Common use of Purple Book Listings Clause in Contracts

Purple Book Listings. To the extent of any BioNTech Enforcement Patent Rights, the Parties shall cooperate with each other to enable BioNTech to make filings with Regulatory Authorities, as required or allowed in connection with (a) in the United States, the FDA’s Purple Book and the Biologics Price Competition and Innovation Act and (b) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents thereof within the Territory. Pfizer shall consider BioNTech’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by applicable Law.

Purple Book Listings. To the extent of any BioNTech Enforcement Patent RightsRights Covering a Product, the Parties shall cooperate with each other to enable BioNTech Pfizer to make filings with Regulatory Authorities, as required or allowed in connection with (ai) in the United States, the FDA’s Purple Book and the Biologics Price Competition and Innovation Act and (bii) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents thereof within the Territorythereof. Pfizer shall consider BioNTech’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by applicable Law.