Common use of Orange Book Listing Clause in Contracts

Orange Book Listing. The Parties will evaluate in good faith and identify all Legacy Patents that may meet the requirements for listing with FDA in the Orange Book, or any foreign Governmental Authority in any jurisdiction outside the United States, in connection with any new drug application or other application for marketing or regulatory approval for any Primary Royalty Product. Primary, its Affiliates, and Primary Sublicensees shall, if and as elected thereby in their reasonable discretion, be entitled to (i) submit such Legacy Patents identified thereby to the FDA for listing in the Orange Book and/or to any foreign Governmental Authority for a similar listing on a timely basis and (ii) maintain with the FDA or other applicable Governmental Authority correct and complete listings of applicable Legacy Patents for any such Primary Royalty Product.

Appears in 4 contracts

Samples: License Agreement (Viamet Pharmaceuticals Holdings LLC), Separation and Distribution Agreement (Viamet Pharmaceuticals Holdings LLC), License Agreement (Viamet Pharmaceuticals Holdings LLC)

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