWOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. firstIF PUBLICLY DISCLOSED.
(iv) 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 ($55,000,000) N/A
2. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the U.S. issued by the FDA [***]
(the “First U.S. Approval Milestone”v) [***] Dollars ]
($vi) [***]
(vii) [***] Dollars ($[***])
3. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the EU issued by the EMA [***] [***] Dollars ]
($viii) [***]
(ix) [***]
(x) [***]
(xi) [***]
(xii) [***]
(xiii) [***]
(xiv) [***] Dollars ($[***])
4. Receipt under If, at any time, the achievement of a milestone described in this Agreement Section 4.2.1 has occurred with respect to which a payment is due hereunder and any of all Regulatory Approvals for a Licensed Product the preceding milestones in this Section 4.2.1 have not been due or been paid, then each such skipped milestone payment shall become due and payable concurrently with the milestone payment for the first Select Indication in Japan issued by milestone, with respect to which payment is due. For clarity, each milestone payment is payable only once; no milestone payment shall be payable for subsequent or repeated achievements of such milestone event with one or more of the MHLW [***] [***] Dollars ($[***]) [***] Dollars ($[***]) same or different Licensed Products. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIALWOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
5. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the U.S. issued by the FDA [***] [***] Dollars ($[***]) [***] 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 ($126,000,000) assuming that each of the milestone events in this Section 5.3.1 were achieved by a Licensed Product that is an Enabled Antibody Product, and (c) in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product, (i) Celgene shall pay the applicable amount with respect to Enabled Antibody Product set forth above associated with the applicable milestone event in lieu of the amount with respect to Licensed Product other than Enabled Antibody Product set forth above, and (ii) subject to the immediate subsequent sentence of this Section 5.3.1, no Regulatory Milestone Payment shall be due hereunder for subsequent or repeated achievement of such milestone event (whether by an Enabled Antibody Product or any other Licensed Product). Notwithstanding the foregoing, in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product and such milestone is subsequently achieved for the first (and only the first) Licensed Product that is not an Enabled Antibody Product (“First Subsequent Regulatory Milestone”), then Celgene will notify Prothena within [***] days following such CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. first achievement and shall be obligated to pay Prothena an additional amount equal to the portion of the Regulatory Milestone Payment for such First Subsequent Regulatory Milestone in excess of the applicable Regulatory Milestone Payment for Enabled Antibody Product associated with such milestone event. By way of example, solely for illustrative purposes, if the First U.S. Approval Milestone is first achieved for an Enabled Antibody Product and subsequently achieved for a Licensed Product that is not an Enabled Antibody Product, then Celgene shall pay to Prothena [***] Dollars ($[***]) for such First Subsequent Regulatory Milestone.
Appears in 1 contract
Development and Regulatory Milestones. Subject Astellas shall pay to Aquinox the terms of this Section 5.3 (and subject further to Section 5.5)one-time, Celgene will notify Prothena non-refundable, non-creditable payments set forth in the table below within [***] days following of the first achievement by Celgene under this Agreement and after a Product of the Effective Date of each applicable milestone event described below in this Section 5.3 with respect to (whether by Astellas or its Affiliate or Sublicensee). For the first (and avoidance of doubt, each of the following milestone payments shall be payable only once regardless of the number of times achieved by one or more Products. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***]BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL FILED WITH THE SECURITIES AND (II) IS EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE TYPE THAT THE REGISTRANT TREATS SECURITIES EXCHANGE ACT OF 1934, AS PRIVATE OR CONFIDENTIALAMENDED. 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 ($55,000,000) N/A
2. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the U.S. issued by the FDA [***](the “First U.S. Approval Milestone”) [***] Dollars ($[***]) [***] Dollars ($[***])
3. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the EU issued by the EMA EXECUTION VERSION CONFIDENTIAL [***] [***] Dollars ($[***]) [***] Dollars ($[***])
4. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in Japan issued by the MHLW [***] [***] Dollars [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] If at the time of the achievement of a milestone for the Primary Indication ($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 whether such prior milestone had actually been achieved. With respect to milestones [***] and [***], (a) if at the time of the achievement of milestone [***], Astellas has not made payment for milestone [***], Astellas shall make the payment for milestone [***] Dollars ($together with the payment for milestone [***], and (b) if at the time of the first [***], Astellas has not made payment for either or both of milestones [***] and [***], Astellas shall make the payment for such prior milestone(s), in each case, irrespective of whether such prior milestone(s) had actually been achieved. With respect to milestones [***] and [***], (i) if at the time of the achievement of milestone [***], Astellas has not made payment for milestone [***], Astellas shall make the payment for milestone [***] together with the payment for milestone [***], and (ii) if at the time of the first [***] (excluding the [***]), Astellas has not made payment for either or both of milestones [***] and [***], Astellas shall make the payment for such prior milestone(s), in each case, irrespective of whether such prior milestone(s) had actually been achieved. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***]BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL FILED WITH THE SECURITIES AND (II) IS EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE TYPE THAT THE REGISTRANT TREATS SECURITIES EXCHANGE ACT OF 1934, AS PRIVATE OR CONFIDENTIAL.
5AMENDED. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the U.S. issued by the FDA [***] [***] Dollars ($[***]) [***] 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 ($126,000,000) assuming that each of the milestone events in this Section 5.3.1 were achieved by a Licensed Product that is an Enabled Antibody Product, and (c) in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product, (i) Celgene shall pay the applicable amount with respect to Enabled Antibody Product set forth above associated with the applicable milestone event in lieu of the amount with respect to Licensed Product other than Enabled Antibody Product set forth above, and (ii) subject to the immediate subsequent sentence of this Section 5.3.1, no Regulatory Milestone Payment shall be due hereunder for subsequent or repeated achievement of such milestone event (whether by an Enabled Antibody Product or any other Licensed Product). Notwithstanding the foregoing, in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product and such milestone is subsequently achieved for the first (and only the first) Licensed Product that is not an Enabled Antibody Product (“First Subsequent Regulatory Milestone”), then Celgene will notify Prothena within [***] days following such CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. first achievement and shall be obligated to pay Prothena an additional amount equal to the portion of the Regulatory Milestone Payment for such First Subsequent Regulatory Milestone in excess of the applicable Regulatory Milestone Payment for Enabled Antibody Product associated with such milestone event. By way of example, solely for illustrative purposes, if the First U.S. Approval Milestone is first achieved for an Enabled Antibody Product and subsequently achieved for a Licensed Product that is not an Enabled Antibody Product, then Celgene shall pay to Prothena [***] Dollars ($[***]) for such First Subsequent Regulatory Milestone.EXECUTION VERSION
Appears in 1 contract
Sources: Exclusive License and Collaboration Agreement (Aquinox Pharmaceuticals, Inc)
Development and Regulatory Milestones. Subject to the terms and conditions of this Section 5.3 Agreement, Qilu shall make each of the one-time, non-refundable, non-creditable milestone payments to Arbutus that are set forth below (and subject further to Section 5.5)each such payment, Celgene will notify Prothena within [***] days following a “Development Milestone Payment”) upon the first achievement of the corresponding milestone event by Celgene or on behalf of Qilu or its Affiliate or Sublicensee with respect to a Licensed Product (each such milestone event, a “Development Milestone Event”) in accordance with this Section 7.2. For clarity, each Development Milestone Payment under this Agreement and after the Effective Date of each milestone event described below in this Section 5.3 7.2 shall be paid only once with respect to the first time the corresponding Development Milestone Event is achieved. In the event that a Development Milestone Event is achieved and an earlier Development Milestone Event has not been achieved (e.g., Development Milestone Event 4 is achieved but Development Milestone Event 3 has not been achieved), then such earlier Development Milestone Event shall be deemed to have been achieved at the same time as the later Development Milestone Event, and only Qilu shall pay to Arbutus the Development Milestone Payment for the earlier Development Milestone Event at the same time that the Development Milestone Payment for the later Development Milestone Event is achieved. Qilu shall notify Arbutus in writing promptly, but in no event later than two (2) Business Days, after the achievement of each Development Milestone Event set forth in this Section 7.2. After receiving such notice, Arbutus shall invoice Qilu for the applicable Development Milestone Payment in accordance with the notice. Qilu shall pay the applicable Development Milestone Payment due to Arbutus in Dollars within twenty (20) Business Days following Qilu’s receipt of such invoice. 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 ($55,000,000) N/A
2. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the U.S. issued by the FDA [***](the “First U.S. Approval Milestone”) CONFIDENTIAL 1 [***] Dollars ($[***]) ] 2 [***] Dollars ($[***])
3. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the EU issued by the EMA ] 3 [***] $[***] 4 [***] $[***] 5 [***] $[***] [***] Dollars ($[***]) [***] Dollars ($[***])
4. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in Japan issued by the MHLW [***] [***] Dollars ($[***]) [***] Dollars ($[***]) CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
5. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the U.S. issued by the FDA [***] [***] Dollars ($[***]) [***] 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 ($126,000,000) assuming that each of the milestone events in this Section 5.3.1 were achieved by a Licensed Product that is an Enabled Antibody Product, and (c) in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product, (i) Celgene shall pay the applicable amount with respect to Enabled Antibody Product set forth above associated with the applicable milestone event in lieu of the amount with respect to Licensed Product other than Enabled Antibody Product set forth above, and (ii) subject to the immediate subsequent sentence of this Section 5.3.1, no Regulatory Milestone Payment shall be due hereunder for subsequent or repeated achievement of such milestone event (whether by an Enabled Antibody Product or any other Licensed Product). Notwithstanding the foregoing, in the event that any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product and such milestone is subsequently achieved for the first (and only the first) Licensed Product that is not an Enabled Antibody Product (“First Subsequent Regulatory Milestone”), then Celgene will notify Prothena within [***] days following such CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. first achievement and shall be obligated to pay Prothena an additional amount equal to the portion of the Regulatory Milestone Payment for such First Subsequent Regulatory Milestone in excess of the applicable Regulatory Milestone Payment for Enabled Antibody Product associated with such milestone event. By way of example, solely for illustrative purposes, if the First U.S. Approval Milestone is first achieved for an Enabled Antibody Product and subsequently achieved for a Licensed Product that is not an Enabled Antibody Product, then Celgene shall pay to Prothena [***] Dollars ($[***]) for such First Subsequent Regulatory Milestone.
Appears in 1 contract
Sources: Technology Transfer and Exclusive License Agreement (Arbutus Biopharma Corp)
Development and Regulatory Milestones. Subject to the terms of and conditions herein (including this Section 5.3 13.7 (Development and subject further to Section 5.5Regulatory Milestones), Celgene will notify Prothena within [***] days following Section 13.11 (Additional Payment Terms) and, in the first achievement by Celgene under this Agreement event Nurix exercises a Profit-Share Option, Section 11.2.3 (Profit-Share Products) and after Section 11.2.4 (Milestone Payments Related to the Effective Date of each milestone event described 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 5.3 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 the 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) a Licensed Product to achieve such milestone (each event under this Agreement, and Celgene shall thereafter pay described in #1-#10 in the applicable non-refundable, non-creditable amounts set forth below associated with the applicable milestone event in accordance with Section 5.3.2 (eachtable below, a “Development and Regulatory Milestone Event,” and each respective payment, a “Development and 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 ($55,000,000) N/A
2. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the U.S. issued by the FDA [***]Product:
(the “First U.S. Approval Milestone”1) [***] Dollars ($[***]) [***] Dollars ($[***])
3. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the EU issued by the EMA [***] [***] Dollars ]
($[***]2) [***] Dollars ($[***])
4. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in Japan issued by the MHLW [***] [***] Dollars ]
($[***]3) [***] Dollars ($[***]) CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
5. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the U.S. issued by the FDA [***] [***] Dollars ]
($[***]4) [***] Dollars ($[***])
6. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the EU issued by the EMA [***] [***] Dollars ]
($[***]5) [***] Dollars ($[***])
7. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in Japan issued by the MHLW [***] [***] Dollars ]
($[***]6) [*] [*]
(7) [*] Dollars ($[*]
(8) [*] [*]
(9) Subject [*] [*]
(10) [*] [*]
1.1.1 [*].
