Examples of Bioprojet Territory in a sentence
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.
Bioprojet shall be solely responsible for (A) the costs associated with the Development activities with respect to the Product for the Partner Territory as set forth in Section 4.2 of this Agreement) and (B) all costs associated with the Development, regulatory and Commercialization activities with respect to the Product for the Bioprojet Territory.
Bioprojet shall promptly notify Partner with respect to any material changes or material issues that may arise in connection with any Regulatory Approvals for the Product in the Bioprojet Territory.
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.
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.
Bioprojet shall promptly notify Harmony with respect to any material changes or material issues that may arise in connection with any Regulatory Approvals for the Product(s) in the Bioprojet Territory.
Bioprojet shall be solely responsible for (A) its share of the Development Cost Share and any additional costs associated with such Product’s Development activities for the Bioprojet Territory as the Parties agree in the Development Budget, and (B) all costs associated with the Development, regulatory, Manufacturing and Commercialization activities with respect to the Product(s) for the Bioprojet Territory.
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.
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.
Bioprojet shall provide Harmony, as well as to the JSC, with copies of all material submissions it makes to, and all material correspondence it receives from, EMA and any other Regulatory Authority pertaining to Product Regulatory Filings or such Product in the Field in Bioprojet Territory.