Common use of Biosimilar Application Clause in Contracts

Biosimilar Application. Notwithstanding Sections 14.4.2.1 or 14.4.2.2, if either Party (or any of their Related Parties) receives a copy of a Biosimilar Application naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(1)(9)(C) of the PHSA), such Party will promptly notify the other Party. If either Party receives any equivalent or similar certification or notice in the United States or any other jurisdiction, either Party will, promptly, notify and provide the other Party copies of such communication. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Application: (a) The Party with the enforcement rights under Sections 14.4.2.1 or 14.4.2.2 (the “Lead Party” for the remainder of this Section 14.4.2.3) will designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who will receive confidential access to the Biosimilar Application. The Lead Party will pay all Patent Costs incurred by such Party for such enforcement under this Section 14.4.2.3. (b) The Lead Party will have the right, after consulting with the other Party, to list any Patents for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 are applicable, insofar as they meet the statutory requirements pursuant to Section 351(l)(1)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7) of the PHSA, to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in Section 351(l) of the PHSA. 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 PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (c) The Lead Party will have the right, after consulting with the other Party, to identify Patents for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 are applicable, or respond to relevant communications under any equivalent or similar listing to those described in the preceding Section 14.4.2.3(b) in any other jurisdiction outside of the United States. If required pursuant to applicable Law, upon the Lead Party’s request, the other Party will assist in the preparation of such list and make such response after consulting with the Lead Party. (d) The other Party will (1) within [***] after the Lead Party’s written request, provide to the Lead Party all information, including a list of Patents Controlled by such other Party and for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 are applicable, that is necessary or reasonably useful to enable the Lead Party to make any lists or communications with respect to such Patents that are described in the foregoing Sections 14.4.2.3(b) or 14.4.2.3(c), and (2) cooperate with the Lead Party’s reasonable requests in connection therewith to the extent required or not prohibited by applicable Law. The Lead Party will consult with the other Party prior to identifying any Patents controlled by such other Party as contemplated by this Section 14.4.2.

Biosimilar Application. Notwithstanding Sections 14.4.2.1 or 14.4.2.29.7.2 (Kissei Enforcement Rights) and 9.7.3 (CG Enforcement Rights), if either Party (or any of their Related Parties) its Affiliates receives a copy of a Biosimilar Application naming a Licensed Collaboration Compound, Product or Companion Diagnostic as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(1)(9)(C351(1)(9)(c) of the PHSAPHSA or an equivalent rule or law in the Territory), such Party will promptly (and in any event within ten (10) Business Days after receipt thereof) notify the other PartyParty and the JPWG. If either Party receives any equivalent or similar certification or notice in the United States States, Japan, or any other jurisdiction, either such Party willwill promptly (and in any event within [***] after receipt thereof) notify the other Party and the JPWG, promptly, notify and provide the other Party with copies of such communication. Regardless of the Party Party, or Affiliate or sublicensee of such Party, as the case may be, that is the “reference product sponsor” for purposes of such Biosimilar Application, with respect to a Biosimilar Application in the Territory: (a) The Party with the enforcement rights under Sections 14.4.2.1 or 14.4.2.2 (the “Lead Party” for the remainder of this Section 14.4.2.3) will designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who will receive confidential access to the Biosimilar Application. The Lead Party will pay all Patent Costs incurred by such Party for such enforcement under this Section 14.4.2.3. (b) The Lead Party Kissei will have the right, after consulting with the other PartyCG, to list any Patents for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 are applicable, insofar as they meet the statutory requirements pursuant to Section 351(l)(1)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7(A) of the PHSA, to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in Section 351(l) of the PHSA. 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 PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (c) The Lead Party will have the right, after consulting with the other Party, to identify Patents for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 Section 9.7.2 (Kissei Enforcement Rights) are applicable, or (b) respond to relevant communications under any equivalent or similar listing to those described in the preceding Section 14.4.2.3(b9.7.4 (Biosimilar Application) in any other jurisdiction outside of the United StatesTerritory. If required pursuant to applicable Applicable Law, upon the Lead PartyXxxxxx’s request, the other Party CG will assist in the preparation of such list and make such response after consulting with the Lead PartyKissei. (db) The other Party will CG shall: (1a) within [***] after the Lead PartyXxxxxx’s written request, provide to the Lead Party Kissei with all informationinformation in its possession and Control, including a list of Patents Controlled by such other Party and CG for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 Section 9.7.2 (Kissei Enforcement Rights) are applicable, that is necessary or reasonably useful to enable the Lead Party Kissei to make any lists or communications with respect to such Patents that are described in the foregoing Sections 14.4.2.3(bSection 9.7.4 (Biosimilar Application) or 14.4.2.3(cSection 9.7.4(d) (Biosimilar Application), and (2b) cooperate with the Lead PartyXxxxxx’s reasonable requests in connection therewith to the extent required or not prohibited by applicable Lawlaw. The Lead Party Kissei will consult with the other Party CG prior to identifying any Patents controlled Controlled by such other Party CG as contemplated by this Section 14.4.29.7.4 (Biosimilar Application). Xxxxxx will consider in good faith advice and suggestions with respect thereto received from CG, and will notify CG of any such lists or communications promptly after they are made. (c) For the avoidance of doubt, the Parties recognize that procedures other than those set forth above in this Section 9.7.4 (Biosimilar Application) may be applicable to Biosimilar Applications that are not governed by the PHSA or equivalent rule or law in Japan. As a result, if the Parties, acting in good faith, mutually determine that certain provisions of law in the United States or in any other country or jurisdiction are applicable to actions taken by the Parties with respect to Biosimilar Applications under this Section 9.7.4 (Biosimilar Application) in such country or jurisdiction, the Parties will comply with any such law in such country or jurisdiction (and any relevant and reasonable procedures established by the applicable governing body in such jurisdiction) in exercising their respective rights and obligations with respect to Biosimilar Applications under this Section 9.7.4 (Biosimilar Application).

