Development/Approval Milestones Clause Samples

Development/Approval Milestones. (a) For each Collaboration Target (other than Mir-21), the milestone payments by Sanofi to Regulus under Column 1 of Table 1 below will be triggered by the first achievement of the specified milestone events by Sanofi, its sublicensees or their respective Affiliates for the first Licensed Compound or Product that targets or mimics such Collaboration Target to achieve the specified milestone event. (b) The milestone payments under Column 2 of Table 1 below will be payable as set forth below for the first achievement of the specified milestone events by Sanofi, its sublicensees or their Affiliates for the first Mir-21 Compound or Mir-21 Product to achieve the specified milestone event. 1. IND Approval […***…] […***…]
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Development/Approval Milestones. (a) For each Collaboration Target (other than Mir-21), the milestone payments by Sanofi to Regulus under Column 1 of Table 1 below will be triggered by the first achievement of the specified milestone events by Sanofi, its sublicensees or their respective Affiliates for the first Licensed Compound or Product that targets or mimics such Collaboration Target to achieve the specified milestone event. (b) The milestone payments under Column 2 of Table 1 below will be payable as set forth below for the first achievement of the specified milestone events by Sanofi, its sublicensees or their Affiliates for the first Mir-21 Compound or Mir-21 Product to achieve the specified milestone event. 1. IND Approval [***] [***] 2. [***] [***] [***] 3. [***] [***] [***] 4. [***] [***] [***] 5. [***] [***] [***] 6. [***] [***] [***] (c) In addition, on a Collaboration Target-by-Collaboration Target basis, after the first achievement of milestone event [***] in Table 1 above by the first Licensed Compound or Product associated with a Collaboration Target to achieve such milestone event for any Indication, if a Licensed Compound or Product for such Collaboration Target (whether the same or a different Licensed Compound or Product) subsequently achieves such milestone event(s) for any additional Indication(s) (each, an “Additional Indication”), then Sanofi will promptly notify Regulus and will pay Regulus an additional milestone payment in an amount equal to [***]% of the applicable milestone payment(s) set forth in Column 1 or Column 2 (as applicable) of Table 1 above for the achievement of such milestone event(s) by such Licensed Compound or Product for each Additional Indication (each, an “Additional Indication Milestone Payment”). (d) If a Licensed Compound or Product for a Collaboration Target fails in development and is replaced by Sanofi with a back-up Licensed Compound or Product targeting the same Collaboration Target, with respect to any milestone payments previously paid with respect to such failed Licensed Compound or Product, Sanofi will not have to pay the same milestone with respect to the corresponding back-up Licensed Compound or Product, and Sanofi will notify Regulus in writing of the selection of the back-up Licensed Compound or Product. All milestone payments due will be payable one time only per Licensed Compound or Product for each Indication.
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Related to Development/Approval Milestones

  • 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 Milestone Payments TriSalus shall pay (or cause to be paid) to Dynavax, in accordance with and subject to the terms of this Section 2.3, Section 2.4 and Section 6.4 (each such milestone, a “Development Milestone”, and each payment in respect thereof, a “Development Milestone Payment”): (i) Upon the successful completion by a Milestone Obligor after the Closing of a [**] study with respect to a Product using PEDD, a payment of [**] US Dollars ($[**]), with such Development Milestone Payment being payable only once (for purposes of the foregoing, successful completion means completion of such study in accordance with the plan for such study); (ii) For the first patient Dosed by a Milestone Obligor in each Phase 1 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (iii) For the first patient Dosed by a Milestone Obligor in each Phase 2 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (iv) For each Phase 2 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 2 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 2 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (v) For each Phase 3 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 3 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 3 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (vi) Upon receipt by a Milestone Obligor of each Regulatory Approval for any Product for any Indication in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; (vii) Upon receipt by a Milestone Obligor for each Regulatory Approval of any Product for any Indication in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; (viii) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vi) for receipt of such Regulatory Approval), regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; and (ix) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vii) for receipt of such Regulatory Approval), regardless ​ of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval.

