Examples of OUS Territory in a sentence
As between the Parties, Solvay shall be the legal and beneficial owner of all Drug Approval Applications for the Product in the Field and related approvals in the OUS Territory.
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Depomed agrees to provide Solvay with a copy (which may be wholly or partly in electronic form) of all Regulatory Filings with respect to the Product for the VMS Indication in the OUS Territory promptly upon the making or submission of such Regulatory Filing, provided that Depomed shall not be obligated to provide any Product Data or information that is not safety data and that is not specific to Product for use outside the Field.
Depomed shall have the right of cross reference, and to use and rely on, all such Drug Approval Applications filed in the OUS Territory by Solvay, its Affiliates or sublicensees.
The Parties intend that all Drug Approval Applications for the Product in the Field in the OUS Territory will be comprised of the Drug Approval Application submitted by Solvay to the FDA as described in Section 5.1(b), plus such additional data and reports not required to be submitted to the FDA but required to be submitted in the OUS Territory.
Solvay shall provide Depomed with advance notice of any meetings with Governmental Authorities relating to the Product in the OUS Territory and Depomed shall have the right to observe such meetings.
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 JSC shall have no authority with respect to Commercialization of the Profit Share Product in the OUS Territory, provided that the JSC shall have the authority to review and discuss, but not approve, the global commercialization strategy in accordance with Section 5.1.2(e) and the JSC shall serve as a forum for discussions regarding Xxxxxxx’x Commercialization of the Profit Share Product in the OUS Territory as described in this Exhibit.
GSK shall be responsible for all Commercialization activities with respect to Cost Profit Sharing Products in the OUS Territory.