Biosimilars. If a Biosimilar Product is launched in a country and any such Biosimilar Product(s) collectively have more than [***] in such country then the royalty rates for such country will be reduced [***]. Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Kiniksa Pharmaceuticals, Ltd.
Biosimilars. Each Party shall promptly, but in any event no later than [***] Business Days after receipt of notice of such application, notify the other Party if it becomes aware of any application for regulatory approval of a biosimilar anywhere in the Territory where any Licensed Product is a reference product under such application. Mersana shall take the lead and be responsible for preparing and filing any responses with any Regulatory Authority and negotiating any patent resolution in connection with any such application as set forth in paragraphs 2 through 6 of Section 351(l) of the United States Public Health Service Act (42 U.S.C. § 262(l)(2)-(6)), or any foreign equivalent thereof and shall use Diligent Efforts in relation thereto. Recepta shall cooperate with Mersana’s reasonable requests for assistance in connection therewith.
Biosimilars. Each Party shall promptly, but in any event no later than [***] after receipt of notice of such application, notify the other Party if it becomes aware of any application for Regulatory Approval of any pharmaceutical product of a Third Party (excluding any Affiliate of Licensee or any Sublicensee (or their further sublicensees)) that relies on a Licensed Product as a Reference Product under the Biologics Price Competition and Innovation Act, or any comparable regulatory regime in any other country in the Territory, and (i) for which biosimilarity or interchangeability (as applicable) with such Licensed Product has been or is sought to be demonstrated and (ii) which seeks Regulatory Approval in such country relying in whole or in part on any data generated in support of a Regulatory Approval for such Licensed Product. Licensee shall take the lead and be responsible for preparing and filing any responses with any Regulatory Authority in the Territory, and each respective Party will be responsible for negotiating any patent resolution in connection with any such application as set forth in paragraphs 2 through 6 of Section 351(1) of the United States Public Health Service Act (42 U.S.C. § 262(1)(2)- (6)), or any foreign equivalent thereof. Each Party shall cooperate with the other Party’s reasonable requests for assistance in connection therewith.
Biosimilars. Each Party shall promptly, but in any event no later than ten (10) business days after receipt of notice of such application, notify the other Party if it becomes aware of any application for regulatory approval of a biosimilar anywhere in the Territory where any Licensed Product is a reference product under such application. Arcus shall take the lead and be responsible for preparing and filing any responses with any Regulatory Authority and negotiating any patent resolution in connection with any such application as set forth in paragraphs 2 through 6 of Section 351(l) of the United States Public Health Service Act (42 U.S.C. § 262(l)(2)-(6)), or any foreign equivalent thereof. Abmuno shall cooperate with Arcus’s reasonable requests for assistance in connection therewith.
Biosimilars. Without limiting Sections 11.4.1 through 11.4.6, in order to facilitate the intent of Sections 11.4.1 through 11.4.6, if either Party receives a copy or otherwise becomes aware of a Biosimilar Application under Section 351(l)(1)(B)(iii) of the PHSA (or other Applicable Law in the relevant jurisdiction) referencing a Licensed Product, the Parties shall coordinate in good faith with regard to any relevant Mersana Patent Rights, Licensee Patent Rights or Joint Patent Rights, in order to (i) allow access for both Parties, to the extent permitted under Section 351(l)(1)(B) and Section 351(l)(1)(C) of the PHSA, to those aspects of the Biosimilar Application relating to the Mersana Patent Rights, Licensee Patent Rights or Joint Patent Rights and related confidential information from the filer, (ii) coordinate regarding the designation pursuant to Section 351(l)(1)(B)(ii) of the PHSA of the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, (iii) agree regarding the listing of any Mersana Patent Rights, Licensee Patent Rights or Joint Patent Rights, as required pursuant to Section 351(l)(1)(3)(A) or Section 351(l)(7) of the PHSA, (iv) respond to [***] Portions of this exhibit have been redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. any communications with respect to such lists from the filer of the Biosimilar Application, (v) 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)(1) of the PHSA, (vi) allow the Party with the right to control such action under Sections 11.4.1 through 11.4.6 (such Party the “Controlling Party”) to make any decision regarding whether any Mersana Patent Rights, Licensee Patent Rights or Joint Patent Rights will be subject to the initial litigation procedure as described in Section 351(l)(1)(4), and (vii) allow the Controlling Party to decide whether to commence such litigation with respect to the Mersana Patent Rights, Licensee Patent Rights or Joint Patent Rights under Section 351(l)(1)(6), and take any equivalent or similar action with regard to any equivalent or similar listing with respect to the Mersana Patent Rights, Licensee Patent Rights or Joint Patent Rights. If required pursuant to Applicable Law, upon the Controlling Party’s request, the other Party shall execute ...
