Clinical Development Activities definition

Clinical Development Activities means and refer to phase I-IV clinical development services, pre-clinical services, post-approval services, program management, general drug development consulting, biostatistics and data management services, medical communications, regulatory consulting, laboratory services, including, but not limited to, analytical, bioanalytical, central laboratory and vaccine testing services, and such other services as Sponsor may from time to time require for drug development.
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Examples of Clinical Development Activities in a sentence

  • In performing the Clinical Development Activities, Kyowa Kirin will not use the services of any employee or consultant, who has been debarred by the FDA or any Regulatory Authority, or, to the best of Kyowa Kirin’s Knowledge, is the subject of debarment proceedings by the FDA or any other Regulatory Authority.

  • The price for Licensed Product provided by Reata to Kyowa Kirin for use in development (including Clinical Development Activities) in the Territory shall be at [***], plus applicable sales tax (if any).

  • Kyowa Kirin agrees that it shall only conduct Clinical Development Activities and other Commercialization activities in the Field in the Territory under this Agreement (and the licenses granted hereunder) for the Licensed Compound and formulations of Licensed Compounds (and Licensed Products comprised of or containing such Licensed Compounds).

  • Subject to the terms and conditions of this Agreement, Reata shall use Commercially Reasonable Efforts to supply Kyowa Kirin with quantities of Licensed Product required for Kyowa Kirin’s and its Affiliates’ development of Licensed Products in the Territory (including for use in Clinical Development Activities and non-clinical studies) in accordance with Kyowa Kirin’s forecasts and orders therefor, as provided below.

  • In connection with any development or Commercialization activities, including Clinical Development Activities undertaken by Kyowa Kirin in connection with Licensed Product, Kyowa Kirin will comply with all Applicable Laws regarding the care and use of experimental animals.

  • Kyowa Kirin will submit a Development Plan to the JSC for its approval, with respect to anticipated Clinical Development Activities and Regulatory Activities with respect to Licensed Products for use in the Field, within [***] of the Effective Date of this Agreement, which Development Plan will include Kyowa Kirin’s preliminary development plans for China.

  • Kyowa Kirin shall keep Reata reasonably informed of its anticipated requirements of Licensed Products for Clinical Development Activities and other development activities in the Territory through the JSC and the Development Plan.

  • Senior Management of AMS is thoroughly familiar with the operations, financial condition, and assets of AMS and warrants that the representations made by SGI in this Agreement are true and correct and that Senior Management is aware of all operating and financial conditions that might impact their purchase of the Shares.

  • If Almirall wishes to perform any Local Clinical Development Activities not described in the then-current EXHIBIT D-1 or EXHIBIT D-3, then Almirall shall propose to the JDC to add such Local Clinical Development Activities to EXHIBIT D-3.

  • No later than [*****] days prior to the earlier of (a) [*****], or (b) any [*****] in connection with or related to any Clinical Study described in (a) above, Almirall shall provide to the JDC a proposed supplement to the Development Plan for the Local Clinical Development Activities in the form of a completed version of the template attached as Schedule 2.4.2 taking into account relevant factors, including the Phase 2b Data.

Related to Clinical Development Activities

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Development Activities means those Development activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • 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.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.