Common use of Compliance with Biosimilar Notices Clause in Contracts

Compliance with Biosimilar Notices. The MA Holder will have the sole right in its discretion to comply with the applicable provisions of 42 U.S.C. § 262(l) (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 from any Third Party regarding any Product that is being Commercialized in the Field in the Territory in the applicable jurisdiction, and the exchange of information between any Third Party and such MA Holder pursuant to such requirements; provided that, prior to any submission of information by MA Holder to a Third Party, the other Party will have the right to review the patent information included in such proposed submission, and to make suggestions as to any changes to such patent information that Pfizer reasonably believes to be necessary; provided further that MA Holder will determine the final content of any such submission. In the case of a Product approved in the United States under the PHS Act (or, in the case of a country in the Territory other than the United States, any similar Law), to the extent permitted by applicable Law, the MA Holder, as the sponsor of the application for the Product, will be the “reference product sponsor” under the PHS Act. The MA Holder will give written notice to the other Party of receipt of a Biosimilar Notice received by MA Holder with respect to a Product, and MA Holder will consult with the other Party with respect to the selection of any Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l) (or any similar law in any country of the Territory outside the United States); provided that the MA Holder will have final say on such selection of Patent Rights. Such other Party agrees to be bound and will cause its Affiliates and use Commercially Reasonable Efforts to cause all Third Party Licensors to be bound by the confidentiality provisions of 42 U.S.C. § 262(l)(1)(B)(iii). In connection with any action brought by such other Party under this Section 10.4.6, such other Party, upon the MA Holder’s request, will reasonably cooperate and will cause its Affiliates and use Commercially Reasonable Efforts to cause all Third Party Licensors to reasonably cooperate with MA Holder in any such action, including timely commencing or joining in any action brought by MA Holder under this Section 10.4.6.

Compliance with Biosimilar Notices. The MA Holder Pfizer will have the sole right in its discretion to comply with the applicable provisions of 42 U.S.C. § 262(l) (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 Pfizer from any Third Party regarding any Product that is being Commercialized in the Field in the Territory in the applicable jurisdiction, and the exchange of information between any Third Party and such MA Holder Pfizer pursuant to such requirements; provided that, prior to any submission of information by MA Holder Pfizer to a Third Party, the other Party BioNTech will have the right to review the patent information included in such proposed submission, solely with respect to BioNTech Patent Rights, and to make suggestions as to any changes to such patent information that Pfizer BioNTech reasonably believes to be necessary; provided further that MA Holder Pfizer will determine the final content of any such submission. In the case of a Product approved in the United States under the PHS Act (or, in the case of a country in the Territory other than the United States, any similar Law), to the extent permitted by applicable Law, the MA HolderPfizer, as the sponsor of the application for the Product, will be the “reference product sponsor” under the PHS Act. The MA Holder Pfizer will give written notice to the other Party BioNTech of receipt of a Biosimilar Notice received by MA Holder Pfizer with respect to a Product, and MA Holder Pfizer will consult with the other Party BioNTech with respect to the selection of any BioNTech Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l) (or any similar law in any country of the Territory outside the United States); provided that the MA Holder Pfizer will have final say on such selection of BioNTech Patent Rights. Such other Party BioNTech agrees to be bound and will cause its Affiliates and use Commercially Reasonable Efforts to cause all Third Party Licensors to be bound by the confidentiality provisions of 42 U.S.C. § 262(l)(1)(B)(iii). In connection with any action brought by such other Party Pfizer under this Section 10.4.67.3.2(f), such other PartyBioNTech, upon the MA HolderPfizer’s request, will reasonably cooperate and will cause its Affiliates and use Commercially Reasonable Efforts to cause all Third Party Licensors to reasonably cooperate with MA Holder Pfizer in any such action, including timely commencing or joining in any action brought by MA Holder Pfizer under this Section 10.4.67.3.2(f). Solely to the extent any BioNTech Patent Rights are involved in any such action, the Parties’ rights and responsibilities regarding any action will be determined in accordance with this Section 7.3.2(f).

