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 Public Health Service Act (“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)(C351(1)(9)(C) of the PHSA), either Party willshall, within [***]] Business Days, notify the other Party so that the other Party may Party. [***] will then 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 certification or notice in any other jurisdiction in the Territory naming a Licensed Productjurisdiction, either Party willshall, within [***]] Business Days, notify and provide the other Party with copies of such communication. Regardless of the Party party that is the “reference product sponsor” for purposes of such Biosimilar Application, : (Ai) GSK will [***] shall have the first right, after consulting with Surface, sole right to designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who will shall receive confidential access to the Biosimilar Application, ; (Bii) GSK will [***] shall have the first right, after consulting with Surface, sole right to (1) list any patents, including those of the [***], insofar as they claim or cover the applicable Licensed Patents, and any other Patent Rights, Product as required pursuant to Section 351(l)(3)(A351(l)(1)(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 other than that specified in Section 351(l) of the PHSA; and and (Ciii) GSK will [***] 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 Territoryjurisdiction. If GSK does not defend a given Patent Right within the Licensed Patents or Joint Patents under this Section 8.2(f)(iii) required pursuant to Applicable Law, [***] shall prepare such list and make such response at [***]’s direction. [***] will provide to [***], within [***] (days of [***]’s request, all information, including a correct and complete list of Patents of Selecta Licensed Technology that is necessary or reasonably useful to enable [***] to make such shorter period lists of time before Patents that cover the time limitapplicable Licensed Product, and cooperate with [***]’s reasonable requests in connection therewith, including meeting any [***] 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. submission deadlines, in each case, to the extent required or permitted by Applicable Law. [***] shall reasonably consult with [***] prior to identifying any Selecta Licensed Technology to a Third Party as contemplated by this Section 17.3. [***] 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. As provided in Section 17.1(b), if any, set forth in the appropriate Laws in the United States or any other country in the Territory to [***] does not waive any statutory rights), or elects not to continue any such defense (in which case it will promptly provide notice thereof to Surface)proceed under this Section 17.3, then Surface will thereafter [***] shall have the right (but not to proceed in place of [***] under this Section 17.3 with the obligation), at its sole discretion, to defend any such Patent Rightroles of the Parties reversed.

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. (i) 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 [***]ten (10) Business Days thereafter, 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 [***]ten (10) Business Days thereafter, notify and provide the other Party with copies of such communication. Regardless . (ii) Solely with respect to a Biosimilar Application referring to a Licensed Product in the Field, 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 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, (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 Patents, [***] and any other Patent RightsPatents, and to respond to communications under any equivalent or similar listing in any other jurisdiction in the TerritoryTerritory in accordance with Section 8.2(f). 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.]