Common use of Receipt of Application; Responsibilities Clause in Contracts

Receipt of Application; Responsibilities. 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 Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(l)(9)(C) of the PHSA), then either Party will, within [***] after receipt thereof, similarly notify the other Party so NVS 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 or notice in any other country in the Territory, either Party will, within [***] of receipt thereof, 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, NVS will have the sole right to manage and prosecute biosimilar litigation, including: (i) NVS will have the sole right to designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA in-house counsel who will receive confidential access to the Biosimilar Application, with the understanding that a representative of HMI, as patent owner of [***] will have the right to view confidential information related to the [***] disclosed under Section 351(l)(1)(B)(iii); (ii) NVS will have the sole right to list any Patent Rights, including [***] insofar as they Cover the applicable Product as required or desired pursuant to Applicable Law, to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for Information exchange than that specified in Section 351(l) of the PHSA; and (iii) NVS will have the sole right to identify Patent Rights or respond to communications under any equivalent or similar listing in any other country in the Territory. However, NVS will reasonably consult with HMI with respect to asserting and enforcing any [***] and will use reasonable efforts to accommodate HMI’s timely comments with respect to activities in connection with the assertion and enforcement of such [***]. If required pursuant to Applicable Law, HMI will prepare such lists and make such responses at NVS’ direction. HMI will: (A) provide to NVS, within [***] days of NVS’ request, all information, including a correct and complete list of [***] Covering any Product, that is [***] to enable NVS to make such lists and communications with respect to the [***]; and (B) cooperate with NVS’ reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by Applicable Law. NVS will: (1) reasonably consult with HMI prior to identifying any [***] to a Third Party as contemplated by this Section 12.6.5 (Biosimilar Litigation) and will consider in good faith HMI’s timely advice and suggestions with respect thereto; and (2) notify HMI of any such lists or communications promptly after they are made.