Active Clinical Development definition

Active Clinical Development means that Barrier is diligently engaging in one or more of the following development activities for the Licensed 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 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 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

  • In addition, and notwithstanding the foregoing, following the completion of Active Clinical Development, Rhizen may develop, have developed, Commercialize, or have Commercialized, the Compound for a non-human use, including without limitation veterinary use, provided that such development or Commercialization is in the form of a co-formulation of the Compound with any other active additional ingredient.

  • 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 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 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").

  • 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").

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

  • Professional development plan means a plan specifically designed to identify goals, activities and measurable objectives that will support continuous learning related to professional knowledge, skills and abilities.

  • 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.