Commercialization Milestones definition

Commercialization Milestones has the meaning set forth in Section 6.1.
Sample 1
Commercialization Milestones means the milestones relating to Regulatory Approval and First Commercial Sale as described in Section 3.
Sample 1
Commercialization Milestones means, collectively, the First Commercial Sale U.S. Target Combo Product Milestone, the First Commercial Sale E.U. Target Combo Product Milestone, the First Sales Milestone and the Second Sales Milestone, and the term “Commercialization Milestone” shall mean any of the Commercialization Milestones.
Sample 1

Examples of Commercialization Milestones in a sentence

  • Licensee will be entitled, from time to time, to make such adjustments to the then applicable Development and Commercialization Plan as Licensee believes, in its good faith judgment, are needed in order to improve Licensee’s ability to meet the Development and Commercialization Milestones.

  • The Small Business Participation Plan provides specific details of how the Offeror will use small business at the first tier subcontract level and throughout the period of performance of the contract, including all options.

  • We note the subheading "Commercialization Milestones to Execute our Growth Strategy" and related disclosure was removed from page 31, including milestone assumptions about "financing goals" and numbers of participating physician practices and weekly cancer tests (combined "120 tests per week total").

  • Connetics agrees to perform the following Commercialization Milestones no later than the date set forth below opposite the appropriate Commercialization Milestone description: [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

  • Development Milestones First Licensed Product to Achieve Milestone Each Subsequent Licensed Product to Achieve Milestone [***] Commercialization Milestones [***] When Licensed Products are sold for monies other than United States dollars, the Net Sales referenced in the table above and elsewhere will first be determined in the foreign currency of the country in which such Licensed Products were sold and then converted into equivalent United States funds.

  • It is understood and agreed, however, that such Commercialization Milestones shall be subject to (i) Regulatory Approvals and reimbursement approvals occurring at the times anticipated by the Parties and (ii) BioMarin, its Affiliates and Third Parties satisfying their respective obligations hereunder (e.g., the Manufacturing Party providing an adequate supply of Collaboration Products to Genzyme).

  • The Steering Committee shall establish, ---------------------------- as part of the initial Commercialization Plan, milestones for Genzyme's marketing and sales of Collaboration Products hereunder (collectively, "Commercialization Milestones").

  • Development Milestones Payment [***] $[***] [***] $[***] [***] $[***] [***] [***] ​ Commercialization Milestones – to be paid when cumulative Net Sales of specified Licensed Products in a Calendar Year in the Territory first achieve the applicable milestone.

  • The Commercialization Milestones shall ---------------------------- include, without limitation, minimum sales levels for the first three (3) years after the first approval by the U.S. FDA of a BLA for the use of a Collaboration Product in the Field.

  • The Commercialization Milestones shall ---------------------------- include, without limitation, [* * *].


More Definitions of Commercialization Milestones

Commercialization Milestones means those commercialization milestones set out in Exhibit A attached hereto.
Sample 1

Related to Commercialization Milestones

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

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

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

  • 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.

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

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

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

  • 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 3.3 (Milestone Payments).

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

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • 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;

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

  • Milestone Event has the meaning set forth in Section 8.4.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Development Program means the implementation of the development plan.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

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

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • Research Program has the meaning set forth in Section 2.1.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

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