Regulatory Milestone Payments definition

Regulatory Milestone Payments has the meaning set forth in Section 9.2.1 (Regulatory Milestones).
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Regulatory Milestone Payments shall have the meaning given to it in Schedule 2;
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Regulatory Milestone Payments and payments in respect of the Net Sales Milestone Events are referred to in this Agreement as “Net Sales Milestone Payments”. Milestone Event Milestone Payment
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Examples of Regulatory Milestone Payments in a sentence

  • On a Product-by-Product basis, if any one of the Development & Regulatory Milestone Events is not required for the Development of a Product, such Development & Regulatory Milestone Payment shall become payable upon achieving the Development & Regulatory Milestone Event following the Development & Regulatory Milestone Event which was not required, i.e., upon the achievement of such following Development & Regulatory Milestone Event two Development & Regulatory Milestone Payments become payable hereunder.

  • If any given Regulatory Milestone Payment is due (except for any of the Regulatory Milestone Events for countries other than Japan, which shall not trigger any of the preceding milestones), and one or more preceding Regulatory Milestone Payments have not been paid for any reason, then payment of all preceding unpaid Regulatory Milestone Payments will be paid at such time as well.

  • For clarity, for each LICENSED PRODUCT achieving regulatory approval in the US, LICENSEE will owe UNIVERSITY a total amount in Regulatory Milestone Payments of seven hundred sixty two thousand five hundred dollars ($762,500) for such LICENSED PRODUCT.

  • According to the preliminary assessment of the Company, the Upfront Payment and the Regulatory Milestone Payments incurred for the Licensed Product meet the criteria for the recognition of the intangible assets and are expected to generate probable future economic benefits to the Company.

  • Client shall pay OXB the Regulatory Milestone Payments on a Target-by-Target basis as set out in Schedule 2 following the first achievement of the Regulatory Milestones with respect to Licensed Product directed to such Target and subject to the further terms in Schedule 2.

  • The Parties agree that an amount of Regulatory Milestone Payments [***] shall be discussed in good faith and determined by the Parties in writing prior to the achievement of such Regulatory Milestone Events.

  • The amount of the Regulatory Milestone Payments and the Sales Milestone Payments are determined with reference to the respective amounts to be paid by Fosun Industrial to Revance pursuant to the Head License Agreement in relation to the relevant indication.

  • In no event will the total amounts payable by the Licensee to BioMedica under this Clause 8.2 (Development and Regulatory Milestone Payments) exceed [***].

  • Subject to the remainder of this Section 6.4 (Regulatory Milestone Payments) and Section 6.6 (Effect of Multispecific Products on Milestone Payments), each Regulatory Milestone Payment will be payable on an Optioned Target-by-Optioned Target basis, only upon [***] achievement of the corresponding Regulatory Milestone Event with respect to the applicable Optioned Target, and no amounts will be due for [***] of such Regulatory Milestone Event with respect to [***] with respect to such Optioned Target.

  • In the event AMAG is the Party in the bankruptcy proceeding and rejects this Agreement, and Norgine elects to retain its rights under this Agreement, Norgine shall make all such payments, including without limitation all product royalties set forth in Section 6.4, all Regulatory Milestone Payments and all Sales Milestone Payments due under this Agreement, for the duration of the applicable Royalty Term.


More Definitions of Regulatory Milestone Payments

Regulatory Milestone Payments has the meaning set forth in Section 3.3.
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Regulatory Milestone Payments is defined in Section 8.2(a).
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Related to Regulatory Milestone Payments

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Milestone Payments means payments made in connection with any Permitted Acquisition or other acquisition (including any license or the acquisition of any license) of any rights in respect of any drug or other pharmaceutical product (and any related property or assets) to sellers (or licensors) of the assets or Equity Interests acquired (or licensed) therein based on the achievement of specified revenue, profit or other performance targets (financial or otherwise).

  • Milestone Payment has the meaning set forth in Section 4.2.

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • Development Milestone is defined in Section 5.3.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Milestone Events has the meaning set forth in Section 7.2.

  • Milestone Event has the meaning set forth in Section 8.2.1.

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Sublicense Revenue means [***].

  • Sublicense Fees shall have the meaning set forth in Section 7.3 below.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Sublicense Revenues means [***].

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.