Development Milestone Payments. Licensee shall pay to Company the onetime milestone payments set forth in the table below within [***] Business Days upon and only after the first achievement of the listed milestone events with respect to the first Licensed Product to achieve such milestone. Licensee shall notify Company within [***] Business Days after the occurrence of each milestone event under this Section 8.2. Milestone Amount (USD) FDA approval for the Licensed Product in an mTNBC indication for patients who have received at least two prior anti-cancer therapies in the metastatic setting (the “$60M mTNBC Milestone”) $60M The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least two (2) prior anti-cancer therapies in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least one (1) prior anti-cancer therapy in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have received two (2) prior chemotherapies in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have not received prior chemotherapy in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in a UC indication $[***] The first Marketing Approval in the PRC for the Licensed Product in one of the following indications: [***] (the “Fourth Indication Milestone”) $[***] The first Marketing Approval in the PRC for the Licensed Product in an indication for any cancer not covered in any of the above milestones for up to four (4) additional cancers $[***] The first patient is recruited by Licensee in the PRC that is a part of a Global Study to register the Licensed Product in a for a [***] indication $[***] Notwithstanding the foregoing, Company shall issue to Licensee a refund of the $60M mTNBC Milestone in the amounts and upon occurrence of the events set forth below within [***] Business Days of occurrence of such events: (a) [***] Dollars ($[***]) in the event that (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval, and (ii) (A) Company’s ASCENT trial fails to achieve its overall survival (“OS”) endpoint and progression-free survival (“PFS”) endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint; (b) [***] Dollars ($[***]) in the event that either (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval or (ii) (A) Company’s ASCENT trial fails to achieve its OS endpoint and PFS endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint; or (c) [***] Dollars ($[***]) in the event that the FDA revokes its approval for the mTNBC indication during the period commencing any time after [***] months after the FDA issued its approval and ending [***] months after the FDA issued its approval.
Appears in 1 contract
Sources: License Agreement (Immunomedics Inc)
Development Milestone Payments. In consideration of the license and rights granted hereunder, Licensee shall pay to Company L▇▇▇▇ each of the onetime milestone payments set forth in the table below within (each, a “Development Milestone Payment”) upon the occurrence of the corresponding milestone set forth in such table (each, a “Development Milestone”). Licensee shall promptly notify L▇▇▇▇ in writing of, but in no event later than [***] Business Days upon after, the occurrence of each Development Milestone for the Product (which notice shall specify the date of such occurrence, and only after such specified date shall be binding on Licensee) (each, a “Development Milestone Notice”); provided, however, that in no event shall a failure to deliver a Development Milestone Notice relieve Licensee of its obligation to pay the first achievement of the listed milestone events with respect applicable Development Milestone Payment when due pursuant to the first Licensed Product to achieve such milestonethis Section 7.2. Licensee shall notify Company within pay each Development Milestone Payment [***] Business Days after the occurrence of the applicable Development Milestone. Each Development Milestone is a single occurrence event, and accordingly each milestone event under this Section 8.2. Development Milestone Amount Payment shall only be payable once for all products that fall within the definition of the Product taken together (USD) FDA approval e.g., all formulations and dosages), and shall be payable upon the first occurrence of the applicable Development Milestone for the Licensed Product in an mTNBC indication (regardless of the specific Product or whether the specific Product for patients who have received at least two prior anti-cancer therapies a Development Milestone is the same as the specific Product for any other Development Milestones). For clarity, and by way of example (with each of the following items occurring sequentially in the metastatic setting order set forth below):
(a) If there is an [***], the “$60M mTNBC Milestone”) $60M The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least two (2) prior anti-cancer therapies in the metastatic setting $corresponding Development Milestone Payment of [***] The first Marketing Approval in the PRC for the Licensed Product in would be payable.
(b) If there is an mTNBC indication for patients who have received at least one (1) prior anti-cancer therapy in the metastatic setting $[***], [***] The first Marketing Approval in would be payable.
(c) If there is [***], the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have received two (2) prior chemotherapies in the metastatic setting $corresponding milestone payment of [***] The first Marketing Approval in would be payable.