Biosimilars. Each Party shall promptly, but in any event no later than ten (10) business days after receipt of notice of such application, notify the other Party if it becomes aware of any application for regulatory approval of any pharmaceutical product of a third party (excluding any Arcus Affiliate, sublicensee (or their further sublicensees), related to this Agreement) that relies on such Licensed Product as a Reference Product under the Biologics Price Competition and Innovation Act, or any comparable regulatory regime in any other country in the Territory, and (i) for which biosimilarity or interchangeability (as applicable) with such Licensed Product has been or is sought to be demonstrated and (ii) which seeks regulatory approval in such country relying in whole or in part on any data generated in support of a Regulatory Approval for such Licensed Product. Arcus shall take the lead and be responsible for preparing and filing any responses with any Regulatory Authority in the Territory and WuXi shall take the lead and be responsible if in the Excluded Territory, and each respective Party will be responsible for negotiating any patent resolution in connection with any such application as set forth in paragraphs 2 through 6 of Section 351(l) of the United States Public Health Service Act (42 U.S.C. § 262(l)(2)-(6)), or any foreign equivalent thereof. Each Party shall cooperate with the other Party’s reasonable requests for assistance in connection therewith.
Biosimilars. Axovant shall be responsible for determining the strategy with respect to certifications, notices and patent enforcement procedures regarding Benitec Patents Covering any Compound or Licensed Product under the U.S. Food, Drug & Cosmetics Act and the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”). Benitec shall cooperate, as reasonably requested by Axovant, in a manner consistent with this Section. Benitec hereby authorizes Axovant to: (i) provide in any BLA or in connection with the BPCIA, a list of Benitec Patents as required under the BPCIA; (ii) except as otherwise expressly provided in this Agreement, exercise any rights exercisable by Axovant as an exclusive licensee under the BPCIA; and (iii) exercise any rights that may be exercisable by Axovant as reference product sponsor under the BPCIA, including (A) engaging in the Patent resolution provisions of the BPCIA with regard to Benitec Patents Covering any Compound or Licensed Product; and (B) determining which Patents will be the subject of an immediate Patent infringement action under 42 U.S.C. § 262(l)(6) of the BPCIA; provided that with respect to Axovant’s exercise of rights under the BPCIA, Axovant shall consult with a representative of Benitec designated by Benitec in writing and qualified to receive confidential information pursuant to § 262(l)(1) of the BPCIA with respect to Axovant’s exercise of any rights exercisable as reference product sponsor, including providing such representative with timely copies of material correspondence relating to such matters, providing such representative the opportunity, reasonably in advance of any related Axovant action, to comment thereon and to consult with and consider in good faith the requests and suggestions of Benitec with respect to such matters.
Biosimilars. Notwithstanding the provisions of Section 8.6 or Section 8.7, if either Party receives notice of any Biosimilar Application or a copy of a Biosimilar Application referencing a Biosimilar Product or a 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 otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for Marketing Approval (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 8.8 will apply. Such Party will promptly, but in any event within [***] Business Days, notify the other Party. [***] then will 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 will 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:
Biosimilars. [***] shall be responsible for determining the strategy with respect to certifications, notices and patent enforcement procedures regarding [***] under the U.S. Food, Drug & Cosmetics Act and the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”). [***] shall cooperate, as reasonably requested by [***] in a manner consistent with this Section 8.4(f) (Biosimilars). [***] hereby authorizes [***] to: (i) provide in any BLA or in connection with the BPCIA, a list of [***] as required under the BPCIA; (ii) [***]; and (iii) [***] including (A) [***]; and (B) [***]; provided that with respect to [***] exercise of rights under the BPCIA, [***] shall consult with a representative of [***] designated by [***] in writing and qualified to receive confidential information pursuant to § 262(l)(1) of the BPCIA with respect to [***] exercise of any rights exercisable as reference product sponsor, including providing such representative with timely copies of material correspondence relating to such matters, providing such representative the opportunity, reasonably in advance of any related [***] action, to comment thereon and to consult with and consider in good faith the requests and suggestions of [***] with respect to such matters.
Biosimilars. Licensee shall be responsible for determining the strategy with respect to certifications, notices and patent enforcement procedures regarding Licensor Patents Covering any Gene Therapy or Licensed Product under the U.S. Food, Drug & Cosmetics Act and the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”). Licensor hereby authorizes Licensee to: (i) provide in any BLA or in connection with the BPCIA, a list of Licensor Patents as required under the BPCIA; (ii) except as otherwise expressly provided in this Agreement, exercise any rights exercisable by Licensee as an exclusive licensee under the BPCIA; and (iii) exercise any rights that may be exercisable by Licensee as reference product sponsor under the BPCIA, including: (A) engaging in the Patent resolution provisions of the BPCIA with regard to Licensor Patents Covering any Gene Therapy or Licensed Product; and (B) determining which Patents will be the subject of an immediate Patent infringement action under 42 U.S.C. § 262(l)(6) of the BPCIA.
