Orange Book Information. Pfizer shall be responsible for all submissions of patent information pertaining to each Agreement Product pursuant to 21 U.S.C. § 355(b)(1)(G) (or any amendment or successor statute thereto), any similar statutory or regulatory requirement enacted in the future regarding biologic products, or any similar statutory or regulatory requirement in any non-United States country or other regulatory jurisdiction.
Orange Book Information. Lumena shall have the sole right, but not the obligation, to submit to all applicable Governmental Authorities patent information pertaining to each Licensed Product pursuant to 21 U.S.C. §355(b)(1)(G) (or any amendment or successor statute thereto) or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction.
Orange Book Information. AMAG shall have the sole right, but not the obligation, to submit to all applicable Governmental Authorities patent information pertaining to each Product pursuant to 21 U.S.C. § 355(b)(1)(G) (or any amendment or successor statute thereto), or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction in the Territory.
Orange Book Information. Anji Pharma shall have the sole right, but not the obligation, to submit to all applicable Governmental Authorities patent information pertaining to each Product for the Catalogue of Approved Drugs in China (i.e., the “Orange Book”).
Orange Book Information. Licensee shall have the sole right, but not the obligation, to select and submit to all applicable Governmental Authorities patent information pertaining to each IPI-145 Product pursuant to 21 U.S.C. § 355(b)(1)(G) (or any amendment or successor statute thereto), or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction.
Orange Book Information. Pfizer will have the sole right, but not the obligation, to submit to all applicable Governmental Authorities patent information pertaining to each Licensed Product pursuant to 21 U.S.C. § 355(b)(1)(G) (or any amendment or successor statute thereto), any similar statutory or regulatory requirement enacted in the future regarding biologic products, or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction. Pfizer shall keep OPKO reasonably apprised of the status of such submissions and shall provide to OPKO all relevant communications, notices and/or documents regarding such submissions in a timely fashion.
Orange Book Information. Pfizer will have the sole right, but not the obligation, to submit to all applicable Governmental Authorities patent information pertaining to each Product pursuant to 21 U.S.C. § 355(b)(1)(G) (or any amendment or successor statute thereto), or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction.
Orange Book Information. Each Party will have the sole right, but not the obligation, to submit to all applicable Governmental Authorities patent information pertaining to its Products pursuant to 21 U.S.C. § 355(b)(1)(G) (or any amendment or successor statute thereto), any similar statutory or regulatory requirement enacted in the future regarding biologic products, or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction.
Orange Book Information. Pfizer will have the sole right, but not the obligation, to submit to all applicable Governmental Authorities patent information pertaining to Licensed Products pursuant to any statutory or regulatory requirement in any country in the Pfizer Territory similar to 21 U.S.C. § 355(b)(1)(G) (or any amendment or successor statute thereto); provided, that, the Parties shall collaborate in good faith to determine whether any Licensed Patent Rights are required to be included in any such intended filings and, prior to making any such filing, Pfizer shall notify Sxxxx of any such filing and discuss in good faith any issues or comments Sxxxx may have with respect to such filing and Pfizer shall take into consideration Sxxxx’x reasonable comments.
Orange Book Information. Fosun shall have the sole right, but not the obligation, to submit to all applicable Governmental Authorities patent information pertaining to each Product pursuant to any statutory or regulatory requirement similar to 21 U.S.C. § 355(b)(1)(G) in any Jurisdiction or regulatory jurisdiction in the Territory. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
