Active Clinical Development definition

Active Clinical Development of a Product means that at any given time TMC is diligently engaging in one or more of the following development activities for such Product in the Field: (a) awaiting protocol approval from an applicable institutional review board, FDA or other Regulatory Authority; (b) patient recruitment, patient treatment, data analysis, or report writing for any clinical trial; (c) regulatory file(s) being drafted or pending; and (d) manufacturing scale-up and validation.
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Active Clinical Development means that Barrier is diligently engaging in one or more of the following development activities for a Product that it has selected to develop: (i) study/protocol design activity; (ii) awaiting protocol approval from the applicable institutional review board, FDA or other Regulatory Authority; (iii) patient recruitment, patient treatment, data analysis, and report writing for any clinical trial; (iv) manufacturing scale-up and validation; or (v) regulatory file(s) being drafted or pending.
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Active Clinical Development solely for purposes of Section 3.1.3 hereof, shall mean TGTX is employing the level of efforts and resources to achieve Regulatory Approval of a Product in a Major Market in a sustained manner that is consistent with the efforts and resources a biopharmaceutical company typically devotes to a product that it has determined has positive market potential, profit potential, and strategic value. If a notice is required to be delivered by TGTX to Rhizen pursuant to Section 3.2.4 hereof, then the Compound shall no longer be considered to be in Active Clinical Development. Once the first Regulatory Approval for a Product in a Major Market is achieved, the Compound may no longer be considered to be in Active Clinical Development for purposes of Section 3.1.3.
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Examples of Active Clinical Development in a sentence

  • Barrier shall send to JJCC during the month of [**] a report on the status of its development of `683 Products and `932 Products indicating whether Barrier has obtained Regulatory Approval or is in Active Clinical Development for the `683 and `932 Products (the "Section 6.4 Report").

  • In the event that (i) Barrier has not obtained Regulatory Approval or Barrier is not conducting Active Clinical Development on a `683 Product or a `932 Product as contemplated in Section 6.2 or 6.3, and (ii) JJCC desires to exercise its termination rights pursuant to Section 6.2 or Section 6.3 above, then, no later than two months following the receipt of such Section 6.4 Report, JJCC shall send to Barrier written notice of its election to do so.

  • In the event that (i) Barrier has not obtained Regulatory Approval or is not conducting Active Early Development or Active Clinical Development on each such Product as contemplated in Sections 8.2 to 8.6 above, and (ii) JPPLP desires to exercise its termination rights pursuant to Sections 8.2, 8.3, 8.4, 8.5 or 8.6 above, then, no later than two months following the receipt of such Section 8.7 Report, JPPLP shall send to Barrier written notice of its election to do so.

  • Barrier shall send to JPPLP a new Section 8.7 Report during the month of [**] and if JPPLP desires to exercise such rights, then JPPLP shall send to Barrier written notice of its election to do no later than two months following the receipt of such new Section 8.7 Report, with a similar waiver and reinstatement occurring on an annual basis until Barrier commences Active Early Development, Active Clinical Development or obtains Regulatory Approval.

  • In the event that JPPLP does not so exercise its right to terminate, then JPPLP shall be deemed to have waived its right to terminate such Patent Right, as applicable, and the related JPPLP Know-How or Oxatomide Know-How; provided, however, that in the event that such failure to obtain Regulatory Approval or conduct Active Early Development or Active Clinical Development is continuing as of [**] then JPPLP's termination rights contained in Sections 8.2 to 8.6, as applicable, shall be reinstated.

  • Barrier shall send to JPPLP during the month of [**], [**] and/or [**] a report on the status of its development for each Product indicating whether Barrier has obtained Regulatory Approval or is in Active Early Development or Active Clinical Development for each such Product (the "Section 8.7 Report").

  • In the event that JJCC does not so exercise its right to terminate, then JJCC shall be deemed to have waived its right to terminate such `683 Patent Right or `932 Patent Rights, as applicable, and the related JJCC Know-how; provided, however, that in the event that such failure to obtain Regulatory Approval or conduct Active Clinical Development is continuing as of [**] then JJCC's termination rights contained in Section 6.2 or 6.3, as applicable, shall be reinstated.

  • Barrier shall send to JJCC a new Section 6.4 Report during the month of [**] and if JJCC desires to exercise such rights, then JJCC shall send to Barrier written notice of its election to do no later than two months following the receipt of such new Section 6.4 Report, with a similar waiver and reinstatement occurring on an annual basis until Barrier commences Active Clinical Development or obtains Regulatory Approval.

  • Subject to the provisions of Section 6.4, in the event that Barrier is not conducting Active Clinical Development on a `932 Product, or has not obtained Regulatory Approval to market a `932 Product, by [**] JJCC shall be entitled, but not obligated, to terminate (i) Barrier's License to the `932 Patent Rights under ** Certain information in these exhibits has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.


More Definitions of Active Clinical Development

Active Clinical Development of a Product means that at any given time TMC is diligently engaging in one or more of the following development activities for such Product in the Field: (a) awaiting protocol approval from an applicable institutional review board, FDA or other Regulatory Authority; (b) patient recruitment, patient treatment, data analysis, or report writing for any clinical trial; (c) regulatory file(s) being drafted or pending; and
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Related to Active Clinical Development

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • 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.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • 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 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.

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

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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.

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

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • 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 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.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • 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, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • 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).

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • Professional development means training programs for

  • 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.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • 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 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.

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.