Commercialization Studies definition

Commercialization Studies means a study or data collection effort for the Licensed Product that is initiated in the Territory after receipt of Marketing Authorization for the Licensed Product and is principally intended to support the Commercialization of the Licensed Product in the Territory; provided, that such study or data collection effort is not principally to support or maintain a Marketing Authorization or obtain a label change or maintain a label.
Sample 1Sample 2Sample 3
Commercialization Studies means a study or data collection effort for Licensed Product that is initiated in the Territory after receipt of Marketing Authorization for Licensed Product and is principally intended to support the Commercialization of Licensed Product in the Territory; provided, that such study or data collection effort is not principally to support or maintain a Marketing Authorization or obtain a label change or maintain a label.
Sample 1Sample 2
Commercialization Studies means any clinical studies GSK wishes to be conducted by or on behalf of GSK in the GSK Territory in support of GSK’s commercialization of the Product in the GSK Territory and which will be initiated in a country after Marketing Approval of the Product in such country. Such studies may include, but shall not be limited to, “marketing studies” to support market uptake, acceptance and differentiation of the Product, epidemiological studies, modeling and pharmacoeconomic studies, and studies in support of modifications or additional sleep disorder related indications. Commercialization Studies shall not include studies designed to generate data in support of new indications unrelated to sleep disorders, or studies investigating the safety or efficacy of the Product in a modified release formulation or a combination product. For the avoidance of doubt, Commercialization Studies shall not include Required Studies, Investigator Sponsored Clinical Studies, Sepracor Studies, studies Sepracor initiated prior to the Effective Date in support of the Product, any studies relating to the Product that Sepracor may initiate in the Sepracor Territory or any other studies that Sepracor may initiate anywhere in the world which do not relate to the Product.
Sample 1

Examples of Commercialization Studies in a sentence

  • The Annual Commercialization Report shall also list all ongoing Commercialization Studies and the status of such studies in the United States, the Major European Countries and Japan.

  • Licensee shall submit to Lilly, every twelve (12) months after First Commercial Sale of a Licensed Product, a written report in reasonably sufficient detail describing the general commercialization progress of Licensee or a Related Party for Licensed Compounds and/or Licensed Products during the previous twelve (12) month period, including a list all ongoing Commercialization Studies and the status of such studies in the United States, the Major European Countries and Japan.

  • This approach marks only registers and flags that are indeed used, avoiding unnecessary saves/restores and thus reducing the runtime overhead.

  • In the event that GSK plans during the Term of this Agreement to undertake any Required Studies or Commercialization Studies, or to support any Investigator Sponsored Clinical Studies in the XXX Xxxxxxxxx, XXX shall generate a Development Plan which shall be presented promptly to the JSC for review to ensure that the Development Plan takes into account and is consistent with the global branding strategy for the Product.

  • In addition to the studies permitted in Sections 4.3 and 5.3, and in accordance with the then applicable approved Development Plan, GSK shall have the right, but not the obligation, to undertake, at GSK’s sole expense, Commercialization Studies in the GSK Territory in support of GSK’s commercialization of the Product.

  • Required Studies, Commercialization Studies and support for Investigator Sponsored Clinical Studies shall not commence until such studies have been presented to the JSC for review and written notice of the studies sent to Sepracor.

  • The Annual Commercialization Report shall also list all ongoing Commercialization Studies and the status of such studies in the Major Markets.

  • GSK shall inform Sepracor pursuant to Section 5.6 of its intention to pursue such Commercialization Studies prior to their initiation.

Related to Commercialization Studies

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

  • 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.

  • 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.

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

  • 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;

  • 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 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.

  • 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.

  • 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 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.

  • 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.

  • Development Program means the implementation of the development plan.

  • 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.

  • 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.

  • 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).

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

  • Clinical Trial means any human clinical trial of a Product.

  • 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.

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

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

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

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

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