Clinical Development Programs definition

Clinical Development Programs means the conduct, in the United States and outside the United States, as applicable, of preclinical and clinical activities and filing and prosecution of regulatory applications in support of regulatory approval and regulatory classification in respect of commercial introduction, marketing and sales of the Products.
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Examples of Clinical Development Programs in a sentence

  • LifeCell and Distributor shall review the implementation and administration of market development and regulatory strategies, priorities, of the Products (“Market Development Programs”) and Clinical Development Programs and activities and procedures related to the marketing and sales of Products.

  • Each Proposed Clinical Plan shall address the specific roles and responsibilities of each Party consistent with this Strategic Alliance Agreement, shall address and/or incorporate any JSC recommendations, and shall propose appropriate Clinical Development Programs for each stage of development set out in such Proposed Clinical Plan.

  • In accordance with this ARTICLE IX, Athersys shall supply (or shall engage a Third-Party manufacturer to supply) sufficient quantities of the Clinical Development Candidates and Cell Therapy Products in final packaged form to the extent reasonably required by Athersys and Angiotech to implement the Clinical Development Programs and by Angiotech to commercialize the Cell Therapy Products in the Territory.

Related to Clinical Development Programs

  • 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.

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

  • Development Program means the implementation of the development plan.

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

  • 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.