Development and Regulatory Milestone Payments definition

Development and Regulatory Milestone Payments shall have the meaning provided in Section 5.2.
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Development and Regulatory Milestone Payments has the meaning set forth in Section 6.2.1 (Development and Regulatory Milestones).
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Examples of Development and Regulatory Milestone Payments in a sentence

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

  • Million in Clinical Development and Regulatory Milestone Payments.

  • The Licensee shall make the payments referred to in Clause 8.2 (Development and Regulatory Milestone Payments), Clause 8.3 (Commercial Milestone Payments), and Clause 8.5 (Net Receipts), and Clause 8.6 (Paediatric Priority Review Voucher) within [***] after receipt of an invoice from BioMedica, provided that each milestone payment shall be due only once.

  • The maximum amount payable by Licensee under Section 7.2(a)(i) (Development and Regulatory Milestone Payments) is Thirty-Five Million Dollars ($35,000,000).

  • If a Combination Product containing SAL200 is the first Licensed Product to achieve a SAL200 Milestone Event then the corresponding milestone payment under Section 7.2(a)(i) (Development and Regulatory Milestone Payments) will be due for such Combination Product, but no additional payment under Section 7.2(a)(iii) (Development and Regulatory Milestone Payments) shall be due for the use of any other Licensed Endolysins in such Combination Product.

  • If a Combination Product achieves a New Endolysin Milestone Event, only one payment under Section 7.2(a)(iii) (Development and Regulatory Milestone Payments) shall be due for such Combination Product and no payment shall be due for the use of any additional Licensed Endolysins in the Combination Product.

  • Lilly shall make milestone payments to Rigel based on achievement of certain development and regulatory milestone events as set forth in this Section 8.2 (Development and Regulatory Milestone Payments).

  • With respect to a given Product for a given Indication, the milestone events set forth in this Section 8.2 (Development and Regulatory Milestone Payments) based upon a Clinical Trial (each, a “Clinical Milestone Event”) are intended to be successive in the order in which they are listed.

  • In addition, with respect to a given Product for a given Indication, the milestone events set forth in this Section 8.2 (Development and Regulatory Milestone Payments) based upon First Commercial Sale or Marketing Approval (each, a “FCS/MA Milestone Event”) are intended to be successive in relation any Clinical Milestone Event.

  • Within [***] of receipt of such invoice, Dermavant will pay to Portola the following non-refundable, non-creditable milestone payments: Total Development and Regulatory Milestone Payments [***] [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

Related to Development and Regulatory Milestone Payments

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

  • Development Milestone is defined in Section 5.3.

  • 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.

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

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

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

  • 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 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 Events has the meaning set forth in Section 7.2.

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

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

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

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

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • Development Plan has the meaning set forth in Section 3.2.

  • 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).

  • 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.

  • 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.

  • Development Program means the implementation of the development plan.

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

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

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

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.