(d) If there is [***], the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have not received prior chemotherapy in the metastatic setting $corresponding milestone payment of [***] The first Marketing Approval in the PRC for the Licensed Product in a UC indication $would be payable.
(e) If there is [***], [***] The first Marketing Approval in would be payable [***].
(f) If there is [***], the PRC for the Licensed Product in one corresponding milestone payment of the following indications: [***] (would be payable. For the “Fourth Indication Milestone”) $[***] The first Marketing Approval in the PRC for the Licensed Product in an indication for any cancer not covered in any avoidance of doubt only four distinct Development Milestones may be achieved and so if all four of the above milestones for up Development Milestones occur, the total amount of Development Milestone Payments required to four (4) additional cancers $[***] The first patient is recruited by Licensee in the PRC that is a part of a Global Study to register the Licensed Product in a for a [***] indication $[***] Notwithstanding the foregoing, Company shall issue to Licensee a refund of the $60M mTNBC Milestone in the amounts and upon occurrence of the events set forth below within [***] Business Days of occurrence of such events:
(a) [***] Dollars ($be made under this Agreement will be [***]) in the event that (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval, and (ii) (A) Company’s ASCENT trial fails to achieve its overall survival (“OS”) endpoint and progression-free survival (“PFS”) endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint;
(b) [***] Dollars ($[***]) in the event that either (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval or (ii) (A) Company’s ASCENT trial fails to achieve its OS endpoint and PFS endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint; or
(c) [***] Dollars ($[***]) in the event that the FDA revokes its approval for the mTNBC indication during the period commencing any time after [***] months after the FDA issued its approval and ending [***] months after the FDA issued its approval.
Appears in 1 contract
Sources: License, Development and Commercialization Agreement (Zura Bio LTD)
Development Milestone Payments. Licensee As additional consideration for the grant of rights under this Agreement, and on the terms and subject to the conditions set forth herein, Allergan shall pay make the following payments to Company Assembly (the onetime milestone payments “Development Milestone Payments”) after the achievement following the Effective Date by or on behalf of Allergan of the applicable event set forth below (collectively, the “Development Milestone Events”). Each of the Development Milestone Payments are payable only once per Permitted Indication as set forth in the table below within [***] Business Days upon and only after the first achievement of each Development Milestone Event regardless of the listed milestone events number of Licensed Products that are developed for such Permitted Indication or subsequent achievement of such Development Milestone Events for such Permitted Indication with respect a different Licensed Product; provided, that, the Development Milestone Events for [* * *] Permitted Indications in addition to the first Licensed Product Initial Indications shall be payable subject to achieve such milestonethe credit provided in Section 4.8.3. Licensee Allergan or Assembly, as applicable, will notify the other Party in writing as soon as reasonably possible following the achievement of a Development Milestone Event. Allergan shall notify Company pay to Assembly the corresponding Milestone Payment within [*** * *] Business Days days after achievement of the occurrence of each milestone event under this Section 8.2applicable Development Milestone Event. The Development Milestone Amount (USD) FDA approval for the Licensed Product in an mTNBC indication for patients who have received at least two prior antiPayments shall be non-cancer therapies in the metastatic setting (the “$60M mTNBC Milestone”) $60M The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least two (2) prior anti-cancer therapies in the metastatic setting $refundable. [*** * *] The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least one (1) prior anti-cancer therapy in the metastatic setting $[*** * *] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have received two (2) prior chemotherapies in the metastatic setting $[*** * *] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have not received prior chemotherapy in the metastatic setting $[*** * *] The first Marketing Approval in the PRC for the Licensed Product in a UC indication $[*** * *] The first Marketing Approval in the PRC for the Licensed Product in one of the following indications: [*** * *] (the “Fourth Indication Milestone”) $[*** * *] The first Marketing Approval in the PRC for the Licensed Product in an indication for any cancer not covered in any of the above milestones for up to four (4) additional cancers $[*** * *] The first patient is recruited by Licensee in the PRC that is a part of a Global Study to register the Licensed Product in a for a [*** * *] indication $[*** * *] Notwithstanding the foregoing, Company shall issue to Licensee a refund of the $60M mTNBC Milestone in the amounts and upon occurrence of the events set forth below within [*** * *] Business Days of occurrence of such events:
(a) [*** * *] Dollars ($[* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] [* * *]) in the event that (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval, and (ii) (A) Company’s ASCENT trial fails to achieve its overall survival (“OS”) endpoint and progression-free survival (“PFS”) endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint;
(b) [***] Dollars ($[***]) in the event that either (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval or (ii) (A) Company’s ASCENT trial fails to achieve its OS endpoint and PFS endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint; or
(c) [***] Dollars ($[***]) in the event that the FDA revokes its approval for the mTNBC indication during the period commencing any time after [***] months after the FDA issued its approval and ending [***] months after the FDA issued its approval.
