Clinical Development Period definition

Clinical Development Period means, with respect to each Product, the period of performance of the clinical and non-clinical investigations and other work necessary to and directly in support of obtaining Regulatory Approval for marketing a Product, commencing [ * ] after a party has obtained regulatory approval to conduct human clinical trials [ * ].
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Examples of Clinical Development Period in a sentence

  • Onyx may elect to prepare and file an IND and to proceed with clinical trials and Clinical Development Period work.

  • Miles’ (and Onyx’, where appropriate) performance of such Co-Development obligations shall be under the management and supervision of the JRDC, and each Party shall keep the JRDC informed as to all significant work in Clinical Development Period hereunder.

  • Such payments will occur with respect to each Development Compound during the Clinical Development Period under the management of the JRDC as long as the Co-Development continues.

  • This presentation shall give an analysis of all relevant data about such Development Compound, including results from all Clinical Development Period efforts and shall set forth a detailed plan and budget for the remaining clinical development needed to obtain Regulatory Approval and a proposed Marketing Plan for the United States after approval.

  • The non-electing Party shall provide all materials and Know-How relating to such Collaboration Compound as are reasonable to assist such Party to perform such Clinical Development Period work.

  • The Parties [ * ] and Miles [ * ] shall use diligent efforts to complete the work in the Clinical Development Period of Collaboration Compounds selected for Co-Development, and to file applications to obtain Regulatory Approval for Collaboration Products in each country in which both Parties bear the Co-Development Costs for a particular Product.

  • Such proposal shall include a summary of all research and preclinical results upon which such Party bases its belief that such Collaboration Compound is appropriate for Clinical Development Period work.

  • Atthe other end, we find economy driven, instrumental models with no community elements and less trust enabling the transactions.

  • Subject to the principle of equal participation, the Parties expect that such Co-Development will rely, to the extent it is economically indicated, on the existing structure and capabilities of Miles for performing Clinical Development Period tasks.

Related to Clinical Development Period

  • Development Period means the period from the date of this Agreement until the Appointed Date;

  • 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.

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

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

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

  • Development Period Security shall have the meaning set forth in Section 6.1(a) hereof.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • 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 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.

  • Clinical Director means an individual who meets the minimum requirements set forth in Title 9, CCR, and has at least two (2) years of full-time professional experience working in a mental health setting.

  • Research Term has the meaning set forth in Section 3.2.

  • Research Program Term has the meaning set forth in Section 2.2.

  • 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 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. [***]

  • spatial development framework means the Kouga Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • Development Program means the implementation of the development plan.

  • 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.

  • 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).

  • 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;

  • 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 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.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • 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.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;