Examples of Bioprojet Territory in a sentence
Each Party or such Affiliate(s) thereof shall provide a signed statement to this effect, if requested by the other Party, in accordance with United States 21 C.F.R. § 314.50(g)(3) or its equivalent as required in any other country or region or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority in the Partner Territory or the Bioprojet Territory, as the case may be.
It is also understood that the JSC shall not have any authority over activities related to the Development and/or Commercialization of the Product for use in the Bioprojet Territory.
For clarity, it is understood that Bioprojet may use and disclose, in accordance with the foregoing, any Partner Know-How provided to Bioprojet by Partner in connection with the development, Commercialization, marketing, promotion and/or distribution of the Product for the Bioprojet Territory.
Each Party or such Affiliate(s) thereof shall provide a signed statement to this effect, if requested by the other Party, in accordance with United States 21 C.F.R. § 314.50(g)(3) or its equivalent as required in any other country or region or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority in the Harmony Territory or the Bioprojet Territory, as the case may be.
Effective from and after the Effective Date, Harmony shall be responsible, at its sole cost and expense, for all medical affairs activities with respect to the Product(s) in the Harmony Territory and shall co-ordinate, develop and implement a medical affairs strategy with respect to each Product across the Harmony Territory and the Bioprojet Territory (including the activities listed in Sections 10.4 to 10.6), including for the pre-Regulatory Approval and post-Regulatory Approval periods.
For the avoidance of doubt, Xxxxxxx shall bear the responsibility of the Commercialization of a Product in the Harmony Territory, provided that such decisions are not inconsistent with the Commercialization Plan or the terms and conditions of this Agreement and Bioprojet shall bear the responsibility of the Commercialization of a Product in the Bioprojet Territory, provided that such decisions are not inconsistent with the terms and conditions of this Agreement.