Examples of OUS Territory in a sentence
Each Party or such Affiliate shall provide a signed statement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) or the equivalent as required in the United States or any country or region of the OUS Territory or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority.
Kadmon and its Affiliates shall not, directly or indirectly, during the Term, (a) develop, manufacture, have manufactured, use, or Commercialize Exclusive Product or any capsule product containing more than 200mg of Ribavirin in the Territory or the OUS Territory or enter into any relationship with any Third Party to develop, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.
The trade dress, style of packaging and the like with respect to each Licensed Product in the Field within the OUS Territory may be determined by GSK in a manner that is consistent with GSK’s standard trade dress and style.
Xxxxxxx shall keep Fate regularly informed through the JDC regarding material regulatory activities with respect to the Profit Share Product in the OUS Territory.
GSK shall be responsible for handling all returns of the Licensed Products in the OUS Territory and Opt Out Products, and if a Licensed Product sold in the OUS Territory or Opt Out Product sold in the United States is returned to Alector, Alector shall promptly ship such Licensed Product to a facility designated by GSK.
The JSC shall have no oversight or authority with respect to Commercialization of the Licensed Products in the OUS Territory.
GSK shall handle all medical questions or inquiries from members of the medical profession in the OUS Territory regarding the Licensed Products and in the United States regarding Opt Out Products and Alector shall, and shall cause its Field Based Representatives to, refer to GSK all such questions and inquiries within [***] hours of receipt and shall respond to all inquiries from GSK and follow the directives of GSK in connection therewith.
Xxxxxxx shall handle all medical questions or inquiries from members of the medical profession in the OUS Territory regarding the Licensed Products.
If argenx receives any orders for a Licensed Product in the OUS Territory, it shall refer such orders to Xxxxxxx.
GSK shall also be solely responsible for handling all aspects of order processing, invoicing and collection, distribution, inventory and receivables for Licensed Products in the OUS Territory and Opt Out Products in the United States.