1.1.2 Each Development and Regulatory Milestone Payment is payable up 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 per Licensed Product as set forth in the foregoing chart 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 achieving or Licensed Degraders for Milestones, Royalties, and Option-Triggering Events)) that contains the applicable milestone event same Licensed Degrader(s) (i.e.as determined in accordance with Section 13.11.1 (Determining Same vs Distinct Licensed Products or Licensed Degraders for Milestones, a maximum of seven (7) Regulatory Milestone Payments may be made pursuant to this Section 5.3.1Royalties, and Option-Triggering Events)), then the corresponding Development and no Regulatory Milestone Payment shall be due hereunder payable at an amount that is [*] of the amount listed above for subsequent or repeated 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 such milestone event Development and Regulatory Milestone Event by a First Licensed Product that is a Profit-Share Product at the time of such achievement, the Milestone Payment for the achievement of such Development and Regulatory Milestone Event by the Second Licensed Product shall [*]);
(whether by an Enabled Antibody Product or any other Licensed Product). For the avoidance of doubtc) if, (a) the maximum amount payable by Celgene pursuant to this Section 5.3.1 after a Development and Regulatory Milestone Event 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 contains one (1) or more specific Licensed Degrader(s), such Development and Regulatory Milestone Event 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 subsequently achieved by a another distinct Licensed Product that is an Enabled Antibody Productcontains any distinct Licensed Degrader(s), then the corresponding Development and (c) in the event that any Regulatory Milestone Payment shall be payable at [*] of the foregoing milestones in this Section 5.3.1 is first achieved amount listed above for an Enabled Antibody Productsuch Development and Regulatory Milestone Payment;
(d) with respect to Development and Regulatory Milestone Events [*], the achievement of [*] shall be deemed to include [*]; and
(e) (i) Celgene shall pay the applicable amount upon achievement of any of Development and Regulatory Milestone Events [*] above with respect to Enabled Antibody Product set forth above associated with a Licensed Product, if the applicable milestone event in lieu first achievement of the amount any of Development and Regulatory Milestone Events [*] with respect to such Licensed Product other than Enabled Antibody Product set forth abovehas not occurred, such unachieved milestone shall simultaneously be deemed achieved and payable, and (ii) subject to the immediate subsequent sentence upon achievement of this Section 5.3.1, no any of Development and Regulatory Milestone Payment shall be due hereunder for subsequent or repeated Events [*] above with respect to a Licensed Product, if the first achievement of Development and Regulatory Milestone Event [*] with respect to such Licensed Product has not occurred, such unachieved milestone event (whether by an Enabled Antibody Product or any other Licensed Product). shall simultaneously be deemed achieved and payable.
1.1.3 Notwithstanding the foregoing, in the event that no Development and Regulatory Milestone Payments shall be due with respect to any of the foregoing milestones in this Section 5.3.1 is first achieved for an Enabled Antibody Product Unprotected Licensed 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 [***] Dollars ($[***]) for such First Subsequent Regulatory Milestone.
Appears in 1 contract
Sources: Collaboration and License Agreement (Nurix Therapeutics, Inc.)