Commercialization Milestones definition

Commercialization Milestones has the meaning set forth in Section 6.2(a).
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
Commercialization Milestones means those commercialization milestones set out in Exhibit A attached hereto.
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.

  • In addition, Licensee, by itself or through its Affiliates or Sublicensees, shall use commercially reasonable efforts to achieve the Development and Commercialization Milestones.

  • 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 foregoing shall constitute Genentech's exclusive remedies for Connetics failure to complete one or more of the Commercialization Milestones above, provided, however, that Genentech's rights and remedies for breach of other provisions of this Agreement, and under the Supply Agreement and the Stock Agreement, shall remain in full force and effect.

  • 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").

  • If Connetics fails to perform any of the Commercialization Milestones for causes beyond Connetics' control, Genentech shall not have the termination rights above, provided that Connetics has mitigated such causes to the extent it can reasonably do so.

  • 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.

  • Notwithstanding anything in this Agreement to the contrary, but subject to its obligation under Section 4.5(a), Oragenics shall have sole and exclusive control over clinical trials (including patient dosing) and regulatory filings (including the jurisdictions in which such filings are made) for the purpose of the Commercialization Milestones in Section 5.2(a)(i)-(iii) as applicable.

  • Upon earlier termination of this Agreement by Can-Xxxx for CKD's non-achievement of the Commercialization Milestones under Section 14.3, CKD’s uncured material breach under Section 14.4, or CKD’s insolvency under Section 14.5, or by Can-Xxxx for CKD’s failure to proceed with Product development pursuant to Section 5.3, all licenses and rights granted to CKD hereunder shall terminate and CKD will immediately cease to develop and commercialize Product.

  • The report will include at a minimum the following information: License Number Name of Licensee Date of Report Reporting period Description of Licensed Products or Licensed Methods Status of Commercialization Milestones The report will be due to THE REGENTS on August 31 of each calendar year for the period January through June of that year and on February 28 of each calendar year for the period July through December of the preceding calendar year.


More Definitions of Commercialization Milestones

Commercialization Milestones means the milestones relating to Regulatory Approval and First Commercial Sale as described in Section 3.
Sample 1
Commercialization Milestones shall have that meaning set forth in Exhibit C.
Sample 1

Related to Commercialization Milestones

  • Development Milestone is defined in Section 5.3.

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

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

  • Project Milestones means the Project milestones set out in Schedule 3;

  • 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 any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • 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 7.2.

  • 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 Development activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

  • 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 1.11(a).

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

  • Development Program means the implementation of the development plan.

  • 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 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 any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Product Candidate means each biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.

  • Research Program has the meaning set forth in Section 3.1.

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

  • Clinical Study means a Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

  • 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.