Common use of Biosimilar Applications Clause in Contracts

Biosimilar Applications. Notwithstanding the foregoing provisions of this Section 6.9, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 6.9.9 shall apply. Such Party shall promptly, but in any event within [***] ([***]) Business Days, notify the other Party. The owner of the relevant Patents shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application: (a) [***] the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii). (b) In each case, after consulting with [***] and considering [***]’s comments in good faith, [***] shall have the right to (a) list any patents, including those Patents within the Prothena IP, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents shall be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). [***] (c) [***] shall have the right, after consulting with [***], to identify Patents, including those Patents within the Prothena IP, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (b) in any other jurisdiction outside of the United States. [***]. (d) [***] shall cooperate with [***]’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] shall consult with [***] prior to identifying any Patents within the Prothena IP to a Third Party as contemplated by this Section 6.9.9. [***] shall consider in good faith advice and suggestions with respect thereto received from [***], and notify [***] of any such lists or communications promptly after they are made. (e) Each Party shall within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. [***]. Except as otherwise provided in this Section 6.9.9, any such action shall be subject to the terms and conditions of Section 6.9.1 through 6.9.8. (f) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.9. Notwithstanding the provisions of this Section 6.9.9, nothing in this Section 6.9.9 shall grant any rights to Prothena with respect to any Celgene IP.

Biosimilar Applications. Notwithstanding the foregoing provisions of this Section 6.96.9.2, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 6.9.9 6.9.2(i) shall apply. Such Party shall promptly, but in any event within [***] ([***]) Business Days, notify the other Party. The owner of the relevant Patents shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application: (ai) [***] the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii). (b) In each case, after consulting with [***] and considering [***]’s comments in good faith, [***] shall have the right to (a) list any patents, including those Patents within the Prothena IP, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents shall be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). [***] (c) [***] shall have the right, after consulting with [***], to identify Patents, including those Patents within the Prothena IP, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (b) in any other jurisdiction outside of the United States. [***]. (d) [***] shall cooperate with [***]’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] shall consult with [***] prior to identifying any Patents within the Prothena IP to a Third Party as contemplated by this Section 6.9.9. [***] shall consider in good faith advice and suggestions with respect thereto received from [***], and notify [***] of any such lists or communications promptly after they are made. (e) Each Party shall within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. [***]. Except as otherwise provided in this Section 6.9.9, any such action shall be subject to the terms and conditions of Section 6.9.1 through 6.9.8. (f) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.9. Notwithstanding the provisions of this Section 6.9.9, nothing in this Section 6.9.9 shall grant any rights to Prothena with respect to any Celgene IP.

