Regulatory Listings Sample Clauses
Regulatory Listings. As between the Parties, OPKO (or its designee) will have the sole right to list, with the applicable Regulatory Authorities, all applicable Patents for a Collaboration Product, including all so-called “Purple Book” or “Orange Book” listings required under the PHSA, and all similar listings in any other relevant countries. For the avoidance of doubt, OPKO will retain final decision-making authority with respect to the listing of all applicable Patents for any Collaboration Product, and will retain the right to perform all actions of a reference product sponsor set forth in the U.S. Hatch-Waxman Act or PHSA (and any foreign equivalent of such laws), regardless of which Party owns such Patent or controls the Prosecution of such Patent, and Entera will reasonably assist OPKO in connection therewith.
Regulatory Listings. To the extent required by law, P&G shall use its Commercially Reasonable Efforts to maintain with the applicable Regulatory Authorities during the term of this Agreement correct and complete listings of applicable Patent Rights for any Product then being commercialized by P&G, including all so called “Orange Book” listings required under the ▇▇▇▇▇-▇▇▇▇▇▇ Act. In furtherance thereof, Curis shall provide P&G with written notice of the issuance of any patent included in the Curis Patent Rights within 10 days after such issuance.