Harmonization Principle definition

Harmonization Principle means the principle that the Development and Commercialization of the Licensed Products in the Kaken Territory, including such activities as clinical indication selection, clinical study design (including dosing), Regulatory Approval strategy (including labelling), CMC, and marketing and commercialization strategy, (a) will be conducted so as to harmonize with the Development and Commercialization of the Licensed Products by or on behalf of CymaBay (and any CymaBay licensee of Licensed Product) in the CymaBay Territory, and (b) in no event will be conducted in a manner that would materially adversely affect the Development or Commercialization of the Licensed Products by or on behalf of CymaBay (or any CymaBay licensee of Licensed Product) anywhere in the CymaBay Territory.
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Harmonization Principle means the principle that the Development and Commercialization of the Licensed Products in the Licensee Territory, including such activities as clinical indication selection, clinical trial design (including dosing), Regulatory Approval strategy (including labelling), CMC, and marketing and commercialization strategy, (a) will be conducted so as to harmonize with the Development and Commercialization of the Licensed Products by or on behalf of C▇▇▇▇▇ in the C▇▇▇▇▇ Territory, and (b) in no event will be conducted in a manner that would materially adversely affect the Development or Commercialization of the Licensed Products by or on behalf of C▇▇▇▇▇ in the C▇▇▇▇▇ Territory.
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Harmonization Principle means the principle that the Development and Commercialization of the Licensed Products in the Licensee Territory, including such activities as clinical indication selection, clinical trial design (including dosing), Regulatory Approval strategy (including labelling), CMC, and marketing and commercialization strategy, (a) will be conducted so as to harmonize with the Development and Commercialization of the Licensed Products by or on behalf of Corbus in the Corbus Territory, and (b) in no event will be conducted in a manner that would materially adversely affect the Development or Commercialization of the Licensed Products by or on behalf of Corbus in the Corbus Territory.
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Examples of Harmonization Principle in a sentence

  • The Parties agree and acknowledge that the Harmonization Principle will serve as a guiding principle for each Party’s Brief and for the arbitrator’s determination.

  • Such plan will include Development activities for the Licensed Products in the Field of Use in the Kaken Territory and will be consistent with the Harmonization Principle and the above timing goals.

  • The activities of Licensee and its Related Parties under this Section 5.1 will be subject to the coordination and other responsibilities of the JDC and JSC and the Harmonization Principle.

  • All such Promotional Materials will be compliant with applicable Law, consistent in all material respects with the Licensee Territory Commercialization Plan, and with the Harmonization Principle.

  • Subject to the oversight of the JSC and to the other terms and conditions of this Section 4.1 and of this Agreement, Kaken will be responsible for all Commercialization activities relating to the Licensed Products in the Field of Use in the Kaken Territory, at its sole cost and expense, in accordance with the Kaken Territory Commercialization Plan and the Harmonization Principle.

  • All such Promotional Materials will be compliant with Applicable Law, consistent in all material respects with the Kaken Territory Commercialization Plan, and with the Harmonization Principle.

  • Subject to the oversight of the JSC and JCC and to the other terms and conditions of this Section 4.1 and of this Agreement, on a Licensed Product-by-Licensed Product basis, Licensee will be responsible for all Commercialization activities relating to the Licensed Products in the Field in the Licensee Territory, at its sole cost and expense, in accordance with the Licensee Territory Commercialization Plan and the Harmonization Principle.

  • The activities of Kaken and its Related Parties under this Section 5.1 will be subject to the coordination and other responsibilities of the JSC and the Harmonization Principle.