Biosimilar Applications. Notwithstanding the foregoing provisions of this Section 6.97.4(a), if either Party (or its Affiliate) receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIABiologics Price Competition and Innovation Act of 2009, as amended, the United States U.S. Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §§ 262(l)(2)), the remainder of this Section 6.9.9 shall 7.4(b) will apply. Such The Party shall promptly, but in any event within [***] ([***]or its Affiliate) Business Days, notify the other Party. The owner receiving such copy of the relevant Patents shall Biosimilar Application will then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §§ 262(l)(1)(B)(iii). If either Party receives ) or any equivalent non-U.S. rule or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the extent permitted by Applicable Lawsregulation. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §§ 262(l)(1)(A), for purposes of such Biosimilar Application: (ai) [***] Licensee will designate, to the extent permitted by Applicable Law, or otherwise Licensor or its Affiliate will designate in accordance with Licensee’s instructions, the outside counsel and in-house counsel who shall will receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §§ 262(l)(1)(B)(ii)) or any equivalent non-U.S. rule or regulation. (bii) In each case, after consulting with [***] and considering [***]’s comments in good faith, [***] shall Licensee will have the right to (aA) list any patents, including those Patents within the Prothena IPLicensed Patents, as required pursuant to 42 U.S.C. §§ 262(l)(3)(A) or 42 U.S.C. §§ 262(l)(7), (bB) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (cC) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §§ 262(l)(1), and (dD) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §§ 262(l)(4), decide which Patent or Patents shall will be selected for litigation under 42 U.S.C. §§ 262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §§ 262(l)(6). [***] (c) [***] shall have the rightIn each case, after consulting with [***], Licensee will have the right to identify Patents, including those Patents within the Prothena IP, or respond to relevant communications take such actions as appropriate under any equivalent non-U.S. rule or similar listing regulation appliable to those described Biosimilars and Biosimilar Applications. If Licensor or its Affiliate is required pursuant to Applicable Law to execute any of these tasks it will do so in the preceding clause (b) in any other jurisdiction outside of the United States. accordance with [***]. (diii) [***] shall Licensor will cooperate with [***]Licensee’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. Licensee will [***] shall consult with [***] Licensor prior to identifying any Patents within the Prothena IP Licensed Patents to a Third Party as contemplated by this Section 6.9.97.4(b). Licensee will [***] shall consider in good faith advice and suggestions with respect thereto received from [***]Licensor, and notify [***] Licensor of any such lists or communications promptly after they are made.. ​ ​ ​ (eiv) Each Party shall within or its Affiliate will [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §§ 262(l)(8)(A)) or any equivalent non-U.S. rule or regulation, notify the other Party. To the extent permitted by Applicable Law, Licensee will have [***] shall have the first right, but not the obligation], to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §§ 262(l)(8)(B) or any equivalent non-U.S. rule or regulation and to file an action for infringement. If required pursuant to Applicable Law, upon Licensee’s request, Licensor or its Affiliate will assist in seeking such injunction or filing such infringement action after [***]] Licensee. Except as otherwise provided in this Section 6.9.97.4(b), any such action shall will be subject to the other terms and conditions of Section 6.9.1 through 6.9.87.4(a). (f) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.9. Notwithstanding the provisions of this Section 6.9.9, nothing in this Section 6.9.9 shall grant any rights to Prothena with respect to any Celgene IP.

Biosimilar Applications. Notwithstanding the foregoing provisions of this Section 6.9, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 6.9.9 shall apply. Such Party shall promptly, but in any event within [***] ([***]) Business Days, notify the other Party. The owner of the relevant Patents shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application: (a) [***] the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii). (b) In each case, after consulting with [***] and considering [***]’s comments in good faith, [***] shall have the right to (a) list any patents, including those Patents within the Prothena IP, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents shall be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). [***] (c) [***] shall have the right, after consulting with [***], to identify Patents, including those Patents within the Prothena IP, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (b) in any other jurisdiction outside of the United States. [***]. (d) [***] shall cooperate with [***]’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] shall consult with [***] prior to identifying any Patents within the Prothena IP to a Third Party as contemplated by this Section 6.9.9. [***] shall consider in good faith advice and suggestions with respect thereto received from [***], and notify [***] of any such lists or communications promptly after they are made. (e) Each Party shall within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. [***]. Except as otherwise provided in this Section 6.9.9, any such action shall be subject to the terms and conditions of Section 6.9.1 through 6.9.8. (f) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Applications under this Section 6.9.8 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.9. Notwithstanding the provisions of this Section 6.9.9, nothing in this Section 6.9.9 shall grant any rights to Prothena with respect to any Celgene IP.

Biosimilar Applications. Notwithstanding the foregoing provisions of this Section 6.9, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 6.9.9 shall apply. Such Party shall promptly, but in any event within [***] ([***]) Business Days, notify the other Party. The owner of the relevant Patents shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application: (a) [***] ], the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, information regarding the process or processes CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii). (b) In each case, after consulting with [***] and considering [***]’s ] comments in good faith, [***] shall have the right to (a) list any patents, including those Patents within the Prothena IP, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents shall be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). .[***]. (c) [***] shall have the right, after consulting with [***], to identify Patents, including those Patents within the Prothena IP, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (b) in any other jurisdiction outside of the United States. [***]. (d) [***] shall cooperate with [***]’s ] reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] shall consult with [***] prior to identifying any Patents within the Prothena IP to a Third Party as contemplated by this Section 6.9.9. [***] shall consider in good faith advice and suggestions with respect thereto received from from[***], and notify [***] of any such lists or communications promptly after they are made. (e) Each Party shall within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. .[***]. Except as otherwise provided in this Section 6.9.9, any such action shall be subject to the terms and conditions of Section 6.9.1 through 6.9.8. (f) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.9. Notwithstanding the provisions of this Section 6.9.9, nothing in this Section 6.9.9 shall grant any rights to Prothena with respect to any Celgene IP or Celgene Antibody IP.

