Common use of Biosimilar Applications Clause in Contracts

Biosimilar Applications. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA (a “Biosimilar Application”) naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (including by the receipt of information disclosed pursuant to Section 351(l)(2) of the PHSA, or in an instance described in Section 351(l)(9)(C) of the PHSA), either Party will, within [***], notify the other Party so that the other Party may seek permission to view the application and related confidential information from the filer of the Biosimilar Application under Section 351(l)(1)(B)(iii) of the PHSA. If either Party receives any equivalent or similar certification, information or notice in any other jurisdiction in the Territory naming a Licensed Product, either Party will, within [***], notify and provide the other Party with copies of such communication. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Application, (A) GSK will have the first right, after consulting with Surface, to 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, (B) GSK will have the first right, after consulting with Surface, to (1) list any Licensed Patents, and any other Patent Rights, as required pursuant to Section 351(l)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7) of the PHSA, (2) respond to any communications with respect to such lists from the filer of the Biosimilar Application, and (3) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange than that specified in Section 351(l) of the PHSA; and (C) GSK will have the first right, after consulting with Surface, to identify Licensed Patents and any other Patent Rights, and to respond to communications under any equivalent or similar listing in any other jurisdiction in the Territory. If GSK does not defend a given Patent Right within the Licensed Patents or Joint Patents under this Section 8.2(f)(iii) within [***] (or such shorter period of time before the time limit, if any, set forth in the appropriate Laws in the United States or any other country in the Territory to not waive any statutory rights), or elects not to continue any such defense (in which case it will promptly provide notice thereof to Surface), then Surface will have the right (but not the obligation), at its sole discretion, to defend any such Patent Right.

Biosimilar Applications. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA (a “Biosimilar Application”) naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (including by the receipt of information disclosed pursuant to Section 351(l)(2) of the PHSA, or such as in an instance described in Section 351(l)(9)(C) of the PHSA), either Party willshall, within [***†], notify the other Party so that the other Party may seek permission to view the application and related confidential information from the filer of the Biosimilar Application under Section 351(l)(1)(B)(iii) of the PHSA. If either Party receives any equivalent Biosimilar Application or similar certification, information or notice otherwise becomes aware that such an equivalent Biosimilar Application has been filed in any other jurisdiction in the Territory naming a Licensed ProductTerritory, either Party willshall, within [***†], notify and provide the other Party with copies of such communicationParty. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Application, (Aa) GSK will AbbVie shall have the first rightsole right to designate, after consulting with Surface, to designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA PHSA, the outside counsel and in-house counsel who will shall receive confidential access to the Biosimilar Application, ; (Bb) GSK will AbbVie shall have the first right, after consulting with Surface, sole right to (1) list any Licensed Patents, including Licensor Patents and any other Patent RightsJoint Patents, insofar as they claim or cover the applicable Licensed Product as required pursuant to Section 351(l)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7) of the PHSA, (2) to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and (3) to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange than that specified in Section 351(l) of the PHSA; and (Cc) GSK will AbbVie shall have the first right, after consulting with Surface, sole right to identify Licensed Patents and any other Patent Rights, and to or respond to communications under any equivalent or similar listing in any other jurisdiction in the Territory. If GSK does not defend required pursuant to Applicable Law, Licensor shall prepare such lists and make such responses at AbbVie’s direction. Licensor shall, upon AbbVie’s request, (i) timely provide to AbbVie all Information, including a given Patent Right within correct and complete list of Licensor Patents covering any Licensed Product, that is necessary or reasonably useful to enable AbbVie to make such lists and communications with respect to the Licensed Patents Licensor Patents, and (ii) cooperate with AbbVie’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or Joint Patents under permitted by Applicable Law. Notwithstanding anything to the contrary in this Section 8.2(f)(iii) within [***] (or such shorter period of time before the time limitAgreement, if any, set forth in the appropriate Laws in the United States or any other country in the Territory to not waive any statutory rights), or elects not to continue any such defense (in which case it will promptly provide notice thereof to Surface), then Surface will AbbVie shall have the right (sole right, but not the obligation), at its sole discretion, to defend prosecute, manage and settle any litigation with respect to any Biosimilar Application, and any Patent proceedings associated with the litigation with respect to such Patent RightBiosimilar Application, including any invalidity, unpatentability or unenforceability challenges, and any oppositions and post-grant proceedings directed to such Patents. Upon AbbVie’s request, Licensor shall cooperate with AbbVie’s reasonable requests in seeking an injunction against any commercial marketing by the filer of a Biosimilar Application as permitted pursuant to Section 351(l)(8)(B) of the PHSA.