Appears in 1 contract
Sources: Research, Development, Collaboration and License Agreement (Assembly Biosciences, Inc.)
Development Milestone Payments. In consideration of the licenses and rights granted to Licensee hereunder, Licensee shall pay to Company Pfizer the onetime milestone payments amounts set forth in the table below within [***] Business Days upon and only after following the first achievement of the listed milestone events with respect to the first Licensed Product to achieve such milestone. Licensee shall notify Company within [***] Business Days after the occurrence of each milestone event under this Section 8.2. Milestone Amount (USD) FDA approval for the Licensed Product in an mTNBC indication for patients who have received at least two prior anti-cancer therapies described in the metastatic setting first column below by, as applicable, Licensee, any Affiliate of Licensee, any sublicensee of Licensee or any Third Party Acquirer (the each such event, a “$60M mTNBC Development Milestone” and each payment, a “Development Milestone Payment”). DEVELOPMENT MILESTONE (IN EACH CASE APPLICABLE ONLY TO THE FIRST PRODUCT TO ACHIEVE SUCH EVENT IN THE FIRST INDICATION IN THE FIELD) $60M The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least two DEVELOPMENT MILESTONE PAYMENT IF THE RELEVANT DEVELOPMENT MILESTONE IS ACHIEVED BY LICENSEE’S PARENT, LICENSEE, OR ANY AFFILIATE OF LICENSEE DEVELOPMENT MILESTONE PAYMENT IF THE RELEVANT DEVELOPMENT MILESTONE IS ACHIEVED BY A THIRD PARTY SUBLICENSEE OR BY A THIRD PARTY ACQUIRER (2) prior anti-cancer therapies in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least one OTHER THAN SPRINGWORKS)
(1) prior anti-cancer therapy in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have received two (2) prior chemotherapies in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have not received prior chemotherapy in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in a UC indication $[***] The first Marketing Approval in the PRC for the Licensed Product in one of the following indications: [***] (the “Fourth Indication Milestone”) $[***] The first Marketing Approval in the PRC for the Licensed Product in an indication for any cancer not covered in any of the above milestones for up to four (4) additional cancers $[***] The first patient is recruited by Licensee in the PRC that is a part of a Global Study to register the Licensed Product in a for a [***] indication $[***] Notwithstanding the foregoing, Company shall issue to Licensee a refund of the $60M mTNBC Milestone in the amounts and upon occurrence of the events set forth below within [***] Business Days of occurrence of such events:
(a) [***] Dollars ($US$[***] US$[***]*
(2) First Commercial Sale of a Product in the event that [***]** US$[***]
(i3) the FDA revokes its approval for the mTNBC indication within First Commercial Sale of a Product in [***]** US$[***]
(4) First Commercial Sale of a Product in [***]** US$[***]
(5) First Commercial Sale of a Product in [***]** US$[***] months For the avoidance of issuing its approvaldoubt, and each Development Milestone Payment shall be payable only once upon the first achievement of the applicable Development Milestone, regardless of the number of Products that achieve such Development Milestone or the number of indications for which such Development Milestone is achieved. The total amount payable with respect to these Development Milestones shall not exceed US$13,750,000, or US$17,750,000 if the Development Milestone in clause (ii1) (A) Company’s ASCENT trial fails to achieve its overall survival (“OS”) endpoint and progression-free survival (“PFS”) endpoint and (B) above is achieved by a prospectively defined high TROP-2 subgroup (with Third Party sublicensee or a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint;
