Development Milestones Sample Clauses
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Development Milestones. Company shall pay, or cause to be paid, to Licensor the following one-time (except with respect to the last event in the table below), non-refundable, non-creditable milestone payments with respect to the first achievement of the milestone events described in the table below (the “Development Milestones”). Company shall notify Licensor in writing of the achievement of any such Development Milestone within ten (10) Business Days and Licensor shall issue Company an invoice for the amount of the corresponding milestone payment, which invoice Company shall pay within [***] days following Company’s receipt of such invoice. Enrollment of [***] patients in the Planned Phase III Clinical Trial [***] Filing of an NDA with the FDA for the Existing Product [***] Approval by the FDA of an NDA for the Existing Product for PAH [***] Approval by the FDA of an NDA for the Existing Product for PH-ILD [***] Approval by the FDA of an NDA for the Existing Product for each additional Indication (other than PAH and PH-ILD)* [***] Approval by the FDA of an NDA for any additional Product* [***] With respect to each Development Milestone, the corresponding milestone payments to be made under this Agreement shall be due and payable only once (except with respect to the Development Milestones marked with an asterisk). For purposes of the Development Milestones, an additional Product entitled to [***] in the foregoing table shall mean a Product with new dosage form, new formulation, new combination and the next generation version of Existing Product. Notwithstanding the foregoing, such Development Milestone payment shall not apply to the Existing Product in the following instances: (a) a different dosage amount; (b) different batch size; or (c) a manufacturing change to the Existing Product in consideration of supply issues (e.g., a change in liposomes used to manufacture the Existing Product due to insufficient supply of the existing liposomes or for cost reasons).
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. On a Research Program-by-Research Program basis, ▇▇▇▇▇▇▇ will make one-time, non-refundable, non-creditable milestone payments (each, a “Development Milestone Payment”) to Morphic upon the first achievement by ▇▇▇▇▇▇▇ 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). ▇▇▇▇▇▇▇ will notify Morphic in writing of the achievement of a Development Milestone Event by ▇▇▇▇▇▇▇ or its Affiliates or Sublicensees no later than [***] after ▇▇▇▇▇▇▇ becomes aware of the achievement thereof. Thereafter, Morphic will provide ▇▇▇▇▇▇▇ with an invoice for the corresponding Development Milestone Payment, and ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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. As further consideration for the grant of the rights hereunder, for the first achievement by C4T or MKDG or its Related Parties of each milestone event set forth in the table below with respect to a Product Directed To each Collaboration Target (each, a “Development Milestone Event”), MKDG shall make the corresponding non-refundable, non-creditable milestone payment to C4T (each, a “Development Milestone Payment”) within [***] after receipt of an invoice for such Development Milestone Payment, in accordance with this Section 6.4.1. For all Development Milestone Events, MKDG shall notify C4T within [***] following the first achievement by MKDG or its Related Parties of each such Development Milestone Event with respect to a Product Directed To each Collaboration Target, and promptly upon receipt of such notice with respect to a Development Milestone Event, C4T shall issue to MKDG an invoice for the corresponding Development Milestone Payment, which MKDG shall pay within [***] of receipt. The Development Milestone Payment for each Development Milestone Event shall be payable [***] per Collaboration Target. Development Milestone Event Development Milestone Payment 1 [***] [***] 2 [***] [***] 3 [***] [***] 4 [***] [***] 5 [***] [***] 6 [***] [***] 7 [***] [***] 8 [***] [***] 9 [***] [***] 10 [***] [***] 11 [***] [***] 12 [***] [***] 13 [***] [***] Total [***] [***]. If any of Development Milestone Events 2-5 is achieved with respect to a Compound or Product prior to the achievement of an “earlier” Development Milestone Event (i.e., one with a lower number in the chart above) with respect to a Compound or Product Directed To the
Development Milestones. Within ten (10) Business Days following the first occurrence of each event (each, a “Development Milestone”) described below for each Research Project Target, Pfizer shall provide written notice to CytomX identifying the Research Project Target and the Development Milestone achieved, and Pfizer shall pay to CytomX the amount set forth below within forty-five (45) days of receipt of CytomX’s invoice with respect to such Development Milestone (each such amount, a “Development Milestone Payment”) to be payable only once with respect to each Research Project Target regardless of how many Agreement PDCs or Licensed Products Targeting such Research Project Target achieve such Development Milestone. Notwithstanding anything to the contrary in this Agreement, Development Milestone Payments shall only be owed pursuant to this Section 5.4.1 for those Agreement PDCs and Licensed Products of which the manufacture or sale is covered by a Valid Claim. For the avoidance of doubt, if any Development Milestone Payment is paid for an Agreement PDC or Licensed Product Targeting the Second Target, such Development Milestone Payment will not be owed by Pfizer if an Agreement PDC or Licensed Product Targeting a Replacement Target (but not an Additional Target) later achieves the same Development Milestone.
(A) Dosing of first subject in a Phase I Clinical Study with an Agreement PDC Targeting such applicable Research Project Target [***] [***]
(B) Dosing of first subject in a Phase II Clinical Study with an Agreement PDC Targeting such applicable Research Project Target [***] [***]
(C) Dosing of first subject in a Phase III Clinical Study with an Agreement PDC Targeting such applicable Research Project Target [***] [***]
(D) First Commercial Sale of a Licensed Product containing an Agreement PDC Targeting such applicable Research Project Target in the United States [***] [***]
(E) First Commercial Sale of a Licensed Product containing an Agreement PDC Targeting such applicable Research Project Target in a Major EU Market Country [***] [***]
(F) First Commercial Sale of a Licensed Product containing an Agreement PDC Targeting such applicable Research Project Target in Asia [***] [***]
(G) First Commercial Sale of a Licensed Product in a Second Tumor Type containing an Agreement PDC Targeting such applicable Research Project Target in the United States [***] [***]
(H) First Commercial Sale of a Licensed Product in a Second Tumor Type containing an Agreement PDC Targeting such app...
Development Milestones. (a) In General. [***] [***] * [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] * [***]
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. 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. 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. (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 […***…].