Biosimilar Applications. Notwithstanding the foregoing provisions of this Section 6.96.9.2, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 6.9.9 6.9.2(i) shall apply. Such Party shall promptly, but in any event within [***] ([***]) Business Days, notify the other Party. The owner of the relevant Patents shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application: (ai) [***] the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii). (b) In each case, after consulting with [***] and considering [***]’s comments in good faith, [***] shall have the right to (a) list any patents, including those Patents within the Prothena IP, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents shall be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). [***] (c) [***] shall have the right, after consulting with [***], to identify Patents, including those Patents within the Prothena IP, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (b) in any other jurisdiction outside of the United States. [***]. (d) [***] shall cooperate with [***]’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] shall consult with [***] prior to identifying any Patents within the Prothena IP to a Third Party as contemplated by this Section 6.9.9. [***] shall consider in good faith advice and suggestions with respect thereto received from [***], and notify [***] of any such lists or communications promptly after they are made. (e) Each Party shall within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. [***]. Except as otherwise provided in this Section 6.9.9, any such action shall be subject to the terms and conditions of Section 6.9.1 through 6.9.8. (f) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.9. Notwithstanding the provisions of this Section 6.9.9, nothing in this Section 6.9.9 shall grant any rights to Prothena with respect to any Celgene IP.

Biosimilar Applications. (a) Notwithstanding the foregoing provisions of this Section 6.99.3, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), Product or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 6.9.9 shall 9.3.9 will apply. Such Party shall promptly, but in any event will within [...***...] ([***]) Business Days, notify the other Party. The owner of the relevant Patents shall will then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall will within [...***...] ([***]) Business Days notify and provide the other Party copies of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar ApplicationApplication the following will apply: (ai) [***] The Parties will mutually agree upon, and BeiGene will designate in accordance with such mutual agreement, the outside counsel and in-house counsel who shall will receive confidential access to the Biosimilar Application, information regarding the * Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission. process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii). (bii) In each case, after consulting with [***] Celgene and considering [***]’s comments in good faith, [***] shall have the right BeiGene will cooperate and mutually agree upon: any Patents to (a) list any patentsbe listed, including those Patents within the Prothena IPBeiGene Patents, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond responses to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate negotiations with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), ) and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents shall will be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence the commencement such litigation under 42 U.S.C. §262(l)(6). [***] Any such action will be subject to the terms and conditions of Section 9.3.2 through 9.3.8 in relation to actions for infringement brought by Celgene (c) [***] provided that, for the avoidance of doubt, BeiGene shall have no rights to enforce any Celgene IP and, as between the Parties, Celgene shall have the right, after consulting sole right to do so). If BeiGene is required pursuant to Law to execute any of these tasks it will do so in accordance with [***], such mutual agreement. (iii) Celgene and BeiGene will cooperate and mutually agree upon Patents to identify Patentsbe identified, including those Patents within the Prothena IPBeiGene Patents, or respond responses to relevant communications under any equivalent or similar listing to those described in the preceding clause (bii) in any other jurisdiction within the Celgene Territory outside of the United States. If BeiGene is required pursuant to Law to execute any of these tasks it will do so in accordance with such mutual agreement. (iv) Each Party will within [...***]. (d) [***...] shall cooperate with [***]’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] shall consult with [***] prior to identifying any Patents within the Prothena IP to a Third Party as contemplated by this Section 6.9.9. [***] shall consider in good faith advice and suggestions with respect thereto received from [***], and notify [***] of any such lists or communications promptly after they are made. (e) Each Party shall within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall Celgene will have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringementpatent infringement of all applicable Patents (including any BeiGene Patents or Joint Patents). [***]If required pursuant to Law, upon Celgene’s request, BeiGene will assist in seeking such injunction or filing such infringement action after consulting with Celgene. Except as otherwise provided in this Section 6.9.9, any Any such action shall will be subject to the terms and conditions of Section 6.9.1 9.3.2 through 6.9.89.3.8 in relation to actions for infringement brought by Celgene (provided that, for the avoidance of doubt, BeiGene shall have no rights to enforce any Celgene IP and, as between the Parties, Celgene shall have the sole right to do so). (fv) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 9.3.9 may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws Law in the United States or in any other country in the Celgene Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 9.3.9 in the United States or in such other country, as applicable, the Parties shall will comply with any such Applicable Laws in such Law for the applicable country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.9. Notwithstanding 9.3.9, with the provisions goal of this Section 6.9.9, nothing granting the Parties the rights as set forth in this Section 6.9.9 shall grant any rights 9.3.9. * Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission. (b) As used herein, the term “Biosimilar Application” means an application or submission filed with a Regulatory Authority for Regulatory Approval of a pharmaceutical or biological product claimed to Prothena with respect be biosimilar or interchangeable to any Celgene IPLicensed Product or otherwise relying on the approval of such Licensed Product, including, for example, an application filed under 42 U.S.C. §262(k).

