Initial Commercialization definition

Initial Commercialization means the end of the calendar month containing the date following the granting of Regulatory Approval (as defined in Section 1.10 hereof) for a Licensed Product for human therapeutic use for prevention of kidney transplant rejection or a major disease (within the meaning of Milestone #2 in Section 3.2 of the 1989 PDL/Roche Agreement) on which X. Xxxxx, its Affiliates or sublicensees first sell such a product to an independent third party not an Affiliate of the seller in a major market within the ROW Territory, where "major market" means either Japan or two of the following three countries: France, Italy or the United Kingdom.
Sample 1
Initial Commercialization means the end of the calendar month
Sample 1
Initial Commercialization means either of the following, depending on context: (a) For the United States, the end of the calendar month containing the date following FDA approval of the Biologics License Application filed for a Licensed Product for human therapeutic use for prevention of kidney transplant rejection or a major disease (within the meaning of Milestone #2 in Section 3.2 of the 1989 Agreement) on which Roche, its Affiliates or sublicensees first sell such a product to an independent third party not an Affiliate of the seller in the Territory. With respect to Daclizumab, "Initial Commercialization" occurred in the United States on December 31, 1997.
Sample 1

Examples of Initial Commercialization in a sentence

  • If the Senior Executives are unable to resolve any matter set forth in an Escalation Notice within thirty (30) days after the applicable Party receives such Escalation Notice, then Otsuka shall have final decision-making authority with respect to all matters within the responsibilities of the JCC; provided that, Otsuka shall not have the right to use such final decision-making authority to require Acucela to fund any Initial Commercialization Costs in excess of the Aggregate Commercialization Cost Cap.

  • Within [*] following the Effective Date, the Parties shall agree in writing to the initial Commercialization Plan for the Product, which shall be based on and consistent with the Initial Commercialization Guidance.

  • The Parties shall discuss the OSA Proposal in good faith and, if the Parties mutually agree upon a go-to-market Commercialization plan for the OSA Target Indications (whether incorporating, in whole or in part, the elements of the OSA Proposal or otherwise), the Initial Commercialization Plan shall be amended by mutual written agreement of the Parties to reflect such mutually agreed upon go-to-market Commercialization plan.

  • Notwithstanding the preceding sentence, Salix shall not make any change to the Commercialization Plan that would have the effect of making the Commercialization Plan inconsistent with the Initial Commercialization Outline except following consultation with Progenics through the Committees and subject to Section 3.5(c).

  • During the Initial Commercialization Period, Lilly shall pay to Xxxxxxxxx royalties on the annual Net Sales of all Products in the Territory in the amounts set forth below (all amounts are in U.S. Dollars).

  • In such case, Roche's obligation to pay PDL royalties with respect to any particular Licensed Product shall terminate on the tenth anniversary of Initial Commercialization of such Licensed Product unless prior to that time such Valid Claim has been issued in the Territory, at which time Roche shall resume paying PDL royalties at the rates specified in Section 4.01(a) above.

  • Reporting System: WISS must submit performance reports through the Workforce Integrated Performance System (WIPS).

  • Attached as Exhibit G is an example of an annual Product royalty payment calculation after the Initial Commercialization Period.

  • Unless earlier terminated pursuant to the terms of this Article XI, this Agreement shall remain in effect until the later of (a) the date of expiration of the last to expire of any Valid Claims or (b) the date of the [ ] anniversary of the Initial Commercialization of the last Licensed Product to be introduced by Roche hereunder, at which time this Agreement shall automatically expire.

  • Such Commercialization Plan shall be consistent with the Initial Commercialization Outline, including all timelines set forth therein, and shall set forth the objectives and planned tasks for the Commercialization of Products for the Territory.


More Definitions of Initial Commercialization

Initial Commercialization means the end of the calendar month containing the date following FDA approval of the Product License Application filed for a Licensed Product for human therapeutic use for prevention of kidney transplant rejection or a major disease (within the meaning of Milestone #2 in Section 3.02 hereof) on which Roche, its Affiliates or sublicensees first sell such a product to an independent third party not an Affiliate of the seller in the Territory.
Sample 1

Related to Initial Commercialization

  • 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.

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

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

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

  • 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;

  • 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).

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • 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.

  • 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.

  • Research Budget has the meaning set forth in Section 2.2.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

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

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

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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.

  • 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.

  • 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)).

  • 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 Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

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

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).