Common use of Biosimilar Notices Clause in Contracts

Biosimilar Notices. Celgene shall comply with the applicable provisions of 42 U.S.C. § 262(1) (or any amendment or successor statute thereto), any similar statutory or regulatory requirement enacted in the future regarding biologic products in the United States, or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction, in each case, with respect to any Biosimilar Notice received by Celgene from any Third Party regarding any Licensed Product that is being Commercialized in the applicable jurisdiction, and the exchange of information between any Third Party and Celgene pursuant to such requirements; provided that, [* * *]; provided further that [* * *]. Celgene shall give written notice to Acceleron of receipt of a Biosimilar Notice received by Celgene with respect to a Licensed Product, and Celgene shall consult with Acceleron with respect to the selection of the Patent Rights to be submitted pursuant to 42 U.S.C. § 262(1) (or any similar law in any country of the Territory outside the United States); provided that [* * *]. Acceleron agrees to be bound by the confidentiality provisions of 42 U.S.C. § 262(1)(1)(B)(iii). In order to establish standing in connection with any action brought by Celgene under this Section 8.8.2, Acceleron, upon Celgene’s request, shall reasonably cooperate with Celgene in any such action at Celgene’s expense, including timely commencing or joining in any action brought by Celgene under this Section 8.8.2 solely to the extent Acceleron Patent Rights are involved in any such action. Notwithstanding anything to the contrary in this Section 8.8, (a) if Acceleron Patent Rights or Joint Patent Rights are involved in any action brought by Celgene under this Section 8.8.2, [* * *], and (b) [* * *].

Biosimilar Notices. Celgene shall comply with the applicable provisions of 42 U.S.C. § 262(1) (or any amendment or successor statute thereto), any similar statutory or regulatory requirement enacted in the future regarding biologic products in the United States, or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction, in each case, with respect to any Biosimilar Notice received by Celgene from any Third Party regarding any Licensed Product that is being Commercialized in the applicable jurisdiction, and the exchange of information between any Third Party and Celgene pursuant to such requirements; provided that, [* * *]; provided further that [* * *]. Celgene shall give written notice to Acceleron of receipt of a Biosimilar Notice received by Celgene with respect to a Licensed Product, and Celgene shall consult with Acceleron with respect to the selection of the Patent Rights to be submitted pursuant to 42 U.S.C. § 262(1) (or any similar law in any country of the Territory outside the United States); provided that [* * *]. Acceleron agrees to be bound by the confidentiality provisions of 42 U.S.C. § 262(1)(1)(B)(iii). In order to establish standing in connection with any action brought by Celgene under this Section 8.8.2, Acceleron, upon Celgene’s request, shall reasonably cooperate with Celgene in any such action at Celgene’s expense, including timely commencing or joining in any action brought by Celgene under this Section 8.8.2 solely to the extent Acceleron Patent Rights are involved in any such action. Notwithstanding anything to the contrary in this Section 8.8, (a) if Acceleron Patent Rights or Joint Patent Rights are involved in any action brought by Celgene under this Section 8.8.2, [* * *], and (b) [* * *].. 8.9