Biosimilar Applications. Notwithstanding the foregoing provisions of this Section 6.98.3.2, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 6.9.9 8.3.3 shall apply. Such Party shall will promptly, but in any event within [***] ten ([***]10) Business Days, notify the other Party. The owner of the relevant Patents shall will then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall will within [***] five ([***]5) Business Days business days notify the other Party of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application: (a) [***] Zogenix will designate, to the extent permitted by Applicable Law, or otherwise Tevard will designate in accordance with Zogenix’s instructions, the outside counsel and in-house counsel who shall will receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii). (b) In each case, after consulting with [***] Tevard and considering [***]Tevard’s comments in good faith, [***] Zogenix shall have the right to (a) list any patents, including those Patents within the Prothena IPTevard Patents, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents shall will be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). [***]If Tevard is required pursuant to Applicable Law to execute any of these tasks it will do so in accordance with Zogenix’s instructions. ||| (c) [***] shall have the right, after consulting with [***], to identify Patents, including those Patents within the Prothena IP, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (b) in any other jurisdiction outside of the United States. [***]. (d) [***] Tevard shall cooperate with [***]Zogenix’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] Zogenix shall consult with [***] Tevard prior to identifying any Patents within the Prothena IP Tevard Patents to a Third Party as contemplated by this Section 6.9.98.3.3. [***] Zogenix shall consider in good faith advice and suggestions with respect thereto received from [***]Tevard, and notify [***] Tevard of any such lists or communications promptly after they are made. (ed) Each Party shall will within [***] five ([***]5) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall Zogenix will have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. [***]If required pursuant to Applicable Law, upon Zogenix’s request, Tevard will assist in seeking such injunction or filing such infringement action after consulting with Zogenix. Except as otherwise provided in this Section 6.9.98.3.3, any such action shall contemplated by this section will be subject to the other terms and conditions of Section 6.9.1 through 6.9.88.3.2. (f) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.9. Notwithstanding the provisions of this Section 6.9.9, nothing in this Section 6.9.9 shall grant any rights to Prothena with respect to any Celgene IP.

