Common use of Regulatory Data Protection Clause in Contracts

Regulatory Data Protection. To the extent required by or permitted by Law, Amgen will, at its sole discretion, decide whether to list with the applicable Regulatory Authorities during the Term any applicable Arrowhead Product Patents claiming any Licensed Compound or Licensed Product that Amgen intends to, or has begun to, Commercialize, and that has become the subject of a Regulatory Approval Application submitted to FDA. In the event Amgen desires to include in such listing any Arrowhead Platform Patent, then the Parties shall meet and discuss such request in good faith and Arrowhead will not unreasonably withhold consent to such listing, provided that it shall not be unreasonable for Arrowhead to withhold its consent if such extension would materially adversely affect such Arrowhead Platform Patent. Such listings may include all so called “Orange Book” listings required under the Xxxxx-Xxxxxx Act or listing of Patents as provided in the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act of 2009 or under 42 U.S.C. § 262(l) or similar provisions in the Territory during the Term. Prior to such decision on listings, the Parties will meet to evaluate and identify all applicable Patents to be listed and Amgen shall reasonably incorporate and address suggestions provided by Arrowhead as to the listing or non-listing of any applicable Patents.

Regulatory Data Protection. To the extent required by or permitted by Law, Amgen Allergan will, at its sole discretion, decide whether to list with the applicable Regulatory Authorities during the Term any applicable Arrowhead Molecular Partners Product Patents claiming covering any Licensed Compound or Licensed Product that Amgen Allergan intends to, or has begun to, to Commercialize, and that has become the subject of a Regulatory Approval Application submitted to FDA. In the event Amgen Allergan desires to include in such listing any Arrowhead Molecular Partners Platform Patent, then the Parties shall meet and discuss such request in good faith and Arrowhead Molecular Partners will not unreasonably withhold consent to such listing, provided that it shall not be unreasonable for Arrowhead Molecular Partners to withhold its consent if such extension would materially adversely affect effect such Arrowhead Molecular Partners Platform Patent. Such listings may include all so called “Orange Book” listings required under the Xxxxx-Xxxxxx Act or listing of Patents as provided in the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act of 2009 or under 42 U.S.C. § 262(l) or similar provisions in the Territory during the Term. Prior to such decision on listings, the Parties will meet to evaluate and identify all applicable Patents to be listed and Amgen Allergan shall reasonably incorporate and address suggestions provided by Arrowhead Molecular Partners as to the listing or non-listing of any applicable Patents.

Regulatory Data Protection. To the extent required by or permitted by Law, Amgen Allergan will, at its sole discretion, decide whether to list with the applicable Regulatory Authorities during the Term any applicable Arrowhead Product Molecular Partners [***] Patents claiming covering any Licensed Compound or Licensed Product that Amgen Allergan intends to, or has begun to, Commercialize, and that has become the subject of a Regulatory Approval Application submitted to FDA. In the event Amgen Allergan desires to include in such listing any Arrowhead Platform Molecular Partners [***] Patent, then the Parties shall meet and discuss such request in good faith and Arrowhead Molecular Partners will not unreasonably withhold consent to such listing, provided that it shall not be unreasonable for Arrowhead Molecular Partners to withhold its consent if such extension would materially adversely affect such Arrowhead Platform Molecular Partners [***] Patent. Such listings may include all so called “Orange Book” listings required under the Xxxxx-Xxxxxx Act or listing of Patents as provided in the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act of 2009 or under 42 U.S.C. § 262(l) or similar provisions in the Territory during the Term. Prior to such decision on listings, the Parties will meet to evaluate and identify all applicable Patents to be listed and Amgen Allergan shall reasonably incorporate and address suggestions provided by Arrowhead Molecular Partners as to the listing or non-listing of any applicable Patents.