Biosimilars or Interchangeables Sample Clauses
The 'Biosimilars or Interchangeables' clause defines how the agreement addresses the use, substitution, or reference to biosimilar or interchangeable biological products in relation to the original biologic covered by the contract. Typically, this clause clarifies whether biosimilars or interchangeable products can be substituted for the reference product in supply, reimbursement, or exclusivity arrangements, and may specify any restrictions or requirements for such substitution. Its core function is to provide clarity and manage expectations regarding the treatment of biosimilars or interchangeables, thereby reducing disputes and ensuring all parties understand their rights and obligations concerning these products.
Biosimilars or Interchangeables. 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 (such as in an instance described in Section 351(l)(9)(C) of the PHSA), either Party shall, 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 Biosimilar Application under Section 351(l)(1)(B)(iii) of the PHSA. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Application, (i) AbbVie shall have the first right to designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application and manufacturing information; (ii) AbbVie shall have the first right and discretion to list or not list any Patents insofar as they claim or cover the applicable Licensed Product or product which is the subject of the Biosimilar Application as required pursuant to Section 351 of the PHSA or related regulations or guidance, 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 of the PHSA or related regulations or guidance; and (iii) AbbVie shall have the first right to identify Patents or respond to communications under any equivalent or similar listing in any other jurisdiction in the Territory; provided, however, that if AbbVie does not take the foregoing actions promptly, then Receptos may do so. At the request of the Party taking such actions, the other Party shall (A) prepare such lists and make such responses with regard to Patents at the direction of the Party taking such actions, (B) provide to the Party taking such actions, within *** days of any request, all Information, including a correct and complete list of such Party’s Patents covering any Licensed Product, that is necessary or reasonably useful to enable the Party taking such actions to make such lists and communications with respect to such Party’s Patents, and (C) cooperate with reasonable requests in connection therewith, including meeting any submission deadl...