Development Milestones. In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).
Development Milestones. (a) As consideration for the License, [***] Licensee will pay Penn each of the following milestone payments (each, a “Development Milestone Payment”) upon the first, second and third achievement of the corresponding milestone by any Licensed Product (assessed on a milestone-by-milestone basis) irrespective of the Licensed Product for which such milestone has been achieved (each, a “Development Milestone”), whether achieved by Licensee or an Affiliate or Sublicensee. For the avoidance of doubt, no Development Milestone Payment shall be due upon the fourth, fifth or any subsequent achievement of any of the below milestones in this Section 4.3.2(a). Licensee shall promptly notify Penn in writing of the achievement of any such Development Milestone and Licensee shall pay Penn in full the corresponding Development Milestone Payment within forty-five (45) days of such achievement. For clarity, each Development Milestone Payment is non-refundable, is not an advance against Royalties due to Penn or any other amounts due to Penn. For further clarity, the maximum cumulative amount of Development Milestone Payments potentially payable under this Agreement is [***]. Initiation of Phase 1 Study (as defined by the enrollment of the 3rd patient) [ ***] [ ***] Initiation of Phase 2 or Phase 1/2 Study (as defined by the enrollment of the 5th patient) [ ***] [ ***] Initiation of Phase 3 or Phase 2/3 Study (as defined by the enrollment of the 5th patient) [ ***] [ ***] Approval of first BLA [ ***] [ ***] Approval of second BLA [ ***] [ ***] Approval of third BLA [ ***] [ ***]
(b) Each time a Development Milestone is achieved for any Licensed Product, then any other Development Milestone Payments with respect to earlier Development Milestones for the same Licensed Product that have not yet been paid will be due and payable together with the Development Milestone Payment for the Development Milestone that is achieved.
Development Milestones. On a Research Program-by-Research Program basis, Xxxxxxx will make one-time, non-refundable, non-creditable milestone payments (each, a “Development Milestone Payment”) to Morphic upon the first achievement by Xxxxxxx or its Affiliates or Sublicensees of each of the development milestone events (each, a “Development Milestone Event”) set forth in TABLE 8.5 (Development Milestones) below for the first Product that is the subject of each Research Program to achieve the applicable Development Milestone Event. For the avoidance of doubt, each Development Milestone Payment hereunder will be payable only once per Research Program upon the first achievement of the applicable Development Milestone Event by a Product that is the subject of such Research Program. No additional Development Milestone Payments will be made for any subsequent achievement of such Development Milestone Event by any other Product that is the subject of the same Research Program. If one or more Development Milestone Events are skipped for Products that are the subject of a particular Research Program, then such skipped Development Milestone Events will be payable upon the first achievement of the subsequent Development Milestone Event by a Product that is the subject of the same Research Program, except that a Development Milestone Event that is specific to one territory will not be deemed to be skipped solely because a subsequent Development Milestone Event was achieved in a different territory (e.g., receipt of Regulatory Approval of a Product in a Major European Country will not be deemed to trigger a Development Milestone Payment for receipt of Regulatory Approval of such Product in the United States if such Regulatory Approval of such Product has not yet occurred in the United States). Xxxxxxx will notify Morphic in writing of the achievement of a Development Milestone Event by Xxxxxxx or its Affiliates or Sublicensees no later than [***] after Xxxxxxx becomes aware of the achievement thereof. Thereafter, Morphic will provide Xxxxxxx with an invoice for the corresponding Development Milestone Payment, and Xxxxxxx will pay to Morphic such Development Milestone Payment within [***] after its receipt of an invoice for such Development Milestone Payment in accordance with Section 8.11 (Invoicing and Payment). If Xxxxxxx or its Affiliates or Sublicensees achieve all Development Milestone Events with respect to Products that are the subject of a particular Research Program (regardless of the...
Development Milestones. Eiger shall pay to BMS the following milestone payments set forth in the table below within [ * ] after the first achievement of the specified milestone event by Eiger, its Affiliates, and Sublicensees for the first Licensed Product to achieve such milestone event in any Indication. Eiger shall provide written notice to BMS within [ * ] after the first achievement of the specified milestone event by Eiger, Affiliates, and Sublicensees. Each milestone payment shall not be refundable or returnable in any event. [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] Total Development Milestones for First Indication [ * ] For purposes of this Section:
(i) A [ * ] means that [ * ].
