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 required by or permitted by Applicable Law, Licensee will have the right to decide whether to list with the applicable Regulatory Authorities during the Term any applicable Patent Rights for a Compound or Product that has become the subject of an application for Regulatory Approval submitted to FDA as a “biosimilar” or equivalent version of a Product. ImmunoGen will reasonably cooperate, at Licensee’s request and expense, in preparing and/or filing such listings within the time frames available or required for such listings to be submitted in connection with such Compound and/or Product.
Purple Book Listings. To the extent of any Sangamo Patent Rights or Licensed Research Program Patent Rights Covering a Product, the Parties shall cooperate with each other to enable Pfizer to make filings with Regulatory Authorities, as required or allowed in connection with (i) in the United States, the FDA’s Purple Book and the Biologics Price Competition and Innovation Act and (ii) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents thereof. Pfizer shall consider Sangamo’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by Applicable Law. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Purple Book Listings. [ * ] shall be responsible for listing Licensed Product Patents in the FDA’s “Purple Book” or any equivalent thereto in any other country in the world with respect to the applicable Royalty Product [ * ] or RC48 Licensed Product or Opt-In Product [ * ] in any country or jurisdiction in such [ * ], provided that: (a) Seagen [ * ]. For clarity, [ * ].
Purple Book Listings. Day One shall have the sole right and authority to list or de-list any MabCare Patents, Day One Patents and Joint Foreground Patents in the Day One Territory, in the FDA’s “Purple Book” or any ex-U.S. equivalent thereto with respect to the Licensed Products. MabCare shall have the sole right and authority to list or de-list any MabCare Patents, Day One Foreground Patents and Joint Foreground Patents in the MabCare Territory in any equivalent to the FDA’s “Purple Book” with respect to the Licensed Products. Each Party shall reasonably cooperate with the other Party in making or withdrawing any such listing for a Patent Rights as set forth above, at the requesting Party’s cost, including applying for such patent listing and signing all necessary documents.
Purple Book Listings. Celgene (or its designee) shall have the sole right to list, with the applicable Regulatory Authorities in the Territory, all applicable Patents (including any Jounce Patents or Joint Patents) for any Licensed Product, including all so-called “Purple Book” listings required under the U.S. Public Health Service Act, and all similar listings in any other relevant countries. For the avoidance of doubt, Celgene will retain final decision-making authority with respect to the listing of all applicable Patents for any Licensed Product, regardless of which Party owns such Patent, and Jounce shall reasonably assist Celgene in connection therewith.
Purple Book Listings. As between the Parties, Gilead (or its designee) will have the sole right to list, with the applicable Regulatory Authorities in the Territory, all applicable Patents (including any Jounce-Owned Patents and/or Joint Patents) for any Licensed Product, including all so-called “Purple Book” listings required under the U.S. Public Health Service Act, and all similar listings in any other relevant countries. For the avoidance of doubt, Gilead will retain final decision-making authority with respect to the listing of all applicable Patents for any Licensed Product, regardless of which Party owns such Patent, and Jounce will reasonably assist Gilead in connection therewith.
Purple Book Listings. Astellas shall be responsible, at its sole cost, for determining which Sutro Program Specific Component Patents, Astellas Patents and Joint Collaboration Patents to list in the FDA’s “Purple Book” or any equivalent thereto in any other country in the world with respect to the Licensed Products, and for listing any such Patent Rights. At Astellas’s request, Sutro shall reasonably cooperate with Astellas (at Astellas’s cost) with respect to listing in the Purple Book or any equivalent thereto a Sutro Patent that is not a Joint Collaboration Patent, provided that notwithstanding anything herein to the contrary, Sutro shall have the final decision-making authority as to whether or not such Sutro Patent may be listed.
Purple Book Listings. To the extent of any Valneva Patent Rights Covering a Product, the Parties shall cooperate with each other to enable Pfizer to make filings with Regulatory Authorities, as required or allowed in connection with (i) in the United States, the FDA’s Purple Book and the Biologics Price Competition and Innovation Act and (ii) outside the United States, under the national implementations of Article 10.l(a)(iii) of Directive 2001/EC/83 or other international equivalents thereof. Pfizer shall consider Valneva’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by Applicable Law.
