Development and Approval Milestones Sample Clauses

Development and Approval Milestones. Xxxxxxx will notify Protagonist in writing within [ * ] after the first achievement by Xxxxxxx or any of its Affiliates or sublicensees of any of the milestone events set forth in a table below in Sections 7.3.1, 7.3.2 and 7.3.3 (each, a “Milestone Event”). In consideration of the rights and licenses granted to Xxxxxxx hereunder, Xxxxxxx shall pay to Protagonist the applicable milestone payment set forth in the tables below (each, a “Milestone Payment”) within [ * ] after receipt of an invoice from Protagonist with respect to achievement of each Milestone Event that occurs prior to or on the Opt-In Effective Date and [ * ] after receipt of an invoice from Protagonist with respect to achievement of each Milestone Event that occurs after the Opt-In Effective Date. Each Milestone Payment shall be payable only once, even if the corresponding Milestone Event occurs more than once or with respect to more than one Licensed Product or (for Milestone Events set forth in in the table in Section 7.3.3) with respect to more than one New Indication. Each Milestone Payment shall be non-refundable and non-creditable.
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Development and Approval Milestones. 7.3.1. Xxxxxxx will notify Protagonist in writing within [*] after the first achievement by Xxxxxxx or any of its Affiliates or sublicensees of any of the milestone events set forth in the table below (each, a “Milestone Event”). In consideration of the rights and licenses granted to Xxxxxxx hereunder, Xxxxxxx shall pay to Protagonist the applicable milestone payment set forth in the tables below (each, a “Milestone Payment”) within [*] after receipt of an invoice from Protagonist with respect to achievement of each Milestone Event that occurs prior to or on the Phase 2A Completion Date and [*] after receipt of an invoice from Protagonist with respect to achievement of each Milestone Event that occurs [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. after the Phase 2A Completion Date.
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Development and Approval Milestones. 47 Section 8.2
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Development and Approval Milestones. Buyer shall provide Seller and Adial with written notice within forty-five (45) days of the first occurrence of each development milestone and approval milestone event set forth in Table 1 below (respectively, the “Development Milestones” and “Approval Milestones”) with respect to any Product containing a Compound (defined below) that has not already been in a Product that has achieved the relevant milestone.
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Development and Approval Milestones. Subject to the terms of this Agreement (including Section 5.1.3), within [*] days after the first achievement by Allergan, its Affiliates or Sublicensees of a Milestone Event set forth below for Licensed Products, Allergan shall make a one-time, non-creditable, non-refundable Milestone Payment to UroGen in the amount below corresponding to such Milestone Event: Milestone Event Milestone Payment [*] [*]
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Development and Approval Milestones. Subject to the terms of this Agreement (including Section 5.1.3), within [*] days after the first achievement by Allergan, its Affiliates or Sublicensees of a Milestone Event set forth below for Licensed Products, Allergan shall make a one-time, non-creditable, non-refundable Milestone Payment to UroGen in the amount below corresponding to such Milestone Event: Milestone Event Milestone Payment Submission of IND application for a Licensed Product to the FDA $ 7,500,000 Initiation of a Phase III Clinical Trial for a Licensed Product for the First Indication $ 20,000,000 Initiation of Phase III Clinical Trial for a Licensed Product for the Second Indication $ 15,000,000 First Commercial Sale of a Licensed Product in the U.S. for the First Indication $ 50,000,000 First Commercial Sale of a Licensed Product in three of the EU5 Countries for the First Indication $ 25,000,000 First Commercial Sale of a Licensed Product in the U.S. for the Second Indication $ 25,000,000 First Commercial Sale of a Licensed Product in three of the EU5 Countries for the Second Indication $ 15,000,000
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Development and Approval Milestones 
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Related to Development and Approval Milestones

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • Regulatory Milestones Celgene shall make the following approval milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the Regulatory Milestone Events set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Milestone Event (For the first Co-Co Product that achieves such event) Milestone Payments (in $ millions) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-2, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.