Compliance with Biosimilar Notices. The MA Holder will have the sole right in its discretion to comply with the applicable provisions of 42 U.S.C. § 262(l) (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 from any Third Party regarding any Product that is being Commercialized in the Field in the Territory in the applicable jurisdiction, and the exchange of information between any Third Party and such MA Holder pursuant to such requirements; provided that, prior to any submission of information by MA Holder to a Third Party, the other Party will have the right to review the patent information included in such proposed submission, and to make suggestions as to any changes to such patent information that Pfizer reasonably believes to be necessary; provided further that MA Holder will determine the final content of any such submission. In the case of a Product approved in the United States under the PHS Act (or, in the case of a country in the Territory other than the United States, any similar Law), to the extent permitted by applicable Law, the MA Holder, as the sponsor of the application for the Product, will be the “reference product sponsor” under the PHS Act. The MA Holder will give written notice to the other Party of receipt of a Biosimilar Notice received by MA Holder with respect to a Product, and MA Holder will consult with the other Party with respect to the selection of any Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l) (or any similar law in any country of the Territory outside the United States); provided that the MA Holder will have final say on such selection of Patent Rights. Such other Party agrees to be bound and will cause its Affiliates and use Commercially Reasonable Efforts to cause all Third Party Licensors to be bound by the confidentiality provisions of 42 U.S.C. § 262(l)(1)(B)(iii). In connection with any action brought by such other Party under this Section 10.4.611.4.6, such other Party, upon the MA Holder’s request, will reasonably cooperate and will cause its Affiliates and use Commercially Reasonable Efforts to cause all Third Party Licensors to reasonably cooperate with MA Holder in any such action, including timely commencing or joining in any action brought by MA Holder under this Section 10.4.611.4.6.

Compliance with Biosimilar Notices. The MA Holder Pfizer will have the sole right in its discretion to comply with the applicable provisions of 42 U.S.C. § 262(l262(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 Pfizer from any Third Party regarding any Product that is being Commercialized in the Field in the Territory in the applicable jurisdiction, and the exchange of information between any Third Party and such MA Holder Pfizer pursuant to such requirements; provided that, prior to any submission of information by MA Holder Pfizer to a Third Party, the other Party Valneva will have the right to review the patent information included in such proposed submission, solely with respect to Valneva Patent Rights, and to make suggestions as to any changes to such patent information that Pfizer Valneva reasonably believes to be necessary; provided further that MA Holder Pfizer will determine the final content of any such submission. In the case of a Product approved in the United States under the PHS Act (or, in the case of a country in the Territory other than the United States, any similar Law), to the extent permitted by applicable Law, the MA HolderPfizer, as the sponsor of the application for the Product, will be the “reference product sponsor” under the PHS Act. The MA Holder Pfizer will give written notice to the other Party Valneva of receipt of a Biosimilar Notice received by MA Holder Pfizer with respect to a Product, and MA Holder Pfizer will consult with the other Party Valneva with respect to the selection of any Valneva Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l262(1) (or any similar law in any country of the Territory outside the United States); provided that the MA Holder Pfizer will have final say on such selection of Valneva Patent Rights. Such other Party Valneva agrees to be bound and will cause its Affiliates and use Commercially Reasonable Efforts to cause all Third Party Licensors to be bound by the confidentiality provisions of 42 U.S.C. § 262(l)(1)(B)(iii262(1)(1)(B)(iii). In connection with any action brought by such other Party Pfizer under this Section 10.4.6, such other Party6.2.2(d). Valneva, upon the MA HolderPfizer’s request, will reasonably cooperate and will cause its Affiliates and use Commercially Reasonable Efforts to cause all Third Party Licensors to reasonably cooperate with MA Holder Pfizer in any such action, including timely commencing or joining in any action brought by MA Holder Pfizer under this Section 10.4.66.2.2(d). Solely to the extent any Valneva Patent Rights are involved in any such action, the Parties’ rights and responsibilities regarding any action will be determined in accordance with this Section 6.2.2(d).