Commercialization Criteria definition

Commercialization Criteria means criteria mutually agreed for each Discovery Project and shall include IP and exclusivity assurances acceptable to Sucampo.
Sample 1
Commercialization Criteria has the meaning set forth in Section 14.2(e).
Sample 1

Examples of Commercialization Criteria in a sentence

  • Phase II 13 Process 13 Evaluation 13 Phase II Technical Criteria 14 Phase II Commercialization Criteria 14 Phase II Programmatic Review Criteria 14 F.

  • This needs to be grasped, as substantial funds are being channelled toward trade support services in an effort to tackle supply-side constraints, improve the business environment, and add value to private sector initiatives.

  • In the event that Collaborator fails to achieve any material Commercialization Criteria within the timeframes set forth the Commercialization Plan or it is reasonably expected that any material Commercialization Criteria for a particular Annual Period will not be met, MSB and Collaborator shall, through the JSC, discuss and agree on a reasonable plan to increase Collaborator’s efforts to Commercialize Product with the goal of achieving the Commercialization Criteria for such Annual Period.

  • Commercialization Criteria for each Compound shall be in writing and shall be attached hereto as an appendix and shall be deemed a part of this Agreement.

  • In the event Endo does not submit an application for Regulatory Approval in *** (“Approval Criteria”), or if Regulatory Approval is obtained in *** after the later of such Regulatory Approval or any governmental agency pricing approval (“Commercialization Criteria”), ***, BDSI may upon *** prior written notice to Endo terminate this Agreement in respect to such Region unless Endo meets the Approval Criteria or the Commercialization Criteria for such Region in such *** period.

  • The Commercialization Criteria will be agreed upon prior to the initiation of the Discovery Project.

  • In the event Endo does not submit an application for Regulatory Approval in *** (“Approval Criteria”), or if Regulatory Approval is obtained in *** after the later of such Regulatory Approval or any governmental agency pricing approval (“Commercialization Criteria”), *** prior written notice to Endo terminate this Agreement in respect to such Region unless Endo meets the Approval Criteria or the Commercialization Criteria for such Region in such *** period.

Related to Commercialization Criteria

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

  • 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 Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

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

  • 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.

  • 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 Program means the implementation of the development plan.

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

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

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

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • 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 Program has the meaning set forth in Section 2.1.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • 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).

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

  • 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.

  • 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;

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Licensed Compound means [***].

  • 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.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.