Biosimilar Applications. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA or any analogous application submitted to any Regulatory Authority in a country outside the United States (a “Biosimilar Application”) naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (including by the receipt of information disclosed pursuant to Section 351(l)(2) of the PHSA, or in an instance described in Section 351(l)(9)(C) of the PHSA), either such Party will, within [***]] Business Days, notify the other Party so that the other Party may seek permission to view the application and related confidential information from the filer of the such Biosimilar Application under Section 351(l)(1)(B)(iii) of the PHSA. If either Party receives any equivalent or similar certification, information or notice in any other jurisdiction in the Territory naming a Licensed Product, either Party will, within [***], notify and provide the other Party with copies of such communication. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Application, (A) GSK Ultragenyx will have the first right, after consulting with Surface, right to (i) 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, (Bii) GSK will have the first right, after consulting with Surface, to (1A) list any Licensed Patents, and any other Patent RightsPatents, as required pursuant to Section 351(l)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7) of the PHSA, (2B) respond to any communications with respect to such lists from the filer of the Biosimilar Application, and (3C) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange than that specified in Section 351(l) of the PHSA; and (Ciii) GSK will have the first right, after consulting with Surface, to identify Licensed Patents and any other Patent RightsPatents, and to respond to communications under any equivalent or similar listing in any other jurisdiction in the Territory. If GSK Ultragenyx does not defend a given Patent Right within the Licensed Patents or Joint Patents under this Section 8.2(f)(iii7.2.4(c) within [***] days (or such shorter period of time before the time limit, if any, set forth in the appropriate Laws Applicable Law in the United States or any other country in the Territory to not waive any statutory rights), or elects not to continue any such defense (in which case it will promptly provide notice thereof to SurfaceAbeona), then Surface Abeona will have the right (right, but not the obligation), at its sole discretiondiscretion and expense, to defend any such Patent RightPatent.

Biosimilar Applications. Lilly shall have the first right, but not the 50 obligation, to prosecute and manage any litigation with respect to Generic/Biosimilar Equivalents involving [**] and any proceedings associated therewith, including any invalidity, unpatentability or unenforceability challenges, oppositions and post-grant proceedings in connection therewith. If either Party receives a notice or a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA or its foreign counterpart for a Generic/Biosimilar Equivalent (a “Biosimilar Application”) naming for which a Licensed Product is a “reference product” as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (including by the receipt of information disclosed pursuant to term is used in Section 351(l)(2351(i)(4) of the PHSA, or in an instance described in Section 351(l)(9)(C) of the PHSA)equivalent under its foreign counterpart, whether or not such notice or copy is provided under any Applicable Laws, either Party willshall, within [***], notify the other Party so that the other Party may seek permission to view the application and related confidential information from the filer of the Biosimilar Application under Section 351(l)(1)(B)(iii) of the PHSA. If either Party receives any equivalent or similar certification, information or notice in any other jurisdiction in the Territory naming a Licensed Product, either Party will, within [***], notify and provide the other Party with copies of such communicationnotice or communication to the extent permitted by Applicable Law. Regardless Xxxxx shall carry out any such rights and responsibilities of the Party that is the “reference product sponsor,” as defined in Section 351(l)(1)(A) of the PHSA, for purposes of such Biosimilar Application, (A) GSK will have the first right, after consulting with Surface, to designate pursuant to including bringing an action for patent infringement under Section 351(l)(1)(B)(ii351(l)(6) of the PHSA based on [**] Covering the outside counsel and in-house counsel who will receive confidential Generic/Biosimilar Equivalent. If requested by Lilly, Verve shall seek to obtain access to the Biosimilar ApplicationApplication and related confidential information, (Bincluding in accordance with Section 351(l)(1)(B)(iii) GSK will have of the first rightPHSA, after consulting with Surfaceif applicable. If permitted pursuant to Applicable Law, to (1) list any Licensed Patentsupon Xxxxx’x request, Verve shall assist Xxxxx in identifying and any other Patent Rights, as required listing [**] Patents pursuant to Section 351(l)(3)(A), Section 351(l)(5)(b)(i)(II), 351(l)(1)(3)(A) or Section 351(l)(7) of the PHSA, (2in preparing, pursuant to section 351(l)(3)(C) respond of the PHSA, a detailed statement regarding the reference product sponsor’s opinion that any such patent will be infringed and a response to any the statement by the filer of the Biosimilar Application concerning validity and enforceability, in negotiating with the filer of the Biosimilar Application pursuant to Section 351(l)(4) of the PHSA, and in selecting Patents for and conducting litigation pursuant to Section 351(l)(5), Section 351(l)(6), and Section 351(l)(9) of the PHSA, to the extent applicable, and shall cooperate with Lilly in responding to relevant communications with respect to such lists and statements from the filer of the Biosimilar Application. Upon Xxxxx’x request, and (3) negotiate with Xxxxx shall assist in seeking an injunction against any commercial marketing by the filer of the a Biosimilar Application as permitted pursuant to whether to utilize a different mechanism for information exchange than that specified in Section 351(l351(l)(8)(B) of the PHSA; and (C) GSK will have PHSA or in filing an action for infringement against the first rightfiler of such Biosimilar Application. Notwithstanding anything to the contrary, after consulting with Surface, to identify Licensed Patents and any other Patent Rights, and to respond to communications under any equivalent or similar listing in any other jurisdiction in the Territory. If GSK does not defend a given Patent Right within the Licensed Patents or Joint Patents under this Section 8.2(f)(iii) within 11.9.6 will not be construed to provide rights to enforce [**] other than a [**] (or such shorter period of time before unless otherwise agreed between the time limit, if any, set forth in Parties including with respect to the appropriate Laws in the United States or any other country in the Territory to not waive any statutory rights), or elects not to continue any such defense (in which case it will promptly provide notice thereof to Surface), then Surface will have the right (but not the obligation), at its sole discretion, to defend any such Patent Rightgood faith consideration contemplated under Section 11.9.2.