Clinical Units definition

Clinical Units means Product for BUYER's use in the initial clinical trials. Clinical Units may not be repackaged in new dosage sizes and a "Clinical Unit" will consist of 0.5 mL in a 1.25 mL syringe.
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Examples of Clinical Units in a sentence

  • For each Thermage Generator ordered hereunder after FDA approval of the Thermage Generator, upon the commencement of commercial sales (excluding Clinical Units), Stellartech agrees that the target price for each Thermage Generator, up to a cumulative maximum of 300, is estimated to be between $4,000 and $5,000 (plus any incremental cost associated with Thermage’s specifications and any adjustments relating to volumes of units purchased by Thermage).

  • Subsequently, the Development Program shall be amended as mutually agreed by both parties in writing to cover Stellartech’s future testing and development efforts, including, but not limited to its efforts with regard to Clinical Units followed by commercially available Products.

  • After completion of the Development Program for Thermage Disposable Devices and prior to the commencement of commercial sales (excluding Clinical Units) therefore, Thermage and Stellartech agree to negotiate in good faith regarding manufacture of the Thermage Disposable Devices, it being understood that Thermage is under no obligation to provide such manufacturing rights to Stellartech.

  • In addition to the indemnity provisions contained within Clause 13, the following provisions shall apply to studies involving human subjects: The clinical phase of the study will be the responsibility of and will be carried out by, Clinical Unit(s) agreed by the Sponsor and Inveresk (“the Clinical Unit(s)”).

  • The terms of the quotation and any resulting Contract between Inveresk and the Sponsor relating to the clinical phase of the study shall be subject to the approval of the Protocol for the clinical phase of the study by the Clinical Unit(s) and, where appropriate, one or more IRBs, and shall be subject to obtaining all necessary Government or statutory consents.

  • Notwithstanding the provisions of Clause 1 of these Conditions, Inveresk shall be entitled to disclose to the prospective Clinical Units approved for this purpose by the Sponsor, information concerning the study provided that Inveresk first obtains from each such prospective Clinical Unit an undertaking with regard to confidentiality in similar terms to those set out in Clause 1, explicitly for the benefit of the Sponsor.

  • Cosmo shall invoice Salix for the applicable Estimated Price for all Commercial Units of Product, the applicable Sample Supply Price for all Sample Units of Product, and the applicable Clinical Supply Price for all Clinical Units of Product, promptly after delivery thereof.

Related to Clinical Units

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • 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 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.

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.