(b) Third Party Acquirer. [***] Dollars ($[***]) Certain information in the event that either this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. * Such Development Milestone Payment shall only be payable if, prior to achieving this Development Milestone, a Third Party Acquirer sublicenses rights to Develop and Commercialize the FDA revokes Compound worldwide in the Field or acquires all or substantially all of the assets of Licensee and (a) subsequently achieves this Development Milestone or (b) achieves the first to occur of a Development Milestone in row (2), (3), (4) or (5) above prior to (i) Licensee, any of its approval Affiliates, any of its sublicensees or any Third Party Acquirer dosing any patient in any Phase III Clinical Trial for the mTNBC indication within [***] months of issuing its approval a Product or (ii) Licensee filing the first NDA with respect to the first Product. ** The Development Milestone Payment corresponding to this Development Milestone shall be due on the one hundred eighty-first (A181st) Company’s ASCENT trial fails to achieve its OS endpoint and PFS endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score day after the First Commercial Sale of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint; or
(c) [***] Dollars ($[***]) the applicable Product in the event that the FDA revokes its approval for the mTNBC indication during the period commencing any time after [***] months applicable jurisdiction. Except as set forth above, each Development Milestone Payment shall be payable by Licensee within sixty (60) days after the FDA issued its approval achievement of the corresponding Development Milestone, and ending [***] months after such payment shall be accompanied by a report identifying the FDA issued its approvalamount payable to Pfizer under this Section 5.2.
Appears in 1 contract
Sources: License Agreement
Development Milestone Payments. Licensee Takeda shall make milestone payments to Affymax based on the first achievement of each milestone event in the Licensed Territory for the Product as set forth in this Section 8.2. Takeda shall pay to Company Affymax the onetime milestone payments amounts set forth in the table below within [***] Business Days upon and only thirty (30) days after the first achievement of the listed corresponding milestone events event with respect to the Product. Each such payment shall be made by wire transfer of immediately available funds into an account designated by Affymax. Each milestone payment by Takeda to Affymax hereunder shall be payable only once, regardless of the number of times achieved by one or more Products. Each such payment is non-refundable and non-creditable against any other payments due hereunder. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. [ * ] $ [ * ] [ * ] $ [ * ] Completion(2) of the first Licensed Product to achieve such milestone. Licensee shall notify Company within [***] Business Days after the occurrence of each milestone event under this Section 8.2. Milestone Amount (USD) FDA approval pivotal Phase III Clinical Trial for the Licensed Product in an mTNBC indication for patients who have received at least two prior anti-cancer therapies in the metastatic setting (the “$60M mTNBC Milestone”) $60M The first Marketing Regulatory Approval in the PRC U.S. by either Party anywhere in the Licensed Territory for treatment of: [ * ] $ [ * ] [ * ] $ [ * ] Pre-Dialysis CKD Anemia $ 15,000,000 Dialysis CKD Anemia $ 15,000,000 Acceptance by FDA of the first NDA submission in the United States for the Licensed Product for treatment of: [ * ] $ [ * ] [ * ] $ [ * ] Pre-Dialysis CKD Anemia $ 10,000,000 Dialysis CKD Anemia $ 10,000,000 [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] Receipt of Regulatory Approval of the Product in an mTNBC either Renal Indication (i.e., Pre-Dialysis CKD Anemia or Dialysis CKD Anemia) whichever is earlier in the following territories: United States $ 50,000,000 [ * ] $ [ * ] Receipt of Regulatory Approval of the Product, in the following territories, in the other Renal Indication (the indication other than that for patients who have received at least two which the preceding milestone was paid): United States $ 45,000,000 [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] Total Milestone Payments $ 280,000,000 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(1) For clarity, [ *]
(2) prior anti-cancer therapies in For purposes of this section, “completion” means locking of the metastatic setting $[**database for analysis of the study.
