Clinical Development Phase definition

Clinical Development Phase means the clinical development period with regard to a CC or Backup-Compound until First Commercial Sale.
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Clinical Development Phase means Phase I, Phase II, Phase III, NDA Phase and Registration Phase.
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Examples of Clinical Development Phase in a sentence

  • Before commencing any portion of the Work, Contractor shall carefully examine all Drawings and Specifications and other information given to Contractor as to materials and methods of construction and other Project requirements.

  • Clinical Development Phase 1 Eupraxia completed a Phase 1, double-blind, placebo-controlled clinical study at three sites in Canada13.

  • Within sixty (60) days following the confirmation by the RDC that the CC Criteria are achieved, ROCHE shall have the right to request to become the Lead Party for the Clinical Development Phase for such Research Project and shall inform EVOTEC by written notice within such period.

  • Either party may, at its discretion, terminate this Agreement, any Research Project, Clinical Development Phase, country-by-country or Product-by-Product without reason upon thirty (30) days prior written notice.

  • Within sixty (60) days following a written notice of ROCHE not to exercise the option right specified in Section 5.2 or following the expiry of the sixty days period specified in Section 5.2, whatever is first, EVOTEC will have sixty (60) days to request to become the Lead Party for the Clinical Development Phase for such Research Project.

  • Golgi-resident polysialic acid defines distinct brain cell populations Sebastian Werneburg, Falk Buettner, Martina Mühlenhoff, Herbert HildebrandtInstitute for Cellular Chemistry, Hannover Medical School, Hannover, GermanyNG2 cells are a heterogeneous population of precursors.

  • AM-101 Clinical Development Phase 1/2 We conducted the first clinical evaluation of AM-101 in a Phase 1/2 double blind, randomized, placebo-controlled trial that included dose escalation from 0.03 to 0.81 mg/mL.

  • During the Clinical Development Phase and Commercialization Phase, CuraGen shall be permitted to appoint one (1) representative to reside at Bayer, at CuraGen's sole discretion, for at least six (6) months of each year.

  • The Bayer / CuraGen agreement provides a good example of this by breaking the overall collaboration into several separate but related phases, including the Qualified Target Production Phase, the Target Screening Phase, the Strategic Project Phase, the Pre- Clinical Development Phase, the Clinical Development Phase and the Commercialization Phase, each with several pages of specific obligations of each party.

  • During the Pre-Clinical Development Phase, Clinical Development Phase and Commercialization Phase, CuraGen shall appoint two (2) representatives to each Global Development Project Team relating to (i) Development Compounds in connection with which CuraGen is participating in the Development Costs and (ii) Metabolic Program Drugs in connection with which CuraGen has not opted out of the Development Costs.

Related to Clinical Development Phase

  • Development Phase means the period before a vehicle type is type approved.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, multi-apartment buildings, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • 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 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.

  • 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 Plan has the meaning set forth in Section 3.2.

  • 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.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • 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.

  • 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.

  • 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 pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • 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.

  • 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;

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • 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).

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.