  • Commercial Milestones (a) Within [*****] calendar days after the end of the first Calendar Year in which aggregate annual Net Sales for that Calendar Year for the Licensed Product in the Territory reach any threshold indicated in the Commercial Milestone Events listed below, EverInsight shall notify VistaGen of the achievement of such Commercial Milestone Event and VistaGen shall invoice EverInsight for the corresponding non-refundable, non-creditable Milestone Payment set forth below and EverInsight shall remit payment to VistaGen within [*****] Business Days after the receipt of the invoice, as described in Section 8.6 (Currency; Exchange Rate; Payments). Annual Net Sales Milestones for Licensed Product Milestone Payments (in Dollars) (each a “Commercial Milestone Event”): (1). [*****] (2). [*****] (3). [*****] (4). [*****] (5). [*****] (b) For the purposes of determining whether a Net Sales Milestone Event has been achieved, Net Sales of Licensed Product(s) in the Territory shall be aggregated. For clarity, the annual Net Sales Milestone Payments set forth in this Section 8.3 (Commercial Milestones) shall be payable only once, upon the first achievement of the applicable Commercial Milestone Event, regardless of how many times such Commercial Milestone Event is achieved. (c) If a Commercial Milestone Event in Section 8.3 (Commercial Milestones) is achieved and payment with respect to any previous Commercial Milestone Event in Section 8.3 has not been made, then such previous Commercial Milestone Event shall be deemed achieved and EverInsight shall notify VistaGen within fifteen (15) calendar days of such achievement. VistaGen shall then invoice EverInsight for such unpaid previous Commercial Milestone Event(s) and EverInsight shall pay VistaGen such unpaid previous milestone payment(s) within thirty (30) Business Days of receipt of such invoice. (d) In the event that, VistaGen believes any Commercial Milestone Event under Section 8.3(a) has occurred but EverInsight has not given VistaGen the notice of the achievement of such Commercial Milestone Event, it shall so notify EverInsight in writing and shall provide to EverInsight data, documentation or other information that supports its belief. Any dispute under this Section 8.3(d) (Commercial Milestones - subsection (d)) that relates to whether or not a Commercial Milestone Event has occurred shall be referred to the JSC to be resolved in accordance with ARTICLE 3 (Governance) and shall be subject to resolution in accordance with Section 14.10 (Dispute Resolution). The Milestone Payments made for each Commercial Milestone Event shall be non-creditable and non-refundable.

  • Milestones Subject to the provisions of the SGIP, the Parties shall agree on milestones for which each Party is responsible and list them in Attachment 4 of this Agreement. A Party’s obligations under this provision may be extended by agreement. If a Party anticipates that it will be unable to meet a milestone for any reason other than a Force Majeure event, it shall immediately notify the other Parties of the reason(s) for not meeting the milestone and: (1) propose the earliest reasonable alternate date by which it can attain this and future milestones, and (2) requesting appropriate amendments to Attachment 4. The Party affected by the failure to meet a milestone shall not unreasonably withhold agreement to such an amendment unless: (1) it will suffer significant uncompensated economic or operational harm from the delay, (2) attainment of the same milestone has previously been delayed, or (3) it has reason to believe that the delay in meeting the milestone is intentional or unwarranted notwithstanding the circumstances explained by the Party proposing the amendment.

  • Targets and Milestones For the purposes of this Access Agreement, the University of Bristol will assess progress in widening participation against a combination of progress measures which, between them, are designed to assess: • The specific impact of a number of key outreach initiatives. • Year on year progress in diversifying our applicant and student population. • Year on year progress in improving conversion of under-represented applicants. Bearing in mind the range of outreach activities which we plan to offer, we intend to measure year on year progress in attracting a wider pool of applicants by focusing particularly on each of the following categories (although additional measures included in our 2012 Agreement have also been retained for continuity of monitoring): • Applicants from low performing schools • Applicants from socio-economic groups 4-7 • Local applicants Progress measures for each of these are provided at Appendix Four. In each case, we have included new measures, to assess improvements in application to intake conversion. As far as possible, measures have been calculated taking account of the expected impact of a number of specific outreach initiatives (the Access to Bristol scheme, summer school programme and personal adviser scheme), each of which also has more detailed performance targets associated with them (also detailed at Appendix Four). Measurement of the University’s intake profile will be focused on the low school performance category, reflecting the role which this plays in our contextual approach to admissions. Measures relating to mature student intake have been included for continuity. The recent decision to grow our undergraduate numbers substantially means that continuing to measure progress in diversifying intake by looking at under-represented groups as a percentage of total intake is no longer meaningful. For each intake-related measure, we have therefore added the number of students which the original percentages might have been expected to deliver. Monitoring against these numbers will give a more accurate picture of progress. All progress measures have been informed by more detailed analysis of progress against the institutional milestones detailed in Appendix Two and will be re-calculated annually to reflect assessment of our progress to date. In addition, it should be noted that we intend to carry out further research, for example, to better understand the impact of educational standards in the Bristol area on our ability to progress at the specified rates; we may need to adjust the progress measures contained in this agreement for future years to reflect the findings.