(3) For clarity, the [ *] The first Marketing Approval in the PRC milestone for the Licensed Product in an mTNBC indication for patients who have received at least one (1) prior anti-cancer therapy in the metastatic setting $[**[ *] The first Marketing Approval in shall be payable upon the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have received two (2) prior chemotherapies in the metastatic setting $[[ ***] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have not received prior chemotherapy in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in a UC indication $[***] The first Marketing Approval in the PRC for the Licensed Product in one of the following indications: [***] (the “Fourth Indication Milestone”) $[***] The first Marketing Approval in the PRC for the Licensed Product in an indication for any cancer not covered in any of the above milestones for up to four ]
(4) additional cancers $[**For clarity, the milestones for [ *] The first patient is recruited by Licensee in the PRC that is a part of a Global Study to register the Licensed Product in a for a [shall be payable upon [ **]
(5) For clarity, if [ *] indication $[***] Notwithstanding the foregoing, Company shall issue to Licensee a refund of the $60M mTNBC Milestone in the amounts and upon occurrence of the events set forth below within [***] Business Days of occurrence of such events:
(a) [***] Dollars ($[**milestones will be payable [ *]) in the event that (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval, and (ii) (A) Company’s ASCENT trial fails to achieve its overall survival (“OS”) endpoint and progression-free survival (“PFS”) endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint;
(b) [***] Dollars ($[***]) in the event that either (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval or (ii) (A) Company’s ASCENT trial fails to achieve its OS endpoint and PFS endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint; or
(c) [***] Dollars ($[***]) in the event that the FDA revokes its approval for the mTNBC indication during the period commencing any time after [***] months after the FDA issued its approval and ending [***] months after the FDA issued its approval.
Appears in 1 contract
Development Milestone Payments. Licensee Within the Royalty Term and upon the terms and subject to the conditions of this Agreement, Purchaser shall pay make (or cause to Company be made) as consideration for any asset relating to CVAC, i.e. (aa) the onetime milestone CVAC Sub-License; (bb) the Know-How License (except for the Further Know-How); and (cc) the Purchased Assets relating to CVAC (i.e. in particular, but without limitation, the Neopharm Agreement and the Transferred Books and Records relating to CVAC as described in Section 2.03(a)(iii)(aa)) each of the one-time, non-refundable, non-creditable payments set forth in the table below within [***] Business Days upon and only after (each, a “Development Milestone Payment”) to Seller no later than thirty (30) days following the first achievement occurrence of the listed corresponding milestone events with respect to event set forth below (each a “Development Milestone Event”). For the sake of clarity, (i) each Development Milestone Payment shall become due and payable upon the first Licensed Product to achieve such milestone. Licensee shall notify Company within [***] Business Days after the occurrence of each the corresponding Development Milestone Event, regardless of whether such Development Milestone Event is achieved by Purchaser or by a Purchaser Related Party,(ii) the following milestones apply individually- with the exception of milestone event under 6 – to two indications (eg second remission ovarian cancer and pancreatic cancer). Example: based on the assumption that second remission ovarian canceer will start directly with Phase III, the aggregate amount of the Development Milestone Payments payable pursuant to this Section 8.2. Milestone Amount (USD2.07(a) FDA approval for the Licensed Product in an mTNBC indication for patients who have received at least two prior anti-cancer therapies in the metastatic setting (the “$60M mTNBC Milestone”) $60M The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least two (2) prior anti-cancer therapies in the metastatic setting shall not exceed $[***] The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least one (1) prior anti-ovarian cancer therapy in the metastatic setting and $[***] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have received two (2) prior chemotherapies in the metastatic setting second cancer indication. A one off milestone of $[***] The will be payable on first Marketing Approval commercial sale in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have not received prior chemotherapy in the metastatic setting $a third indication. [***] The first Marketing Approval in the PRC for the Licensed Product in a UC indication $$ [***] The first Marketing Approval in the PRC for the Licensed Product in one of the following indications: [***] (the “Fourth Indication Milestone”) $$ [***] The first Marketing Approval in the PRC for the Licensed Product in an indication for any cancer not covered in any of the above milestones for up to four (4) additional cancers $[***] The first patient is recruited by Licensee in the PRC that is a part of a Global Study to register the Licensed Product in a for a $ [***] indication $[***] Notwithstanding the foregoing, Company shall issue to Licensee a refund of the $60M mTNBC Milestone in the amounts and upon occurrence of the events set forth below within $ [***] Business Days of occurrence of such events:
(a) [***] Dollars ($$ [***] [***] $ [***] [***] $ [***] [***] $ [***]) in the event that (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval, and (ii) (A) Company’s ASCENT trial fails to achieve its overall survival (“OS”) endpoint and progression-free survival (“PFS”) endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint;
(b) [***] Dollars ($[***]) in the event that either (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval or (ii) (A) Company’s ASCENT trial fails to achieve its OS endpoint and PFS endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint; or
(c) [***] Dollars ($[***]) in the event that the FDA revokes its approval for the mTNBC indication during the period commencing any time after [***] months after the FDA issued its approval and ending [***] months after the FDA issued its approval.
