Phase III Development definition

Phase III Development means the conduct of Phase III Clinical Studies of SST Product in the United States as set forth in the then-current Development Plan, including all Development activities incidental thereto.
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Phase III Development means those activities consisting of Phase III clinical trials intended to support regulatory approval of a Licensed Product, including the collection and analysis of data from those trials.
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Phase III Development means any and all activities directed to third phase of human clinical trials of a drug which are large-scale trials to gain evidence of the efficacy and safety in a number of human subjects sufficient to support registration for a product or compound with the FDA, as described in 21 C.F.R. § 312.21(c), as may be amended, or, with respect to any country or jurisdiction other than the United States, its equivalent in such other country or jurisdiction.
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Examples of Phase III Development in a sentence

  • For clarity, the claims of any such Phase III Development Candidate Patent shall not read on any other peptide compound.

  • Unless agreed upon by the Parties under Section 5.5(d)(i), the Participating Phase III Party shall prepare for review and approval by the JDC a plan for such Phase III Development.

  • In the event Array exercises its Co-Funding Option with respect to a Licensed Product, Array shall be obligated to [ * ] AZ for [ * ] of such Phase III Development Costs for such Licensed Product, subject to the provisions of this Section 3.5.

  • AZ agrees to keep Array informed on an ongoing basis as to the actual Phase III Development Costs incurred to date as compared to the Phase III Development Costs reflected in the Co-Development Plan and Budget.

  • BI shall have the right, during the Term of this Agreement and after achievement and payment of the Phase III Clinical Trial Development Milestone for a Development Candidate, to request the transfer and assignment of Zealand Pharma s rights in and to any Phase III Development Candidate Patent for such Development Candidate (the “Selected Zealand Pharma Patents”).

  • A Phase III Development Candidate Patent shall be prosecuted pursuant to Section 14.1 if the Phase III Development Candidate Patent is a Zealand Pharma Patent, and pursuant to Section 14.4 if the Phase III Development Candidate Patent is a Collaboration Patent.

  • Should AZ have [ * ] Phase III Development Costs in the period prior to Array’s termination of its Co-Funding Option AZ shall invoice Array in respect of [ * ] of costs within [ * ] of such costs being [ * ] and such payments shall be due [ * ] of receipt of invoice by Array.

  • Within [ * ] days after Array’s receipt of such statement, Array shall [ * ] AZ [ * ] of the Phase III Development Costs [ * ] such quarterly period in accordance with the statement for such Co-Funded Product; provided, however, that Array shall not be required to [ * ] AZ for [ * ].

  • BI shall have the right, during the Term and after achievement and payment of the Phase III Clinical Trial Development/Regulatory Milestone for a Development Candidate, to request the transfer and assignment of Zealand Pharma’s rights in and to any Phase III Development Candidate Patent for such Development Candidate (the “Selected Zealand Pharma Patents”).

  • Array shall have the right, on a Licensed Product-by-Licensed Product basis, to elect to fund [ * ] of the Phase III Development Costs of such Licensed Product, all in accordance with this Section 3.5 (the “Co-Funding Option”).