Common use of Regulatory Data Protection Clause in Contracts

Regulatory Data Protection. To the extent required by or permitted by Law, Allergan will, at its sole discretion, decide whether to list with the applicable Regulatory Authorities during the Term any applicable Molecular Partners Product Patents covering any Licensed Product that 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 Allergan desires to include in such listing any Molecular Partners Platform Patent, then the Parties shall meet and discuss such request in good faith and Molecular Partners will not unreasonably withhold consent to such listing, provided that it shall not be unreasonable for Molecular Partners to withhold its consent if such extension would materially adversely effect such 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 Allergan shall reasonably incorporate and address suggestions provided by 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, Allergan Amgen will, at its sole discretion, decide whether to list with the applicable Regulatory Authorities during the Term any applicable Molecular Partners Arrowhead Product Patents covering claiming any Licensed Compound or Licensed Product that Allergan Amgen 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 Allergan Amgen desires to include in such listing any Molecular Partners Arrowhead Platform Patent, then the Parties shall meet and discuss such request in good faith and Molecular Partners Arrowhead will not unreasonably withhold consent to such listing, provided that it shall not be unreasonable for Molecular Partners Arrowhead to withhold its consent if such extension would materially adversely effect affect such Molecular Partners 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 Allergan Amgen shall reasonably incorporate and address suggestions provided by Molecular Partners Arrowhead as to the listing or non-listing of any applicable Patents.

Regulatory Data Protection. To the extent required by or permitted by Law, Allergan will, at its sole discretion, decide whether to list with the applicable Regulatory Authorities during the Term any applicable Molecular Partners Product [***] Patents covering any Licensed Product that 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 Allergan desires to include in such listing any Molecular Partners Platform [***] Patent, then the Parties shall meet and discuss such request in good faith and Molecular Partners will not unreasonably withhold consent to such listing, provided that it shall not be unreasonable for Molecular Partners to withhold its consent if such extension would materially adversely effect affect such 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 Allergan shall reasonably incorporate and address suggestions provided by Molecular Partners as to the listing or non-listing of any applicable Patents.