Appears in 1 contract
Sources: Sub License, License and Asset Purchase Agreement (Prima BioMed LTD)
Development Milestone Payments. Licensee Facet shall make milestone payments (each a “Milestone Payment”) to Trubion based on the first achievement of each milestone event in the Field, in the Territory for each Product as set forth in this Section 9.3. No Milestone Payment shall be made twice with respect to the same Product. For the purposes of this Section 9.3, two Products are deemed the “same Product” if one Product contains, as its active pharmaceutical ingredient, [ * ]. Facet shall pay to Company Trubion the onetime milestone payments amounts set forth in the table below below, within [***[ * ] Business Days upon and only after the first achievement of the listed corresponding milestone events event with respect to the first Licensed Product. Each Milestone Payment is non-refundable and non-creditable against any other payments due hereunder, provided that if the Development of a Product is abandoned, any Milestone Payments made with respect to achieve such milestone. Licensee shall notify Company within [***] Business Days abandoned Product may be credited against the corresponding Milestone Payments payable on a Product which achieves such milestones after the occurrence abandonment of each milestone event under the other Product. For the purposes of this Section 8.2. Milestone Amount (USD) FDA approval for the Licensed Product in an mTNBC indication for patients who have received at least two prior anti-cancer therapies in the metastatic setting (9.3, the “$60M mTNBC Milestone”[ * ]” of a Clinical Trial shall occur upon [ * ], “[ * ]” and “[ * ]” shall be [ * ] or, [ * ]. Notwithstanding anything to the contrary in this Agreement, if Trubion is deemed pursuant to Section 14.2(b) $60M The first Marketing Approval in to have exercised its Opt-Out Option with respect to all Products on account of an uncured material breach by Trubion, the PRC for the Licensed Product in an mTNBC indication for patients who have received at least two (2) prior anti-cancer therapies in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least one (1) prior anti-cancer therapy in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have received two (2) prior chemotherapies in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have not received prior chemotherapy in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in a UC indication $[***] The first Marketing Approval in the PRC for the Licensed Product in one amount of the following indications: [***milestone payments due pursuant to this Section 9.3 with respect to milestone events achieved by all Products after Facet has provided Trubion with written notice of continuation in accordance with Section 14.2(b) shall be reduced by [ * ]. [ * ] (= Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the “Fourth Indication Milestone”) $[***] The first Marketing Approval in the PRC for the Licensed Product in an indication for any cancer not covered in any Securities and Exchange Commission pursuant to Rule 24b-2 of the above milestones for up to four (4) additional cancers $[***Securities Exchange Act of 1934, as amended. [ * ] The first patient is recruited by Licensee in the PRC that is a part of a Global Study to register the Licensed Product in a for a [***$ [ * ] indication $[***[ * ] Notwithstanding the foregoing, Company shall issue to Licensee a refund of the $60M mTNBC Milestone in the amounts and upon occurrence of the events set forth below within [***$ [ * ] Business Days of occurrence of such events:
(a) [***[ * ] Dollars ($[***$ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ] [ * ] $ [ * ]) in the event that (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval, and (ii) (A) Company’s ASCENT trial fails to achieve its overall survival (“OS”) endpoint and progression-free survival (“PFS”) endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint;
(b) [***] Dollars ($[***]) in the event that either (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval or (ii) (A) Company’s ASCENT trial fails to achieve its OS endpoint and PFS endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint; or
(c) [***] Dollars ($[***]) in the event that the FDA revokes its approval for the mTNBC indication during the period commencing any time after [***] months after the FDA issued its approval and ending [***] months after the FDA issued its approval.
