OUS Territory definition

OUS Territory means that portion of the Territory that is outside of the United States.

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OUS Territory means the “Territory” as defined in the Asset Purchase Agreement as the same may be varied from time to time in accordance with the terms of the Asset Purchase Agreement.

OUS Territory means worldwide, excluding the United States.

Examples of OUS Territory in a sentence

• In addition, Solvay shall at all times have the right to cross reference, use and rely upon any and all portions of Drug Approval Applications filed by Depomed for the VMS Indication in the OUS Territory.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• The Parties shall establish a joint Development committee (the “Joint Development Committee” or “JDC”) to: (i) oversee, and make decisions with respect to ▇▇▇▇▇▇▇’▇ Development of the Profit Share Product in the U.S. and OUS Territory pursuant to Article IV of this Exhibit; and (ii) perform the other functions with respect to the Profit Share Product that are expressly delegated to the JDC in this Exhibit.

More Definitions of OUS Territory

OUS Territory means the entire world and all countries, territories and possessions therein, excluding

OUS Territory means the entire world and all countries, territories and possessions therein, excluding the U.S. 1. 104 “Out-of-Pocket Expenses” means amounts paid by or on account of a Party to Third Party vendors or contractors for supplies and materials for use, or for services provided by them, directly in the performance of activities relating to the Collaboration Candidates and Licensed Products under this Agreement (or other activities for which sharing of Out-of-Pocket Expenses is otherwise specified in this Agreement). For clarity, Out-of-Pocket Expenses do not include: (a) payments for the Parties’ or their Affiliates’ salaries or benefits, benefits, utilities, travel expenses, general office supplies, insurance, information technology, capital expenditures (unless such capital expenditures are used exclusively for the performance of activities under a Research Plan and, then, only to the extent such capital expenditures are depreciable by Fate), or the like; or (b) amounts paid relating to activities that were not performed under this Agreement.

OUS Territory means the entire world and all countries, territories and possessions therein, excluding the U.S.

OUS Territory means the Territory, excluding the U.S.

OUS Territory means worldwide, excluding the United States. 1. 100 “Out-of-Pocket Costs” means [***]. 1. 101 “Parties” means Alector and GSK.