  • Development Milestone Payments In partial consideration for the rights and licenses granted to Coya hereunder, within ten days after the first achievement of each milestone event in a given Indication set forth in this Section 5.2 (Development Milestone Payments) with respect to a Product (each, a “Development Milestone Event”) by or on behalf of Coya or any of its Affiliates or Sublicensees, Coya shall provide ARScience Bio written notice to ARScience Bio identifying the Development Milestone Event achieved. Upon receipt of any such notice of first achievement of a Development Milestone Event by Coya or its Affiliates or Sublicensees, ARScience Bio will promptly invoice Coya for the applicable Development Milestone Event and Coya will make a milestone payment to ARScience Bio in the amount set forth in this Section 5.2 (Development Milestone Payments) corresponding to such Development Milestone Event (each, a “Development Milestone Payment”) within 45 days of receipt of such invoice. On an Indication-by-Indication basis, each Development Milestone Payment shall be payable only upon the first achievement of the corresponding Development Milestone Event by a Product, in any given Indication for which the Development Milestone Events have not been previously achieved (each such Indication, a “New Indication”). No amounts shall be due for subsequent or repeated achievements of such Development Milestone Event with respect to the same or different Mono Product or Combination Product, as applicable, in such Indication. Accordingly and for clarity, the Development Milestone Payment shall be paid only once, when first achieved by Coya, an Affiliate or a Sublicensee, but no payment shall be due if the same milestone is subsequently achieved by one of Coya, an Affiliate or a Sublicensee. For clarity, the amounts owed in Column (a) below shall be due for the first Combination Product to achieve the Development Milestone Events in a New Indication and the amounts owned in Column (c) below shall be due for the first Mono Product to achieve the Development Milestone Events in a New Indication. Any Combination Product or Mono Product to achieve the Development Milestone Events in a New Indication after the first achievement of the Development Milestone Events as described in the foregoing sentence will cause the amounts in Column (b) with respect to a Combination Product and Column (d) with respect to a Mono Product to be due and payable by Coya upon each such occurrence. If the first Product to achieve a Development Milestone Event in any Indication is a Combination Product, the amounts in Column (a) below shall be due and payable by Coya. If the next Product to achieve a Development Milestone Event in a New Indication is a Mono Product, the amounts in Column (c) below would be due and payable by Coya; provided, that if such next Product to achieve a Development Milestone Event in a New Indication is a Combination Product, the amounts in Column (b) would be due and payable by Coya. By way of example, if a Combination Product achieves IND Acceptance in ALS, and is the first Product to achieve a Development Milestone Event under this Agreement, [***] will be due and payable by Coya. If subsequently a Mono Product achieves IND Acceptance in ALS, no Development Milestone Payments will be due and payable by Coya under this Agreement. However, if subsequently any Combination Product achieves IND Acceptance in Alzheimer’s disease, [***] would be due and payable by Coya.

  • Commercial Milestones In partial consideration of the rights granted by AstraZeneca to Licensee hereunder, Licensee shall pay to AstraZeneca the following payments, which shall be non-refundable, non-creditable and fully earned upon the first achievement of the applicable milestone event:

  • 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 it will suffer significant uncompensated economic or operational harm from the delay, (1) attainment of the same milestone has previously been delayed, or (2) 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.

  • Development Diligence Novartis shall dedicate commercially reasonable efforts, during each [**] month period, necessary to continue the advancement of Licensed Compounds and Licensed Products with respect to at least one Profile towards the next clinical Development milestone or approval milestone, as described in Sections 7.4.2 or 7.4.3, respectively. If Novartis (itself or through its Affiliates or sublicensees) fails to dedicate commercially reasonable efforts, during any [**] month period, necessary to continue the advancement of Licensed Compounds and Licensed Products with respect to at least one Profile towards such next milestone, then any dispute regarding Novartis’ failure of development diligence with respect to such Profile shall be resolved in accordance with Article 13.

  • Commercial Milestone Payments For each Licensed Product, Licensee shall pay Arvinas the following one-time milestone event payments when the aggregate Net Sales of such Licensed Product in one or more particular country(ies) for a given calendar year (“Annual Net Sales”), where such Licensed Product is a Valid Claim Licensed Product at the time of sale in each of such country(ies), first achieves the corresponding threshold as set forth in this Section 6.3.2 below, subject to the terms of this Section 6.3 and the payment provisions in Article 7 below: Commercial Milestone Event Milestone Event Payment (US$)

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

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