Appears in 1 contract
Sources: Collaboration and License Agreement (Facet Biotech Corp)
Development Milestone Payments. Licensee Subject to the terms and conditions of this Agreement, MERCK shall pay to Company DOV the onetime milestone following payments set forth in based on the table below within [***] Business Days upon and only after achievement of the following milestones ("Development Milestones"):
(a) MERCK shall make the following payments for the first achievement of the listed milestone events with respect to the first Licensed Product to achieve such milestone. Licensee shall notify Company within [***] Business Days after the occurrence of each milestone event under this Section 8.2. Milestone Amount (USD) FDA approval for the Licensed Product in an mTNBC indication for patients who have received at least two prior anti-cancer therapies in the metastatic setting (the “$60M mTNBC Milestone”) $60M The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least two (2) prior anti-cancer therapies in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an mTNBC indication for patients who have received at least one (1) prior anti-cancer therapy in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have received two (2) prior chemotherapies in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have not received prior chemotherapy in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in a UC indication $[***] The first Marketing Approval in the PRC for the Licensed Product in one of the following indications: [***] (the “Fourth Indication Milestone”) $[***] The first Marketing Approval in the PRC for the Licensed Product in an indication Development Milestones by MERCK or any Related Party for any cancer not covered in any of the above milestones for up to four (4) additional cancers $[***] The first patient is recruited by Licensee in the PRC that is a part of a Global Study to register the Licensed Product in a for a [***] indication $[***] Notwithstanding the foregoing, Company shall issue to Licensee a refund of the $60M mTNBC Milestone in the amounts and upon occurrence of the events set forth below within [***] Business Days of occurrence of such eventsProduct:
(ai) [***] Dollars $US [***]
(ii) [***] $US [***]
(iii) [***] $US [***] [LOGO] Restricted Confidential Limited Access *** CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO THIS MATERIAL.
(iv) [***] $US [***]
(v) [***] $US [***]
(vi) [***] $US [***]
(vii) [***] $US [***]
(viii) [***] $US [***]
(b) MERCK shall make the following payments for the achievement by MERCK or any Related Party of the following Development Milestones for a second Indication for the first Product:
(i) [***] $US [***]
(ii) [***] $US [***]
(c) The above Development Milestones are not refundable or creditable against any other payments or obligations of MERCK coming due and do not create any future performance obligations on the part of DOV, except as expressly set forth in this Agreement. These payments shall not be triggered by any clinical development work performed by DOV (i) prior to the Closing Date or (ii) after the Closing Date if such work is not in the performance of activities as a CRO pursuant to the Drug Development Plan. MERCK shall notify DOV in writing within thirty (30) days following the achievement of each Development Milestone, and shall make the appropriate payment within thirty (30) days after the achievement of such Development Milestone. The milestone payment shall be payable only upon the initial achievement of such Development Milestone and no amounts shall be due hereunder for subsequent or repeated achievement of such Development Milestone.
(d) (i) If during the Term of the Agreement, MERCK has not Initiated the first Phase II Clinical Trial for DOV 21,947 by [***], MERCK shall make a payment to DOV of [***] dollars ($US $[***]) in the event that (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval, and (ii) (A) Company’s ASCENT trial fails to achieve its overall survival (“OS”) endpoint and progression-free survival (“PFS”) endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint;
(b) [***] Dollars ($[***]) in the event that either (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval or (ii) (A) Company’s ASCENT trial fails to achieve its OS endpoint and PFS endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint; or
(c) [***] Dollars ($[***]) in the event that the FDA revokes its approval for the mTNBC indication during the period commencing any time after [***] months after the FDA issued its approval and ending [***] months after the FDA issued its approval).