Biosimilar Application. Notwithstanding Sections 14.4.2.1 or 14.4.2.2, if either Party (or any of their Related Parties) receives a copy of a Biosimilar Application naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(1)(9)(C) of the PHSA), such Party will promptly notify the other Party. If either Party receives any equivalent or similar certification or notice in the United States or any other jurisdiction, either Party will, promptly, notify and provide the other Party copies of such communication. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Application: (a) The Party with the enforcement rights under Sections 14.4.2.1 or 14.4.2.2 (the “Lead Party” for the remainder of this Section 14.4.2.3) will designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who will receive confidential access to the Biosimilar Application. The Lead Party will pay all Patent Costs incurred by such Party for such enforcement under this Section 14.4.2.3. (b) The Lead Party will have the right, after consulting with the other Party, to list any Patents for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 are applicable, insofar as they meet the statutory requirements pursuant to Section 351(l)(1)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7) of the PHSA, to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in Section 351(l) of the PHSA. 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 PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (c) The Lead Party will have the right, after consulting with the other Party, to identify Patents for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 are applicable, or respond to relevant communications under any equivalent or similar listing to those described in the preceding Section 14.4.2.3(b) in any other jurisdiction outside of the United States. If required pursuant to applicable Law, upon the Lead Party’s request, the other Party will assist in the preparation of such list and make such response after consulting with the Lead Party. (d) The other Party will (1) within [***] after the Lead Party’s written request, provide to the Lead Party all information, including a list of Patents Controlled by such other Party and for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 are applicable, that is necessary or reasonably useful to enable the Lead Party to make any lists or communications with respect to such Patents that are described in the foregoing Sections 14.4.2.3(b) or 14.4.2.3(c), and (2) cooperate with the Lead Party’s reasonable requests in connection therewith to the extent required or not prohibited by applicable Law. The Lead Party will consult with the other Party prior to identifying any Patents controlled by such other Party as contemplated by this Section 14.4.214.4.2.3. The Lead Party will consider in good faith advice and suggestions with respect thereto received from the other Party, and will notify the other Party of any such lists or communications promptly after they are made. (e) The Parties recognize that procedures other than those set forth above in this Section 14.4.2.3 may be applicable to Biosimilar Applications that are not governed by the PHSA. As a result, in the event that the Parties acting in good faith mutually determine that certain provisions of Law in the United States or in any other country in the Territory are applicable to actions taken by the Parties with respect to Biosimilar Applications under this Section 14.4.2.3 in such country, the Parties will comply with any such applicable Law in such country (and any relevant and reasonable procedures established by the) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 14.4.2.3.

Biosimilar Application. Notwithstanding Sections 14.4.2.1 or 14.4.2.214.4.2.3, if either Party (or any of their Related Parties) receives a copy of a Biosimilar Application naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(1)(9)(C) of the PHSA), such Party will promptly notify the other Party. If either Party receives any equivalent or similar certification or notice in the United States or any other jurisdiction, either Party will, promptly, notify and provide the other Party copies of such communication. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Application: (a) The Party with the enforcement rights under Sections 14.4.2.1 or 14.4.2.2 14.4.2.3 (the “Lead Party” for the remainder of this Section 14.4.2.314.4.2.4) will designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who will receive confidential access to the Biosimilar Application. The Lead Party will pay all Patent Costs incurred by such Party for such enforcement under this Section 14.4.2.314.4.2.4. (b) The Lead Party will have the right, after consulting with the other Party, to list any Patents for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 14.4.2.3 are applicable, insofar as they meet the statutory requirements pursuant to Section 351(l)(1)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7) of the PHSA, to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in Section 351(l) of the PHSA. 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 PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (c) The Lead Party will have the right, after consulting with the other Party, to identify Patents for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 14.4.2.3 are applicable, or respond to relevant communications under any equivalent or similar listing to those described in the preceding Section 14.4.2.3(b14.4.2.4(b) in any other jurisdiction outside of the United States. If required pursuant to applicable Law, upon the Lead Party’s request, the other Party will assist in the preparation of such list and make such response after consulting with the Lead Party. (d) The other Party will (1) within [...***...] after the Lead Party’s written request, provide to the Lead Party all information, including a list of Patents Controlled by such other Party and for which the enforcement rights in Sections 14.4.2.1 and 14.4.2.2 14.4.2.3 are applicable, that is necessary or reasonably useful to enable the Lead Party to make any lists or communications with respect to such Patents that are described in the foregoing Sections 14.4.2.3(b14.4.2.4(b) or 14.4.2.3(c14.4.2.4(c), and (2) cooperate with the Lead Party’s reasonable requests in connection therewith to the extent required or not prohibited by applicable Law. The Lead Party will consult with the other Party prior to identifying any Patents controlled by such other Party as contemplated by this Section 14.4.214.4.2.4. The Lead Party will consider in good faith advice and suggestions with respect thereto received from the other Party, and will notify the other Party of any such lists or communications promptly after they are made. (e) The Parties recognize that procedures other than those set forth above in this Section 14.4.2.4 may be applicable to Biosimilar Applications that are not governed by the PHSA. As a result, in the event that the Parties acting in good faith mutually determine that certain provisions of Law in the United States or in any other country in the Territory are applicable to actions taken by the Parties with respect to Biosimilar Applications under this Section 14.4.2.4 in such country, the Parties will comply with any such Law in such country (and any relevant and reasonable procedures established by the applicable governing body in such country) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 14.4.2.4.