Common use of Regulatory Data Protection Clause in Contracts

Regulatory Data Protection. To the extent required by Law, EISAI shall use Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable Patents for any Licensed Product that EISAI intends to, or has begun to, Commercialize and that have become the subject of an application for Regulatory Approval submitted to FDA, such listings to include all so called “Orange Book” listings required under the Xxxxx-Xxxxxx Act and all so called “Patent Register” listings as required in Canada. Prior to such listings, the Parties shall meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, except as may otherwise be provided in a Joint Development and Commercialization Agreement and subject to Section 9.6, EISAI shall retain final decision-making authority as to the listing of all applicable Patents for such Licensed Product, regardless of which Party owns such Patent.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Epizyme, Inc.), Collaboration and License Agreement (Epizyme, Inc.)

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Regulatory Data Protection. To the extent required by Law, EISAI EPIZYME shall use Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable Patents for any Licensed Product that EISAI EPIZYME intends to, or has begun to, Commercialize and that have become the subject of an application for Regulatory Approval submitted to FDA, such listings to include all so called “Orange Book” listings required under the Xxxxx-Xxxxxx Act and all so called “Patent Register” listings as required in Canada. Prior to such listings, the Parties shall meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, except as may otherwise be provided in a Joint Development and Commercialization Agreement and subject to Section 9.6, EISAI EPIZYME shall retain final decision-making authority as to the listing of all applicable Patents for such Licensed Product, regardless of which Party owns such Patent.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Epizyme, Inc.), Collaboration and License Agreement (Epizyme, Inc.)

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