Appears in 1 contract
Sources: Exclusive License, Development and Commercialization Agreement (Dov Pharmaceutical Inc)
Development Milestone Payments. Licensee shall pay (i) In addition to Company the onetime milestone payments Closing Date Merger Consideration (less the Remaining Option Consideration and Rights Proceeds Amount, if any) and any Net TNF Sales Payments (as defined below), upon the attainment of the development ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. milestones set forth in below (each, a “Development Milestone”), Parent shall, or shall cause the table below within Surviving Corporation to, [***] Business Days upon and only after the first achievement of the listed milestone events with respect to the first Licensed Product to achieve such milestone. Licensee shall notify Company within [***] Business Days after the occurrence of each milestone event under this Section 8.2. Development Milestone, deliver to the Paying Agent (for further payment to the holders of Stock Certificates and Stock Agreements outstanding immediately prior to the Effective Time), via wire transfer of immediately available funds, the respective amounts set forth below minus, in each case, the applicable Contingent Consideration Distribution Fee associated therewith and any amount designated by the Stockholders’ Representatives to be placed in the Administrative Expense Account (each, a “Development Milestone Amount Payment” and collectively, the “Development Milestone Payments”):
(USDA) Upon FDA approval of Reslizumab for the Licensed Product treatment of eosinophilic esophagitis, a cash payment of [**];
(B) Upon marketing authorization of Reslizumab for the treatment of eosinophilic esophagitis being granted by the European Commission in an mTNBC indication for patients who have received at least two accordance with Regulation (EC) No. 726/2004, a cash payment of [**];
(C) If Res 5-0010 Asthma Study Completion has not occurred on or prior antito the Closing Date, then upon the occurrence of the Res 5-cancer therapies in the metastatic setting 0010 Asthma Study Completion, a cash payment of $50,000,000 (fifty million dollars) (the “$60M mTNBC MilestoneRes 5-0010 Asthma Payment”);
(D) $60M The first Marketing Approval in the PRC Upon FDA approval of Reslizumab for the Licensed Product in an mTNBC indication for patients who have received at least two (2) prior anti-cancer therapies in the metastatic setting $any asthma indication, a cash payment of [***] The first Marketing Approval in the PRC ];
(E) Upon marketing authorization of Reslizumab for the Licensed Product treatment of any asthma indication being granted by the European Commission in an mTNBC indication for patients who have received at least one accordance with Regulation (1EC) prior anti-cancer therapy in the metastatic setting $No. 726/2004, a cash payment of [***] The first Marketing Approval in the PRC for the Licensed Product in ]; and
(F) Upon FDA approval of an ER+ HER2- mBC indication for patients who have received two (2) prior chemotherapies in the metastatic setting $Oral Anti-TNF Product, a cash payment of [***] The first Marketing Approval in the PRC for the Licensed Product in an ER+ HER2- mBC indication for patients who have not received prior chemotherapy in the metastatic setting $[***] The first Marketing Approval in the PRC for the Licensed Product in a UC indication $[***] The first Marketing Approval in the PRC for the Licensed Product in one of the following indications: [***] (the “Fourth Indication Milestone”) $[***] The first Marketing Approval in the PRC for the Licensed Product in an indication for any cancer not covered in any of the above milestones for up to four (4) additional cancers $[***] The first patient is recruited by Licensee in the PRC that is a part of a Global Study to register the Licensed Product in a for a [***] indication $[***] Notwithstanding the foregoing, Company shall issue to Licensee a refund of the $60M mTNBC Milestone in the amounts and upon occurrence of the events set forth below within [***] Business Days of occurrence of such events:
(a) [***] Dollars ($[***]) in the event that (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval, and (ii) (A) Company’s ASCENT trial fails to achieve its overall survival (“OS”) endpoint and progression-free survival (“PFS”) endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint;
(b) [***] Dollars ($[***]) in the event that either (i) the FDA revokes its approval for the mTNBC indication within [***] months of issuing its approval or (ii) (A) Company’s ASCENT trial fails to achieve its OS endpoint and PFS endpoint and (B) a prospectively defined high TROP-2 subgroup (with a score of 3 or 4) trial fails to achieve its OS endpoint and its PFS endpoint; or
(c) [***] Dollars ($[***]) in the event that the FDA revokes its approval for the mTNBC indication during the period commencing any time after [***] months after the FDA issued its approval and ending [***] months after the FDA issued its approval.
Appears in 1 contract
Sources: Merger Agreement (Cephalon Inc)