Patent Listings. Licensee shall have the right and responsibility to make all filings with Regulatory Authorities in the Territory with respect to the AstraZeneca Patents, including as required or allowed (i) in the United States, in the FDA’s Orange Book and (ii) in the European Union, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents; provided that Licensee shall consult with AstraZeneca to determine the course of action with respect to such filings.
Appears in 6 contracts
Samples: License Agreement (Biohaven Research Ltd.), License Agreement (Dermavant Sciences LTD), License Agreement (Dermavant Sciences LTD)
Patent Listings. As between the Parties, Licensee shall have the sole right to make decisions regarding and Licensee shall have the right and responsibility to make all filings with Regulatory Authorities in the Field in the Territory with respect to the AstraZeneca Patents, and Licensee Patents, including as required or allowed (ia) in the United States, in the FDA’s Orange Book and (iib) in the European Union, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents; provided that Licensee shall consult with AstraZeneca to determine the course of action with respect to such filings.
Appears in 2 contracts
Samples: License Agreement (Arcutis Biotherapeutics, Inc.), License Agreement (Arcutis Biotherapeutics, Inc.)
Patent Listings. As between the Parties, Licensee shall have the sole right to make decisions regarding and responsibility to make all filings with Regulatory Authorities in the Territory with respect to the AstraZeneca Patents, including as required or allowed (ia) in the United States, in the FDA’s Orange Book and (iib) in the European Union, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents; provided that . To the extent reasonably practicable, Licensee shall reasonably consult with AstraZeneca to determine the course of action with respect to such filings.
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