Biosimilar Applications. Notwithstanding the foregoing provisions of this Section 6.97.11, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws applicable Law (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its their successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §§ 262(l)(2)), the remainder of this Section 6.9.9 7.11.8 shall apply. Such Party shall promptly, but in any event within [***] ([***]) Business Daysof becoming aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization, notify the other Party. The owner of the relevant Patents Patent Rights shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §§ 262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the extent permitted by Applicable Lawsapplicable Law. Regardless of the Party that is the “reference product sponsor,” ”, as defined in 42 U.S.C. §§ 262(l)(1)(A), for purposes of such Biosimilar Application: (a) [***] Juno shall designate, to the extent permitted by applicable Law, or otherwise Editas shall designate in accordance with Juno’s instructions, the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §§ 262(l)(1)(B)(ii). (b) In each case, after consulting with [***] Editas and considering [***]’s Editas’ comments in good faith, [***] Juno shall have the right to (ai) list any patentsPatent Rights, including those any Editas Licensed Background Patents, Editas Licensed Collaboration Patents, Joint Collaboration Patents within the Prothena IPand Joint Patents, as required pursuant to 42 U.S.C. §§ 262(l)(3)(A) or 42 U.S.C. §§ 262(l)(7), (bii) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (ciii) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §§ 262(l)(1), ) and (div) as to the Patents Patent Rights that will be subject to the litigation procedure as described in 42 U.S.C. §§ 262(l)(4), decide which Patent or Patents Rights shall be selected for litigation under 42 U.S.C. §§ 262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §§ 262(l)(6). [***]If Editas is required pursuant to applicable Law to execute any of these tasks, it shall do so in accordance with Juno’s instructions. (c) [***] Juno shall have the right, after consulting with [***]Editas, to identify Patent Rights, including any Editas Licensed Background Patents, including those Editas Licensed Collaboration Patents, Joint Collaboration Patents within the Prothena IPand Joint Patents, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (b) in any other jurisdiction outside of the United States. [***]If Editas is required pursuant to applicable Law to execute any of these tasks, it shall do so in accordance with Juno’s instructions. (d) [***] Editas shall cooperate with [***]Juno’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Lawsapplicable Law. [***] Juno shall consult with [***] Editas prior to identifying any Editas Licensed Background Patents, Editas Licensed Collaboration Patents, Joint Collaboration Patents within the Prothena IP or Joint Patents to a Third Party as contemplated by this Section 6.9.97.11.8. [***] Juno shall consider in good faith advice and suggestions with respect thereto received from [***]Editas, and notify [***] Editas of any such lists or communications promptly after they are made. (e) Each Party shall notify the other Party within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §§ 262(l)(8)(A), notify the other Party. To the extent permitted by Applicable applicable Law, [***] Juno shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §§ 262(l)(8)(B) and to file an action for infringement. [***]If required pursuant to applicable Law, upon Juno’s request, Editas shall assist in seeking such injunction or filing such infringement action after consulting with Juno. Except as otherwise provided in this Section 6.9.97.11.8, any such action shall be subject to the terms and conditions of Section 6.9.1 Sections 7.11.1 through 6.9.87.11.7. (f) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 7.11.8 may apply with respect to Biosimilar Applications, either in the United States or elsewhere. In the event that If the Parties determine that certain provisions of Applicable Laws applicable Law in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 7.11.8 in such country, the Parties shall comply with any such Applicable Laws applicable Law in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.97.11.8 in a manner to effectuate the intent of this Section 7.11.8. Notwithstanding the foregoing provisions of this Section 6.9.97.11.8, nothing in this Section 6.9.9 7.11.8 shall grant any rights to Prothena Editas with respect to any Celgene Juno IP.

Biosimilar Applications. Notwithstanding the foregoing provisions of this Section 6.96.9.2, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 6.9.9 6.9.2(i) shall apply. Such Party shall promptly, but in any event within [***] ([***]) Business Days, notify the other Party. The owner of the relevant Patents shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application: (ai) [***] the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii). (b) In each case, after consulting with [***] and considering [***]’s comments in good faith, [***] shall have the right to (a) list any patents, including those Patents within the Prothena IP, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents shall be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). [***] (c) [***] shall have the right, after consulting with [***], to identify Patents, including those Patents within the Prothena IP, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (b) in any other jurisdiction outside of the United States. [***]. (d) [***] shall cooperate with [***]’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] shall consult with [***] prior to identifying any Patents within the Prothena IP to a Third Party as contemplated by this Section 6.9.9. [***] shall consider in good faith advice and suggestions with respect thereto received from [***], and notify [***] of any such lists or communications promptly after they are made. (e) Each Party shall within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. [***]. Except as otherwise provided Certain information in this Section 6.9.9, any such action shall be subject to document has been omitted and filed separately with the terms Securities and conditions of Section 6.9.1 through 6.9.8. (f) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 may apply Exchange Commission. Confidential treatment has been requested with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.9. Notwithstanding the provisions of this Section 6.9.9, nothing in this Section 6.9.9 shall grant any rights to Prothena with respect to any Celgene IPomitted portions.