(ii) The set of milestone payments in the table above shall be payable by Eiger to BMS once per Indication upon the first achievement of each such milestone event for the first such Licensed Compound (whether the first such Licensed Compound is the lead Licensed Compound or any back-up Licensed Compound) to achieve the milestone event. Milestones payments for additional Indications that achieve the above milestones events for such additional Indication will be at [ * ] of the above milestone payment amounts for the first Indication. [*] = 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.
(iii) If a particular milestone event is not achieved with respect to an Indication (“Skipped Milestone”), such Skipped Milestone will be deemed to have been achieved upon the occurrence of the next most successive milestone with respect to such Indication, and payment for such Skipped Milestone then shall be due.
(iv) For purposes of this Section 8.2.1, “Indication” shall mean any separately defined, well-categorized class of human disease, syndrome or medical condition for which a separate marketing authorization application may be filed with a Regulatory Authority.
Development Milestones. The Milestone Payments for Development events are set forth in Table 1 below. Such Milestone Payments will be payable to Moderna by Merck within [***] of the first achievement [***] by Merck (or its Affiliate or Sublicensee) of the applicable Milestone Event with respect to a Development Milestone Product (as defined below). For the purposes of this Section 8.4, “Development Milestone Product” shall mean:
Development Milestones. (a) As additional consideration for the License, Licensee will pay Penn the following milestone payments (each, a “Development Milestone Payment”) upon the achievement of […***…] (each, a “Development Milestone”), whether achieved by Licensee or an Affiliate or Sublicensee. Licensee shall promptly notify Penn in writing of the achievement of any such Development Milestone and Licensee shall pay Penn in full the corresponding Development Milestone Payment within […***…] of such achievement. For clarity, each Development Milestone Payment is non-refundable, is not an advance against royalties due to Penn or any other amounts due to Penn. […***…] $[…***…] […***…] $[…***…] […***…] $[…***…] […***…] $[…***…] […***…] $[…***…]
(b) Each time a Development Milestone is achieved, then any other Development Milestone Payments with respect to earlier Development Milestones that have not yet been paid will be due and payable together with the Development Milestone Payment for the Development Milestone that is actually achieved; provided, however, that if there is a dispute over whether the “[…***…]” Development Milestone has been achieved, such Development Milestone shall be paid by Licensee no later than […***…].
(c) For clarity, Development Milestone Payments are due and payable on Licensed Product and on products that, upon FDA approval, would become Licensed Product, and for further clarity, the maximum Development Milestone Payments payable by Licensee under this Agreement is $[…***…].
(d) Each Development Milestone in the Table above will be payable […***…], provided that, if a […***…] at any point […***…], then […***…] provided that […***…] would remain […***…].
Development Milestones. As further consideration for Daiichi Sankyo’s grant of the rights and licenses to Rain hereunder, Rain shall pay Daiichi Sankyo the following nonrefundable, non-creditable, one-time milestone payments with respect to the Product upon achievement of the development milestone events described below. Milestone Event Payment Amount
a) [***] [*** ]
b) [***] [*** ]
c) [***] [*** ]
d) [***] [*** ]
e) [***] [*** ]
f) [***] [*** ]
g) [***] [*** ]
h) [***] [*** ] i) [***] [*** ]
j) [***] [*** ]
k) [***] [*** ]
l) [***] [*** ] m) [***] [*** ] n) [***] [*** ] Rain shall [***] (and in any event within [***] after achievement of such milestone event) notify Daiichi Sankyo in writing of the achievement of any such milestone event. After receipt of such notice from Rain, Daiichi Sankyo shall issue Rain an invoice for the amount of the corresponding milestone payment. Rain shall pay Daiichi Sankyo within [***] after receipt of an invoice therefor from Daiichi Sankyo. If at the time any given milestone payment set forth in this Section 5.2 is due [***] and one or more preceding milestone payments for antecedent milestone events [***] have not been paid, then such unpaid precedent milestone payments shall be paid at such time as well. Notwithstanding the foregoing, [***], then, milestone event a) and b) are achieved and milestone payments for milestone event a) and b) shall become due. Rain shall notify Daiichi Sankyo in writing (i) [***] after the achievement of such milestone event (“First Notice”) and (ii) on [***] (“Second Notice”). Daiichi Sankyo shall issue Rain invoice for milestone event b) after receiving First Notice and issue invoice for milestone event a) after receiving Second Notice, which invoices Rain shall pay Daiichi Sankyo in accordance with this Section 5.2. For clarity, Rain shall be required to pay each development milestone payment only once, regardless of the order in which the milestone events occur.