Biosimilar Applications. Notwithstanding the foregoing provisions of this Section 6.97.11, if either Party receives a copy of a Biosimilar Application referencing a Licensed BMS Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its their successor provisions, or any similar provisions in a country any jurisdiction outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §§ 262(l)(2)), the remainder of this Section 6.9.9 7.11.7 shall apply. Such Party shall promptly, but in any event within [***] ([***]) Business Days, notify the other PartyParty of such Biosimilar Application. The owner of the relevant Patents shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary necessary, under 42 U.S.C. §§ 262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” ”, as defined in 42 U.S.C. §§ 262(l)(1)(A), for purposes of such Biosimilar Application: (a) [***] shall designate, to the extent permitted by Applicable Law, or [***], the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §§ 262(l)(1)(B)(ii). (b) In each case, after consulting with [***] and considering [***]’s ] comments in good faith, [***] shall have the right to (ai) list any patentsPatents, including those any Immatics Patents within the Prothena IPand Joint Patents, as required pursuant to 42 U.S.C. §§ 262(l)(3)(A) or 42 U.S.C. §§ 262(l)(7), (bii) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (ciii) identify Patents on such lists that are available under a license to the filer of the Biosimilar Application, (iv) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §§ 262(l)(1), and (dv) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §§ 262(l)(4), decide which Patent or Patents shall be selected for litigation under 42 U.S.C. §§ 262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §§ 262(l)(6). If Immatics is required pursuant to Applicable Law to execute any of these tasks, it shall do so in accordance with BMS’ instructions. (c) [***]] shall have the right to bring an action for declaratory judgment pursuant to 42 U.S.C. § 262(l)(9)(C) if the filer of the Biosimilar Application fails to provide any of the information required by 42 U.S.C. § 262(l)(2)(A) or otherwise fails to comply with any provision set forth in 42 U.S.C. § 262. (cd) [***] shall have the right, after consulting with [***], to identify Patents, including those any Immatics Patents within the Prothena IPand Joint Patents, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (b) in any other jurisdiction outside of the United States. If [***] is required pursuant to Applicable Law to execute any of these tasks, it shall do so in accordance with [***]. (de) [***] shall cooperate with [***]’s ] reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] shall consult with [***] prior to identifying any Immatics Patents within the Prothena IP or Joint Patents to a Third Party as contemplated by this Section 6.9.97.11.7. [***] shall consider in good faith advice and suggestions with respect thereto received from [***], ] and notify [***] of any such lists or communications promptly after they are made. (ef) Each Party shall notify the other Party within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §§ 262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §§ 262(l)(8)(B) and to file an action for infringement. If required pursuant to Applicable Law, upon [***] request, [***] shall assist in seeking such injunction or filing such infringement action after consulting with [***]. Except as otherwise provided in this Section 6.9.97.11.7, any such action shall be subject to the terms and conditions of Section 6.9.1 Sections 7.11.1 through 6.9.87.11.6. (fg) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 7.11.7 may apply with respect to Biosimilar Applications, either in the United States or elsewhere. In the event that If the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 7.11.7 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.97.11.7 in a manner to effectuate the intent of this Section 7.11.7. Notwithstanding the foregoing provisions of this Section 6.9.97.11.7, nothing in this Section 6.9.9 7.11.7 shall grant any rights to Prothena [***] with respect to any Celgene BMS Licensed IP.

Biosimilar Applications. Notwithstanding the foregoing provisions of this Section 6.9, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 6.9.9 shall apply. Such Party shall promptly, but in any event within [***] ([***]) Business Days, notify the other Party. The owner of the relevant Patents shall then CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application: (a) [***] the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii). (b) In each case, after consulting with [***] and considering [***]’s ] comments in good faith, [***] shall have the right to (a) list any patents, including those Patents within the Prothena IP, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents shall be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). [***]. (c) [***] shall have the right, after consulting with [***], to identify Patents, including those Patents within the Prothena IP, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (b) in any other jurisdiction outside of the United States. [***]. (d) [***] shall cooperate with [***]’s ] reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] shall consult with [***] prior to identifying any Patents within the Prothena IP to a Third Party as contemplated by this Section 6.9.9. [***] shall consider in good faith advice and suggestions with respect thereto received from [***], and notify [***] of any such lists or communications promptly after they are made. (e) Each Party shall within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. [***]. Except as otherwise provided in this Section 6.9.9, any such action shall be subject to the terms and conditions of Section 6.9.1 through 6.9.8. (f) The Parties recognize that procedures other than those set forth above in this Section 6.9.9 may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.9. Notwithstanding the CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. provisions of this Section 6.9.9, nothing in this Section 6.9.9 shall grant any rights to Prothena with respect to any Celgene IP.