Development Milestones. AVROBIO will pay to BioMarin the following non-creditable, non-refundable milestone payments within [***] following the first achievement of the corresponding events described in the table below by the first Licensed Product being Developed by or on behalf of AVROBIO, its Affiliates or sublicensees to achieve such event. For clarity, each Development Milestone payment below shall be made only once, upon the first attainment of the applicable milestone event by any Licensed Product being Developed by or on behalf of AVROBIO, its Affiliates or sublicensees. MILESTONE EVENT MILESTONE PAYMENT 1. [***] $[***]
Development Milestones. COMPANY shall adhere to the schedule of development milestones and dates set forth in APPENDIX H. If COMPANY fails to meet any deadline set forth in APPENDIX H, COMPANY shall provide LICENSOR with a written report outlining the efforts undertaken thus far and the steps COMPANY will take to meet the unsatisfied milestone, which shall also include an adjustment in the time required to meet such milestone or a substitute milestone (“Time Adjustment Proposal”). For clarity, a non-limiting example of a reasonable request for a Time Adjusted Delay contemplated herein is regulatory review delay of the responsible agency. Such report shall be submitted to LICENSOR for consideration within [* * *] days after the failure to meet the milestone. If COMPANY fails to provide the report, LICENSOR reasonably declines to accept the Time Adjustment Proposal, or if COMPANY fails to meet the new deadlines set in the Time Adjustment Proposal approved by LICENSOR, LICENSOR shall have the option in its sole discretion and following [* * *] days written notice to COMPANY to terminate the license granted hereunder, to allow this Agreement to continue in full force and effect, or to convert the license granted hereunder to a nonexclusive license upon written notice to COMPANY. Notwithstanding the foregoing, if COMPANY effects an assignment permitted by Article 13 prior to the first commercial Sale of a Licensed Product, the deadline set forth on Appendix H for such due diligence milestone event may, at the election of the COMPANY, be extended by a period of [* * *], with the option to extend by a period of an additional [* * *] with payment of a nonrefundable fee of [* * *], provided, however that such extensions shall not relive COMPANY of its obligation to continue to use commercially reasonable efforts to bring Licensed Product to market.
Development Milestones. Company shall pay to BMS the following one-time milestone payments set forth in the table below within [***] after the first achievement of the specified milestone event by Company, its Affiliates, and Sublicensees for the first Licensed Product to achieve such milestone event. Company shall provide written notice to BMS within [***] after the first achievement of the specified milestone event by Company, Affiliates, and Sublicensees. Each milestone payment shall not be refundable or returnable in any event, nor shall it be creditable against royalties or other payments: [***] For purposes of this Section:
(i) The set of milestone payments in the table above shall be payable by Company to BMS upon the first achievement of each such milestone event for the first Licensed Compound to achieve the milestone event.
(ii) For each additional Licensed Compound that subsequently achieves the same milestone event that the first Licensed Compound achieved, the milestone payment for such additional Licensed Compound shall be (1) fifty percent (50%) of the payments set forth in the above table and (2) subject to credit or deferral as set forth in clause (iii) below.
(iii) If Development is discontinued for a Licensed Compound before the Regulatory Approval(s) is obtained in the U.S., the EU or Japan for that Licensed Compound, the milestone payments achieved for the next most advanced subsequent Licensed Compound in Development, will be waived for any previously paid milestone payments for that discontinued Licensed Compound. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
(iv) [***].
(v) [***].
(vi) [***].
(vii) [***].
(viii) [***].
(ix) [***].
(x) [***].
(xi) [***].
(xii) [***].
